Efficacy and Biomarker Exploration of Sintilimab Combined With Chemotherapy in the Treatment of Advanced Penile Squamous Cell Carcinoma—A Report of Two Cases

Mei, Xinkuan; Zhao, Yongjun; Zhang, Yiruo; Liao, Jinhua; Jiang, Chen; Qian, Hesheng; Du, Yingying

doi:10.3389/fonc.2022.823459

Cited by 4 publications

(3 citation statements)

References 14 publications

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“…Hu et al [16]reported a 49-year-old recurrent penile SCC patient with medium PD-L1 expression and low TMB obtained complete response after multimodal therapy, including resection of palliative right inguinal metastases, four cycles of paclitaxel+bleo-mycin+cisplatin and continuous sintilimab. However, it was also recently reported that immunotherapy combined with chemotherapy had good therapeutic effect in advanced penile SCC patients [17,18]. Our patient presented with high PD-L1 expression levels and TMB, microsatellite stable.…”

Section: Discussionsupporting

confidence: 55%

Sintilimab-Induced Diabetic Ketoacidosis in A Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Lv¹,

Wu²,

Zhang³

et al. 2022

Preprint

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Penile squamous cell carcinoma (SCC) is a rare disease. Treatment options for advanced penile cancer are often limited and prognosis remains poor. We reported a 52-year-old male recurrent and metastatic penile SCC patient with high PD-L1 expression(90%) and TMB(14.4 muts/Mb). He had undergone penectomy, bilateral inguinal lymph node dissection and excision of the abdominal wall mass during two surgeries. Despite cisplatin-based concurrent chemoradiotherapy and sequential chemotherapy with docetaxel plus cisplatin were then carried out, the carcinoma still had progressed. The patient then obtained progression free survival exceeding 32 months with continuous sintilimab, although new onset of ICI-induced diabetes after 24 cycles of sintilimab and required sustained insulin treatment. He didn’t have positive type 1 diabetes associated autoantibodies, but had susceptible HLA genotype DR3-DQ2 haplotype. This is the first patient with radiation and multichemorefractory penile SCC obtained remarkable anti-tumor effect of partial regression exceeding 32 months during continuous sintilimab.

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Section: Discussionsupporting

confidence: 55%

Sintilimab-Induced Diabetic Ketoacidosis in A Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Lv¹,

Wu²,

Zhang³

et al. 2022

Preprint

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“…Hu et al [ 18 ] reported a recurrent PSCC patient with medium PD-L1 expression and low TMB who obtained complete response after multimodal therapy that included surgical resection, adjuvant chemotherapy, and continuous sintilimab. It was also recently reported that immunotherapy combined with chemotherapy could have good therapeutic effects in advanced PSCC patients [ 19 , 20 ]. Our patient was first reported as obtaining a partial response to combined treatment with sintilimab plus the target drug, with progression-free survival exceeding 32 months.…”

Section: Discussionmentioning

confidence: 99%

Sintilimab-Induced Diabetic Ketoacidosis in a Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Zhang

et al. 2022

Current Oncology

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Penile squamous cell carcinoma (PSCC) is a rare disease. The treatment options for advanced penile cancer are often limited, and the prognosis remains poor. We reported a 52-year-old male recurrent and metastatic PSCC patient with high PD-L1 expression (90%) and TMB (14.4 muts/Mb). He had undergone penectomy, bilateral inguinal lymph node dissection, and excision of the abdominal wall mass. Despite cisplatin-based concurrent chemoradiotherapy and sequential chemotherapy with docetaxel plus cisplatin then being carried out, the carcinoma still progressed. The patient then obtained progression-free survival with continuous sintilimab, although he experienced the new onset of ICI-induced diabetes after 24 cycles of sintilimab and required sustained insulin treatment. He had negative type 1 diabetes-associated autoantibodies and the susceptible HLA genotype DR3-DQ2 haplotype. This is the first patient with radiation and multichemorefractory PSCC who has obtained the remarkable anti-tumor effect of partial regression exceeding 32 months during continuous sintilimab and anlotinib treatment.

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“…14 Previous reports on checkpoint inhibition noted some clinical benefit for this patient population. [15][16][17][18][19][20][21] These reports were based on a limited number of patients with penile cancer. To our knowledge, the PERICLES trial is the first prospective clinical trial designed specifically to investigate the efficacy of immune checkpoint blockade for penile cancer.…”

Section: Exploratory Biomarker Analysesmentioning

confidence: 99%

Atezolizumab With or Without Radiotherapy for Advanced Squamous Cell Carcinoma of the Penis (The PERICLES Study): A Phase II Trial

Vries

Rafael

Gil-Jimenez

et al. 2023

JCO

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PURPOSE Patients with advanced penile squamous cell carcinoma have a poor prognosis (21% 2-year overall survival [OS] from diagnosis). We assessed the activity of atezolizumab (anti–PD-L1) in patients with advanced penile cancer, with or without radiotherapy (RT). PATIENTS AND METHODS A single-center, nonrandomized phase II study with two treatment arms was conducted in 32 patients with histologically confirmed advanced penile cancer. All patients received atezolizumab (1,200 mg) once every 3 weeks. Twenty patients, who were expected to benefit from RT for locoregional disease control, received additional irradiation. The primary end point was 1-year progression-free survival (PFS) for the complete cohort and was reached if the actual 1-year PFS was at least 35%. Secondary end points included OS, objective response rate (ORR), and tolerability. Exploratory biomarker analyses were conducted in pretreatment specimens. RESULTS Median follow-up was 29.1 months (IQR, 18.1-33.5). Grade 3-4 adverse events related to atezolizumab or RT were observed in 3/32 (9.4%) and 13/20 (65%) patients, respectively. One-year PFS was 12.5% (95% CI, 5.0 to 31.3), which did not meet the study's primary end point. Median OS was 11.3 months (95% CI, 5.5 to 18.7). In the objective response-evaluable population (n = 30; 93.8%), the ORR was 16.7% (95% CI, 6 to 35), including 2 (6.7%) complete responders and 3 (10%) partial responders. Improved PFS was observed in patients with high-risk human papillomavirus (hrHPV)–positive tumors ( P = .003) and those with high infiltration of intratumoral CD3+CD8+ T cells ( P = .037). CONCLUSION Although the primary end point of 1-year PFS was not met, durable antitumor activity to atezolizumab was observed in a subset of patients. Biomarkers, such as hrHPV and intratumoral CD3+CD8+ T-cell infiltration, may help to better select responders.

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Efficacy and Biomarker Exploration of Sintilimab Combined With Chemotherapy in the Treatment of Advanced Penile Squamous Cell Carcinoma—A Report of Two Cases

Abstract: Penile squamous cell carcinoma is a rare malignant tumor of the male reproductive system. We report two cases of advanced penile squamous cell carcinoma with persistent partial response/complete response after sintilimab combined with chemotherapy and analyze the relevant tumor biomarkers.

Cited by 4 publications

References 14 publications

Sintilimab-Induced Diabetic Ketoacidosis in A Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Sintilimab-Induced Diabetic Ketoacidosis in A Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Sintilimab-Induced Diabetic Ketoacidosis in a Patient with Radiation and Multichemorefractory Penile Cancer: A Case Report and Literature Review

Atezolizumab With or Without Radiotherapy for Advanced Squamous Cell Carcinoma of the Penis (The PERICLES Study): A Phase II Trial

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