1. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study
- Author
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Olivier Raffy, Adrien Dixmier, Gérard Zalcman, Clara Fontaine-Delaruelle, Damien Pouessel, Olivier Molinier, Sandrine Hiret, Franck Morin, Patrick-Aldo Renault, Julien Mazieres, Charles Dayen, Patrick Dumont, Catherine Becht, Sylvestre Le Moulec, Eric Pichon, Benjamin Besse, Clarisse Audigier-Valette, Claire Poulet, Fabrice Barlesi, Alexis B. Cortot, Denis Moro-Sibilot, and Alexandra Langlais
- Subjects
0301 basic medicine ,Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,Bevacizumab ,Adolescent ,Paclitaxel ,medicine.medical_treatment ,Population ,Docetaxel ,Kaplan-Meier Estimate ,Neutropenia ,Gastroenterology ,Drug Administration Schedule ,03 medical and health sciences ,chemistry.chemical_compound ,Young Adult ,0302 clinical medicine ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,Lung cancer ,education ,Aged ,Neoplasm Staging ,Aged, 80 and over ,Chemotherapy ,education.field_of_study ,Cross-Over Studies ,business.industry ,Hazard ratio ,Middle Aged ,medicine.disease ,Progression-Free Survival ,030104 developmental biology ,Oncology ,chemistry ,030220 oncology & carcinogenesis ,Disease Progression ,Female ,business ,medicine.drug - Abstract
Purpose Second-line chemotherapy regimens have demonstrated poor benefit after failure of platinum-based chemotherapy in advanced non-squamous non–small-cell lung cancer (nsNSCLC). Methods In this multicentre, open-label phase III trial, patients with advanced nsNSCLC treated with one or two prior lines, including one platinum-based doublet, were centrally randomised to receive 90 mg/m2 of paclitaxel (D1, D8, D15) plus 10 mg/kg of bevacizumab (D1, D15) every 28 days or docetaxel (75 mg/m2) every 21 days; crossover was allowed after disease progression. Primary end-point was progression-free survival (PFS). ClinicalTrials.gov registration number: NCT01763671 . Results One hundred sixty six patients were randomised (paclitaxel plus bevacizumab: 111, docetaxel: 55). The median PFS was longer in patients receiving paclitaxel plus bevacizumab than in patients receveing docetaxel [5·4 months versus 3·9 months, adjusted hazard ratio (HR) 0·61 (95% confidence interval [CI]: 0·44–0·86); p = 0·005]. Objective response rates (ORRs) were 22·5% (95% CI: 14·8–30·3) and 5·5% (95% CI: 0·0–11·5) (p = 0·006), respectively. Median overall survivals were similar (adjusted HR 1·17; p = 0·50). Crossover occurred in 21 of 55 (38·2%) docetaxel-treated patients. Grade III-IV adverse events (AEs) were reported in 45·9% and 54·5% of patients treated with paclitaxel and bevacizumab or docetaxel, respectively (p = NS), including neutropenia (19·3% versus 45·4%), neuropathy (8·3% versus 0·0%) and hypertension (7·3% versus 0·0%). Three patients died due to treatment-related AEs (1·8% in each group). Conclusion Weekly paclitaxel plus bevacizumab as second- or third-line improves PFS and ORR compared with docetaxel in patients with nsNSCLC, with an acceptable safety profile. These results place weekly paclitaxel plus bevacizumab as a valid option in this population. Clinical trials registration number ClinicalTrials.gov Identifier: NCT01763671 .
- Published
- 2020