Braik Tareq, Yim Barbara, Evans Arthur T, Kassem Mohammed, Mullane Michael, Lad Thomas, Hussein Lily, Cleveland Barbara, McDunn Susan
Hematology and Oncology Division, John H Stroger Jr Hospital of Cook County, Chicago, IL USA Email:
J Community Support Oncol. 2014 Feb;12(2):65-70. doi: 10.12788/jcso.0017.
Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.
In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.
Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true benefit from pyridoxine can be excluded. No difference in HFS grades was observed.
Single-institution study.
Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.
卡培他滨是一种口服氟嘧啶，用于治疗多种恶性肿瘤。手足综合征（HFS）是卡培他滨的一种剂量限制性毒性反应，在某些患者中会限制该药物的使用。一些研究人员观察到，吡哆醇（维生素B6）可改善由卡培他滨引起的HFS。我们设计了一项前瞻性试验，以确定吡哆醇能否预防接受卡培他滨治疗患者的HFS。
在我们的双盲、安慰剂对照试验中，我们将接受卡培他滨治疗的符合条件的患者随机分配，使其在接受含卡培他滨的化疗方案的同时，每日服用100 mg吡哆醇或安慰剂。在卡培他滨治疗的前4个周期观察患者。主要终点是两个研究组中发生的HFS的发生率和分级。
2008年至2011年期间，77例患者被随机分配接受吡哆醇（n = 38）或安慰剂（n = 39）治疗。研究的两组中卡培他滨的剂量相当。两组患者在中位2个化疗周期后均出现HFS。吡哆醇组38例患者中有10例（26%）发生HFS，安慰剂组39例患者中有8例（21%）发生HFS（P = 0.547）。因此，吡哆醇组HFS风险高5个百分点（差异的95%置信区间[CI]为，-13个百分点至+25个百分点）。根据我们的研究结果，可以排除吡哆醇的真正益处。未观察到HFS分级的差异。
单机构研究。
与含卡培他滨的化疗同时给予预防性吡哆醇（维生素B6）对预防HFS无效。
