Samuel A Jacobs, James J Lee, Thomas J George, James L Wade, Philip J Stella, Ding Wang, Ashwin R Sama, Fanny Piette, Katherine L Pogue-Geile, Rim S Kim, Patrick G Gavin, Corey Lipchik, Huichen Feng, Ying Wang, Melanie Finnigan, Brian F Kiesel, Jan H Beumer, Norman Wolmark, Peter C Lucas, Carmen J Allegra, Ashok Srinivasan
PURPOSE: In metastatic colorectal cancer (mCRC), HER2 ( ERBB2 ) gene amplification is implicated in anti-EGFR therapy resistance. We sought to determine the recommended phase II dose (RP2D) and efficacy of neratinib, a pan-ERBB kinase inhibitor, combined with cetuximab, in patients with progressive disease (PD) on anti-EGFR treatment. PATIENTS AND METHODS: Twenty-one patients with quadruple-wild-type, refractory mCRC enrolled in this 3+3 phase Ib study. Standard dosage cetuximab was administered with neratinib at 120 mg, 160 mg, 200 mg, and 240 mg/day orally in 28-day cycles...
November 17, 2020: Clinical Cancer Research