Meeting News Coverage

NO16968: Xelox improved 7-year OS in advanced colon cancer

2012 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 NO16968 trial.

Earlier 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 2012 ASCO 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 5-FU/leucovorin.

Roughly one in four patients in the Xelox group needed locoregional and/or systemic treatments after recurrence compared with 33% for 5-FU/leucovorin.

“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 Jason Harris

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.

Twitter Follow HemOncToday.com on Twitter.

2012 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 NO16968 trial.

Earlier 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 2012 ASCO 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 5-FU/leucovorin.

Roughly one in four patients in the Xelox group needed locoregional and/or systemic treatments after recurrence compared with 33% for 5-FU/leucovorin.

“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 Jason Harris

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.

Twitter Follow HemOncToday.com on Twitter.

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