TY - JOUR
T1 - Clinical outcomes and survival of advanced renal cancer patients in phase i clinical trials
AU - Malik, Laeeq
AU - Parsons, Helen
AU - Mahalingam, Devalingam
AU - Ehler, Benjamin
AU - Goros, Martin
AU - Mejia, Alex
AU - Brenner, Andrew
AU - Sarantopoulos, John
N1 - Publisher Copyright:
© 2014 Elsevier Inc. All rights reserved.
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Metastatic
KW - Phase I
KW - Renal
KW - Survival
KW - Trial
UR - http://www.scopus.com/inward/record.url?scp=84922596009&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84922596009&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2014.01.011
DO - 10.1016/j.clgc.2014.01.011
M3 - Article
C2 - 24582088
AN - SCOPUS:84922596009
SN - 1558-7673
VL - 12
SP - 359
EP - 365
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 5
ER -