阿比特龙醋酸酯联合泼尼松与多西他赛或多西他赛联合泼尼松在转移性去势抵抗性前列腺癌患者疾病进展后加用阿比特龙醋酸酯联合泼尼松治疗的 II 期随机试验：ABIDO-SOGUG 试验。
A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial.
机构信息
Medical Oncology, Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain.
Medical Oncology, Instituto Catalá d'Oncologia (ICO), Badalona, Spain.
出版信息
Eur J Cancer. 2022 Nov;175:110-119. doi: 10.1016/j.ejca.2022.08.002. Epub 2022 Sep 11.
BACKGROUND
We aimed to compare the efficacy and safety of maintaining or withdrawing abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer who had experienced cancer progression to this treatment and were beginning a docetaxel-based therapy.
PATIENTS AND METHODS
Phase II, randomised, open-label study conducted in patients with metastatic castration-resistant prostate cancer who were asymptomatic or mildly symptomatic. After open-label treatment with AAP, patients who had experienced cancer progression to AAP were randomised to 75 mg/m of docetaxel plus AAP or to receive 75 mg/m of docetaxel plus 10 mg of prednisone orally daily. The primary outcome was the radiographic progression-free survival rate at 12 months as evaluated by the investigators in all randomised patients.
RESULTS
A total of 148 patients were included in open-label treatment with AAP, and of them, 94 patients were randomised to receive either docetaxel plus AAP (intervention group; n = 47) or docetaxel plus prednisone (control group; n = 47). The 12-month radiographic progression-free survival rates did not differ between the intervention group (34.9%; 95% CI 20.7-49.2) and the control group (33.9%; 95% CI 19.5-48.3). There were no significant differences in the time to radiographic progression and the overall survival between the intervention and control groups. Grade 3-5 neutropenia with the combination of docetaxel plus prednisone and AA was more frequent than with docetaxel plus prednisone (59.6% versus 27.7%).
CONCLUSION
Our results indicate that the therapeutic strategy of maintaining AAP added to docetaxel in chemotherapy-naïve patients who have experienced cancer progression to AAP treatment should not be further evaluated and should be avoided in clinical practice.
CLINICAL TRIALS
NCT02036060 https://clinicaltrials.gov/ct2/show/NCT02036060.
背景
我们旨在比较维持或停用醋酸阿比特龙联合泼尼松（AAP）治疗转移性去势抵抗性前列腺癌（mCRPC）患者的疗效和安全性，这些患者在接受该治疗后发生肿瘤进展，并且开始接受多西他赛为基础的治疗。
患者和方法
这是一项在无症状或轻度症状的转移性去势抵抗性前列腺癌患者中开展的 II 期、随机、开放性标签研究。在接受 AAP 的开放性标签治疗后，对发生 AAP 治疗后肿瘤进展的患者进行随机分组，一组接受 75mg/m2 多西他赛联合 AAP 治疗，另一组接受 75mg/m2 多西他赛联合 10mg 泼尼松口服治疗。主要终点为研究者评估的所有随机患者的影像学无进展生存期在 12 个月时的发生率。
结果
共有 148 例患者接受了 AAP 的开放性标签治疗，其中 94 例患者被随机分为接受多西他赛联合 AAP（干预组；n=47）或多西他赛联合泼尼松（对照组；n=47）治疗。干预组（34.9%；95%CI，20.7-49.2）和对照组（33.9%；95%CI，19.5-48.3）的 12 个月影像学无进展生存期率无差异。两组之间的影像学进展时间和总生存期也无显著差异。多西他赛联合泼尼松联合 AAP 的中性粒细胞减少症（3-5 级）比多西他赛联合泼尼松更常见（59.6%比 27.7%）。
结论
我们的结果表明，对于已经接受 AAP 治疗后发生肿瘤进展的化疗初治患者，在多西他赛中维持 AAP 的治疗策略不应进一步评估，在临床实践中应避免使用。
临床试验
NCT02036060 https://clinicaltrials.gov/ct2/show/NCT02036060。
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