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Phase III, placebo-controlled trial (SUCCEED) evaluating ridaforolimus as maintenance therapy in advanced sarcoma patients following clinical benefit from prior standard cytotoxic chemotherapy: Long-term (≥ 24 months) overall survival results.
Session Type and Session Title:
Poster Discussion Session, Sarcoma
J Clin Oncol 30, 2012 (suppl; abstr 10010)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: The mammalian target of rapamycin (mTOR) regulates cell growth and proliferation and is abnormally activated in many sarcomas. Ridaforolimus, an oral mTOR inhibitor, demonstrated clinical activity in previous nonrandomized trials in advanced sarcomas following failure of prior chemotherapy. Methods: An international, multicenter, placebo-controlled, phase 3 trial was conducted to evaluate maintenance therapy with ridaforolimus in patients with metastatic soft-tissue or bone sarcomas who achieved disease control from prior chemotherapy. Patients were randomized (1:1) to receive oral ridaforolimus (40 mg) or placebo once daily for 5 days each week. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and safety and tolerability. For OS, patients were to be followed at 3-month intervals for at least 24 months and up to 60 months after randomization. Results: 702 of 711 randomized patients received treatment. At the time of the data cutoff for OS (386 deaths), patients in the study population had been followed for at least 15 months. Median OS was 93.3 weeks with ridaforolimus vs 83.4 weeks with placebo (hazard ratio [HR]=0.88; 95% confidence interval [CI]: 0.72, 1.08; P=0.23). Ridaforolimus significantly improved PFS vs placebo (HR=0.72; 95% CI: 0.61, 0.85; P=0.0001; median PFS: 17.7 weeks vs 14.6 weeks); PFS improved across all prespecified baseline characteristics. As expected from the class of mTOR inhibitors, the most common adverse events with ridaforolimus were stomatitis, thrombocytopenia, noninfectious pneumonitis, hypertriglyceridemia, hyperglycemia, infections, and rash. Conclusions: Oral ridaforolimus was generally well-tolerated and significantly improved PFS in metastatic sarcoma patients with benefit from prior chemotherapy, offering an effective treatment alternative to surveillance alone. Results of a long-term OS analysis (prespecified to occur at 67% mortality, 24 months minimum follow-up) in the intent-to-treat population will be available in early 2012.
Abstracts by Jean-Yves Blay:
Final overall survival (OS) analysis with modeling of crossover impact in the phase III GRID trial of regorafenib vs placebo in advanced gastrointestinal stromal tumors (GIST).Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 156
An updated overall survival analysis with correction for protocol-planned crossover of the international, phase III, randomized, placebo-controlled trial of regorafenib in advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID).Meeting: 2015 Gastrointestinal Cancers Symposium | Abstract No: 110
Genomic alterations to predict response to irinotecan-based chemotherapy in metastatic colorectal cancer.Meeting: 2015 Gastrointestinal Cancers Symposium | Abstract No: 586
Educational Book Articles by Jean-Yves Blay:
Presentations by Jean-Yves Blay:
Combination therapy with established and novel targeted agents to improve outcomes inMeeting: 2010 ASCO Annual Meeting
patients with advanced GISTSession: Lessons Learned from Clinical Trials in Gastrointestinal Stromal Tumor (Education Session)
Consolidation with high dose chemotherapy for responding patients to standard chemotherapy in advanced, metastatic soft tissue sarcoma (STS) - a randomized trial from FNCLCC - French Sarcoma GroupMeeting: 2009 ASCO Annual MeetingSession: Sarcoma (Oral Abstract Session)