Irinotecan (CPT-11) in metastatic colorectal cancer patients resistant to 5-fluorouracil (5-FU): a phase II study.
The efficacy and toxicity of irinotecan (CPT-11) 350 mg/m(2) i.v. once every 3 weeks was assessed in 60 patients with advanced colorectal cancer (CRC) showing failure to 5-fluorouracil (5-FU) treatment. The overall objective response rate was 13.6% (1 complete response and 4 partial responses) and 25 patients (42.4%) showed stable disease; the median time to disease progression was 4.4 months and the median survival was 10.5 months. The main non-hematological toxicities were alopecia (80.3% of patients), diarrhea (75.0%), and nausea/vomiting (71.7%); neutropenia was the main hematological toxicity. Grade 3 or 4 diarrhea appeared in 21 of 131 cycles (16.1%), whereas grade 3 or 4 neutropenia appeared in 78 cycles (25.0%). In conclusion, the present phase II study confirms that CPT-11 350 mg/m(2) every 3 weeks is active and well tolerated as second-line chemotherapy for CRC in 5-FU resistant patients.
Antón
A
A
Department of Oncological Medicine, Hospital Miguel Servet, Paseo de Isabel la Católica 1-3, 50013 Zaragoza, Spain. aantont@salud.aragob.es
Aranda
E
E
Carrato
A
A
Marcuello
E
E
Massutti
B
B
Cervantes
A
A
Abad
A
A
Sastre
J
J
Fenández-Martos
C
C
Gallén
M
M
Díaz-Rubio
E
E
Huarte
L
L
Balcells
M
M
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D013030:Spain; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin