Phase I trial of nedaplatin chemotherapy concurrent with radiotherapy for untreated locoregionally advanced nasopharyngeal carcinoma
Phase I trial of nedaplatin chemotherapy concurrent with radiotherapy for untreated locoregionally advanced nasopharyngeal carcinoma
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DOI：
10.1007/s00280-016-2971-4
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发表时间：
2016-01
影响因子：
3
通讯作者：
Zibin Liang;Si-yang Wang;Zhong Lin;S. Feng;Zhi-Bin Cheng;Yaqi Yang;Ying Kuang;C. Fidelis;S. Ullah;Feng Li
中科院分区：
文献类型：
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作者：
Zibin Liang;Si-yang Wang;Zhong Lin;S. Feng;Zhi-Bin Cheng;Yaqi Yang;Ying Kuang;C. Fidelis;S. Ullah;Feng Li
本研究采用奈达铂（NDP）单药化疗联合放疗治疗局部晚期鼻咽癌（NPC）。本研究旨在确定最大耐受剂量（MTD），推荐剂量（RD）和临床疗效的治疗局部晚期NPC patients.Experimental designTwenty患者参加。入选标准包括当地晚期NPC（III期或IVa期），既往未接受过任何治疗，预期生存期≥3个月。放疗方案为1.8-2.0戈伊/d，每周5 d，NDP剂量递增70-100 mg/m2，第1天。每21天重复一次周期（第1天、第22天和第43天），直至完成放化疗。剂量限制性毒性（DLT）包括：4级贫血; 4级中性粒细胞减少持续≥5天; 3级和4级发热性中性粒细胞减少症; 4级血小板减少症; 3-4级非血液学毒性（脱发，恶心除外）和任何5级respons.Results95%的评估患者经历了治疗反应。所有患者的中位进展时间为41.9个月。两年总生存率为95%，无进展生存率为85%。DLT包括3级发热性中性粒细胞减少症。NDP的RD为90 mg/m2，第1- 3周期。结论NDP联合放疗，每21 d给药1次，共3个周期，对局部晚期鼻咽癌有疗效。该方案导致轻微的不良反应和良好的患者依从性。根据研究结果，II期试验的NDP RD为90 mg/m2。
PurposeIn this phase I study, single-agent chemotherapy was conducted in patients with locoregionally advanced nasopharyngeal carcinoma (NPC) using nedaplatin (NDP) and concomitant radiotherapy. The study sought to determine the maximum tolerated dose (MTD), recommended dose (RD) and the clinical efficacy of this treatment in locoregionally advanced NPC patients.Experimental designTwenty patients were enrolled. The eligibility criteria included local advanced NPC (stage III or IVa) without any previous treatment and an expected survival of ≥3 months. The regimen consisted of 1.8–2.0 Gy daily radiation for 5 days a week and NDP with dose escalation of 70–100 mg/m2on day 1. The cycles were repeated every 21 days (day 1, day 22 and day 43) until the completion of chemoradiation. Dose-limiting toxicities (DLTs) included: grade 4 anemia; grade 4 neutropenia lasting for ≥5 days; grades 3 and 4 febrile neutropenia; grade 4 thrombocytopenia; grades 3–4 non-hematological toxicity (with the exception of alopecia, nausea) and any of the grade 5 responses.ResultsNinety-five percent of the assessed patients experienced a treatment response. The median time to progression among all patients was 41.9 months. Two-year overall survival was 95 %, while the progression-free survival was 85 %. DLT included febrile neutropenia of grade 3. The RD of NDP was 90 mg/m2during cycles 1–3.ConclusionNDP combined with radiotherapy and administered every 21 days for three cycles was active in patients with locoregionally advanced NPC. The regimen resulted in mild adverse effects and good patient compliance. Based on the findings from the study, the RD of NDP for phase II trial was found to be 90 mg/m2.