ABSTRACTS <strong>XIV</strong> <strong>Congresso</strong> <strong>Nazionale</strong> <strong>Società</strong> <strong>Italiana</strong> <strong>di</strong> Urologia OncologicaComunicazioni n. 133ESTRAMUSTINE (E) IN COMBINATION TO ALTERNATINGORAL ETOPOSIDE (VP16) AND WEEKLY VINBLASTINE(VLB) IN METASTATIC (M) HORMONE-REFRACTORY(HR) PROSTATIC CARCINOMA (PC): A MONOINSTITU-TIONAL STUDYBoccalon M. 1 , Maruzzi D. 2 , Lo Re G. 1 , Lenardon O. 1 , RusticiC. 1 , Bettin A. 2 , Salamini R. 3 , Garbeglio A. 2 , Tumolo S. 11Oncology Unit; 2 Urology, G.H. “S. Maria degli Angeli”; 3 Unit ofEpidemiology and Biostatistics, C.R.O. – IRCCS, Aviano,PordenoneIntroduction: Oral VP16 and VLB combined to E were reported(Hudes G. et al., JCO 17, 10,3160-6, 1999; Pienta K.J. et al.,JCO 12, 10, 2005-12, 1994) with promising results in M-HR-PC.Aims of the study: To evaluate feasibility, activity and toxicity oftwo alternating regimens and their impact on response durationand survival.Patients and Methods: Between 4/99 and 7/04, 25 patients (pts)entered onto the study. Eligibility criteria required: hystological<strong>di</strong>agnosis of M-PC, HR, adequate renal, hepatic, bone marrowand car<strong>di</strong>ac function, PS3 months.Me<strong>di</strong>an age was 70 years (range: 51-80); me<strong>di</strong>an PS: 1 (0-2);basal me<strong>di</strong>an PSA level: 70.9 ng/ml (0.19-623). Bone, nodaland visceral metastases were present in 23, 6 and 1 pts respectively.Eighteen were naive and 7 pretreated pts.Treatment: VLB 4 mg/mq (A) iv was administered on day1,8,15,22 and after 1 week of rest was followed by oral VP16 50mg/day for 14-21 days (B). Concomitant oral E 12 mg/kg/twicea day was associated to A/B. Cycle was repeated after one weekof rest for 3-6 cycles or until progression. Acenocumarol wasadministered as prophilactic intent of pulmonary thromboembolism(PTE) and deep venous thrombosis (DVT).Results: In 25 treated pts a total of 60 cycles were administered(range 1-5). Toxicity: neutropenia G3 and gynecomastiain 3 and DVT in 1 pt respectively. On 24 evaluable pts,me<strong>di</strong>an na<strong>di</strong>r of PSA was 48.6 ng/ml (range 0.10-438) witha me<strong>di</strong>an reduction of PSA of 48% (range 6-99,9%). PSAresponse (>50%) was achieved in 11/24 pts (45%). Nine ptsex<strong>per</strong>ienced a subjective response with pain improvementand reduction of antalgic drugs consumption. Out of 8 ptswith misurable <strong>di</strong>sease were obtained 1 CR and 2 PR.Me<strong>di</strong>anPFS and OS were 4 and 14.8 months respectively. Six pts arestill alive. Univariate analysis demonstrated no correlationbetween basal PSA values, PSA response, Hb and FAL levelsand survival.Conclusions: The combination of E to alternating VP16/VLB isfeasible and active in unselected M-HR-PC with acceptabletoxicity. In light of these encouraging results on survival inunselected pts, a comparative study with VLB-E is warranted.Comunicazioni n. 135INTERMITTENT ANDROGEN SUPPRESSION NEL CARCI-NOMA PROSTATICO E TESTOSTERONEMearini L., Zucchi A., Mearini E., Giannantoni A., Lilli P.,Porena M.Clinica Urologica, Università <strong>di</strong> PerugiaIntroduzione e Obiettivi: La Intermittent Androgen Suppression(IAS) sembra avere non solo effetti positivi in termini <strong>di</strong> riduzionedegli effetti collaterali e dei costi, ma anche nel <strong>di</strong>lazionarela comparsa della fase <strong>di</strong> ormonorefrattarietà. La riduzionedegli effetti collaterali e la ripresa del meccanismo apoptoticosono strettamente correlati ai livelli <strong>di</strong> testosteronemiadurante le fasi off. Riportiamo la nostra es<strong>per</strong>ienza in un gruppo<strong>di</strong> 120 pazienti sottoposti a IAS, in cui abbiamo analizzatoi livelli <strong>di</strong> testosterone durante il primo ciclo off, <strong>per</strong> verificarese tale terapia è realmente intermittente.Meto<strong>di</strong>: La soppressione androgenica completa iniziava al terminedella sta<strong>di</strong>azione clinica dei 120 pazienti e mantenutadurante la prima fase “ON”; la prima fase “OFF” dello stu<strong>di</strong>oiniziava al raggiungimento <strong>di</strong> un PSA na<strong>di</strong>r 10 ng/ml (PSA basale>20 ng/ml) o <strong>per</strong> PSA >4 ng/ml (PSA basale
ABSTRACTS <strong>XIV</strong> <strong>Congresso</strong> <strong>Nazionale</strong> <strong>Società</strong> <strong>Italiana</strong> <strong>di</strong> Urologia Oncologicasu<strong>per</strong>iori nel gruppo ADT. follow-up me<strong>di</strong>o: RP 49.1 mesi,ADT 48.3 mesi (NS).Downstaging: 5.2% gruppo RP vs 11.6% (11 pazienti pT=)gruppo ADT (p
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