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Multicenter Study
. 2022 May;10(5):e004839.
doi: 10.1136/jitc-2022-004839.

Clinical activity of PD-1 inhibition in the treatment of locally advanced or metastatic basal cell carcinoma

Gino Kim In  1 , Aparna Nallagangula  2 , Jacob Seung Choi  3 , Lisa Tachiki  4 , Matthew J Blackburn  5 , Stephen Capone  6 , Kathryn B Bollin  7 , Daniel Y Reuben  8 , Keisuke Shirai  9 , Sandy Zhang-Nunes  10 , Omar Ragab  11 , Alicia Terando  12 , Jenny C Hu  13 , Han Lee  13 , Shailender Bhatia  4 , Sunandana Chandra  3 , Jose Lutzky  2 , Geoffrey Thomas Gibney  5
Affiliations
Multicenter Study

Clinical activity of PD-1 inhibition in the treatment of locally advanced or metastatic basal cell carcinoma

Gino Kim In et al. J Immunother Cancer. 2022 May.

Abstract

Background: Basal cell carcinoma (BCC) is the most common malignancy worldwide, yet the management of patients with advanced or metastatic disease is challenging, with limited treatment options. Recently, programmed death receptor 1 (PD-1) inhibition has demonstrated activity in BCC after prior Hedgehog inhibitor treatment.

Methods: We conducted a multicenter, retrospective analysis of BCC patients treated with PD-1 inhibitor therapy. We examined the efficacy and safety of PD-1 therapy, as well as clinical and pathological variables in association with outcomes. Progression-free survival (PFS), overall survival (OS) and duration of response (DOR) were calculated using Kaplan-Meier methodology. Toxicity was graded per Common Terminology Criteria for Adverse Events V.5.0.

Results: A total of 29 patients with BCC who were treated with PD-1 inhibition were included for analysis, including 20 (69.0%) with locally advanced and 9 (31.0%) with metastatic disease. The objective response rate was 31.0%, with five partial responses (17.2%), and four complete responses (13.8%). Nine patients had stable disease (31.0%), with a disease control rate of 62.1%. The median DOR was not reached. Median PFS was 12.2 months (95% CI 0.0 to 27.4). Median OS was 32.4 months (95% CI 18.1 to 46.7). Two patients (6.9%) developed grade 3 or higher toxicity, while four patients (13.8%) discontinued PD-1 inhibition because of toxicity. Higher platelets (p=0.022) and any grade toxicity (p=0.024) were significantly associated with disease control rate.

Conclusions: The clinical efficacy of PD-1 inhibition among patients with advanced or metastatic BCC in this real-world cohort were comparable to published trial data. Further investigation of PD-1 inhibition is needed to define its optimal role for patients with this disease.

Keywords: immunotherapy; programmed cell death 1 receptor; skin neoplasms.

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Conflict of interest statement

Competing interests: GKI reports having consulting/advisory board roles with Boehringer-Ingelheim, Novartis, BMS, Castle Biosciences, Regeneron, Sanofi; receiving research support from Regeneron, Array, Idera, Roche/Genentech, Replimune, Xencor, InstilBio, and having speaker roles for Merck. DYR reports having consulting/advisory board roles with Castle Biosciences. JCH reports having consulting/advisory board roles with Regeneron. All other authors have nothing to disclose.

Figures

Figure 1
Figure 1
CONSORT diagram of basal cell carcinoma patients included in analysis. CONSORT, Consolidated Standards of Reporting Trials.
Figure 2
Figure 2
Swimmer’s plot of BCC patients treated with PD-1 inhibition. BCC, basal cell carcinoma.
Figure 3
Figure 3
(A) Progression-free survival of BCC patients treated with PD-1 inhibition. (B) Overall survival of BCC patients treated with PD-1 inhibition. BCC, basal cell carcinoma.
See this image and copyright information in PMC

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