title: A pilot study of cisplatin, irinotecan, leucovorin and 5-fluorouracil (PILF) combination chemotherapy for advanced gastric cancer.
abstract: OBJECTIVE
  Irinotecan, in combination with leucovorin/5-fluorouracil (FU) or with cisplatin, is known to be active for treating advanced gastric cancer (AGC). This pilot study evaluated a novel three-drug combination of irinotecan, leucovorin/FU and cisplatin as a first-line treatment of AGC. The primary endpoint was to assess the feasibility in anticipation of conducting a larger phase II study.
  
  
  METHODS
  Chemotherapy-naive AGC patients received irinotecan 150 mg/m(2) on day 1, and leucovorin 200 mg/m(2) and a 22-h infusion of FU 1000 mg/m(2) on days 1 and 2. Cisplatin 30 mg/m(2) was administered on day 2. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Of the 17 eligible patients, two patients had an ECOG performance status of 2 and their median age was 48 years (range: 31 to 69). A total of 117 chemotherapy cycles were delivered (median: 6, range: 1 to 12). The causes of treatment discontinuation were disease progression in 9 patients (53%), refusal (35%) and toxicity (12%). Although grade 3 or 4 neutropenia (41% of patients) was the major toxicity that required dose adjustments, only one episode of febrile neutropenia occurred. Grade 3 or 4 nausea and vomiting, diarrhea and fatigue were observed in 35%, 35% and 29% of patients, respectively. None of the patients died of toxicity during treatment. Of the 16 patients who were evaluable for response, 7 (44%) experienced a partial response.
  
  
  CONCLUSIONS
  This novel multi-drug combination was tolerated well in patients with AGC. Based on the encouraging efficacy and tolerability, a randomized phase II study is ongoing in this disease setting.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Soo Yeon
authors.initials: SY
authors.lastname: Jeon
authors.forename: Kwang Il
authors.initials: KI
authors.lastname: Ko
authors.forename: Eunmi
authors.initials: E
authors.lastname: Nam
authors.forename: Soo-Mee
authors.initials: SM
authors.lastname: Bang
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
authors.forename: Woon Ki
authors.initials: WK
authors.lastname: Lee
authors.forename: Min
authors.initials: M
authors.lastname: Chung