Breast Cancer

Trastuzumab is significantly more effective alone or in combination with lapatinib than is lapatinib alone for the treatment of human epidermal growth factor receptor 2–positive breast cancer in patients receiving neoadjuvant chemotherapy, according to findings from two randomized phase III trials.

The studies – GeparQuinto and the NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial – underscore the value of testing new therapies in the neoadjuvant setting.

In the GeparQuinto trial, 30% of 307 HER2-positive patients treated with the anti-HER2 humanized monoclonal antibody trastuzumab had a pathological complete response, compared with only 23% of 308 HER2-positive patients treated with the tyrosine kinase inhibitor lapatinib, which targets both HER1 and HER2 (odds ratio, 0.68).

Although the patients randomized to receive trastuzumab had significantly more edema (39% vs. 29%) and dyspnea (30% vs. 21%), those randomized to receive lapatinib experienced significantly more diarrhea (75% vs. 47%) and skin rash (55% vs. 32%), and significantly more patients in the lapatinib group discontinued treatment (33% vs. 14%), Dr. Michael Untch and his colleagues reported in the Jan. 17 issue of the Lancet Oncology.

Women with previously untreated unilateral or bilateral primary invasive breast carcinoma were enrolled in the study between Nov. 7, 2007, and July 9, 2010, at 126 centers in Germany and 1 center in Switzerland. Patients were eligible for inclusion if they had locally advanced tumor stages cT3 or cT4, hormone receptor (HR)-negative tumors, or HR-positive tumors with clinically positive axillary nodes (cN+ for cT2) or pNSLN+ for cT1 disease (Lancet Oncol. 2012 Jan. 17 [doi:10.1016/S1470-2045(11)70397-7]).

They received neoadjuvant treatment including four cycles of epirubicin given at 90 mg/m² intravenously along with cyclophosphamide at a dose of 600 mg/m² intravenously, every 3 weeks, and four cycles of docetaxel at 100 mg/m² intravenously every 3 weeks, plus either trastuzumab or lapatinib throughout all cycles prior to surgery. Trastuzumab was given at a starting loading dose of 8 mg/kg and then at 6 mg/kg intravenously every 3 weeks; the lapatinib dose was 1,000-1,250 mg/day orally.

"Pathological complete response rates were significantly lower with lapatinib treatment than with trastuzumab, irrespective of the definitions of pathological complete response that were used. These results confirm the efficacy of a neoadjuvant regimen containing trastuzumab," wrote Dr. Untch, of Helios-Klinikum, Berlin-Buch, Berlin, and his colleagues from the German Breast Group and the Arbeitsgemeinschaft Gynäkologische Onkologie-Breast (AGO-B) Study Group.

The investigators noted that lapatinib may provide a lower pathological complete response because of a reduced ability to block the HER2 pathway, compared with trastuzumab. Also, trastuzumab may have additional antitumor efficacy "by inducing an immune response via antibody-derived cellular cytotoxicity," they wrote.

In addition to providing additional evidence of the feasibility – and low cardiac toxicity – of "exposing the tumor for as long as possible to the synergistic effect of chemotherapy and trastuzumab before surgery," these findings suggest lapatinib should not be used outside of clinical trials as single anti-HER2 treatment in patients undergoing neoadjuvant chemotherapy, the investigators concluded.

Indeed, these findings "should lead to the conclusion that this regimen [the combination of lapatinib with standard chemotherapy] does not seem to have any advantages compared with a standard trastuzumab-based regimen for the adjuvant treatment of HER2-positive, early-stage breast cancer," Dr. Stephen K. Chia of the British Columbia Cancer Agency, Vancouver, B.C., wrote in an accompanying editorial (Lancet Oncol. 2012 Jan. 17 [doi:10.106/S1470-2045(12)70013-X]).

Another lesson learned from the GeparQuinto trial, according to Dr. Chia, is that the preoperative setting, which the research community and patients "seem to have embraced as both standard of care therapy and as an important strategy to test new therapeutic regimens," is ideally suited for this purpose.

"Moving forward into the future, no adjuvant trials should be done without an adequate signal from preoperative trials showing safety, efficacy, target modulation, and, ideally, the identification of predictive biomarkers such that we no longer pick a loser to study in larger and more resource-intensive adjuvant trials," he said. Dr. Chia noted that the second study demonstrating improved efficacy of trastuzumab – NeoALTTO – is a good example of such a preoperative study supporting the rationale for adjuvant trials with the combination of these agents, in this case the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial, which is underway. The lapatinib group for ALTTO has been closed due to the demonstration of futility.

In NeoALTTO, which was published concomitantly with GeparQuinto in the Lancet, trastuzumab was more effective – although not significantly – than lapatinib alone for the treatment of HER2-positive breast cancer, but it was most effective in combination with lapatinib, Dr. José Baselga of Massachusetts General Hospital Cancer Center, Boston, and his colleagues from the NeoALTTO Study Team reported.

Pathological complete response in this parallel groups, open-label study, occurred in 51% of 152 patients in the combination treatment group, compared with 30% of the 149 patients in the trastuzumab group and 25% of the 154 patients in the lapatinib group, for an adjusted odds ratio of 2.6 for the combination vs. trastuzumab alone (Lancet 2012 Jan. 17 [doi:10.106/S0140-6736(11)61847-3]).

As in the GeparQuinto Trial, no major cardiac dysfunction occurred, and diarrhea was more frequent in the patients receiving lapatinib (23% and 21% of those in the lapatinib and combination groups, respectively, vs. 2% in the trastuzumab group who had grade 3 diarrhea).

NeoALTTO participants were enrolled between Jan. 5, 2008, and May 27, 2010, at 86 sites in 23 countries. Participants had histologically confirmed invasive HER2-positive breast cancer with tumors at least 2 cm in diameter. Lapatinib was given at 1,500 mg orally to those in the lapatinib-only group, and at 1,000 mg for those in the combination group; trastuzumab was given at a loading dose of 4 mg/m² followed by 2 mg/kg on subsequent doses for both groups.

The anti-HER2 treatments were given alone for 6 weeks, and paclitaxel at 80 mg/m² weekly was then added for an additional 12 weeks.

"Dual targeting of HER2-positive tumors with trastuzumab and lapatinib is undertaken because of primary and acquired resistance to both agents, their partly non-overlapping mechanisms of action, and the well characterized synergistic interaction between them in HER2 breast-cancer models," the investigators noted.

