Therapeutic Advances in Medical Oncology (Oct 2021)

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

  • Gabriel Rinnerthaler,
  • Simon Peter Gampenrieder,
  • Andreas Petzer,
  • Michael Hubalek,
  • Edgar Petru,
  • Margit Sandholzer,
  • Johannes Andel,
  • Marija Balic,
  • Thomas Melchardt,
  • Cornelia Hauser-Kronberger,
  • Clemens A. Schmitt,
  • Hanno Ulmer,
  • Richard Greil

DOI
https://doi.org/10.1177/17588359211042301
Journal volume & issue
Vol. 13

Abstract

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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/m 2 capecitabine twice daily on days 1 to 14 in combination with 80 mg/m 2 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).