Cargando…
Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial
BACKGROUND: The purpose of the study was to improve treatment efficacy for locally advanced rectal cancer (LARC) by shifting half of adjuvant chemotherapy preoperatively to one induction and two consolidation cycles. PATIENTS AND METHODS: Between October 2011 and April 2013, 66 patients with LARC we...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Sciendo
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137354/ https://www.ncbi.nlm.nih.gov/pubmed/30210040 http://dx.doi.org/10.2478/raon-2018-0028 |
_version_ | 1783355170386608128 |
---|---|
author | Golo, Danijela But-Hadzic, Jasna Anderluh, Franc Brecelj, Erik Edhemovic, Ibrahim Jeromen, Ana Omejc, Mirko Oblak, Irena Secerov-Ermenc, Ajra Velenik, Vaneja |
author_facet | Golo, Danijela But-Hadzic, Jasna Anderluh, Franc Brecelj, Erik Edhemovic, Ibrahim Jeromen, Ana Omejc, Mirko Oblak, Irena Secerov-Ermenc, Ajra Velenik, Vaneja |
author_sort | Golo, Danijela |
collection | PubMed |
description | BACKGROUND: The purpose of the study was to improve treatment efficacy for locally advanced rectal cancer (LARC) by shifting half of adjuvant chemotherapy preoperatively to one induction and two consolidation cycles. PATIENTS AND METHODS: Between October 2011 and April 2013, 66 patients with LARC were treated with one induction chemotherapy cycle followed by chemoradiotherapy (CRT), two consolidation cycles, surgery and three adjuvant capecitabine cycles. Radiation doses were 50.4 Gy for T2-3 and 54 Gy for T4 tumours in 1.8 Gy daily fraction. The doses of concomitant and neo/adjuvant capecitabine were 825 mg/m(2)/12h and 1250mg/m(2)/12h, respectively. The primary endpoint was pathologic complete response (pCR). RESULTS: Forty-three (65.1%) patients were treated according to protocol. The compliance rates for induction, consolidation, and adjuvant chemotherapy were 98.5%, 93.8% and 87.3%, respectively. CRT was completed by 65/66 patients, with G ≥ 3 non-hematologic toxicity at 13.6%. The rate of pCR (17.5%) was not increased, but N and the total-down staging rates were 77.7% and 79.3%, respectively. In a median follow-up of 55 months, we recorded one local relapse (LR) (1.6%). The 5-year disease-free survival (DFS) and overall survival (OS) rates were 64.0% (95% CI 63.89–64.11) and 69.5% (95% CI 69.39–69.61), respectively. CONCLUSIONS: In LARC preoperative treatment intensification with capecitabine before and after radiotherapy is well tolerated, with a high compliance rate and acceptable toxicity. Though it does not improve the local effect, it achieves a high LR rate, DFS, and OS. |
format | Online Article Text |
id | pubmed-6137354 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Sciendo |
record_format | MEDLINE/PubMed |
spelling | pubmed-61373542018-09-14 Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial Golo, Danijela But-Hadzic, Jasna Anderluh, Franc Brecelj, Erik Edhemovic, Ibrahim Jeromen, Ana Omejc, Mirko Oblak, Irena Secerov-Ermenc, Ajra Velenik, Vaneja Radiol Oncol Research Article BACKGROUND: The purpose of the study was to improve treatment efficacy for locally advanced rectal cancer (LARC) by shifting half of adjuvant chemotherapy preoperatively to one induction and two consolidation cycles. PATIENTS AND METHODS: Between October 2011 and April 2013, 66 patients with LARC were treated with one induction chemotherapy cycle followed by chemoradiotherapy (CRT), two consolidation cycles, surgery and three adjuvant capecitabine cycles. Radiation doses were 50.4 Gy for T2-3 and 54 Gy for T4 tumours in 1.8 Gy daily fraction. The doses of concomitant and neo/adjuvant capecitabine were 825 mg/m(2)/12h and 1250mg/m(2)/12h, respectively. The primary endpoint was pathologic complete response (pCR). RESULTS: Forty-three (65.1%) patients were treated according to protocol. The compliance rates for induction, consolidation, and adjuvant chemotherapy were 98.5%, 93.8% and 87.3%, respectively. CRT was completed by 65/66 patients, with G ≥ 3 non-hematologic toxicity at 13.6%. The rate of pCR (17.5%) was not increased, but N and the total-down staging rates were 77.7% and 79.3%, respectively. In a median follow-up of 55 months, we recorded one local relapse (LR) (1.6%). The 5-year disease-free survival (DFS) and overall survival (OS) rates were 64.0% (95% CI 63.89–64.11) and 69.5% (95% CI 69.39–69.61), respectively. CONCLUSIONS: In LARC preoperative treatment intensification with capecitabine before and after radiotherapy is well tolerated, with a high compliance rate and acceptable toxicity. Though it does not improve the local effect, it achieves a high LR rate, DFS, and OS. Sciendo 2018-09-11 /pmc/articles/PMC6137354/ /pubmed/30210040 http://dx.doi.org/10.2478/raon-2018-0028 Text en © 2018 Danijela Golo, Jasna But-Hadzic, Franc Anderluh, Erik Brecelj, Ibrahim Edhemovic, Ana Jeromen, Mirko Omejc, Irena Oblak, Ajra Secerov-Ermenc, Vaneja Velenik, published by Sciendo http://creativecommons.org/licenses/by-nc-nd/3.0 This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License. |
spellingShingle | Research Article Golo, Danijela But-Hadzic, Jasna Anderluh, Franc Brecelj, Erik Edhemovic, Ibrahim Jeromen, Ana Omejc, Mirko Oblak, Irena Secerov-Ermenc, Ajra Velenik, Vaneja Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title | Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title_full | Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title_fullStr | Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title_full_unstemmed | Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title_short | Induction Chemotherapy, Chemoradiotherapy and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer - Long-term Results of Phase II OIGIT-01 Trial |
title_sort | induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase ii oigit-01 trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137354/ https://www.ncbi.nlm.nih.gov/pubmed/30210040 http://dx.doi.org/10.2478/raon-2018-0028 |
work_keys_str_mv | AT golodanijela inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT buthadzicjasna inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT anderluhfranc inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT breceljerik inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT edhemovicibrahim inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT jeromenana inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT omejcmirko inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT oblakirena inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT secerovermencajra inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial AT velenikvaneja inductionchemotherapychemoradiotherapyandconsolidationchemotherapyinpreoperativetreatmentofrectalcancerlongtermresultsofphaseiioigit01trial |