Abstract
On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-re...Continue Reading
References
Nov 1, 1995·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J CarmichaelA L Harris
Oct 1, 1996·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A MichelottiP F Conte
Feb 3, 2000·Journal of the National Cancer Institute·P TherasseS G Gwyther
Mar 7, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·G BatistL W Lee
Jun 16, 2001·Oncology·M SpielmannP Pouillart
Nov 8, 2001·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J A OshaughnessyS Laws
Jan 12, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Richard L SchilskyMark J Ratain
Feb 21, 2002·The Oncologist·Harold Varmus
May 16, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·L ZelekM Spielmann
Jun 18, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joyce O'ShaughnessyRobert Leonard
Nov 28, 2002·The Oncologist·Joyce O'ShaughnessyMatti Aapro
Dec 31, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Viviane HessRichard Herrmann
Oct 1, 2004·Medical Oncology·S-H LeeY-H Im
Dec 22, 2004·Cancer·Brian I RiniEric J Small
Feb 16, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Emilio BajettaRoberto Buzzoni
May 14, 2005·Annals of Oncology : Official Journal of the European Society for Medical Oncology·B T HennessyV Valero
Jul 9, 2005·Clinical Breast Cancer·Raquel AndresAlejandro Tres
Apr 15, 2006·The Oncologist·William B Ershler
Dec 13, 2006·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D SantiniG Tonini
May 29, 2007·Breast Cancer Research and Treatment·Susan DentMaureen Trudeau
Jan 4, 2008·Cancer Chemotherapy and Pharmacology·Hong Suk SongSi Young Kim
Jan 17, 2008·Oncology·Mustafa BenekliSuleyman Buyukberber
May 6, 2008·British Journal of Cancer·A AwadaJ Baselga
Jun 3, 2008·Oncology·D LaessigV Heinemann
Aug 20, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kathy S AlbainJoyce O'Shaughnessy
Dec 18, 2008·Annals of Oncology : Official Journal of the European Society for Medical Oncology·V RoyUNKNOWN North Central Cancer Treatment Group
Mar 11, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stephen ChanPierre Fumoleau
Citations
Aug 12, 2014·Cancer Chemotherapy and Pharmacology·Ji Soo ParkHyun Cheol Chung
Sep 2, 2010·Clinical Breast Cancer·Elizabeth A Comen, Monica N Fornier
Nov 26, 2015·Scientific Reports·Qingkun SongH Kim Lyerly
Feb 22, 2012·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E P StavrouS Pearson
Oct 28, 2010·British Journal of Cancer·S-E Al-BatranE Jäger
Mar 17, 2011·British Journal of Cancer·H J StemmlerV Heinemann
Jun 29, 2012·Anti-cancer Drugs·Hongyan HuangSantai Song