三种以吉西他滨联合顺铂（GP）、顺铂联合氟尿嘧啶（PF）和顺铂联合卡培他滨（PX）为方案的诱导化疗方案治疗局部晚期初治鼻咽癌的疗效和安全性比较：两项前瞻性研究的汇总分析。
Comparison of efficacy and safety of three induction chemotherapy regimens with gemcitabine plus cisplatin (GP), cisplatin plus fluorouracil (PF) and cisplatin plus capecitabine (PX) for locoregionally advanced previously untreated nasopharyngeal carcinoma: A pooled analysis of two prospective studies.
机构信息
Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
出版信息
Oral Oncol. 2021 Mar;114:105158. doi: 10.1016/j.oraloncology.2020.105158. Epub 2021 Jan 25.
PURPOSE
We compared, in this pooled analysis, the differences in efficacy and safety between three induction chemotherapy regimens including gemcitabine plus cisplatin (GP), cisplatin plus fluorouracil (PF) and cisplatin plus capecitabine (PX) in patients recruited into our two prospective studies for previously untreated locoregionally advanced nasopharyngeal carcinoma (NPC).
METHODS
GP, PF or PX followed by radical concurrent chemoradiotherapy was given to patients with previously untreated locoregionally advanced (stage III to IVA) NPC prospectively recruited into our two prospective studies. The study endpoints included progression-free survival (PFS) and overall survival (OS), locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), cancer-specific survival (CSS), and major acute and late treatment-related toxicities (grade ≥ 3).
RESULTS
From 2006 to 2016, 278 patients were enrolled (84, 94 and 100 patients in GP, PF and PX group respectively). After a median follow-up of 80 months, the 3-year PFS, OS, LRFS, DMFS and CSS of the whole population were 78.7%, 88.1%, 84.9%, 80.9% and 89.8%, respectively. There were no significant differences in prespecified survival endpoints among GP, PF and PX in both stage III and stage IVA patients. GP had lower incidences of severe (grade ≥ 3) anemia and diarrhea in stage III patients, as well as severe anemia, dehydration, renal impairment and vomiting in stage IVA patients. The incidences of grade ≥ 3 late toxicities were similar among these 3 induction regimens.
CONCLUSION
GP had similar efficacy and potentially fewer treatment-related complications compared with PF and PX as induction chemotherapy for previously untreated locoregionally advanced NPC.
目的
我们在这项汇总分析中比较了吉西他滨联合顺铂（GP）、顺铂联合氟尿嘧啶（PF）和顺铂联合卡培他滨（PX）三种诱导化疗方案在我们两项前瞻性研究中招募的未经治疗的局部晚期鼻咽癌（NPC）患者中的疗效和安全性差异。
方法
未经治疗的局部晚期（III 期至 IVA 期）NPC 患者前瞻性入组我们的两项前瞻性研究，接受 GP、PF 或 PX 诱导化疗，然后行根治性同期放化疗。研究终点包括无进展生存期（PFS）和总生存期（OS）、局部区域无复发生存期（LRFS）、远处转移无复发生存期（DMFS）、癌症特异性生存期（CSS）以及主要急性和晚期治疗相关毒性（≥3 级）。
结果
2006 年至 2016 年，共入组 278 例患者（GP、PF 和 PX 组分别为 84、94 和 100 例）。中位随访 80 个月后，全人群 3 年 PFS、OS、LRFS、DMFS 和 CSS 分别为 78.7%、88.1%、84.9%、80.9%和 89.8%。在 III 期和 IVA 期患者中，GP、PF 和 PX 在预设生存终点方面均无显著差异。在 III 期患者中，GP 组贫血和腹泻发生率较低（≥3 级），而在 IVA 期患者中，GP 组贫血、脱水、肾功能损害和呕吐发生率较低。这三种诱导化疗方案的≥3 级晚期毒性发生率相似。
结论
GP 作为未经治疗的局部晚期 NPC 的诱导化疗方案，与 PF 和 PX 相比，疗效相当，且潜在治疗相关并发症更少。
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