title: Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer.
abstract: 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.
authors.affiliation: National Cancer Center Hospital, Tokyo, Japan. tokusaka@ncc.go.jp
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Akihiro
authors.initials: A
authors.lastname: Funakoshi
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ioka
authors.forename: Kenji
authors.initials: K
authors.lastname: Yamao
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohkawa
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Shoji
authors.initials: S
authors.lastname: Nakamori
authors.forename: Haruo
authors.initials: H
authors.lastname: Iguchi
authors.forename: Tetsuhide
authors.initials: T
authors.lastname: Ito
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Kohei
authors.initials: K
authors.lastname: Nakachi
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D044466:Asian People; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine