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Biomedical subjects

T R Fleming

Publications and source records attributed to T R Fleming.

At least 109 records · Page 6Linked to original sources
PubMed1980

Definitive radiation therapy for prostatic carcinoma: Mayo clinic experience.

Primary radiation therapy for clinically localized prostatic cancer is effective and safe. Of our 147 patients treated between 1964 and 1973, 144 were evaluated 5 years after the initial date of radiation therapy. At 5 years the over-all survival rate was 80 per cent and the rate of survival free of disease was 63 per cent. More than 70 per cent of the patients were free of progression 5 years after the date of the first radiation treatment. Analysis revealed a highly significant association between tumor grade and patient survival (p less than 0.001), and between tumor grade and the interval free of disease (p less than 0.002). The relationship between tumor stage and time to progression of disease also was significant (p approximately equal to 0.01) but there was no relationship between lower stage and longer survival. Of the 142 patients who completed treatment only 20 (14 per cent) had local recurrence of the prostatic cancer after radiation therapy, representing a local control rate of 86 per cent 5 years after treatment. A few of the patients underwent post-treatment prostatic biopsy after radiation therapy. If a biopsy is done for increased prostatic induration and the results are positive adjuvant treatment is recommended. In the absence of urologic symptoms of progressive induration of the prostate gland biopsy is not instrumental in predicting the course of the cancer.

Adenocarcinoma↗
PubMed1980

A role of cis-dichlorodiammineplatinum(II) in squamous cell lung cancer.

Forty-one patients with advanced squamous cell lung cancer and no prior chemotherapy were entered in a prospectively randomized trial comparing dianhydrogalactitol plus Adriamycin (DA) versus DA plus cis-dichlorodiammineplatinum(II) (DAP). The DAP regimen was superior to the DA regimen in regression rate (53% versus 27%), median regression duration (255 versus 122 days), median time to tumor progression (approximately 175 versus 58 days), and median survival time (185 versus 126 days). Patients who were greater than 60 years old responded particularly well to the DAP regimen and accounted for most of the survival advantage. Nausea, vomiting, and myelosuppression were more frequent and severe with the DAP regimen. This study seems to indicate a role of cis-dichlorodiammineplatinum(II) in patients with advanced squamous cell lung cancer. The particular advantage noted for older patients needs further evaluation.

Adult↗
PubMed1979

Dianhydrogalactitol and radiation therapy. Treatment of supratentorial glioma.

Dianhydrogalactitol was the most active of 177 agents tested against a mouse ependymoblastoma tumor. We conducted a prospectively randomized trial comparing whole-brain irradiation alone vs identical irradiation plus dianhydrogalactitol in 42 patients with grade 3 and 4 supratentorial astrocytomas. Patients receiving dianhydrogalactitol in addition to irradiation had a significantly longer median survival time (67 vs 35 weeks) than did patients receiving only irradiation. The major toxic effect of dianhydrogalactitol is hematologic suppression of a cumulative nature. Dianhydrogalactitol may play an important role (in conjunction with radiation therapy) in the initial treatment of patients with supratentorial glioma. Our data may indicate that the mouse ependymoblastoma system is a useful screen for agents to be used in the treatment of human glioma.

Adult↗
PubMed1979

VP-16, cyclophosphamide, adriamycin and cis-platinum (V:CAP-I) in patients with metastatic adenocarcinoma of the lung.

In an attempt to improve upon the 42% regression rate of the CAP-I regimen in patients with advanced adenocarcinoma of the lung, VP-16 was added to that regimen. VP-16, as a single agent, had a response rate of 12.5% (3/24) In a similar group of patients. The new regimen, V:CAP-I, had a tumor regression rate of 35% (7/20) and an estimated median survival of 171 days. Hence, we were unable to conclude that the addition of VP-16 to the CAP-I regimen statistically improved the regression rate of the CAP-I regimen.

