Shared Local Oncology Care After Allogeneic Hematopoietic Cell Transplantation: A Randomized Clinical Trial.

Background

To determine the efficacy and safety of sharing follow-up care after HCT between the HCT specialty center and local oncologists.

确定在HCT后，HCT专科中心与当地肿瘤科医生共享随访护理的疗效和安全性。

DESIGN, SETTING, AND PARTICIPANTS: This 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.

设计、设置和参与者：这是一项多中心协作的随机临床试验，涉及在波士顿（马萨诸塞州）的达纳-法伯癌症研究所（DFCI）-一个高容量的造血干细胞移植（HCT）中心-以及8个当地肿瘤科诊所接受HCT治疗的患者。

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.

符合条件的患者从2017年12月到2021年12月被纳入研究，并在中性粒细胞植入后按1:1的比例随机分配到共享护理与常规护理组，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进行分层。

Data analyses were performed in January 2024.

数据分析于2024年1月完成。

intervention

Shared 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.

联合护理模式包括在DFCI和当地肿瘤科诊所交替进行移植后随访，直至第100天；而常规护理模式下，所有移植后的随访仅在DFCI进行。

main_outcomes_and_measures

Coprimary 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.

主要终点为第100天的非复发死亡率(NRM)，以及通过FACT-BMT（癌症治疗功能评估-骨髓移植）工具和QLQ-C30（欧洲癌症研究与治疗组织的生活质量问卷）在第180天测量的生活质量(QOL)。

Prespecified secondary outcomes included day 100 QOL and 1-year overall survival.

预先设定的次要终点包括第100天的生活质量和1年总生存。

Results

A 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.

共有302名参与者（中位年龄[范围]为63[20-79]岁；女性117名[38.7%]；男性185名[61.3%]）被纳入分析；其中152人被随机分配到共享护理组，150人被分配到常规护理组。

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).

第100天时，共享护理组与常规护理组的非复发死亡率（NRM）无劣势（2.6% [95% 置信区间, 0.7% 至 6.6%] 对比 2.7% [95% 置信区间, 0.7% 至 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).

在第180天，FACT-BMT总分（平均差异，3.8；95%置信区间，-2.1至9.6；P = .20）或QLQ-C30全球评分（1.9；95%置信区间，-4.9至8.8；P = .58）没有差异。

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).

在第100天，共享护理的FACT-BMT总分更好（平均差异，6.6；95%置信区间，1.0至12.1；P = .02），QLQ-C30全球评分也是如此（8.8；95%置信区间，1.8至15.7；P = .02）。

conclusions_and_relevance

This 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.

这项随机临床试验发现，共享护理在第100天的非复发死亡率(NRM)上结果非劣效，但在第180天的生活质量(QOL)上结果相似，且在第100天时生活质量有所改善。

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.

这些数据表明，共享护理是安全的，能够早期改善生活质量，并且有潜力成为造血干细胞移植(HCT)后护理的常规模式。

trial_registration

ClinicalTrials.gov Identifier: NCT03244826.

临床试验注册号：NCT03244826。