Mulhall John P, Brock Gerald, Oelke Matthias, Fode Mikkel, Probst Kai A, Henneges Carsten, d'Anzeo Gianluca, Rossi Andrea, Büttner Hartwig
Department of Urology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Division of Urology, Department of Surgery, University of Western Ontario, London, Ontario, Canada.
J Sex Med. 2016 Apr;13(4):679-83. doi: 10.1016/j.jsxm.2016.01.022. Epub 2016 Mar 25.
The multicenter, randomized, double-blind, double-dummy, placebo-controlled REACTT trial suggested that treatment with tadalafil once daily (OaD) started early after bilateral nerve-sparing radical prostatectomy (nsRP) for prostate cancer may contribute to erectile function (EF)-recovery, which was predefined as achieving an International Index of Erectile Function (IIEF)-EF score ≥22. Here, we report descriptive post-hoc analyses, using the more strict definition for EF-recovery of returning back to the pre-surgery IIEF-EF-level ("back-to-baseline analysis").
REACTT included 422 men <68 years with adenocarcinoma of the prostate and preoperative IIEF-EF ≥22 who underwent nsRP at 50 centers from 9 European countries and Canada. Patients were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg OaD (n = 139), tadalafil 20 mg on-demand (pro-re-nata, PRN; n = 142), or placebo (n = 141), followed by 6-week drug-free washout (DFW) and 3-month open-label tadalafil OaD treatment (OLT).
Proportion of patients returning to their preoperative IIEF-EF category (22-25 or ≥26) at the end of DBT, DFW, and OLT.
Overall, 92.4% of patients had pre-surgery (baseline) IIEF-EF scores ≥26 (tadalafil OaD 94.2%, PRN 91.6%, placebo 91.5%), 7.4% had IIEF-EF 22-25. At the end of DBT, 22.3% of patients on tadalafil OaD had achieved "back-to-baseline" IIEF-EF, compared with 11.3% on tadalafil PRN and 7.8% on placebo. Of all 58 patients "back-to-baseline" at the end of DBT, only 1 PRN-group patient had started from a baseline IIEF-EF <26. The treatment-group difference at the end of DBT was not maintained after DFW. After 3 months of OLT with tadalafil OaD, the proportion of patients with "back-to-baseline" IIEF-EF had almost doubled in all 3 groups.
Changing the definition for EF-recovery from IIEF-EF ≥22 to the more strict definition of "returning back-to-baseline IIEF-EF" had no major impact. Tadalafil OaD started early after nsRP improved drug-assisted EF, but had no effect on unassisted EF following treatment cessation after 9 months.
多中心、随机、双盲、双模拟、安慰剂对照的REACTT试验表明，对于前列腺癌患者，在双侧保留神经的根治性前列腺切除术（nsRP）后早期开始每日一次（OaD）服用他达拉非治疗，可能有助于勃起功能（EF）恢复，勃起功能恢复的预定义标准为国际勃起功能指数（IIEF）-EF评分≥22。在此，我们报告描述性事后分析，采用更严格的EF恢复定义，即恢复到手术前IIEF-EF水平（“恢复至基线分析”）。
REACTT研究纳入了422名年龄<68岁、患有前列腺腺癌且术前IIEF-EF≥22的男性患者，这些患者来自9个欧洲国家和加拿大的50个中心并接受了nsRP手术。患者在nsRP术后按1:1:1随机分为三组，分别接受为期9个月的双盲治疗（DBT），其中一组每日服用5毫克他达拉非（n = 139），一组按需服用20毫克他达拉非（n = 142），另一组服用安慰剂（n = 141），随后是为期6周的停药期（DFW）和为期3个月的开放标签他达拉非OaD治疗（OLT）。
在DBT、DFW和OLT结束时，恢复到术前IIEF-EF类别（22 - 25或≥26）的患者比例。
总体而言，92.4%的患者术前（基线）IIEF-EF评分≥26（每日服用他达拉非组为94.2%，按需服用组为91.6%，安慰剂组为91.5%），7.4%的患者IIEF-EF为22 - 25。在DBT结束时，每日服用他达拉非组22.3%的患者实现了“恢复至基线”的IIEF-EF，按需服用他达拉非组为11.3%，安慰剂组为7.8%。在DBT结束时所有58名“恢复至基线”的患者中，只有1名按需服用组患者起始基线IIEF-EF<26。DFW后，DBT结束时的治疗组差异未持续存在。在使用每日服用他达拉非进行3个月的OLT后，所有三组中“恢复至基线”IIEF-EF的患者比例几乎翻倍。
将EF恢复的定义从IIEF-EF≥22更改为更严格的“恢复至基线IIEF-EF”定义没有重大影响。nsRP术后早期开始每日服用他达拉非可改善药物辅助的EF，但在9个月治疗停止后对自主EF没有影响。
