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Biomedical subjects

T Palangie

Publications and source records attributed to T Palangie.

At least 55 records · Page 3Linked to original sources

[Metastatic breast cancer: a comparative study of the efficacy of tamoxifen and the sequential administration of tamoxifen and medroxyprogesterone acetate].

Seventy-nine patients with an histologically proven disseminated breast cancer, never treated before with additive hormonal therapy, entered into a randomized trial between june 1981 and december 1982. In the first group 44 patients were given continually a daily dose of tamoxifen (TAM) of 20 mg/m2. In the 2nd group 35 patients were given a daily dose of TAM of 20 mg/m2 for 15 days and then an oral daily dose of medroxyprogesterone acetate of 350 mg/m2 for the next 15 days. In both groups I and II, the treatment was stopped at the first manifestation of progression of the disease. The hormonal receptor status was determined in 30 patients of the group I and 23 patients of the group II. An objective response to treatment was observed in 48 per cent of the patients of the group I and 60 per cent of the group II. This difference is not significant (X2 = 1,05). However, the mean duration of therapeutic response is significantly higher in the group II (p = 0,01).

Adenocarcinoma↗

[Metastatic breast cancer: controlled trial of chemotherapy with and without hormones].

Two hundred and twenty-three patients with disseminated breast cancer entered in a randomized trial: Group I: 130 patients were given a monthly 5 day- course of a cytotoxic chemotherapy protocol including Adriamycine, Vincristine, Cyclophosphamide, 5 Fluoro-uracile (A.V.L.F.); Group II: 93 patients were given alternatively the same program and a non cross resistant program including: VM 26, Mitomycine C, Methotrexate (V.M.M.). The patients of these groups were randomized into three subgroups: Subgroup O: chemotherapy alone; Subgroup N: chemotherapy + Tamoxifen (20 mg/m2/day); Subgroup NN: chemotherapy + Tamoxifen + Norethisterone (40 mg/m2/day). Objective response rates to cytotoxic chemotherapy were respectively of 65 per cent and 68 per cent in groups I and II of chemotherapy. Further more mean-duration of response and survival were not different. Objective response rates were comparable in the three subgroups of chemo-hormonotherapy. However, the survival was significantly better in the subgroup N (with Tamoxifen) when compared with the subgroup O (without hormonotherapy), and marginally better (p = 0,09) when compared with the NN subgroup (with Tamoxifen + Norethisterone).

Adult↗

[Phase-1 study of the tolerance for increasing doses of recombinant human alpha 2 interferon in patients with advanced cancer].

Thirteen patients with malignant tumors were entered into a phase I trial with recombinant DNA human alpha 2 interferon (IFN alpha 2). The patients were given I.M. escalating doses of IFN alpha 2 ranging from 1-10(6) to 200-10(6) IU with a 72 hours washout between injections. In the majority of the patients, subjective symptoms were noted: fever, headache, chills, nausea, myalgias. Asthenia, anorexia, drowsiness appeared after the highest doses and disappeared without any sequellae. Leucopenia and thrombopenia were seen in 11 out of 13 patients. Hepatocellular toxicity was observed in 9 cases. Cardiac and vascular functions were not impaired by IFN alpha 2. The pharmacokinetic studies showed a maximum serum concentration between 4 and 6 hours after injection and the peak value was directly proportional to the dose. No neutralizing INF alpha 2 serum factor was detected during the treatment. The peak value for serum beta 2 microglobulin occurred 48 hours after and the N.K. activity was variably modified by IFN alpha 2 injections. A major clinical response was observed in 1 case, a minor response in 3 cases and a stabilisation of the disease in 4 cases.

Adult↗

Administration of fibroblast interferon to patients with advanced breast cancer: possible effects on skin metastasis and on hormone receptors.

Eleven patients with metastasized breast cancer received 8 intramuscular injections of 6 x 10(6) units of human fibroblast interferon over a period of 40 days. The injections did not cause local irritation or inflammation. Fever occurred in only 1 of the 11 patients. Although several types of metastases were monitored, only skin nodules consistently (10 out of 11 patients) exhibited changes that were suggestive of a therapeutic effect of the treatment regimen: either a simple decrease in size of some nodules or central necrosis accompanied by an inflammatory reaction. NK-activity of peripheral blood leukocytes was significantly increased after administration of the first dose; the effect of subsequent injections was less clear. Receptors for estrogens and progestogens were increased in the tumor biopsies of 2 out of 2 and 5 out of 6 patients tested respectively.

Breast Neoplasms↗

[Ovarian adenocarcinoma stage III and IV treated by a combination of adriamycin, cyclophosphamide, 5-fluorouracil and cis-DDP. Therapeutic role of cis-DDP in this combination].

