NO16968: XELOXA Adjuvant Treatment with Capecitabine and Oxaliplatin (XELOX) in Stage III Colon Cancer ESMO/ECCO Presidential Session III D. Haller, J. Tabernero, J. Maroun, F. de Braud, T. Price, E. Van Cutsem, M. Hill, F. Gilberg, K. Rittweger, H.-J. Schmoll
NO16968: XELOXA Adjuvant Treatment with Capecitabine and Oxaliplatin (XELOX) in Stage III Colon Cancer. ESMO/ECCO Presidential Session III D. Haller, J. Tabernero, J. Maroun, F. de Braud, T. Price, E. Van Cutsem, M. Hill, F. Gilberg, K. Rittweger, H.-J. Schmoll. Rationale for XELOXA trial. - PowerPoint PPT Presentation
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
NO16968: XELOXAAdjuvant Treatment with
Capecitabine and Oxaliplatin (XELOX) in Stage III Colon Cancer
ESMO/ECCO Presidential Session III
D. Haller, J. Tabernero, J. Maroun, F. de Braud, T. Price, E. Van Cutsem, M. Hill, F. Gilberg, K. Rittweger,
H.-J. Schmoll
Rationale for XELOXA trial
• In 2002, when planning the study, the standard of care for adjuvant treatment of colon cancer was bolus 5-FU/LV (either Mayo Clinic or Roswell Park regimen)
• Based on upcoming results of X-ACT trial, capecitabine was expected to be at least equivalent to bolus 5-FU/LV in stage III colon cancer
• Two large trials were ongoing investigating the additional benefit of oxaliplatin to bolus or infusional 5-FU/LV (NSABP C-07 and MOSAIC)
Rationale for XELOXA trial
• In order to investigate oral fluoropyrimidines plus oxaliplatin, based on the X-ACT trial, capecitabine was chosen as a partner with oxaliplatin vs the standard of care at the time (bolus 5-FU/LV)
• XELOXA became the third of 3 parallel conducted studies (NSABP C-07, MOSAIC and XELOXA) investigating the role of oxaliplatin in adjuvant treatment of colon cancer
• In contrast to NSABP C-07 and MOSAIC, which included stage II and III patients, XELOXA investigated only stage III given the preliminary results of the X-ACT trial (stage III disease only)
Chemo/radiotherapy-naive
stage III colon ≤8 weeks since resection
N=1886
• Primary endpoint: superiority of DFS
• Secondary endpoints: RFS, OS, tolerability
n=944
n=942
RANDO MISATION
Adjuvant XELOX vs 5-FU/LV: NO16968 (XELOXA) Phase III trial
Bolus 5-FU/LV (6 months) Mayo Clinic [n=664]
orRoswell Park [n=278]
XELOX (6 months) capecitabine 1000mg/m2 bid d1–14
oxaliplatin130mg/m2 d1 q3w
8 cycles
Eligibility
18 years old, ECOG 1
• Stage III colon carcinoma, 1 positive lymph node
• Randomised 8 weeks after surgery
• Informed consent
• Normal or mild renal impairment
• No seizures, CNS disorders, psychiatric disability, cardiac disease (CHF, symptomatic CAD or arrhythmias), or MI 12 months
• Normal neutrophils, platelets, creatinine, bilirubin, ALAT, ASAT, alkaline phosphatase
Stratification factors
• Patients stratified by
– geographic region
– number of lymph nodes involved (≤3 vs ≥4)
– baseline CEA (normal vs abnormal)
– 5-FU/LV regimen (Mayo vs Roswell Park)
– number of lymph nodes sampled per geographical region