Daniel R. Zwahlen , Christina Schröder , Lisa Holer , Jürg Bernhard , Tobias Hölscher , Winfried Arnold , Bülent Polat , Guido Hildebrandt , Arndt-Christian Müller , Paul Martin Putora , Alexandros Papachristofilou , Corinne Schär , Stefanie Hayoz , Marcin Sumila , Kathrin Zaugg , Matthias Guckenberger , Piet Ost , Davide Giovanni Bosetti , Christiane Reuter , Silvia Gomez , Pirus Ghadjar
{"title":"前列腺切除术后生化复发前列腺癌的挽救性放射治疗后勃起功能的保留：SAKK 09/10 随机三期试验的五年结果","authors":"Daniel R. Zwahlen , Christina Schröder , Lisa Holer , Jürg Bernhard , Tobias Hölscher , Winfried Arnold , Bülent Polat , Guido Hildebrandt , Arndt-Christian Müller , Paul Martin Putora , Alexandros Papachristofilou , Corinne Schär , Stefanie Hayoz , Marcin Sumila , Kathrin Zaugg , Matthias Guckenberger , Piet Ost , Davide Giovanni Bosetti , Christiane Reuter , Silvia Gomez , Pirus Ghadjar","doi":"10.1016/j.ctro.2024.100786","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>To evaluate effects of dose intensified salvage radiotherapy (sRT) on erectile function in biochemically recurrent prostate cancer (PC) after radical prostatectomy (RP).</p></div><div><h3>Materials and methods</h3><p>Eligible patients had evidence of biochemical failure after RP and a PSA at randomization of ≤ 2 ng/ml. Erectile dysfunction (ED) was investigated as secondary endpoint within the multicentre randomized trial (February 2011 to April 2014) in patients receiving either 64 Gy or 70 Gy sRT. ED and quality of life (QoL) were assessed using CTCAE v4.0 and the EORTC QoL questionnaires C30 and PR25 at baseline and up to 5 years after sRT.</p></div><div><h3>Results</h3><p>344 patients were evaluable. After RP 197 (57.3 %) patients had G0-2 ED while G3 ED was recorded in 147 (42.7 %) patients. Subsequently, sexual activity and functioning was impaired. 5 years after sRT, 101 (29.4 %) patients noted G0-2 ED. During follow-up, 44.2 % of patients with baseline G3 ED showed any improvement and 61.4 % of patients with baseline G0-2 ED showed worsening. Shorter time interval between RP and start of sRT (p = 0.007) and older age at randomization (p = 0.005) were significant predictors to more baseline ED and low sexual activity in the long-term. Age (p = 0.010) and RT technique (p = 0.031) had a significant impact on occurrence of long-term ED grade 3 and worse sexual functioning. During follow-up, no differences were found in erectile function, sexual activity, and sexual functioning between the 64 Gy and 70 Gy arm.</p></div><div><h3>Conclusion</h3><p>ED after RP is a known long-term side effect with significant impact on patients’ QoL. ED was further affected by sRT, but dose intensification of sRT showed no significant impact on erectile function recovery or prevalence of de novo ED after sRT. Age, tumor stage, prostatectomy and RT-techniques, nerve-sparing and observation time were associated with long-term erectile function outcome.</p><p><span>ClinicalTrials.gov</span><svg><path></path></svg>. Identifier: NCT01272050.</p></div>","PeriodicalId":10342,"journal":{"name":"Clinical and Translational Radiation Oncology","volume":"47 ","pages":"Article 100786"},"PeriodicalIF":2.7000,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2405630824000636/pdfft?md5=99572a5febf51f89c7dd929f0add23fd&pid=1-s2.0-S2405630824000636-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Erectile function preservation after salvage radiation therapy for biochemically recurrent prostate cancer after prostatectomy: Five-year results of the SAKK 09/10 randomized phase 3 trial\",\"authors\":\"Daniel R. Zwahlen , Christina Schröder , Lisa Holer , Jürg Bernhard , Tobias Hölscher , Winfried Arnold , Bülent Polat , Guido Hildebrandt , Arndt-Christian Müller , Paul Martin Putora , Alexandros Papachristofilou , Corinne Schär , Stefanie Hayoz , Marcin Sumila , Kathrin Zaugg , Matthias Guckenberger , Piet Ost , Davide Giovanni Bosetti , Christiane Reuter , Silvia Gomez , Pirus Ghadjar\",\"doi\":\"10.1016/j.ctro.2024.100786\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><p>To evaluate effects of dose intensified salvage radiotherapy (sRT) on erectile function in biochemically recurrent prostate cancer (PC) after radical prostatectomy (RP).</p></div><div><h3>Materials and methods</h3><p>Eligible patients had evidence of biochemical failure after RP and a PSA at randomization of ≤ 2 ng/ml. Erectile dysfunction (ED) was investigated as secondary endpoint within the multicentre randomized trial (February 2011 to April 2014) in patients receiving either 64 Gy or 70 Gy sRT. ED and quality of life (QoL) were assessed using CTCAE v4.0 and the EORTC QoL questionnaires C30 and PR25 at baseline and up to 5 years after sRT.