Postoperative chemoradiation for resected gastric cancer - is the Macdonald Regimen Tolerable a retrospective multi-institutional studyReport as inadecuate




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Radiation Oncology

, 6:127

First Online: 29 September 2011Received: 09 July 2011Accepted: 29 September 2011

Abstract

BackgroundPostoperative chemoradiation as per Intergroup-0116 trial -Macdonald regimen- is considered standard for completely resected high risk gastric cancer. However, many concerns remain with regards to the toxicity of this regimen. To evaluate the safety and tolerability of this regimen in a routine clinical practice setting, we analyzed our experience with its use. As we did not expect a different toxic profile in patients pts with positive margins R1 resection, these were studied together with pts after complete resection R0.

Patients and MethodsPostoperative chemoradiation therapy was given according to the original Intergroup-0116 regimen. Overall survival OS and disease free survival DFS rates were calculated using the Kaplan-Meier method. Comparison of OS and DFS between R0 and R1 pts was done using the log-rank test.

ResultsBetween 6-2000 and 12-2007, 166 pts after R0 129 pts or R1 37 pts resection of locally advanced gastric adenocarcinoma received postoperative chemoradiation; 61% were male and the median age was 63 years range, 23-86; 78% had T ≥ 3 tumors and 81% had N+ disease; 87% of the pts completed radiotherapy and 54% completed the entire chemoradiation plan; 46.4% had grade ≥ 3 toxicity and 32% were hospitalized at least once for toxicity. Three pts 1.8% died of toxicity: diarrhea 1, neutropenic sepsis 1 and neutropenic sepsis complicated by small bowel gangrene 1. The most common hematological toxicity was neutropenia, grade ≥ 3 in 30% of pts and complicated by fever in 15%. The most common non-hematological toxicities were nausea, vomiting and diarrhea. With a median follow-up of 51 months range, 2-100, 62% of the R0 patients remain alive and 61% are free of disease. Median DFS and OS for R0 were not reached. R0 pts had a significantly higher 3-year DFS 60% vs. 29%, p = 0.001 and OS 61% vs. 33%, p = 0.01 compared with R1 pts.

ConclusionsIn our experience, postoperative chemoradiation as per Intergroup-0116 seems to be substantially toxic, with a mortality rate which seems higher than reported in that trial. Efficacy data appears comparable to the original report. Following postoperative chemoradiation, involvement of surgical margins still has a detrimental impact on patient outcome.

KeywordsPostoperative chemoradiation resected gastric cancer Israeli experience Electronic supplementary materialThe online version of this article doi:10.1186-1748-717X-6-127 contains supplementary material, which is available to authorized users.

Yulia Kundel, Ofer Purim contributed equally to this work.

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Author: Yulia Kundel - Ofer Purim - Efraim Idelevich - Konstantin Lavrenkov - Sofia Man - Svetlana Kovel - Natalia Karminsky - Raph

Source: https://link.springer.com/







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