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
| العنوان: | 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 |
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| المؤلفون: | 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 |
| المساهمون: | 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 |
| المصدر: | Journal of Clinical Oncology. 35:1281-1287 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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. |
| وصف الملف: | ELETTRONICO |
| تدمد: | 1527-7755 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::93ab92bcce61585d774ca44803023d78Test https://doi.org/10.1200/jco.2016.69.4844Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....93ab92bcce61585d774ca44803023d78 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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