Table 4 Summary of Italian patients who achieved a complete response in the avelumab MCC EAP
Patient 1 | Patient 2 | Patient 3 | Patient 4 | Patient 5 | Patient 6 | |
|---|---|---|---|---|---|---|
Previous treatment prior to EAP enrollment | Surgery; radiotherapy; chemotherapy (cisplatin) | Surgery; radiotherapy; chemotherapy (carboplatin and etoposide) | Chemotherapy (cisplatin and etoposide) | Radiotherapy; chemotherapy (cisplatin-containing) | Surgery; radiotherapy; chemotherapy (cisplatin and etoposide) | Chemotherapy (carboplatin and etoposide) |
Age at start of avelumab, years | 79 | 76 | 71 | 80 | 70 | 66 |
Sex | Male | Male | Male | Male | Male | Male |
ECOG PS | 1 | 0 | 0 | 1 | 0 | 0 |
Major comorbidities or immunosuppressive conditions | None | Type 2 diabetes mellitus | None | Type 2 diabetes mellitus; hypertension; benign prostatic hyperplasia; glaucoma | None | None |
Metastatic sites | Hepatic hilum; common iliac; right thigh and leg lymphedema | Retroperitoneal lymph nodes | Mediastinal and paratracheal lymph nodes | Lymph nodes and retroperitoneum | Thoracic, supraclavicular and inguinal lymph nodes; mesenteric tissue; right paraumbilical area | Abdomen (pancreas, stomach, spleen, and colon) |
Date of first avelumab dose | August 22, 2017 | May 2017 | October 25, 2017 | February 20, 2017 | December 14, 2016 | May 17, 2018 |
Date of documented CR | October 2, 2017 (including metabolic CR) | March 2019 | March 14, 2018 (including metabolic CR) | December 9, 2017 | February 2, 2017 | August 28, 2018 |
Treatment-related toxicity | Transient subclinical hypothyroidism (not requiring treatment) | Pruritus (not requiring treatment); grade 1 asymptomatic pneumonitis (resolved with drug interruption) | Grade 2 pruritus | Grade 1 pruritus; potential correlation with basaloid penile intraepithelial neoplasia (surgically treated) | Slight fever and joint pain (resolved with acetaminophen) | Grade 1 thrombocytopenia (resolved without treatment) |
New lesions with avelumab treatment | None | None | None | None | None | None |
Date of last avelumab dose | September 6, 2019 | February 2020 | January 30, 2020 | July 29, 2020 | July 23, 2020 | July 2, 2020 |
Additional local/systemic anticancer therapy | None | None | None | None | None | None |
Date of last follow-up | April 27, 2020 | July 13, 2020 | May 12, 2020 | July 29, 2020 | October 12, 2020 | July 2, 2020 |
Progression free at last follow-up | Yes | Yes | Yes | Yes | Yes | Yes |