title: Baseline patient-reported kidney cancer-specific symptoms as an indicator for median survival in sorafenib-refractory metastatic renal cell carcinoma.
abstract: BACKGROUND
  The goal of the study was to determine the relationship of baseline Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI) scores with median progression-free survival (mPFS) and median overall survival (mOS) after treatment with axitinib in patients with sorafenib-refractory metastatic renal cell carcinoma.
  
  
  METHODS
  As part of a multicenter, open-label, phase II study, patients (N = 62) reported symptoms at baseline using the FKSI, with higher scores indicating less severe symptoms. A Weibull (fully parametric) model was fit to time-to-event data to establish the relationship of baseline FKSI score with mPFS and mOS. Kaplan-Meier curves were obtained as sensitivity analyses.
  
  
  RESULTS
  Longer progression-free and overall survivals were associated with higher (more favorable) baseline FKSI-15 and FKSI disease-related symptoms (FKSI-DRS) subscale specific to kidney cancer scores. For example, for FKSI-15 scores of 0 (most symptoms), 30, and 60 (no symptoms), the mPFS were 0.72, 3.83, and 20.43 months, respectively, and the mOS were 1.05, 6.27, and 37.53 months. Similar patterns and interpretations were observed for the FKSI-DRS scores. The results from the Kaplan-Meier analyses supported the parametric model.
  
  
  CONCLUSIONS
  Baseline patient-reported kidney cancer symptoms are linked to mPFS and mOS in a clear and interpretable way. These results support the evaluation of patient-reported symptoms at baseline in clinical trials and in clinical practice to measure symptom severity and potentially predict progression-free and overall survival outcomes.
  
  
  CONCLUSIONS
  The results provide a heightened opportunity to use patient data not only to assist in medical treatment planning but also to prepare patients, who have advanced disease and an already reduced expected lifespan, with an opportunity to deal with the psychosocial aspects of the dying process.
authors.affiliation: Pfizer Oncology, Global Outcomes Research, Pfizer Inc, MS 6025-A3221, 50 Pequot Ave, New London, CT 06320, USA. Peter.C.Trask@Pfizer.com
authors.forename: Peter C
authors.initials: PC
authors.lastname: Trask
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Bushmakin
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cappelleri
authors.forename: Jamal
authors.initials: J
authors.lastname: Tarazi
authors.forename: Brad
authors.initials: B
authors.lastname: Rosbrook
authors.forename: Paul
authors.initials: P
authors.lastname: Bycott
authors.forename: Sinil
authors.initials: S
authors.lastname: Kim
authors.forename: Walter M
authors.initials: WM
authors.lastname: Stadler
authors.forename: Brian
authors.initials: B
authors.lastname: Rini
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001557:Benzenesulfonates / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D019008:Drug Resistance, Neoplasm / Q000502:physiology; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011379:Prognosis; D011725:Pyridines / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design; D057566:Self Report; D000077157:Sorafenib; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib