Yeo Winnie, Chan Paul K S, Ho Wing M, Zee Benny, Lam Kwok C, Lei Kenny I K, Chan Anthony T C, Mok Tony S K, Lee Jam J, Leung Thomas W T, Zhong Sheng, Johnson Philip J
MRCP, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong. winnieyeo@ cuhk.edu.hk
J Clin Oncol. 2004 Mar 1;22(5):927-34. doi: 10.1200/JCO.2004.05.161.
For cancer patients receiving cytotoxic chemotherapy, hepatitis B virus (HBV) reactivation is a well described complication resulting in varying degrees of liver damage. The objectives of this study were to assess the efficacy of the antiviral agent lamivudine in reducing the incidence of HBV reactivation and diminishing morbidity and mortality of cancer patients with chronic HBV infection during chemotherapy.
Two groups were compared in this nonrandomized study. The prophylactic lamivudine group consisted of 65 patients in a phase II study who were treated with lamivudine before and until 8 weeks after discontinuing chemotherapy. The historical controls consisted of 193 consecutive patients who underwent chemotherapy without prophylactic lamivudine. Significant prognosticators for the development of HBV reactivation were determined based on data from the controls. Potential confounding factors were identified between the two groups. The outcomes were compared.
In the controls, lymphoma and anthracycline usage were factors identified to be associated with reactivation. The two groups were comparable in most baseline characteristics, although in the prophylactic lamivudine group, there were significantly more patients with lymphoma and receiving anthracyclines. In the prophylactic lamivudine group, there was significantly less HBV reactivation (4.6% v 24.4% in the controls; P <.001), fewer incidences of hepatitis (17.5% v 44.6%; P <.0001) that were less severe (4.8% v 18.7%; P =.0005), and less disruption of chemotherapy (15.4% v 34.6%; P =.0029). The reduction in overall mortality was not statistically different.
Prophylactic lamivudine significantly reduced the incidence of HBV reactivation and the overall morbidity of cancer patients undergoing chemotherapy.
对于接受细胞毒性化疗的癌症患者,乙肝病毒(HBV)再激活是一种已被充分描述的并发症,可导致不同程度的肝损伤。本研究的目的是评估抗病毒药物拉米夫定在降低慢性HBV感染的癌症患者化疗期间HBV再激活发生率以及降低发病率和死亡率方面的疗效。
在这项非随机研究中对两组进行了比较。预防性拉米夫定组由65例参与II期研究的患者组成,这些患者在化疗前及化疗停药后8周接受拉米夫定治疗。历史对照由193例未接受预防性拉米夫定化疗的连续患者组成。基于对照组的数据确定了HBV再激活发生的显著预后因素。确定了两组之间潜在的混杂因素。对结果进行了比较。
在对照组中,淋巴瘤和蒽环类药物的使用被确定为与再激活相关的因素。两组在大多数基线特征方面具有可比性,尽管在预防性拉米夫定组中,淋巴瘤患者和接受蒽环类药物治疗的患者明显更多。在预防性拉米夫定组中,HBV再激活明显较少(4.6% 对对照组的24.4%;P <.001),肝炎发病率较低(17.5% 对44.6%;P <.0001)且病情较轻(4.8% 对18.7%;P =.0005),化疗中断情况也较少(15.4% 对34.6%;P =.0029)。总体死亡率的降低无统计学差异。
预防性使用拉米夫定可显著降低接受化疗的癌症患者HBV再激活的发生率和总体发病率。