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.
- Phase I
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