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Biomedical subjects

L Denis

Publications and source records attributed to L Denis.

At least 91 records · Page 5Linked to original sources
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 Only one patient had flutamide withdrawn because of diarrhea and only five patients had treatment modification because of liver toxicity.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

Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group.

72 patients with hormone resistant, progressing prostatic cancer completed a self-administered questionnaire to assess subjective morbidity and quality of life before they were entered into a phase III trial of estramustine (34) vs. mitomycin (38). At least one post-treatment assessment was available in 43 patients. This considerable degree of non-compliance is explained by practical problems related to completion and collection of the questionnaires in these rapidly deteriorating patients. Doctors underestimated subjective morbidity (pain, decreased performance status, nausea) in 30-50% of the cases. Decreased functional status, fatigue and pain were identified as the most frequent major morbidities before study entry. In most patients, treatment did not reduce this morbidity. The routine application of self-administered quality of life questionnaires has considerable practical problems but yields clinically worthwhile information about subjective morbidity. Simple but relevant monitoring of subjective morbidity by the patient should be mandatory in cancer trials where palliation is a major endpoint.

Attitude of Health Personnel↗
PubMed1990

The pharmacokinetics of Casodex in prostate cancer patients after single and during multiple dosing.

The pharmacokinetics of Casodex have been investigated in patients with prostatic carcinoma following single oral doses of 10 mg, 30 mg and 50 mg and during daily administration at these dose levels. Casodex displays prolonged absorption following a single dose, with peak plasma concentrations observed at up to 8 h for doses of 10 mg and 30 mg and up to 48 h for the 50 mg dose. The area under the plasma concentration-time curve increased linearly with dose, and Casodex was eliminated slowly from plasma (t1/2 about 6 days). During daily administration, Casodex accumulates about 10-fold in plasma at all dose levels; this is consistent with its long plasma elimination half-life, estimated by curve fitting of these multiple dose data to be 7-10 days. Trough plasma concentrations increased linearly with dose after both single and multiple dosing, achieving mean values of 1.80, 6.89 and 9.33 micrograms/ml for the 10 mg, 30 mg and 50 mg dose levels, respectively, after 12 weeks' dosing. Neither efficiency of renal function nor age had any apparent effect on the pharmacokinetics of Casodex. The pharmacokinetics of Casodex make it ideally suited to once-daily administration.

Absorption↗
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↗
PubMed1990

Prostatic cancer. An overview.

Reliable study results are scarce in prostate cancer for several reasons. The treated tumors represent a wide variety of natural history and therapeutic response. One assumes to select 'soft' or minimally toxic treatment for patients with good prognostic factors while aggressive treatment is reserved for infaust prognosis. Stage, grade and prognostic factors may influence the indication and choice of treatment. Better treatment selection will depend on the outcome of actual ongoing randomized trials, the development of new drugs or existing drugs in new indications and, above all, basic studies on the growth potential and invasiveness of the prostate cancer cell. Defining the correct treatment for the right cancer in the right patient is our clinical challenge for the next decade.

Humans↗
PubMed1990

Restaging procedures, criteria of response, and relationship between pathological response and survival.

The first priorities for upfront chemotherapy in TCCB are to prove in randomized phase III trials that the addition of toxic chemotherapy to toxic standard locoregional treatment can improve survival and/or permit bladder preservation. If such proof is obtained, we will need to distinguish patients who benefit from chemotherapy from those who do not. One way to make such a distinction is to separate responders from nonresponders. The prognostic value of downstaging to P0 or noninvasive cancer is significantly different from the prognosis associated with the continued presence of invasive disease. The available data regarding clinical assessment of response still appear to indicate that only the demonstration of a lack of response (see Table 2: cIR, cSD, cPD, greater than or equal to cT2) is reliable, However, there may be some patients, who after two courses of chemotherapy, still show the presence of invasive bladder cancer together with signs of tumor cell kill and may be further downstaged to P0 during the next two courses of chemotherapy. The clinical assessment of cCR and cPR is too inaccurate to be used as a basis for decisions concerning continuation of chemotherapy or bladder preservation. The decision to leave the bladder untreated after a cCR carries the risk of jeopardizing cure. More studies on the evaluation of response of the primary tumor are needed, probably with a central role for the pathologist to evaluate not only the gross presence, minimal residual disease, or true absence of cancer but also the adequacy of site and deepness of the restaging TUR biopsy.

Carcinoma, Transitional Cell↗
PubMed1990

Cystic adventitial disease of the popliteal artery.

Cystic adventitial disease of the popliteal artery is a rare and benign disease. The appearance of claudication in a young non-smoking male and the typical angiographic findings usually confirm the pathology.

Acute Disease↗