PO55

IF 1.8

Brachytherapy Pub Date : 2023-09-01 DOI:10.1016/j.brachy.2023.06.156

Valentine Ho, Sarat Chander, Scott Williams, Sylvia Van Dyk, Elizabeth Pu

{"title":"PO55","authors":"Valentine Ho, Sarat Chander, Scott Williams, Sylvia Van Dyk, Elizabeth Pu","doi":"10.1016/j.brachy.2023.06.156","DOIUrl":null,"url":null,"abstract":"Purpose Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Materials and Methods Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. Results 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. Conclusions HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis. Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis.","PeriodicalId":93914,"journal":{"name":"Brachytherapy","volume":"101 1","pages":"0"},"PeriodicalIF":1.8000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"PO55\",\"authors\":\"Valentine Ho, Sarat Chander, Scott Williams, Sylvia Van Dyk, Elizabeth Pu\",\"doi\":\"10.1016/j.brachy.2023.06.156\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Purpose Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Materials and Methods Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. Results 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. Conclusions HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis. Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis.\",\"PeriodicalId\":93914,\"journal\":{\"name\":\"Brachytherapy\",\"volume\":\"101 1\",\"pages\":\"0\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Brachytherapy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.brachy.2023.06.156\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brachytherapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.brachy.2023.06.156","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

摘要

