Intermittent More Complete Androgen Blockade in 5-year Tentative Treatment of Advanced Prostate Cancer T3NxMx-1
Article published in Urologia Polska 2005/58/1.

authors

Sławomir Dutkiewicz

Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy "ATTIS" w Warszawie
Konsultant ds. urologii: prof. nadzw. dr hab. Sławomir Dutkiewicz

keywords

prostate, prostate cancer, intermittent hormonal therapy, more complete androgen blockade mMAB

summary

aim of the study

The aim of the study was to evaluate the efficacy and to assess the feasibility of pharmacological intermittent more complete androgen blockade (mMAB) in patients with advanced prostate cancer (T3NxMx-1).

materials and methods

The five-year study included 14 patients aged 67 to 82 years (average 73). Zoladex LA 10.8 mg was administered subcutaneously every 3th month of treatment, and 1 tablet Casodex and 1 tablet Proscar every day. At the time when PSA was <0.1 ng/ml Zoladex and Casodex were withdrawn, and only Proscar was left. The mMAB treatment was resumed when PSA rose to ł0.1 ng/ml. Before mMAB and at 3-month intervals, the following laboratory tests were performed: PSA, sedimentation, bilirubine, transaminase, phosphatase, ultrasonography (USG); all adverse events were recorded. After over 5 years, the results of the prospective study and the duration of the therapy and intermission were analysed. The following criteria of assessment were adopted: CR - complete response - examination tests normal, improved condition, reduction of prostate dimensions in USG and PSA value <0.1 ng/ml; PR - partial response i.e. no progression, PSA level decrease to the reference values and a reduction of prostate dimensions in USG; NR - no response i.e. progression, increased prostate dimensions in USG and/or metastases in scintigraphy, PSA above the normal range.

results

The mean follow-up time of the prospective study was 60 months. After the initial 6 months, mMAB therapy was discontinued in two patients because they were qualified for radiotherapy. A successive patient (no. 5) was discontinued the therapy after 4 years because he left Warsaw to go abroad. The results of mMAB after 60 months were based on 11 patients' records, and a complete response was confirmed in 7 patients, partial response in 3 patients and no response in one patient. After the initial 12 months of mMAB, the mean off-therapy period duration was 10.8 months i.e. ranged from 3 to 18 months. The second therapy period duration ranged from 3 to 12 months (mean 6.3 months), 10 patients were responders and the mean off-therapy time in the second cycle was 12.1 months (from 3 to 20). The third cycle therapy ranged in duration from 3 to 15 months (mean 5.1 months) and the mean off-therapy period from 2 to 12 (mean 8.1).

conclusions

1. Results of this study show that pharmacological intermittent mMAB is an efficient method of treatment in advanced prostate cancer.

2. Intermittent mMAB was associated with significant two off-therapy periods between two therapy cycles and with a chance of second hormonal response. However, the duration of the off-therapy period in the next cycle was short.

3. Side effects were of mild or moderate intensity and did not necessitate discontinuation of the therapy.

references

correspondence