PMID- 17194911
OWN - NLM
STAT- MEDLINE
DCOM- 20070129
LR  - 20220318
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 25
IP  - 1
DP  - 2007 Jan 1
TI  - Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage 
      III colon cancer: a planned safety analysis in 1,864 patients.
PG  - 102-9
AB  - PURPOSE: To report the results of a planned safety analysis from a phase III 
      trial comparing capecitabine plus oxaliplatin (XELOX) with bolus 
      fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. 
      PATIENTS AND METHODS: Patients with stage III colon carcinoma were randomly 
      assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 
      3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered 
      as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) 
      regimen for a similar length of time. A total of 1,886 patients were randomly 
      assigned. RESULTS: The safety population comprised 1,864 patients, of whom 938 
      received XELOX and 926 received FU/LV. Most treatment-related adverse events 
      (AEs) occurred at similar rates in both treatment arms. However, patients 
      receiving XELOX experienced less all-grade diarrhea, alopecia, and more 
      neurosensory toxicity, vomiting, and hand-foot syndrome than those patients 
      receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE 
      and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 
      3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 
      neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. 
      Treatment-related mortality within 28 days from the last study dose was 0.6% in 
      the XELOX group and 0.6% in the FU/LV group. CONCLUSION: XELOX has a manageable 
      tolerability profile in the adjuvant setting. Efficacy data will be available 
      within the next 24 months.
FAU - Schmoll, Hans-Joachim
AU  - Schmoll HJ
AD  - Martin Luther University, Halle, Germany. 
      hans-joachim.schmoll@medizin.uni-halle.de
FAU - Cartwright, Thomas
AU  - Cartwright T
FAU - Tabernero, Josep
AU  - Tabernero J
FAU - Nowacki, Marek P
AU  - Nowacki MP
FAU - Figer, Arie
AU  - Figer A
FAU - Maroun, Jean
AU  - Maroun J
FAU - Price, Timothy
AU  - Price T
FAU - Lim, Robert
AU  - Lim R
FAU - Van Cutsem, Eric
AU  - Van Cutsem E
FAU - Park, Young-Suk
AU  - Park YS
FAU - McKendrick, Joseph
AU  - McKendrick J
FAU - Topham, Claire
AU  - Topham C
FAU - Soler-Gonzalez, Gemma
AU  - Soler-Gonzalez G
FAU - de Braud, Filipo
AU  - de Braud F
FAU - Hill, Mark
AU  - Hill M
FAU - Sirzen, Florin
AU  - Sirzen F
FAU - Haller, Daniel G
AU  - Haller DG
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Organoplatinum Compounds)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Capecitabine
MH  - Chemotherapy, Adjuvant/*methods
MH  - Colonic Neoplasms/*drug therapy/mortality
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Fluorouracil/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Leucovorin/administration & dosage
MH  - Middle Aged
MH  - Organoplatinum Compounds/*administration & dosage/*therapeutic use
MH  - Oxaliplatin
MH  - Research Design
MH  - Safety
MH  - Treatment Outcome
EDAT- 2006/12/30 09:00
MHDA- 2007/01/30 09:00
CRDT- 2006/12/30 09:00
PHST- 2006/12/30 09:00 [pubmed]
PHST- 2007/01/30 09:00 [medline]
PHST- 2006/12/30 09:00 [entrez]
AID - 25/1/102 [pii]
AID - 10.1200/JCO.2006.08.1075 [doi]
PST - ppublish
SO  - J Clin Oncol. 2007 Jan 1;25(1):102-9. doi: 10.1200/JCO.2006.08.1075.