Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advanced or Metastatic PRCC

Prior treatment

• Patients with history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years;
• Patients who received systemic anti-cancer therapy for PRCC prior to the index date; The following is exception:
  • Prior systemic anti-cancer therapy in the neoadjuvant or adjuvant setting are acceptable if it was completed more than 12 months before metastatic/recurrent disease was diagnosed.
  • For patients who received prior systemic neoadjuvant/adjuvant therapies within 12 months before metastatic/recurrent disease was diagnosed, the neoadjuvant/adjuvant therapy will be counted as 1L therapy.
  • Patients are deemed eligible if the first therapy was only sustained for ≤ 3 days.
• Patients who treated with any combination of chemotherapy, targeted therapy, or immunotherapy with sunitinib or sorafenib as 1L therapy.
  • Other exclusion criteria revised according to study D5086C00001 (SAMETA) will also be applied, only if explicit evidence can be identified in the EMR data.

Other illness

• Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney;
• Patients with severe conditions that are greater or equal to grade 3 by the definition of CTCAE 5.0 criteria when included into the study;

Other

• Patients who meet one or more following criteria will be excluded from the real-world cohort:
• Patients with missing both day and month of index date;

• Patients must meet all the following criteria to be included in the real-world cohort:
• Age ≥ 18 years at the index date
• One of the following:
  • 1)diagnosed with unresectable and locally advanced, or metastatic PRCC; 2)diagnosed with unresectable and locally advanced, or metastatic RCC, and with papillary (papillary ≥ 50%) as the dominant and presumed primary histology type.
  • 3.Patients who received 1L therapy of sunitinib or sorafenib 4.Patients with tumor assessment or relevant clinical visit within 6-month follow-up since index date. (The rationale and details of 6-month minimal follow-up is presented in section 3.6). Death events within 6-month will be included.