Clinical outcomes and survival of advanced renal cancer patients in phase i clinical trials

Laeeq Malik, Helen Parsons, Devalingam Mahalingam, Benjamin Ehler, Martin Goros, Alex Mejia, Andrew Brenner, John Sarantopoulos

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Clinical investigators and advanced renal cancer patients are keen in knowing the expected outcome if they enroll in clinical trials after disease progression. We conducted a retrospective study of 70 renal cancer patients who were treated in 25 phase I trials. Participation in an early phase clinical trial is a reasonable and safe option for selected patients who have exhausted standard treatment. Background/Introduction: 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. Patients and 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). Conclusion: Advanced renal cancer patients with select clinical characteristics could consider phase I trials after exhausting standard therapeutic options.

Original languageEnglish (US)
Pages (from-to)359-365
Number of pages7
JournalClinical Genitourinary Cancer
Volume12
Issue number5
DOIs
StatePublished - 2014

Fingerprint

Kidney Neoplasms
Clinical Trials
Survival
Treatment Failure
Multivariate Analysis
Retrospective Studies
Time and Motion Studies
Therapeutics
L-Lactate Dehydrogenase
Observational Studies
Disease Progression
Albumins
Research Personnel
Demography
Neoplasm Metastasis
Liver

Keywords

  • Metastatic
  • Phase I
  • Renal
  • Survival
  • Trial

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Clinical outcomes and survival of advanced renal cancer patients in phase i clinical trials. / Malik, Laeeq; Parsons, Helen; Mahalingam, Devalingam; Ehler, Benjamin; Goros, Martin; Mejia, Alex; Brenner, Andrew; Sarantopoulos, John.

In: Clinical Genitourinary Cancer, Vol. 12, No. 5, 2014, p. 359-365.

Research output: Contribution to journalArticle

Malik, Laeeq ; Parsons, Helen ; Mahalingam, Devalingam ; Ehler, Benjamin ; Goros, Martin ; Mejia, Alex ; Brenner, Andrew ; Sarantopoulos, John. / Clinical outcomes and survival of advanced renal cancer patients in phase i clinical trials. In: Clinical Genitourinary Cancer. 2014 ; Vol. 12, No. 5. pp. 359-365.
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