No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT) |
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| Institution: | 1. Department of Radiotherapy, Pisa University, Italy;2. Cattedra di radioterapia, Università Cattolica S. Cuore, Rome, Italy;3. Oncology Referral Center, National Cancer Institute, Aviano, Italy;4. Department of Radiotherapy, “La Sapienza University”, Rome, Italy;5. Department of Radiotherapy, Perugia University, Italy;6. Department of Radiotherapy, Trieste University, Italy;7. Department of Radiotherapy, Hospital of Venice, Italy;8. Department of Radiotherapy, Florence University, Italy;9. Department of Radiotherapy, Hospital of Arezzo, Italy;10. Oncological Institute of Veneto, Padova, Italy;11. Department of Radiotherapy, Hospital of Belluno, Italy;12. Department of Radiotherapy, “Centro Oncologico Fiorentino”, Sesto Fiorentino, Italy;13. Department of Medical Oncology, Pisa University, Italy;1. Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France;2. Department of Radiotherapy, Centre Val d’Aurelle, Montpellier, France;3. Biostatistics Unit, Centre Val d’Aurelle, Montpellier Cedex 05, France;4. Department of Radiotherapy, Centre Léon Bérard, Lyon, France;5. Department of Radiotherapy, Hôpital Saint Louis, Paris, France;6. Department of Medical Oncology, Clinique Armoricaine de Radiologie, Saint-Brieuc, France;7. Department of Oncology, Hôpital Saint André, Bordeaux, France;8. Department of Digestive Oncology, Hôpital la Timone, Marseille Cedex 5, France;9. Department of Medical Oncology, Centre Alexis Vautrin, Vandœuvre-les-Nancy, France;10. R&D UNICANCER, Paris Cedex 13, France;11. Department of Radiotherapy, Centre Antoine Lacassagne, Nice, France;1. Centre Antoine Lacassagne, Nice, France;2. CRLC Val d’Aurelle-Paul Lamarque, Montpellier, France;3. Institut de Cancérologie de la Loire, St Etienne, France;4. Institut de Cancérologie de l’Ouest Gauducheau, Nantes, France;5. Institut Gustave Roussy, Villejuif, France;6. Unicancer, Paris, France;1. The Royal Marsden NHS Foundation Trust, London, United Kingdom;2. Vall d''Hebron University Hospital, Universitat Autònoma de Barcelona, Department of Medical Oncology, Barcelona, Spain;3. University of Uppsala, Uppsala, Sweden;4. Biomedical Research Institute INCLIVA, Department of Hematology and Medical Oncology, University of Valencia, Spain;6. Southampton General Hospital, Cancer Sciences Unit, University of Southampton, United Kingdom;5. Poole Hospital NHS Foundation Trust, Department of Medical Oncology, Bournemouth University, United Kingdom;1. Radiation Oncology Department – Gemelli ART, Università Cattolica S Cuore, Largo A Gemelli 8, 00168 Rome, Italy;1. Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France;2. Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France;3. Hospices Civils de Lyon, Pôle IMER, Lyon, France;4. Department of Radiotherapy, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France;6. Department of Radiotherapy, Centre Antoine-Lacassagne, University Nice-Sophia, Nice, France |
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| Abstract: | Background and purposeTo evaluate the effect of adjuvant chemotherapy (ACT) in locally advanced rectal cancer (LARC) after neoadjuvant chemoradiation (NACT-RT). The study was funded by the Italian National Research Council (CNR).MethodsFrom September 1992 to January 2001, 655 patients with LARC (clinically T3–4, any N) treated with NACT-RT and surgery, were randomized in two arms: follow-up (Arm A) or 6 cycles of ACT with 5 fluorouracil (5FU)-Folinic Acid (Arm B). NACT-RT consisted of 45 Gy/28/ff concurrent with 5FU (350 mg/sqm) and Folinic Acid (20 mg/sqm) on days 1–5 and 29–33; surgery was performed after 4–6 weeks. Median follow up was 63·7 months. Primary end point was overall survival (OS).Results634/655 patients were evaluable (Arm A 310, Arm B 324); 92·5% of Arm A and 91% of Arm B patients received the preoperative treatment as in the protocol; 294 patients of Arm A (94·8%) and 296 of Arm B (91·3%) underwent a radical resection; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms. 83/297 (28%) patients in Arm B, never started ACT. Five year OS and DFS did not show any significant difference in the two treatment arms. Distant metastases occurred in 62 patients (21%) in Arm A and in 58 (19·6%) in Arm B.ConclusionsIn patients with LARC treated with NACT-RT, the addition of ACT did not improve 5 year OS and DFS and had no impact on the distant metastasis rate. |
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| Keywords: | Rectal cancer Adjuvant chemotherapy Preoperative radiochemotherapy |
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