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ABVD方案治疗马拉维霍奇金淋巴瘤的安全性、有效性及可负担性:一项前瞻性队列研究

Safety, efficacy, and affordability of ABVD for Hodgkin lymphoma in Malawi: a prospective cohort study.

作者信息

Mponda Marriam, Kudowa Evaristar, Craven Dalton M, Eastburg Luke C, Chikasema Maria, Kasonkanji Edwards, Tomoka Tamiwe, Roush Sophie Maharry, Simwinga Lusayo, Mumba Noel, Gopal Satish, Fedoriw Yuri, Painschab Matthew S

机构信息

University of North Carolina (UNC) Project Malawi, Lilongwe, Malawi.

Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

出版信息

EClinicalMedicine. 2024 Feb 8;69:102480. doi: 10.1016/j.eclinm.2024.102480. eCollection 2024 Mar.

Abstract

BACKGROUND

ABVD (doxorubicin, bleomycin, vinblastine, and dexamethasone) is a proven, curative regimen for Hodgkin lymphoma (HL). Prospective data describing HL treatment in sub-Saharan Africa are limited. We aimed to fill this knowledge gap, using data from Malawi.

METHODS

We report a prospective observational cohort of HL (aged 15) from a single, tertiary referral centre in Malawi. We enrolled patients with pathologicially confirmed Hodgkin lymphoma between June 1, 2013, and Dec 31, 2021 with follow-up censored on May 31, 2022. Patients were treated with ABVD and concurrent antiretroviral therapy if HIV-positive and were followed up for 5 years. The primary outcome was overall survival; secondary outcomes included progression-free survival, response assessment, and adverse events. Microcosting of HL diagnosis, treatment, and follow-up was embedded.

FINDINGS

We enrolled 38 patients with a median age of 27 years (interquartile range 19-46); eleven (28%) were HIV-positive. Of 35 patients treated with ABVD, 24 (71%) had stage III/IV, nine (26%) unfavourable limited stage, and two (6%) favourable limited stage. Among HIV-infected individuals, mean CD4 count at HL diagnosis was 179 cells/uL and ten (91%) had HIV RNA < 400 copies/mL. Grade 3/4 neutropenia occurred in 24 (68%) patients and caused treatment delay in 16 (46%). Of ten deaths, seven were due to HL, two possible treatment-related toxicity, and one uncertain. 2-year overall survival was 82% (95% CI 70-96%) and 2-year progression-free survival was 64% (95% CI 50-83%). PFS appeared better for HIV-positive patients (HR 0.23 (95% CI 0.05-1.02)) after controlling for stage and performance status (p = 0.05). We estimated $2708 (2022 USD) for HL diagnosis, treatment, and follow-up in our cohort.

INTERPRETATION

Our findings suggest that treatment with ABVD is safe, efficacious, and affordable for HL in Malawi. Outcomes are worse than in high-income countries due to HL progression. Future studies are needed to understand outcome inequities and to assess efficacy of therapies for patients with relapsed or refractory HL in Malawi.

FUNDING

National Institutes of Health, Lineberger Comprehensive Cancer Center.

摘要

背景

阿霉素、博来霉素、长春花碱和地塞米松(ABVD)方案是一种已被证实的霍奇金淋巴瘤(HL)治愈方案。关于撒哈拉以南非洲地区HL治疗的前瞻性数据有限。我们旨在利用马拉维的数据填补这一知识空白。

方法

我们报告了来自马拉维一家单一的三级转诊中心的HL(年龄≥15岁)前瞻性观察队列。我们纳入了2013年6月1日至2021年12月31日期间经病理确诊为霍奇金淋巴瘤的患者,并于2022年5月31日进行随访审查。患者接受ABVD治疗,若为HIV阳性则同时接受抗逆转录病毒治疗,并随访5年。主要结局是总生存期;次要结局包括无进展生存期、疗效评估和不良事件。纳入了HL诊断、治疗和随访的微观成本核算。

结果

我们纳入了38例患者,中位年龄为27岁(四分位间距19 - 46岁);11例(28%)为HIV阳性。在接受ABVD治疗的35例患者中,24例(71%)为Ⅲ/Ⅳ期,9例(26%)为不良局限期,2例(6%)为有利局限期。在HIV感染个体中,HL诊断时的平均CD4细胞计数为179个/μL,10例(91%)的HIV RNA<400拷贝/mL。24例(68%)患者发生3/4级中性粒细胞减少,其中16例(46%)导致治疗延迟。在10例死亡病例中,7例死于HL,2例可能与治疗相关的毒性反应,1例死因不明。2年总生存率为82%(95%CI 70 - 96%),2年无进展生存率为64%(95%CI 50 - 83%)。在控制分期和体能状态后,HIV阳性患者的无进展生存期似乎更好(HR 0.23(95%CI 0.05 - 1.02))(p = 0.05)。我们估计我们队列中HL诊断、治疗和随访的费用为2708美元(2022年美元)。

解读

我们的研究结果表明,ABVD治疗对马拉维的HL患者是安全、有效且可负担的。由于HL进展,结局比高收入国家更差。未来需要开展研究以了解结局的不平等情况,并评估马拉维复发或难治性HL患者的治疗疗效。

资助

美国国立卫生研究院,Lineberger综合癌症中心。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0acd/10864874/c5f204b8e971/gr1.jpg

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