Cancer Center, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Yuzhong District, Congqing 400042, PR China.
Jpn J Clin Oncol. 2010 May;40(5):425-31. doi: 10.1093/jjco/hyp183. Epub 2010 Jan 19.
This Phase II study was conducted to evaluate the activity and feasibility of a regimen of nedaplatin and 5-fluorouracil as induction chemotherapy, followed by intensity-modulated radiotherapy concurrent with chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma.
Patients received neoadjuvant chemotherapy comprised two cycles of 5-fluorouracil at 700 mg/m(2)/day administered on days 1-4 as continuous intravenous infusion and nedaplatin (100 mg/m(2) administered i.v. over 2 h) given after the administration of 5-fluorouracil on day 1, repeated every 3 weeks, followed by intensity-modulated radiotherapy concurrent with nedaplatin. During intensity-modulated radiotherapy, nedaplatin was administered at a dose of 100 mg/m(2) intravenous infusion on days 1, 22 and 43, given approximately 60 min before radiation.
Fifty-nine (95.8%) of the 60 patients were assessable for response. Thirty-eight cases of complete response and 14 cases of partial response were confirmed after completion of chemoradiation, with the objective response rate of 86.7% (95% CI, 78.1-95.3%). The median follow-up period was 48 months (range, 30-62 months). The 3-year progression-free survival and overall survival were 75.0% (95% CI, 63.0-87.0%) and 85.5% (95% CI, 75.9-95.1%). No patient showed Grade 3 or higher renal dysfunction. The most commonly observed late effect was xerostomia, but the severity diminished over time, and the detectable xerostomia at 24 months was 10.2%. There were no treatment-related deaths during this study.
Neoadjuvant chemotherapy with nedaplatin and 5-fluorouracil followed by concomitant nedaplatin and intensity-modulated radiotherapy is an effective and safe treatment for Southern China patients affected by locoregionally advanced nasopharyngeal carcinoma.
本 II 期研究旨在评估奈达铂和 5-氟尿嘧啶作为诱导化疗方案的活性和可行性，随后进行强度调制放疗（IMRT）联合化疗治疗局部晚期鼻咽癌患者。
患者接受新辅助化疗，包括两个周期的 5-氟尿嘧啶（700mg/m²/天）持续静脉输注，第 1-4 天给药，奈达铂（100mg/m²，静脉注射 2 小时）在第 1 天 5-氟尿嘧啶给药后给予，每 3 周重复一次，随后进行 IMRT 联合奈达铂治疗。在 IMRT 期间，奈达铂在第 1、22 和 43 天以 100mg/m² 的剂量静脉输注，大约在放疗前 60 分钟给予。
60 例患者中有 59 例（95.8%）可评估疗效。放化疗完成后，38 例完全缓解，14 例部分缓解，客观缓解率为 86.7%（95%CI，78.1-95.3%）。中位随访时间为 48 个月（范围，30-62 个月）。3 年无进展生存率和总生存率分别为 75.0%（95%CI，63.0-87.0%）和 85.5%（95%CI，75.9-95.1%）。无患者出现 3 级或以上肾功能不全。最常见的晚期效应是口干，但随着时间的推移，严重程度减轻，24 个月时可检测到的口干率为 10.2%。研究期间无治疗相关死亡。
奈达铂和 5-氟尿嘧啶新辅助化疗后联合奈达铂和强度调制放疗是治疗华南地区局部晚期鼻咽癌患者的有效且安全的治疗方法。
