title: Clinical outcomes and survival of advanced renal cancer patients in phase I clinical trials.
abstract: BACKGROUND
  The purpose of this study was to describe the basic demographic characteristics, and analyze the response and survival experience of advanced renal cancer subjects treated in a phase I trial.
  
  
  METHODS
  We conducted a retrospective observational study in 70 renal cancer patients participating in 25 phase I trials. Descriptive statistics, Kaplan-Meier, and multivariate Cox proportional hazards analyses were used to examine factors associated with time from study entry to treatment failure (TTF) and survival.
  
  
  RESULTS
  The median age at diagnosis was 56.50 years. Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 23.19% (n = 16) of the patients; 49.18% (n = 30) had received 2 or more previous lines of systemic therapy; and 84.29% (n = 59) of patients had 2 or more metastatic sites. A median number of 4.00 cycles of treatment was delivered. Four partial responses (6.25%) and 38 cases of stable disease lasting > 4 months (43.75%) were observed. The median TTF was 16.00 weeks. In multivariate analyses, men and patients with lactate dehydrogenase > 1.5 times the upper limit of normal had a shorter TTF. The median overall survival was 45.57 weeks (319.00 days). In multivariate analysis, factors predicting shorter survival were ECOG performance status ≥ 1 (P = .023), age younger than 60 years (P = .015), albumin < 3.4 g/dL (P = .042), and liver metastases (P = .010).
  
  
  CONCLUSIONS
  Advanced renal cancer patients with select clinical characteristics could consider phase I trials after exhausting standard therapeutic options.
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX. Electronic address: Malikl@uthscsa.edu.
authors.forename: Laeeq
authors.initials: L
authors.lastname: Malik
authors.affiliation: Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Helen
authors.initials: H
authors.lastname: Parsons
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX.
authors.forename: Devalingam
authors.initials: D
authors.lastname: Mahalingam
authors.affiliation: Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Ehler
authors.affiliation: Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Martin
authors.initials: M
authors.lastname: Goros
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX.
authors.forename: Alex
authors.initials: A
authors.lastname: Mejia
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX.
authors.forename: Andrew
authors.initials: A
authors.lastname: Brenner
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX.
authors.forename: John
authors.initials: J
authors.lastname: Sarantopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic / Q000401:mortality*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: Metastatic; Phase I; Renal; Survival; Trial