Adenocarcinoma↗
PubMed1979

Evaluation of response criteria in advanced lung cancer.

Because we found it illogical to attempt measurement of nonmeasurable but visible tumors in patients with advanced lung cancer, we devised and used a separate set of response criteria for patients with evaluable, nonmeasurable tumors. Patients with evaluable disease who had obtained a tumor regression after therapy were compared to patients with measurable disease who had obtained a tumor regression according to standard criteria. Among 191 cases evaluated (54% with measurable and 46% with evaluable disease), 59 tumor regressions were found (35 in patients with measurable disease and 24 in patients with evaluable disease). Evaluating regressions in patients with both types of disease, we could not detect statistical differences in regression rates, times to regression, durations of regression or survival. We believe the response criteria used for patients with evaluable, nonmeasurable lung cancer to be valid in assessing response to therapy.

Antineoplastic Agents↗
PubMed1979

Pulmonary resection for metastatic nonosteogenic sarcoma.

Analysis was made of 112 patients who underwent resection of metastatic pulmonary noldules for nonosteogenic sarcoma at the Mayo Clinic from 1950--76. The 5-year post-thoracotomy survival was 29% with a median survival of 18 months. There has been no substantial change between 1950 and 1976 in post-thoracotomy survival among all patients who received this operation here. Prognosis was especially grim (p less than 0.01) for patients with pre-thoracotomy disease-free intervals of less than 12 months, and for those experiencing extrathoracic recurrences vs. further pulmonary recurrent tumor (p = .01) following thoracotomy. The following discriminants were not significantly associated with postthoracotomy survival: age, sex, histology, number of lesions fully excised, or site of lung lesions. We conclude that the therapeutic value of thoracotomy in the treatment of metastatic nonosteogenic sarcomas has not changed here during the past quarter of a century. Whether the recent more common use of thoracotomy in metastatic disease of this type is therapeutically worthwhile cannot be clearly determined from the data available.

Humans↗
PubMed1979

Different chemotherapeutic sensitivities and host factors affecting prognosis in advanced ovarian carcinoma versus minimal residual disease.

Treatment of patients with advanced ovarian carcinoma (stages IIIB and IV) using either cyclophosphamide alone (1 g/m2) or cyclophosphamide (500 mg/m2) plus adriamycin (40 mg/m2) by iv injection every 3 weeks each produced partial regression in approximately one third of the patients. Survival curves and time-to-progression curves for the two regimens were nearly identical in these patients with advanced disease. These same regimens produced different results when used monthly in patients who had minimal residual disease (stages II and IIIA). In patients with minimal residual disease the therapeutic index of the combination regimen was superior to that of cyclophosphamide alone. Prognosis was better overall among patients with minimal residual disease than among patients with advanced disease. Within the minimal-disease group grossly complete excision of tumor prior to chemotherapy was associated with still better prognosis. Among patients with advanced disease, prognosis was significantly better for older patients despite their generally less favorable performance scores. Much of this prognostic superiority appeared to be related to menopausal status and presumably to the depletion of endogenous estrogens in the older patients.

Cyclophosphamide↗
PubMed1979

A multiple testing procedure for clinical trials.

A multiple testing procedure is proposed for comparing two treatments when response to treatment is both dichotomous (i.e., success or failure) and immediate. The proposed test statistic for each test is the usual (Pearson) chi-square statistic based on all data collected to that point. The maximum number (N) of tests and the number (m1 + m2) of observations collected between successive tests is fixed in advance. The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations. The power is also found to be virtually the same. However, by affording the opportunity to terminate early when one treatment performs markedly better than the other, the multiple testing procedure may eliminate the ethical dilemmas that often accompany clinical trials.

Clinical Trials as Topic↗
PubMedDate not supplied

Effects on overviews of early stopping rules for clinical trials.

