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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

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Abstract

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).

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Data availability

The datasets generated and/or analysed during the current study are available in https://figshare.com/, https://doi.org/10.6084/m9.figshare.19122641

Abbreviations

LBP:

Lobaplatin

CRT:

Chemoradiotherapy

HNSCC:

Head and neck squamous cell carcinoma

ORR:

Objective response rate

OS:

Overall survival

PFS:

Progression-free survival

IMRT:

Intensity-modulated radiotherapy

PTV:

Planned target volume

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Funding

This study was also supported by the Major Research Project of Innovation Groups of Guizhou Education Department (Qian Jiao He KY [2017]038), and the Basic Science and Technology Research Program of Guizhou Province (Qian Ke He Ji [2017] 1148).

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Author notes

  1. Mang Zhang and Yu Chen contributed equally to this article.

Authors and Affiliations

  1. Department of Head and Neck Oncology, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China

    Mang Zhang, Yu Chen, Weili Wu, Feng Jin, Yuanyuan Li, Jinhua Long, Xiuling Luo, Xiuyun Gong, Xiaoxiao Chen, Lina Liu & Hong Tang

  2. Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guiyang, China

    Yu Chen, Weili Wu, Feng Jin, Yuanyuan Li, Jinhua Long, Lina Liu & Hong Tang

  3. Guizhou University Hospital, Guiyang, China

    Mang Zhang

  4. Guizhou Medical University, Guiyang, China

    Ziqi Wang

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  1. Mang Zhang
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Contributions

FJ and WW participated in the design and supervision of the study. YL, JL, XL, XG, XC, LL, HT and YC were responsible for the clinical work in the study, MZ, ZW were responsible for data sorting and analysis, and were the major contributors in writing the manuscript. WW was responsible for the review and revision of the first draft. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Weili Wu.

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Conflict of interest

The authors declare that they have no competing interests.

Ethical approval and consent to participate

The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study has been performed in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee, the approval number is 2017-01, and all patients signed informed consent.

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Zhang, M., Chen, Y., Wu, W. et al. 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. J Cancer Res Clin Oncol 149, 18081–18091 (2023). https://doi.org/10.1007/s00432-023-05497-1

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