Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study

Published on May 1, 2021in International Journal of Clinical Oncology3.402
· DOI :10.1007/S10147-020-01829-0
Nobuhiro Hanai17
Estimated H-index: 17
Yasushi Shimizu13
Estimated H-index: 13
(Hokkaido University)
+ 23 AuthorsAkihiro Homma26
Estimated H-index: 26
(Hokkaido University)
To fill the data gap between clinical trials and real-world settings, this study assessed the overall effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) during Japanese real-world clinical practice. This was a multicenter, retrospective study in Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017. Data on the clinical use, effectiveness, and safety of nivolumab were extracted from patient medical records. Overall, 256 patients were enrolled in this study. The median duration of nivolumab treatment was 72.5 days, with patients receiving a median of 6.0 (range 1–27) doses. Median overall survival (OS) was 9.5 (95% confidence interval [CI] 8.2–12.0) months and the estimated 12-month OS rate was 43.2%. The objective response rate (ORR) was 15.7% overall and 21.1%, 7.1%, and 13.6% in patients with primary nasopharynx, maxillary sinus, and salivary gland tumors, respectively, who had been excluded from CheckMate 141. Grade ≥ 3 immune-related adverse events occurred in 5.9% of patients. No new safety signals were identified compared with adverse events noted in CheckMate 141. The effectiveness and safety of nivolumab in real-world clinical practice are consistent with data from the CheckMate 141 clinical trial. Therapeutic response was also observed in the groups of patients excluded from CheckMate 141. UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436)
#1Cristina P. Rodriguez (UW: University of Washington)H-Index: 14
#2Qian Vicky Wu (Fred Hutchinson Cancer Research Center)H-Index: 5
Last. Renato G. Martins (UW: University of Washington)H-Index: 40
view all 13 authors...
Background: This clinical trial combined pembrolizumab and vorinostat in recurrent/metastatic squamous cell carcinomas of the head and neck(HN), and salivary gland cancer(SGC). Methods:Patients with progressing incurable HN and SGC ECOG ≤1, no prior immunotherapy, RECIST1.1 measurable disease, normal organ function were eligible. Pembrolizumab 200mg was given IV q21 days, and vorinostat 400 mg given orally 5 days on and 2 days off at the start of each 21 day cycle. Primary endpoints were safety ...
#1Takahiro Wakasaki (Kyushu University)H-Index: 13
#2Ryuji Yasumatsu (Kyushu University)H-Index: 16
Last. Takashi Nakagawa (Kyushu University)H-Index: 17
view all 7 authors...
Abstract Objective Although nivolumab treatment is effective in extending the overall survival (OS) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), only a few patients benefit from this treatment. Recent studies have reported that chemotherapy and cetuximab might be effective for R/M HNSCC after nivolumab treatment. In the present study, we aimed to elucidate the effectiveness of chemotherapy after nivolumab treatment in patients with R/M HNSCC. Me...
#1Ryo MoritaH-Index: 4
#2Kyoichi OkishioH-Index: 16
Last. Yuichiro OheH-Index: 75
view all 26 authors...
Abstract Objectives To describe the treatment patterns and determine the effectiveness and safety of nivolumab treatment for non-small cell lung cancer (NSCLC) in real-world setting in Japan Materials and Methods Japanese patients with NSCLC who received nivolumab were analyzed retrospectively. Patients who had started nivolumab treatment between April 2016 and December 2016 were enrolled. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to p...
#2K.J. Harrington (The Royal Marsden NHS Foundation Trust)H-Index: 2
Summary Background Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. Methods KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizum...
#1Khalil Saleh (Institut Gustave Roussy)H-Index: 4
#2Amaury DasteH-Index: 11
Last. Caroline EvenH-Index: 21
view all 12 authors...
Abstract Background Immune checkpoint inhibitors (ICI) are active in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Recent data suggest that exposure to ICI improves response to salvage chemotherapy (SCT) in advanced non–small-cell lung cancer. We evaluated response to chemotherapy in patients who had progressed on ICI in patients with R/M SCCHN. Patients and methods A retrospective study was conducted at 4 French centres. Eligibility criteria were p...
#1Charbél Talani (Linköping University)H-Index: 1
#2Antti MäkitieH-Index: 48
Last. Lovisa Farnebo (Linköping University)H-Index: 14
view all 6 authors...
Background Cancers of the head and neck have a high mortality rate, and roughly 10% of the patients die within six months of diagnosis. To our knowledge little has been written about this group. We wished to identify risk factors for early death, to predict and monitor patients at risk better and, if possible, avoid unjustified major treatment.
