Shared Local Oncology Care After Allogeneic Hematopoietic Cell Transplantation

IF 22.5 1区 医学 Q1 ONCOLOGY JAMA Oncology Pub Date : 2025-01-09 DOI:10.1001/jamaoncol.2024.5786
Gregory A. Abel, Haesook T. Kim, Ira Zackon, Edwin T. Alyea, Alexandra S. Bailey, John P. Winters, Kenneth R. Meehan, John L. Reagan, Jeanna H. Walsh, Thomas P. Walsh, Alexandra Ivanov, Meredith A. Faggen, Sarah Sinclair, Amy C. Joyce, Sara D. Close, Amy Emmert, Jon Koreth, Joseph H. Antin, Corey S. Cutler, Vincent T. Ho, Robert J. Soiffer
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Abstract

ImportanceAlthough sharing care with local oncologists after allogeneic hematopoietic cell transplantation (HCT) has been proposed for patients living far from HCT centers, it is not known whether a shared strategy is safe or improves patient quality of life (QOL).ObjectiveTo determine the efficacy and safety of sharing follow-up care after HCT between the HCT specialty center and local oncologists.Design, Setting, and ParticipantsThis was a multicenter collaborative randomized clinical trial of patients undergoing HCT at Dana-Farber Cancer Institute (DFCI)—a high volume HCT center in Boston (Massachusetts)—and 8 local oncology practices. Eligible patients were enrolled from December 2017 to December 2021 and were randomized 1:1 to shared vs usual care after neutrophil engraftment, stratified by local sites in Massachusetts, Rhode Island, New Hampshire, New York, and Maine. Data analyses were performed in January 2024.InterventionShared care involved alternating post-HCT visits at DFCI and local oncology practices through day 100; for usual care, all post-HCT visits occurred only at DFCI.Main Outcomes and MeasuresCoprimary outcomes were nonrelapse mortality (NRM) at day 100, and QOL measured by the FACT-BMT (Functional Assessment of Cancer Therapy–Bone Marrow Transplantation) instrument and the QLQ-C30 (European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire) at day 180. Prespecified secondary outcomes included day 100 QOL and 1-year overall survival.ResultsA total of 302 participants (median [range] age, 63 [20-79] years; 117 [38.7%] females; 185 [61.3%] males) were included in the analysis; 152 were randomized to shared care and 150 to usual care. Day 100 NRM was noninferior for shared vs usual care (2.6% [95% CI, 0.7% to 6.6%] vs 2.7% [95% CI, 0.7% to 6.7%]; P = .98). There were no differences at day 180 for the FACT-BMT total score (mean difference, 3.8; 95% CI, −2.1 to 9.6; P = .20) or QLQ-C30 global score (1.9; 95% CI, −4.9 to 8.8; P = .58). At day 100, the FACT-BMT total score was better for shared care (mean difference, 6.6; 95% CI, 1.0 to 12.1; P = .02) as was the QLQ-C30 global score (8.8; 95% CI, 1.8 to 15.7; P = .02).Conclusions and RelevanceThis randomized clinical trial found that shared care resulted in noninferior NRM at day 100 but similar QOL at day 180, with improved QOL at day 100. These data suggest that shared care is safe, improves QOL early on, and has the potential to become a routine model for post-HCT care.Trial RegistrationClinicalTrials.gov Identifier: NCT03244826
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同种异体造血细胞移植术后的局部肿瘤护理
尽管在异基因造血细胞移植(HCT)后与当地肿瘤学家共享护理已被提议用于远离HCT中心的患者,但尚不清楚共享策略是否安全或是否能提高患者的生活质量(QOL)。目的探讨HCT专科中心与当地肿瘤医师共享HCT术后随访护理的有效性和安全性。设计、环境和参与者这是一项多中心协作随机临床试验,在丹娜-法伯癌症研究所(DFCI) -波士顿(马萨诸塞州)的高容量HCT中心-和8个当地肿瘤诊所接受HCT的患者。符合条件的患者于2017年12月至2021年12月入组,中性粒细胞植入后按1:1随机分为共享治疗和常规治疗,按马萨诸塞州、罗德岛州、新罕布什尔州、纽约州和缅因州的当地地点分层。数据分析于2024年1月进行。干预:共享护理包括在第100天在DFCI和当地肿瘤诊所交替进行hct后访问;对于常规护理,所有hct后访问仅发生在DFCI。主要结果和测量主要结果为第100天的非复发死亡率(NRM),以及第180天用FACT-BMT(肿瘤治疗-骨髓移植功能评估)仪器和QLQ-C30(欧洲癌症研究和治疗组织生活质量问卷)测量的生活质量。预先指定的次要结局包括100天的生活质量和1年的总生存期。结果共302例受试者(年龄中位数[范围]为63[20-79]岁;女性117例(38.7%);185例(61.3%)男性纳入分析;152例随机分配到共同护理组,150例随机分配到常规护理组。第100天的NRM与常规护理相比并不逊色(2.6% [95% CI, 0.7%至6.6%]vs 2.7% [95% CI, 0.7%至6.7%];P = .98)。在第180天,FACT-BMT总分无差异(平均差异3.8;95% CI,−2.1 ~ 9.6;P = 0.20)或QLQ-C30整体评分(1.9;95% CI,−4.9 ~ 8.8;P = .58)。在第100天,共同护理组的FACT-BMT总分更好(平均差异为6.6;95% CI, 1.0 ~ 12.1;P = .02), QLQ-C30整体评分(8.8;95% CI, 1.8 ~ 15.7;P = .02)。结论和相关性这项随机临床试验发现,共享护理在第100天的NRM不差,但在第180天的生活质量相似,在第100天的生活质量有所改善。这些数据表明,共享护理是安全的,可以在早期改善生活质量,并有可能成为hct后护理的常规模式。临床试验注册号:NCT03244826
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来源期刊
JAMA Oncology
JAMA Oncology Medicine-Oncology
自引率
1.80%
发文量
423
期刊介绍: JAMA Oncology is an international peer-reviewed journal that serves as the leading publication for scientists, clinicians, and trainees working in the field of oncology. It is part of the JAMA Network, a collection of peer-reviewed medical and specialty publications.
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