Comparing Combination Treatments in HER2-Positive Early Breast Cancer

Excerpt:

“In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine plus pertuzumab (T-DM1+P).

“According to the results of the KRISTINE trial, the TCH+P regimen was also associated with a higher rate of breast conserving surgery. However, researchers reported that T-DM1+P had a notably better safety profile and that health-related quality of life and physical functioning were maintained longer.

“ ‘Neoadjuvant TCH+P achieved a superior pCR rate compared with T-DM1+P and was associated with a higher breast-conserving-surgery rate,’ said Sara A. Hurvitz, MD, General Internal Medicine, Hematology & Oncology, UCLA Medical Center in Santa Monica, CA. ‘However, neoadjuvant T-DM1+P had a more favorable safety profile, with lower incidence of grade 3 or greater adverse events, serious adverse events, and adverse events leading to treatment discontinuation.’ ”

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Two-Year Overall Survival Data from Two Pivotal Opdivo® (nivolumab) Trials Demonstrate Sustained Benefit In Patients with Advanced Non-Small Cell Lung Cancer

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) announced today two-year overall survival data from two pivotal Phase 3 studies evaluating Opdivo (nivolumab) versus docetaxel in previously treated metastatic non-small cell lung cancer (NSCLC). Opdivo continued to demonstrate improved overall survival (OS), the primary endpoint for both studies, at the landmark two-year time point. In CheckMate -057, a trial in previously treated non-squamous NSCLC, 29% of patients treated with Opdivo were alive at two years (n=81/292) versus 16% of those treated with docetaxel (n=45/290) (HR: 0.75 [95% CI: 0.63, 0.91]). In CheckMate -017, a trial in previously treated squamous NSCLC, 23% of patients treated withOpdivo were alive at two years (n=29/135) versus 8% of those treated with docetaxel (n=11/137) (HR: 0.62 [95% CI: 0.47, 0.80]). In Checkmate -057 and -017, treatment-related adverse events (AEs) occurred in 71% and 61% of Opdivo-treated patients. The safety profile of Opdivo at two years was consistent with previous reports of data from both studies.”

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Advanced Breast Cancer Slowed with Avastin Combo (CME/CE)

Excerpt:

“Adding bevacizumab (Avastin) to letrozole (Femara) improved progression-free survival (PFS) in estrogen receptor-positive metastatic breast cancer (ER+MBC) but not other outcomes, an open-label, multicenter phase III trial showed.

“While median PFS increased by 4.6 months in patients who received combined therapy versus letrozole alone, there was no significant difference in overall survival (hazard ratio 0.87; 95% CI 0.65-1.18; P=0.188), Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported online in the Journal of Clinical Oncology.

“In addition, there was a marked increase in grade 3 to 4 toxicities, particularly hypertension (24% versus 2%) and proteinuria (11% versus 0%), the researchers said, emphasizing that the role of bevacizumab in this setting will need to be clarified with research on predictive markers.”

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MammaPrint Genetic Test Can Reduce Use of Post-surgery Chemotherapy Among Early-stage Breast Cancer Patients

Excerpt:

“Among patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria, the MammaPrint genetic test identified a large group of patients for whom five-year distant metastasis–free survival was equally good whether or not they received adjuvant chemotherapy (chemotherapy given post-surgery), according to results from the randomized, phase III microarray in node negative disease may avoid chemotherapy (MINDACT) clinical trial to be presented here at the AACR Annual Meeting 2016, April 16-20.”

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Patients With EGFR Expressing NSCLC Benefit Most From Necitumumab Added to Chemotherapy

Excerpt:

“Patients with epidermal growth factor receptor (EGFR) expressing advanced squamous non-small-cell lung cancer benefit most from necitumumab added to gemcitabine and cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.

“The randomised phase III SQUIRE trial demonstrated that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved overall survival in patients with stage IV squamous  by 1.6 months compared to chemotherapy alone. The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.”

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NSCLC Drug Hits Speed Bump on Road to FDA Approval

Excerpt:

“The FDA should wait for results of an ongoing phase III clinical trial before deciding whether to approve the EGFR inhibitor rociletinib for non-small cell lung cancer (NSCLC), advisers recommended today.

“The Oncologic Drugs Advisory Committee (ODAC) voted 12-1 in favor of the delay, although several committee members acknowledged that the drug demonstrated activity in two phase II trials submitted in support of the application for accelerated approval. Others, however, expressed a desire to see more compelling efficacy data from the larger, phase III trial, and some expressed uncertainty about about how to interpret the drug’s safety, specifically a 33% incidence of QT-prolongation in the single-arm phase II trials.

“Additionally, FDA staff review of the trial data ‘revealed high variability of systemic exposure to rociletinib and its major metabolites. Rociletinib demonstrated nonlinear pharmacokinetics, as systemic exposures did not increase when the dose increased from 500 mg to 1000 mg.’ ”

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Possible Treatment on Horizon for Advanced KRAS-Mutant NSCLC

Excerpt:

“Promising early phase clinical trials have led to the initiation of the phase III JUNIPER trial, which is assessing abemaciclib (LY2835219) for patients with previously treated KRAS-mutant lung cancer, a traditionally hard to treat genetic subtype.

“JUNIPER is an open label phase III study currently recruiting patients with stage IV non–small cell lung cancer (NSCLC) with a detectable KRAS mutation who have progressed following treatment with platinum-based chemotherapy (NCT02152631). Patients will be randomized to receive either abemaciclib or erlotinib, both with best supportive care.

“ ‘KRAS mutations are common in patients with NSCLC, but there have been few clinical advances in our treatment for these patients,’ said investigator Jonathan W. Goldman, MD, of the Department of Medicine, Hematology/Oncology, member of the Signal Transduction and Therapeutics Program Area at UCLA’s Jonsson Comprehensive Cancer Center, who explored the drug in a phase I trial.”

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Janssen's Zytiga Boosts Survival in Early-Stage Prostate Cancer

“Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared with placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.

“Data presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated that in the COU-AA-302 trial, Zytiga (abiraterone acetate) increased OS to 53.6 months versus the 41.8 months achieved by patients treated with prednisone alone. This benefit was shown to be 4.4 greater than that previously reported for the combo in the final analysis of the COU-AA-302 trial in 2014.

“The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in group 1 were in an earlier, less advanced and less symptomatic stage of the disease, while those in group 2 were in a later, more advanced and more symptomatic stage of the disease.”


New Treatments for Gastrointestinal Neuroendocrine Tumors


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…