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
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) Population | C + FOLFIRI (n=101) | C + FOLFOX (n=188) | Total (n=289) | |
---|---|---|---|---|
OS | Number of events (death), n (%) | 62 (61.4%) | 123 (65.4%) | 185 (64.0%) |
HR (95% CI) | 1.103 (0.813-1.498) | |||
Median, months | 26.6 | 27.0 | 26.8 | |
95% CI | 21.5-33.8 | 22.8-30.1 | 23.4-29.7 |
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