Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer

Takuji Okusaka, Junji Furuse, Akihiro Funakoshi, Tatsuya Ioka, Kenji Yamao, Shinichi Ohkawa, Narikazu Boku, Yoshito Komatsu, Shoji Nakamori, Haruo Iguchi, Tetsuhide Ito, Kazuhiko Nakagawa, Kohei Nakachi

研究成果: Contribution to journalArticle査読

51 被引用数 (Scopus)


Erlotinib combined with gemcitabine has not been evaluated in Japanese patients with unresectable pancreatic cancer. This two-step phase II study assessed the safety and pharmacokinetics of erlotinib 100mg/day (oral) plus gemcitabine 1000mg/m2 (i.v. days 1, 8, 15) in a 28-day cycle in the first step, and efficacy and safety in the second step. The primary end-point was safety. One hundred and seven patients were enrolled (first step, n=6; second step, n=101). The most common adverse event was RASH (compiled using the preferred terms rash, acne, exfoliative rash, dermatitis acneiform, erythema, eczema, dermatitis and pustular rash) in 93.4% of patients. One treatment-related death occurred. While interstitial lung disease-like events were reported in nine patients (8.5%; grade 1/2/3, 3.8/2.8/1.9%), all patients recovered or improved. The median overall survival, the 1-year survival rate and median progression-free survival were 9.23months, 33.0% and 3.48months, respectively. The overall response and disease control rates were 20.3% and 50.0%, respectively. In Japanese patients with unresectable pancreatic cancer, erlotinib plus gemcitabine had acceptable toxicity and efficacy that was not inferior to that seen in Western patients. (Cancer Sci 2011; 102: 425-431)

ジャーナルCancer Science
出版ステータス出版済み - 2 2011

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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