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诱导化疗、手术和风险适应辅助治疗结合舌保护治疗口腔舌鳞癌的Ⅱ期临床试验

Tongue conservation treatment for oral tongue squamous cell carcinoma with induction chemotherapy, surgery, and risk-adapted adjuvant therapy: A phase II trial.

机构信息

Department of Otolaryngology, National Yang Ming Chiao Tung University, Taipei, Taiwan.

Department of Otolaryngology, Taipei Veterans General Hospital, Taipei, Taiwan.

出版信息

Cancer Rep (Hoboken). 2022 Feb;5(2):e1456. doi: 10.1002/cnr2.1456. Epub 2021 May 29.

Abstract

BACKGROUND

To assess the feasibility of tongue conservation treatment with induction chemotherapy (ICT), tongue conservation surgery, and risk-adapted postoperative adjuvant therapy in oral tongue squamous cell carcinoma (OTSCC).

METHODS

Patients with newly diagnosed OTSCC cT2-4 N0-2 M0 were recruited. The ICT with a regimen of docetaxel, cisplatin, and oral tegafur/uracil (DCU) was administrated every 21 days. After the first cycle of ICT (DCU1), patients with a more than 30% decrease in the longest diameter of primary tumor underwent a second cycle of ICT (DCU2). Tongue conservation surgery was performed after ICT, and risk-adapted adjuvant therapy was organized based on pathological features.

RESULTS

From July 2011 to December 2015, a total of 23 patients were enrolled, 87% of whom were classified as stage III-IV. Clinical responders to DCU1 and DCU2 were determined in 90.5% (19/21) and 88.2% (15/17) of patients. Tongue conservation surgery was performed in 16 responders to ICT. Only one patient had a positive margin (6.3%), and a complete pathologic response was achieved in eight patients (50%). Only one patient developed local recurrence after a median follow-up of 58.6 months (range, 7.9-105.2). The 5-year overall survival (0% vs. 87.5%, P = 0.001) and disease-specific survival (0% vs. 93.3%, P = 0.000) were significantly different between the DCU1 nonresponders and responders.

CONCLUSION

Tongue conservation treatment with ICT, followed by conservation surgery and risk-adapted adjuvant therapy, is feasible for patients with OTSCC who are good responders to ICT. However, the outcomes of nonresponders are dismal. Further study in a larger patient population is warranted.

摘要

背景

评估诱导化疗(ICT)、舌保留手术和风险适应术后辅助治疗在口腔舌鳞状细胞癌(OTSCC)中的可行性。

方法

招募新诊断为 OTSCC cT2-4 N0-2 M0 的患者。每 21 天给予多西紫杉醇、顺铂和口服替加氟/尿嘧啶(DCU)方案的 ICT。在第一周期 ICT(DCU1)后,最长肿瘤直径减少超过 30%的患者接受第二周期 ICT(DCU2)。ICT 后进行舌保留手术,并根据病理特征组织风险适应辅助治疗。

结果

2011 年 7 月至 2015 年 12 月,共纳入 23 例患者,其中 87%为 III-IV 期。90.5%(19/21)和 88.2%(15/17)的患者对 DCU1 和 DCU2 有临床反应。16 例 ICT 反应者行舌保留手术。只有 1 例患者边缘阳性(6.3%),8 例患者(50%)完全病理缓解。在中位随访 58.6 个月(范围 7.9-105.2)后,只有 1 例患者局部复发。5 年总生存率(0% vs. 87.5%,P=0.001)和疾病特异性生存率(0% vs. 93.3%,P=0.000)在 DCU1 无反应者和反应者之间有显著差异。

结论

对于对 ICT 反应良好的 OTSCC 患者,采用 ICT 联合舌保留手术和风险适应术后辅助治疗是可行的。然而,无反应者的结局不佳。需要在更大的患者人群中进行进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7506/8842695/7a3783633c09/CNR2-5-e1456-g002.jpg

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