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Biomedical subjects

M Staquet

Publications and source records attributed to M Staquet.

At least 19 recordsLinked to original sources
PubMed1996

Guidelines for reporting results of quality of life assessments in clinical trials.

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

Clinical Trials as Topic↗
PubMed1987

Validation of the clinical predictive values of the in vitro phase II clonogenic assay in cancer of the breast and ovary.

The in vitro evaluation of new antineoplastic agents has been advocated as a method of selecting drugs for Phase I-II trials in patients. This paper is an attempt to validate, in an unbiased manner, the so-called in vitro Phase II clonogenic assay with regard to its predictive power in the clinic. Breast and ovarian cancer were chosen because of the relatively large number of drugs clinically evaluated for these diseases; 298 patients were studied. For metastatic breast cancer 12 drugs, six clinically active and six inactive, were tested. It was found that in patients without prior chemotherapy, there is an association between results in vitro and in vivo. In metastatic ovarian cancer, 11 drugs, four of which are known to be clinically inactive, were studied. The same positive association was seen for patients without prior chemotherapy. The implications of these findings are discussed.

Breast Neoplasms↗
PubMed1986

Phase I trials of single agents in adult solid tumours: preclinical and clinical aspects.

Considerable progress has been made in the treatment of cancer. However, there is still a need for new drug development. The preclinical antitumour activity of new anticancer agents is evaluated by sequential testing in murine tumours and human xenografts in mice. More recently, the human tumour stem cell assay has been introduced into the preclinical screen. Toxicology studies are done in animals in order to characterize qualitatively and quantitatively the side effects of the new compounds. These toxicology studies allow an appropriate starting dose to be selected for clinical trials. Most commonly, the starting dose for clinical trials corresponds to 1/10 of the dose that will induce a 10% lethality in the mouse (LD10), if that dose is tolerated by the dog. The escalation scheme for clinical trials must be a compromise between the safety of the patient and quickly reaching biologically active doses. This may be achieved by using the so-called modified Fibonacci scheme. A slightly more rapid alternative is to increase the dose by 100% until the equivalent of the LD10 in the mouse is reached, and then by 50% until toxic effects are observed. Further dose increases depend on the type and severity of these toxic side-effects. Patients included in phase I clinical trials of anticancer agents must have histologically proven malignant disease that cannot be treated by conventional therapeutic modalities. They should have normal haematological, renal and hepatic functions and should be expected to live long enough to evaluate properly the toxic effects of the new compounds.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1984

Predictive tests for the response to cancer chemotherapy: limitations related to the prediction of rare events.

The reliability of a predictive test may be characterized by its sensitivity and specificity. The probability that a predicted event will actually occur depends on these indexes as well as the frequency of the predicted event. If such a test is used to predict for the therapeutic effect of single-agent chemotherapy in cancer patients, its predictive value is markedly affected by a generally low therapeutic efficacy in an unselected population.

Antineoplastic Agents↗
PubMed1981

Reporting results of cancer treatment.

On the initiative of the World Health Organization, two meetings on the Standardization of Reporting Results of Cancer Treatment have been held with representatives and members of several organizations. Recommendations have been developed for standardized approaches to the recording of baseline data relating to the patient, the tumor, laboratory and radiologic data, the reporting of treatment, grading of acute and subacute toxicity, reporting of response, recurrence and disease-free interval, and reporting results of therapy. These recommendations, already endorsed by a number of organizations, are proposed for international acceptance and use to make it possible for investigators to compare validly their results with those of others.

Humans↗
PubMed1980

Effect of parenteral dezocine and placebo in cancer pain.

A double-blind, placebo-controlled crossover trial was carried out in 20 hospitalized patients with continuous pain due to cancer to assess the analgesic effectiveness and tolerance of a single intramuscular injection of 10 mg dezocine. Subjective assessments of pain, made at hourly intervals over 4 hours, showed that dezocine produces a statistically significant greater and sustained relief of pain than did placebo. Only minor side-effects were reported.

Bridged Bicyclo Compounds, Heterocyclic↗
PubMed1979

A double-blind study of dezocine in cancer pain.

A double-blind crossover comparison of intramuscularly administration of 10 mg dezocine (Wy 16225), 10 mg morphine, and placebo in ten patients with cancer pain has shown that a dezocine single dose is superior to placebo in producing relief of moderate to severe pain. No side effects were observed.

Analgesics↗
PubMed1978

Effect of a nitrogen analog of tetrahydrocannabinol on cancer pain.

Two consecutive, randomized, double-blind trials were performed to test the analgesic properties of a synthetic nitrogen analog of tetrahydrocannabinol (NIB). In the first trial, the test preparation was superior to placebo and approximately equivalent to 50 mg of codeine phosphate. In the second study, the tetrahydrocannabinol analog was superior to placebo and to 50 mg secobarbital. NIB is not useful clinically because of the frequency of side effects.

Analgesics↗
PubMed1978

Adjuvant therapy of T1 bladder carcinoma: preliminary results of an EORTC randomized study.

This paper reports the preliminary results of an ongoing clinical trial in patients with category T1 bladder cancer who are randomized after transurethral resection to receive either thiotepa, VM-26, or no treatment. While there are no significant differences between the three treatment groups with respect to the time until first recurrence, thiotepa has significantly reduced the recurrence rate as compared to either VM-26 (P = 0.03) or no treatment (P = 0.04) among the 215 patients for whom follow-up information is currently available.

Humans↗