XELOX-RT Is Practical Regimen for Borderline Resectable Rectal Cancer

ORLANDO-Neoadjuvantcapecitabine (Xeloda), oxaliplatin(Eloxatin), and preoperative pelvicradiotherapy (XELOX-RT) is a welltoleratedregimen in patients with locallyadvanced rectal cancer and produceshigh rates of curative resection,according to Robert Glynne-Jones,MBBS (Mount Vernon Centre forCancer Treatment, London, UK). Dr.Glynne-Jones reported data from theSOCRATES phase II study of this regimenin patients with locally advancedrectal cancer (abstract 3527)."This is a practical and convenientregimen. Capecitabine simplifies thedelivery of chemoradiation, reducingproblems associated with radiotherapyscheduling during chemotherapy.XELOX-RT reduces the burden onpatients and staff compared with usingintravenous chemotherapy duringchemoradiation," Dr. Glynne-Jones said.Combined Phase I and II DataPatients with primary unresectablelocally advanced rectal cancer receivedcapecitabine (500, 650, 825 mg/m²twice daily) 7 days/week during RT,oxaliplatin (130 mg/m² on days 1 and29), and synchronous preoperative RT(25 fractions of 1.8 Gy, 45 Gy total)over 25 days. The maximum tolerateddose (MTD) of capecitabine was 650mg/m² twice daily, and this dose wasused in the phase II part of the study.Pathologic CompleteResponse Rate of 19%This analysis combined data fromthe phase I and phase II componentsof the SOCRATES study. It included18 patients from the phase I dose escalationstudy and 78 patients treated atthe recommended phase II dose. Of 96patients enrolled, 95 received treatmentwith XELOX-RT, and 85 underwenta potentially curative resection.Of the patients undergoing surgery,75 patients (88%) had an R0 and 8patients (9%) had an R1 resection. Ofthe 83 resected specimens, 16 (19%)showed a pRegimen Is Well Tolerated"This analysis confirms that the recommendedXELOX-RT regimen isfeasible with RT. The most commontreatment-related adverse events (allgrades) were diarrhea (66%), transientparesthesias (56%), and nausea(51%)," Dr. Glynne-Jones said.Only 21 of the 95 patients (22%)had grade 3 or 4 adverse events. Themost common grade 3 or 4 side effectswere gastrointestinal disturbances (diarrhea,nausea, vomiting, pain), lethargy,and dehydration. Only three patientshad hand-foot syndrome, allgrade 1.Dr. Glynne-Jones concluded that,"XELOX-RT is highly effective for theneoadjuvant treatment of borderlineunresectable rectal cancer. To date, 85patients (90%) have undergone surgery,and 75 (88%) have had a histologicallyconfirmed R0 resection. XELOX-RT achieved a pathologic completeresponse rate of 19% and enabled ahigh level of R0 resections. The regimenat the recommended dose is welltolerated, with few grade 3 or 4 adverseevents and no treatment-relateddeaths."