BOLERO-2 clinical trial results

Introduction and Exploration of Fulvestrant in Breast CancerPanelists:Adam M. Brufsky, MD, PhD, University of Pittsburgh; Sara Hurvitz, MD, UCLA;
Joyce A. O'Shaughnessy, MD, US Oncology; Edith A. Perez, MD, Mayo Clinic; Hope S. Rugo, MD, UCSF;
Andrew D. Seidman, MD, MSKCC

For High-Definition, Click Interest in treatment with novel combinations of targeted agents and hormonal therapies in hormone receptor-positive breast cancer caused the establishment of several unique clinical trials, including BOLERO-2, suggests moderator Adam M. Brufsky, MD, PhD.

Combination of Anastrozole and Fulvestrant in MBCInitially, some researchers did not believe the combination of an mTOR inhibitor and hormonal therapy would prove to be effective. This skepticism was partially based on earlier research into the mTOR inhibitor temsirolimus, which did not demonstrate efficacy in this space, Brufsky suggests. However, since this initial setback, the treatment paradigm changed to include more exposure to aromatase inhibitors (AIs) and longer durations of treatment with hormonal therapies, explains Hope S. Rugo, MD. Also, the mTOR inhibitor dose in initial trials may not have been correct, based on levels of stomatitis, a common side effect of mTOR inhibition.

Initially, research into the mTOR inhibitor everolimus was undertaken in the neoadjuvant setting, looking for a potential biomarker, explains Rugo. In this trial, a great deal of information was uncovered about treatment with everolimus, including the occurrence of interstitial pneumonitis and other side effects. Additionally, the trial demonstrated a slight clinical benefit and a significant drop in Ki67.

BOLERO-2 Trial: Everolimus in Metastatic Breast CancerThe rationale to explore mTOR inhibition in the metastatic setting stemmed from information on the PI3K pathway and the increased mutational burden in advanced disease. The phase III BOLERO-2 trial was undertaken to explore this rationale further. In the trial, patients were randomized 2:1 to receive exemestane plus everolimus or exemestane and placebo. Most patients enrolled were chemotherapy naive and a large amount had visceral disease, which generally indicates the need for treatment with chemotherapy, Rugo notes.

In the trial, there was a large difference in progression-free survival favoring treatment with everolimus. Interestingly, Rugo explains, the progression free survival benefit was less pronounced by local assessment than by independent central evaluation, which is not generally the case.

Management of mTOR Inhibitor Side Effects in Breast CancerExamining the toxicity profile, the main concern that has been raised was the occurrence of stomatitis. In general, Rugo notes, grade 3 stomatitis occurred in 8% of patients. However, Joyce A. O'Shaughnessy, MD, recommends the utilization of a steroid mouthwash as a preventive option. This approach seems to be largely effective in most patients, Rugo and O'Shaughnessy agree.

View More From This Discussion

Episode 1 Introduction and Exploration of Fulvestrant in Breast Cancer

Episode 2 Combination of Anastrozole and Fulvestrant in MBC

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The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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How clinical trial managers can improve organizational efficiency without affecting quality

Steps required to make an environment (processes, organizational structure, and IT systems) that lets the enhanced operations. Clinical trials are complex and expensive, and are made complex and expensive by the processes and technologies which a clinical team has to follow.

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