Phase II study of a 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive-stage small-cell lung cancer.
BACKGROUND
Irinotecan has been introduced to improve the treatment of small-cell lung cancer (SCLC). We conducted a trial involving a 3-week schedule of irinotecan combined with cisplatin (IP) to validate the efficacy and toxicity of this regimen in patients with previously untreated extensive-stage SCLC (ES-SCLC).


METHODS
Twenty-eight patients with previously untreated ES-SCLC were enrolled in the study between January 2003 and December 2005. Irinotecan 60 mg/m(2) was administered intravenously on days 1 and 8 in combination with cisplatin 60 mg/m(2) on day 1 every 21 days.


RESULTS
Twenty-eight patients were followed until July 2007. The median follow-up time was 15.6 months. The actual dose intensities (DIs) of cisplatin and irinotecan were 97.7 and 92.2%, respectively. Among the 28 ES-SCLC patients, the objective response rate was 89.3% (25 patients). The major grade 3/4 hematological toxicity was neutropenia (26.9% of cycles). Grade 3/4 non-hematological toxicities were rare. The median progression-free and overall survival times were 8.7 and 16.5 months, with a 1-year survival rate of 66.6% and 2-year survival rate of 22.2%.


CONCLUSIONS
The 3-week schedule of IP was feasible and showed a high DI of irinotecan and decreased toxicity.
Lee
Jeong Eun
JE
Department of Internal Medicine, College of Medicine, Chungnam National University Hospital and Cancer Research Institute, Daejeon, South Korea.
Park
Hee Sun
HS
Jung
Sung Soo
SS
Kim
Ju Ock
JO
Kim
Sun Young
SY
D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin