دورية أكاديمية

Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomised phase III trial

التفاصيل البيبلوغرافية
العنوان: Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomised phase III trial
المؤلفون: Breugom, A.J., van Gijn, W., Muller, E.W., Berglund, Å., van den Broek, C.B.M., Fokstuen, T., Gelderblom, H., Kapiteijn, E., Leer, J.W.H., Marijnen, C.A.M., Martijn, H., Meershoek-Klein Kranenbarg, E., Nagtegaal, I.D., Påhlman, L., Punt, C.J.A., Putter, H., Roodvoets, A.G.H., Rutten, H.J.T., Steup, W.H., Glimelius, B., van de Velde, C.J.H., cooperative investigators of the Dutch Colorectal Cancer Group and the Nordic Gastrointestinal Tumour Adjuvant Therapy Group
بيانات النشر: Oxford University Press
سنة النشر: 2014
المجموعة: HighWire Press (Stanford University)
مصطلحات موضوعية: Original article
الوصف: <$O_ST_ABS>Background<$C_ST_ABS>The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomised 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. <$O_ST_ABS>Patients and Methods<$C_ST_ABS>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 total mesorectal excision. Radiotherapy consisted of 5x5 Gy. Chemoradiotherapy consisted of 25x1.8-2 Gy combined with 5-FU based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR), or eight courses capecitabine (SCRIPT). Randomisation 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. <$O_ST_ABS>Results<$C_ST_ABS>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, five-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group (HR 0.93, 95% CI 0.62-1.39; p =0.73). The hazard ratio 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). <$O_ST_ABS>Conclusion<$C_ST_ABS>The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative ...
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اللغة: English
العلاقة: http://annonc.oxfordjournals.org/cgi/content/short/mdu560v1Test; http://dx.doi.org/10.1093/annonc/mdu560Test
DOI: 10.1093/annonc/mdu560
الإتاحة: https://doi.org/10.1093/annonc/mdu560Test
http://annonc.oxfordjournals.org/cgi/content/short/mdu560v1Test
حقوق: Copyright (C) 2014, European Society for Medical Oncology
رقم الانضمام: edsbas.5D3D65B1
قاعدة البيانات: BASE