A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

Summary

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Timeline

Start

2013-12-02

Primary completion

2017-11-20

Completion

2018-06-30

Outcome

Met primary endpoint

paper HR 0·85, 95% CI 0·71-1·02; pnon-inferiority<0·0001 PMID 29555258 ↗

paper mXELIRI with or without bevacizumab is well tolerated and non-inferior to FOLFIRI with or without bevacizumab in terms of overall survival. PMID 29555258 ↗

Publications

• Xu RH, Muro K, Morita S, Iwasa S, Han SW, Wang W, Kotaka M, Nakamura M, Ahn JB, Deng YH, Kato T, Cho SH, Ba Y, Matsuoka H, Lee KW, Zhang T, Yamada Y, Sakamoto J, Park YS, Kim TW. Modified XELIRI (capecitabine plus irinotecan) versus FOLFIRI (leucovorin, fluorouracil, and irinotecan), both either with or without bevacizumab, as second-line therapy for metastatic colorectal cancer (AXEPT): a multicentre, open-label, randomised, non-inferiority, phase 3 trial. Lancet Oncol. 2018 May;19(5):660-671. doi: 10.1016/S1470-2045(18)30140-2. Epub 2018 Mar 16.
• Kotaka M, Xu R, Muro K, Park YS, Morita S, Iwasa S, Uetake H, Nishina T, Nozawa H, Matsumoto H, Yamazaki K, Han SW, Wang W, Ahn JB, Deng Y, Cho SH, Ba Y, Lee KW, Zhang T, Satoh T, Buyse ME, Ryoo BY, Shen L, Sakamoto J, Kim TW. Study protocol of the Asian XELIRI ProjecT (AXEPT): a multinational, randomized, non-inferiority, phase III trial of second-line chemotherapy for metastatic colorectal cancer, comparing the efficacy and safety of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab. Chin J Cancer. 2016 Dec 22;35(1):102. doi: 10.1186/s40880-016-0166-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Comparator	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	CPT-11 (Irinotecan)	Unknown	150 mg/m2	Intravenous
Subject	CPT-11 (Irinotecan)	Unknown	180 mg/m2	Intravenous
Subject	CPT-11 (Irinotecan)	Unknown	200 mg/m2	Intravenous
Subject	Capecitabine	Small molecule	1600 mg/m2	Oral
Comparator	fluorouracil	Small molecule	400 mg/m2	Intravenous
Comparator	fluorouracil	Small molecule	2400 mg/m2	Intravenous
Comparator	l-LV (dl-LV)	Unknown	200 mg/m2	Intravenous
Comparator	l-LV (dl-LV)	Unknown	400 mg/m2	Intravenous

Indications