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Annals of Oncology 4:241-244, 1993
© 1993 European Society for Medical Oncology


research-article

Carboplatin and 5-fluorouracil in poor performance status patients with advanced urothelial cancer

M. G. Arena1, C. N. Sternberg1,, M. Zeuli1, P. De Carli1, A. Cancrini1, V. Pansadoro2 and F. Calabresi1

1Regina Elena Cancer Institute; Rome, Italy
2CTO Hospital USL RMVI; Rome, Italy
3Clinic Pio XI Rome, Italy

Cora N. Sternberg, MD, FACP Via Aurelia 559, 00165-Rome, Italy

BACKGROUND: In view of the difficulties in administering aggressive treatment to elderly patients, frequently with concomitant medical problems, a treatment program with the combination of carboplatin and 5-FU for advanced urothelial tumors was designed. The aim was to maintain an efficacious therapeutic schedule while minimizing toxicity.

PATIENTS AND METHODS: Twenty-three patients with advanced bidimensionally measurable urothelial carcinoma were given carboplatin 100 mg/m2 and 5-fluorouracil 500 mg/m2 days 1–3 which was escalated to carboplatin 125 mg/m2 and 5-fluorouracil 625 mg/m2. 5 patients were > 70 years, the ECOG performance status was 2–3 in 10 patients (43%), and the creatinine was > 2.0 mg/dl in 3 patients (13%). Five patients (22%) had pre-existing cardiac disease, and I had hepatopathy. Nine patients (39%) had prior cisplatin.

RESULTS: Ten patients remained at level 1, and 12 others had the dosage escalated to level 2. Twenty-one patients are evaluable for response. Response was observed in 5 of 21 (24%) evaluable patients (95% confidence limits 15%–33%), only at dose level 2. There was 1 CR (5%) and 4 PR (19%). There were no responses in patients who had prior DDP versus 5 of 13 (38%) responses in patients who had not had prior DDP. The median time to response was 2 months. The median duration of response was 8 months. At level 2 myelotoxicity was significant, and led to a return to level 1 in 2 patients. Nine of 12 patients (75%) treated at level 2 had grade 3 leukopenia, and 1 patient had nadir sepsis. 4 patients (33%) had grade 4 thrombocytopenia.

CONCLUSIONS: Moderate activity was shown with this regimen in untreated patients at level 2. This regimen presents a feasible outpatient alternative for patients who are unable to undergo more aggressive chemotherapy.

carboplatin, chemotherapy, poor performance status, transitional cell carcinoma, urothelium


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