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转移性前列腺癌老年患者对紫杉烷类化疗耐受性的预测因素(ANCHISES-NCT05471427):一项前瞻性观察性试验,纳入接受紫杉烷类化疗的转移性激素敏感性和去势抵抗性前列腺癌患者。

Predictive factors for tolerance to taxane based chemotherapy in older adults affected by metastatic prostate cancer (ANCHISES-NCT05471427): A prospective observational trial including patients with metastatic hormone sensitive and castrate resistant prostate cancer treated with taxane chemotherapy.

作者信息

Francolini Giulio, Frosini Giulio, Di Cataldo Vanessa, Detti Beatrice, Carnevale Maria Grazia, Banini Marco, Peruzzi Anna, Salvestrini Viola, Visani Luca, Olmetto Emanuela, Becherini Carlotta, Allegra Andrea, Burchini Luca, Scotti Vieri, Mangoni Monica, Meattini Icro, Desideri Isacco, Livi Lorenzo

机构信息

Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Largo G. A. Brambilla 3, 50134 Florence, Italy.

Department of Biomedical, Experimental and Clinical Sciences "M. Serio", University of Florence, Florence, Italy.

出版信息

J Geriatr Oncol. 2023 Jan;14(1):101411. doi: 10.1016/j.jgo.2022.11.010. Epub 2022 Dec 8.

Abstract

INTRODUCTION

Taxane-based chemotherapy is one of the main cornerstones for treatment of metastatic prostate cancer (mPCa). In aged and well-fit patients, an indication for taxane chemotherapy should remain similar to the general population. Aiming to explore predictive factors of fitness to taxane chemotherapy in older adult patients, a prospective observational study was carried out in our institution.

MATERIALS AND METHODS

We collected data from a prospective mono-centric database of patients aged ≥70 years old that were treated in our department. All patients underwent taxane treatment (either docetaxel or cabazitaxel, the latter only in second line setting) starting with standard treatment schedules (75 mg/m or 25 mg/m every three weeks, respectively). Data about G8 score post treatment decreases were collected and reported. We explored associations between baseline age, G8 score, and Charlson Comorbidity Index (CCI) with taxane dose reduction (DR), treatment temporary suspension (TS), or definitive interruption (TDI). Logistic regression analysis was performed to explore potential predictive factors for tolerability in patients treated with docetaxel.

RESULTS

One hundred-eighteen patients underwent taxane chemotherapy between 2011 and 2022, the majority of cases in metastatic castrate resistant prostate cancer (mCRPC) setting (85.6%). In the overall population, DR was performed in 40.7% of cases, and TS and TDI were deemed necessary in 28% and 22.9% of patients, respectively. Forty-seven percent of patients reported a significant deterioration in terms of G8 score (from > to ≤14). Sixty-two percent of the overall population were deemed fit for further treatment after taxane chemotherapy. Rate of DR, TS, and TDI was 29.4%, 11.8% and 9.2% in the docetaxel subgroup, vs 48%, 60% and 12% of patients treated with cabazitaxel, respectively. Lower baseline G8 was reported as a continuous variable and the only independent predictive factor for TDI in docetaxel subgroup (odds ratio [OR] 0.41, 95% confidence interval [CI] 0.25-0.68, p = 0.0008).

DISCUSSION

Our data suggest that tolerability of taxane regimens in a pre-treated population of older patients with prostate cancer is acceptable, despite a non-negligible rate of TDI. Taxane chemotherapy should not be denied a priori in order to avoid undertreatment of older adult patients.

摘要

引言

基于紫杉烷的化疗是转移性前列腺癌(mPCa)治疗的主要基石之一。在年龄较大且身体状况良好的患者中,紫杉烷化疗的适应证应与普通人群相似。为了探索老年患者对紫杉烷化疗适应性的预测因素,我们机构开展了一项前瞻性观察性研究。

材料与方法

我们从本部门治疗的年龄≥70岁患者的前瞻性单中心数据库中收集数据。所有患者均接受紫杉烷治疗(多西他赛或卡巴他赛,后者仅用于二线治疗),起始采用标准治疗方案(分别为每三周75mg/m²或25mg/m²)。收集并报告治疗后G8评分下降的数据。我们探讨了基线年龄、G8评分和Charlson合并症指数(CCI)与紫杉烷剂量减少(DR)、治疗暂时中断(TS)或最终中断(TDI)之间的关联。进行逻辑回归分析以探索多西他赛治疗患者耐受性的潜在预测因素。

结果

2011年至2022年间,118例患者接受了紫杉烷化疗,大多数病例处于转移性去势抵抗性前列腺癌(mCRPC)阶段(85.6%)。在总体人群中,40.7%的病例进行了剂量减少,分别有28%和22.9%的患者认为有必要暂时中断和最终中断治疗。47%的患者报告G8评分显著恶化(从>14降至≤14)。总体人群中有62%被认为适合在紫杉烷化疗后进一步治疗。多西他赛亚组中剂量减少、暂时中断和最终中断的发生率分别为29.4%、11.8%和9.2%,而接受卡巴他赛治疗的患者分别为48%、60%和12%。较低的基线G8作为连续变量被报告为多西他赛亚组中最终中断治疗的唯一独立预测因素(比值比[OR]0.41,95%置信区间[CI]0.25 - 0.68,p = 0.0008)。

讨论

我们的数据表明,在既往接受治疗的老年前列腺癌患者人群中,紫杉烷方案的耐受性是可以接受的,尽管最终中断治疗的发生率不可忽视。不应事先拒绝紫杉烷化疗,以免老年患者治疗不足。

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