PMID- 21084429
OWN - NLM
STAT- MEDLINE
DCOM- 20110810
LR  - 20221207
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 22
IP  - 5
DP  - 2011 May
TI  - Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel 
      with planned crossover to the alternate single agent in metastatic breast cancer.
PG  - 1094-1101
LID - S0923-7534(19)38525-4 [pii]
LID - 10.1093/annonc/mdq578 [doi]
AB  - BACKGROUND: Safety and efficacy of gemcitabine plus docetaxel (GD) and 
      capecitabine plus docetaxel (CD) were compared in patients with metastatic breast 
      cancer, where the alternate crossover monotherapy (GD-->C or CD-->G) was 
      predetermined. PATIENTS AND METHODS: Patients were randomly assigned to 3-week 
      cycles of either gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 
      mg/m(2) on day 1 or capecitabine 1000 mg/m(2) twice daily on days 1-14 plus 
      docetaxel 75 mg/m(2) day 1. Upon progression, patients received crossover 
      monotherapy. Primary end point was time to progression (TtP). Secondary end 
      points evaluated overall response rate (ORR), overall survival (OS), and adverse 
      events (AEs). RESULTS: Despite over-accrual of 475 patients, the trial matured 
      with only 324 of 385 planned TtP events due to patient discontinuations. Human 
      epidermal growth factor receptor 2 status was not captured in this study. More CD 
      patients (28%) discontinued due to AEs than GD patients (18.0%, P = 0.009). TtP 
      [hazard ratio (HR) = 1.101, 95% confidence interval (CI) 0.885-1.370, P = 0.387] 
      and OS (HR = 1.031, 95% CI 0.830-1.280, P = 0.785) were not significantly 
      different comparing GD and CD. ORR was not statistically different (P = 0.239) 
      comparing GD (72 of 207, 34.8%) and CD (78 of 191, 40.8%). TtP, OS, and ORR were 
      not significantly different comparing crossover groups. GD caused greater 
      fatigue, hepatotoxicity, neutropenia, and thrombocytopenia but not febrile 
      neutropenia; CD caused more hand-foot syndrome, gastrointestinal toxicity, and 
      mucositis. CONCLUSIONS: GD and CD produced similar efficacy and toxicity profiles 
      consistent with prior clinical experience.
FAU - Seidman, A D
AU  - Seidman AD
AD  - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York. 
      Electronic address: seidmana@mskcc.org.
FAU - Brufsky, A
AU  - Brufsky A
AD  - Women's Cancer Center, Magee Women's Hospital, Pittsburgh.
FAU - Ansari, R H
AU  - Ansari RH
AD  - Michiana Hematology Oncology, South Bend.
FAU - Hart, L L
AU  - Hart LL
AD  - Florida Cancer Specialists, Venice.
FAU - Stein, R S
AU  - Stein RS
AD  - Department of Molecular Physiology and Biophysics, Vanderbilt-Ingram Cancer 
      Center, Nashville.
FAU - Schwartzberg, L S
AU  - Schwartzberg LS
AD  - Hematology and Medical Oncology, The West Clinic, Memphis, USA.
FAU - Stewart, J F
AU  - Stewart JF
AD  - Calvary Mater Hospital, Waratah, Australia.
FAU - Russell, C A
AU  - Russell CA
AD  - Department of Clinical Medicine, University of Southern California, Los Angeles, 
      USA.
FAU - Chen, S-C
AU  - Chen SC
AD  - Department of Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan.
FAU - Fein, L E
AU  - Fein LE
AD  - Centro de Oncologia Rosario, Santa Fe, Argentina.
FAU - De La Cruz Vargas, J A
AU  - De La Cruz Vargas JA
AD  - Department of Oncology and Clinical Research, Acapulco Oncology Group, Acapulco, 
      Mexico.
FAU - Kim, S-B
AU  - Kim SB
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
FAU - Cavalheiro, J
AU  - Cavalheiro J
AD  - Hospital de Clinicas, Porto Alegre, Brazil.
FAU - Zhao, L
AU  - Zhao L
AD  - Lilly USA, LLC, Indianapolis.
FAU - Gill, J F
AU  - Gill JF
AD  - Lilly USA, LLC, Indianapolis.
FAU - Obasaju, C K
AU  - Obasaju CK
AD  - Lilly USA, LLC, Indianapolis.
FAU - Orlando, M
AU  - Orlando M
AD  - Eli Lilly and Company, Indianapolis, USA.
FAU - Tai, D F
AU  - Tai DF
AD  - Lilly USA, LLC, Indianapolis.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101117
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Taxoids)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 15H5577CQD (Docetaxel)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - U3P01618RT (Fluorouracil)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality/pathology
MH  - Capecitabine
MH  - Cross-Over Studies
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Disease-Free Survival
MH  - Docetaxel
MH  - Female
MH  - Fluorouracil/administration & dosage/analogs & derivatives
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Taxoids/administration & dosage
MH  - Gemcitabine
EDAT- 2010/11/19 06:00
MHDA- 2011/08/11 06:00
CRDT- 2010/11/19 06:00
PHST- 2010/11/19 06:00 [entrez]
PHST- 2010/11/19 06:00 [pubmed]
PHST- 2011/08/11 06:00 [medline]
AID - S0923-7534(19)38525-4 [pii]
AID - 10.1093/annonc/mdq578 [doi]
PST - ppublish
SO  - Ann Oncol. 2011 May;22(5):1094-1101. doi: 10.1093/annonc/mdq578. Epub 2010 Nov 
      17.