Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI‐Bevacizumab Versus FOLFOX‐Bevacizumab for Metastatic Colorectal Cancer (STEAM)

AbstractBackground.First‐line treatment for metastatic colorectal cancer (mCRC) typically entails a biologic such as bevacizumab (BEV) with 5‐fluorouracil/leucovorin/oxaliplatin (FOLFOX) or 5‐fluorouracil/leucovorin/irinotecan (FOLFIRI). STEAM (NCT01765582) assessed the efficacy of BEV plus FOLFOX/FOLFIRI (FOLFOXIRI), administered concurrently (cFOLFOXIRI‐BEV) or sequentially (sFOLFOXIRI‐BEV, FOLFOX‐BEV alternating with FOLFIRI‐BEV), versus FOLFOX‐BEV for mCRC.Patients and Methods.Patients with previously untreated mCRC (n = 280) were randomized 1:1:1 to cFOLFOXIRI‐BEV, sFOLFOXIRI‐BEV, or FOLFOX‐BEV and treated with 4–6‐month induction followed by maintenance. Coprimary objectives were overall response rate (ORR; first‐line cFOLFOXIRI‐BEV vs. FOLFOX‐BEV) and progression‐free survival (PFS; pooled first‐line cFOLFOXIRI‐BEV and sFOLFOXIRI‐BEV vs. FOLFOX‐BEV). Secondary/exploratory objectives included overall survival (OS), liver resection rates, biomarker analyses, and safety.Results.ORR was 72.0%, 72.8%, and 62.1% and median PFS was 11.9, 11.4, and 9.5 months with cFOLFOXIRI‐BEV, sFOLFOXIRI‐BEV, and FOLFOX‐BEV, respectively. OS was similar between arms. ORR between cFOLFOXIRI‐BEV and FOLFOX‐BEV did not significantly differ (p = .132); thus, the primary ORR endpoint was not met. cFOLFOXIRI‐BEV and sFOLFOXIRI‐BEV numerically improved ORR and PFS, regardless of RAS status. Median PFS was higher with pooled concurrent and seq...

Source: The Oncologist - July 16, 2019 Category: Cancer & Oncology Authors: Herbert I. Hurwitz, Benȷamin R. Tan, James A. Reeves, Henry Xiong, Brad Somer, Heinz-Josef Lenz, Howard S. Hochster, Frank Scappaticci, John F. Palma, Richard Price, John J. Lee, Alan Nicholas, Nicolas Sommer, Johanna Bendell Tags: Gastrointestinal Cancer Source Type: research