Noninferiority trials in second-line treatments of nonsmall cell lung cancer: a systematic review of literature with meta-analysis of phase III randomized clinical trials
| Autor: | Paola Tombesi, Emanuela Scarpi, Cinzia Castellani, Fabrizio Drudi, Davide Tassinari, Federica Carloni, Sergio Sartori, Luigi Lazzari-Agli |
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| Rok vydání: | 2011 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Guanine Lung Neoplasms Antineoplastic Agents Docetaxel Pemetrexed law.invention Gefitinib Randomized controlled trial Glutamates law Internal medicine Carcinoma Non-Small-Cell Lung medicine Clinical endpoint Humans Survival rate Randomized Controlled Trials as Topic business.industry Odds ratio Clinical Trials Phase III as Topic Meta-analysis Quinazolines Taxoids business Topotecan medicine.drug |
| Zdroj: | American journal of clinical oncology. 35(6) |
| ISSN: | 1537-453X |
| Popis: | BACKGROUND To assess the role of the novel second-line treatments in nonsmall cell lung cancer (NSCLC). METHODS A systematic review of the literature with meta-analysis of phase III randomized clinical trials (RCTs) was independently performed by 3 authors. All the trials comparing any novel treatment with every-3-weeks docetaxel (3WD) and designed as noninferiority trial were included in the analysis. One-year survival rate (SR) was the primary end point, and quality of life and safety represented the secondary end points. RESULTS Four RCTs met the selection criteria. The outcomes of 3355 patients were analyzed in the pooled analysis. No heterogeneity was documented in the primary analysis either including all the trials or analyzing separately gefitinib and the chemotherapeutic alternatives to 3WD. The cumulative odds ratio was 0.927 (P=0.313) for 1-year SR, 0.889 (P=0.323) for the chemotherapeutic alternatives to 3WD and 0.953 (P=0.616) for gefitinib. The experimental arms showed a significant advantage in quality of life in the cumulative analysis (odds ratio=1.623, P=0.01) and in the subgroup of patients treated with gefitinib (odds ratio=1.962, P |
| Databáze: | OpenAIRE |
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