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Biomedical subjects

D C Tormey

Publications and source records attributed to D C Tormey.

At least 109 records · Page 6Linked to original sources
PubMed1984

Long-term tamoxifen adjuvant therapy in node-positive breast cancer: a metabolic and pilot clinical study.

One hundred twenty-four disease-free postoperative women with ipsilateral-node-positive breast carcinoma were evaluated to assess the metabolic handling and clinical side effects of adjuvant tamoxifen for periods in excess of five years. The patients received postoperative combination chemotherapy for a median of 14 months. Thirty-eight patients received no tamoxifen. Tamoxifen 10 mgs bid was administered to 86 patients during the chemotherapy duration and has been continued in 43 of these patients for up to five years after termination of chemotherapy. Serum samples obtained in 7 patients at 3 to 4-month intervals during the first 5 years revealed that levels of tamoxifen, N-desmethyltamoxifen, and metabolite Y were generally constant throughout the period of drug administration. There was no difference in side effects observed after stopping chemotherapy between the group continuing tamoxifen and the groups stopping tamoxifen or never receiving the drug. Relapse-free survival was superior with increasing duration of exposure to tamoxifen, but this observation can only be considered preliminary due to the small number of patients involved and the study design. The clinical effects observed and the failure to demonstrate the development of a host-metabolic tolerance to tamoxifen provides a rational basis for developing a clinical trial to continue adjuvant tamoxifen therapy for periods in excess of four years after chemotherapy.

Adult↗
PubMed1984

Decreases in serum high-density-lipoprotein cholesterol and total cholesterol resulting from naturally produced and recombinant DNA-derived leukocyte interferons.

A three-phase study was conducted to examine the effect of leukocyte interferon administration on serum high-density-lipoprotein (HDL) cholesterol and total cholesterol levels. In the initial phase, human leukocyte interferon decreased HDL cholesterol (P less than 0.05) and total cholesterol (P less than 0.05) levels in patients with breast carcinoma. Decreases began with initiation of the interferon administration, were sustained throughout the period of treatment, and increased toward pretreatment values with discontinuation of interferon. In the second phase of the study, in neither of two comparison groups of women receiving cytotoxic chemotherapy, excluding interferon, did any similar decrease in HDL cholesterol occur. In a third comparison group of women being treated for metastatic breast carcinoma, a predicted and significant (P less than 0.01) drop in HDL cholesterol level without a concomitant lowering of total cholesterol level occurred immediately following the initiation of androgen therapy. To confirm that the observed cholesterol level decreases were associated with interferon rather than a contaminant thereof, analyses were also carried out on samples from a study utilizing interferon rather than a contaminant thereof, analyses were also carried out on samples from a study utilizing interferon produced by recombinant DNA techniques and purified to homogeneity. A similar decrease in HDL cholesterol (P less than 0.05) and total cholesterol (P less than 0.01) was observed. A definite relationship therefore appears to exist between the administration of human leukocyte interferon and decreased plasma levels of HDL cholesterol and total cholesterol.

Aged↗
PubMed1984

A comparison of intermittent vs. continuous and of adriamycin vs. methotrexate 5-drug chemotherapy for advanced breast cancer. A Cancer and Leukemia Group B study.

The therapeutic effectiveness of intermittent vs. continuous combination chemotherapy and of the substitution of adriamycin for methotrexate in a 5-drug regimen was evaluated in women with metastatic breast carcinoma. Patients were randomly allocated to receive continuous therapy with cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, prednisone ( CMFVP -C, 86 patients), intermittent CMFVP ( CMFVP -I, 109 patients), or intermittent CAFVP (107 patients). The CR + PR rate with CAFVP (71%) was superior to CMFVP -C (50%, p = 0.003) and to CMFVP -I (50%, p = 0.002). The remission duration with CAFVP (14 months, median) was superior to CMFVP -I (7 months) (p less than 0.01), and tended to be superior to CMFVP -C (9 months) (p = 0.07). There was a survival advantage of CAFVP (19 months, median) over CMFVP -I (13 months) (p = 0.01), but not over CMFVP -C (16 months) (p = 0.24). Among CR + PR patients, the survival with CAFVP (29 months, median) was superior (p = 0.02) to both CMFVP -I (18 months) and CMFVP -C (21 months). The CMFVP -C regimen was associated with the highest incidence of leukopenia and neurologic toxicity, but the lowest incidence of GI toxicity. The results indicate that the CAFVP regimen is well tolerated and is superior to the CMFVP regimens.

Age Factors↗
PubMed1984

Aggressive combined modality therapy for advanced local-regional breast carcinoma.

