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Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor-positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial).

Breast Center, Genolier Cancer Center, Genolier, Switzerland. Electronic address: maapro@genolier.net. Hospital Virgen del Rocío, Avenida Manuel Siurot s/n, Seville, 41013, Spain. Electronic address: ruizsabater@gmail.com. Perola Byington Reference Center, Av Brig Luis Antonio 733, lj 8/9, São Paulo, Brazil. Electronic address: robertohegg@gmail.com. Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Oddział Onkologii Klinicznej, ul, Dr K. Jaczewskiego 7, 20-090, Lublin, Poland. Electronic address: bozena-budny@wp.pl. Hospital Arnau de Vilanova, Lleida, Calle Lleida 147, Alpicat 25110, Lleida, Spain. Electronic address: serafinmorales01@gmail.com. Senatore Antonio Perrino Hospital, ASL Brindisi Via Statale 7 (Via Appia), 72100 Brindisi, Italy. Electronic address: saverio.cinieri@ieo.it. Breast and Gynecology Unit, Araujo Jorge Hospital, Goias Anticancer Association, Rua 239, 206 Setor Universitario, 74175-120, Goiania, Brazil. Electronic address: ruffojr@terra.com.br. Centro Integral Oncologico Clara Campal, C/Oña 10, 28050, Madrid, Spain. Electronic address: lgestevez@mdanderson.es. Marie Curie Oncology Center, ul. Roentgena 5, 02-781, Warsaw, Poland. Electronic address: eszombara@coi.waw.pl. Centro de Novos Tratamentos Itajaí - Clínica de Neoplasias Litoral Aderbal Ramos da Silva, 148, Centro, Itajaí/SC/Brasil, CEP, 88301-220, Brazil. Electronic address: giuliano_borges@yahoo.com.br. Istituti Hospitalieri di Cremona, Viale Concordia 1, 26100, Cremona, Italy. Electronic address: r.passalacqua@asst-cremona.it. Pierre Fabre Médicament, 45 Place Abel Gance, 92654, Boulogne-Billancourt, France. Electronic address: helene.hervieu@pierre-fabre.com. Pierre Fabre Laboratories, Langalde, 3 avenue Hubert Curien, BP13562, 31035, Toulouse, CEDEX, France. Electronic address: melanie.groc@pierre-fabre.com. Pierre Fabre Médicament, 45 Place Abel Gance, 92654, Boulogne-Billancourt, France. Electronic address: gustavo.villanova@pierre-fabre.com.

Breast (Edinburgh, Scotland). 2019;:7-14
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Abstract

BACKGROUND Single-agent paclitaxel and vinorelbine are recommended treatments for advanced breast cancer (ABC) non-responsive to hormone therapy and without visceral crisis. This phase II trial compared first-line oral vinorelbine versus weekly paclitaxel for ABC. METHODS Eligible female patients had measurable locally recurrent/metastatic estrogen receptor-positive HER2-negative breast cancer and had received prior endocrine therapy (any setting) but no chemotherapy for ABC. Patients were stratified by prior taxane and visceral metastases and randomized to either oral vinorelbine 80 mg/m2 (first cycle at 60 mg/m2, escalated to 80 mg/m2 in the absence of grade 3/4 toxicity) or intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR; confirmed complete or partial response, or stable disease for ≥6 weeks). RESULTS The 131 randomized patients had received a median of 2 prior endocrine therapies; >70% had prior (neo)adjuvant chemotherapy and 79% visceral metastases. DCR was 75.8% (95% confidence interval: 63.6-85.5%) with vinorelbine and 75.4% (63.1-85.2%) with paclitaxel. The most common grade 3/4 adverse events were neutropenia (52%), fatigue (11%), and vomiting (5%) with vinorelbine, and neutropenia (17%), dyspnea (6%), hypertension (6%), and peripheral sensory neuropathy (5%) with paclitaxel. Grade 2 alopecia occurred in 2% of vinorelbine-treated and 34% of paclitaxel-treated patients. Neither arm showed relevant global health status changes. CONCLUSION Oral vinorelbine and paclitaxel demonstrated similar DCRs (∼75%). Safety profiles differed and, together with administration route and convenience, may influence treatment choice (EudraCT number, 2012-003530-16).

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