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Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer

Claus Rödel, Torsten Liersch, Robert Michael Hermann, Dirk Arnold, Thomas Reese, Matthias Hipp, Alois Fürst, Nimrod Schwella, Michael Bieker, Gunter Hellmich, Hermann Ewald, Jörg Haier, Florian Lordick, Michael Flentje, Heiko Sülberg, Werner Hohenberger, Rolf Sauer

From the Departments of Radiation Therapy and Surgery, University of Erlangen-Nürnberg, Erlangen; Departments of General Surgery and Radiation Oncology and Radiotherapy, University of Göttingen, Göttingen; Departments of Haematology and Oncology and Radiotherapy, Martin Luther University Halle-Wittenberg, Halle-Wittenberg; Department of Radiotherapy, University of Regensburg; Department of Surgery, Caritas-Hospital St Josef, Regensburg; Departments of Haematology, Oncology, and Immunology and Radiotherapy, Philipps-University Hospital, Marburg; Department of General and Abdominal Surgery, Dresden-Friedrichstadt Hospital, and Teaching Hospital of Technical University Dresden, Dresden; Department of General Surgery and Thoracic Surgery, University Hospital of Schleswig-Holstein, Kiel; Department of General Surgery, University Hospital Münster, Münster; Third Department of Internal Medicine (Hematology/Medical Oncology), Klinikum Rechts der Isar, Technical University of Munich, Munich; Department of Radiation Oncology, University of Würzburg, Würzburg; and WiSP Research Institute, Langenfeld, Germany

Address reprint requests to Claus Rödel, MD, Department of Radiotherapy, University of Erlangen, Universitätsstr 27, 91054 Erlangen, Germany; e-mail: claus.roedel{at}strahlen.med.uni-erlangen.de

Purpose: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.

Patients and Methods: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m² on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m² on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m² bid on days 1 to 14; oxaliplatin 130 mg/m² on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.

Results: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.

Conclusion: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.

Supported by a grant from Hoffmann- La Roche AG, Grenzach-Wyhlen, Germany, and Sanofi-Aventis Pharma GmbH, Berlin, Germany.

Presented in part at the 2006 Gastrointestinal Cancers Symposium, January 26-28, 2006, San Francisco, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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