Updated efficacy, safety, and biomarker analyses of STEAM, a randomized, open-label, phase II trial of sequential (s) and concurrent (c) FOLFOXIRI-bevacizumab (BV) vs FOLFOX-BV for first-line (1L) treatment (tx) of patients with metastatic colorectal cancer (mCRC).
2017; Lippincott Williams & Wilkins; Volume: 35; Issue: 4_suppl Linguagem: Inglês
10.1200/jco.2017.35.4_suppl.657
ISSN1527-7755
AutoresHerbert I. Hurwitz, Benjamin Tan, James A. Reeves, Henry Q. Xiong, Bradley G. Somer, Heinz‐Josef Lenz, Howard S. Höchster, Frank A. Scappaticci, John F. Palma, Christoph Mancao, John J. Lee, Alan Nicholas, Nicolas Sommer, Johanna C. Bendell,
Tópico(s)Cancer Treatment and Pharmacology
Resumo657 Background: STEAM (NCT01765582) assessed efficacy and safety of 1L cFOLFOXIRI-BV and sFOLFOXIRI-BV vs FOLFOX-BV. Updated efficacy, safety, and exploratory biomarker data are reported. Methods: 280 tx-naive pts with mCRC were randomized 1:1:1 to BV-containing (5 mg/kg q2w) arms (cFOLFOXIRI, sFOLFOXIRI [alternating FOLFOX and FOLFIRI every 4 weeks {q4w}], or FOLFOX) in a 4–6 month (mo) induction phase, followed by maintenance. Primary objectives include progression-free survival (PFS). Secondary objectives include overall survival (OS). Tumor-relevant biomarker evaluations were exploratory. Results: Median PFS significantly improved and median OS showed a positive trend with cFOLFOXIRI-BV vs FOLFOX-BV. PFS significantly improved with cFOLFOXFIRI-BV vs FOLFOX-BV in BRAF wild type (WT); there was a positive trend in RAS WT and mutant (MUT) pts; no tx difference observed in BRAF MUT pts. In the safety pop., (n = 271), 88% had Grade ≥ 3 tx emergent AEs: 91% cFOLFOXIRI-BV; 87% sFOLFOXIRI-BV; 86% FOLFOX-BV. Conclusions: Improved PFS and a positive trend in OS were observed for cFOLFOXIRI-BV vs FOLFOX-BV. A positive PFS trend was seen in RAS WT and MUT pts, with significantly improved PFS in BRAF WT. The small number of BRAF MUT pts precluded estimation of tx effects. AEs for all 3 txs were consistent with previous reports. Clinical trial information: NCT01765582. [Table: see text]
Referência(s)