“Adding 6 months of androgen suppression (AS) to radiation therapy improved biochemical disease-free survival in high-risk localized prostate cancer patients – even at radiation doses of 78 Gy – and it did so with acceptable adverse effects, according to a randomized European Organisation for Research and Treatment of Cancer trial reported in the Journal of Clinical Oncology.
“At 7.2 years’ median follow-up, the study found that combination therapy led to a 5-year biochemical disease-free survival of 82.6% (95% CI 78.4-86.1) versus 69.8% for radiation alone (95% CI 64.9-74.2) – translating to a hazard ratio of 0.52 (95% CI 0.41-0.66, P=0.001, 319 events). Adjuvant AS also improved clinical progression-free survival, for an HR of 0.63 (95% CI 0.48-0.84, P=0.001, 205 events).
“No statistically significant interaction between treatment effect and radiation dose emerged: heterogeneity P=0.79 and P=0.66, for biochemical disease-free survival and progression-free survival, respectively, according to Michel Bolla, MD, of Grenoble University Hospital in France, and colleagues.”
Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…
“Abituzumab did not extend progression-free survival (PFS) compared with placebo in a phase II study of patients with metastatic castration-resistant prostate cancer. The agent did, however, offer a lower incidence of bone lesion progression, and researchers say it still warrants further investigation.
“Previous research has suggested that integrins play a role in the progression of metastatic prostate cancer and associated bone lesions, wrote researchers led by Maha Hussain, MB, ChB, of the University of Michigan in Ann Arbor. Abituzumab is a pan-αv integrin inhibitor; a phase I trial previously showed that the agent has activity in patients with castration-resistant prostate cancer and bone metastases.
“The new phase II trial randomized 180 patients between three arms: a 750-mg abituzumab group, a 1,500-mg abituzumab group, or placebo. All groups also received standard of care. The results were published in Clinical Cancer Research.”
“Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it received a recommendation by an independent data monitoring committee (IDMC) that the J-ALEX Study, a phase III study targeting ALK fusion gene positive non-small cell lung cancer (NSCLC) being conducted in Japan, should be stopped early as the study met its primary endpoint at a pre-planned interim analysis. The study showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) when treated with Alecensa® compared to crizotinib.
“The J-ALEX study is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 patients with ALK fusion gene positive advanced or recurrent NSCLC who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to the Alecensa group or the crizotinib group in a one to one ratio.”
“Several recent studies have shown promise for the treatment of pancreatic NETs (pNETs). In the phase II CALGB-80701, which investigated the addition of bevacizumab (Avastin) to a treatment paradigm of everolimus and octreotide (Sandostatin) LAR in patients with locally advanced or metastatic pNETs, bevacizumab extended progression-free survival (PFS) by more than 3 months compared with everolimus and octreotide LAR alone.
“Response rate was also higher in the bevacizumab arm, with a 31% response to everolimus plus bevacizumab versus a 12% response in the control arm. Toxicity, however, was significantly higher in the bevacizumab arm.”
“Array BioPharma (Nasdaq: ARRY) today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.”
“Among women with locally advanced or metastatic hormone receptor-positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant, according to data from the phase III BELLE-2 trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.
“ ‘BELLE-2 is a randomized, phase III clinical trial designed to assess the efficacy of the investigational PI3K inhibitor buparlisib in combination with fulvestrant in breast cancer patients whose tumors no longer respond to aromatase inhibitors,’ said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.”
“The approval was based on a substantial improvement in overall survival (OS) in a phase 3 study.
“The FDA has expanded the approval for single-agent Opdivo (nivolumab) to include the frontline treatment of patients with BRAF wild-type advanced melanoma, based on a substantial improvement in overall survival (OS) compared with the chemotherapy dacarbazine in a phase 3 study.
“In the data assessed by the FDA from the CheckMate-066 trial, the median OS with Opdivo was not reached versus 10.8 months for dacarbazine, representing a 58 percent reduction in the risk of death. Median progression-free survival (PFS) with Opdivo was 5.1 versus 2.2 months for dacarbazine.”
“Immunomedics, Inc. (Nasdaq: IMMU) today announced that patients with metastatic triple-negative breast cancer (TNBC) lived for a median of seven months without tumor progression, after receiving at least 3 doses of sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC) for solid cancer therapy, in a Phase 2 clinical study. The study also indicated that the responses were very durable, showing a median time-to-progression, based on computed tomography, of 9.4 months (range of 1.8+ to 13.2+ months), which included patients with stable disease, and partial and complete responses.
” ‘Patients in this late-stage setting usually have a median PFS of three to four months when treated with other agents,’ stated Aditya Bardia, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center in Boston, and an investigator in this trial. ‘Sacituzumab govitecan is a promising agent that offers hope for these patients with poor prognosis,’ Dr. Bardia added.”