RESULTSThe prostate-specific antigen (PSA) level decreased to < 0.5 ng/mL in 79% of patients undergoing primary treatment and in 67% of patients undergoing salvage treatment. A higher Gleason grade and PSA levels were associated with a poorer outcome. No patient developed a fistula, 4% developed urinary retention requiring transurethral prostatectomy and 4% had persistent incontinence. The rates of erectile dysfunction were high (86%). The median inpatient stay was 2 days.
CONCLUSIONEarly results suggest that cryotherapy offers a safe alternative for primary and recurrent prostate cancer, particularly for older and less fit patients. Long-term data are required to assess the durability of response and the effect on survival.
There is no consensus as to the management of untreated poor prognosis or relapsed/refractory germ cell tumours. We have studied an intensive cisplatin-based regimen that incorporates high-dose methotrexate (HD MTX) and actinomycin-D and etoposide every 14 days (GAMEC). Sixty-two patients were enrolled in a phase 2 study including 27 who were untreated (IGCCCG, poor prognosis) and 35 with progression despite conventional platinum based chemotherapy. The pharmacokinetics of the drugs were correlated with standard outcome measures. Twenty of the untreated patients were progression free following GAMEC and appropriate surgery, as were 18 individuals in the pretreated group. None of the established prognostic factors for therapy for pretreated patients could identify a poor-prognosis group. Five out of nine late relapses to prior chemotherapy were progression free following GAMEC and appropriate surgery. All patients had at least one episode of febrile neutropenia and there were five (8%) treatment-related deaths. PK values were not predictive of efficacy or toxicity, although the dose intensity in the pretreated group of patients, especially of HD MTX, was significantly correlated with progression-free survival (PFS). GAMEC is a novel intensive regimen for this group of patients producing encouraging responses, although with significant toxicity. For those in whom it fails, further therapy is still possible with durable responses being seen.
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