目的:近距离放疗剂量递增联合外束放疗(EBRT)可改善中高风险局部前列腺癌的长期生化控制，高剂量率近距离放疗(HDR)作为单药治疗已被证明是安全有效的治疗局部前列腺癌。我们比较了2007年至2018年在单一机构接受HDR近距离放疗作为强化治疗(HDR- b)和HDR近距离放疗作为单药治疗(HDR- m)的不良中高危疾病患者的长期疗效和毒性数据。材料和方法:经人类研究伦理委员会批准，对2007年3月20日至2018年7月31日接受HDR治疗的局限性前列腺癌序贯患者进行回顾性记录审查。复发和毒性数据来自医疗记录或在适当情况下直接接触患者。主要结局指标包括由Phoenix标准定义的生化无进展生存期(bPFS)和根据CTCAE v4.0分级的毒性。采用Cox比例风险模型进行多因素回归，确定HDR-M组和HDR-B组bPFS的风险比。结果268例患者为不良-中危或高危，其中HDR-B和HDR-M分别为233例和35例。HDR-B和HDR-M的中位随访时间分别为7.6年和5.1年。7例接受HDR-M治疗的高危患者中，5例既往有盆腔放疗。在HDR-B组中，94%的患者接受近距离治疗剂量为2次20Gy, 89%的患者接受EBRT剂量为23次46Gy。HDR-M给药剂量分别为2次27Gy(54.3%)、3次33Gy(28.6%)和3次34.5Gy(14.3%)。71%的HDR-B患者、37%的HDR-M患者和66%的总体患者使用ADT, 43%的患者接受12个月或更长时间的治疗。HDR-B的5年bPFS为85.6%(95%可信区间[CI] 79.6%-90.0%)， 10年bPFS为71.8% (95% CI 62.1%-79.4%)， HDR-M的5年bPFS为77.5% (95% CI 58.1%-88.7%)， 10年bPFS为53.3% (95% CI 26.2%-74.4%)，多因素风险比为2.10 (p=0.08)。原发性肿瘤分期、Gleason分级组和ADT使用是生化失败的重要预测因子，其风险比分别为1.3 (p=0.01)、1.4 (p=0.03)和0.6 (p=0.02)。在5年和10年，HDR-B的总生存率分别为94%和87%，HDR-M的总生存率分别为96%和69%。HDR-B的粗尿道狭窄率为15.9% (n=37, 95% CI 11.7%-21.2%)， HDR-M为11.4% (n=4, 95% CI 4.2%-27.5%)，总体为15.3% (95% CI 11.4%-20.1%)，其中39例需要干预，中位时间为2.2年。HDR-M组出现狭窄的4例患者中，2例既往盆腔照射作为危险因素。2010年之前治疗的患者狭窄总发生率为25% (95% CI 17.7%-33.5%)，中位随访11.5年，2010年以后治疗的患者狭窄总发生率为8% (95% CI 4.5%-13.5%)，中位随访5.9年，超声规划软件和硬件更新实施后，从单一植入方案改为多次植入方案。HDR-B和HDR-M的漏尿率分别为12.4% (95% CI 8.8%-17.4%)和0%(95% CI 0%-8.6%)， HDR-B患者中有6% (95% CI 3.6%-9.9%)需要使用尿垫或干预。HDR-B组症状性晚期直肠炎发生率为9% (95%CI 5.9% ~ 13.5%)， HDR-M组为0% (95%CI 0 ~ 8.6%)。未发生4级及以上晚期毒性反应。结论HDR近距离放疗配合外束流放疗对不良中高危局部前列腺癌具有较高的长期生化控制率。早期数据表明，在选定的患者中，HDR近距离放疗可促进生化控制，对晚期尿失禁和症状性直肠炎发生率低，无明显损害。剂量递增的近距离放疗联合外束放疗(EBRT)改善了中高风险局部前列腺癌的长期生化控制，高剂量率近距离放疗(HDR)作为单一疗法已被证明在治疗局部前列腺癌中是安全有效的。我们比较了2007年至2018年在单一机构接受HDR近距离放疗作为强化治疗(HDR- b)和HDR近距离放疗作为单药治疗(HDR- m)的不良中高危疾病患者的长期疗效和毒性数据。经人类研究伦理委员会批准，对2007年3月20日至2018年7月31日接受HDR治疗的局部前列腺癌序贯患者进行回顾性记录审查。复发和毒性数据来自医疗记录或在适当情况下直接接触患者。主要结局指标包括由Phoenix标准定义的生化无进展生存期(bPFS)和根据CTCAE v4.0分级的毒性。目的:近距离放疗剂量递增联合外束放疗(EBRT)可改善中高风险局部前列腺癌的长期生化控制，高剂量率近距离放疗(HDR)作为单药治疗已被证明是安全有效的治疗局部前列腺癌。我们比较了2007年至2018年在单一机构接受HDR近距离放疗作为强化治疗(HDR- b)和HDR近距离放疗作为单药治疗(HDR- m)的不良中高危疾病患者的长期疗效和毒性数据。材料和方法:经人类研究伦理委员会批准，对2007年3月20日至2018年7月31日接受HDR治疗的局限性前列腺癌序贯患者进行回顾性记录审查。复发和毒性数据来自医疗记录或在适当情况下直接接触患者。主要结局指标包括由Phoenix标准定义的生化无进展生存期(bPFS)和根据CTCAE v4.0分级的毒性。