Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial
| العنوان: | Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial |
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| المؤلفون: | Breugom, A.J., Gijn, W. van, Muller, E.W., Berglund, A., Broek, C.B.M. van den, Fokstuen, T., Gelderblom, H., Kapiteijn, E., Leer, J.W.H., Marijnen, C.A.M., Martijn, H., Kranenbarg, E.M.K., Nagtegaal, I.D., Pahlman, L., Punt, C.J.A., Putter, H., Roodvoets, A.G.H., Rutten, H.J.T., Steup, W.H., Glimelius, B., Velde, C.J.H. van de, Dutch Colorectal Canc Grp, Nordic Gastrointestinal Tumour Adj |
| المساهمون: | CCA -Cancer Center Amsterdam, Oncology, Surgery, RS: GROW - Oncology, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy |
| المصدر: | Annals of Oncology, 26, 4, pp. 696-701 Annals of Oncology, 26(4), 696-701 Annals of oncology, 26(4), 696-701. Oxford University Press Annals of Oncology, 26(4), 696-701. Oxford University Press Annals of Oncology, 26, 696-701 |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Male, rectal adenocarcinoma, medicine.medical_specialty, Colorectal cancer, preoperative radiotherapy, medicine.medical_treatment, Leucovorin, Adenocarcinoma, Preoperative care, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Antineoplastic Combined Chemotherapy Protocols, medicine, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Humans, Cumulative incidence, Survival rate, Capecitabine, Digestive System Surgical Procedures, Neoplasm Staging, Netherlands, business.industry, Rectal Neoplasms, total mesorectal excision, Incidence, Hematology, Middle Aged, medicine.disease, Prognosis, Total mesorectal excision, Chemotherapy regimen, Combined Modality Therapy, Surgery, Radiation therapy, Survival Rate, adjuvant chemotherapy, Oncology, Chemotherapy, Adjuvant, preoperative chemoradiotherapy, Female, Radiotherapy, Adjuvant, Fluorouracil, Neoplasm Recurrence, Local, business, Chemoradiotherapy, Follow-Up Studies |
| الوصف: | The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME).The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 ? 5 Gy. Chemoradiotherapy consisted of 25 ? 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival.Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39).The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete planned accrual.Dutch Colorectal Cancer group, CKTO 2003-16, ISRCTN36266738.? The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0923-7534 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b56d89e18969de59c370078ca7ce04aTest https://doi.org/10.1093/annonc/mdu560Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8b56d89e18969de59c370078ca7ce04a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 09237534 |
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