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Biomedical subjects

M Zelen

Publications and source records attributed to M Zelen.

At least 55 records · Page 3Linked to original sources
PubMed1981

Alternatives to classic randomized trials.

Randomized clinical trials are regarded as the most credible way of generating scientific data that compare the benefits of different therapies. However, randomized trials present difficulties in their execution. Often physicians are unwilling to participate in such studies because they do not wish to inform the patient that the treatment program will be chosen by a chance mechanism. They believe that such a discussion may compromise the physician-patient relationship. Alternatives to classic randomized trials have been discussed. Also considered are some aspects of the strategy of clinical experimentation. It has been pointed out that the initiation of definitive Phase III trials made on the basis of little prior expectation of success ("trying something out") tends to generate false-positive results.

Clinical Trials as Topic↗
PubMed1980

Antiemetics in patients receiving chemotherapy for cancer: a randomized comparison of delta-9-tetrahydrocannabinol and prochlorperazine.

Delta-9-tetrahydrocannabinol (THC) is an effective antiemetic as compared with placebos in patients receiving chemotherapy for cancer. In this study we compared THC with prochlorperazine (compazine) in a randomized, double-blind, crossover trial with patients who had failed to benefit from standard antiemetic therapy. Regardless of the emetic activity of the chemotherapeutic agents, there were more complete responses to THC courses (in 36 of 79 courses) than to prochlorperazine (in 16 of 78 courses). Of 25 patients who were treated with both drugs and who expressed a preference, 20 preferred THC (P = 0.005). Among patients under 20 years of age there was a higher proportion of complete responses to THC courses (15 of 20) than among older patients (21 of 59 courses; P = 0.004). Increased food intake occurred more frequently with THC (P = 0.008) and was associated with the presence of a "high." Of 36 THC courses resulting in complete antiemetic responses, 32 were associated with a high. We conclude that THC is an effective antiemetic in many patients who receive chemotherapy for cancer and for whom other antiemetics are ineffective. (N Engl J Med 302:135--138, 1980).

Adolescent↗
PubMed1979

A new design for randomized clinical trials.

This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients in the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline, they receive the best standard treatment. In the analyses of results, all those in the second group, regardless of treatment, are compared with those in the first group. Any loss of statistical efficiency can be overcome by increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage that, before providing consent, a patient will know whether an experimental treatment is to be used.

Clinical Trials as Topic↗
PubMed1978

The Radiation Therapy Oncology Group: a progress report.

The Radiation Therapy Oncology Group (RTOG), founded in 1971, comprises 35 university hospitals which are participating in 21 active protocols, four registries and eight pilot studies, including Phase I/II studies. Case accession has grown to over 1000 in 1977 with 19,801 patients being entered in the RTOG initial registration. Goals of the RTOG include: advancing knowledge of the role of radiation therapy in disease management; improving control of primary and regional disease; reducing morbidity and complications from treatment; and collaborating with other oncology disciplines to obtain data on multimodality therapy.

Clinical Trials as Topic↗
PubMed1977

Therapeutic trials in the management of metastatic brain tumors by different time/dose fraction schemes of radiation therapy.

Two consecutive studies have been performed by the Radiation Therapy Oncology Group on patients with metastatic brain tumors. Approximately 1,000 patients were entered into each trial. Treatment schedules of varying dose-time fractionations were used. Results were evaluated on the basis of improvement in general performance and neurologic function status. Survival also was recorded. Patients who received corticosteroids in conjunction with radiation therapy experienced a more rapid improvement in neurologic function than patients who did not receive steroid therapy. This was noted particularly in patients with poor neurologic function status. However, by the 4th week this difference had disappeared. Survival times were not altered by the addition of steroid therapy. Preliminary results of the second study suggest that ultra-short fractionation schedules are less effective than the longer ones used in the first study. A dose of 3,000 rads given in 10 equal fractions for a period of 2 weeks appeared to be the most satisfactory schedule for most patients with intracranial metastases.

Adrenal Cortex Hormones↗
PubMed1976

Immunocompetence, immunodeficiency and prognosis in cancer.

Immunocompetence and prognosis are related in solid tumors, malignant lymphomas, and acute leukemia. Among the parameters of immunocompetence vigorous delayed-type hypersensitivity responses to recall antigens or to primary immunization with Keyhole limpet hemocyanin, vigorous in vitro lymphocyte blastogenic responses to mitogens such as PHA, and relatively high B-lymphocyte levels, all correlate with a good prognosis. The spectrum of immune reactivity as measured by established delayed-type hypersensitivity to recall antigens and in vitro blastogenic responses to mitogens and antigens is similar in melanoma patients and their nontumor-bearing spouses. In melanoma, only patients with widespread inoperable metastatic disease show severe immunological deficiency and this is selective for certain antigens. There are highly significant differences in response to specific antigens when patients with melanoma and lung cancer are compared. Immunotherapy with BCG and C. parvum can boost immunocompetence as measured by recall DTH skin testing. However, the relationship between the initial immunocompetence and prognosis still holds in patients receiving BCG immunotherapy to prevent recurrence of melanoma. These data indicate that a broader survey of immunological reactivity in cancer patients is needed, that immunological testing is useful in cancer prognosis clinically, and that the results of immunological testing can be used to evaluate therapy and to indicate new pathways for improved treatment.

B-Lymphocytes↗
PubMed1975

L-Phenylalanine mustard (L-PAM) in the management of primary breast cancer. A report of early findings.

Prolonged l-phenylalanine mustard (L-PAM) administration as an adjuvant to mastectomy in the management of patients with primary breast cancer and pathologically positive axillary nodes was evaluated by a prospective, randomized, clinical trial. Treatment failures occurred in 22 per cent of 108 patients receiving placebo and 9.7 per cent of 103 women given L-PAM (p = 0.01). A statistically significant difference (p = 0.02) existed in favor of L-PAM relative to disease-free interval. In premenopausal women, the difference with respect to disease-free interval of treated and control groups was highly significant (p = 0.008). A treatment failure occurred in 30 per cent of premenopausal patients receiving placebo and 3 per cent of those treated with L-PAM (p = 0.008). Whereas a similar trend was observed in postmenopausal patients, the difference is not statistically significant. Thus, L-PAM has been demonstrated to be effective in the treatment of women with primary breast cancer, particularly those who are premenopausal. Results were achieved with minimal undesirable side effects.

Bone Marrow↗