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Annals of Oncology Advance Access originally published online on May 2, 2006
Annals of Oncology 2006 17(7):1103-1110; doi:10.1093/annonc/mdl085
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© 2006 European Society for Medical Oncology

Improved incidence of pT0 downstaged surgical specimens in locally advanced rectal cancer (LARC) treated with induction oxaliplatin plus 5-fluorouracil and preoperative chemoradiation

F. A. Calvo1,*, F. J. Serrano2, J. A. Diaz-González2, M. Gomez-Espi2, E. Lozano2, R. Garcia2, D. de la Mata2, J. A. Arranz3, P. García-Alfonso3, G. Pérez-Manga3 and E. Álvarez4

1 Department of Oncology; 2 Radiation Oncology Service; 3 Medical Oncology Service; 4 Department of Pathology, Hospital General Universitario Gregorio Marañón, Madrid, Spain

* Correspondence to: Prof. F. A. Calvo, Chairman Department of Oncology, Hospital General Universitario Gregorio Marañón, Dr. Esquerdo 46, 28007 Madrid, Spain. Tel. +34 91 586 85 99; Fax +34 91 586 80 18; E-mail: fcalvo.hgugm{at}salud.madrid.org

Purpose: To compare efficacy in terms of pathologic response in LARC patients treated with preoperative chemoradiation, with or without a short-intense course of induction oxaliplatin.

Patients and Methods: From 05/98 to 10/02, 114 patients were treated with preoperative chemoradiation (4500–5040 cGy + oral Tegafur 1200 mg/day) for cT3-4N+/xM0 rectal cancer. Starting 05/01, 52 consecutive patients additionally received induction FOLFOX-4, oxaliplatin (85 mg/m2 iv d1), 5-FU (400 mg/m2 iv bolus d1) and 600 mg/m2 iv continuous infusion in 22 h with leucovorin (200 mg iv) d1 and d2, every 15 days (2 cycles), followed by the previously described Tegafur chemoradiation regime. Surgery was performed in 5–6 weeks. Pathological assessment investigated post-treatment T and N status in the rectal wall and peri-rectal tissues.

Results: Patients, tumor and treatment characteristics were comparable between groups. Incidence of pT0 specimens was significantly increased by induction FOLFOX-4 (P = 0.006). Total T and N downstaging were 58% versus 75% and 42% versus 40%, respectively (P = ns). T downstaging of ≥2 categories was significantly superior in FOLFOX-4 group (P = 0.029).

Conclusions: Short-intense induction FOLFOX-4 significantly improves pathologic complete response in LARC patients treated with tegafur-sensitized preoperative chemoradiation. The 44% rate of pT0-1 specimens observed in the oxaliplatin group should impulse innovative surgical approaches to promote ano-rectal sphincter conserving protocols.

Key words: neoadjuvant oxaliplatin, chemoradiation, tegafur, rectal cancer, downstaging


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