These findings provide proof of concept that dual inhibition of HER2 is better than a single-agent approach, Dr. Baselga and his colleagues said, noting that the higher pathological complete response rate for the combination was clear across all subgroups tested, which is consistent with the findings from other studies of anti-HER2 treatment in HER2-positive tumors.

"Our study also supports investigation of novel targeted agents for breast cancer in the neoadjuvant setting, when tumors have not yet acquired resistance to therapy and when chances of clinical benefit are highest," they said.

GeparQuinto was funded by GlaxoSmithKline, Roche, and Sanofi-Aventis; lapatinib was provided free of charge. Dr. Untch said he had no relevant financial disclosures, but several other GeparQuinto investigators made financial disclosures relating to these and other pharmaceutical companies. The NeoALTTO trial was funded by GlaxoSmithKline. Dr. Baselga said he has received honoraria from Roche, and his institution has received funding from GlaxoSmithKline and Roche. Several other NeoALTTO investigators made financial disclosures involving GlaxoSmithKline and/or other pharmaceutical companies. Dr. Chia, the author of the editorial that accompanied the article in the Lancet Oncology on the GeparQuinto trial, disclosed that he has received honoraria from GlaxoSmithKline, manufacturer of lapatinib, and F. Hoffmann-La Roche, manufacturer of trastuzumab, as well as an unrestricted research grant from Hoffmann-La Roche.

Trastuzumab is significantly more effective alone or in combination with lapatinib than is lapatinib alone for the treatment of human epidermal growth factor receptor 2–positive breast cancer in patients receiving neoadjuvant chemotherapy, according to findings from two randomized phase III trials.

The studies – GeparQuinto and the NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial – underscore the value of testing new therapies in the neoadjuvant setting.

In the GeparQuinto trial, 30% of 307 HER2-positive patients treated with the anti-HER2 humanized monoclonal antibody trastuzumab had a pathological complete response, compared with only 23% of 308 HER2-positive patients treated with the tyrosine kinase inhibitor lapatinib, which targets both HER1 and HER2 (odds ratio, 0.68).

Although the patients randomized to receive trastuzumab had significantly more edema (39% vs. 29%) and dyspnea (30% vs. 21%), those randomized to receive lapatinib experienced significantly more diarrhea (75% vs. 47%) and skin rash (55% vs. 32%), and significantly more patients in the lapatinib group discontinued treatment (33% vs. 14%), Dr. Michael Untch and his colleagues reported in the Jan. 17 issue of the Lancet Oncology.

Women with previously untreated unilateral or bilateral primary invasive breast carcinoma were enrolled in the study between Nov. 7, 2007, and July 9, 2010, at 126 centers in Germany and 1 center in Switzerland. Patients were eligible for inclusion if they had locally advanced tumor stages cT3 or cT4, hormone receptor (HR)-negative tumors, or HR-positive tumors with clinically positive axillary nodes (cN+ for cT2) or pNSLN+ for cT1 disease (Lancet Oncol. 2012 Jan. 17 [doi:10.1016/S1470-2045(11)70397-7]).

They received neoadjuvant treatment including four cycles of epirubicin given at 90 mg/m² intravenously along with cyclophosphamide at a dose of 600 mg/m² intravenously, every 3 weeks, and four cycles of docetaxel at 100 mg/m² intravenously every 3 weeks, plus either trastuzumab or lapatinib throughout all cycles prior to surgery. Trastuzumab was given at a starting loading dose of 8 mg/kg and then at 6 mg/kg intravenously every 3 weeks; the lapatinib dose was 1,000-1,250 mg/day orally.

"Pathological complete response rates were significantly lower with lapatinib treatment than with trastuzumab, irrespective of the definitions of pathological complete response that were used. These results confirm the efficacy of a neoadjuvant regimen containing trastuzumab," wrote Dr. Untch, of Helios-Klinikum, Berlin-Buch, Berlin, and his colleagues from the German Breast Group and the Arbeitsgemeinschaft Gynäkologische Onkologie-Breast (AGO-B) Study Group.

The investigators noted that lapatinib may provide a lower pathological complete response because of a reduced ability to block the HER2 pathway, compared with trastuzumab. Also, trastuzumab may have additional antitumor efficacy "by inducing an immune response via antibody-derived cellular cytotoxicity," they wrote.

In addition to providing additional evidence of the feasibility – and low cardiac toxicity – of "exposing the tumor for as long as possible to the synergistic effect of chemotherapy and trastuzumab before surgery," these findings suggest lapatinib should not be used outside of clinical trials as single anti-HER2 treatment in patients undergoing neoadjuvant chemotherapy, the investigators concluded.

Indeed, these findings "should lead to the conclusion that this regimen [the combination of lapatinib with standard chemotherapy] does not seem to have any advantages compared with a standard trastuzumab-based regimen for the adjuvant treatment of HER2-positive, early-stage breast cancer," Dr. Stephen K. Chia of the British Columbia Cancer Agency, Vancouver, B.C., wrote in an accompanying editorial (Lancet Oncol. 2012 Jan. 17 [doi:10.106/S1470-2045(12)70013-X]).

Another lesson learned from the GeparQuinto trial, according to Dr. Chia, is that the preoperative setting, which the research community and patients "seem to have embraced as both standard of care therapy and as an important strategy to test new therapeutic regimens," is ideally suited for this purpose.

"Moving forward into the future, no adjuvant trials should be done without an adequate signal from preoperative trials showing safety, efficacy, target modulation, and, ideally, the identification of predictive biomarkers such that we no longer pick a loser to study in larger and more resource-intensive adjuvant trials," he said. Dr. Chia noted that the second study demonstrating improved efficacy of trastuzumab – NeoALTTO – is a good example of such a preoperative study supporting the rationale for adjuvant trials with the combination of these agents, in this case the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial, which is underway. The lapatinib group for ALTTO has been closed due to the demonstration of futility.

In NeoALTTO, which was published concomitantly with GeparQuinto in the Lancet, trastuzumab was more effective – although not significantly – than lapatinib alone for the treatment of HER2-positive breast cancer, but it was most effective in combination with lapatinib, Dr. José Baselga of Massachusetts General Hospital Cancer Center, Boston, and his colleagues from the NeoALTTO Study Team reported.

