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Peter Iversen

Publications and source records attributed to Peter Iversen.

25 records · Page 2Linked to original sources
PubMed2003

Bicalutamide monotherapy for early stage prostate cancer: an update.

PURPOSE: The current evidence is considered to support 150 mg of the nonsteroidal antiandrogen bicalutamide for early stage prostate cancer. MATERIALS AND METHODS: Data from phase III trials of 150 mg bicalutamide monotherapy for locally advanced disease are discussed. In addition, the first overall results are examined from the bicalutamide early prostate cancer program conducted at a median followup of 3 years, in which patients with localized or locally advanced disease were randomized to receive 150 mg bicalutamide or placebo as well as standard care. RESULTS: Mature data from phase III studies have shown that 150 mg bicalutamide monotherapy provide similar survival outcome to that observed with castration in patients with locally advanced (M0) disease. Moreover, 150 mg bicalutamide have benefits over castration in terms of quality of life, particularly sexual interest and physical capacity, and preservation of bone mineral density. In the bicalutamide early prostate cancer program 150 mg significantly reduced the risk of objective progression in patients with localized or locally advanced disease at 3 years of median followup, with the greatest benefit seen in patients with poorer prognosis. Followup is ongoing to further determine the benefit of 150 mg bicalutamide in early prostate cancer. CONCLUSIONS: Bicalutamide is emerging as a useful treatment option for early prostate cancer.

Androgen Antagonists↗
PubMed2002

Antiandrogen monotherapy: indications and results.

Many patients with prostate cancer for whom hormonal therapy is indicated are still physically and sexually active; quality of life is therefore a vital issue when considering treatment options. Traditional castration-based therapies, although effective, have implications with respect to quality of life, causing loss of libido, impotence, fatigue, and reduced bone mineral density. Monotherapy with a nonsteroidal antiandrogen is an attractive therapeutic alternative to castration, offering effective therapy with potential quality-of-life benefits. Of the available nonsteroidal antiandrogens, bicalutamide has been most extensively evaluated in the monotherapy setting. Mature combined data (56% mortality) from 2 large randomized studies show no statistically significant difference in overall survival between bicalutamide 150-mg monotherapy and castration in patients with locally advanced, nonmetastatic (stage M0) disease. Survival outcome in patients with metastatic (stage M1) disease (43% mortality) favored castration, although the difference in median survival between the groups was only 6 weeks. Bicalutamide 150-mg monotherapy was associated with significant advantages compared with castration, in terms of sexual interest and physical capacity, in patients with either M0 and M1 stage disease. Data from a small subgroup of patients with stage M0 disease suggest that bicalutamide may also reduce the risk of osteoporosis compared with castration. Long-term therapy with bicalutamide 150-mg monotherapy is generally well tolerated, with a predictable side-effect profile. The most common side effects are male breast pain and gynecomastia. Emerging evidence also supports the use of bicalutamide 150 mg, both as immediate monotherapy and as adjuvant therapy in early stage (localized or locally advanced) prostate cancer.

Aged↗
PubMed2002

Parenteral estrogen versus combined androgen deprivation in the treatment of metastatic prostatic cancer -- Scandinavian Prostatic Cancer Group (SPCG) Study No. 5.

OBJECTIVE: In the mid-1980s, interest in parenteral estrogen therapy for prostate cancer was renewed when it was found that it influenced liver metabolism only marginally and had very few cardiovascular side-effects. In this study high-dose polyestradiol phosphate (PEP; Estradurin) was compared to combined androgen deprivation (CAD) for the treatment of patients with metastatic prostate cancer. The aim of the study was to compare anticancer efficacy and adverse events, especially cardiovascular side-effects. MATERIAL AND METHODS: A total of 917 patients with T0-4, NX, M1, G1-3 prostate cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were randomized to treatment with either PEP 240 mg i.m. twice a month for 2 months and thereafter once a month or flutamide (Eulexin) 250 mg t.i.d. per os in combination with either triptorelin (Decapeptyl) 3.75 mg per month i.m. or, on an optional basis, bilateral orchidectomy. A total of 556 patients had died at the time of this analysis. RESULTS: There was no difference between the treatment arms in terms of time to biochemical or clinical progression and overall or disease-specific survival. There was no increase in cardiovascular mortality in the PEP arm. The PEP group had a higher prevalence of cardiovascular disease prior to the study and a significantly higher incidence of non-fatal ischemic heart events and heart decompensation during the study. CONCLUSIONS: PEP has an equal anticancer efficacy to CAD and does not increase cardiovascular mortality. Final evaluation of cardiovascular morbidity is awaiting further analysis and follow-up. PEP is considerably cheaper than CAD.

Aged↗
PubMed2002

Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: first analysis of the early prostate cancer program.

PURPOSE: We determine the efficacy and tolerability of bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with clinically localized or locally advanced prostate cancer. MATERIALS AND METHODS: This international program consists of 3 ongoing, randomized, double-blind, placebo controlled clinical trials (trials 23, 24, and 25). Men with localized or locally advanced (T1-T4, Nx/N0, M0) prostate cancer were randomized to receive 150 mg. bicalutamide daily or placebo, in addition to standard care with radical prostatectomy, radiotherapy or watchful waiting. Primary end points are time to objective progression and overall survival. In this first analysis data from the trials were combined in a single overview analysis according to protocol. RESULTS: Data are available for 8,113 patients (4,052 randomized to bicalutamide, 4,061 to standard care alone) at a median followup of 3.0 years. Treatment with bicalutamide provided a highly significant reduction of 42% in the risk of objective progression compared with standard care alone (9.0% versus 13.8%, hazards ratio 0.58; 95% confidence interval 0.51, 0.66; p <<0.0001). The overall result was reflected in 2 of the 3 trials (trials 24 and 25) with trial 3 (trial 23) showing a nonsignificant difference at this time. Reductions in the risk of disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. Overall survival data are currently immature and longer followup will determine if there is also a survival benefit with bicalutamide. The most frequently reported side effects of bicalutamide were gynecomastia and breast pain. CONCLUSIONS: Immediate treatment with 150 mg. bicalutamide daily, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. This benefit must be balanced with the morbidity associated with long-term hormonal therapy. Followup is ongoing to determine potential survival benefits of this treatment approach.

Adult↗