Adam Idasiak, Barbara Ziółkowska, Marcin Rajczykowski, Katarzyna Galwas, Iwona Dębosz-Suwińska, Marcin Zeman, Jolanta Mrochem-Kwarciak, Rafał Suwiński
{"title":"局部晚期直肠癌术前加速超分割放疗（HART）与术前超分割放射化疗（HART-CT）的随机临床试验。","authors":"Adam Idasiak, Barbara Ziółkowska, Marcin Rajczykowski, Katarzyna Galwas, Iwona Dębosz-Suwińska, Marcin Zeman, Jolanta Mrochem-Kwarciak, Rafał Suwiński","doi":"10.1093/bjr/tqae176","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to compare pathological response rates after reoperative hyperfractionated radiotherapy with co-administration of chemotherapy based on 5FU (HART-CT) vs. preoperative hyperfractionated radiotherapy (HART) in patients with resectable rectal cancer.</p><p><strong>Methods: </strong>Patients with T2/N+ or T3/any N rectal cancer were randomized either to HART twice a day (28 fractions of 1.5 Gy) to total dose 42 Gy or to HART-CT. Tumor regression grade was postoperatively assessed according to the 4-point scale as recommended by the AJCC. The secondary endpoints included overall survival (OS), disease-free survival (DFS), toxicity of preoperative treatment, locoregional and distant failure rates. There were 187 patients eligible for analysis: 95 in HART and 92 in the HART-CT. Median follow-up was 5.6 years.</p><p><strong>Results: </strong>The analysis demonstrated a significantly higher chance of achieving pCR in HART-CT arm: complete response was achieved in 4/95, 4% (HART) and 11/92, 12% (HART-CT) (p = 0.045). The differences in OS and DFS, while tending to favor HART-CT, were not significant (p = 0.13, HR = 0.82, 95% CI 0.63-1.06) and (p = 0.32; HR = 0.88, 95% CI 0.69-1.13), respectively. The locoregional failure and distant metastases rates did not statistically differ between the trial arms. The rate of late complications were similar (p = 0.51), grade 3+ being 8% versus 11% in the HART/HART-CT group, respectively.</p><p><strong>Conclusions: </strong>The hyperfractionated preoperative radiotherapy with concurrent 5-Fu based chemotherapy (HART-CT) improved pathological response rate compared to HART. This translated into favorable OS and DFS in HART-CT, but the differences did not reach the threshold for significance.</p><p><strong>Advances in knowledge: </strong>A new hyperfractionated chemo-RT scheme is proposed. Histopathological major response (TRG 0-1) is associated with better clinical outcome.</p>","PeriodicalId":9306,"journal":{"name":"British Journal of Radiology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized clinical trial on accelerated preoperative hyperfractionated radiotherapy (HART) vs preoperative hyperfractionated radio-chemotherapy (HART-CT) in locally advanced rectal cancer.\",\"authors\":\"Adam Idasiak, Barbara Ziółkowska, Marcin Rajczykowski, Katarzyna Galwas, Iwona Dębosz-Suwińska, Marcin Zeman, Jolanta Mrochem-Kwarciak, Rafał Suwiński\",\"doi\":\"10.1093/bjr/tqae176\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>The aim of this study was to compare pathological response rates after reoperative hyperfractionated radiotherapy with co-administration of chemotherapy based on 5FU (HART-CT) vs. preoperative hyperfractionated radiotherapy (HART) in patients with resectable rectal cancer.</p><p><strong>Methods: </strong>Patients with T2/N+ or T3/any N rectal cancer were randomized either to HART twice a day (28 fractions of 1.5 Gy) to total dose 42 Gy or to HART-CT. Tumor regression grade was postoperatively assessed according to the 4-point scale as recommended by the AJCC. The secondary endpoints included overall survival (OS), disease-free survival (DFS), toxicity of preoperative treatment, locoregional and distant failure rates. There were 187 patients eligible for analysis: 95 in HART and 92 in the HART-CT. Median follow-up was 5.6 years.