Pathological complete response in this parallel groups, open-label study, occurred in 51% of 152 patients in the combination treatment group, compared with 30% of the 149 patients in the trastuzumab group and 25% of the 154 patients in the lapatinib group, for an adjusted odds ratio of 2.6 for the combination vs. trastuzumab alone (Lancet 2012 Jan. 17 [doi:10.106/S0140-6736(11)61847-3]).

As in the GeparQuinto Trial, no major cardiac dysfunction occurred, and diarrhea was more frequent in the patients receiving lapatinib (23% and 21% of those in the lapatinib and combination groups, respectively, vs. 2% in the trastuzumab group who had grade 3 diarrhea).

NeoALTTO participants were enrolled between Jan. 5, 2008, and May 27, 2010, at 86 sites in 23 countries. Participants had histologically confirmed invasive HER2-positive breast cancer with tumors at least 2 cm in diameter. Lapatinib was given at 1,500 mg orally to those in the lapatinib-only group, and at 1,000 mg for those in the combination group; trastuzumab was given at a loading dose of 4 mg/m² followed by 2 mg/kg on subsequent doses for both groups.

The anti-HER2 treatments were given alone for 6 weeks, and paclitaxel at 80 mg/m² weekly was then added for an additional 12 weeks.

"Dual targeting of HER2-positive tumors with trastuzumab and lapatinib is undertaken because of primary and acquired resistance to both agents, their partly non-overlapping mechanisms of action, and the well characterized synergistic interaction between them in HER2 breast-cancer models," the investigators noted.

These findings provide proof of concept that dual inhibition of HER2 is better than a single-agent approach, Dr. Baselga and his colleagues said, noting that the higher pathological complete response rate for the combination was clear across all subgroups tested, which is consistent with the findings from other studies of anti-HER2 treatment in HER2-positive tumors.

"Our study also supports investigation of novel targeted agents for breast cancer in the neoadjuvant setting, when tumors have not yet acquired resistance to therapy and when chances of clinical benefit are highest," they said.

GeparQuinto was funded by GlaxoSmithKline, Roche, and Sanofi-Aventis; lapatinib was provided free of charge. Dr. Untch said he had no relevant financial disclosures, but several other GeparQuinto investigators made financial disclosures relating to these and other pharmaceutical companies. The NeoALTTO trial was funded by GlaxoSmithKline. Dr. Baselga said he has received honoraria from Roche, and his institution has received funding from GlaxoSmithKline and Roche. Several other NeoALTTO investigators made financial disclosures involving GlaxoSmithKline and/or other pharmaceutical companies. Dr. Chia, the author of the editorial that accompanied the article in the Lancet Oncology on the GeparQuinto trial, disclosed that he has received honoraria from GlaxoSmithKline, manufacturer of lapatinib, and F. Hoffmann-La Roche, manufacturer of trastuzumab, as well as an unrestricted research grant from Hoffmann-La Roche.

Trastuzumab is significantly more effective alone or in combination with lapatinib than is lapatinib alone for the treatment of human epidermal growth factor receptor 2–positive breast cancer in patients receiving neoadjuvant chemotherapy, according to findings from two randomized phase III trials.

The studies – GeparQuinto and the NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial – underscore the value of testing new therapies in the neoadjuvant setting.

In the GeparQuinto trial, 30% of 307 HER2-positive patients treated with the anti-HER2 humanized monoclonal antibody trastuzumab had a pathological complete response, compared with only 23% of 308 HER2-positive patients treated with the tyrosine kinase inhibitor lapatinib, which targets both HER1 and HER2 (odds ratio, 0.68).

Although the patients randomized to receive trastuzumab had significantly more edema (39% vs. 29%) and dyspnea (30% vs. 21%), those randomized to receive lapatinib experienced significantly more diarrhea (75% vs. 47%) and skin rash (55% vs. 32%), and significantly more patients in the lapatinib group discontinued treatment (33% vs. 14%), Dr. Michael Untch and his colleagues reported in the Jan. 17 issue of the Lancet Oncology.

Women with previously untreated unilateral or bilateral primary invasive breast carcinoma were enrolled in the study between Nov. 7, 2007, and July 9, 2010, at 126 centers in Germany and 1 center in Switzerland. Patients were eligible for inclusion if they had locally advanced tumor stages cT3 or cT4, hormone receptor (HR)-negative tumors, or HR-positive tumors with clinically positive axillary nodes (cN+ for cT2) or pNSLN+ for cT1 disease (Lancet Oncol. 2012 Jan. 17 [doi:10.1016/S1470-2045(11)70397-7]).

They received neoadjuvant treatment including four cycles of epirubicin given at 90 mg/m² intravenously along with cyclophosphamide at a dose of 600 mg/m² intravenously, every 3 weeks, and four cycles of docetaxel at 100 mg/m² intravenously every 3 weeks, plus either trastuzumab or lapatinib throughout all cycles prior to surgery. Trastuzumab was given at a starting loading dose of 8 mg/kg and then at 6 mg/kg intravenously every 3 weeks; the lapatinib dose was 1,000-1,250 mg/day orally.

"Pathological complete response rates were significantly lower with lapatinib treatment than with trastuzumab, irrespective of the definitions of pathological complete response that were used. These results confirm the efficacy of a neoadjuvant regimen containing trastuzumab," wrote Dr. Untch, of Helios-Klinikum, Berlin-Buch, Berlin, and his colleagues from the German Breast Group and the Arbeitsgemeinschaft Gynäkologische Onkologie-Breast (AGO-B) Study Group.

The investigators noted that lapatinib may provide a lower pathological complete response because of a reduced ability to block the HER2 pathway, compared with trastuzumab. Also, trastuzumab may have additional antitumor efficacy "by inducing an immune response via antibody-derived cellular cytotoxicity," they wrote.

In addition to providing additional evidence of the feasibility – and low cardiac toxicity – of "exposing the tumor for as long as possible to the synergistic effect of chemotherapy and trastuzumab before surgery," these findings suggest lapatinib should not be used outside of clinical trials as single anti-HER2 treatment in patients undergoing neoadjuvant chemotherapy, the investigators concluded.

