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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.
Camerini, A; Morabito, A; Montanino, A; Bernabé, R; Grossi, F; Ramlau, R; Ciuleanu, T-E; Ceresoli, G-L; Pasello, G; de Marinis, F; Bosch-Barrera, J; Laundreau, P; Gautier, S; Ta Thanh Minh, C; Kowalski, D.
Affiliation
  • Camerini A; Medical Oncology Department, Versilia Hospital, Lido di Camaiore, Italy. Electronic address: andrea.camerini@uslnordovest.toscana.it.
  • Morabito A; Thoracic Medical Oncology, Istituto Nazionale Tumori, "Fondazione G. Pascale", IRCCS, Napoli, Italy.
  • Montanino A; Thoracic Medical Oncology, Istituto Nazionale Tumori, "Fondazione G. Pascale", IRCCS, Napoli, Italy.
  • Bernabé R; Medical Oncology Department, Hospital Virgen del Rocio, Institute for Biomedical Research, Seville, Spain.
  • Grossi F; Division of Medical Oncology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Ramlau R; Oncology Department, Poznan University of Medical Sciences, Poland.
  • Ciuleanu TE; Oncology Institute "Pr Dr Ion Chiricuta", Cluj-Napoca, Romania.
  • Ceresoli GL; Oncology Department, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
  • Pasello G; Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.
  • de Marinis F; Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan, Italy.
  • Bosch-Barrera J; Lung Cancer Unit, Catalan Institute of Oncology, Hospital Universitari Dr Josep Trueta, Girona, Spain.
  • Laundreau P; Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.
  • Gautier S; IRPF, Pierre Fabre Médicament, Toulouse, France.
  • Ta Thanh Minh C; Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.
  • Kowalski D; Lung Cancer and Chest Tumours Department, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
ESMO Open ; 6(2): 100051, 2021 04.
Article in En | MEDLINE | ID: mdl-33611164
ABSTRACT

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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Carcinoma, Non-Small-Cell Lung / Lung Neoplasms Type of study: Clinical_trials / Observational_studies / Risk_factors_studies Aspects: Patient_preference Limits: Humans Language: En Journal: ESMO Open Year: 2021 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Carcinoma, Non-Small-Cell Lung / Lung Neoplasms Type of study: Clinical_trials / Observational_studies / Risk_factors_studies Aspects: Patient_preference Limits: Humans Language: En Journal: ESMO Open Year: 2021 Document type: Article