化疗依从性对局邵晚期鼻咽癌患者疗效影响的研究

摘要

Objective To evaluate the impact of chemotherapy compliance on the therapeutic efficacy of induction chemotherapy plus concurrent chemoradiotherapy versus induction chemotherapy plus radiotherapy alone for patients with locally advanced nasopharyngeal carcinoma (NPC). Methods Based on intention to treat analysis (ITT) for 400 patients, 314 patients were analyzed by per protocol (PP) analysis. The patients were divided into induction chemotherapy plus concurrent chemoradiotherapy group (IC/CCRT, 127 patients) or induction chemotherapy plus radiotherapy group (IC/RT, 187 patients). The patients who completed 2 cycles of induction chemotherapy and at least 2 cycles of concurrent chemotherapy in the IC/CCRT group and the patients who completed 2 cycles of induction chemotherapy in the IC/RT group were analyzed. Radiotherapy was given by two-dimensional technique with γ-ray, X-ray and electron beams. The chemotherapy regimen was FUDR plus carboplatin for induction chemotherapy and carboplatin alone for concurrent chemotherapy. Results The follow-up rate was 96.2%. 295 patients were followed to at 3 years. Based on PP analysis, Grade 3/4 toxicity was found in 23.6% of the patients in IC/CCRT group and 13.4% in the IC/RT group (χ~2 =5,50,P=0.019). No grade 4 toxicity was found in the IC/RT group. The median follow-up time was 3.9 years, and no significant difference was found between the two groups in 3-year overall survival (78.1% : 84.6% ;χ~2 = 0. 61, P =0. 435), disease-free survival (74.3 % : 70.1% ;χ~2= 0. 12, P= 0.731), Iocoregional relapse-free survival (89.7% : 89.5% ; χ~2= 0. 10, P= 0.748), or distant metastasis-free survival (78.9%:76.5% ;χ~2=0.05,P=0.825). Conclusions With more severe toxicities, the IC/CCRT regimen does not improve the overall survival in locally advanced NPC patients compared with the IC/RT regimen.%目的 评价化疗依从性对诱导+同期放化疗与诱导化放疗治疗局部晚期(Ⅲ、Ⅳ_a期)鼻咽癌疗效的影响.方法 对400例患者经意向性治疗(ITT)分析后选择依从性较好的314例进行符合方案集(PP)分析.将314例患者分为诱导+同期放化疗组(127例)和诱导化放疗组(187例),其中诱导加同期放化组为完成全部两程诱导化疗和至少两程同期化疗,诱导化放组为完成全部两程诱导化疗.放疗采用传统二维放疗技术,全组均采用~(60)Co γ线或直线加速器6～8 MV X射线照射,颈后三角区域应用8～12 MeV电子线治疗.诱导化疗采用氟尿嘧啶脱氧核苷+卡铂联合,同期化疗采用单药卡铂.结果 随访率为96.2%,随访满3年者295例.诱导+同期放化疗组的3+4级毒副反应发生率比诱导化放疗组要高(23.6%:13.4%;χ~2=5.50,P=0.019)且后者无4级反应.两组3年总生存率(78.1%:84.6%)、无瘤生存率(74.3%:70.1%)、无局部区域复发生存率(89.7%:89.5%)和无远处转移生存率(78.9%:76.5%)均相似(χ~2=0.61、0.12、0.10、0.05,P=0.435、0.731、0.748、0.825).结论 对局部晚期鼻咽癌患者,诱导+同期放化疗与诱导化放疗方案的3年生存率相似但严重毒副反应发生率高.