Indeed, these findings "should lead to the conclusion that this regimen [the combination of lapatinib with standard chemotherapy] does not seem to have any advantages compared with a standard trastuzumab-based regimen for the adjuvant treatment of HER2-positive, early-stage breast cancer," Dr. Stephen K. Chia of the British Columbia Cancer Agency, Vancouver, B.C., wrote in an accompanying editorial (Lancet Oncol. 2012 Jan. 17 [doi:10.106/S1470-2045(12)70013-X]).

Another lesson learned from the GeparQuinto trial, according to Dr. Chia, is that the preoperative setting, which the research community and patients "seem to have embraced as both standard of care therapy and as an important strategy to test new therapeutic regimens," is ideally suited for this purpose.

"Moving forward into the future, no adjuvant trials should be done without an adequate signal from preoperative trials showing safety, efficacy, target modulation, and, ideally, the identification of predictive biomarkers such that we no longer pick a loser to study in larger and more resource-intensive adjuvant trials," he said. Dr. Chia noted that the second study demonstrating improved efficacy of trastuzumab – NeoALTTO – is a good example of such a preoperative study supporting the rationale for adjuvant trials with the combination of these agents, in this case the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial, which is underway. The lapatinib group for ALTTO has been closed due to the demonstration of futility.

In NeoALTTO, which was published concomitantly with GeparQuinto in the Lancet, trastuzumab was more effective – although not significantly – than lapatinib alone for the treatment of HER2-positive breast cancer, but it was most effective in combination with lapatinib, Dr. José Baselga of Massachusetts General Hospital Cancer Center, Boston, and his colleagues from the NeoALTTO Study Team reported.

Pathological complete response in this parallel groups, open-label study, occurred in 51% of 152 patients in the combination treatment group, compared with 30% of the 149 patients in the trastuzumab group and 25% of the 154 patients in the lapatinib group, for an adjusted odds ratio of 2.6 for the combination vs. trastuzumab alone (Lancet 2012 Jan. 17 [doi:10.106/S0140-6736(11)61847-3]).

As in the GeparQuinto Trial, no major cardiac dysfunction occurred, and diarrhea was more frequent in the patients receiving lapatinib (23% and 21% of those in the lapatinib and combination groups, respectively, vs. 2% in the trastuzumab group who had grade 3 diarrhea).

NeoALTTO participants were enrolled between Jan. 5, 2008, and May 27, 2010, at 86 sites in 23 countries. Participants had histologically confirmed invasive HER2-positive breast cancer with tumors at least 2 cm in diameter. Lapatinib was given at 1,500 mg orally to those in the lapatinib-only group, and at 1,000 mg for those in the combination group; trastuzumab was given at a loading dose of 4 mg/m² followed by 2 mg/kg on subsequent doses for both groups.

The anti-HER2 treatments were given alone for 6 weeks, and paclitaxel at 80 mg/m² weekly was then added for an additional 12 weeks.

"Dual targeting of HER2-positive tumors with trastuzumab and lapatinib is undertaken because of primary and acquired resistance to both agents, their partly non-overlapping mechanisms of action, and the well characterized synergistic interaction between them in HER2 breast-cancer models," the investigators noted.

These findings provide proof of concept that dual inhibition of HER2 is better than a single-agent approach, Dr. Baselga and his colleagues said, noting that the higher pathological complete response rate for the combination was clear across all subgroups tested, which is consistent with the findings from other studies of anti-HER2 treatment in HER2-positive tumors.

"Our study also supports investigation of novel targeted agents for breast cancer in the neoadjuvant setting, when tumors have not yet acquired resistance to therapy and when chances of clinical benefit are highest," they said.

GeparQuinto was funded by GlaxoSmithKline, Roche, and Sanofi-Aventis; lapatinib was provided free of charge. Dr. Untch said he had no relevant financial disclosures, but several other GeparQuinto investigators made financial disclosures relating to these and other pharmaceutical companies. The NeoALTTO trial was funded by GlaxoSmithKline. Dr. Baselga said he has received honoraria from Roche, and his institution has received funding from GlaxoSmithKline and Roche. Several other NeoALTTO investigators made financial disclosures involving GlaxoSmithKline and/or other pharmaceutical companies. Dr. Chia, the author of the editorial that accompanied the article in the Lancet Oncology on the GeparQuinto trial, disclosed that he has received honoraria from GlaxoSmithKline, manufacturer of lapatinib, and F. Hoffmann-La Roche, manufacturer of trastuzumab, as well as an unrestricted research grant from Hoffmann-La Roche.

Catch up with what you missed as we count down the 10 most-read stories on OncologyReport.com last year.

10. Everolimus Posts Big Win in ER-Positive Breast Cancer By Patrice Wendling
This first report of the BOLERO-2 trial -- a potential practice changer -- came out of the European Multidisciplinary Cancer Congress in Stockholm.

Courtesy flickr user woodleywonderworks (Creative Commons)

9. Multimodal DCIS Therapy, Tamoxifen Cuts Breast Cancer Deaths By Neil Osterweil
A meta-analysis from Australia found that adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ. It was presented at the American Society of Radiation Oncology (ASTRO) meeitng in Miami Beach.

8. Crizotinib Approval Personalizes Lung Cancer Therapy By Miriam E. Tucker
The swift approval of crizotinib capsules by the Food and Drug Administration as the first and only targeted therapy for locally advanced or metastatic ALK-positive non–small cell lung cancer represented another milestone in biomarker-driven, personalized medicine. Crizotinib was approved, along with a companion diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, which identifies the anaplastic lymphoma kinase (ALK) fusion gene that the drug targets.

7. Clinicians Slow to Embrace Sipuleucel-T for Prostate Cancer By Diana Mahoney
Most physicians have strong opinions on sipuleucel-T, including dubbing its approval "a milestone in the history of oncology," but many of them refused to speak about it on the record. Our persistent reporter found the reasons for their reluctance to use the first cancer vaccine went beyond reimbursement issues belabored in the financial press.

6. Drug Shortages Increasingly Take Toll on Care By Elizabeth Mechcatie
With their increasing prevalence, drug shortages in the United States have led to delays in treatment, forced the use of less effective alternatives, and encouraged a burgeoning gray market that sells tough-to-obtain medications at highly inflated prices, according to stakeholders gathered at a recent Food and Drug Administration meeting.