Use of inappropriate stopping rules for clinical trials results in an excess of false positive conclusions when no true survival differences exist. Overviews of such trials, however, consist mainly of trials which were not stopped early, plus a few of reduced sample size which were. Simulations confirm that the level of such an overview is minimally elevated. Additional follow-up for survival further corrects the level. In fact, for individual trials conducted according to inappropriate rules, late tests have nearly correct level. On the other hand, publication bias (differential reporting of positive results) can substantially increase the level of an overview if only published studies are included.

Clinical Trials as Topic↗
PubMedDate not supplied

Surrogate markers in AIDS and cancer trials.

There is significant need for rapid yet reliable evaluation of promising new interventions for the treatment of patients with cancer or HIV infection. Considerable attention has been given to identifying replacement or 'surrogate' endpoints for the true clinical efficacy endpoints, in order to reduce the cost, size and duration of clinical trials. We discuss issues which affect the validity of surrogate markers. The reliability of the CD4 lymphocyte count marker is carefully considered in clinical trials of anti-retroviral agents in HIV infected individuals. The nature of surrogate markers and their reliability is discussed in cancer prevention, screening and treatment trials. Some suggested uses of marker information are also considered.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Phase II trial of amonafide in advanced pancreas cancer. A Southwest Oncology Group study.

Amonafide is a new synthetic anticancer agent whose mechanism of action is through inhibition of macromolecular synthesis as well as DNA intercalation. The Southwest Oncology Group (SWOG) has investigated this drug in a phase II study of pancreas cancer. Thirty-six patients were registered on this study: of these 29 were eligible for response evaluation, and 20 received the two cycles required for making a response assessment. Patients met the standard phase II criteria of no prior chemotherapy, measurable disease and a SWOG performance status of 2 or less. Toxicity, predominantly hematologic with significant neutropenia and thrombocytopenia, was quite severe. Four treatment related deaths were encountered. No responses were seen in thirty-six patients studied. We conclude that this drug is not active against adenocarcinoma of the pancreas.

Adenine↗
PubMedDate not supplied

Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes.

OBJECTIVE: To determine the efficacy of the nonoxynol 9 contraceptive sponge in preventing sexual acquisition of the human immunodeficiency virus (HIV). DESIGN: Prospective, randomized placebo-controlled trial. SETTING: Research clinic for prostitutes in Nairobi, Kenya. PATIENTS AND INTERVENTIONS: One hundred thirty-eight HIV-seronegative women were enrolled, of whom 74 were assigned to nonoxynol 9 sponge use and 64 to placebo use. These two groups did not significantly differ with respect to demographic characteristics, sexual practices, or prevalence of genital infections at enrollment, except for a lower number of sex partners per week and a higher initial prevalence of genital ulcers among women assigned to nonoxynol 9 sponge use. Among the 116 women who returned for follow-up, the mean durations of follow-up were 14 and 17 months for the two groups, respectively. MAIN OUTCOME MEASURE: HIV seroconversion. RESULTS: Nonoxynol 9 sponge use was associated with an increased frequency of genital ulcers (relative risk [RR], 3.3; P less than .0001) and vulvitis (RR, 3.3; P less than .0001) and a reduced risk of gonococcal cervicitis (RR, 0.4; P less than .0001). Twenty-seven (45%) of 60 women in the nonoxynol 9 sponge group and 20 (36%) of 56 women in the placebo group developed HIV antibodies. The hazard ratio for the association between nonoxynol 9 sponge use and HIV seroconversion was 1.7 (95% confidence interval [CI], 0.9 to 3.0). Using multivariate analysis to control for the presence of genital ulcers at enrollment, the adjusted hazard ratio for the association between nonoxynol 9 sponge use and seroconversion was 1.6 (95% CI, 0.8 to 2.8). CONCLUSIONS: Genital ulcers and vulvitis occurred with increased frequency in nonoxynol 9 sponge users. We were unable to demonstrate that nonoxynol 9 sponge use was effective in reducing the risk of HIV infection among highly exposed women.

Adult↗