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ePoster Display

203P - Randomized study of single-agent metronomic versus weekly oral vinorelbine (VNR) as first-line chemotherapy in patients with HR+/HER2- advanced breast cancer

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Breast Cancer

Presenters

Marina Cazzaniga

Citation

Annals of Oncology (2021) 32 (suppl_5): S447-S456. 10.1016/annonc/annonc688

Authors

M.E. Cazzaniga1, N. Martinez Jañez2, B.D. Kukielka-Budny3, M. Ulanska4, H. Bourgeois5, M. Muñoz Mateu6, S. Morales Murillo7, J. Bayo8, L. Cortesi9, T. Pinter10, M. Palacova11, N. Cherciu12, E. Petru13, J. Ettl14, C. De Almeida15, R. Raymond15, G.R. Villanova15, C. Ta Thanh Minh15, A.C.F. Rodrigues16, G. Freyer17

Author affiliations

  • 1 Medical Oncology Dept., Ospedale San Gerardo - ASST Monza, 20900 - Monza/IT
  • 2 Oncología Médica, Hospital Universitario Ramón y Cajal, 28034 - MADRID/ES
  • 3 Oncology Department, Lublin Oncology Center, 20-090 - Lublin/PL
  • 4 Oncology Department, Regional Oncology Center M. Kopernika in Lodz, Provincial Multidisciplinary Center of Oncology and Traumatology, 93-411 - Lodz/PL
  • 5 Medical Oncology, Clinique Victor Hugo, 72000 - Le Mans/FR
  • 6 Servicio De Oncologia, Hospital Clinic I Provincial, 08036 - BARCELONA/ES
  • 7 Medical Oncology Department, Hospital Arnau de Vilanova - Lleida, 25110 - Alpicat/ES
  • 8 Oncología Médica, Hospital Juan Ramón Jiménez, 21005 - HUELVA/ES
  • 9 Oncology And Haematology Department, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41125 - Modena/IT
  • 10 Oncology Department, Petz Aladar County Teaching Hospital, 9024 - Gyor/HU
  • 11 Clinic Of Comprehensive Care, Masaryk Memorial Cancer Institute, 656 53 - Brno/CZ
  • 12 Oncology Department, Oncolab Craiova, 200385 - Craiova/RO
  • 13 Obstetrics And Gynecology Department, ​LKH-Univ. Klinikum Graz - Universitätsklinik für Frauenheilkunde und Geburtshilfe, 8036 - Graz/AT
  • 14 Obs Gyn, Frauenklinik und Poliklinik der Technischen Universitaet München, 81675 - Munich/DE
  • 15 Medical & Patient /consumer Division, Pierre Fabre Médicament, 92654 - Boulogne-Billancourt/FR
  • 16 Oncology Department, Instituto Portugues de Oncologia Centro do Porto E.P.E. (IPO-Porto), 4200-162 - Porto/PT
  • 17 Service D'oncologie Médicale, Lyon Sud Hospital Center - HCL, 69495 - Pierre Benite/FR
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Abstract 203P

Background

Single-agent chemotherapy (CT) is a valuable option for patients with advanced breast cancer (ABC) and weekly oral VNR is one of the recommended agents. Metronomic VNR increases patient’s exposure to the drug while improving safety. In early studies, minimal toxicity and promising efficacy were observed with metronomic VNR 50 mg thrice weekly (tw). We randomized patients with ABC to receive either metronomic or weekly oral first-line VNR.

Methods

Open-label, multicentre, randomized phase II study evaluating Disease Control Rate (DCR) as primary endpoint in patients previously untreated with CT for HR+/HER2- ABC, pretreated with endocrine-therapy (ET) and no longer candidates to further ET. Arm A: Metronomic VNR 50 mg tw, Arm B: VNR 60 mg/m2 weekly at cycle 1, increased to 80 mg/m2 weekly for subsequent cycles in the absence of grade 3-4 neutropenia, until progression or intolerance.

Results

163 patients included (82 in arm A, 81 in arm B): 86% had ≥ 2 organs involved and 63% had previous 1-2 lines of ET. Relative dose intensity ≥ 90% per patient (pt) was 58.5% in arm A and 29% in arm B. Primary endpoint was reached in both arms with DCR of 63.4% [95% CI: 52.0; 73.8] in arm A and 72.8% [95% CI: 61.8; 82.1] in arm B, respectively. Median PFS was 4.0 [95% CI: 2.8; 5.4] and 5.6 [95% CI: 4.4; 7.8] months in arm A and arm B, respectively. Median overall survival was 22.3 months [95% CI: 19.0; 27.3] in Arm A and 26.7 months [95% CI: 22.2; 37.8] in arm B. Grade 3-5 adverse events were 31% in arm A and 60% in arm B, including 24% versus 51% of neutropenia, and 0% versus 2.5% of febrile neutropenia, respectively. We observed less gastrointestinal toxicity in arm A than in arm B: 46% versus 73%, any grade. Two toxic deaths were observed in each arm (2 sepsis, 1 enterocolitis, 1 cardiac failure).