采用Cox比例风险模型进行多因素回归，确定HDR-M组和HDR-B组bPFS的风险比。结果268例患者为不良-中危或高危，其中HDR-B和HDR-M分别为233例和35例。HDR-B和HDR-M的中位随访时间分别为7.6年和5.1年。7例接受HDR-M治疗的高危患者中，5例既往有盆腔放疗。在HDR-B组中，94%的患者接受近距离治疗剂量为2次20Gy, 89%的患者接受EBRT剂量为23次46Gy。HDR-M给药剂量分别为2次27Gy(54.3%)、3次33Gy(28.6%)和3次34.5Gy(14.3%)。71%的HDR-B患者、37%的HDR-M患者和66%的总体患者使用ADT, 43%的患者接受12个月或更长时间的治疗。HDR-B的5年bPFS为85.6%(95%可信区间[CI] 79.6%-90.0%)， 10年bPFS为71.8% (95% CI 62.1%-79.4%)， HDR-M的5年bPFS为77.5% (95% CI 58.1%-88.7%)， 10年bPFS为53.3% (95% CI 26.2%-74.4%)，多因素风险比为2.10 (p=0.08)。原发性肿瘤分期、Gleason分级组和ADT使用是生化失败的重要预测因子，其风险比分别为1.3 (p=0.01)、1.4 (p=0.03)和0.6 (p=0.02)。在5年和10年，HDR-B的总生存率分别为94%和87%，HDR-M的总生存率分别为96%和69%。HDR-B的粗尿道狭窄率为15.9% (n=37, 95% CI 11.7%-21.2%)， HDR-M为11.4% (n=4, 95% CI 4.2%-27.5%)，总体为15.3% (95% CI 11.4%-20.1%)，其中39例需要干预，中位时间为2.2年。HDR-M组出现狭窄的4例患者中，2例既往盆腔照射作为危险因素。2010年之前治疗的患者狭窄总发生率为25% (95% CI 17.7%-33.5%)，中位随访11.5年，2010年以后治疗的患者狭窄总发生率为8% (95% CI 4.5%-13.5%)，中位随访5.9年，超声规划软件和硬件更新实施后，从单一植入方案改为多次植入方案。HDR-B和HDR-M的漏尿率分别为12.4% (95% CI 8.8%-17.4%)和0%(95% CI 0%-8.6%)， HDR-B患者中有6% (95% CI 3.6%-9.9%)需要使用尿垫或干预。HDR-B组症状性晚期直肠炎发生率为9% (95%CI 5.9% ~ 13.5%)， HDR-M组为0% (95%CI 0 ~ 8.6%)。未发生4级及以上晚期毒性反应。结论HDR近距离放疗配合外束流放疗对不良中高危局部前列腺癌具有较高的长期生化控制率。早期数据表明，在选定的患者中，HDR近距离放疗可促进生化控制，对晚期尿失禁和症状性直肠炎发生率低，无明显损害。剂量递增的近距离放疗联合外束放疗(EBRT)改善了中高风险局部前列腺癌的长期生化控制，高剂量率近距离放疗(HDR)作为单一疗法已被证明在治疗局部前列腺癌中是安全有效的。我们比较了2007年至2018年在单一机构接受HDR近距离放疗作为强化治疗(HDR- b)和HDR近距离放疗作为单药治疗(HDR- m)的不良中高危疾病患者的长期疗效和毒性数据。经人类研究伦理委员会批准，对2007年3月20日至2018年7月31日接受HDR治疗的局部前列腺癌序贯患者进行回顾性记录审查。复发和毒性数据来自医疗记录或在适当情况下直接接触患者。主要结局指标包括由Phoenix标准定义的生化无进展生存期(bPFS)和根据CTCAE v4.0分级的毒性。采用Cox比例风险模型进行多因素回归，确定HDR-M组和HDR-B组bPFS的风险比。确定了268例不良-中度或高风险疾病患者，其中233例和35例分别接受HDR-B和HDR-M治疗。HDR-B和HDR-M的中位随访时间分别为7.6年和5.1年。7例接受HDR-M治疗的高危患者中，5例既往有盆腔放疗。在HDR-B组中，94%的患者接受近距离治疗剂量为2次20Gy, 89%的患者接受EBRT剂量为23次46Gy。HDR-M给药剂量分别为2次27Gy(54.3%)、3次33Gy(28.6%)和3次34.5Gy(14.3%)。71%的HDR-B患者、37%的HDR-M患者和66%的总体患者使用ADT, 43%的患者接受12个月或更长时间的治疗。HDR-B的5年bPFS为85.6%(95%可信区间[CI] 79.6%-90.0%)， 10年bPFS为71.8% (95% CI 62.1%-79.4%)， HDR-M的5年bPFS为77.5% (95% CI 58.1%-88.7%)， 10年bPFS为53.3% (95% CI 26.2%-74.4%)，多因素风险比为2.10 (p=0.08)。