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Background <p>Nivolumab is the standard treatment for platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Several studies have reported the efficacy of paclitaxel plus cetuximab (PC) combination therapy in this patient population.</p> Methods <p>We conducted a retrospective analysis of patients with platinum-refractory R/M-HNSCC treated with nivolumab or PC at our institution between January 2015 and March 2022. Eligibility criteria included histologically confirmed HNSCC, ECOG performance status (PS) 0–2, with platinum-refractory R/M disease, defined as recurrence or disease progression within 6&#xa0;months after platinum-based definitive chemoradiotherapy.</p> Results <p>The baseline characteristics of the 56 patients (21 PC/35 nivolumab) were ECOG PS 1–2 (76/54%), metastatic sites ≥ 2 (33/46%), local recurrence (62/23%), and median tumor size (43.2/26.2&#xa0;mm). Median progression-free survival (mPFS) tended to favor PC over nivolumab (4.3/2.7&#xa0;months, hazard ratio [HR]: 0.7, p = 0.41), and median overall survival tended to be inferior for PC (8.0/23.2&#xa0;months, HR: 1.58, p = 0.20). Similar results were obtained after adjusting for several relevant factors. The objective response rate was numerically higher with PC (31/19%). Grade 3/4 adverse events were more frequent with PC (29/6%), and the most prevalent were leukopenia (19%) for PC and liver dysfunction (6%) for nivolumab. Subsequent treatment with PC and nivolumab was administered to 75% and 72% of patients, respectively; the mPFS of these patients was significantly lower with PC (1.6/9.2&#xa0;months, HR: 9.9, p &lt; 0.001).</p> Conclusion <p>Both PC and nivolumab are viable treatment options for platinum-refractory R/M-HNSCC, though their efficacy and safety profiles should be carefully considered.</p>

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Paclitaxel plus cetuximab versus nivolumab for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma: a retrospective analysis

  • 期刊论文

  • 发表日期：

    2025年1月14日

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  • Hiroyuki Kodama,
  • Shigenori Kadowaki,
  • Yasunobu Ishizuka,
  • Munehiro Wakabayashi,
  • Tomoki Sakakida,
  • Kazunori Honda,
  • Toshiki Masuishi,
  • Yukiya Narita,
  • Hiroya Taniguchi,
  • Masashi Ando,
  • Toshihiro Kishikawa,
  • Hoshino Terada,
  • Shintaro Beppu,
  • Daisuke Nishikawa,
  • Hidenori Suzuki,
  • Nobuhiro Hanai,
  • Kei Muro

摘要

Background

Nivolumab is the standard treatment for platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Several studies have reported the efficacy of paclitaxel plus cetuximab (PC) combination therapy in this patient population.

Methods

We conducted a retrospective analysis of patients with platinum-refractory R/M-HNSCC treated with nivolumab or PC at our institution between January 2015 and March 2022. Eligibility criteria included histologically confirmed HNSCC, ECOG performance status (PS) 0–2, with platinum-refractory R/M disease, defined as recurrence or disease progression within 6 months after platinum-based definitive chemoradiotherapy.

Results

The baseline characteristics of the 56 patients (21 PC/35 nivolumab) were ECOG PS 1–2 (76/54%), metastatic sites ≥ 2 (33/46%), local recurrence (62/23%), and median tumor size (43.2/26.2 mm). Median progression-free survival (mPFS) tended to favor PC over nivolumab (4.3/2.7 months, hazard ratio [HR]: 0.7, p = 0.41), and median overall survival tended to be inferior for PC (8.0/23.2 months, HR: 1.58, p = 0.20). Similar results were obtained after adjusting for several relevant factors. The objective response rate was numerically higher with PC (31/19%). Grade 3/4 adverse events were more frequent with PC (29/6%), and the most prevalent were leukopenia (19%) for PC and liver dysfunction (6%) for nivolumab. Subsequent treatment with PC and nivolumab was administered to 75% and 72% of patients, respectively; the mPFS of these patients was significantly lower with PC (1.6/9.2 months, HR: 9.9, p < 0.001).

Conclusion

Both PC and nivolumab are viable treatment options for platinum-refractory R/M-HNSCC, though their efficacy and safety profiles should be carefully considered.