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Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051.

Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer.

Author information

1
Department of Oncology, Ramón y Cajal University Hospital, Madrid, Spain.
2
Department of Oncology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
3
Baselga Institute of Oncology, Hospital Quiron, Barcelona, Spain.
4
Medica Scientia Innovation Research (MedSIR), Barcelona, Spain.
5
Centre François Baclesse, Caen, France.
6
Clinique Victor Hugo, Le Mans, France.
7
Department of Medical Oncology, Centro di Riferimento Oncologico (CRO) Aviano, Istituto di Ricerca e Cura a Carattere Scientifico, National Cancer Institute, Aviano, Italy.
8
Department of Oncology and Comprehensive Breast Health Center, Taipei Veterans General Hospital, Taipei, Taiwan.
9
School of Medicine, National Yang-Ming University, Taipei, Taiwan.
10
Sénopôle Saint Louis Assistance Publique - Hôpitaux de Paris, Université Denis Diderot, Paris, France.
11
Oncology Centre, King Saud University Medical City, Riyadh, Saudi Arabia.
12
Instituto Oncológico Dr Rosell - Hospital General de Catalunya, Sant Cugat del Vallès.
13
Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
14
Gomel Regional Clinical Oncology Dispensary, Gomel, Belarus.
15
Medical Oncology Unit, Instituto Oncológico Baselga, Hospital Ruber Internacional, Madrid, Spain.
16
Instituto Oncológico Baselga, Complejo Ruber Juan Bravo, Madrid, Spain.
17
Medical Oncology Department, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.

Abstract

Background:

There is no standard treatment after progression on second-line chemotherapy for metastatic breast cancer (MBC). We compared vinflunine with physician's choice of alkylating agent (AA) for patients with heavily pretreated MBC.

Patients and methods:

In this open-label phase III trial, patients with MBC were included if they had received at least two prior chemotherapy regimens for MBC and had received anthracycline, taxane, antimetabolite and vinca alkaloid therapy. Patients were no longer candidates for these chemotherapies because of resistance and/or intolerance. Patients were randomised to either vinflunine 280 mg/m2 intravenously every 3 weeks (q3w) or AA monotherapy q3w. Stratification factors were performance status, number of prior chemotherapy lines for MBC, disease measurability and study site. The primary end point was overall survival (OS).

Results:

A total of 594 patients were randomised (298 to vinflunine, 296 to AA). There was no difference between treatment arms in OS (hazard ratio 1.04, P = 0.67; median 9.1 months for vinflunine versus 9.3 months for AA), progression-free survival (hazard ratio 0.94, P = 0.49; median 2.5 versus 1.9 months, respectively) or overall response rate (6% versus 4%, respectively). However, the disease control rate was significantly higher with vinflunine than AA (44% versus 35%, respectively; P = 0.04). The most common adverse events (any grade) were haematological and gastrointestinal disorders and asthenia in both arms. The most common grade 3/4 adverse events were neutropenia (19% versus 11% with vinflunine versus AA, respectively) and asthenia (10% versus 4%).

Conclusions:

Vinflunine 280 mg/m2 q3w did not improve OS compared with the physician's choice of AA as third- or later-line therapy for MBC. Vinflunine demonstrated an acceptable safety profile, suggesting that vinflunine 320 mg/m2 merits evaluation.

ClinicalTrials.gov:

NCT01091168.

PMID:
29481630
DOI:
10.1093/annonc/mdy051

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