• Gastrointestinal Cancers
• Radiology
• Radiation Therapy
• Oncology Clinical Trials

• Oncology
• Gastrointestinal Cancers
• Radiology
• Radiation Therapy
• Oncology Clinical Trials

Preliminary findings demonstrate that patients with rectal cancer receiving radiotherapy with a combination of capecitabine and oxaliplatin have better local regional control compared with those receiving capecitabine plus radiotherapy. Hua Ren, MD, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, presented interim data from the ongoing phase 3 open-label Adjuvant Treatment of Concurrent R and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer trial [NCT00714077].

The current postoperative therapy regimen for patients with advanced rectal cancer usually consists of radiotherapy and the chemotherapeutic agent capecitabine. It is unknown whether combination capecitabine and platinum-based chemotherapy has superior effects on clinical outcomes. This multicenter study assessed the efficacy and safety of these 2 chemoradiotherapy treatment regimens.

A total of 414 patients with rectal cancer were stratified by their pathologic stage (II or III) and randomized 1:1 to either the capecitabine (Cap) group (190 patients) or the capecitabine/oxaliplatin (CapOx) group (224 patients). Capecitabine was administered at 825 mg/m² alone (Cap) or at 825 mg/m² twice daily with 50 mg/m² oxaliplatin at the beginning of each week (CapOx). All patients underwent radiotherapy at 50 Gy in 25 fractions with 2 dose cycles of concurrent chemotherapy. After 5 weeks of treatment, each group received 4 to 6 dose cycles of CapOx and fluorouracil.

By 3-year follow-up, there were no differences in disease-free survival rate in the Cap group compared with the CapOx group (71.79% vs 71.6%; P = .799). Overall survival rates were also similar (89.0% vs 85.1%, P = .916). Although there was no difference in cumulative metastatic rate (19.9% vs 20.7%, P = .834), patients in the Cap group had a higher local recurrence rate than those in the CapOx group (8.1% vs 3.2%, P = .034).

There were no newly identified toxicities in either group. However, the Cap group had significantly fewer cases of thrombocytopenia (6.7% vs 14.2%, P = .012) and fatigue (60.3% vs 71.8%, P = .014).

The authors concluded that although there were significant differences in local recurrences, further patient recruitment is needed to obtain planned sample size calculations.

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