Final analysis of the phase 2 APEC study: Overall survival (OS) data and biomarker subanalyses for first-line FOLFOX or FOLFIRI with cetuximab (cet) once every 2 weeks in patients (pts) with KRAS or RAS (KRAS and NRAS, exons 2-4) wild-type (wt) metastatic colorectal cancer (mCRC).

Authors

null

Ann-Lii Cheng

National Taiwan University Hospital, Taipei, Taiwan

Ann-Lii Cheng , Gerardo H. Cornelio , Lin Shen , Timothy Jay Price , Tsai-Sheng Yang , Ik-Joo Chung , Guanghai Dai , Jen-Kou Lin , Atul Sharma , Kun-Huei Yeh , Brigette Ma , Adel Zaatar , Zhongzhen Guan , Nehal Masood , Vichien Srimuninnimit , Thomas Cheung Yau , Frank Beier , Sudipto Chatterjee , Robert S.C. Lim

Organizations

National Taiwan University Hospital, Taipei, Taiwan, San Juan De Dios Hospital, Pasay City, Philippines, Beijing Cancer Hospital, Beijing, China, Queen Elizabeth Hospital, University of Adelaide, Woodville, Australia, Chang Gung Memorial Hospital, Taoyuan, Taiwan, Chonnam National University Hwasun Hospital, Hwasuneup, South Korea, General Hospital of the People's Liberation Army, Beijing, China, Taipei Veterans General Hospital, Taipei, Taiwan, All India Institute of Medical Sciences, New Delhi, India, State Key Laboratory of Oncology in South China, Sir Y K Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute and Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong, Mount Miriam Cancer Hospital, Penang, Malaysia, Sun Yat-sen University Cancer Center, Guangzhou, China, Aga Khan University and Hospital, Karachi, Pakistan, Siriraj Hospital, Bangkok, Thailand, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong, Merck KGaA, Darmstadt, Germany, National University Health System, Singapore, Singapore

Research Funding

Pharmaceutical/Biotech Company

Background: The Asia-Pacific, multicenter, nonrandomized, phase II APEC study previously reported that first-line therapy for pts with KRAS ex 2 wt mCRC consisting of C once every 2 weeks combined with FOLFOX or FOLFIRI achieved efficacy and safety profiles comparable to those reported in analogous pivotal studies involving weekly C. This final analysis presents OS data from the KRAS wt intent-to-treat (ITT) population, as well as subgroup efficacy analyses stratified by BRAF, PIKC3A, and all RAS mutation status. Methods: Eligible pts received C once every 2 weeks (day 1 of each cycle, 500 mg/m2) with FOLFOX or FOLFIRI (investigator’s choice). Study treatment continued until disease progression, dose-limiting toxicity or consent withdrawal. The primary endpoint was best confirmed overall response as assessed by RECIST 1.0; progression-free survival (PFS) and OS were secondary endpoints. In the evaluable populations, the status of BRAF, PIK3CA, and all RAS mutations was assessed retrospectively by pyrosequencing. Results: 42 months after the last patient was enrolled, median OS in the KRAS wt population was 26.8 months (Table). There were no unexpected safety findings. Additional biomarker results—including objective response rate (ORR), PFS, and OS subgroup analyses stratified on BRAF, PIKC3A, and all RAS mutation status—will be presented. Conclusions: The observed median OS of 26.8 months in the KRAS wt population is comparable to that reported in prior pivotal studies involving weekly C plus FOLFOX or FOLFIRI in the first line. These results suggest that C plus FOLFOX or FOLFIRI in a once-every-2-weeks regimen is active and tolerable as first-line therapy in this Asia-Pacific study population and a convenient alternative to weekly administration. Clinical trial information: NCT00778830

ITT (KRAS wt) PopulationC + FOLFIRI (n=101)C + FOLFOX (n=188)Total
(n=289)
OSNumber of events (death), n (%)62 (61.4%)123 (65.4%)185 (64.0%)
HR (95% CI)1.103 (0.813-1.498)
Median, months26.627.026.8
95% CI21.5-33.822.8-30.123.4-29.7

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Translational Research

Clinical Trial Registration Number

NCT00778830

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 566)

DOI

10.1200/jco.2015.33.3_suppl.566

Abstract #

566

Poster Bd #

B10

Abstract Disclosures