A 49-year-old male patient presented because of pain in the lymph nodes, with long prepuce and a 30-year history of gunshot wounds. The patient was diagnosed with pSCC in Jan 2019. The tumor was about 5.0 cm by 5.0 cm in size with bilateral inguinal lymph node metastases, T2N3M0 and phase IV poor differentiated. HPV status was negative. Under general anesthesia, partial penile resection and bilateral inguinal lymphadenectomy were performed. The pathology was poor differentiated pSCC ((Figure 1A), involving the cavernous body of the penis and the cavernous body of the urethra, with nerve invasion and lymphocyte infiltration, and no cancer seen at the cutting edge. Cancer metastasis could be seen in lymph nodes (2/10, left 1/6; right 1/4). In Mar 2019, under general anesthesia he subsequently underwent 3D laparoscopic pelvic lymph node dissection. The pathology suggested that no metastatic carcinoma was seen in the lymph nodes after operation (0/18). The patient refused adjuvant therapy.
A right groin mass began to appear, and gradually increased in May. We found that the groin mass on the right side was unclear borders, red and swollen skin on the surface, a feeling of undulation, and near to rupture. The tumor showed as an irregular soft tissue shadow, about 10.3 cm by 7.0 cm, with some cystic changes, and no clear boundary with the local muscle (Figure 2B). Palliative resection of the right inguinal metastasis was performed. During the operation, the tumor was closely related to muscles and blood vessels, and the tumor was most likely to be removed. Pathology showed that fibrous tissue had cancer infiltration with necrosis (Figure 1E), consistent with recurrence or metastasis of penile squamous cell carcinoma.
According to our experiences and the reports, we determined to use combined adjuvant therapy as one of the therapeutic options. At the same time, we performed genetic profiling and PD-L1/CD8 protein-expressing analyses on the tumor tissue.
Next-generation high-throughput gene-targeted sequencing, including 808 tumor diagnosis and treatment-related genes was performed. The tumor mutation burden (TMB, 2.25 Muts/Mb) was low, as the median TMB in pSCC was 4.5 Muts/Mb. The microsatellite stability is stable (MSS). And mutations positively or negatively related to immune efficacy were not detected.
The tumor content accounts for 50% of the sample with active tumor-infiltrating lymphocytes (TIL). PD-L1 22C3 IHC analysis with Tumor Proportion Score (TPS) Interpretation was about 20-30%, while Combined Positive Score (CPS) was about 50-60% (Figure 1B-D). The CD8+ cytotoxic T-lymphocytes (CTLs) was about 30-40% (Figure 1F-H).
The results of genetic profiling and PD-L1/CD8 expressing analyses were as follows: 
About 2 weeks after surgery, a postoperative combined adjuvant therapy was carried out. The patient's treatment plans are presented in a timeline (Figure 2A). The therapeutic regimen (TBP, body surface area: 2.09 m2) is paclitaxel 270 mg intravenous drip on day 1; bleomycin 15 mg intravenous drip on days 1/8/15; cisplatin intravenous drip 50 mg on days 2/3/4 and sintilimab injection 200 mg on day 1. Every three weeks is a cycle. The patient reached complete imaging remission (CR) after 4 cycles of combined therapy (Figure 2B). Until Mar 2021, the enhanced CT after 28 cycles (21 months) of sintilimab still presented a sustainable CR (Figure 2B). The patient was still alive and there is no sign of recurrence or any adverse events.