Thirty-two women with advanced local regional breast carcinoma, including nine patients with histologically diagnosed inflammatory cancer, were entered on a prospective pilot study. They were treated aggressively with initial surgery, two courses of induction chemotherapy with cyclophosphamide, methotrexate, 5-fluorouracil, +/- prednisone, +/- tamoxifen (CMF [P] [T]), local-regional radiotherapy, and then maintenance chemotherapy with CMF(P) (T) alternating with doxorubicin, vincristine, +/- tamoxifen (AV[T]). The patients have been followed for 19-70 months from the time of mastectomy and their actuarial three-year survival is 65% with a median survival that has not yet been reached. Median disease-free survival (time to progression) is currently 29.5 months. Women whose gross disease could not be totally resected surgically had shorter disease-free survivals than those rendered surgically free of disease (p = 0.01). Clinically evident cardiotoxicity was seen in 25% of the patients and was felt to be primarily due to the combination of doxorubicin and radiation therapy. It was significantly more common (Plt less than 0.05) in patients with left chest irradiation (seven of 18 women) as opposed to those with right-sided irradiation (one of 14).

Adult↗
PubMed1984

A comparison of fast homoarginine-sensitive alkaline phosphatase and carcinoembryonic antigen as markers in colon carcinoma.

The diagnostic value of a recently described cancer marker, fast homoarginine-sensitive alkaline phosphatase ( FHAP ), was compared with the established marker, carcinoembryonic antigen (CEA), in the diagnosis of colon cancer. Comparisons were made with respect to sensitivity, specificity, predictive value of a positive result, and efficiency. An upper limit of normal of 2.1 units/L was assumed for FHAP , based on earlier studies. Two values for the upper limit of normal for CEA were tested: 2.5 ng/mL and 5.0 ng/mL. When 2.5 ng/mL was used as the upper limit of normal for CEA, FHAP was less sensitive, more specific, and had a higher predictive value. The diagnostic efficiency was not significantly different. When the upper limit of normal for CEA was set at 5.0 ng/mL, the two tests were roughly equal in sensitivity, specificity, predictive value, and diagnostic efficiency.

Alkaline Phosphatase↗
PubMed1983

A randomized trial of five and three drug chemotherapy and chemoimmunotherapy in women with operable node positive breast cancer.

Women with breast carcinoma and four or more involved ipsilateral axillary lymph nodes were randomly assigned to receive an induction course and 2 yr of maintenance chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF, 150 patients), CMF plus vincristine and prednisone (CMFVP, 166 patients), or chemoimmunotherapy with CMF plus the methanol extraction residue of BCG (CMF-MER, 85 patients). After 5 yr of accrual and a median follow-up of 34 mo, CMFVP is superior to CMF (p less than 0.01) with disease-free survival estimates at 4 yr of 60% for CMFVP compared to 45% for CMF. The disease-free survival advantage of CMFVP over CMF was greater in postmenopausal (p = 0.02) than in premenopausal patients (p = 0.09). CMF-MER was similar to CMF alone. CMF related side effects were similar in each regimen (see text), except for a greater incidence of leukopenia during induction with CMF than with CMFVP (p less than 0.01).

Adult↗
PubMed1983

Evaluation of tamoxifen doses with and without fluoxymesterone in advanced breast cancer.

From a group of 108 female patients with measurable and/or evaluable metastatic breast carcinoma, 52 were randomized to receive tamoxifen and 56 to receive tamoxifen and fluoxymesterone. The fluoxymesterone dose, given orally twice a day, was 7 mg/m2 body surface area. The tamoxifen dose per patient, also given orally twice a day, ranged from 2 to 100 mg/m2 body surface area. Eighty-five percent of the patients had received previous chemotherapy and 60% previous hormone therapy. The complete and partial remission rate was better with the tamoxifen and fluoxymesterone regimen (p = 0.016), with remission rates of 15% for tamoxifen alone and 38% for the combination. The tamoxifen and fluoxymesterone regimen appeared to have higher remission rates in all subsets of pretreatment variables. Duration of remission with each regimen was similar, but the overall time to treatment failure for tamoxifen and fluoxymesterone was longer than for tamoxifen alone (180 versus 64 days, p = 0.01). Median survival with the combination was 380 days compared to 330 days for tamoxifen. No significant dose-response relationships emerged. Side effects were not different between dose levels or regimens except for the androgen effects in the tamoxifen and fluoxymesterone combination. These results suggest that there is no major dose-response effect for doses ranging from 2 to 100 mg/m2 body surface area given twice daily in this largely (94%) postmenopausal pretreated patient group, and that the tamoxifen and fluoxymesterone regimen is superior to tamoxifen alone.

Adult↗
PubMed1983

Phase II trial of the dopaminergic inhibitor pimozide in previously treated melanoma patients.