Conclusions

Although the study was not comparative, PFS and OS were numerically higher in the weekly arm, while tolerance and dose intensity were better in the metronomic arm, suggesting “peak effect”. Awaiting the results of other ongoing randomized studies in combination or later lines, weekly single agent VNR should be preferred over metronomic single agent VNR in first line CT after progression on ET in HR+ ABC pts.

Clinical trial identification

EudraCT 2014-003860-19.

Editorial acknowledgement

An editorial assistance in the writing of the abstract was provided by Nicole Fort, Medical Oncology. The authors thank all investigators and coinvestigators who could not be listed as authors, all study teams of all participating centers, nurses, patients and their families for participation in the study.

Legal entity responsible for the study

Pierre Fabre Médicament.

Funding

Pierre Fabre Médicament.

Disclosure

M.E. Cazzaniga: Financial Interests, Institutional, Advisory Board: Lilly. N. Martinez Jañez: Financial Interests, Institutional, Expert Testimony: AstraZeneca; Financial Interests, Institutional, Expert Testimony: Daiichi Sankyo; Financial Interests, Institutional, Expert Testimony: Sankyo; Financial Interests, Institutional, Expert Testimony: Pfizer; Financial Interests, Institutional, Expert Testimony: Novartis; Financial Interests, Institutional, Expert Testimony: Lilly; Financial Interests, Institutional, Expert Testimony: Pierre Fabre; Financial Interests, Institutional, Expert Testimony: Roche; Financial Interests, Institutional, Expert Testimony: GSK; Financial Interests, Institutional, Other, Travel Support: Roche; Financial Interests, Institutional, Other, Travel Support: AstraZeneca; Financial Interests, Institutional, Other, Travel Support: Novartis; Financial Interests, Institutional, Other, Travel Support: Pfizer. M. Muñoz Mateu: Financial Interests, Institutional, Expert Testimony: Roche; Financial Interests, Institutional, Expert Testimony: Novartis; Financial Interests, Institutional, Expert Testimony: Eisai; Financial Interests, Institutional, Other: Roche; Financial Interests, Institutional, Other: Lilly. L. Cortesi: Financial Interests, Institutional, Other, Honororia: AstraZeneca; Financial Interests, Institutional, Other, Honororia: MSD; Financial Interests, Institutional, Other, Honororia: Pfizer; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Tesaro; Financial Interests, Institutional, Advisory Role: Clovis. M. Palacova: Financial Interests, Institutional, Expert Testimony: AstraZeneca; Financial Interests, Institutional, Expert Testimony: Novartis; Financial Interests, Institutional, Expert Testimony: Pfizer; Financial Interests, Institutional, Expert Testimony: Eli Lilly; Financial Interests, Institutional, Expert Testimony: Amgen. E. Petru: Financial Interests, Institutional, Expert Testimony: AstraZeneca; Financial Interests, Institutional, Expert Testimony: Daiichi Sankyo; Financial Interests, Institutional, Expert Testimony: Sankyo; Financial Interests, Institutional, Expert Testimony: Pfizer; Financial Interests, Institutional, Expert Testimony: Novartis; Financial Interests, Institutional, Expert Testimony: Lilly; Financial Interests, Institutional, Expert Testimony: Pierre Fabre; Financial Interests, Institutional, Expert Testimony: Roche; Financial Interests, Institutional, Expert Testimony: GSK; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Other, Travel Support: AstraZeneca; Financial Interests, Institutional, Other, Travel Support: GSK; Financial Interests, Institutional, Other, Travel Support: Pfizer; Financial Interests, Institutional, Other, Travel Support: Lilly. J. Ettl: Financial Interests, Institutional, Expert Testimony: AstraZeneca; Financial Interests, Institutional, Expert Testimony: Daiichi Sankyo; Financial Interests, Institutional, Expert Testimony: Sankyo; Financial Interests, Institutional, Expert Testimony: Pfizer; Financial Interests, Institutional, Expert Testimony: Novartis; Financial Interests, Institutional, Expert Testimony: Lilly; Financial Interests, Institutional, Expert Testimony: Pierre Fabre; Financial Interests, Institutional, Expert Testimony: Roche; Financial Interests, Institutional, Expert Testimony: Tesaro; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Odenate; Financial Interests, Institutional, Other, Travel Support: AstraZeneca; Financial Interests, Institutional, Other, Travel Support: Daiichi Sankyo; Financial Interests, Institutional, Other, Travel Support: Celgene; Financial Interests, Institutional, Other, Travel Support: Pfizer; Financial Interests, Institutional, Other, Travel Support: Novartis; Financial Interests, Institutional, Other, Travel Support: Lilly; Financial Interests, Institutional, Other, Travel Support: Tesaro. C. De Almeida: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. R. Raymond: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre Médicament. G.R. Villanova: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. C. Ta Thanh Minh: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. A.C.F. Rodrigues: Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Training: Pfizer; Financial Interests, Institutional, Training: AstraZeneca. G. Freyer: Financial Interests, Institutional, Principal Investigator: Pierre Fabre; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Pierre Fabre. All other authors have declared no conflicts of interest.

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