A Pilot Study of Cisplatin, Irinotecan, Leucovorin and 5-fluorouracil (PILF) Combination Chemotherapy for Advanced Gastric Cancer.
- Author:
Se Hoon PARK
1
;
Soo Yeon JEON
;
Kwang Il KO
;
Eunmi NAM
;
Soo Mee BANG
;
Eun Kyung CHO
;
Dong Bok SHIN
;
Jae Hoon LEE
;
Woon Ki LEE
;
Min CHUNG
Author Information
1. Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. dbs@gilhospital.com
- Publication Type:Original Article
- Keywords:
Stomach neoplasm;
Irinotecan;
5-fluorouracil;
Cisplatin
- MeSH:
Cisplatin*;
Diarrhea;
Disease Progression;
Disulfiram;
Drug Therapy;
Drug Therapy, Combination*;
Fatigue;
Febrile Neutropenia;
Fluorouracil*;
Humans;
Leucovorin*;
Nausea;
Neutropenia;
Pilot Projects*;
Stomach Neoplasms*;
Vomiting
- From:Cancer Research and Treatment
2006;38(3):121-125
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: 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. MATERIALS AND METHODS: Chemotherapy-naive AGC patients received irinotecan 150 mg/m2 on day 1, and leucovorin 200 mg/m2 and a 22-h infusion of FU 1000 mg/m2 on days 1 and 2. Cisplatin 30 mg/m2 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. CONCLUSION: 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.