Pimozide, a potent neuroleptic which inhibits the release of pituitary releasing factors and is an effective dopamine antagonist, was administered to 30 patients with previously treated metastatic melanoma. Six patients were inevaluable because of poor drug tolerance (two), disease progression within 1 week and death within 2 weeks (three), and death from other causes (one). Among the 24 evaluable patients, two had complete response, two had partial response, and two had disease stabilization. Responses were observed in soft tissue, lymph nodes, liver, and lung. Toxic effects consisted of extrapyramidal manifestations in nine patients and malaise in seven. Pimozide has activity in patients with previously treated metastatic melanoma (17% response rate in evaluable patients) and merits consideration of further study in combination regimens.

Adult↗
PubMed1982

Comparison of induction chemotherapies for metastatic breast cancer. An Eastern Cooperative Oncology Group Trial.

Patients with advanced breast carcinoma and no prior chemotherapy were prospectively evaluated to assess the induction capabilities of cyclophosphamide, methotrexate and 5-fluorouracil (CMF), Adriamycin and vincristine (AV), and CMF plus prednisone (CMFP). The crossover responsiveness from CMF or CMFP to AV and of AV to CMF were also assessed. A disproportionate randomization led to 166 analyzable cases on AV, 79 on CMF were also assessed. A disproportionate randomization led to 166 analyzable cases on AV, 79 on CMF and 86 on CMFP induction. One hundred and twelve patients were evaluated on crossover. Induction response rates were similar with 56% on AV, 57% on CMF and 63% on CMFP. Crossover response rates ranged from 32% to 41%. CMFP and AV were superior to CMF in terms of response duration (P = 0.05), and CMFP was superior to either in terms of time to treatment failure (P = 0.04), and survival (P = 0.03). Treatment failures occurred in only the on-study organ sites of disease in 73% of the patients and did not appear to be related to the response achieved. CMF was associated with more thrombocytopenia than either AV or CMFP (P = 0.03). AV was associated with fewer infections than CMFP (P = 0.02), less diarrhea than CMFP (P = 0.04), more emesis than CMF (P = 0.02), and more neurologic toxicity than either CMF or CMFP (P less than 0.0001). There was also more emesis with CMF than with CMFP (P = 0.006). CMFP was associated with greater delivery of CMF than was the CMF regimen despite a similar day 1 leukocyte distribution. These results strongly suggest that CMF(P) and AV are clinically noncross-resistant regimens, that AV and CMF are essentially equivalently active induction regimens, and that CMFP is superior to CMF and AV.

Aged↗
PubMed1982

A randomized trial of postoperative five-versus three-drug chemotherapy after mastectomy: a Cancer and Leukemia Group B (CALGB) study.

The Cancer and Leukemia Group B (CALB) has conducted a randomized study of adjuvant chemotherapy in patients with breast cancer who have involved axillary nodes at the time of mastectomy. Five-drug treatment (CMFVP) was compared with three-drug treatment (CMF). For patients with more than three involved nodes, the CMFVP regimen produced a significantly prolonged disease-free survival in comparison to the CMF regimen.

Breast Neoplasms↗
PubMed1982

Use of circulating pregnancy-specific beta 1 glycoprotein as a marker in carcinoma of the breast in women.

Pregnancy-specific beta 1 glycoprotein (SP1) was determined by radioimmunoassay in sera from 27 normal women, 33 women with benign breast disease, and 191 women with carcinoma of the breast, staged for extent of the disease. All diagnostic groups exhibited substantial overlap in SP1 values. Those with benign breast diseases tended to have values at least as high as those with cancer. Normal patients tended to have slightly lower values, but this difference may well have been due to the younger ages of the normal patients in our sample, because SP1 values tended to increase with age. Immunochemical dilutions of SP1 in the serum with the highest value (10.2 ng/ml) did not differ significantly from standard placental SP1.

Aged↗
PubMed1982

Dibromodulcitol and adriamycin +/- tamoxifen in advanced breast cancer.

The therapeutic effectiveness of combining tamoxifen with a combination chemotherapy regimen was tested in 135 patients with advanced breast cancer previously treated with chemotherapy. Patients were randomly allocated to received dibromodulcitol + Adriamycin (DA, 55 patients) or DA + tamoxifen (DAT, 67 patients). An additional 13 patients less than 50 years of age were assigned to DAT (DATN). Pretreatment characteristics were similar across both regimens. DAT and DATN yielded similar results in the less than 50-year-old cohort. DAT tended to be superior to DA with respect to response rate (55% versus 36%, p = 0.004), time to treatment failure (medians: 170 days versus 110 days, log rank p = 0.001), responders' time to treatment failure (360 days versus 220 days, p = 0.035), and survival (340 days versus 270 days, p = 0.18). Toxicity was similar in both regimens. Thus, addition of tamoxifen to a second-line DA regimen appears to increase the therapeutic effectiveness. It is suggested that the addition of this antiestrogen to other chemotherapy regimens would also be beneficial.

Adult↗