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Phase II study of cetuximab with irinotecan for KRAS wild‐type colorectal cancer in J apanese patients
Author(s) -
Terazawa Tetsuji,
Nishitani Hitoshi,
Kato Ken,
Hashimoto Hironobu,
Akiyoshi Kohei,
Ito Yuriko,
Nakamoto Akihiro,
Iwasa Satoru,
Nakajima Takako Eguchi,
Hamaguchi Tetsuya,
Yamada Yasuhide,
Shimada Yasuhiro
Publication year - 2017
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12405
Subject(s) - medicine , irinotecan , cetuximab , kras , gastroenterology , colorectal cancer , clinical endpoint , rash , adverse effect , neutropenia , oncology , cancer , chemotherapy , randomized controlled trial
Aim Cetuximab improves the prognosis for wild‐type KRAS metastatic colorectal cancer ( MCRC ). We evaluated the safety and efficacy of cetuximab in combination with irinotecan in Japanese patients with wild‐type KRAS MCRC refractory to irinotecan, oxaliplatin and fluoropyrimidines. Methods Cetuximab was administered initially at a dose of 400 mg/m 2 , followed by weekly infusions at 250 mg/m 2 . Irinotecan was administered every 2 weeks at 150 mg/m 2 . Primary endpoint was the incidence of grade 3/4 adverse events; secondary endpoints included overall survival ( OS ), progression‐free survival ( PFS ), response rate ( RR ), time to treatment failure ( TTF ), and TTF for irinotecan. Results Thirty‐four patients were enrolled. Grade 3 or 4 toxicities were leucopenia (11.8%), neutropenia (23.5%), anemia (11.8%), fatigue (2.9%), anorexia (2.9%), diarrhea (14.7%) and hypomagnesemia (5.9%). Skin toxicities were as follows (any grade/grade 3): acne (94.2/8.8%), rash (55.9/0%), nail changes (75.5/8.8%) and hand‐foot syndrome (55.9/5.9%). Median PFS was 6.0 months (95% CI ; 4.7–7.4). Median OS was 12.9 months (95% CI ; 10.0–15.9). RR was 26.4%. Median TTF was 5.1 months and median TTF for irinotecan was 5.0 months (95% CI ; 4.3–5.6). Conclusion Cetuximab with irinotecan therapy was well tolerated in Japanese patients with wild‐type KRAS colorectal cancer refractory to irinotecan, oxaliplatin and fluoropyrimidine, thus demonstrating the feasibility of their usage.