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目的观察联合化疗治疗肝功能Child-Pugh A级和B级中晚期原发性肝癌(PLC)的疗效及不良反应。方法选取2013年7月至2015年7月间广西医科大学附属柳铁中心医院、贵阳中医学院第三附属医院、广西科技大学第二附属医院、广西中医药大学第三附属医院和广西柳州市融水县人民医院等6个肿瘤中心共72例中晚期PLC患者。接受雷替曲塞+奥沙利铂(RALOX方案)化疗34例和5-氟尿嘧啶+亚叶酸钙+奥沙利铂(FOLFOX4方案)化疗38例。采用Child-Pugh肝功能分级标准将患者分为A组(Child-Pugh A级,31例)和B组(Child-Pugh B级,41例)。化疗后每42天观察对比两组患者客观缓解率(OR)、疾病控制率(DCR)、中位生存时间(mOS)、中位无进展生存期(mPFS)、1年存活率(SR)、不良反应和化疗耐受性。结果 A组患者退出化疗2例(6.5%),B组退出化疗10例(24.4%),两组比较,差异有统计学意义(P<0.05)。A组共完成211个化疗周期,其中PR6例,SD11例,PD12例,OR6例(20.7%),DCR为17例(58.6%),mOS为7.6个月,mPFS为3.7个月,1年SR为8例(27.6%);B组患者完成217个化疗周期,其中PR4例,SD9例,PD18例,OR为4例(12.9%),DCR为13例(41.9%),mOS为6.7个月,mPFS为3.1个月,1年SR为5例(16.1%)。两组患者疗效比较,差异无统计学意义(P>0.05)。两组不良反应多为轻、中度,经积极处理可缓解,两组患者消化道反应、肝毒性差异有统计学意义,心脏毒性、周围神经毒性、手足综合症、肾毒性及骨髓抑制等,两组无统计学意义。较重的不良反应,如严重心脏毒性和手足综合征等,大多数发生在B组,提示肝功能较差可能导致较明显的化疗不良反应。结论联合化疗对肝功能Child-Pugh A级和B级中晚期PLC患者均有良好的疾病控制率及生存获益,不良反应可耐受。两组比较,Child-Pugh A级比B级中晚期PLC在联合化疗中获益更大。
Objective To observe the curative effect and adverse reactions of combined chemotherapy on Child-Pugh class A and B advanced primary liver cancer (PLC). Methods From July 2013 to July 2015, the Third Affiliated Hospital of Guangxi Medical University, the Third Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangxi University of Science and Technology, the Third Affiliated Hospital of Guangxi University of Traditional Chinese Medicine and Guangxi Liuzhou Financial Center Water County People’s Hospital and other 6 tumor centers in a total of 72 patients with advanced PLC. Thirty-four patients received raltitrexed plus oxaliplatin (RALOX regimen) and 38 patients received fluorouracil plus leucovorin plus oxaliplatin (FOLFOX4 regimen). The patients were divided into group A (Child-Pugh class A, 31 cases) and group B (Child-Pugh class B, 41 cases) using Child-Pugh liver function grading standard. The objective response rate, disease control rate (DCR), median survival time (mOS), median progression-free survival (mPFS), 1-year survival rate Adverse reactions and chemotherapy tolerance. Results In group A, 2 patients (6.5%) withdrew from chemotherapy and 10 patients (24.4%) in group B withdrew from chemotherapy. The difference was statistically significant (P <0.05). A total of 211 chemotherapy cycles were completed in group A, including 6 cases of PR6, 11 cases of SD, 12 cases of PD, OR6 (20.7%), DCR of 17 cases (58.6%), mOS of 7.6 months, mPFS of 3.7 months 8 cases (27.6%). The patients in group B completed 217 cycles of chemotherapy, including 4 cases (12.9%) with PR, 4 cases with SD, 9 cases with PD, 13 cases (41.9%) with DCR and 6.7 months , mPFS was 3.1 months, 1 year SR was 5 cases (16.1%). There was no significant difference in curative effect between the two groups (P> 0.05). Two groups of adverse reactions were mostly mild, moderate, and can be alleviated by active treatment. There was significant difference in the digestive tract reaction and hepatotoxicity between the two groups. Cardiac toxicity, peripheral neurotoxicity, hand-foot syndrome, nephrotoxicity and bone marrow suppression, The two groups had no statistical significance. Severe adverse reactions, such as severe cardiotoxicity and hand-foot syndrome, etc., most occurred in group B, suggesting that poor liver function may lead to more obvious side effects of chemotherapy. Conclusions Combination chemotherapy has good disease control rate and survival benefit to Child-Pugh A grade and PLC grade B patients with advanced liver disease. Adverse reactions are tolerable. In both groups, Child-Pugh A-Class had a greater benefit than combined B-phase PLC in combination chemotherapy.