Pembrolizumab for the treatment of advanced salivary gland carcinoma
Journal
American Journal of Clinical Oncology: Cancer Clinical Trials
Journal Volume
41
Journal Issue
11
Pages
1083-1088
Date Issued
2018
Author(s)
Cohen R.B.
Delord J.-P.
Doi T.
Piha-Paul S.A.
Liu S.V.
Gilbert J.
Algazi A.P.
Damian S.
Le Tourneau C.
Day D.
Varga A.
Elez E.
Wallmark J.
Saraf S.
Thanigaimani P.
Cheng J.
Keam B.
Abstract
Objectives: Treatment options for patients with unresectable or metastatic salivary gland carcinoma (SGC) are limited. Safety and efficacy of pembrolizumab for SGC expressing programmed death ligand 1 (PD-L1) were explored. Materials and Methods: A cohort of patients with advanced, PD-L1-positive SGC was enrolled in the nonrandomized, multicohort, phase Ib trial of pembrolizumab in patients with PD-L1-positive advanced solid tumors (KEYNOTE-028; NCT02054806). Key inclusion criteria included recurrent or metastatic disease, failure of prior systemic therapy, and PD-L1 expression on ?1% of tumor or stroma cells (per a prototype immunohistochemistry assay). Patients received pembrolizumab 10 mg/kg every 2 weeks for ?2 years or until confirmed disease progression or unacceptable toxicity. Primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by investigator review. Results: Twenty-six patients with PD-L1-positive SGC were enrolled and treated; median age was 57 years, 88% were men, and 74% had received prior therapy for recurrent/metastatic disease. Confirmed objective response rate after median follow-up of 20 months was 12% (95% confidence interval, 2%-30%), with 3 patients achieving partial response; there were no complete responses. Median duration of response was 4 months (range, 4 to 21 mo). Treatment-related adverse events occurred in 22 patients (85%), resulting in discontinuation in 2 patients and death in 1 (interstitial lung disease); those occurring in ?15% of patients were diarrhea, decreased appetite, pruritus, and fatigue. Conclusions: Pembrolizumab demonstrated promising antitumor activity and a manageable safety profile in patients with advanced, PD-L1-positive SGC. Copyright ? 2018 The Author(s). Published by Wolters Kluwer Health, Inc.
Subjects
Anti-PD-1; Immunotherapy; Pembrolizumab; Salivary gland cancer
SDGs
Other Subjects
alanine aminotransferase; aspartate aminotransferase; bilirubin; pembrolizumab; programmed death 1 ligand 1; acne; adult; advanced cancer; aged; alanine aminotransferase blood level; anemia; arthralgia; aspartate aminotransferase blood level; asthenia; bilirubin blood level; cancer chemotherapy; cancer patient; clinical article; clinical effectiveness; cohort analysis; Conference Paper; decreased appetite; diarrhea; drug fatality; drug withdrawal; fatigue; female; follow up; hepatitis; human; hypothyroidism; interstitial lung disease; male; multicenter study; myalgia; nausea; open study; patient safety; phase 1 clinical trial; pruritus; response evaluation criteria in solid tumors; salivary gland carcinoma; side effect; treatment response time
Publisher
Lippincott Williams and Wilkins
Type
conference paper