Capecitabine in combination with bendamustine in pretreated women with HER2-negative metastatic breast cancer: results of a phase II trial (AGMT MBC-6)

• Published in: Therapeutic advances in medical oncology Vol. 13; p. 17588359211042301
• Main Authors: Rinnerthaler, Gabriel, Gampenrieder, Simon Peter, Petzer, Andreas, Hubalek, Michael, Petru, Edgar, Sandholzer, Margit, Andel, Johannes, Balic, Marija, Melchardt, Thomas, Hauser-Kronberger, Cornelia, Schmitt, Clemens A., Ulmer, Hanno, Greil, Richard
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 2021; Sage Publications Ltd; SAGE Publishing
• Subjects: Adverse events; Anthracycline; Antitumor activity; Breast cancer; Cardiomyopathy; Dyspnea; ErbB-2 protein; Hematology; Metastases; Metastasis; Nausea; Neutropenia; Non-Hodgkin's lymphoma; Original Research; Patients; Remission; Respiration; Toxicity; advanced breast cancer; combination therapy; chemotherapy
• ISSN: 1758-8359; 1758-8340; 1758-8359
• DOI: 10.1177/17588359211042301

Background:
Bendamustine, a medication approved for the treatment of indolent non-Hodgkin lymphoma, has already shown anticancer activity in metastatic breast cancer (MBC). Here, we present the results of a phase II trial of bendamustine in combination with capecitabine in pre-treated patients with MBC.
Patients and methods:
AGMT MBC-6 is a multicentre, open-label, single-arm phase II study in HER2-negative MBC. All patients were pre-treated with anthracyclines and/or taxans and had measurable disease. Patients received per os 1000 mg/m2 capecitabine twice daily on days 1 to 14 in combination with 80 mg/m2 bendamustine intravenously on days 1 and 8 of a 3-week cycle for a maximum of eight cycles, followed by a capecitabine maintenance therapy. The primary endpoint was overall response rate (ORR).
Results:
From September 2013 to May 2015, 40 patients were recruited in eight Austrian centres. The median age was 60 years (range 29–77). Twenty-five per cent of patients had triple-negative breast cancer (TNBC) and 93% showed visceral involvement. With 17 partial and one complete remission, ORR was 46%. Median progression-free survival (PFS) was 7.5 months [95% confidence interval (CI) 6.1–10.7]. The most common non-haematological adverse events (AEs) of grade 3 were hand-foot syndrome (13%), fatigue (10%), nausea (8%), and dyspnoea (8%). One grade 4 non-haematological AE (hepatic failure) and three grade 4 haematological AEs (neutropenia) were observed. One patient died of restrictive cardiomyopathy, in which a relationship to capecitabine cannot be excluded, but seems unlikely.
Conclusion:
The combination of capecitabine and bendamustine shows promising efficacy and moderate toxicity. Further evaluation of this drug combination is warranted.
The clinical trial AGMT MBC-6 was registered at ClinicalTrials.gov, (https://clinicaltrials.gov/; identifier: NCT01891227).