PMID- 34691243 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220427 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 13 DP - 2021 TI - Capecitabine in combination with bendamustine in pretreated women with HER2-negative metastatic breast cancer: results of a phase II trial (AGMT MBC-6). PG - 17588359211042301 LID - 10.1177/17588359211042301 [doi] LID - 17588359211042301 AB - 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). CI - (c) The Author(s), 2021. FAU - Rinnerthaler, Gabriel AU - Rinnerthaler G AD - IIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria. FAU - Gampenrieder, Simon Peter AU - Gampenrieder SP AUID- ORCID: 0000-0002-3966-1071 AD - IIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria. FAU - Petzer, Andreas AU - Petzer A AD - Internal Department I for Medical Oncology and Hematology, Barmherzige Schwestern Hospital/Linz, Linz, Austria. FAU - Hubalek, Michael AU - Hubalek M AD - Department of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria. FAU - Petru, Edgar AU - Petru E AD - Department of Obstetrics and Gynaecology, Medical University Graz, Graz, Austria. FAU - Sandholzer, Margit AU - Sandholzer M AD - Department of Oncology, Hematology and Gastroenterology, Infectiology, Academic Teaching Hospital Feldkirch, Austria. FAU - Andel, Johannes AU - Andel J AD - Department of Internal Medicine II, Pyhrn-Eisenwurzen Klinikum Steyr, Steyr, Austria. FAU - Balic, Marija AU - Balic M AD - Division of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria. FAU - Melchardt, Thomas AU - Melchardt T AD - IIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, AustriaSalzburg Cancer Research Institute with Laboratory of Immunological and Molecular Cancer Research and Center for Clinical Cancer and Immunology Trials, Salzburg, Austria. FAU - Hauser-Kronberger, Cornelia AU - Hauser-Kronberger C AD - Department of Pathology, Paracelsus Medical University Salzburg, Salzburg, Austria. FAU - Schmitt, Clemens A AU - Schmitt CA AD - Department of Internal Medicine 3 - Hematology and Oncology, Kepler University Hospital, Johannes Kepler University, Linz, Austria. FAU - Ulmer, Hanno AU - Ulmer H AD - Department of Medical Statistics and Informatics, Medical University Innsbruck, Innsbruck, Austria. FAU - Greil, Richard AU - Greil R AD - IIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria. LA - eng SI - ClinicalTrials.gov/NCT01891227 PT - Journal Article DEP - 20211019 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC8529308 OTO - NOTNLM OT - advanced breast cancer OT - chemotherapy OT - combination therapy COIS- Conflict of interest statement: Conflicts of interest with Mundipharma: Employment or leadership position: none; Consultant or advisory role: Andreas Petzer, Richard Greil; Fees for non-CME services received directly from commercial interest or their agents: none; Contracted research: Richard Greil; Ownership interest: none; Traveler grants: none. EDAT- 2021/10/26 06:00 MHDA- 2021/10/26 06:01 PMCR- 2021/10/19 CRDT- 2021/10/25 06:27 PHST- 2021/03/29 00:00 [received] PHST- 2021/08/09 00:00 [accepted] PHST- 2021/10/25 06:27 [entrez] PHST- 2021/10/26 06:00 [pubmed] PHST- 2021/10/26 06:01 [medline] PHST- 2021/10/19 00:00 [pmc-release] AID - 10.1177_17588359211042301 [pii] AID - 10.1177/17588359211042301 [doi] PST - epublish SO - Ther Adv Med Oncol. 2021 Oct 19;13:17588359211042301. doi: 10.1177/17588359211042301. eCollection 2021.