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Table 4 Summary of Italian patients who achieved a complete response in the avelumab MCC EAP

From: Avelumab treatment in Italian patients with metastatic Merkel cell carcinoma: experience from an expanded access program

  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
  1. CR complete response, EAP expanded access program, ECOG PS Eastern Cooperative Oncology Group performance status, MCC Merkel cell carcinoma