5. Practice Changers Expected at San Antonio Breast Cancer Symposium By Jane Salodof MacNeil
The 2011 San Antonio Breast Cancer Symposium featured a hefty number of studies that could change clinical practice. One of the most exciting SABCS meetings in recent years, it featured the phase III BOLERO-2 and CLEOPATRA trials, a new Oncotype DX assay for ductal carcinoma in situ, reports from four bisphosphonate trials, and a controversial brachytherapy study.

4. FDA Approves Brentuximab for Two Lymphomas By Elizabeth Mechcatie
The Food and Drug Administration on Aug. 19 gave an accelerated approval to brentuximab, a CD30-directed antibody drug-conjugate, for the treatment of Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, after other treatments have failed.

3. FDA Approves Vemurafenib for Advanced Melanoma By Jane Salodof MacNeil
The Food and Drug Administration announced on August 17 the approval of vemurafenib, a highly anticipated metastatic melanoma therapy that targets the BRAF V600E mutation found in 40%-60% of patients. It also approved the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic test designed to help determine whether a patient’s melanoma cells carry the BRAF V600E mutation.

2. Novel Therapies Put Multiple Myeloma 'On the Ropes' By Susan London
A sweep of new agents are poised to deliver what could be a knock-out blow to multiple myeloma, according to the director of the myeloma program at the University of California, San Francisco. Some are second- or third-generation agents in a mainstay class that appear to have less toxicity than and/or overcome resistance to their predecessors, Dr. Jeffrey L. Wolf said at the annual Oncology Congress in San Francisco. Others come from classes not previously used in this disease.

1. NICE Rejects Ipilimumab by Jennie Smith
A drug considered a breakthrough treatment for advanced melanoma was turned down by England’s clinical and cost-effectiveness agency. The National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy). The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab.

Did you miss any of last year's top reads in oncology? Click here to receive our weekly e-newsletter.

Catch up with what you missed as we count down the 10 most-read stories on OncologyReport.com last year.

10. Everolimus Posts Big Win in ER-Positive Breast Cancer By Patrice Wendling
This first report of the BOLERO-2 trial -- a potential practice changer -- came out of the European Multidisciplinary Cancer Congress in Stockholm.

Courtesy flickr user woodleywonderworks (Creative Commons)

9. Multimodal DCIS Therapy, Tamoxifen Cuts Breast Cancer Deaths By Neil Osterweil
A meta-analysis from Australia found that adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ. It was presented at the American Society of Radiation Oncology (ASTRO) meeitng in Miami Beach.

8. Crizotinib Approval Personalizes Lung Cancer Therapy By Miriam E. Tucker
The swift approval of crizotinib capsules by the Food and Drug Administration as the first and only targeted therapy for locally advanced or metastatic ALK-positive non–small cell lung cancer represented another milestone in biomarker-driven, personalized medicine. Crizotinib was approved, along with a companion diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, which identifies the anaplastic lymphoma kinase (ALK) fusion gene that the drug targets.

7. Clinicians Slow to Embrace Sipuleucel-T for Prostate Cancer By Diana Mahoney
Most physicians have strong opinions on sipuleucel-T, including dubbing its approval "a milestone in the history of oncology," but many of them refused to speak about it on the record. Our persistent reporter found the reasons for their reluctance to use the first cancer vaccine went beyond reimbursement issues belabored in the financial press.

6. Drug Shortages Increasingly Take Toll on Care By Elizabeth Mechcatie
With their increasing prevalence, drug shortages in the United States have led to delays in treatment, forced the use of less effective alternatives, and encouraged a burgeoning gray market that sells tough-to-obtain medications at highly inflated prices, according to stakeholders gathered at a recent Food and Drug Administration meeting.

5. Practice Changers Expected at San Antonio Breast Cancer Symposium By Jane Salodof MacNeil
The 2011 San Antonio Breast Cancer Symposium featured a hefty number of studies that could change clinical practice. One of the most exciting SABCS meetings in recent years, it featured the phase III BOLERO-2 and CLEOPATRA trials, a new Oncotype DX assay for ductal carcinoma in situ, reports from four bisphosphonate trials, and a controversial brachytherapy study.

4. FDA Approves Brentuximab for Two Lymphomas By Elizabeth Mechcatie
The Food and Drug Administration on Aug. 19 gave an accelerated approval to brentuximab, a CD30-directed antibody drug-conjugate, for the treatment of Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, after other treatments have failed.

3. FDA Approves Vemurafenib for Advanced Melanoma By Jane Salodof MacNeil
The Food and Drug Administration announced on August 17 the approval of vemurafenib, a highly anticipated metastatic melanoma therapy that targets the BRAF V600E mutation found in 40%-60% of patients. It also approved the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic test designed to help determine whether a patient’s melanoma cells carry the BRAF V600E mutation.

2. Novel Therapies Put Multiple Myeloma 'On the Ropes' By Susan London
A sweep of new agents are poised to deliver what could be a knock-out blow to multiple myeloma, according to the director of the myeloma program at the University of California, San Francisco. Some are second- or third-generation agents in a mainstay class that appear to have less toxicity than and/or overcome resistance to their predecessors, Dr. Jeffrey L. Wolf said at the annual Oncology Congress in San Francisco. Others come from classes not previously used in this disease.

1. NICE Rejects Ipilimumab by Jennie Smith
A drug considered a breakthrough treatment for advanced melanoma was turned down by England’s clinical and cost-effectiveness agency. The National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy). The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab.

Did you miss any of last year's top reads in oncology? Click here to receive our weekly e-newsletter.

Catch up with what you missed as we count down the 10 most-read stories on OncologyReport.com last year.

10. Everolimus Posts Big Win in ER-Positive Breast Cancer By Patrice Wendling
This first report of the BOLERO-2 trial -- a potential practice changer -- came out of the European Multidisciplinary Cancer Congress in Stockholm.

Courtesy flickr user woodleywonderworks (Creative Commons)

9. Multimodal DCIS Therapy, Tamoxifen Cuts Breast Cancer Deaths By Neil Osterweil
A meta-analysis from Australia found that adding radiotherapy and tamoxifen to breast-conserving surgery significantly reduces the local recurrence rate and the breast cancer–specific death rate in women with ductal carcinoma in situ. It was presented at the American Society of Radiation Oncology (ASTRO) meeitng in Miami Beach.

