Oncology Division, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK.
Br J Cancer. 2012 Aug 7;107(4):585-7. doi: 10.1038/bjc.2012.318. Epub 2012 Jul 19.
Pyridoxine is frequently used to treat capecitabine-induced hand-foot syndrome (HFS), although the evidence of benefit is lacking. We performed a randomised placebo-controlled trial to determine whether pyridoxine could avoid the need for capecitabine dose modifications and improve outcomes.
A total of 106 patients planned for palliative single-agent capecitabine (53 in each arm, 65%/35% colorectal/breast cancer) were randomised to receive either concomitant pyridoxine (50 mg po) or matching placebo three times daily.
Compared with placebo, pyridoxine use was associated with an increased rate of avoiding capecitabine dose modifications (37% vs 23%, relative risk 0.59, 95% CI 0.29, 1.20, P=0.15) and fewer grade 3/4 HFS-related adverse events (9% vs 17%, odds ratio 0.51, 95% CI 0.15-1.6, P=0.26). Use of pyridoxine did not improve response rate or progression-free survival.
Pyridoxine may reduce the need for capecitabine dose modifications and the incidence of severe HFS, but does not impact on antitumour effect.
虽然缺乏证据表明其有益，但临床常使用吡哆醇治疗卡培他滨引起的手足综合征（HFS）。我们进行了一项随机安慰剂对照试验，以确定吡哆醇是否可以避免卡培他滨剂量调整并改善结局。
共 106 例计划接受姑息性单药卡培他滨治疗的患者（每组 53 例，结直肠癌/乳腺癌分别占 65%/35%）被随机分配接受每日三次的吡哆醇（50mg 口服）或匹配安慰剂治疗。
与安慰剂相比，吡哆醇的使用与避免卡培他滨剂量调整的比率增加相关（37% vs 23%，相对风险 0.59，95%CI 0.29,1.20，P=0.15），3/4 级 HFS 相关不良事件的发生率较低（9% vs 17%，比值比 0.51，95%CI 0.15-1.6，P=0.26）。吡哆醇的使用并未改善缓解率或无进展生存期。
吡哆醇可能减少卡培他滨剂量调整的需要和严重 HFS 的发生率，但对抗肿瘤作用没有影响。
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