原发性肿瘤分期、Gleason分级组和ADT使用是生化失败的重要预测因子，其风险比分别为1.3 (p=0.01)、1.4 (p=0.03)和0.6 (p=0.02)。在5年和10年，HDR-B的总生存率分别为94%和87%，HDR-M的总生存率分别为96%和69%。HDR-B的粗尿道狭窄率为15.9% (n=37, 95% CI 11.7%-21.2%)， HDR-M为11.4% (n=4, 95% CI 4.2%-27.5%)，总体为15.3% (95% CI 11.4%-20.1%)，其中39例需要干预，中位时间为2.2年。HDR-M组出现狭窄的4例患者中，2例既往盆腔照射作为危险因素。2010年之前治疗的患者狭窄总发生率为25% (95% CI 17.7%-33.5%)，中位随访11.5年，2010年以后治疗的患者狭窄总发生率为8% (95% CI 4.5%-13.5%)，中位随访5.9年，超声规划软件和硬件更新实施后，从单一植入方案改为多次植入方案。HDR-B和HDR-M的漏尿率分别为12.4% (95% CI 8.8%-17.4%)和0%(95% CI 0%-8.6%)， HDR-B患者中有6% (95% CI 3.6%-9.9%)需要使用尿垫或干预。HDR-B组症状性晚期直肠炎发生率为9% (95%CI 5.9% ~ 13.5%)， HDR-M组为0% (95%CI 0 ~ 8.6%)。未发生4级及以上晚期毒性反应。HDR近距离放射治疗与外束放射治疗相结合，对不良的中高风险局部前列腺癌具有较高的长期生化控制率。早期数据表明，在选定的患者中，HDR近距离放疗可促进生化控制，对晚期尿失禁和症状性直肠炎发生率低，无明显损害。采用Cox比例风险模型进行多因素回归，确定HDR-M组和HDR-B组bPFS的风险比。确定了268例不良-中度或高风险疾病患者，其中233例和35例分别接受HDR-B和HDR-M治疗。HDR-B和HDR-M的中位随访时间分别为7.6年和5.1年。7例接受HDR-M治疗的高危患者中，5例既往有盆腔放疗。在HDR-B组中，94%的患者接受近距离治疗剂量为2次20Gy, 89%的患者接受EBRT剂量为23次46Gy。HDR-M给药剂量分别为2次27Gy(54.3%)、3次33Gy(28.6%)和3次34.5Gy(14.3%)。71%的HDR-B患者、37%的HDR-M患者和66%的总体患者使用ADT, 43%的患者接受12个月或更长时间的治疗。HDR-B的5年bPFS为85.6%(95%可信区间[CI] 79.6%-90.0%)， 10年bPFS为71.8% (95% CI 62.1%-79.4%)， HDR-M的5年bPFS为77.5% (95% CI 58.1%-88.7%)， 10年bPFS为53.3% (95% CI 26.2%-74.4%)，多因素风险比为2.10 (p=0.08)。原发性肿瘤分期、Gleason分级组和ADT使用是生化失败的重要预测因子，其风险比分别为1.3 (p=0.01)、1.4 (p=0.03)和0.6 (p=0.02)。在5年和10年，HDR-B的总生存率分别为94%和87%，HDR-M的总生存率分别为96%和69%。HDR-B的粗尿道狭窄率为15.9% (n=37, 95% CI 11.7%-21.2%)， HDR-M为11.4% (n=4, 95% CI 4.2%-27.5%)，总体为15.3% (95% CI 11.4%-20.1%)，其中39例需要干预，中位时间为2.2年。HDR-M组出现狭窄的4例患者中，2例既往盆腔照射作为危险因素。2010年之前治疗的患者狭窄总发生率为25% (95% CI 17.7%-33.5%)，中位随访11.5年，2010年以后治疗的患者狭窄总发生率为8% (95% CI 4.5%-13.5%)，中位随访5.9年，超声规划软件和硬件更新实施后，从单一植入方案改为多次植入方案。HDR-B和HDR-M的漏尿率分别为12.4% (95% CI 8.8%-17.4%)和0%(95% CI 0%-8.6%)， HDR-B患者中有6% (95% CI 3.6%-9.9%)需要使用尿垫或干预。HDR-B组症状性晚期直肠炎发生率为9% (95%CI 5.9% ~ 13.5%)， HDR-M组为0% (95%CI 0 ~ 8.6%)。未发生4级及以上晚期毒性反应。HDR近距离放射治疗与外束放射治疗相结合，对不良的中高风险局部前列腺癌具有较高的长期生化控制率。早期数据表明，在选定的患者中，HDR近距离放疗可促进生化控制，对晚期尿失禁和症状性直肠炎发生率低，无明显损害。

