Sponghini Andrea Pietro, Rondonotti David, Platini Francesca, Cena Tiziana, Ferrante Daniela, Stratica Florian, Gatti Alice, Magnani Corrado, Gennari Alessandra
Division of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Department of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.
J Tradit Complement Med. 2021 May 5;11(5):466-469. doi: 10.1016/j.jtcme.2021.04.005. eCollection 2021 Sep.
Hematopoietic toxicities are a serious consequence of myelosuppressive CT that may result in dose reductions, delays or even discontinuation of CT, which, in turn, may compromise patient outcomes. Concerns about tolerability and costs of CSFs are still ongoing, therefore the potential use of supportive therapeutics agents are still of interest.
We performed a monocentric, phase II study using Simon's two-stage design. The primary endpoint was the evaluation of the potential clinical benefit of a special kind of honey (Life-Mel Honey) administered prophylactically to reduce the incidence of hematopoietic toxicities following chemotherapy. We have enrolled patients undergoing adjuvant or first-line chemotherapy.
From November 2013 to May 2014 (First stage) and from November 2014 to April 2016 (Second stage), 39 patients were enrolled at our Institution. The majority of patients was male (24/39, 61.5%), medium age was 60.4 years (range 34-77 years). The median follow up was 74.5 days (SD +/- 28.5). Overall, the majority of patients could underwent their chemoterapy with a regular schedule (25/39, 64.1%), while 9/39 patients (23.1%) need to delay chemotherapy due to hematological adverse events of various grade. Ten/39 patients (25.6%) had a grade 1 neutrophils count decreased, 56.4% a grade 1 platelets count decrease and 64.1% a grade 1 hemoglobin decrease. Therefore, Life-Mel Honey showed an interesting profile to reduce hematological toxicities. The proportion of responses is sufficiently high to recommend this honey to go to a next step in the clinical trial phase.
造血毒性是骨髓抑制性化疗的严重后果，可能导致化疗剂量减少、延迟甚至中断，进而可能影响患者的治疗结果。对集落刺激因子的耐受性和成本的担忧仍然存在，因此支持性治疗药物的潜在用途仍备受关注。
我们采用西蒙两阶段设计进行了一项单中心II期研究。主要终点是评估一种特殊蜂蜜（Life-Mel蜂蜜）预防性给药以降低化疗后造血毒性发生率的潜在临床益处。我们纳入了接受辅助化疗或一线化疗的患者。
从2013年11月至2014年5月（第一阶段）以及从2014年11月至2016年4月（第二阶段），我们机构共纳入了39例患者。大多数患者为男性（24/39，61.5%），中位年龄为60.4岁（范围34 - 77岁）。中位随访时间为74.5天（标准差±28.5）。总体而言，大多数患者能够按常规计划进行化疗（25/39，64.1%），而9/39例患者（23.1%）因各种级别的血液学不良事件需要延迟化疗。10/39例患者（25.6%）中性粒细胞计数下降1级，56.4%的患者血小板计数下降1级，64.1%的患者血红蛋白下降1级。因此，Life-Mel蜂蜜在降低血液学毒性方面表现出有趣的特征。缓解比例足够高，推荐这种蜂蜜进入临床试验的下一阶段。
