Department of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Department of Biostatistics, Mayo Clinic, Rochester, MN, USA.
Bone Marrow Transplant. 2021 Apr;56(4):960-962. doi: 10.1038/s41409-020-01095-8. Epub 2020 Oct 31.
Following publication of the ALLOZITHRO trial, the FDA released a safety announcement warning that azithromycin should not be given long-term to prevent BOS in patients with a blood or lymph cancer who have undergone allogeneic HSCT. Our site typically initiated azithromycin when patients were diagnosed with BOS post-transplant rather than empirically as prevention. The purpose of our study was to discern whether the use of azithromycin at the time of diagnosis of BOS increased risk of disease relapse in patients who received an allogeneic HSCT for malignant disease. We retrospectively reviewed 432 patients in 3 cohorts: Cohort (1) patients who received greater than or equal to 2 weeks of azithromycin therapy (n = 98); Cohort (2) patients who received azithromycin therapy for less than 2 weeks (n = 63); and Cohort (3) patients who never received azithromycin therapy (n = 271). Neither patients in Cohort 1 (HR 0.44; 95% CI, 0.12-1.53, P = 0.19) nor Cohort 2 (HR 0.66; 95% CI, 0.2-2.19, P = 0.49) were associated with an increased risk of relapse when compared to those who had never received azithromycin. Our data indicate that the prolonged use of azithromycin after allogeneic HSCT is not associated with an increased rate of hematologic relapse.
在 ALLOZITHRO 试验发表后，FDA 发布了一则安全公告，警告称，对于接受异基因 HSCT 的血液或淋巴癌患者，不应长期使用阿奇霉素来预防 BOS。我们的站点通常在患者移植后诊断出 BOS 时才开始使用阿奇霉素，而不是作为预防措施进行经验性使用。我们的研究目的是确定在诊断为 BOS 时使用阿奇霉素是否会增加接受异基因 HSCT 治疗恶性疾病的患者疾病复发的风险。我们回顾性地分析了 3 个队列中的 432 名患者：队列 1（1）患者接受了大于或等于 2 周的阿奇霉素治疗（n=98）；队列 2（2）患者接受了小于 2 周的阿奇霉素治疗（n=63）；和队列 3（3）患者从未接受过阿奇霉素治疗（n=271）。与从未接受过阿奇霉素治疗的患者相比，队列 1（HR 0.44；95% CI，0.12-1.53，P=0.19）和队列 2（HR 0.66；95% CI，0.2-2.19，P=0.49）的患者均未显示复发风险增加。我们的数据表明，异基因 HSCT 后长期使用阿奇霉素与血液学复发率增加无关。
