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Biomedical subjects

G Falkson

Publications and source records attributed to G Falkson.

At least 181 records · Page 10Linked to original sources
PubMed1982

A comparison of adriamycin versus vincristine and adriamycin, and cyclophosphamide versus vincristine, actinomycin-D, and cyclophosphamide for advanced sarcoma.

This randomized study, conducted by the Eastern cooperative Oncology Group, compared Adriamycin (doxorubicin) (70 mg/m2) versus vincristine (1.4 mg/m2) and Adriamycin (50 mg/m2); and cyclophosphamide (750 mg/m2) versus vincristine (1.4 mg/m2), actinomycin-D (0.4 mg/m2), and cyclophosphamide (750 mg/m2) for treatment of metastatic mesenchymal malignancies. The respective response rate seen in 200 evaluable patients to the treatments were, 27, 19, and 11%. The response rate to Adriamycin was significant better than the response to vincristine, actinomycin-D, and cyclophosphamide (P = 0.03, two-sided). The respective median survivals on the three treatments were 37, 34, and 41 weeks and were not significantly different. Moderate or severe vomiting occurred in 60% of patients receiving vincristine-cyclophosphamide-adriamycin, a greater frequency than in Adriamycin alone (P = .09 two-sided) Severe or life-threatening hematologic toxicity (leukocytes less than 2000, platelets less than 50,000) occurred in 30% of patients receiving the Adriamycin combination, a markedly increased frequency when compared to the other two regimens (P equals 0.07, P = 0.02, two-sided). This trial establishes that Adriamycin has a better response rate than the combination of vincristine-actinomycin-D-cyclophosphamide in advanced sarcomas. The combination of vincristine, Adriamycin, and cyclophosphamide increased toxicity and did not add to the therapeutic effect achieved with Adriamycin alone.

Adult↗
PubMed1982

Clinical and chemotherapeutic study of hepatocellular carcinoma in Malaysia: a comparison with African and American patients.

Twenty Malaysian patients with unresectable primary liver cell cancer were prospectively studied at the General Hospital, Kuala Lampur, and were compared for clinical features with an equal number each of African and American patients being studied by the Eastern Cooperative Oncology Group. The patients received intravenous 5-FU and oral MeCCNU which was used for the first time in an Asian country. Most of the Malaysian patients were Chinese, belonged to younger age groups, and presented with massive hepatomegaly, jaundice, and fever. Toxicity to MeCCNU invariably occurred in the form of leukopenia or thrombocytopenia, but none life threatening. Partial response was seen in 20% of Malaysians as compared to 16% in Americans and none in Africans. Malaysians achieved a median survival of 16 weeks compared to 28 weeks in Americans and only eight weeks in Africans. Malaysian Chinese patients were all HBc Ab + ve. Other factors which may have played an etiologic role in the induction of primary liver cancer included alcohol, Chinese herbal medicines, aflatoxin and habitual use of medicated rubbing oils.

Adult↗
PubMed1982

Effect of methanol extraction residue of Bacillus Calmette-Guerin in advanced Hodgkin's disease.

One-hundred-ninety-six patients with Stage III and IV Hodgkin's disease were prospectively randomized to receive either treatment with the methanol extraction residue of Bacillus Calmette-Guerin (MER/BCG) or no immunotherapy. Prior to the MER/BCG randomization, patients received six courses of induction and two years of maintenance chemotherapy so that a group with a presumptively low tumor burden could be established. Only patients achieving a complete remission were evaluated. During the first two years of immunotherapy, the MER/BCG group had a relapse frequency twice that of controls. The overall crude relapse frequency and disease-free survival were similar between the two treatment groups. The MER/BCG dose schedule used in this study was associated with a high frequency of unacceptable toxicity. Ulcerations of greater than 1 cm occurred in one-third of the patients with associated pain, fever, and occasional lymphadenopathy. A high degree of patient noncompliance (36%) was observed. Age (P = 0.002), prior radiotherapy (P = 0.032), and chemotherapy (P = 0.044) were prognostic factors found to significantly influence remission duration. These factors were balanced between patients treated with immunotherapy and those who were not. MER/BCG therapy did not significantly delay or prevent relapse.

Adult↗
PubMed1982

Carcinoembryonic antigen as a marker in patients with breast cancer receiving postsurgical adjuvant chemotherapy.

