Han, Ji-Youn; Lee, Dae Ho; Lee, Sung Young; Park, Chun Gun; Kim, Hyae Young; Lee, Hong Gi; Lee, Jae Jin; Kim, Heung Tae; Lee, Jin Soo
Cancer
2005Dec ; 104 ( 12 ) :2759-65.
PMID : 16294344
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Han, Ji-Youn -
Lee, Dae Ho -
Lee, Sung Young -
Park, Chun Gun -
Kim, Hyae Young -
Lee, Hong Gi -
Lee, Jae Jin -
Kim, Heung Tae -
Lee, Jin Soo -
ABSTRACT
BACKGROUND: A Phase II study was conducted to evaluate the efficacy and toxicity of an irinotecan plus capecitabine combination, a new nonplatinum regimen, in chemonaive patients with advanced nonsmall cell lung carcinoma (NSCLC).
METHODS: Between July 2003 and April 2004, 53 patients with a histologically confirmed diagnosis of NSCLC were enrolled. All but 5 patients were male, 52 (98%) had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, 39 (74%) had AJCC Stage IV disease, and the median age was 61 years. Treatment consisted of intravenous irinotecan at a dose of 90 mg/m(2) on Days 1 and 8 and oral capecitabine at a dose of 1000 mg/m(2) twice daily on Days 1-14 of each 21-day cycle, given up to 12 cycles.
RESULTS: Of 53 patients enrolled, 22 achieved objective tumor responses (all partial responses) for an overall response rate of 41.5% (95% confidence interval [95% CI], 28.2-54.8%). After a median follow-up of 17.4 months, the median survival was 14.6 months with a 1-year survival rate of 60.1% (95% CI, 46.9-73.4%) and a median progression-free survival of 5.1 months. Treatment was very well tolerated, with only 10% of patients experiencing NCI-CTC Grade 3 or 4 toxicities. The most common toxicities were hand-foot syndrome and diarrhea. In multiple logistic regression analysis for overall response, only the stage predicted for significantly better response (P = 0.04). Squamous cell carcinoma was marginally predictive for better response (P = 0.08).
CONCLUSIONS: The irinotecan plus capecitabine regimen demonstrated an antitumor activity that is favorably comparable with other commonly used cisplatin-based regimens. Given the mild toxicity profile and favorable survival outcome, this nonplatinum regimen warrants further evaluation in a randomized trial. CI - Copyright 2005 American Cancer Society.
Irinotecan, capecitabine, antitumor activity, nonsmall cell lung carcinoma.
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Camptothecin/administration & dosage/analogs & derivatives, Capecitabine, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology, Deoxycytidine/administration & dosage/analogs & derivatives, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Fluorouracil/analogs & derivatives, Humans, Infusions, Intravenous, Lung Neoplasms/*drug therapy/mortality/*pathology, Male, Middle Aged, Neoplasm Staging, Probability, Prognosis, Risk Assessment, Statistics, Nonparametric, Survival Rate, Treatment Outcome
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