Search PubMed⌕ Search

Biomedical subjects

R Sylvester

Publications and source records attributed to R Sylvester.

At least 109 records · Page 6Linked to original sources
PubMed1990

Orchidectomy versus Zoladex plus Eulexin in patients with metastatic prostate cancer (EORTC 30853).

A total of 327 patients with metastatic prostate cancer have been randomized to either orchidectomy or treatment with goserelin (Zoladez) 3.6 mg depot preparation combined with flutamide (Eulexin) 250 mg t.i.d. in a phase III study (EORTC 30853). A small but statistically significant difference in time to subjective and objective progression of disease was found in favour of the combination treatment. However, time from objective progression to death was longer in the group initially allocated to orchidectomy. Thus no difference was found in overall survival between the two treatment groups. The clinical significance of these differences requires further follow up and analysis.

Aged↗
PubMed1990

Orchidectomy versus Buserelin in combination with cyproterone acetate, for 2 weeks or continuously, in the treatment of metastatic prostatic cancer. Preliminary results of EORTC-trial 30843.

This prospective randomized phase III trial compares orchidectomy as standard androgen-deprivative therapy of advanced (metastatic) prostatic cancer with treatment using the LHRH agonist Buserelin administered as nasal spray 3 daily doses of 400 micrograms, and combined with cyproterone acetate (CPA) 3 daily doses of 50 mg orally for 2 weeks initially to prevent flare-up of the disease, or continuously as complete androgen blockade. The trial was closed to entry in September 1989 when 367 patients were recruited. Patients were stratified for performance status (WHO) and metastatic status prior to randomization. According to patient and disease characteristics spreading of patients over the 3 arms was without statistical significant differences. Ineligibility was 5 and 4% of the patients were only partly evaluable. In March 1990 a first, preliminary analysis was performed. At that time 207 patients were off-study for progression or death and median follow-up was 1 yr. As to time-to-progression and survival there were no significant differences between the 3 arms. The meaning of this in regard to results of other trials with complete androgen blockade is discussed.

Aged↗
PubMed1990

Comparison of the effects of high dose Estramustine phosphate and mitomycin C on the time to progression and length of survival of patients with progressive, advanced endocrine-independent prostatic cancer: an interim analysis of EORTC-GU Group study no. 30865.

Patients with hormone escaped advanced progressive prostate cancer were randomized either to receive either high-dose Estramustine phosphate orally or Mitomycin C by i.v. injection every 6 weeks until signs of progression or death supervened. Patients on both arms progressed rapidly, with a median time to progression of 5 months and a median length of survival of only 10 months. Toxicity was very considerable in both arms.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Some limitations of the radioisotope bone scan in patients with metastatic prostatic cancer. A subanalysis of EORTC trial 30853. The EORTC Urological Group.

This article reviews the serial bone scans of 149 of 327 patients entered into a randomized prospective trial comparing orchidectomy versus zoladex and flutamide in patients with metastatic prostatic cancer. Attention is drawn to the difficulty of evaluating the response rate and of the importance of tumor load in determining survival. The use of sequential bone scans once the diagnosis of metastatic disease has been confirmed is of questionable value as the scans are expensive and contribute little to the further management of the patient in the absence of symptoms requiring relief.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

EORTC protocol 30853: orchidectomy versus zoladex plus flutamide in the management of metastatic carcinoma of the prostate. Interim statistical analysis of the side effects of treatment.

The toxicity and side effects of combination therapy with zoladex and flutamide have not been excessive compared with those due to orchidectomy. Pain due to the flare phenomenon has not been observed with zoladex and flutamide. Treatment modification has been necessary in 12 of the 149 patients receiving the combination therapy, compared with one of 148 patients who had surgical castration. Only one patient had flutamide withdrawn because of diarrhea and only five patients had treatment modification because of liver toxicity.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Prostatic specific antigen and the prediction of prognosis in metastatic prostatic cancer.