</p></div><div><h3>Results</h3><p>344 patients were evaluable. After RP 197 (57.3 %) patients had G0-2 ED while G3 ED was recorded in 147 (42.7 %) patients. Subsequently, sexual activity and functioning was impaired. 5 years after sRT, 101 (29.4 %) patients noted G0-2 ED. During follow-up, 44.2 % of patients with baseline G3 ED showed any improvement and 61.4 % of patients with baseline G0-2 ED showed worsening. Shorter time interval between RP and start of sRT (p = 0.007) and older age at randomization (p = 0.005) were significant predictors to more baseline ED and low sexual activity in the long-term. Age (p = 0.010) and RT technique (p = 0.031) had a significant impact on occurrence of long-term ED grade 3 and worse sexual functioning. During follow-up, no differences were found in erectile function, sexual activity, and sexual functioning between the 64 Gy and 70 Gy arm.</p></div><div><h3>Conclusion</h3><p>ED after RP is a known long-term side effect with significant impact on patients’ QoL. ED was further affected by sRT, but dose intensification of sRT showed no significant impact on erectile function recovery or prevalence of de novo ED after sRT. Age, tumor stage, prostatectomy and RT-techniques, nerve-sparing and observation time were associated with long-term erectile function outcome.</p><p><span>ClinicalTrials.gov</span><svg><path></path></svg>. Identifier: NCT01272050.</p></div>\",\"PeriodicalId\":10342,\"journal\":{\"name\":\"Clinical and Translational Radiation Oncology\",\"volume\":\"47 \",\"pages\":\"Article 100786\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-04-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2405630824000636/pdfft?md5=99572a5febf51f89c7dd929f0add23fd&pid=1-s2.0-S2405630824000636-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Radiation Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2405630824000636\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Radiation Oncology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405630824000636","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
材料与方法符合条件的患者在接受根治性前列腺切除术（RP）后有生化失败的证据，且随机分组时PSA≤2纳克/毫升。勃起功能障碍（ED）是多中心随机试验（2011 年 2 月至 2014 年 4 月）的次要终点，研究对象是接受 64 Gy 或 70 Gy sRT 治疗的患者。采用 CTCAE v4.0 以及 EORTC QoL 问卷 C30 和 PR25 对基线和 sRT 后 5 年的 ED 和生活质量（QoL）进行了评估。手术后，197 名患者（57.3%）的 ED 为 G0-2 级，147 名患者（42.7%）的 ED 为 G3 级。随后，患者的性活动和性功能都受到了影响。sRT 5 年后，101 名患者（29.4%）的 ED 为 G0-2。在随访期间，44.2% 的基线 G3 ED 患者的情况有所改善，61.4% 的基线 G0-2 ED 患者的情况有所恶化。RP 和开始 sRT 之间的时间间隔较短（p = 0.007）和随机时的年龄较大（p = 0.005）是导致更多基线 ED 和长期性活动较少的重要预测因素。年龄（p = 0.010）和 RT 技术（p = 0.031）对长期 ED 3 级和性功能较差的发生有显著影响。在随访期间，64 Gy 和 70 Gy 治疗组在勃起功能、性活动和性功能方面没有发现差异。前列腺电切术进一步影响了ED，但前列腺电切术剂量的增加对勃起功能的恢复或前列腺电切术后新发ED的发生率没有显著影响。年龄、肿瘤分期、前列腺切除术和 RT 技术、神经保留和观察时间与长期勃起功能结果有关。NCT01272050：NCT01272050。
Erectile function preservation after salvage radiation therapy for biochemically recurrent prostate cancer after prostatectomy: Five-year results of the SAKK 09/10 randomized phase 3 trial
Objectives
To evaluate effects of dose intensified salvage radiotherapy (sRT) on erectile function in biochemically recurrent prostate cancer (PC) after radical prostatectomy (RP).
Materials and methods
Eligible patients had evidence of biochemical failure after RP and a PSA at randomization of ≤ 2 ng/ml. Erectile dysfunction (ED) was investigated as secondary endpoint within the multicentre randomized trial (February 2011 to April 2014) in patients receiving either 64 Gy or 70 Gy sRT. ED and quality of life (QoL) were assessed using CTCAE v4.0 and the EORTC QoL questionnaires C30 and PR25 at baseline and up to 5 years after sRT.
Results
344 patients were evaluable. After RP 197 (57.3 %) patients had G0-2 ED while G3 ED was recorded in 147 (42.7 %) patients. Subsequently, sexual activity and functioning was impaired. 5 years after sRT, 101 (29.4 %) patients noted G0-2 ED. During follow-up, 44.2 % of patients with baseline G3 ED showed any improvement and 61.4 % of patients with baseline G0-2 ED showed worsening. Shorter time interval between RP and start of sRT (p = 0.007) and older age at randomization (p = 0.005) were significant predictors to more baseline ED and low sexual activity in the long-term. Age (p = 0.010) and RT technique (p = 0.031) had a significant impact on occurrence of long-term ED grade 3 and worse sexual functioning. During follow-up, no differences were found in erectile function, sexual activity, and sexual functioning between the 64 Gy and 70 Gy arm.
Conclusion
ED after RP is a known long-term side effect with significant impact on patients’ QoL. ED was further affected by sRT, but dose intensification of sRT showed no significant impact on erectile function recovery or prevalence of de novo ED after sRT. Age, tumor stage, prostatectomy and RT-techniques, nerve-sparing and observation time were associated with long-term erectile function outcome.
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