New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer

Excerpt:

“As a single agent, abemaciclib has shown exciting potential in heavily pretreated patients with refractory, hormone-receptor (HR)–positive, HER2-negative advanced breast cancer, following phase II findings of the MONARCH 1 trial.

“Results of the single-arm study, which were presented during the 2016 ASCO Annual Meeting1, show that the CDK4/6 inhibitor induced a response rate of nearly 20% in this patient population. The median progression-free survival (PFS) was 6 months (95% CI 4.2-7.5) and the median overall survival (OS) was 17.7 months (95% CI, 16 to not reached). Previously, abemaciclib received a breakthrough therapy designation in this setting from the FDA in October 2015.”

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Lead NEMO Author Shares Excitement With Binimetinib in NRAS-Mutant Melanoma

Excerpt:

“For patients with NRAS-mutant melanoma who progress following treatment with an immunotherapy agent, the MEK inhibitor binimetinib offers a promising option, explains Reinhard Georg Dummer, MD.

“Results of the open-label phase III NEMO trial, which were presented during the 2016 ASCO Annual Meeting,1 most recently demonstrated the agent’s potential. In the study, binimetinib was found to reduce the risk of progression or death by 38% when compared with dacarbazine in this subgroup of patients.

“Additionally, median progression-free survival (PFS) with binimetinib was 2.8 months versus 1.5 months with dacarbazine (HR, 0.62; 95% CI, 0.47-0.80; P <.0001). The objective response rate with binimetinib was 15%, including 1 complete response, compared with 7% for dacarbazine.”

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HYPRO: Shorter RT Course No Better, Worse in Localized Prostate Cancer

Excerpt:

“A randomized phase III trial found that a hypofractionated radiotherapy (RT) regimen was not superior to, but generally equivalent to a conventional RT scheme in men with localized prostate cancer. The study joins a growing body of literature on hypofractionation in this malignancy, generally showing that the shorter courses are a reasonable option.

“A low α-β ratio for prostate cancer has generated interest in hypofractionation, as it could increase the tumor dose without increasing toxicities. ‘Moreover, hypofractionated radiotherapy is delivered in fewer fractions, improving patients’ convenience, hospital logistics, and possibly reducing healthcare costs,’ wrote study authors led by Luca Incrocci, MD, PhD, of Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands.

“A study was presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago that found a hypofractionated regimen of 60 Gy in 20 fractions was noninferior to conventional RT. Another, presented this past January at the ASCO Genitourinary Cancers Symposium, again found a 60 Gy/20 fractions regimen was noninferior to conventional RT and to another hypofractionated regimen of 57 Gy/19 fractions.”

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Video: Lisa A. Carey, MD, and Julie Gralow, MD: Top Breast Cancer Papers Presented at the 2016 ASCO Annual Meeting

Excerpt:

“Lisa A. Carey, MD, of the University of North Carolina, and Julie Gralow, MD, of the University of Washington, discuss the most important data presented this year on treating breast malignancies (Abstracts LBA1, 500, and 507).”

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Everolimus Survival Benefit Suggested in Updated NET Trial Results

Excerpt:

“Patients with nonfunctioning neuroendocrine tumors (NETs) of lung or gastrointestinal (GI) origin continued to live longer when treated with the mammalian target of rapamycin (mTOR) inhibitor everolimus (Afinitor) than with placebo, ongoing follow-up in a randomized trial has shown.

“A second planned interim analysis of the RADIANT-4 trial showed a 27% reduction in the estimated risk of death for patients who received everolimus compared with placebo. However, the difference did not meet the statistical threshold for overall survival (OS) significance.

“As previously reported, the trial met the primary endpoint of progression-free survival (PFS), and a first interim survival analysis showed a trend in favor of the everolimus arm. Follow-up for survival will continue, James C. Yao, MD, a professor at The University of Texas MD Anderson Cancer Center, reported at the 2016 ASCO Annual Meeting.”

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Binimetinib Improves PFS in NRAS-Mutated Metastatic Melanoma

Excerpt:

“The novel MEK inhibitor binimetinib resulted in improved progression-free survival (PFS) and response rates vs dacarbazine in patients with NRAS-mutated advanced unresectable/metastatic melanoma, according to results of an open-label phase III trial.

“ ‘NRAS mutations are present in approximately 20% of all patients with metastatic melanoma,’ said Reinhard Dummer, MD, of the University Hospital Zurich in Switzerland. ‘It activates the MAPK pathway and by this drives cell proliferation and anti-apoptotic mechanisms.’ Preclinical studies have shown that NRAS-mutant melanoma is sensitive to MEK inhibition, and binimetinib inhibits both MEK1 and MEK2. A phase II study showed clinical activity in NRAS-mutant metastatic melanoma.

“The NEMO trial included 402 patients randomized 2:1 to receive either binimetinib (269 patients) or dacarbazine (133 patients; 19 were not treated and were not evaluated for safety). Patients were either treatment-naive or had progressed on or after immunotherapy. The primary endpoint of the study was PFS. The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting held earlier this month in Chicago (abstract 9500).”

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Can Patients Discontinue Immunotherapy and Still Benefit?

Excerpt:

“At present in clinical practice, immunotherapy with anti-PD-1 agents is administered indefinitely until intolerable toxicities or progressive disease sets in. But there has been anecdotal evidence that patients who stop treatment may still derive benefit, and now there is evidence of this from a post hoc analysis of a randomized study.

“It comes from the CheckMate 069 trial that evaluated the combination of nivolumab (Opdivo, Bristol-Myers Squibb Company) and ipilimumab (Yervoy, Bristol-Myers Squibb Company) vs ipilimumab alone in patients with metastatic melanoma.

“New results from a post hoc analysis of this trial, presented at the recent American Society of Clinical Oncology (ASCO) 2016 Annual Meeting (abstract 9518), show that a subgroup of patients who discontinued combination immunotherapy because of treatment-related adverse events achieved an impressive overall response rate (ORR) of 66%.”

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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…