8. Crizotinib Approval Personalizes Lung Cancer Therapy By Miriam E. Tucker
The swift approval of crizotinib capsules by the Food and Drug Administration as the first and only targeted therapy for locally advanced or metastatic ALK-positive non–small cell lung cancer represented another milestone in biomarker-driven, personalized medicine. Crizotinib was approved, along with a companion diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, which identifies the anaplastic lymphoma kinase (ALK) fusion gene that the drug targets.

7. Clinicians Slow to Embrace Sipuleucel-T for Prostate Cancer By Diana Mahoney
Most physicians have strong opinions on sipuleucel-T, including dubbing its approval "a milestone in the history of oncology," but many of them refused to speak about it on the record. Our persistent reporter found the reasons for their reluctance to use the first cancer vaccine went beyond reimbursement issues belabored in the financial press.

6. Drug Shortages Increasingly Take Toll on Care By Elizabeth Mechcatie
With their increasing prevalence, drug shortages in the United States have led to delays in treatment, forced the use of less effective alternatives, and encouraged a burgeoning gray market that sells tough-to-obtain medications at highly inflated prices, according to stakeholders gathered at a recent Food and Drug Administration meeting.

5. Practice Changers Expected at San Antonio Breast Cancer Symposium By Jane Salodof MacNeil
The 2011 San Antonio Breast Cancer Symposium featured a hefty number of studies that could change clinical practice. One of the most exciting SABCS meetings in recent years, it featured the phase III BOLERO-2 and CLEOPATRA trials, a new Oncotype DX assay for ductal carcinoma in situ, reports from four bisphosphonate trials, and a controversial brachytherapy study.

4. FDA Approves Brentuximab for Two Lymphomas By Elizabeth Mechcatie
The Food and Drug Administration on Aug. 19 gave an accelerated approval to brentuximab, a CD30-directed antibody drug-conjugate, for the treatment of Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, after other treatments have failed.

3. FDA Approves Vemurafenib for Advanced Melanoma By Jane Salodof MacNeil
The Food and Drug Administration announced on August 17 the approval of vemurafenib, a highly anticipated metastatic melanoma therapy that targets the BRAF V600E mutation found in 40%-60% of patients. It also approved the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic test designed to help determine whether a patient’s melanoma cells carry the BRAF V600E mutation.

2. Novel Therapies Put Multiple Myeloma 'On the Ropes' By Susan London
A sweep of new agents are poised to deliver what could be a knock-out blow to multiple myeloma, according to the director of the myeloma program at the University of California, San Francisco. Some are second- or third-generation agents in a mainstay class that appear to have less toxicity than and/or overcome resistance to their predecessors, Dr. Jeffrey L. Wolf said at the annual Oncology Congress in San Francisco. Others come from classes not previously used in this disease.

1. NICE Rejects Ipilimumab by Jennie Smith
A drug considered a breakthrough treatment for advanced melanoma was turned down by England’s clinical and cost-effectiveness agency. The National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy). The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab.

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SAN ANTONIO – Total skin-sparing mastectomy with complete preservation of the breast skin envelope was associated with favorable oncologic and ischemic outcomes in a large, high-risk cohort of women who underwent the procedure over a 10-year period in San Francisco, a study has shown.

The findings suggest that the surgery, which produces superior cosmesis and is associated with a high rate of patient satisfaction, is a reasonable option for many women facing therapeutic or prophylactic mastectomy, Dr. Anne G. Warren Peled said at the San Antonio Breast Cancer Symposium.

The total skin-sparing mastectomy (TSSM) allows preservation of the nipple-areola dermal layer when ductal tissue is removed during mastectomy. "The procedure is increasingly offered to women for both therapeutic and prophylactic indications, and when combined with immediate breast reconstruction, can produce excellent aesthetic results," explained Dr. Warren Peled, a surgical resident at the University of California, San Francisco.

Because the oncologic safety of the procedure and the potential for higher rates of postoperative complications continue to be debated, Dr. Warren Peled and her colleagues sought to evaluate both outcomes using data collected in a prospectively maintained database. The investigators analyzed patient and tumor characteristics, treatment details, and the development of any postoperative complications, as well as local or distant recurrences, for 428 patients (mean age, 46.9 years) who underwent 657 TSSMs and immediate breast reconstruction at the UCSF Medical Center in 2001-2010.

"The mastectomy incisions included radial, lateral, periareolar, and inframammary incisions, and the areolar and nipple complex tissue was separated from the dermal layer of skin by sharp dissection with inversion of the nipple skin to ensure the removal of all of the nipple duct tissue," Dr. Warren Peled said during a poster discussion. Of the 657 mastectomies, 412 were therapeutic procedures, and 245 (58 bilateral and 187 contralateral) were prophylactic, she said.

Most of the tumors were stage 0 (111) or stage I (135), although stage II (95), III (48), and IV (7) tumors were also observed, Dr. Warren Peled reported. Some 14 mastectomies were for recurrent cancer, she noted. In addition, 210 patients underwent neoadjuvant chemotherapy, 144 had postmastectomy radiation therapy, and 78 had adjuvant chemotherapy, she said.

With respect to nipple involvement on pathological analysis, 11 specimens had evidence of in situ cancer and 9 had evidence of invasive cancer, leading to re-excision in 7 cases, removal of the nipple-areolar complex (NAC) in 9 cases, and NAC radiation in 4 cases, said Dr. Warren Peled.

The conventional, two-stage, expander-implant method – in which a tissue expander placed under the chest muscle is implanted and gradually inflated to expand the tissue in preparation for the synthetic implant 3-6 months later – was used in 80% of the postmastectomy reconstructions, Dr. Warren Peled said. The remaining 20% of the reconstructions included either the placement of a permanent silicon implant at the time of mastectomy (4.7%) or autologous reconstruction (15.3%), she said.

A review of the oncologic outcomes in the 412 patients who underwent therapeutic mastectomies showed that, at a median follow-up of 28 months, four patients (1%) experienced local recurrence only, eight (1.9%) experienced distant recurrence only, and four experienced both local and distant recurrence (1%), Dr. Warren Peled reported. Among the local recurrences, two each were invasive (0.7%) and in situ cancer (1.8%), and among the distant recurrences, all eight (2.7) were invasive cancers. Among those with both local and distant recurrences, three (1%) and one (0.9%) were invasive and in situ, respectively, she said,

Of the 126 patients who had a minimum 36 months’ follow-up (median, 45 months), 2 patients (1.6%) had local recurrence only, one of which was invasive; 1 patient (0.8%) had distant recurrence only; and 1 (0.8%) had both, Dr. Peled said, noting that the recurrences in the latter two patients were invasive.