Serial plasma CEA levels were determined over a period of 1-3 years in 114 patients receiving adjuvant chemotherapy for T1, 2 or 3a N+ MO breast cancer. CEA values were correlated with clinical status, scintiscans, and other biochemical parameters. CEA values greater than 2.5 ng/ml were considered abnormal. Forty-one patients had normal values throughout the adjuvant period. In 73 patients where abnormal values occurred, four different patterns were seen: (1) a statistically significant number (30/73) had initial elevations with a decreasing titer; (2) rising titer (10/73); (3) fluctuating titer of transient elevation (25/73); and (4) persistent elevation (8/73). Seventeen patients developed overt metastases, this was associated with a rising CEA in nine patients (P less than 0.002). CEA was more sensitive for predicting relapse than alkaline phosphatase or LDH. The correlation between CEA determination and the eventual development of metastatic disease is striking, and has implications for the design of future clinical trials. Results indicate that CEA could be used to identify high risk patients, to estimate efficacy of chemotherapeutic regime, and to determine optimal duration of therapy.

Antineoplastic Agents↗
PubMed1982

Adjuvant chemotherapy for operable breast cancer in premenopausal women.

Surgery alone does not cure breast cancer, and adjuvant chemotherapy has changed the management of this disease. Data obtained in 81 premenopausal women with operable breast cancer, treated at our clinic, are presented. Patients with axillary node disease were treated on three different protocols: cyclophosphamide + methotrexate + fluoro-uracil + vincristine + prednisone (CMFVP), cyclophosphamide + methotrexate + fluoro-uracil (CMF), and CMF + immunotherapy with methanol extract residue of BCG (CMF + MER). Patient discriminants and treatment regimens are discussed. Analysis of the results obtained in 49 patients in one study showed an extension of disease-free survival to 4,25 years, that CMFVP was superior to CMF with or without MER, and that immunotherapy was not beneficial. The literature is briefly reviewed and the motivation for our newer studies stated.

Adult↗
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

Mesnum as a protector against kidney and bladder toxicity with high-dose ifosfamide treatment.

Thirty-two patients with advanced cancer were treated in a phase I-II trial with ifosfamide plus mesnum. At doses up to 300 mg ifosfamide/kg the administration of mesnum prevented most of the expected kidney and bladder toxicity. With this high dose range hemopoietic dose-limiting. Only one of twelve evaluable patients with breast cancer showed definite therapeutic benefit. Complete remission or partial remission was seen in three patients with non-Hodgkin lymphoma and one patient with Hodgkin's disease.

Adult↗
PubMed1982

Phase II evaluation of dibromodulcitol, ICRF-159, and maytansine for sarcomas.

Patients with objectively measurable soft tissue sarcomas, osteosarcomas, chondrosarcomas, and mesotheliomas were treated with dibromodulcitol (DBD) (180 mg/m2 p.o. days 1-10 q4 wks.). ICRF-159 (300 mg/m2 p.o. tid days 1-3 q4 wks), or maytansine (MAYT) (1.5 mg/m2 I.V. q3 wks.). Forty-five evaluable patients received DBD, 47 MAYT, and 37 ICRF-159. Only patients who had had their histopathologic diagnoses confirmed by a pathology reference panel were included in the final analysis. Two patients had objective partial responses: a patient with osteosarcoma who responded to DBD and a patient with fibrosarcoma who had a partial response of brief duration to ICRF-159. Approximately 70% of the patients treated with each drug were of ECOG performance status 0 or 1, and over half had moderate or worse toxicity. It seems unlikely that these drugs have significant therapeutic activity for common mesenchymal malignancies.

Adolescent↗
PubMed1982

PALA in advanced breast cancer. A phase II pilot study by the ECOG.

Thirty-three patients with advanced breast cancer were treated with PALA at a schedule of 1500 mg/m2/day for 5 days every 3 weeks. Time to progression varied from 4-305 days from the start of therapy (median, 49 days) with 3 partial responses (9%) for 231, 180, and 64 days, respectively. Toxicity was considerable, with severe skin and mucosal toxicity occurring in 48% and 39% of cases, respectively. Hematologic toxicity was usually mild. We conclude PALA has limited activity in advanced breast cancer, but may be of advantage in combination chemotherapy because of the relative bone marrow-sparing properties.

Adult↗
PubMed1982

Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study.

