Metronomic oral vinorelbine in previously untreated advanced non-small-cell lung cancer patients unfit for platinum-based chemotherapy: results of the randomized phase II Tempo Lung trial
| Autor: | Giulia Pasello, Giovanni Luca Ceresoli, R. Bernabé, S. Gautier, Francesco Grossi, Dariusz M. Kowalski, Agnese Montanino, C. Ta Thanh Minh, Rodryg Ramlau, P. Laundreau, Alessandro Morabito, Andrea Camerini, F. De Marinis, Joaquim Bosch-Barrera, Tudor-Eliade Ciuleanu |
|---|---|
| Přispěvatelé: | Pierre Fabre |
| Rok vydání: | 2021 |
| Předmět: |
Cancer Research
medicine.medical_specialty Lung Neoplasms carcinoma non-small-cell lung Population administration and dosage frail randomized controlled trial vinorelbine Phases of clinical research Neutropenia urologic and male genital diseases Vinorelbine Gastroenterology Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans Prospective Studies Lung cancer education Lung Platinum Original Research education.field_of_study business.industry Hazard ratio Combination chemotherapy medicine.disease respiratory tract diseases Oncology Quality of Life business medicine.drug |
| Zdroj: | ESMO Open Digital.CSIC. Repositorio Institucional del CSIC instname |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2021.100051 |
| Popis: | [Background] To assess the efficacy and safety of a metronomic schedule of oral vinorelbine (mVNR) in advanced non-small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy. [Patients and methods] This was a multicenter, prospective, randomized, open-label phase II study in treatment-naive patients with TNM stage IIIB/IV NSCLC. Patients received mVNR at a fixed dose of 50 mg × 3 or standard schedule 60-80 mg/m2 weekly until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4). Main secondary objectives were safety, disease control rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL). [Results] A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively. The median G4PFS was 4.0 months [95% confidence interval (CI): 2.6-4.3] and 2.2 months (95% CI: 1.5-2.9), hazard ration (HR) = 0.63 (95% CI: 0.45-0.88), P = 0.0068 in favor of metronomic arm; G4DCR was 45.8% and 26.8% in the mVNR and standard arms, respectively. Grade 3-4 treatment-related adverse events were less frequent in the mVNR arm (25.3% versus 54.4%) mainly owing to a reduction in all grades (15.7% versus 51.9%) and grade 3-4 neutropenia (10.8% versus 42%). PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively. No difference in median OS was observed. QoL was comparable between arms. [Conclusions] Metronomic oral vinorelbine significantly prolonged median G4PFS in advanced NSCLC patients unfit for platinum combinations as first-line treatment. It was associated with a clear reduction in toxicity and may be considered as an important option in this challenging population. Pierre Fabre Médicament was the Sponsor of the study. The study was funded by Pierre Fabre Médicament. Conduct of the study: Pierre Fabre Médicament with the support of Clinipace clinical research organization (CRO) for the monitoring, of C-Med (CRO) for the data management and statistical analyses. |
| Databáze: | OpenAIRE |
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