Nephrotoxicity of heptaplatin: a randomized comparison with cisplatin in advanced gastric cancer.

PURPOSE: Heptaplatin is a newly developed platinum derivative which has been reported to be less toxic than cisplatin. This study was designed to evaluate the nephrotoxicity of heptaplatin in comparison with that of cisplatin. METHODS: Previously untreated advanced gastric cancer patients with normal renal function were randomly assigned into either group I (heptaplatin 400 mg/m(2) i.v. over 1 h on day 1 plus 5-fluorouracil (5-FU) 1000 mg/m(2) per day continuous i.v. from day 1 to day 5), or group II (cisplatin 60 mg/m(2) i.v. over 1 h on day 1 plus 5-FU 1000 mg/m(2) per day continuous i.v. from day 1 to day 5), with the cycles repeated every 4 weeks. Renal function parameters before, during, and after the chemotherapy were compared between the two groups. RESULTS: A total of 99 patients were enrolled in the study, 51 in group I and 48 in group II. The 24-h proteinuria on day 5 was markedly increased in group I (95+/-108 mg/day to 9098+/-4514 mg/day, means+/-SD) in comparison with the increase observed in group II (104+/-148 mg/day to 151+/-102 mg/day), and creatinine clearance showed a greater decrease in group I (83.1+/-23.6 ml/min to 44.9+/-17.3 ml/min) than in group II (89.6+/-22.1 ml/min to 72.8+/-21.0 ml/min). The differences in these parameters between the two groups were statistically significant throughout the subsequent cycles. CONCLUSIONS: Our findings show that nephrotoxicity was more severe in patients treated with heptaplatin 400 mg/m(2) than with cisplatin 60 mg/m(2) when it was combined with 5-FU. Measures to more effectively prevent nephrotoxicity should be developed for the safe use of heptaplatin.

Retrospective Analysis of the Results of Adjuvant Chemotherapy in Breast Cancer Patients with 10 or More Positive Nodes: Nonrandomized Comparison of Adriamycin-Containing Regimens.

PURPOSE: To evaluate the results of adriamycin-based adjuvant chemotherapy with or without high dose chemotherapy (HDC) with stem cell transplantation (SCT) in breast cancer with 10 or more positive axillary nodes. MATERIALS AND METHODS: Seventy-one breast cancer patients who had undergone surgery and had 10 or more positive axillary nodes were included in this study held between January 1997 and December 1999. The pathologic and clinical records were reviewed retrospectively. RESULTS: Twenty-nine patients were treated with adriamycin followed by 8 courses of CMF (group I); 22 patients received 4 courses of adriamycin and 7 patients received 3 courses of adriamycin. Twenty-six patients received median 6 courses of CAF (group II) and 16 patients underwent HDC and autologous SCT (group III). With a median follow-up of 27.1 months, relapses were observed in 24 patients (33.8%) and the 3-year disease-free survival (DFS) rate was 57.1%; group I/II 55.4%, and group III 62.7%. The three-year overall survival (OS) rate was 86.1%; group I/II 83.0%, group III 93.8%. There were no difference in the 3-year DFSs or in the OSs of group I and group II. However, patients who received only 3 courses of the sequential adriamycin in group I showed a significantly poorer 3-year OS than those that received 4 courses of adriamycin (42.9% vs. 95.5%). CONCLUSION: Our study shows that adriamycin-containing combination chemotherapy is as effective as HDC with SCT in patients with 10 or more positive axillary lymph nodes judging by 3-year DFS and OS, and shows that three courses of adriamycin seems to be inadequate.