Literature DB >> 21387266

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer.

Devika Gajria1, Kim Feigin, Lee K Tan, Sujata Patil, Stephanie Geneus, Maria Theodoulou, Larry Norton, Clifford A Hudis, Tiffany A Traina.   

Abstract

BACKGROUND: Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7-7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first-line and second-line settings.
METHODS: Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7-7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression-free survival (PFS).
RESULTS: Forty-one patients were treated. After a median of 7 cycles (range, 1-32 cycles), partial responses were observed in 20% of patients, and stable disease for ≥6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment-related toxicities were hand-foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2-4), and vomiting (0% grade 2-4) were rare.
CONCLUSIONS: Capecitabine administered for 7 days followed by a 7-day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal.
Copyright © 2011 American Cancer Society.

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Year:  2011        PMID: 21387266     DOI: 10.1002/cncr.25992

Source DB:  PubMed          Journal:  Cancer        ISSN: 0008-543X            Impact factor:   6.860


  7 in total

1.  Efficacy of different dosing schedules of capecitabine for metastatic breast cancer: a single-institution experience.

Authors:  Anupama Suresh; Akannsha Ganju; Evan Morgan; Marilly Palettas; Julie A Stephens; Joseph Liu; Michael Berger; Craig Vargo; Anne Noonan; Raquel Reinbolt; Mathew Cherian; Jeffrey VanDeusen; Sagar Sardesai; Robert Wesolowski; Daniel G Stover; Maryam Lustberg; Bhuvaneswari Ramaswamy; Nicole Williams
Journal:  Invest New Drugs       Date:  2020-01-14       Impact factor: 3.850

Review 2.  Capecitabine monotherapy: review of studies in first-line HER-2-negative metastatic breast cancer.

Authors:  Joyce A O'Shaughnessy; Manfred Kaufmann; Friederike Siedentopf; Philippe Dalivoust; Marc Debled; Nicholas J Robert; Nadia Harbeck
Journal:  Oncologist       Date:  2012-03-14

3.  Fixed-dose capecitabine is feasible: results from a pharmacokinetic and pharmacogenetic study in metastatic breast cancer.

Authors:  Michelle A Rudek; Roisin M Connolly; Janelle M Hoskins; Elizabeth Garrett-Mayer; Stacie C Jeter; Deborah K Armstrong; John H Fetting; Vered Stearns; Laurie A Wright; Ming Zhao; Stanley P Watkins; Howard L McLeod; Nancy E Davidson; Antonio C Wolff
Journal:  Breast Cancer Res Treat       Date:  2013-04-16       Impact factor: 4.872

4.  Efficacy of bevacizumab-capecitabine in combination for the first-line treatment of metastatic breast cancer.

Authors:  Stephen Dyar; Alvaro Moreno-Aspitia
Journal:  Breast Cancer (Auckl)       Date:  2011-11-28

5.  Dose-intense capecitabine, oxaliplatin and bevacizumab as first line treatment for metastatic, unresectable colorectal cancer: a multi-centre phase II study.

Authors:  Christopher G C A Jackson; Katrina Sharples; Paul I Thompson; Anne O'Donnell; Bridget Anne Robinson; David J Perez; Jacqui Adams; Richard Isaacs; Sanjeev Deva; Victoria A Hinder; Michael P Findlay
Journal:  BMC Cancer       Date:  2014-10-02       Impact factor: 4.430

6.  Efficacy and safety of capecitabine-based first-line chemotherapy in advanced or metastatic breast cancer: a meta-analysis of randomised controlled trials.

Authors:  Weijiao Yin; Guangsheng Pei; Gang Liu; Li Huang; Shegan Gao; Xiaoshan Feng
Journal:  Oncotarget       Date:  2015-11-17

7.  Decreased gastrointestinal toxicity associated with a novel capecitabine schedule (7 days on and 7 days off): a systematic review.

Authors:  Karen A Cadoo; Devika Gajria; Emily Suh; Sujata Patil; Maria Theodoulou; Larry Norton; Clifford A Hudis; Tiffany A Traina
Journal:  NPJ Breast Cancer       Date:  2016-03-30
  7 in total

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