Department of Radiation Oncology, Fudan University, Shanghai Cancer Center, Shanghai, People's Republic of China.
Cancer. 2013 Dec 1;119(23):4111-8. doi: 10.1002/cncr.28324. Epub 2013 Aug 27.
The authors studied the efficacy of neoadjuvant chemotherapy, consisting of a taxane, cisplatin, and 5-fluorouracil (5-FU) (the TPF regimen) followed by concurrent chemoradiation, in 2 separately designed and synchronously executed phase 2 trials for stage III and IVA/IVB nasopharyngeal cancer (NPC).
Patients with newly diagnosed NPC were accrued to 2 trials, 1 for patients with stage III disease and the other for patients with IVA/IVB disease. All patients received TPF (docetaxel 75 mg/m(2), cisplatin 75 mg/m(2), and 5-FU 2500 mg/m(2) every 3 weeks for 3 cycles) followed by cisplatin 40 mg/m(2) per week concurrently with either 3-dimensional conformal radiation therapy or intensity-modulated radiation therapy.
From January 2007 to July 2011, 52 eligible patients with stage III NPC and 64 eligible patients with nonmetastatic stage IV NPC were accrued. With a median follow-up of 32.9 months, the 3-year overall survival rates were 94.8% (95% confidence interval [CI], 87.6%-100%) and 90.2% (95% CI, 81.8%-98.6%) for the stage III NPC group and the IVA/IVB NPC group, respectively. The 3-year progression-free survival, distant metastasis-free survival, and local progression-free survival rates were 78.2% (95% CI, 64.6%-91.8%), 90.5% (95% CI, 79.7%-100%), and 93.9%(87.1%-100%), respectively, for patients with stage III NPC and 85.1% (95% CI, 75.1%-95.1%), 88% (95% CI, 78.6%-97.4%), and 100%, respectively, for patients with stage IVA/IVB NPC. The most common severe (grade 3/4) hematologic and nonhematologic adverse events were neutropenia (64 patients; 55.2%) and nausea/vomiting (23 patients; 19.8%).
Neoadjuvant TPF followed by concurrent chemoradiation was well tolerated and produced encouraging outcomes in patients with locally advanced NPC in this hypothesis-generating study. The authors concluded that randomized controlled trials are warranted to definitively confirm this aggressive and potentially efficacious strategy.
作者研究了新辅助化疗（包括紫杉烷、顺铂和氟尿嘧啶[5-FU]，即 TPF 方案）联合同期放化疗在 2 项分别设计和同步进行的 III 期和 IVA/IVB 期鼻咽癌（NPC）的 2 期临床试验中的疗效。
新诊断为 NPC 的患者入组 2 项试验，1 项用于 III 期疾病患者，另 1 项用于 IVA/IVB 期疾病患者。所有患者接受 TPF（多西他赛 75mg/m2、顺铂 75mg/m2 和 5-FU 2500mg/m2，每 3 周 3 个周期）治疗，随后给予每周顺铂 40mg/m2 与三维适形放疗或调强放疗同时进行。
从 2007 年 1 月至 2011 年 7 月，入组了 52 例 III 期 NPC 患者和 64 例非转移性 IVA/IVB 期 NPC 患者。中位随访 32.9 个月，III 期 NPC 组和 IVA/IVB NPC 组的 3 年总生存率分别为 94.8%（95%置信区间[CI]，87.6%-100%）和 90.2%（95% CI，81.8%-98.6%）。III 期 NPC 组的 3 年无进展生存率、远处无转移生存率和局部无进展生存率分别为 78.2%（95% CI，64.6%-91.8%）、90.5%（95% CI，79.7%-100%）和 93.9%（87.1%-100%），IVA/IVB NPC 组分别为 85.1%（95% CI，75.1%-95.1%）、88%（95% CI，78.6%-97.4%）和 100%。最常见的严重（3/4 级）血液学和非血液学不良事件为中性粒细胞减少症（64 例；55.2%）和恶心/呕吐（23 例；19.8%）。
在这项假设生成研究中，新辅助 TPF 联合同期放化疗在局部晚期 NPC 患者中耐受性良好，并取得了令人鼓舞的结果。作者得出结论，需要进行随机对照试验来明确证实这种积极且可能有效的策略。
