Two different schedules of irinotecan (CPT-11) in patients with advanced colorectal carcinoma relapsing after a 5-fluorouracil and leucovorin combination. A randomized study

Autor: A. Dimitrakopoulos, George Papastratis, T. Giannakakis, N. Tsavaris, H. Tsipras, H. Margaris, M. Vadiaka, Panagiotis Gouveris, Efstathios Papalambros, D. Karadima, C. Kosmas, Sofia Rokana, Aristidis Polyzos, N. Ziras
Rok vydání: 2003
Předmět:
Male
Oncology
Cancer Research
Colorectal cancer
medicine.medical_treatment
Leucovorin
Toxicology
Thymidylate synthase
law.invention
Randomized controlled trial
law
Antineoplastic Combined Chemotherapy Protocols
Pharmacology (medical)
Neoplasm Metastasis
Infusions
Intravenous
biology
Middle Aged
Fluorouracil
Colonic Neoplasms
Disease Progression
Female
Colorectal Neoplasms
therapeutics
medicine.drug
medicine.medical_specialty
medicine.drug_class
Adenocarcinoma
Irinotecan
Antimetabolite
Disease-Free Survival
Drug Administration Schedule
health services administration
Internal medicine
medicine
Carcinoma
Humans
Karnofsky Performance Status
neoplasms
Aged
Pharmacology
Chemotherapy
Rectal Neoplasms
business.industry
medicine.disease
digestive system diseases
Surgery
stomatognathic diseases
biology.protein
Camptothecin
Neoplasm Recurrence
Local
Topoisomerase I Inhibitors
business
Zdroj: Cancer Chemotherapy and Pharmacology. 52:514-519
ISSN: 1432-0843
0344-5704
DOI: 10.1007/s00280-003-0659-z
Popis: To evaluate the efficacy and safety of irinotecan as second-line treatment in patients with advanced colorectal cancer (ACC) failing or relapsing after 5-fluorouracil (5-FU) plus leucovorin (LV) standard chemotherapy.Irinotecan was randomly administered in two different schedules (once every 3 weeks, and every 10 days) in patients failing prior 5-FU plus LV. Patients were randomized to two treatment groups: group A received irinotecan 350 mg/m2 every 21 days and group B received irinotecan 175 mg/m2 days 1 and 10 every 21 days.Group A comprised 60 patients: 34 male/26 female, median age 64 years (range 48-70 years), and median Karnofsky performance status (PS) 90. Their metastatic sites included liver (n=47), lymph nodes (n=27), lung (n=14), abdomen (n=14), pelvis (n=8), "other" (n=2), and local recurrence (n=12). Group B comprised 60 patients: 36 male/24 female, median age 62 years (46-70 years), and median PS 90. Their metastatic sites included liver (n=49), lymph nodes (n=29), lung (n=17), abdomen (n=16), pelvis (n=11), "other" (n=2), and local recurrence (n=13). Group A showed the following responses: complete response (CR) 2, partial response (PR) 12, stable disease (SD) 21, progressive disease (PD) 26, overall response rate (ORR) 23%, tumor growth control 58%. Group B showed the following responses: CR 1, PR 14, SD 22, PD 23; ORR 25%; tumor growth control 62%. Toxicities included acute cholinergic syndrome (group A 53%, group B 19%; P0.0001), late-onset diarrhea grade 1/2 (group A 21%, group B 46%) and grade 3/4 (group A 41%, group B 66%; P0.0001), nausea and vomiting grade 1/2 (group A 34%, group B 59%) and grade 3/4 (group A 30%, group B 12%; P0.0001), neutropenia grade 3/4 (group A 27%, group B 28%; P0.03), with febrile neutropenia seen in only four patients in group A, anemia grade more than 2 (group A 28%, group B 12%; P0.05), asthenia grade more than 3 (group A 24%, group B 18%; P0.001), and alopecia grade more than 3 (group A 40%, group B 34%; P0.2).. The present study indicates that, in patients with ACC who have relapsed after 5-FU plus LV, the administration of irinotecan fractionated into two doses every 21 days yields a similar efficacy to, but a much lower incidence of toxicity than, the same total dose of irinotecan administered once every 21 days.
Databáze: OpenAIRE
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