In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 17002-17002
Abstract:
17002 Background: A current option for recurrent NSCLC is monotherapy with docetaxel. However, cisplatin, if tolerable, may still have power for this condition. Irinotecan is also a key drug for NSCLC. The objectives of this study were to evaluate the clinical relevance of weekly chemotherapy consisting of irinotecan and cisplatin as a 2nd-line therapy for NSCLC. Methods: Patients meeting all following criteria were eligible: proven NSCLC refractory or recurrent after previous single-regimen chemotherapy, PS (0–2), age 〉 15 years, adequate organ functions, measurable lesions by RECIST, life expectancy exceeding 8 weeks, and written informed consent. Patients with any of the following conditions were ineligible: previous treatment with irinotecan and/or surgery, requirement of thoracic irradiation, interstitial lung disease, pleural effusion or ascites requiring treatment, pericardial effusion, symptomatic brain metastasis, concomitant malignancy or other inadequate condition. Irinotecan (60 mg/m 2 in 500 ml electrolyte soln, day 1) and cisplatin (25 mg/m 2 in 500 ml saline, day 1, without further hydration) were administered every week for at least 6 courses unless encountering defined skip criteria. Calculated minimum sample size was 43 based on Simon two-stage optimal design with p0=0.10, p1=0.25, α error=0.05 and β error=0.20; planned sample size was 48. The primary endpoint was response rate, and the secondary ones were toxicity and survival time. Results: Since February 2002, 48 patients (consisting of 29 with adeno-, 14 with squamous cell, 3 with large cell carcinoma and 2 with NSCLC not further specified) with a median age of 62-years were enrolled, with 1 death before treatment. Therefore, 47 patients were eligible for evaluation of response rate and toxicity, whereas all 48 were analyzed for survival. Chemotherapy was administered for a median 6 courses (range, 0–15). Response rate was 25.5% (95% CI: 12.9–38.1%). Toxicity of grade 3 or 4 consisted of neutropenia (29.8%), thrombocytopenia (6.4%), anemia (29.8%), diarrhea (10.6%) and nausea (21.3%). MST was 10.6 months, and 1-year survival rate was 43%. Conclusions: This 2nd-line chemotherapy for NSCLC showed promising efficacy with tolerable toxicity. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2006.24.18_suppl.17002
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2006
detail.hit.zdb_id:
2005181-5
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