ORLANDO-Neoadjuvant capecitabine(Drug information on capecitabine) (Xeloda), oxaliplatin(Drug information on oxaliplatin) (Eloxatin), and preoperative pelvic radiotherapy (XELOX-RT) is a welltolerated regimen in patients with locally advanced rectal cancer and produces high rates of curative resection, according to Robert Glynne-Jones, MBBS (Mount Vernon Centre for Cancer Treatment, London, UK). Dr. Glynne-Jones reported data from the SOCRATES phase II study of this regimen in patients with locally advanced rectal cancer (abstract 3527). "This is a practical and convenient regimen. Capecitabine simplifies the delivery of chemoradiation, reducing problems associated with radiotherapy scheduling during chemotherapy. XELOX-RT reduces the burden on patients and staff compared with using intravenous chemotherapy during chemoradiation," Dr. Glynne- Jones said. Combined Phase I and II Data Patients with primary unresectable locally advanced rectal cancer received capecitabine (500, 650, 825 mg/m2 twice daily) 7 days/week during RT, oxaliplatin (130 mg/m2 on days 1 and 29), and synchronous preoperative RT (25 fractions of 1.8 Gy, 45 Gy total) over 25 days. The maximum tolerated dose (MTD) of capecitabine was 650 mg/m2 twice daily, and this dose was used in the phase II part of the study. Pathologic Complete Response Rate of 19% This analysis combined data from the phase I and phase II components of the SOCRATES study. It included 18 patients from the phase I dose escalation study and 78 patients treated at the recommended phase II dose. Of 96 patients enrolled, 95 received treatment with XELOX-RT, and 85 underwent a potentially curative resection. Of the patients undergoing surgery, 75 patients (88%) had an R0 and 8 patients (9%) had an R1 resection. Of the 83 resected specimens, 16 (19%) showed a p Regimen Is Well Tolerated "This analysis confirms that the recommended XELOX-RT regimen is feasible with RT. The most common treatment-related adverse events (all grades) were diarrhea (66%), transient paresthesias (56%), and nausea (51%)," Dr. Glynne-Jones said. Only 21 of the 95 patients (22%) had grade 3 or 4 adverse events. The most common grade 3 or 4 side effects were gastrointestinal disturbances (diarrhea, nausea, vomiting, pain), lethargy, and dehydration. Only three patients had hand-foot syndrome, all grade 1. Dr. Glynne-Jones concluded that, "XELOX-RT is highly effective for the neoadjuvant treatment of borderline unresectable rectal cancer. To date, 85 patients (90%) have undergone surgery, and 75 (88%) have had a histologically confirmed R0 resection. XELOX- RT achieved a pathologic complete response rate of 19% and enabled a high level of R0 resections. The regimen at the recommended dose is well tolerated, with few grade 3 or 4 adverse events and no treatment-related deaths."