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
<$O_ST_ABS>Background<$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 w... Mehr ...
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Dokumenttyp: | TEXT |
Erscheinungsdatum: | 2014 |
Verlag/Hrsg.: |
Oxford University Press
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Schlagwörter: | Original article |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-26632031 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | http://annonc.oxfordjournals.org/cgi/content/short/mdu560v1 |
<$O_ST_ABS>Background<$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 ...