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Preoperative Concurrent Chemoradiotherapy in Locally Advanced Rectal Cancer With High-Dose Radiation and Oxaliplatin-Containing Regimen: The Lyon R0–04 Phase II Trial

Jean-Pierre Gérard, Olivier Chapet, Chantal Nemoz, Pascale Romestaing, Françoise Mornex, Régis Coquard, Nicolas Barbet, Dan Atlan, Patrice Adeleine, Gilles Freyer

From the Department of Radiation Oncology, Lyon Sud Pierre Bénite; Clinique Saint-Jean, and Department of Biostatistics, Hospices Civils Lyon, Lyon; Clinique Denis, Mâcon; Hôpital Européen Georges Pompidou, Paris; and Department of Medical Oncology, Centre Hospitalier Lyon Sud Pierre Bénite, Pierre Bénire, France.

Address reprint requests to Jean-Pierre Gérard, MD, Centre Antoine-Lacassagne, Direction, 33 avenue de Valombrose, 06189 Nice Cedex 2, France; email: jean-pierre.gerard{at}cal.nice.fnclcc.fr.

Purpose: The combination of radiation, fluorouracil, and oxaliplatin in locally advanced rectal cancer has been shown to be feasible in a phase I trial. The purpose of this phase II trial was to assess tolerance and efficacy of this regimen in a preoperative setting.

Patients and Methods: Between May 2000 and October 2001, 40 operable patients were entered onto the study. Radiotherapy was delivered with a three-field technique to a dose of 50 Gy over 5 weeks with a concomitant boost approach. Two cycles of chemotherapy were given synchronously on weeks 1 and 5, with oxaliplatin 130 mg/m² on day 1 followed by 5-day continuous infusion of fluorouracil 350 mg/m² and L-folinic acid 100 mg/m². Surgery was planned 5 weeks later.

Results: All patients completed treatment without modification except one who experienced grade 3/4 toxicity. Grade 3 toxicity was seen in seven patients. Surgery was performed in all patients after a mean interval time of 5 weeks. An objective clinical response was seen in 30 patients (75%). Sphincter-saving surgery was possible in 26 patients. No postoperative deaths occurred. In four patients (10%), a reoperation was necessary (anastomotic fistula, n = 2; pelvic abscess, n = 2). In six cases the operative specimen was sterilized (15%), and in 12 cases (30%), only few residual cells were detected.

Conclusion: Such a combined preoperative chemoradiotherapy and oxaliplatin-containing regimen is well tolerated with no increase in surgical toxicity. The good response rate observed warrants its use in further clinical trials.

Supported by grants from Ligue Contre le Cancer, Comité du Rhône et de Saône et Loire, France.

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