An assessment of ischemic complications showed 13 cases (1.9%) of partial nipple loss; 10 cases (1.5%) of complete nipple loss, and 78 cases (11.8%) of skin flap necrosis, Dr. Peled said, noting that the group’s current nipple loss rate is lower than 1%, thanks to serial improvements in surgical technique.

The findings indicate that TSSM "can be performed with low rates of nipple involvement and locoregional recurrence," Dr. Warren Peled stated. Although the short-term findings are encouraging, the study cannot speak to the long-term oncologic safety of the procedure. "Longer term follow-up is needed to confirm the oncologic safety over time," she said.

Dr. Warren Peled had no relevant financial conflicts to disclose.

SAN ANTONIO – Total skin-sparing mastectomy with complete preservation of the breast skin envelope was associated with favorable oncologic and ischemic outcomes in a large, high-risk cohort of women who underwent the procedure over a 10-year period in San Francisco, a study has shown.

The findings suggest that the surgery, which produces superior cosmesis and is associated with a high rate of patient satisfaction, is a reasonable option for many women facing therapeutic or prophylactic mastectomy, Dr. Anne G. Warren Peled said at the San Antonio Breast Cancer Symposium.

The total skin-sparing mastectomy (TSSM) allows preservation of the nipple-areola dermal layer when ductal tissue is removed during mastectomy. "The procedure is increasingly offered to women for both therapeutic and prophylactic indications, and when combined with immediate breast reconstruction, can produce excellent aesthetic results," explained Dr. Warren Peled, a surgical resident at the University of California, San Francisco.

Because the oncologic safety of the procedure and the potential for higher rates of postoperative complications continue to be debated, Dr. Warren Peled and her colleagues sought to evaluate both outcomes using data collected in a prospectively maintained database. The investigators analyzed patient and tumor characteristics, treatment details, and the development of any postoperative complications, as well as local or distant recurrences, for 428 patients (mean age, 46.9 years) who underwent 657 TSSMs and immediate breast reconstruction at the UCSF Medical Center in 2001-2010.

"The mastectomy incisions included radial, lateral, periareolar, and inframammary incisions, and the areolar and nipple complex tissue was separated from the dermal layer of skin by sharp dissection with inversion of the nipple skin to ensure the removal of all of the nipple duct tissue," Dr. Warren Peled said during a poster discussion. Of the 657 mastectomies, 412 were therapeutic procedures, and 245 (58 bilateral and 187 contralateral) were prophylactic, she said.

Most of the tumors were stage 0 (111) or stage I (135), although stage II (95), III (48), and IV (7) tumors were also observed, Dr. Warren Peled reported. Some 14 mastectomies were for recurrent cancer, she noted. In addition, 210 patients underwent neoadjuvant chemotherapy, 144 had postmastectomy radiation therapy, and 78 had adjuvant chemotherapy, she said.

With respect to nipple involvement on pathological analysis, 11 specimens had evidence of in situ cancer and 9 had evidence of invasive cancer, leading to re-excision in 7 cases, removal of the nipple-areolar complex (NAC) in 9 cases, and NAC radiation in 4 cases, said Dr. Warren Peled.

The conventional, two-stage, expander-implant method – in which a tissue expander placed under the chest muscle is implanted and gradually inflated to expand the tissue in preparation for the synthetic implant 3-6 months later – was used in 80% of the postmastectomy reconstructions, Dr. Warren Peled said. The remaining 20% of the reconstructions included either the placement of a permanent silicon implant at the time of mastectomy (4.7%) or autologous reconstruction (15.3%), she said.

A review of the oncologic outcomes in the 412 patients who underwent therapeutic mastectomies showed that, at a median follow-up of 28 months, four patients (1%) experienced local recurrence only, eight (1.9%) experienced distant recurrence only, and four experienced both local and distant recurrence (1%), Dr. Warren Peled reported. Among the local recurrences, two each were invasive (0.7%) and in situ cancer (1.8%), and among the distant recurrences, all eight (2.7) were invasive cancers. Among those with both local and distant recurrences, three (1%) and one (0.9%) were invasive and in situ, respectively, she said,

Of the 126 patients who had a minimum 36 months’ follow-up (median, 45 months), 2 patients (1.6%) had local recurrence only, one of which was invasive; 1 patient (0.8%) had distant recurrence only; and 1 (0.8%) had both, Dr. Peled said, noting that the recurrences in the latter two patients were invasive.

An assessment of ischemic complications showed 13 cases (1.9%) of partial nipple loss; 10 cases (1.5%) of complete nipple loss, and 78 cases (11.8%) of skin flap necrosis, Dr. Peled said, noting that the group’s current nipple loss rate is lower than 1%, thanks to serial improvements in surgical technique.

The findings indicate that TSSM "can be performed with low rates of nipple involvement and locoregional recurrence," Dr. Warren Peled stated. Although the short-term findings are encouraging, the study cannot speak to the long-term oncologic safety of the procedure. "Longer term follow-up is needed to confirm the oncologic safety over time," she said.

Dr. Warren Peled had no relevant financial conflicts to disclose.

SAN ANTONIO – Total skin-sparing mastectomy with complete preservation of the breast skin envelope was associated with favorable oncologic and ischemic outcomes in a large, high-risk cohort of women who underwent the procedure over a 10-year period in San Francisco, a study has shown.

The findings suggest that the surgery, which produces superior cosmesis and is associated with a high rate of patient satisfaction, is a reasonable option for many women facing therapeutic or prophylactic mastectomy, Dr. Anne G. Warren Peled said at the San Antonio Breast Cancer Symposium.

The total skin-sparing mastectomy (TSSM) allows preservation of the nipple-areola dermal layer when ductal tissue is removed during mastectomy. "The procedure is increasingly offered to women for both therapeutic and prophylactic indications, and when combined with immediate breast reconstruction, can produce excellent aesthetic results," explained Dr. Warren Peled, a surgical resident at the University of California, San Francisco.