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Purpose Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Materials and Methods Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. Results 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. Conclusions HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis. Dose escalation with brachytherapy in combination with external beam radiotherapy (EBRT) improves long-term biochemical control in intermediate- and high-risk localised prostate cancer, and high dose rate brachytherapy (HDR) as monotherapy has been shown to be safe and effective in treating localised prostate cancer. We compare long-term efficacy and toxicity data for patients with unfavourable-intermediate and high-risk disease treated with HDR brachytherapy as boost (HDR-B) and HDR brachytherapy as monotherapy (HDR-M) between 2007 and 2018 at a single institution. Retrospective record review was performed for sequential patients treated with HDR for localised prostate cancer from 20th March 2007 to 31st July 2018 after Human Research Ethics Committee approval. Recurrence and toxicity data was derived from medical records or direct patient contact where appropriate. Primary outcome measures included biochemical progression-free survival (bPFS), as defined by Phoenix criteria and toxicity, graded according to CTCAE v4.0. Multivariate regression using Cox proportional hazards model was performed to determine hazard ratio for bPFS between HDR-M and HDR-B groups. 268 patients with unfavourable-intermediate or high risk disease were identified, with 233 and 35 patients receiving HDR-B and HDR-M respectively. The median follow-up was 7.6 years for HDR-B and 5.1 years for HDR-M. Of 7 patients who received HDR-M with high risk disease, 5 had prior pelvic irradiation. In the HDR-B group, the brachytherapy dose delivered was 20Gy in 2 fractions in 94% of patients, and EBRT dose received was 46Gy in 23 fractions in 89%. The HDR-M dose delivered was 27Gy in 2 fractions (54.3%), 33Gy in 3 fractions (28.6%) and 34.5Gy in 3 fractions (14.3%). ADT was used in 71% of HDR-B patients, 37% of HDR-M patients, and 66% overall, with 43% receiving 12 months or more. The bPFS was 85.6% ((95% confidence interval [CI] 79.6%-90.0%) at 5 years and 71.8% (95% CI 62.1%-79.4%) at 10 years for HDR-B, and 77.5% (95% CI 58.1%-88.7%) at 5 years and 53.3% (95% CI 26.2%-74.4%) at 10 years for HDR-M, with a multivariate hazard ratio of 2.10 (p=0.08). Significant predictors of biochemical failure were primary tumour stage, Gleason grade group, and ADT use, with hazard ratios of 1.3 (p=0.01), 1.4 (p=0.03) and 0.6 (p=0.02). At 5 and 10 years, overall survival was 94% and 87% for HDR-B and 96% and 69% for HDR-M. The crude urethral stricture rate was 15.9% (n=37, 95% CI 11.7%-21.2%) for HDR-B, 11.4% (n=4, 95% CI 4.2%-27.5%) for HDR-M and 15.3% (95% CI 11.4%-20.1%) overall, with 39 requiring intervention at a median time of 2.2 years. Of the four patients in HDR-M group experiencing stricture, two had prior pelvic irradiation as risk factors. The overall rate of stricture was 25% (95% CI 17.7%-33.5%) with a median follow-up of 11.5 years for patients treated before 2010, and 8% (95% CI 4.5%-13.5%) with a median follow-up of 5.9 years for those treated 2010 onwards, after ultrasound planning software and hardware updates were implemented, and change from single implantation procedure regimen to multiple implantations. The rate of any urinary leakage was 12.4% (95% CI 8.8%-17.4%) and 0%(95% CI 0%-8.6%) for HDR-B and HDR-M respectively, with 6% (95% CI 3.6%-9.9%) of HDR-B requiring pad use or intervention. The rate of symptomatic late proctitis was 9% (95% CI 5.9%-13.5%) in HDR-B and 0% (95%CI 0-8.6%) in HDR-M. No late grade 4 or above toxicities occurred. HDR brachytherapy as boost with external beam radiotherapy has high long-term biochemical control rates for unfavourable-intermediate- to high-risk localised prostate cancer. Early data suggests encouraging biochemical control and no significant detriment with HDR brachytherapy as monotherapy in selected patients, with low rate of late urinary incontinence and symptomatic proctitis.

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Brachytherapy

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