Gastrointestinal Cancers Symposium
SAN FRANCISCO — Patients with stage III colon
cancer assigned to Xelox realized a significant improvement in OS compared with
those assigned to 5-FU plus leucovorin, according to final results from the
results showed that patients assigned to adjuvant Xelox (Roche) had
superior DFS at 57 months (HR=0.80; 95% CI 0.69-0.93) but no significant
advantage in OS at 59 months (HR=0.87). In these final results, OS was 73% for
Xelox — a combination of oxaliplatin and capecitabine
(Xeloda, Hoffmann-La Roche) — compared with 67% for bolus 5-FU/leucovorin
at a median follow-up of 83 months (HR=0.83; 95% CI, 0.70-0.99).
The intent-to-treat population included 944 patients
assigned to Xelox and 942 assigned to 5-FU/leucovorin.
“Death rate was 30% for 5-FU/leucovorin and 26% for
Xelox,” said Hans-Joachim Schmoll, MD, PhD. “Deaths due
to colon cancer is the most important figure. The death rate due to colon
cancer was 26% for 5-FU/leucovorin and 20% for Xelox, which is an absolute
difference of 6% for survival.”
Schmoll, of Martin Luther University Halle-Wittenberg in
Halle, Germany, presented phase 3 results at the
Gastrointestinal Cancers Symposium.
Absolute 7-year OS was 73% with Xelox vs. 67% for
5-FU/leucovorin. Schmoll said the HRs were unchanged after adjusting for
stratification and prognostic variables for both DFS (HR=0.79; 95% CI,
0.68-0.91) and OS (0.84; 95% CI, 0.71-1.00.)
The HR for DFS was 0.80 (95% CI, 0.69-0.93) at a median
follow-up of 74 months. Seven-year DFS rates were 63% for Xelox and 56% for
Roughly one in four patients in the Xelox group needed
locoregional and/or systemic treatments after recurrence compared with 33% for
“Xelox should be considered a standard adjuvant
treatment option in patients with stage III colon cancer,” Schmoll said.
“Disease-free survival benefits observed with Xelox translates into a
significant OS gain after a median follow-up of 7 years.” – by
For more information:
- Schmoll HJ. #388. Presented at: ASCO Gastrointestinal Cancers
Symposium; Jan. 19-21, 2012; San Francisco.
Disclosure: Dr. Schmoll reports serving as a
consultant or adviser for Merck and Roche, as well as receiving research
funding from those companies.