BRCA1/2携带者输卵管切除术加延迟卵巢切除术与输卵管-卵巢切除术:一项前瞻性偏好试验的三年结果

Majke H. D. Van Bommel, Miranda P. Steenbeek, Joanna Inthout, Tessa Van Garderen, Marline G. Harmsen, Marieke Arts‐De Jong, Angela H. E. M. Maas, Judith B. Prins, Johan Bulten, Helena C. Van Doorn, Marian J. E. Mourits, Rachel Tros, Ronald P. Zweemer, Katja N. Gaarenstroom, Brigitte F. M. Slangen, Monique M. A. Brood‐Van Zanten, M. Caroline Vos, Jurgen M. J. Piek, Luc R. C. W. van Lonkhuijzen, Mirjam J. A. Apperloo, Sjors F. P. J. Coppus, Nicoline Hoogerbrugge, Rosella P. M. G. Hermens, Joanne A. De Hullu
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Data were collected pre‐surgery and at 3 months, 1 and 3 years of post‐surgery.SettingMulticentre prospective preference trial in thirteen hospitals in the Netherlands.Population<jats:italic>BRCA1/2</jats:italic> pathogenic variant (PV) carriers aged 25–40 (<jats:italic>BRCA1</jats:italic>) or 25–45 (<jats:italic>BRCA2</jats:italic>), who were premenopausal, without a future child wish and without current (treatment for) malignancy.MethodsTreatment allocation was based on patients' preference: either RRS from the age of 25 years with delayed oophorectomy at the maximum age of 45 (<jats:italic>BRCA1</jats:italic>) or 50 (<jats:italic>BRCA2</jats:italic>), or RRSO between the ages of 35–40 (<jats:italic>BRCA1</jats:italic>) or 40–45 (<jats:italic>BRCA2</jats:italic>). After RRSO, hormone replacement therapy (HRT) was recommended, if not contraindicated. Primarily, menopause‐related QoL as measured with the Greene Climacteric Scale (GCS) was compared between the RRS and RRSO without HRT group. Secondarily, GSC‐scores of the RRS group were compared with the scores of the RRSO with HRT after surgery group. A higher GSC‐score reflects more climacteric symptoms.ResultsUntil April 2023, 410 participants had undergone RRS and 160 RRSO. The <jats:italic>BRCA1/BRCA2</jats:italic> proportions were 51.4%/48.6%. The mean age at surgery (SD) was 37.9 (3.5) years. Participants 3 years after RRSO without HRT had a 4.3 (95% CI 2.1–6.5; <jats:italic>p</jats:italic> &lt; 0.001) point higher increase in GCS‐score from baseline compared to those after RRS, while the difference was 7.9 (95% CI 5.9–9.8) and 8.5 (95% CI 6.5–10.5) points at 3 and 12 months, respectively. 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引用次数: 0

摘要

目的比较降低风险的输卵管切除术(RRS)与降低风险的输卵管切除术(RRSO)术后至术后 3 年与绝经相关的生活质量(QoL)。人群BRCA1/2致病性变异(PV)携带者,年龄在25-40岁(BRCA1)或25-45岁(BRCA2),绝经前,无生育意愿,目前无恶性肿瘤(治疗)。方法根据患者的意愿进行治疗分配:或者从 25 岁开始进行 RRS,并在最高 45 岁(BRCA1)或 50 岁(BRCA2)时延迟进行输卵管切除术;或者在 35-40 岁(BRCA1)或 40-45 岁(BRCA2)之间进行 RRSO。RRSO 后,如果没有禁忌症,建议采用激素替代疗法(HRT)。首先,比较了 RRSO 组和不使用 HRT 的 RRSO 组使用格林 Climacteric Scale(GCS)测量的更年期相关 QoL。其次,将 RRS 组的 GSC 分数与术后接受 HRT 的 RRSO 组的分数进行比较。结果截至2023年4月,410名参与者接受了RRS手术,160名参与者接受了RRSO手术。BRCA1/BRCA2比例为51.4%/48.6%。手术时的平均年龄(标清)为 37.9 (3.5) 岁。RRSO 术后 3 年未接受 HRT 的患者与 RRS 术后的患者相比,GCS 评分比基线高出 4.3 (95% CI 2.1-6.5; p < 0.001)分,而 3 个月和 12 个月时的差异分别为 7.9 (95% CI 5.9-9.8) 分和 8.5 (95% CI 6.5-10.5) 分。结论在这项多中心优选试验中,RRS术后的更年期相关生活质量优于RRSO术后,即使在RRSO术后进行HRT治疗。两组间的差异在术后一年前最为明显。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Salpingectomy With Delayed Oophorectomy Versus Salpingo‐Oophorectomy in BRCA1/2 Carriers: Three‐Year Outcomes of a Prospective Preference Trial
ObjectiveTo compare menopause‐related quality of life (QoL) after risk‐reducing salpingectomy (RRS) versus risk‐reducing salpingo‐oophorectomy (RRSO) until 3 years of post‐surgery.DesignA prospective study (TUBA study) with treatment allocation based on patients' preference. Data were collected pre‐surgery and at 3 months, 1 and 3 years of post‐surgery.SettingMulticentre prospective preference trial in thirteen hospitals in the Netherlands.PopulationBRCA1/2 pathogenic variant (PV) carriers aged 25–40 (BRCA1) or 25–45 (BRCA2), who were premenopausal, without a future child wish and without current (treatment for) malignancy.MethodsTreatment allocation was based on patients' preference: either RRS from the age of 25 years with delayed oophorectomy at the maximum age of 45 (BRCA1) or 50 (BRCA2), or RRSO between the ages of 35–40 (BRCA1) or 40–45 (BRCA2). After RRSO, hormone replacement therapy (HRT) was recommended, if not contraindicated. Primarily, menopause‐related QoL as measured with the Greene Climacteric Scale (GCS) was compared between the RRS and RRSO without HRT group. Secondarily, GSC‐scores of the RRS group were compared with the scores of the RRSO with HRT after surgery group. A higher GSC‐score reflects more climacteric symptoms.ResultsUntil April 2023, 410 participants had undergone RRS and 160 RRSO. The BRCA1/BRCA2 proportions were 51.4%/48.6%. The mean age at surgery (SD) was 37.9 (3.5) years. Participants 3 years after RRSO without HRT had a 4.3 (95% CI 2.1–6.5; p < 0.001) point higher increase in GCS‐score from baseline compared to those after RRS, while the difference was 7.9 (95% CI 5.9–9.8) and 8.5 (95% CI 6.5–10.5) points at 3 and 12 months, respectively. Among participants with HRT after surgery, the RRSO group had a 2.4 (95% CI 0.8–3.9; p = 0.002) point higher increase in GCS‐score from baseline compared to the RRS group.ConclusionsIn this multicentre preference trial, menopause‐related QoL was better after RRS than after RRSO, even with HRT after RRSO. Differences between arms were most pronounced until one‐year post‐surgery.
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