Preoperative Chemotherapy in Patients With Intermediate-Risk Rectal Adenocarcinoma Selected by High-Resolution Magnetic Resonance Imaging: The GEMCAD 0801 Phase II Multicenter Trial
Por:
Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J and Pericay C
Publicada:
1 oct 2014
Resumen:
Background. The need for preoperative chemoradiation or short-course radiation in all T3 rectal tumors is a controversial issue. A multicenter phase II trial was undertaken to evaluate the efficacy and safety of neoadjuvant capecitabine and oxaliplatin combined with bevacizumab in patients with intermediate-risk rectal adenocarcinoma.
Methods. We recruited 46 patients with T3 rectal adenocarcinoma selected by magnetic resonance imaging (MRI) who were candidates for (R0) resection located in the middle third with clear mesorectal fascia and who were selected by pelvic MRI. Patients received four cycles of neoadjuvant capecitabine and oxaliplatin combined with bevacizumab (final cycle without bevacizumab) before total mesorectal excision (TME). In case of progression, preoperative chemoradiation was planned. The primary endpoint was overall response rate (ORR).
Results. On an intent-to-treat analysis, the ORR was 78% (n = 36; 95% confidence interval [CI]: 63%-89%) and no progression was detected. Pathologic complete response was observed in nine patients (20%; 95% CI: 9-33), and T downstaging was observed in 48%. Forty-four patients proceeded to TME, and all had R0 resection. During preoperative therapy, two deaths occurred as a result of pulmonary embolism and diarrhea, respectively, and one patient died after surgery as a result of peritonitis secondary to an anastomotic leak (AL). A 13% rate of AL was higher than expected. The 24-month disease-free survival rate was 75% (95% CI: 60%-85%), and the 2-year local relapse rate was 2% (95% CI: 0%-11%).
Conclusion. In this selected population, initial chemotherapy results in promising activity, but the observed toxicity does not support further investigation of this specific regimen. Nevertheless, these early results warrant further testing of this strategy in an enriched population and in randomized trials.
Filiaciones:
Fernandez-Martos C:
Fundación Instituto Valenciano de Oncología, Valencia, Spain
cfmartos
Brown G:
Royal Marsden Hospital, London and Surrey, United Kingdom
Estevan R:
Fundación Instituto Valenciano de Oncología, Valencia, Spain
Salud A:
Hospital Arnau de Vilanova, Lleida, Spain
Montagut C:
Hospital del Mar, Barcelona, Spain
Maurel J:
Hospital Clinic, Barcelona, Spain
Safont MJ:
Hospital General Univeristario, Valencia, Spain
Aparicio J:
Hospital Universitario La Fe, Valencia, Spain
Feliu J:
Hospital Universitario La Paz, Madrid, Spain
Vera R:
Hospital de Navarra, Pamplona, Spain
Alonso V:
Hospital Miguel Servet, Zaragoza, Spain
:
Hospital General, Elche, Spain
Martin M:
Hospital Santa Creu y Sant Pau, Barcelona, Spain
Pera M:
Hospital del Mar, Barcelona, Spain
Sierra E:
Hospital Arnau de Vilanova, Lleida, Spain
Serra J:
Corporación Sanitaria Parc Taulí, Sabadell, Barcelona, Spain
Delgado S:
Hospital Clinic, Barcelona, Spain
Roig JV:
Hospital General Univeristario, Valencia, Spain
Santos J:
Fundación Instituto Valenciano de Oncología, Valencia, Spain
Pericay C:
Corporación Sanitaria Parc Taulí, Sabadell, Barcelona, Spain
Green Published, Bronze
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