Serum prostate-specific antigen (PSA) levels were studied in the EORTC trial of zoladex plus flutamide versus orchidectomy in metastatic prostatic cancer. Forty-four of 60 patients had a decrease of PSA to less than or equal to 10 ng/ml at 3 to 6 months after treatment. The combination of a PSA less than 10 ng/ml after 3 to 6 months treatment and less than 15 spots on the bone scintigram at entry gave the highest probability of not having progressed by 24 months. A rising PSA anticipated bone progression by 6 to 12 months in 13 of 28 patients (46%). The PSA at entry to the trial was related to survival; a discriminant of 300 ng/ml distinguished a poor and better risk group. The lowest level of PSA reached during the first 6 months of treatment was also a univariate survival factor.

Antigens, Neoplasm↗
PubMed1990

Comparability of EORTC and DAPROCA studies in advanced prostatic cancer.

Very often not enough patients are entered and/or the follow-up is insufficient to be able to draw valid conclusions in cancer clinical trials. In this article, we discuss the possibility of pooling the data from two or more trials asking the same or similar questions in order to overcome such problems. How comparable the studies should be for combining their data, in terms of design, patient population, follow-up, and end-points, is discussed in the first part of this paper. Whether these general considerations were completely or partially fulfilled in the two prostatic studies of the EORTC and DAPROCA is the subject of the second part of this article. Problems of interpreting apparently contradictory results, like the superiority of zoladex and flutamide over orchidectomy in terms of time to progression with no clear superiority in terms of overall duration of survival, is also discussed.

Aged↗
PubMed1990

Zoladex and flutamide versus bilateral orchiectomy. A randomized phase III EORTC 30853 study. The EORTC GU Group.

A total of 327 patients with metastatic prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex depot supplemented by flutamide 250 mg 3 qid. Statistically significant increases in time to subjective and objective progression were recorded in favor of the combination treatment. No differences in time to death by cancer or overall death were recorded. The clinical significance of these differences will be reassessed once additional follow-up is available and further analysis of the overall clinical material has been carried out.

Aged↗
PubMed1990

Zoladex and flutamide versus orchiectomy in the treatment of advanced prostatic cancer. A combined analysis of two European studies, EORTC 30853 and DAPROCA 86.

A total of 591 patients with advanced prostatic cancer have been randomized to either orchiectomy or treatment with zoladex 3.6 mg as a depot preparation combined with flutamide 250 mg tid in two European studies, EORTC protocol 30853 and DAPROCA 86. Identical design and comparable patient characteristics in the two studies have allowed combined analysis. A small but statistically significant difference in time to objective progression or death from prostatic cancer was found in favor of the combination treatment. However, time from objective progression to death was longer in the group initially allocated to orchiectomy. Thus, no difference between treatment groups in overall survival was found. As a conclusion, the combined androgen blockade was not superior to orchiectomy in the treatment of patients with advanced prostatic cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Orchidectomy vs. Zoladex plus flutamide in patients with metastatic prostate cancer. The EORTC GU Group.

Treatment with bilateral orchidectomy was compared with Zoladex, 3.6 mg depot, plus flutamide, 250 mg t.i.d., in a randomized prospective study by the European Organization for Research and Treatment of Cancer (EORTC). Small but statistically significant differences in time to subjective and objective progression of disease were found in favor of Zoladex plus flutamide. However, time from objective progression to death was longer in the orchidectomy group. The clinical significance of these differences requires further follow-up and analysis. No difference was found in overall survival between the 2 treatment groups.

Aged↗
PubMed1989

Using permutation tests and bootstrap confidence limits to analyze repeated events data from clinical trials.

In clinical trials comparing treatments for superficial bladder cancer, patients are at risk of repeated recurrences of their disease. Statistical methods of analyzing such data are required. This article presents a nonparametric approach. A statistical test to compare the recurrence or tumor rates in two treatment groups, using the randomization distribution, is described. Confidence intervals for the rate ratio are determined from the bootstrap distribution. The implementation of both requires Monte Carlo methods. Computer simulations support the use of these nonparametric methods when there are more than 60 recurrences in each treatment group. An example illustrating their use is given. The strategy adopted for analysis of these data could be applied to other clinical trials where standard methodology is inappropriate.

Biometry↗