Preoperative Chemoradiotherapy with Capecitabine and Oxaliplatin in Locally Advanced Rectal Cancer. A Phase I-II Multicenter Study of the Dutch Colorectal Cancer Group

Authors: Hospers, Geke¹; Punt, Cornelis²; Tesselaar, Margot³; Cats, Annemieke⁴; Havenga, Klaas⁵; Leer, Jan⁶; Marijnen, Corrie³; Jansen, Edwin⁷; Krieken, Han⁸; Wiggers, Theo⁵; Velde, Cornelis⁹; Mulder, Nanno¹⁰

Source: Annals of Surgical Oncology, Volume 14, Number 10, October 2007 , pp. 2773-2779(7)

Publisher: Springer

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Abstract:

We studied the maximum tolerated dose (MTD) and efficacy of oxaliplatin added to capecitabine and radiotherapy (Capox-RT) as neoadjuvant therapy for rectal cancer.

T3-4 rectal cancer patients received escalating doses of oxaliplatin (day 1 and 29) with a fixed dose of capecitabine of 1000 mg/m² twice daily (days 1-14, 25-38) added to RT with 50.4 Gy and surgery after 6-8 weeks. The MTD, determined during phase I, was used in the subsequent phase II, in which R0 resection rate (a negative circumferential resection margin) was the primary end point.

Twenty-one patients were evaluable. In the phase I part, oxaliplatin at 85 mg/m² was established as MTD. In phase II, the main toxicity was grade III diarrhea (18%). All patients underwent surgery, and 20 patients had a resectable tumor. An R0 was achieved in 17/21 patients, downstaging to T0-2 in 7/21 and a pCR in 2/21.

Combination of Capox-RT has an acceptable acute toxicity profile and a high R0 resection rate of 81% in locally advanced rectal cancer. However the pCR rate was low.

Keywords: Rectal cancer; Radiotherapy; Oxaliplatin; Capecitabine; Chemoradiation; Phase I-II study

Document Type: Research article

DOI: 10.1245/s10434-007-9396-6

Affiliations: 1: Medical Oncology, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands, Email: g.a.p.hospers@int.umcg.nl 2: Medical Oncology, St. Radboud University Medical Center, Nijmegen, The Netherlands 3: Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands 4: Gastroenterology, Netherlands Cancer Institute, Amsterdam, The Netherlands 5: Surgical Oncology, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands 6: Radiotherapy, St. Radboud University Medical Center, Nijmegen, The Netherlands 7: Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands 8: Pathology, St. Radboud University Medical Center, Nijmegen, The Netherlands 9: Surgical Oncology, Leiden University Medical Center, Leiden, The Netherlands 10: Medical Oncology, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands

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