#1Scott J. AntoniaH-Index: 82
#2Hossein Borghaei (Fox Chase Cancer Center)H-Index: 51
Last. Julie R. Brahmer (Johns Hopkins University)H-Index: 92
view all 20 authors...
Summary Background Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival. Methods We pooled data from four clinical studies of nivolumab in patients with previously treated ...
#1Ryusuke Hori (Tenri Hospital)H-Index: 4
#2Shogo ShinoharaH-Index: 16
Last. Koichi OmoriH-Index: 29
view all 15 authors...
Recently, a global phase III study demonstrated that nivolumab markedly improved patient outcomes in recurrent or metastatic head and neck carcinoma (RMHNC). However, the efficacy of nivolumab in patients who are ineligible for clinical trials is unknown. We investigated nivolumab efficacy in real-world patients and prognostic factors associated with the response to nivolumab. This study was conducted at 11 institutes associated with Kyoto University and its Affiliated Hospitals-Head and Neck On...
#1Isaku Okamoto (TMU: Tokyo Medical University)H-Index: 8
#2Hiroki Sato (TMU: Tokyo Medical University)H-Index: 22
Last. Kiyoaki Tsukahara (TMU: Tokyo Medical University)H-Index: 16
view all 11 authors...
AbstractBackground: No large-scale retrospective studies have examined the efficacy and safety of nivolumab.Objective: This retrospective study aimed to investigate the efficacy and safety of nivol...
#1Yuxiang Ma (SYSU: Sun Yat-sen University)H-Index: 22
#2Wenfeng Fang (SYSU: Sun Yat-sen University)H-Index: 32
Last. Li Zhang (SYSU: Sun Yat-sen University)H-Index: 76
view all 12 authors...
LESSONS LEARNED: Nivolumab treatment at doses of 3 mg/kg once every 2 weeks (Q2W), 240 mg Q2W, and 360 mg once every 3 weeks was well tolerated in the Chinese population, with no new safety signals identified.Comparison of intensive pharmacokinetic profiles of nivolumab at 3 mg/kg Q2W in Chinese versus global populations revealed no ethnic differences of nivolumab treatment.Nivolumab shows promising preliminary antitumor activity in nasopharyngeal carcinoma. BACKGROUND: This phase I/II study inv...
Cited By6
#1Ryuji Yasumatsu (Kyushu University)H-Index: 16
#2Yasushi Shimizu (Hokkaido University)H-Index: 13
Last. Akihiro Homma (Hokkaido University)H-Index: 26
view all 26 authors...
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. 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 (...
Although several prognostic factors in nivolumab therapy have been reported in recurrent or metastatic head and neck cancer (RM-HNC) patients, these factors remain controversial. Here, we conducted a multicenter retrospective cohort study to investigate the impact of clinico-hematological factors on survival in RM-HNC patients treated with nivolumab. We reviewed 126 RM-HNC patients from seven institutes. We evaluated the prognostic effects of clinico-hematological factors on survival. The median...
#1Takahiro Hongo (Kyushu University)H-Index: 5
#2Hidetaka Yamamoto (Kyushu University)H-Index: 44
Last. Akihiro TamaeH-Index: 6
view all 15 authors...
The antitumor efficacies of immune checkpoint inhibitors (ICIs) and the usefulness of potential predictive markers such as programmed death-ligand 1 (PD-L1) expression, density of tumor-infiltrating lymphocytes (TILs) and microsatellite instability (MSI) in sinonasal squamous cell carcinoma (SNSCC) have not been fully elucidated. We retrospectively analyzed 131 SNSCCs with immunohistochemistry for PD-L1 expression, TIL subpopulations and loss of mismatch repair (MMR) proteins as a surrogate for ...
Distant metastasis is a poor prognostic factor in recurrent/metastatic squamous cell carcinoma of the head and neck. However, limited information on the prognostic impact of locoregional disease is available, despite its life-threatening features. We investigated the prognostic impact of incurable locoregional disease and distant metastasis in recurrent/metastatic squamous cell carcinoma of the head and neck. We retrospectively analyzed 156 patients with recurrent/metastatic squamous cell carcin...
#1Makoto TaharaH-Index: 50
#2Naomi Kiyota (Kobe University)H-Index: 30
Last. Ryuichi HayashiH-Index: 27
view all 6 authors...
Background null On the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting. null Methods null All patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 m...
#1Yukio Yoshioka (Hiroshima University)H-Index: 12
#2Tomoaki Hamana (Hiroshima University)H-Index: 6
Last. Tetsuji Okamoto (University of East Asia)H-Index: 23
view all 6 authors...
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