A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy

• Published in: Cancer chemotherapy and pharmacology Vol. 71; no. 2; pp. 481 - 488
• Main Authors: Sym, Sun Jin, Hong, Junshik, Park, Jinny, Cho, Eun Kyung, Lee, Jae Hoon, Park, Yeon Ho, Lee, Woon Ki, Chung, Min, Kim, Hyung-Sik, Park, Se Hoon, Shin, Dong Bok
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.02.2013; Springer; Springer Nature B.V
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; Cancer Research; Female; Fluorouracil - administration & dosage; Fluorouracil - therapeutic use; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Leucovorin - administration & dosage; Leucovorin - therapeutic use; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Oncology; Original Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; Irinotecan; Chemotherapy; Second-line; Stomach cancer; Antineoplastic agent; Toxicity; Calcium folinate; Metastasis; Randomization; Isomerases; Phase II trial; Advanced stage; Topoisomerase I inhibitor; Gastric disease; Fluorouracil; Camptothecin derivatives; Human; Treatment resistance; Enzyme; Fluoropyrimidine derivatives; Transferases; DNA topoisomerase; Enzyme inhibitor; Malignant tumor; Stomach adenocarcinoma; Thymidylate synthase; Induction treatment; First line treatment; Treatment; Antimetabolic; Methyltransferases; Pyrimidine derivatives; Digestive diseases; Monotherapy; Cancer
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-012-2027-3

Background The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC). Methods A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m 2 iv on day 1) or mFOLFIRI (CPT-11 150 mg/m 2 plus LV 20 mg/m 2 on day 1 followed by 5-FU 2,000 mg/m 2 over 48 h), every 2 weeks. The primary end point was objective response rate (ORR). Results Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4–30.9] and 20.0 % (95 % CI 5.6–34.3) for the CPT-11 and mFOLFIRI arms, respectively ( P  = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2–4.3) for CPT-11 versus 3.0 months (95 % CI 2.0–3.7) for mFOLFIRI ( P  = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0–8.7), compared with 6.7 months (95 % CI 5.3–8.2) ( P  = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively. Conclusions Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.