A randomized comparison of the relative efficacy and toxicity of daunorubicin (DNR) at 30 or 45 mg/sq m or adriamycin (ADM) at 30 mg/sq m, given on the first 3 days of a 7-day continuous infusion of cytosine arabinoside (ara-C) at 100 mg/sq m/day, shows the outcome to be dependent on anthracycline, dose, and patient age. DNR 45 is significantly better than DNR 30 or ADM 30 for inducing complete remissions (CR) in patients younger than 60 yr, (72%, 59%, 58% CRs, respectively). DNR 30 is better than DNR 45 or ADM 30 for inducing CR in patients older than 60 yr (47%, 31%, 35%, respectively). There was a corresponding shift in the induction mortality for the age, dose, and anthracycline groups. Adriamycin was significantly more toxic to the gastrointestinal tract than daunorubicin. The duration of complete remission, with cyclic courses of maintenance therapy, was independent of the patient's age, the dose, or choice of anthracycline used in induction, and of whether the maintenance courses were given every 4 wk or every 8 wk.

Adolescent↗
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↗
PubMed1982

Combined doxorubicin and radiation therapy in malignant pleural mesothelioma.

Ten patients with histologically confirmed inoperable malignant mesothelioma of the pleura were treated with doxorubicin and fractionated radiotherapy courses. Three patients derived significant clinical benefit from this treatment, although only one of the three had measureable tumor shrinkage that could be defined as partial response. Two of the ten patients showed only progressive disease, while the remaining five showed disease stabilization for 30--100 weeks. The treatment was subjectively well-tolerated and hematopoietic toxicity was acceptable. Radiation pneumonitis did not occur. Two of the four patients who lived greater than or equal to 94 weeks developed fibrosis of the irradiated hemithorax. The median survival time for all patients was 46 weeks. Although the combined treatment could be given with acceptable toxic effects and although four patients benefited from it, the best objective assessment, namely, survival time, did not appear to be adequately influenced to justify an extension of this series.

Adult↗
PubMed1982

A pilot study of mitomycin-C and tamoxifen (MT) versus dibromodulcitol, adriamycin, and tamoxifen (DAT).

The aim of this study was to compare the treatment efficacy of mitomycin-C plus tamoxifen (MT) to adriamycin, dibromodulcitol and tamoxifen (DAT) in previously treated patients with metastatic breast cancer. Thirty-two patients with measurable or evaluable disease were entered on the study. Twenty-three were prospectively randomized to receive DAT (Group 1) or MT (Group 2). Nine patients with prior exposure to adriamycin were directly assigned to receive MT (Group 3). Thirty-one patients were evaluable for response and toxicity. The hematological toxicities were comparable among the three treatment groups. DAT gave more nausea and vomiting than MT. One patient developed irreversible fatal congestive heart failure while receiving DAT. The response for Group 1 was 5/11, Group 2, 3/12, and Group 3, 3/8. The duration of response for patients in Group 1 was 455+, 315, 251, 239, 231 days, in Group 2 it was 328+, 144+, 119, and in Group 3 it was 35+, 84, and 112 days. The median time to treatment failure did not differ significantly between Group 1 (114 days), 2 (83 days) and 3 (61 days) (p = 0.24). The median survival time was similar among the three groups (p = 0.41). This pilot study suggests that MT and DAT are both effective treatment programs in patients with metastatic breast cancer who have failed prior chemotherapy regimens.

Antibiotics, Antineoplastic↗
PubMed1981

The superiority of CCNU in the treatment of advanced Hodgkin's disease: Cancer and Leukemia Group B Study.

In a randomized study, the effect of single agent therapy, with CCNU was compared with that of BCNU in previously treated patients with advanced Hodgkin's disease. The dosage of CCNU was 100 mg/m2 p.o. q. 6 weeks and of BCNU, 200 mg/m2, p. 6 weeks with dose modification adjusted to individual tolerance. For 60 evaluable patients the response rate (complete and partial was 60 for CCNU and 28% for BCNU (p = 0.025); median duration of response was 4.5 months and 2.0 months, respectively (P = 0.26). Median survival for responders was 11.0 months and for non-responders 5.0 months. No major difference was observed in hematologic toxicity between the two compounds. Used as single agents in equitoxic dosages, CCNU is superior to BCNU for the treatment of previously treated advanced Hodgkin's disease, and CCNU has the additional advantage of oral administration.

Adult↗