FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy

Larkins, Erin; Blumenthal, Gideon M.; Yuan, Weishi; He, Kun; Sridhara, Rajeshwari; Subramaniam, Sriram; Zhao, Hong; Liu, Chao; Yu, Jingyu; Goldberg, Kirsten B.; McKee, Amy E.; Keegan, Patricia; Pazdur, Richard

doi:10.1634/theoncologist.2016-0496

Cited by 177 publications

(123 citation statements)

References 3 publications

Supporting

Mentioning

122

Contrasting

Unclassified

Order By: Relevance

“…Therapeutic monoclonal antibodies targeting PD‐1 or PD‐L1 have demonstrated notable clinical efficacy in the treatment of various advanced cancers . Up to the end of 2017, five monoclonal antibodies targeting PD‐1 or PD‐L1 have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of various advanced cancers (Table ), including melanoma , non‐small‐cell lung cancer (NSCLC) , head and neck squamous cell cancer , classical Hodgkin lymphoma , urothelial carcinoma , hepatocellular carcinoma , Merkel cell carcinoma , renal cell carcinoma , and colorectal cancer . Immune checkpoint therapy, which was first approved as second‐line treatment and has been extended to first‐line treatment , becomes an alternative option for cancer therapy.…”

Section: Introductionmentioning

confidence: 99%

PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions

2019

View full text Add to dashboard Cite

This article summarizes the latest clinical applications of PD‐1/PD‐L1 blockade therapy in advanced non‐small cell lung cancer (NSCLC) worldwide and in China, reporting the bottlenecks related to the use of this therapy in clinic. An exploration of the underlying mechanism of PD‐1/PD‐L1 blockade therapy and biomarker identification will maximize the application of immune checkpoint inhibitors in advanced NSCLC and facilitate bedside‐to‐bench studies in cancer immunotherapy.

show abstract

Section: Introductionmentioning

confidence: 99%

PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions

2019

View full text Add to dashboard Cite

show abstract

“…Although the field is evolving with the development of immunotherapies and targeted therapies, we assert that regimens such as TPC could be considered instead of the EXTREME regimens in future development of definitive trials likely to involve combinations of immunotherapy and chemotherapy in this patient population [1], [2], [3], [4], [5], [6], [7], [8]. …”

Section: Discussionmentioning

confidence: 99%

Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

et al. 2018

View full text Add to dashboard Cite

Lessons Learned. Chemotherapy for recurrent, metastatic squamous cell carcinoma of the head and neck need not be known for extreme toxicity.The weekly regimen studied here has been demonstrated to be tolerable and effective.Background.The objective of this study was to establish the response rate, progression‐free survival (PFS) and overall survival (OS), and safety profile of weekly docetaxel, platinum, and cetuximab (TPC) in patients with relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN).Materials and Methods.Twenty‐nine patients with metastatic or recurrent SCCHN with an Eastern Cooperative Oncology Group (ECOG) performance status <3 were enrolled in an institutional review board‐approved phase II trial. This study permitted prior chemoradiation, radiation, and/or surgery, provided that 3 months had elapsed since the end of the potentially curative treatment. Patients received cisplatin 30 mg/m2 or carboplatin area under the curve (AUC) 2, docetaxel 30 mg/m2, and cetuximab 250 mg/m2 weekly for 3 weeks, followed by a break during the fourth week, for a 28‐day cycle. Planned intrapatient dose modifications were based on individual toxicity.Results.Twenty‐seven patients received TPC and were evaluable for response and toxicity. Rates of complete response (CR), partial response (PR), and confirmed PR were 3%, 52%, and 30%, respectively. The overall objective response rate was 56%. Estimated median PFS and OS were 4.8 and 14.7 months, respectively. The rates of grade 3 and 4 worst‐grade adverse events (AEs) per patient were 85% and 7%, respectively. Dose density through cycle 4 was preserved for all patients; however, treatment beyond cycle 6 with the TPC regimen proved unfeasible.Conclusion.Weekly docetaxel, cisplatin, and cetuximab is an effective regimen for patients with metastatic or recurrent SCCHN. Response rates, PFS, and OS compare favorably with other combination chemotherapy treatments. Grade 4 toxicity rates observed in this study were substantially lower than those described with regimens using less frequent, higher‐dose chemotherapy schedules.

show abstract

“…The use of such agents has resulted in prolonged disease‐free remission and overall survival in malignancies that were previously fatal (Freeman et al, ; Hanahan & Weinberg, ; Iwai et al, ). To date, PD‐1 inhibitors have been approved for the treatment of advanced and refractory cancers including melanoma, non‐small‐cell lung cancer, renal cell carcinoma, head and neck cancer, Hodgkin lymphoma, urothelial cancer, cervical cancer, and gastric cancer; their use is expected to continue to increase with additional approvals (Chen et al, ; Chung et al, ; Fashoyin‐Aje et al, ; Finkelmeier, Waidmann, & Trojan, ; Hauschild & Schadendorf, ; Hodi et al, ; Larkins et al, ; Printz, ; Suzman et al, ).…”

Section: Introductionmentioning

confidence: 99%

“…To date, PD-1 inhibitors have been approved for the treatment of advanced and refractory cancers including melanoma, non-smallcell lung cancer, renal cell carcinoma, head and neck cancer, Hodgkin lymphoma, urothelial cancer, cervical cancer, and gastric cancer; their use is expected to continue to increase with additional approvals Chung et al, 2019;Fashoyin-Aje et al, 2019;Finkelmeier, Waidmann, & Trojan, 2018;Hauschild & Schadendorf, 2016;Hodi et al, 2010;Larkins et al, 2017;Printz, 2017;Suzman et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

Oral immune‐related adverse events associated with PD‐1 inhibitor therapy: A case series

et al. 2020

View full text Add to dashboard Cite

Objective The aim of this study was to characterize clinical and histopathological features, and management outcomes of patients with oral immune‐related adverse events (irAEs) secondary to programmed cell death‐1 (PD‐1) inhibitors. Methods This was a case series of cancer patients receiving PD‐1 inhibitor therapy who were referred to oral medicine for the development of oral irAEs. Demographic, clinical, and histopathological data were collected from electronic medical records. Results There were 13 patients (7 males) with a median age of 68 years (range: 39–82) who were treated with nivolumab (n = 7) or pembrolizumab (n = 6). Oral irAEs included lichenoid lesions (n = 10), erythema multiforme (EM) (n = 2), and acute graft‐versus‐host disease reactivation (n = 1), with or without ulcerations (n = 8). Four patients (31%) presented with only oral irAEs. Oral biopsies showed lichenoid mucositis (n = 4). Management with topical and systemic steroids led to complete symptomatic response in most patients (n = 12). PD‐1 inhibitor therapy was temporarily discontinued (n = 3) and discontinued indefinitely (n = 2) due to severe oral irAEs. Conclusion Patients receiving PD‐1 inhibitors may develop oral irAEs characterized by lichenoid lesions, ulcers, or EM. Topical and systemic steroids appear to be effective in managing oral lesions although the severity of irAEs may necessitate PD‐1 inhibitor therapy dose modification.

show abstract

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy

Cited by 177 publications

References 3 publications

PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions

PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions

Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

Oral immune‐related adverse events associated with PD‐1 inhibitor therapy: A case series

Contact Info

Product

Resources

About