A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer

• DOI: 10.21873/anticanres.13104
• Publication Date: 2018-12-28T01:55:22Z
• Authors: MATTHEW R. KEARNEY; EMERSON Y. CHEN; GINA M. VACCARO; JOHN STROTHER; ANDREA BURT; KENDRA TODD; JEFF DONOVAN; KERSTIN M. KAMPA-...; CHARLES D. LOPEZ
• Keywords: Adult; Male; Organoplatinum Compounds; Leucovorin; Middle Aged; Irinotecan; Disease-Free Survival; 3. Good health; Erlotinib Hydrochloride; 03 medical and health sciences; 0302 clinical medicine; Antineoplastic Combined Chemotherapy Protocols; Humans; Camptothecin; Female; Fluorouracil; Neoplasm Metastasis; Colorectal Neoplasms; Aged

Based on our pre-clinical data, we hypothesized that sequencing chemotherapy with erlotinib would increase the tumor response rate in patients with metastatic colorectal cancer.A phase II trial (planned n=58) using second-line therapy for metastatic colorectal cancer with either oxaliplatin-based (mFOLFOX6) or irinotecan-based (FOLFIRI) combination chemotherapy and 100 mg erlotinib daily on days 3-8 after each infusion (days 1 and 2) every 14 days. The primary endpoint was the response rate compared to the historical response rate.The FOLFIRI/erlotinib arm met the pre-specified response rate criteria of at least 10% to expand accrual to the intended sample size. The trial was halted after an interim safety analysis (n=11) due to excess grade 3 neutropenia, dose reductions and treatment delays. Grade 3 or 4 neutropenia was observed in 64% of patients. The response rate was 18%.In second-line treatment for metastatic colorectal cancer, mFOLFOX6 or FOLFIRI with erlotinib in a sequence-dependent fashion is not feasible despite potential promising activity.