Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.
Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.
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TPF 诱导化疗随后手术和放疗治疗局部晚期口腔鳞状细胞癌的随机 III 期试验的长期结果
DOI：
10.18632/oncotarget.4531
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发表时间：
2015-07-30
期刊：
影响因子：
--
通讯作者：
Zhang ZY
中科院分区：
文献类型：
--
作者：
Zhong LP;Zhang CP;Ren GX;Guo W;William WN Jr;Hong CS;Sun J;Zhu HG;Tu WY;Li J;Cai YL;Yin QM;Wang LZ;Wang ZH;Hu YJ;Ji T;Yang WJ;Ye WM;Li J;He Y;Wang YA;Xu LQ;Zhuang Z;Lee JJ;Myers JN;Zhang ZY
以前，我们进行了一项随机III期试验TPF（多西他赛，顺铂和5-氟尿嘧啶）诱导化疗手术治疗局部晚期口腔鳞状细胞癌（OSCC），并发现总生存率没有改善。这项研究报告了我们最初试验的长期随访结果。所有患者均为临床III期或IVA局部晚期OSCC。实验组患者接受2周期TPF诱导化疗（多西他赛75 mg/m2 d1，顺铂75 mg/m2 d1，5-氟尿嘧啶750 mg/m2/d d1 - 5），随后进行根治性手术和术后放疗;对照组患者接受根治性手术和术后放疗。主要终点是总生存期。在256例中位随访70个月的患者中，估计5年总生存率、无病生存率、局部无复发生存率和无远处转移生存率分别为61.1%、52.7%、55.2%和60.4%。实验组和对照组的存活率无显著差异。然而，与病理学反应不良的患者和对照组相比，病理学反应良好的患者结局有所改善。虽然TPF诱导化疗并没有改善III期和IVA期口腔鳞癌患者的长期生存相比，手术前期，诱导化疗后良好的病理反应可能会被用作一个主要的终点和预测在未来的研究。此外，本试验中观察到的阴性结果可能代表了效力不足研究的II型错误。未来更大规模的III期临床试验是必要的，以调查是否有显着的好处存在TPF诱导化疗手术治疗的口腔鳞癌。
Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC.