PMID- 35343258 OWN - NLM STAT- MEDLINE DCOM- 20220331 LR - 20220401 IS - 1526-2359 (Electronic) IS - 1073-2748 (Print) IS - 1073-2748 (Linking) VI - 29 DP - 2022 Jan-Dec TI - Biweekly Raltitrexed Combined With Irinotecan as Second-Line Therapy for Patients With Metastatic Colorectal Cancer: A Phase II Trial. PG - 10732748221080332 LID - 10.1177/10732748221080332 [doi] LID - 10732748221080332 AB - OBJECTIVE: Irinotecan-based doublet chemotherapy strategy was standard second-line backbone for patients with oxaliplatin-refractory metastatic colorectal cancer. The aim of this study was to evaluate tolerability and efficacy of raltitrexed combined with irinotecan biweekly administered as the second-line therapy for mCRC patients. METHODS: The study was a prospective, single-center, non-randomized, open-label phase II clinical trial. Patients with mCRC after failure with oxaliplatin and fluoropyrimidine or its derivatives were enrolled. Irinotecan (180 mg/m(2)) and raltitrexed (2.5 mg/m(2)) were given intravenously on day 1. Cycles were repeated every 2 weeks. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events (AEs). RESULTS: Between December 2012 and October 2016, 33 and 35 patients enrolled were assessed for response and safety, respectively. The ORR was 8.6%, and the DCR was 71.4%. The median PFS was 4.5 months (95% CI 3.8-5.2). The median OS was 12.0 months (95% CI 8.5-15.5). Four patients received conversion therapy to no evidence of disease (NED), and 2 patients were still alive with beyond 24 months survival. The most common grade 3/4 AEs were anorexia (14.3%), vomiting (14.3%), nausea (11.4%), fatigue (8.6%), and leukopenia (8.6%). No one died from treatment-related events. The incidence and severity of toxicity were irrelevant to UGT1A1 status. CONCLUSIONS: The combination of irinotecan with raltitrexed is an efficient, convenient, and acceptable toxic regimen for second-line treatment for mCRC patients. FAU - Cheng, Ke AU - Cheng K AUID- ORCID: 0000-0002-6034-8872 AD - Department of Abdominal Oncology, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Zhou, Yu-Wen AU - Zhou YW AD - Department of Biotherapy, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Chen, Ye AU - Chen Y AD - Department of Abdominal Oncology, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Li, Zhi-Ping AU - Li ZP AD - Department of Abdominal Oncology, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Qiu, Meng AU - Qiu M AD - Department of Abdominal Oncology, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Liu, Ji-Yan AU - Liu JY AD - Department of Biotherapy, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China. LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PL - United States TA - Cancer Control JT - Cancer control : journal of the Moffitt Cancer Center JID - 9438457 RN - 0 (Quinazolines) RN - 0 (Thiophenes) RN - 7673326042 (Irinotecan) RN - FCB9EGG971 (raltitrexed) SB - IM MH - *Antineoplastic Combined Chemotherapy Protocols MH - *Colorectal Neoplasms/pathology MH - Humans MH - Irinotecan MH - Prospective Studies MH - Quinazolines MH - Thiophenes PMC - PMC8961360 OTO - NOTNLM OT - chemotherapy OT - irinotecan OT - metastatic colorectal cancer OT - raltitrexed OT - second-line COIS- Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2022/03/29 06:00 MHDA- 2022/04/01 06:00 PMCR- 2022/03/26 CRDT- 2022/03/28 08:52 PHST- 2022/03/28 08:52 [entrez] PHST- 2022/03/29 06:00 [pubmed] PHST- 2022/04/01 06:00 [medline] PHST- 2022/03/26 00:00 [pmc-release] AID - 10.1177_10732748221080332 [pii] AID - 10.1177/10732748221080332 [doi] PST - ppublish SO - Cancer Control. 2022 Jan-Dec;29:10732748221080332. doi: 10.1177/10732748221080332.