癌症合并 HIV 患者使用卡铂和紫杉醇的安全性和耐受性（AMC-078），一项艾滋病恶性肿瘤联合会（AMC）研究。

Safety and Tolerability of Carboplatin and Paclitaxel in Cancer Patients with HIV (AMC-078), an AIDS Malignancy Consortium (AMC) Study.

机构信息

Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.

CorEvitas, Waltham, MA, USA.

出版信息

Oncologist. 2022 Aug 5;27(8):623-e624. doi: 10.1093/oncolo/oyac004.

DOI:10.1093/oncolo/oyac004

PMID:35429391

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9355812/

Abstract

BACKGROUND

Persons living with human immunodeficiency virus are an underserved population for evidence-based cancer treatment. Paclitaxel and carboplatin (PCb) is an active regimen against a variety of solid tumors, including several seen in excess in patients with HIV infection. We performed a pilot trial to evaluate the safety of full-dose PCb in people living with human immunodeficiency virus and cancer.

METHODS

Eligible patients, stratified by concurrent antiretroviral therapy (ART) that included CYP3A4 inhibitors or not, received paclitaxel (175 mg/m2) in combination with carboplatin (target AUC 6) intravenously every 3 weeks for up to 6 cycles.

RESULTS

Sixteen evaluable patients received 64 cycles of PCb, including 6 patients treated with CYP3A4 inhibiting ART (ritonavir). The adverse event profile was consistent with the known toxicity profile of PCb, with no differences between the 2 strata. There were 4 partial responses (25%, 95% CI: 7%-52%), and overall, CD4+ lymphocyte count was similar after completion of therapy (median: 310/μL) compared with baseline values (median: 389/μL). Pharmacokinetic studies in 6 patients revealed no significant differences in Cmax or AUCinf for paclitaxel between the 2 cohorts.

CONCLUSION

Full doses of PCb chemotherapy are tolerable when given concurrently with ART in people living with human immunodeficiency virus with cancer, including patients receiving CYP3A4 inhibitors.

CLINICALTRIALS.GOV IDENTIFIER: NCT01249443.

摘要

背景

艾滋病毒感染者是接受循证癌症治疗服务不足的人群。紫杉醇和卡铂（PCb）是一种针对多种实体瘤的有效方案，包括艾滋病毒感染者中常见的几种肿瘤。我们进行了一项试点试验，以评估全剂量 PCb 在艾滋病毒感染者和癌症患者中的安全性。

方法

根据是否同时接受包括 CYP3A4 抑制剂在内的抗逆转录病毒治疗（ART）进行分层，符合条件的患者每 3 周接受一次静脉注射紫杉醇（175mg/m2）联合卡铂（目标 AUC 6），最多 6 个周期。

结果

16 名可评估的患者接受了 64 个周期的 PCb 治疗，其中 6 名患者接受了 CYP3A4 抑制 ART（利托那韦）治疗。不良事件谱与 PCb 的已知毒性谱一致，两个亚组之间没有差异。有 4 例部分缓解（25%，95%CI：7%-52%），总的来说，与基线值（中位数：389/μL）相比，治疗完成后 CD4+淋巴细胞计数相似（中位数：310/μL）。6 名患者的药代动力学研究表明，两组之间紫杉醇的 Cmax 或 AUCinf 没有显著差异。