Interferon Not Beneficial for Most Stage III Melanoma

“Final results for the Sunbelt Melanoma Trial, published online this month in the Journal of Clinical Oncology, show that thanks to current diagnostic techniques, most stage III melanoma patients do not benefit from treatment with interferon. Kelly McMasters, M.D., Ph.D., the Ben A. Reid, Sr., M.D. Professor and Chair of the Hiram C. Polk, Jr., M.D. Department of Surgery at the University of Louisville, was the principal investigator and initiated the trial.

“The first of more than 3600 trial participants were enrolled in 1997. Patients with small amounts of  detected in a single lymph node were either treated with high-dose interferon therapy or simply observed. The , representing 79 institutions across North America, were followed for up to 10 years to determine long-term outcomes in terms of disease-free survival and overall survival.”


NICE Draft Guidance Recommends Nivolumab for Advanced Skin Cancer

“NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.

“The independent Committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licence.

“Professor Carole Longson, Health Technology Evaluation Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.’ ”


Study Shows Statins Could Be Effective against Small Cell Lung Cancer

“In a recent study, researchers at Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western), in collaboration with international colleagues, found that statins could be an effective therapeutic against metastatic small cell lung cancer (SCLC).

“The study of 876 late-stage SCLC patients, published today in the peer-reviewed scientific journal PLOS ONE, showed that statins, a class of drugs primarily used to lower cholesterol in patients at risk for heart disease, appeared to provide an increase in overall survival for those cancer patients who received them.

” ‘Small cell lung cancer is one of the most aggressive types of cancer, and yet in nearly three decades, no new classes of treatments have been adopted as new benchmarks for standard therapy,’ said Dr. Glen Weiss, M.D., M.B.A., Director of Clinical Research and Medical Oncologist at CTCA at Western in Goodyear, Ariz., and the study’s senior author. ‘Our study showed that statins appear to provide a statistically significant survival benefit among patients with metastatic SCLC.’ “


Jason Luke on Significance of Biomarker Development for Immunotherapy in Melanoma

“Although nivolumab (Opdivo) and ipilimumab (Yervoy) together demonstrate superior survival in previously untreated patients with advanced melanoma, the combination comes with additional toxicity and an increased price tag, says Jason Luke, MD, assistant professor of Medicine at the University of Chicago Medicine.

“ ‘There have been several studies designed around trying to predict which patients are most likely to benefit from anti–PD-1 or immunotherapy combinations. I really think that is going to be an essential part of the future approach to treatment, says Luke. ‘Not all patients respond to these treatments. There are additional toxicities with the combinations, and there are also cost issues because of how catastrophically expensive these drugs are. We really need to know which patients are most likely to respond and which aren’t.’ “


The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…


Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”


Promising Drug Combination for Advanced Prostate Cancer

“A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.

” ‘We hope to find a well-tolerated and effective treatment to slow the progression of prostate cancer in men with advanced prostate cancer. The approach combines several drugs and attacks the cancer on several fronts,’ said Dr. Fred Saad, researcher at the University of Montreal Hospital Research Centre (CRCHUM) and principal investigator of the study.

“Antonio Paris, 59, is one of the patients participating in the CRCHUM. “Since I started the new treatment 14 months ago, my cancer first remitted and now is stable,” he said.”


HER2-Enriched Molecular Subgroup Highly Sensitive to Breast Cancer Regimens

“The primary analysis of the phase III CALGB 40601 trial found that pathologic complete response (pCR) to dual HER2 blockade was not statistically higher than anti-HER2 monotherapy. However, there was a high level of intertumoral heterogeneity, and patients with the HER2-enriched subtype had a high pCR with both single and dual anti-HER2 therapy, according to data recently published in the Journal of Clinical Oncology.

“ ‘This trial paves the way for integrating molecular analyses into other trials in HER2-positive breast cancer, and may allow us to take a less-is-more approach for women who are selected to be highly sensitive to targeted treatments and to have a good prognosis,’ said lead study author Lisa Carey, MD, a UNC Lineberger member, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research at the University of North Carolina School of Medicine, and the physician-in-chief of the North Carolina Cancer Hospital, in a statement.”


Dual HER2 Blockade Fails to Improve Response Rate in HER2-Positive Breast Cancer

“Dual HER2 blockade with trastuzumab and lapatinib was no better than trastuzumab alone in producing pathologic complete responses (pCR) in metastatic HER2-positive breast cancer patients in the neoadjuvant setting, according to a new study. Those with hormone receptor–negative disease did see an improvement with the dual blockade.

“ ‘In randomized neoadjuvant trials, dual HER2 targeting generally results in higher pCR rates, but the magnitude of this effect has varied,’ wrote study authors led by Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill. The new trial was a three-arm study of preoperative therapy in 305 patients with stage II/III HER2-positive breast cancer; 118 patients were randomized to paclitaxel along with trastuzumab and lapatinib, 120 to paclitaxel with trastuzumab alone, and another 67 to paclitaxel along with only lapatinib. That last trial arm was closed early. Results were published online ahead of print in the Journal of Clinical Oncology.”