Department of Urology, Akita University School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.
Department of Urology, Hirosaki University School of Medicine, Hirosaki, Japan.
Med Oncol. 2021 Mar 13;38(4):37. doi: 10.1007/s12032-021-01480-3.
We conducted a risk-adapted upfront docetaxel (DOC) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Here, we reported an interim analysis of the study. The study enrolled 68 patients with newly diagnosed mHSPC between 2016 and 2018. According to the presence of visceral metastasis, an EOD score ≥ 3, or prostate-specific antigen (PSA) level at 3 months of ≥ 1 ng/mL, patients were divided into low- and high-risk groups. Patients were treated with androgen deprivation therapy (ADT) with or without bicalutamide; those in the high-risk group received upfront treatment involving six cycles of DOC (70 mg/m). Short-term treatment effect, adverse events, and quality of life (QOL) were evaluated. Fifty (73.5%) were classified in the high-risk group, and 46 (67%) received upfront ADT + DOC. In the ADT + DOC group, 43.5% (20/46) patients achieved a PSA level ≤ 0.2 ng/mL. PSA nadir and time to PSA nadir were 0.291 ng/mL and 288 days, respectively. In the ADT + DOC group, 76.1% (35/42) patients had adverse events (AEs) of grade ≥ 3. During a median follow-up of 18.5 months, 36.4% (8/22) patients in the ADT group and 43.5% (20/46) in the ADT + DOC group had CRPC. Two QOL scores including the physical status and appetite loss at 6 months significantly worsened in the ADT + DOC group but was resolved by 12 months. Upfront DOC achieved high PSA responses without long-term QOL deterioration. However, the short-term outcomes were limited. Longer follow-up is needed to determine the survival advantage.
我们对转移性激素敏感前列腺癌（mHSPC）患者进行了风险适应的 upfront docetaxel（DOC）治疗。在此，我们报告了该研究的中期分析结果。该研究纳入了 2016 年至 2018 年间新诊断为 mHSPC 的 68 例患者。根据内脏转移的存在、EOD 评分≥3 或 PSA 水平在 3 个月时≥1ng/ml，将患者分为低危组和高危组。患者接受雄激素剥夺治疗（ADT）联合或不联合比卡鲁胺治疗；高危组患者接受包括 6 个周期 DOC（70mg/m）的 upfront 治疗。评估短期治疗效果、不良反应和生活质量（QOL）。50 例（73.5%）患者被归类为高危组，其中 46 例（67%）接受了 upfront ADT+DOC。在 ADT+DOC 组中，43.5%（20/46）患者 PSA 水平≤0.2ng/ml。PSA 最低点和 PSA 最低点时间分别为 0.291ng/ml 和 288 天。在 ADT+DOC 组中，76.1%（35/42）患者发生了≥3 级不良反应（AE）。在中位随访 18.5 个月时，ADT 组和 ADT+DOC 组的 CRPC 发生率分别为 36.4%（8/22）和 43.5%（20/46）。6 个月时，ADT+DOC 组的身体状况和食欲丧失两项 QOL 评分显著恶化，但在 12 个月时得到缓解。 upfront DOC 可实现高 PSA 缓解，而不会导致长期 QOL 恶化。然而，短期结局有限。需要更长时间的随访来确定生存优势。