</p><p><strong>Results: </strong>The analysis demonstrated a significantly higher chance of achieving pCR in HART-CT arm: complete response was achieved in 4/95, 4% (HART) and 11/92, 12% (HART-CT) (p = 0.045). The differences in OS and DFS, while tending to favor HART-CT, were not significant (p = 0.13, HR = 0.82, 95% CI 0.63-1.06) and (p = 0.32; HR = 0.88, 95% CI 0.69-1.13), respectively. The locoregional failure and distant metastases rates did not statistically differ between the trial arms. The rate of late complications were similar (p = 0.51), grade 3+ being 8% versus 11% in the HART/HART-CT group, respectively.</p><p><strong>Conclusions: </strong>The hyperfractionated preoperative radiotherapy with concurrent 5-Fu based chemotherapy (HART-CT) improved pathological response rate compared to HART. This translated into favorable OS and DFS in HART-CT, but the differences did not reach the threshold for significance.</p><p><strong>Advances in knowledge: </strong>A new hyperfractionated chemo-RT scheme is proposed. Histopathological major response (TRG 0-1) is associated with better clinical outcome.</p>\",\"PeriodicalId\":9306,\"journal\":{\"name\":\"British Journal of Radiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-09-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjr/tqae176\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjr/tqae176","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Randomized clinical trial on accelerated preoperative hyperfractionated radiotherapy (HART) vs preoperative hyperfractionated radio-chemotherapy (HART-CT) in locally advanced rectal cancer.
Objectives: The aim of this study was to compare pathological response rates after reoperative hyperfractionated radiotherapy with co-administration of chemotherapy based on 5FU (HART-CT) vs. preoperative hyperfractionated radiotherapy (HART) in patients with resectable rectal cancer.
Methods: Patients with T2/N+ or T3/any N rectal cancer were randomized either to HART twice a day (28 fractions of 1.5 Gy) to total dose 42 Gy or to HART-CT. Tumor regression grade was postoperatively assessed according to the 4-point scale as recommended by the AJCC. The secondary endpoints included overall survival (OS), disease-free survival (DFS), toxicity of preoperative treatment, locoregional and distant failure rates. There were 187 patients eligible for analysis: 95 in HART and 92 in the HART-CT. Median follow-up was 5.6 years.
Results: The analysis demonstrated a significantly higher chance of achieving pCR in HART-CT arm: complete response was achieved in 4/95, 4% (HART) and 11/92, 12% (HART-CT) (p = 0.045). The differences in OS and DFS, while tending to favor HART-CT, were not significant (p = 0.13, HR = 0.82, 95% CI 0.63-1.06) and (p = 0.32; HR = 0.88, 95% CI 0.69-1.13), respectively. The locoregional failure and distant metastases rates did not statistically differ between the trial arms. The rate of late complications were similar (p = 0.51), grade 3+ being 8% versus 11% in the HART/HART-CT group, respectively.
Conclusions: The hyperfractionated preoperative radiotherapy with concurrent 5-Fu based chemotherapy (HART-CT) improved pathological response rate compared to HART. This translated into favorable OS and DFS in HART-CT, but the differences did not reach the threshold for significance.
Advances in knowledge: A new hyperfractionated chemo-RT scheme is proposed. Histopathological major response (TRG 0-1) is associated with better clinical outcome.
期刊介绍：
BJR is the international research journal of the British Institute of Radiology and is the oldest scientific journal in the field of radiology and related sciences.
Dating back to 1896, BJR’s history is radiology’s history, and the journal has featured some landmark papers such as the first description of Computed Tomography "Computerized transverse axial tomography" by Godfrey Hounsfield in 1973. A valuable historical resource, the complete BJR archive has been digitized from 1896.
Quick Facts:
- 2015 Impact Factor – 1.840
- Receipt to first decision – average of 6 weeks
- Acceptance to online publication – average of 3 weeks
- ISSN: 0007-1285
- eISSN: 1748-880X
Open Access option
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
