A phase II study of irinotecan plus cisplatin for patients with advanced stage IIIB or IV NSCLC previously treated with nonplatinum‐based chemotherapy
- 10 August 2006
- Vol. 107 (4) , 799-805
- https://doi.org/10.1002/cncr.22063
Abstract
BACKGROUND. Irinotecan (I) and cisplatin (P) are active chemotherapy agents with clinical synergy in non–small‐cell lung cancer (NSCLC). We evaluated the efficacy of IP regimen as a salvage treatment of patients with NSCLC that progressed after nonplatinum‐containing regimen(s). METHODS. Eligibility required histologically confirmed NSCLC, bidimensionally measurable disease, ECOG PS 0‐2, and progressive disease after nonplatinum‐based chemotherapy. Treatment consisted of I (65 mg/m2) and P (30 mg/m2) i.v. on Days 1 and 8 of a 21‐day cycle, for a maximum of 6 cycles. An informed consent was obtained from all patients. RESULTS. Between August 2002 and May 2004, 32 patients with median age of 56 years (range, 42–74) were enrolled. Twenty‐four (75%) patients were men, and 28 (88%) had ECOG PS 0 or 1. Twenty‐five patients had adenocarcinoma and 6 had squamous‐cell carcinoma. All patients were evaluated for response and toxicity, and the response rate was 40.6%. After a median follow‐up of 18.5 months, the median survival time was found to be 9.3 months, with a 1‐year survival rate of 43.8%. Toxicities were moderate and manageable, with 47% G3 and 9% G4 neutropenia, 19% G3 diarrhea, and 22% G3 asthenia. There was no G4 nonhematologic toxicity. CONCLUSIONS. The irinotecan and cisplatin combination is an active and well‐tolerated regimen for the patients with advanced NSCLC that progressed after nonplatinum‐containing regimen(s). Cancer 2006. © 2006 American Cancer Society.Keywords
This publication has 13 references indexed in Scilit:
- Randomized Phase II study of two opposite administration sequences of irinotecan and cisplatin in patients with advanced nonsmall cell lung carcinomaCancer, 2006
- Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II studyBritish Journal of Cancer, 2005
- Erlotinib in Previously Treated Non–Small-Cell Lung CancerNew England Journal of Medicine, 2005
- Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With ChemotherapyJournal of Clinical Oncology, 2004
- American Society of Clinical Oncology Treatment of Unresectable Non–Small-Cell Lung Cancer Guideline: Update 2003Journal of Clinical Oncology, 2004
- Three-week schedule of irinotecan and cisplatin in advanced non-small cell lung cancer: a multicentre phase II studyLung Cancer, 2003
- Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based ChemotherapyJournal of Clinical Oncology, 2000
- Phase II Study of Irinotecan Plus Cisplatin in Patients With Advanced Non–Small-Cell Lung CancerJournal of Clinical Oncology, 1999
- Phase I clinical and pharmacologic study of weekly cisplatin combined with weekly irinotecan in patients with advanced solid tumors.Journal of Clinical Oncology, 1998
- Optimal two-stage designs for phase II clinical trialsControlled Clinical Trials, 1989