Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG)
| Autor: | P. Economopoulou, Athanasios Kotsakis, Kostas Kalbakis, Leonidas Chelis, Lambros Vamvakas, N. Vardakis, F. Koinis, Ch. Nikolaou, Aris Polyzos, V. Georgoulias, Nikolaos Kentepozidis, P. Katsaounis, Ch. Christofyllakis |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Pemetrexed Adenocarcinoma Irinotecan 03 medical and health sciences 0302 clinical medicine Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Survival rate Aged Neoplasm Staging Aged 80 and over Salvage Therapy Cisplatin Chemotherapy business.industry General Medicine Middle Aged Prognosis Gemcitabine Survival Rate Regimen 030104 developmental biology Docetaxel 030220 oncology & carcinogenesis Carcinoma Squamous Cell Carcinoma Large Cell Camptothecin Female business Follow-Up Studies medicine.drug |
| Zdroj: | Clinical and Translational Oncology. 19:317-325 |
| ISSN: | 1699-3055 1699-048X |
| DOI: | 10.1007/s12094-016-1532-y |
| Popis: | Platinum-based chemotherapy is the standard front-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, non-platinum combinations of third-generation chemotherapeutic agents are considered an alternative therapeutic option for patients who cannot tolerate the toxic effects of platinum compounds. In this study, the efficacy and toxicity of the combination of irinotecan plus cisplatin (IC) was compared to pemetrexed plus cisplatin (PC) regimen, in platinum-naive patients with advanced NSCLC, who had been previously treated with the combination of a taxane plus gemcitabine. A total of 124 patients with locally advanced or metastatic NSCLC were randomly assigned to either irinotecan 110 mg/m2 on day 1 and 100 mg/m2 on day 8 plus cisplatin 80 mg/m2 on day 8 every 3 weeks (IC arm) or pemetrexed 500 mg/m2 plus cisplatin 80 mg/m2 on day 1 every 3 weeks (PC arm). The primary endpoint of the study was the overall response rate (ORR). The ORR and median progression-free survival (PFS) in the IC arm were 18 % and 3.3 months, respectively, while in the PC arm were 19 % and 4.2 months (p = ns). Median overall survival (OS) was significantly higher in patients with PC (6.9 vs. 10.9; p = 0.013). PC regimen had a better toxicity profile compared to IC, with a statistically significant lower incidence of grade 3/4 neutropenia (3 vs. 31 %; p = 0.0001) and diarrhea (1.6 vs. 14.7 %, p = 0.018). In patients with advanced NSCLC pretreated with docetaxel/gemcitabine, the combination of pemetrexed/cisplatin is associated with increased OS and is better tolerated than the combination of irinotecan/cisplatin and should be considered as a valid therapeutic option for platinum-naive, previously treated patients. NCT00614965. |
| Databáze: | OpenAIRE |
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