Because the oncologic safety of the procedure and the potential for higher rates of postoperative complications continue to be debated, Dr. Warren Peled and her colleagues sought to evaluate both outcomes using data collected in a prospectively maintained database. The investigators analyzed patient and tumor characteristics, treatment details, and the development of any postoperative complications, as well as local or distant recurrences, for 428 patients (mean age, 46.9 years) who underwent 657 TSSMs and immediate breast reconstruction at the UCSF Medical Center in 2001-2010.

"The mastectomy incisions included radial, lateral, periareolar, and inframammary incisions, and the areolar and nipple complex tissue was separated from the dermal layer of skin by sharp dissection with inversion of the nipple skin to ensure the removal of all of the nipple duct tissue," Dr. Warren Peled said during a poster discussion. Of the 657 mastectomies, 412 were therapeutic procedures, and 245 (58 bilateral and 187 contralateral) were prophylactic, she said.

Most of the tumors were stage 0 (111) or stage I (135), although stage II (95), III (48), and IV (7) tumors were also observed, Dr. Warren Peled reported. Some 14 mastectomies were for recurrent cancer, she noted. In addition, 210 patients underwent neoadjuvant chemotherapy, 144 had postmastectomy radiation therapy, and 78 had adjuvant chemotherapy, she said.

With respect to nipple involvement on pathological analysis, 11 specimens had evidence of in situ cancer and 9 had evidence of invasive cancer, leading to re-excision in 7 cases, removal of the nipple-areolar complex (NAC) in 9 cases, and NAC radiation in 4 cases, said Dr. Warren Peled.

The conventional, two-stage, expander-implant method – in which a tissue expander placed under the chest muscle is implanted and gradually inflated to expand the tissue in preparation for the synthetic implant 3-6 months later – was used in 80% of the postmastectomy reconstructions, Dr. Warren Peled said. The remaining 20% of the reconstructions included either the placement of a permanent silicon implant at the time of mastectomy (4.7%) or autologous reconstruction (15.3%), she said.

A review of the oncologic outcomes in the 412 patients who underwent therapeutic mastectomies showed that, at a median follow-up of 28 months, four patients (1%) experienced local recurrence only, eight (1.9%) experienced distant recurrence only, and four experienced both local and distant recurrence (1%), Dr. Warren Peled reported. Among the local recurrences, two each were invasive (0.7%) and in situ cancer (1.8%), and among the distant recurrences, all eight (2.7) were invasive cancers. Among those with both local and distant recurrences, three (1%) and one (0.9%) were invasive and in situ, respectively, she said,

Of the 126 patients who had a minimum 36 months’ follow-up (median, 45 months), 2 patients (1.6%) had local recurrence only, one of which was invasive; 1 patient (0.8%) had distant recurrence only; and 1 (0.8%) had both, Dr. Peled said, noting that the recurrences in the latter two patients were invasive.

An assessment of ischemic complications showed 13 cases (1.9%) of partial nipple loss; 10 cases (1.5%) of complete nipple loss, and 78 cases (11.8%) of skin flap necrosis, Dr. Peled said, noting that the group’s current nipple loss rate is lower than 1%, thanks to serial improvements in surgical technique.

The findings indicate that TSSM "can be performed with low rates of nipple involvement and locoregional recurrence," Dr. Warren Peled stated. Although the short-term findings are encouraging, the study cannot speak to the long-term oncologic safety of the procedure. "Longer term follow-up is needed to confirm the oncologic safety over time," she said.

Dr. Warren Peled had no relevant financial conflicts to disclose.

SAN ANTONIO – Dr. Howard A. Burris III, Dr. William J. Gradishar, and Dr. Hope S. Rugo remark on the implications of the CLEOPATRA trial, in which the addition of pertuzumab to a standard chemotherapy combination of trastuzumab and docetaxel led to an additional 6 months of progression-free survival in patients with HER2-positive metastatic breast cancer, at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Howard A. Burris III, Dr. William J. Gradishar, and Dr. Hope S. Rugo remark on the implications of the CLEOPATRA trial, in which the addition of pertuzumab to a standard chemotherapy combination of trastuzumab and docetaxel led to an additional 6 months of progression-free survival in patients with HER2-positive metastatic breast cancer, at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Howard A. Burris III, Dr. William J. Gradishar, and Dr. Hope S. Rugo remark on the implications of the CLEOPATRA trial, in which the addition of pertuzumab to a standard chemotherapy combination of trastuzumab and docetaxel led to an additional 6 months of progression-free survival in patients with HER2-positive metastatic breast cancer, at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – Dr. Howard Burris, Dr. William J. Gradishar, and Dr. Hope Rugo discuss the implications of the BOLERO-2 trial, which coupled everolimus with exemestane in women with advanced hormone resistant, estrogen receptor-positive breast cancer.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – The Oncology Report's editor-in-chief, Dr. Howard A. Burris III, and its associate editor Dr. William J. Gradishar discuss an ONCOTYPE DX assay for ductal carcinoma in situ at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. Hope S. Rugo, associate editor of The Oncology Report, discusses the use of bisphosphonates as antitumor agents in early-stage breast cancer at the 2011 San Antonio Breast Cancer Symposium.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar and Dr. Hope S. Rugo, associate editors of The Oncology Report, discuss fulvestrant and anastrozole as first-line therapy for postmenopausal women with hormone receptor-positive breast cancer.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

SAN ANTONIO – Dr. William J. Gradishar, associate editor of The Oncology Report, discusses the conflicting results from multiple clinical trials over the last decade and whether bisphosphonates reduce cancer recurrence and metastatic risk.

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society

Overall death rates for cancer dropped by 1.8% per year in men and 1.6% per year in women from 2004 to 2008 in the United States, while incidence rates declined by 0.6% per year in men and were stable in women over the same period, according to a new report from the American Cancer Society.

The most rapid declines in death rates occurred among African American and Hispanic men (2.4% and 2.3% per year, respectively). Even with the decline, African American men still have a 33% higher death rate than white men, and a 15% higher incidence. African American women have a 16% higher death rate but a 6% lower incidence than white women, the society said.

Lung cancer accounted for almost 40% of the total decline in deaths for men, and breast cancer accounted for 34% of the total decline in deaths among women, the report noted.

A total of 1.6 million new cancer cases are projected in the United States for 2012, along with 577,190 deaths, according to the society.

Note: Estimates are based on 1995-2008 incidence rates as reported by the North American Association of Central Cancer Registries.

Source: American Cancer Society