Single agent carboplatin for CS IIA/B testicular seminoma. A phase II study of the German Testicular Cancer Study Group (GTCSG).

BACKGROUND: The aim was to investigate the use of single agent carboplatin in patients with seminoma stage IIA/B. PATIENTS AND METHODS: In a prospective phase II trial, single agent carboplatin at a dose of AUC 7 mg.min/ml every 4 weeks for three cycles in stage IIA (n=51) or four cycles in stage IIB (n=57) was given to 108 patients with previously untreated seminoma stage IIA/B. Patients with residual masses of >or=3 cm were scheduled to receive secondary surgery. RESULTS: A complete response (CR) was achieved by 88/108 (81%) patients, 17/108 (16%) achieved a partial response (PR), two of 108 (2%) showed no change, and one patient progressed. In all patients with PR the residual disease was

Absorption of intravesically applied drugs: comparison of normal and ileal augmented rabbit bladder.

PURPOSE: Drug absorption within urinary diversions has been reported to cause prolonged and higher grade toxicity. Therefore, continuous urine drainage has been recommended during chemotherapy in patients with continent urinary diversion. We developed an animal model in which to examine the significance of drug absorption in normal rabbit bladders compared with ileal augmented bladders. MATERIALS AND METHODS: Ten rabbits with ileal bladder augmentation and 5 control animals were used for absorption studies with methotrexate and ofloxacin. One, 4 and 12 months after surgery the rabbits received an intravesical instillation of either drug. During 2 hours blood samples were drawn. To avoid overfilling the bladder by urine it was emptied after 30, 60, 90 and 120 minutes, and refilled with fresh solution to yield a relatively constant drug amount. After 12 months the animals were sacrificed. Area of the native bladder wall and of the intestinal segment was measured to allow the correction of absorbed drug amounts per surface area. Moreover, the median villous heights of native and augmented ileum were compared histologically. Serum levels of methotrexate and ofloxacin were determined by high performance liquid chromatography. RESULTS: The maximum serum concentration of the 2 drugs was typically seen after 60 to 120 minutes. During the 1-year period peak serum concentrations of ofloxacin remained consistently higher in ileal augmented than in control rabbits, although this did not achieve statistical significance at all instillation time points. For methotrexate a statistically significant difference was not shown for either time point. When absorption was corrected for total bladder surface area, the enhancement of ofloxacin absorption by ileal augmentation weakened and attained statistical significance only at the 1-month time point. Histological examinations after 12 months showed that augmented intestinal mucosa had a significantly smaller villous height than native ileum. CONCLUSIONS: Our data demonstrate that bladder surface is the most important factor for increased absorption but time dependent histological changes of the integrated intestinal mucosa also influence absorption. There is a broad interindividual discrepancy. Therefore, general rules in patients with urinary diversion may not be justified.

[Long-term outcome of surgical therapy of metastatic non-seminomatous germ cell tumor in advanced tumor stages]. / Langzeitergebnisse der operativen Therapie des metastasierten nicht-seminomatösen Germinalzelltumors (NSGT) in fortgeschrittenen Tumorstadien.

We present long-term results (minimum follow-up 5 years) in 145 patients with advanced non-seminomatous germ cell tumours, who underwent radical retroperitoneal lymphadenectomy (RPLA) after chemotherapy. We correlated patients' outcomes (death of disease) to different kinds of chemotherapy and to intraoperative findings. We found that patients who were treated by a modified Einhorn scheme with cisplatin, etoposide and bleomycin have a good prognosis. In all, 90% showed no evidence of disease (NED). The NED rate was significantly lower in patients who were treated by sequential alternative chemotherapy (DOD = 37%). We determined the following prognostic factors which predict a poor outcome: salvage RPLA in the case of progressive disease or tumour marker increase during chemotherapy (DOD = 89%, P < 0.0001) residual tumour in multiple-organ systems (DOD = 41%, P = 0.0006) vital tumour in RPLA specimen (DOD = 53%, P < 0.0001) residual tumour mass > 5 cm (DOD = 41%, P = 0.0188). We found that histopathological findings of the primary tumour and tumour stage IIc-IIIc according to the Lugano classification have no prognostic significance for death of disease.