Salvage Chemotherapy After Nivolumab for Recurrent or Metastatic Head and Neck Carcinoma

Fushimi, Chihiro; Okamoto, Isaku; Matsuki, Takashi; Masubuchi, Tatsuo; Okada, Takenori; Sato, Hiroki; Tsukahara, Kiyoaki; Kondo, Takahito; Yamashita, Taku; Hanyu, Kenji; Omura, Go; Takahashi, Hideaki; Tada, Yuichiro; Miura, Kouki

doi:10.21873/anticanres.14532

Cited by 25 publications

(21 citation statements)

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“…Several recent studies have demonstrated the efficacy of subsequent chemotherapy following immunotherapy in patients with HNC [6][7][8][9]. A previous study reported a significantly longer OS (7.8 months, P = 0.0028, n = 25) in Japanese R/M SCCHN patients who received salvage chemotherapy following nivolumab treatment than that in patients who received best supportive care (3.5 months, n = 31) [7]. In the current study, paclitaxel ± cetuximab was the most frequently administered (n = 52) subsequent chemotherapy in patients who received chemotherapy following nivolumab.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, several studies have demonstrated the efficacy of subsequent chemotherapy in HNC following immunotherapy [6][7][8][9]. Saleh et al reported an objective response rate (ORR) of 30% in patients who received chemotherapy after disease progression on immunotherapy, which was three to five times higher than that in those who had received chemotherapy as a second-line treatment in clinical trials [6].…”

Section: Introductionmentioning

confidence: 99%

“…Saleh et al reported an objective response rate (ORR) of 30% in patients who received chemotherapy after disease progression on immunotherapy, which was three to five times higher than that in those who had received chemotherapy as a second-line treatment in clinical trials [6]. Similar studies in Japan have demonstrated the efficacy of subsequent chemotherapy following immunotherapy in patients with HNC; however, these studies included only a small number of Japanese patients [7][8][9]. Furthermore, in patients with R/M HNC in whom disease progresses following first-line therapy, treatment options remain heterogeneous, and treatment patterns and outcomes show substantial variations across countries [10].…”

Section: Introductionmentioning

confidence: 99%

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Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

et al. 2021

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Background We have previously reported the effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) in real-world clinical practice in Japan. Here, we report long-term outcomes from this study in the overall population and subgroups stratified by subsequent chemotherapy. Methods In this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R/M) HNC receiving nivolumab were followed up for 2 years. Effectiveness endpoints included overall survival (OS), OS rate, progression-free survival (PFS), and PFS rate. Safety endpoints included the incidence of immune-related adverse events (irAEs). Results Overall, 256 patients received a median of 6.0 doses (range: 1–52) of nivolumab over a median duration of 72.5 days (range: 1–736). Median OS was 9.5 months [95% confidence interval (CI) 8.2–12.0] and median PFS was 2.1 months (95% CI 1.8–2.7). A significant difference between 2-year survivors (n = 62) and non-2-year survivors was observed by median age (P = 0.0227) and ECOG PS (P = 0.0001). Of 95 patients who received subsequent chemotherapy, 54.7% received paclitaxel ± cetuximab. The median OS and PFS from the start of paclitaxel ± cetuximab were 6.9 months (95% CI 5.9–11.9) and 3.5 months (95% CI 2.3–5.5), respectively. IrAEs were reported in 17.2% of patients. Endocrine (7.0%) and lung (4.3%) disorders were the most common irAEs; kidney disorder (n = 1) was newly identified in this follow-up analysis. Conclusions Results demonstrated the long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

et al. 2021

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“…Nivolumab was approved for recurrent or metastatic head and neck cancer (R/M HNC) after platinum drug administration in Japan in March 2017. Further evidence of efficacy has since been obtained [2][3][4][5][6][7][8][9][10].…”

Section: Introductionmentioning

confidence: 98%

Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients

Matsuki

Okamoto

Fushimi

et al. 2020

Cancers

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No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy and investigated prognostic factors associated with survival. Further, we evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Median progression-free survival (PFS) was 3.7 months, and two-year PFS rate was 19.6%. BOR was assessed as complete response (CR) in 6%, partial response (PR) in 13%, stable disease (SD) in 30%, and progressive disease (PD) in 52% of the patients. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. On multivariate analysis, the development of irAEs was significantly associated with better OS and PFS. Better BOR was significantly associated with longer OS and PFS. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.

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“…In many cases, salvage chemotherapy with cytotoxic anticancer agents and molecular targeted drugs is administered, even in PD status patients who received nivolumab treatment. Fushimi et al 10 reported that salvage chemotherapy led to a significantly longer OS compared to best supportive care, even for R/M HNC. Regular medical interviews, blood tests, and diagnostic imaging are important to screen for irAEs, even if salvage chemotherapy is performed after discontinuing treatment.…”

Section: Discussionmentioning

confidence: 99%

Laryngeal Cancer With Lung Metastases Showing Long-Term Complete Response and Delayed Immune-Related Adverse Event After Nivolumab Discontinuation

et al. 2021

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We report a case of laryngeal cancer with multiple lung metastases that maintained a complete response (CR) for 18 months after discontinuing nivolumab treatment, with colitis developing 5 months after drug discontinuation. A 65-year-old man was diagnosed with T3N2cM0 stage IVA right supraglottic squamous cell carcinoma that progressed after 1 course of TPF (cisplatin, docetaxel, and 5-fluorouracil) as induction chemotherapy. He underwent total laryngectomy, bilateral neck dissection, pharyngeal reconstruction with anterolateral thigh flap, and creation of a permanent tracheostoma; extranodal extension was detected in the right cervical lymph node metastasis, and the patient underwent adjuvant radiotherapy. Multiple lung metastases occurred during radiotherapy, and the patient was deemed platinum refractory; nivolumab treatment was thus initiated. The tumor proportion score for programmed death-ligand 1—evaluated via antibody testing of the laryngeal tumor—was <1. The patient received 240 mg/body nivolumab every 2 weeks; a computed tomography performed after course 16 of nivolumab treatment confirmed a CR. He exhibited grade 2 thyroid dysfunction, grade 1 interstitial pneumonia, and grade 2 colitis after 6, 7, and 14 months of receiving nivolumab, respectively; treatment was discontinued as despite maintaining a CR, interstitial pneumonia occurred twice. Colitis appeared 5 months after nivolumab discontinuation; nevertheless, a CR was maintained after 18 months.

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Salvage Chemotherapy After Nivolumab for Recurrent or Metastatic Head and Neck Carcinoma

Cited by 25 publications

References 9 publications

Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients

Laryngeal Cancer With Lung Metastases Showing Long-Term Complete Response and Delayed Immune-Related Adverse Event After Nivolumab Discontinuation

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