FIRST-LINE CETUXIMAB WITH FOLFOX OR FOLFIRI. EVERY 2 WEEKS IN KRAS WILD-TYPE METASTATIC. COLORECTAL CANCER: PHASE II APEC ...
poster discussions
Annals of Oncology
PD 0028
FIRST-LINE CETUXIMAB WITH FOLFOX OR FOLFIRI EVERY 2 WEEKS IN KRAS WILD-TYPE METASTATIC COLORECTAL CANCER: PHASE II APEC STUDY
Ann-Lii Cheng1, Gerardo Cornelio2, Lin Shen3, Timothy Price4, Tsai-Sheng Yang5, Ik-Joo Chung6, Guang-Hai Dai7, Jen-Kou Lin8, Atul Sharma9, Kun-Huei Yeh10, Brigette Ma11, Adel Zaatar12, Zhong-Zhen Guan13, Nehal Masood14, Vichien Srimuninnimit15, Thomas Yau16, Barbara Sarholz17, Robert Lim18 1 National Taiwan University Hospital, Taipei, Taiwan, 2San Juan de Dios Hospital, Pasay City, Philippines, 3Beijing Cancer Hospital, Beijing, China, 4Queen Elizabeth Hospital and University of Adelaide, Woodville South, Australia, 5Chang Gung Memorial Hospital-LinKou, Taoyuan, Taiwan, 6Chonnam National University Hwasun Hospital, Hwasun-eup, Korea, 7The General Hospital of the People’s Liberation Army, Beijing, China, 8Taipei Veterans General Hospital, Taipei, Taiwan, 9 All India Institute of Medical Sciences, New Delhi, India, 10National Taiwan University Hospital, Taipei, Taiwan, 11Prince of Wales Hospital, New Territories, Malaysia, 12Mount Miriam Cancer Hospital, Penang, Malaysia, 13Sun Yatsen University Cancer Center, Guangzhou, China, 14The Aga Khan University & Hospital, Karachi, Pakistan, 15Siriraj Hospital, Bangkok, Thailand, 16Queen Mary Hospital, Hong Kong, Hong Kong, 17Merck KGaA, Darmstadt, Germany, 18 National University Hospital, Singapore, Singapore Background: Randomized studies have shown that the addition of weekly cetuximab to FOLFOX or FOLFIRI improves clinical outcome in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer (mCRC). This Asia-Pacific multicenter non-randomized phase II study investigated the efficacy and safety of both FOLFOX and FOLFIRI in combination with every 2 weeks cetuximab as first-line therapy in patients with KRAS wild-type mCRC. Methods: Eligible patients received every 2 weeks cetuximab (day 1, 500 mg/m2 every 14 days) with, based on investigator’s choice, either FOLFOX (oxaliplatin 100 mg/m2, folinic acid [FA] 200 mg/m2 L-form or 400 mg/m2 racemic, then 5-fluorouracil [5-FU], as a 400 mg/m2 iv bolus and a 2400 mg/m2 infusion over 46 h) or FOLFIRI (irinotecan 180 mg/ m2, FA 200 mg/m2 L-form, or 400 mg/m2 racemic, then 5-FU, as a 400 mg/m2 iv bolus and a 2400 mg/m2 infusion over 46 h). Study treatment was continued until disease progression, the occurrence of unacceptable toxicity or consent withdrawal. The primary endpoint was tumor response; assessed radiologically (RECIST 1.0) every 8 weeks.
iv | poster discussions
Volume 24 | Supplement 4 | June 2013
Annals of Oncology
poster discussions
PD-0028 Table Results: Data cut-off was 86 weeks after the date of the last patient included. The intention to treat (ITT)/safety population comprised 289 patients; 65.1% received FOLFOX plus cetuximab and 34.9% FOLFIRI plus cetuximab. Baseline characteristics were generally well balanced between treatment groups. However, leukocyte count >10000/mm3 was more frequent (16.5% vs 7.9%) and prior adjuvant treatment less frequent (21.3% vs 46.5%) in patients receiving FOLFOX plus cetuximab. A best overall response (complete + partial) rate of 58.8% and a median progression-free survival (mPFS) time of 11.1 months were observed in the combined ITT population (Table). 70.9% of patients showed ≥20% reduction in tumor diameter at 8 weeks from baseline. A post-hoc analysis showed a mPFS time of 12.7 months for this group. The overall R0 resection rate in the ITT population was 10.0%. Survival data are not yet mature. Cetuximab dose intensity was >80% in 77.7% of patients in the FOLFOX plus cetuximab group and 74.3% of patients in the FOLFIRI plus cetuximab group. The most frequent grade 3/4 adverse events (reported for >10% of patients in either arm) were neutropenia, diarrhea, hypokalemia, neuropathy (FOLFOX plus cetuximab group only) and skin reactions. Conclusion: In this study population from the Asia-Pacific region, first-line treatment with chemotherapy plus cetuximab was active and well-tolerated. Efficacy and safety profiles of every 2 weeks cetuximab combined with FOLFOX or FOLFIRI were similar to those reported for either chemotherapy plus weekly cetuximab in pivotal studies.
Volume 24 | Supplement 4 | June 2013
doi:10.1093/annonc/mdt202 | iv
