Italian, Multicenter, Phase III, Randomized Study of Cisplatin Plus Etoposide With or Without Bevacizumab as First-Line Treatment in Extensive-Disease Small-Cell Lung Cancer: The GOIRC-AIFA FARM6PMFJM Trial
| Autor: | Luca Boni, Carmelo Tibaldi, Claudio Dazzi, F. Zanelli, Ferdinando Riccardi, Editta Baldini, Nicoletta Zilembo, Rita Chiari, Francesca Ambrosio, Andrea Ardizzoni, Andrea Camerini, Gianni Michele Turolla, Francesco Grossi, Saverio Cinieri, Marcello Tiseo, Efisio Defraia, Vito D'Alessandro, Matteo Brighenti, Anna Rita Trolese |
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| Přispěvatelé: | Tiseo, Marcello, Boni, Luca, Ambrosio, Francesca, Camerini, Andrea, Baldini, Editta, Cinieri, Saverio, Brighenti, Matteo, Zanelli, Francesca, Defraia, Efisio, Chiari, Rita, Dazzi, Claudio, Tibaldi, Carmelo, Turolla, Gianni Michele, D'Alessandro, Vito, Zilembo, Nicoletta, Trolese, Anna Rita, Grossi, Francesco, Riccardi, Ferdinando, Ardizzoni, Andrea |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Bevacizumab Phases of clinical research Disease-Free Survival law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Medicine Progression-free survival Lung cancer Survival rate Etoposide Aged Aged 80 and over Antineoplastic Combined Chemotherapy Protocol business.industry Middle Aged medicine.disease Small Cell Lung Carcinoma Surgery Lung Neoplasm Regimen 030104 developmental biology 030220 oncology & carcinogenesis Female Cisplatin business Human medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 35:1281-1287 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2016.69.4844 |
| Popis: | Purpose Considering promising results in phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line cisplatin plus etoposide for treatment of extensive-disease (ED) small-cell lung cancer (SCLC). Patients and Methods Treatment-naive patients with ED-SCLC were randomly assigned to receive either cisplatin plus etoposide (arm A) or the same regimen with bevacizumab (arm B) for a maximum of six courses. In the absence of progression, patients in arm B continued bevacizumab alone until disease progression or for a maximum of 18 courses. The primary end point was overall survival (OS). Results Two hundred four patients were randomly assigned and considered in intent-to-treat analyses (103 patients in arm A and 101 patients in arm B). At a median follow-up of 34.9 months in arm A and arm B, median OS times were 8.9 and 9.8 months, and 1-year survival rates were 25% and 37% (hazard ratio, 0.78; 95% CI, 0.58 to 1.06; P = .113), respectively. A statistically significant effect of bevacizumab on OS in patients who received maintenance was seen (hazard ratio, 0.60; 95% CI, 0.40 to 0.91; P = .011). Median progression-free survival times were 5.7 and 6.7 months in arm A and arm B, respectively ( P = .030). Regarding hematologic toxicity, no statistically significant differences were observed; for nonhematologic toxicity, only hypertension was more frequent in arm B (grade 3 or 4, 1.0% v 6.3% in arms A v B, respectively; P = .057). Conclusion The addition of bevacizumab to cisplatin and etoposide in the first-line treatment of ED-SCLC had an acceptable toxicity profile and led to a statistically significant improvement in progression-free survival, which, however, did not translate into a statistically significant increase in OS. Further research with novel antiangiogenic agents, particularly in the maintenance setting, is warranted. |
| Databáze: | OpenAIRE |
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