Estimation of kidney function in cancer patients.

INTRODUCTION: The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula has not been validated in patients with cancer. The present investigation was undertaken in order to study how well estimated glomerular filtration rate (eGFR) using the new CKD-EPI equation correlates with measured GFR (mGFR) by (51)chrome ethylene diamine tetraacetic acid ((51)Cr-EDTA) clearance in a group of patients with cancer not known as having cancer. MATERIAL AND METHODS: We investigated 185 patients with cancer who were referred for isotope measurement of GFR with (51)Cr-EDTA before initiating chemotherapy treatment. The agreement between CKD-EPI and (51)Cr-EDTA was assessed using a Bland-Altman plot. Test performance was analysed in a contingency table and bias, precision and the percentage of estimates within 30% of the mGFR (P30) were assessed. RESULTS: Bland-Altman plot analysis showed a limit of agreement in the range from -25.59 to 27.92 ml/min./1.73 m(2). This formula was therefore not interchangeable with (51)Cr-EDTA, as the above differences are of clinical importance. Bias was low: 1.16 ml/min./1.73 m(2); P30 was high: 89.73%; and precision was 13.37 ml/min./1.73 m(2). As a screening test, the CKD-EPI had a high specificity of 98% (95% confidence interval (CI): 96 to 100%) and a high negative predictive value 97% (95% CI: 95 to 100%). The accuracy of the validation test was 96% (95% CI: 93 to 99%). CONCLUSION: The CKD-EPI may be used as a screening tool for CKD in the general population, but cannot replace isotope tests when a high GFR measurement accuracy is needed.

Phase II study of a 3-day schedule with topotecan and cisplatin in patients with previously untreated small cell lung cancer and extensive disease.

INTRODUCTION: Treatment with a topoisomerase I inhibitor in combination with a platinum results in superior or equal survival compared with etoposide-based treatment in extensive disease small cell lung cancer (SCLC). Five-day topotecan is inconvenient and therefore shorter schedules of topotecan and cisplatin are needed. The aim of this phase II study was to establish the response rate and response duration in chemo-naive patients with SCLC receiving a 3-day topotecan and cisplatin schedule. METHODS: Simons optimal two-stage design was used. Patients with previously untreated extensive disease SCLC, adequate organ functions and performance status less than 3 were eligible. Topotecan (2.0 mg/m, intravenously) was administered on days 1 to 3 with cisplatin (50 mg/m, intravenously) on day 3 every 3 weeks for a total of six cycles. RESULTS: Forty-three patients received 219 cycles of chemotherapy. Median age was 59 (range 44-74), 79% had performance status 0 or 1. Thirty-one patients completed all six cycles. Grade 3/4 anemia, neutrocytopenia, and thrombocytopenia were recorded in 9.5%, 66.7%, and 21.4% of patients, respectively. Fourteen percent of patients experienced neutropenic fever. No episodes of fatal sepsis occurred. Non-hematologic toxicity was mild and manageable. Overall and complete response rates were 72.1% and 9.3%, respectively. The median overall survival and response duration were 10.3 months (95% confidence interval: 8.6-12.0) and 7.0 months (95% confidence interval: 6.3-7.7), respectively. CONCLUSION: Three-day topotecan with cisplatin on day 3 is active and safe in extensive disease SCLC. An ongoing phase III randomized trial compares this combination to standard treatment.