Open AccessPhase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer
Author(s) -
Okusaka Takuji,
Furuse Junji,
Funakoshi Akihiro,
Ioka Tatsuya,
Yamao Kenji,
Ohkawa Shinichi,
Boku Narikazu,
Komatsu Yoshito,
Nakamori Shoji,
Iguchi Haruo,
Ito Tetsuhide,
Nakagawa Kazuhiko,
Nakachi Kohei
Publication year - 2011
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/j.1349-7006.2010.01810.x
Subject(s) - gemcitabine , erlotinib , medicine , pancreatic cancer , phases of clinical research , erlotinib hydrochloride , gastroenterology , oncology , cancer , chemotherapy , epidermal growth factor receptor
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 100 mg/day (oral) plus gemcitabine 1000 mg/m 2 (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 9.23 months, 33.0% and 3.48 months, 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)