PMID- 28979818 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 2156-6976 (Print) IS - 2156-6976 (Electronic) IS - 2156-6976 (Linking) VI - 7 IP - 9 DP - 2017 TI - Erlotinib in combination with bevacizumab and FOLFOX4 as second-line chemotherapy for patients with metastatic colorectal cancer. PG - 1971-1977 AB - BACKGROUND: We conducted a phase II study by combining FOLFOX4 plus bevacizumab (BV) with erlotinib (ER) as second-line chemotherapy for patients with metastatic colorectal cancer (mCRC). METHODS: Patients were divided into two groups in randomized double-blind manner. One group was given FOLFOX4 plus 5 mg/kg BV on day 1 of 2-week cycle. The other group was given 2-week-cycle of BV + FOLFOX4, and 100 mg ER every day. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), clinical response rates and adverse events (AEs). RESULTS: 66 patients received 2nd-line treatment of ER + BV+ FOLFOX4, and 65 received BV + FOLFOX4. Median PFS was 9.6 months of ER + BV + FOLFOX4 group, significantly better than 6.9 months of BV + FOLFOX4 group (P = 0.021, HR = 1.15, 95% CI = 0.88-1.39). Medium OS for ER + BV + FOLFOX4 group was 12.5 months, not statistically different than 12.1 months for BV + FOLFOX4 group (P = 00.146, HR = 0.63, 95% CI = 0.34-1.02). Combined partial response and stable disease rate was 48.5% for ER + BV + FOLFOX4 group, significantly higher than 32.2% for BV + FOLFOX4 group (P = 0.015). Patients in ER + BV + FOLFOX4 group had higher incidence rates of AEs. CONCLUSION: In second-line chemotherapy for patients with mCRC, combining erlotinib with FOLFOX4 plus bevacizumab may improve PFS, clinical response rates, but not OS. AEs, though with high incidence rates, were generally tolerable among patients receiving multiple reagents. FAU - Shi, Sha AU - Shi S AD - Department of Gastroenterology, Liaocheng People's HospitalLiaocheng 252000, China. FAU - Lu, Kemei AU - Lu K AD - Department of Gastroenterology, Liaocheng People's HospitalLiaocheng 252000, China. FAU - Gao, Hui AU - Gao H AD - Department of Gastroenterology, Liaocheng People's HospitalLiaocheng 252000, China. FAU - Sun, Huidong AU - Sun H AD - Department of General Surgery, Liaocheng People's HospitalLiaocheng 252000, China. FAU - Li, Senlin AU - Li S AD - Department of General Surgery, Liaocheng People's HospitalLiaocheng 252000, China. LA - eng PT - Journal Article DEP - 20170901 PL - United States TA - Am J Cancer Res JT - American journal of cancer research JID - 101549944 PMC - PMC5622230 OTO - NOTNLM OT - FOLFOX4 OT - Metastatic colorectal cancer OT - bevacizumab OT - erlotinib OT - second-line chemotherapy COIS- None. EDAT- 2017/10/06 06:00 MHDA- 2017/10/06 06:01 PMCR- 2017/09/01 CRDT- 2017/10/06 06:00 PHST- 2016/08/31 00:00 [received] PHST- 2016/09/25 00:00 [accepted] PHST- 2017/10/06 06:00 [entrez] PHST- 2017/10/06 06:00 [pubmed] PHST- 2017/10/06 06:01 [medline] PHST- 2017/09/01 00:00 [pmc-release] PST - epublish SO - Am J Cancer Res. 2017 Sep 1;7(9):1971-1977. eCollection 2017.