A randomized phase III trial (389): Oral topotecan/cisplatin (TC) vs IV etoposide/cisplatin (PE) as treatment for chemotherapy-naïve patients (pts) with extensive disease small cell lung cancer (ED-SCLC): Interim tolerability results

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 7046-7046 ◽  
Author(s):  
J. R. Eckardt ◽  
J. Von Pawel ◽  
G. Manikhas ◽  
Z. Papai ◽  
A. Tomova ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Extensive Disease ◽  
Phase Iii Trial ◽  
Oral Topotecan

Irinotecan plus carboplatin versus etoposide plus carboplatin in extensive disease small cell lung cancer: Results of the German randomized phase III trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8029-8029
Author(s):  
A. H. Schmittel ◽  
M. Sebastian ◽  
L. Fischer von Weikersthal ◽  
T. Gauler ◽  
P. Hortig ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Extensive Disease ◽  
Phase Iii Trial ◽  
Grade 3

8029 Background: Superiority of irinotecan over etoposide in combination with cis- or carboplatin was demonstrated in a Japanese and a Scandinavian phase III trial. However, both cisplatin-based North American phase III studies could not detect any difference in efficacy. We report the final results of the German randomized phase III trial comparing etoposide/carboplatin (PE) to irinotecan/carboplatin (IP) in small cell lung cancer (SCLC) extensive disease. Methods: Chemotherapy-naïve extensive disease SCLC patients were randomly assigned to receive carboplatin AUC 5 mg × min/mL either in combination with 50 mg/m2 of irinotecan on days 1, 8 and 15 (IP, Arm A) or with etoposide 140mg/m2 days 1–3 (EP). IP treatment was repeated every 4 weeks, EP every 3 weeks. Response assessment was performed after cycles 2, 4 and 6 and every 3 months thereafter. Toxicity was assessed once weekly. Primary endpoint was detection of progression free survival (PFS), secondary endpoints were overall survival (OS), response rate, and toxicity. Results: A total of 216 patients from 8 centres were randomized. No significant differences in survival or response rate could be detected. Median PFS was 6 months in both arms. Median OS was 10 months (95% confidence interval (CI) 8.3 -11.7) in the IP arm and 9 months (95% CI 7.6 -10.4) in the EP arm. 1 year survival was 37% (95% CI 25.6 - 47.6) and 28% (95% CI 18.2 - 37.4) in the IP and EP arm. 62% of patients in the IP and 63% in the EP arm had a confirmed complete or partial remission according to RECIST criteria. Significant differences in grade 3 and 4 toxicity were observed for thrombopenia (22% IP vs 47% EP) and neutropenia (23% IP vs 61% PE) without differences in the rate of febrile neutropenia. Grade 3 and 4 diarrhea was manageable and as expected significantly more frequent with IP (15%) than with EP (6%). Conclusions: Our phase III trial shows equivalent efficacy of irinotecan when compared to etoposide in combination with carboplatin. [Table: see text]

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