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Background <p>To evaluate the efficacy and safety of nimotuzumab combined with docetaxel and cisplatin (TPN) as the first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).</p> Methods <p>In this multicenter, open-label, phase 2 trial (ClinicalTrials.gov identifier: NCT03708822), patients with RM-NPC received intravenous nimotuzumab (200&#xa0;mg on days 1, 8, and 15), docetaxel (75&#xa0;mg/m<sup>2</sup> on day 1), and cisplatin (75&#xa0;mg/m<sup>2</sup> on day 1) every 3&#xa0;weeks for 6 cycles. The primary endpoint was the objective response rate (ORR), and the secondary endpoints included the disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and safety.</p> Results <p>Between October 15, 2018, and July 20, 2022, 52 patients were enrolled. The ORR and DCR in the intention-to-treat population were 65.4% and 90.4%, respectively. With a median follow-up of 38.1&#xa0;months, the median PFS and OS were 7.4 and 40.4&#xa0;months, respectively. The majority of adverse events were grades 1–2. Grade 3/4 adverse events were neutropenia (42.3%), leukopenia (32.7%), febrile neutropenia (11.5%), nausea (7.7%), fatigue (5.8%), infection (5.8%), thrombocytopenia (1.9%), and anorexia (1.9%). There was no treatment-related death. Low baseline plasma Epstein-Barr virus (EBV) DNA level and the clearance of plasma EBV DNA after 2 cycles of treatment were associated with longer PFS. Additionally, patients who received ≥ 2400&#xa0;mg of nimotuzumab and ≥ 4 cycles of docetaxel plus cisplatin had superior ORR and survival.</p> Conclusions <p>First-line therapy with the TPN regimen showed promising efficacy with a well-tolerated safety profile in RM-NPC patients.</p> Trial registration <p>ClinicalTrials.gov: NCT03708822.</p>

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Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial

  • 期刊论文

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  • 发表日期：

    2025年5月6日

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  • Qihua Zou,
  • Yi Cao,
  • Yulin Lai,
  • Yu Fang,
  • Yuchen Zhang,
  • Panpan Liu,
  • Lixia Lu,
  • Hao Wu,
  • Tianying Huang,
  • Ning Su,
  • Zhihua Li,
  • Xicheng Wang,
  • Xiaopeng Tian,
  • Lirong Li,
  • Yingxian Liu,
  • Qingqing Cai,
  • Yi Xia

摘要

Background

To evaluate the efficacy and safety of nimotuzumab combined with docetaxel and cisplatin (TPN) as the first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

Methods

In this multicenter, open-label, phase 2 trial (ClinicalTrials.gov identifier: NCT03708822), patients with RM-NPC received intravenous nimotuzumab (200 mg on days 1, 8, and 15), docetaxel (75 mg/m2 on day 1), and cisplatin (75 mg/m2 on day 1) every 3 weeks for 6 cycles. The primary endpoint was the objective response rate (ORR), and the secondary endpoints included the disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and safety.

Results

Between October 15, 2018, and July 20, 2022, 52 patients were enrolled. The ORR and DCR in the intention-to-treat population were 65.4% and 90.4%, respectively. With a median follow-up of 38.1 months, the median PFS and OS were 7.4 and 40.4 months, respectively. The majority of adverse events were grades 1–2. Grade 3/4 adverse events were neutropenia (42.3%), leukopenia (32.7%), febrile neutropenia (11.5%), nausea (7.7%), fatigue (5.8%), infection (5.8%), thrombocytopenia (1.9%), and anorexia (1.9%). There was no treatment-related death. Low baseline plasma Epstein-Barr virus (EBV) DNA level and the clearance of plasma EBV DNA after 2 cycles of treatment were associated with longer PFS. Additionally, patients who received ≥ 2400 mg of nimotuzumab and ≥ 4 cycles of docetaxel plus cisplatin had superior ORR and survival.

Conclusions

First-line therapy with the TPN regimen showed promising efficacy with a well-tolerated safety profile in RM-NPC patients.

Trial registration

ClinicalTrials.gov: NCT03708822.