A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma,Journal of Cancer Research and Clinical Oncology

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A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma
Journal of Cancer Research and Clinical Oncology ( IF 2.7 ) Pub Date : 2023-11-20 , DOI: 10.1007/s00432-023-05497-1
Mang Zhang _{1,

2} , Yu Chen _{1,

3} , Weili Wu _{1,

3} , Feng Jin _{1,

3} , Yuanyuan Li _{1,

3} , Jinhua Long _{1,

3} , Xiuling Luo ₁ , Xiuyun Gong ₁ , Xiaoxiao Chen ₁ , Lina Liu _{1,

3} , Hong Tang _{1,

3} , Ziqi Wang ₄

Affiliation

Purpose

To compare the toxicity and clinical efficacy of TL (docetaxel + lobaplatin) induction chemotherapy combined with lobaplatin concurrent chemoradiotherapy and TPF (docetaxel + cisplatin + 5-fluorouracil) induction chemotherapy combined with cisplatin concurrent chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Methods and patients

In total, 128 patients with locally advanced head and neck cancer were prospectively enrolled between August 2016 and April 2021. They were randomly divided into trial group and control group, all using chronological dosage mode. The trial group used TL regimen induction chemotherapy combined with lobaplatin concurrent chemoradiotherapy; the control group used TPF regimen induction chemotherapy and cisplatin concurrent chemotherapy. The endpoints were adverse events and survival rates at 1, 3 and 5 years.

Results

Median follow-up was 42 months (20–71 months). (1) Adverse events: During induction chemotherapy, compared with TPF group, grade 3–4 leukocytes and neutrophils, diarrhea, 1–2 hyperbilirubinemia, nausea / vomiting, oral mucositis, fatigue, anorexia, hyponatremia were significantly lower in TL group (p<0. 05): 6% vs. 35%, 14% vs. 53%, 0% vs. 6%, 15% vs. 40%, 9% vs. 56%, 0% vs. 10%, 3% vs. 13%, 2% vs. 23%, 15% vs. 74%. During chemoradiotherapy, the incidence of hyponatremia, hypokalaemia and grade 1–2 nausea was significantly lower in the TL group (p<0. 05), with 24% vs. 69%, 20% vs. 65% and 24% vs. 44%, respectively. However, more grade 3–4 thrombocytopenia were observed in the TL group (15% vs. 3%, p<0. 05). (2) There was no significant difference in the recent objective response rate (ORR) between patients with TL group and TPF group (p=0.961). (3) There was no statistical difference in 1, 3 and 5 years OS between TL group and TPF group, respectively, (71.0% vs. 67.5%, p=0.573), (56.6% vs. 56.9%, p=0.814), (52.5% vs. 52.9%, p=0.841); 1, 3 and 5 years PFS are: (63.4% vs. 64.0%, p=0.883), (51.1% vs. 54.0%, p=0.705) and (47.3% vs. 45.9%, p=0.887), None of them were significantly different. Multivariate analysis of COX regression showed that T stage (p=0.01) and surgery (p=0.046) were independent factors affecting PFS and OS, respectively. OS subgroup analysis shows that people receiving the TL regimen in postoperative and nodal stage N1 and N2 patients tended to survive longer than those receiving the TPF regimen.

Conclusion

Patients with postoperative, N1 or N2 stage locally advanced head and neck squamous cell carcinoma (HNSCC) may have more significant clinical benefits when treated with TL regimen. TL regimen has advantages in reducing toxic side effects and can be used as one of the first-line treatment options.

Trial registration

ClinicalTrials.gov (No. NCT03117257).

中文翻译：

多西紫杉醇联合洛铂与TPF方案诱导化疗同步放化疗治疗局部晚期头颈鳞癌的前瞻性II期随机研究

目的

比较TL（多西他赛+洛铂）诱导化疗联合洛铂同步放化疗与TPF（多西他赛+顺铂+5-氟尿嘧啶）诱导化疗联合顺铂同步放化疗治疗局部晚期头颈部鳞状细胞癌的毒性及临床疗效癌。

方法和患者

2016年8月至2021年4月期间，前瞻性入组了128名局部晚期头颈癌患者。他们被随机分为试验组和对照组，均采用时间顺序给药模式。试验组采用TL方案诱导化疗联合洛铂同步放化疗；对照组采用TPF方案诱导化疗和顺铂同步化疗。终点是不良事件以及 1 年、3 年和 5 年的生存率。

结果

中位随访时间为 42 个月（20-71 个月）。 (1)不良事件：诱导化疗期间，与TPF组相比，TL组3~4级白细胞和中性粒细胞、腹泻、1~2级高胆红素血症、恶心/呕吐、口腔粘膜炎、乏力、厌食、低钠血症明显降低( p <0 id=83>p <0 id=84>p <0 id=85>p =0.961）。 (3) TL组与TPF组1、3、5年OS分别无统计学差异(71.0% vs. 67.5%, p =0.573)、(56.6% vs. 56.9%, p =0.814) ，（52.5% 与 52.9%， p =0.841）； 1、3 和 5 年 PFS 分别为：（63.4% vs. 64.0%， p =0.883）、（51.1% vs. 54.0%， p =0.705）和（47.3% vs. 45.9%， p =0.887），无他们有显着的不同。 COX 回归的多变量分析显示，T 分期 ( p = 0.01) 和手术 ( p = 0.046) 分别是影响 PFS 和 OS 的独立因素。 OS 亚组分析显示，术后和淋巴结期 N1 和 N2 患者接受 TL 方案的患者往往比接受 TPF 方案的患者存活时间更长。