Seventy-one patients with advanced ovarian carcinoma (stage III and IV) were included in this study between october 1977 to june 1981. Surgical resection was initially judged impossible in 17 cases, partial in 38 and complete in 16 cases. Forty-seven patients (group A) were given a monthly course of a three drug combination including adriamycin (ADM: 40 mg/m2 day 1), cyclophosphamide (CPM: 400 mg/m2 on days 2, 3, 4), 5 fluoro-uracile (5 F.U.: 600 mg/m2 on days 2, 3, 4). Twenty four patients (group B) were given the same drug combination plus cis-DDP (80 mg/m2 on day 4). After failure of the treatment in group A, 20 patients received the same combination chemotherapy as in group B (group C). The overall response rate of treatment was comparable in both groups A and B: 62 per cent (29/47) in group A including 32 per cent of complete clinical responses (15/47), 66 per cent in group B (16/24) including 33 per cent of complete clinical responses (8/24). The median of survival was 24 months in group A and 21 in group B. Twenty per cent (4/20) of the patients in group C had an objective response to cis-DDP after failure of the combination of adriamycin-cyclophosphamide-5 fluoro-uracile. The quality of initial surgical resection, the size of non resectable tumors and the clinical response to treatment appear as parameters of significant prognostic value.

Adenocarcinoma↗

[Metastatic breast cancers: comparison of the prognostic significance and the sensitivity to chemotherapy according to the presence of estradiol and progesterone receptors].

102 patients with disseminated breast cancer entered this retrospective study. An estrogen receptor (ER) assay was realized in 91 patients and a progesterone receptor (PgR) assay in 90 cases; 44 per cent of the patients were considered as ER+ and 29 per cent as PgR+; 56 per cent were considered as ER- PgR-. The objective response rate to cytotoxic chemotherapy after 4 months of treatment was 66 per cent for ER-, 73 per cent for ER+, 67 per cent for PgR- and 74 per cent for PgR+. However, the mean duration of response was significantly shorter for ER- patients, and no difference appeared between PgR+ and PgR- patients. The acturial survival curves demonstrated a favorable prognostic significance of ER+ as compared to ER- p = 0,03), but the difference was slightly more significant for PgR+ as compared to PgR- (p = 0,008). The prognostic significance of PgR in patients with advanced breast cancer treated with cytotoxic chemotherapy does not appear to be related to the sensitivity to this treatment.

Antineoplastic Agents↗

[Disseminated breast carcinoma. Study of activity of immunotherapy with BCG and duration of the phase of intensive chemotherapy. Results of a randomized trial (author's transl)].

144 patients with disseminated breast cancer entered into a 4 arm randomized trial. They received a chemotherapy protocol combining monthly administration of adriamycin (40 mg/m2 on day 1), vincristine (1,2 mg/m2 of day 2), cyclophosphamide (400 mg/m2 on days 3, 4, 5), 5 fluorouracil (500 mg/m2 on days 3, 4, 5). Patients in groups I and III were given 6 courses at monthly intervals and patients in groups II and IV were given 10 courses. Then they were given indefinitely a monthly course of cyclophosphamide (100 mg/m2/day for 7 days), melphalan (2,5 mg/m2/day for 7 days), methotrexate (25 mg/m2/week for 3 weeks). Patients in groups III and IV were given 3 applications of living BCG disposed on a scratched area between courses of chemotherapy. The overall response rate was 73 per cent (105/144) and was comparable in each treatment group. The mean duration of response and the mean survival times were comparable in each treatment group. The mean duration of response and the mean survival times were comparable in the 4 treatment arms. The initial tumor mass, serial levels of CEA and skin responses to recall antigens were of prognostic significance. Age, hormonal status, initial lymphocytes count had no prognostic significance.

Adult↗

[Inflammatory breast carcinoma treated with a combination of chemotherapy and radiation therapy. Results of a randomized trial studying the therapeutic role of an immunotherapy with BCG (author's transl)].

Seventy-seven patients with inflammatory breast carcinoma were included in a randomized trial between march 1977 and september 1979. All patients were treated with the same association of chemotherapy and radiation therapy. Chemotherapy included adriamycin on day 1 (45 mg/m2), vincristine on day 2(1,2 mg/m2), cyclophosphamide on days 3, 4 and 5 (400 mg/m2/day) and 5 fluoro-uracil on days 3, 4, and 5 (500 mg/m2/day). Each course of chemotherapy was repeated every 28 days for one year. Patients were then given a maintenance course of chemotherapy for one year. Radiation therapy with CO60 was applied after 4 courses of intensive chemotherapy. The dose distributed was 70 Gy over seven weeks. During radiation therapy, chemotherapy was administered according the same scheme, but adriamycin was excluded. All the patients were randomly distributed into two groups before treatment: group I patients received chemotherapy and radiation therapy alone; group II patients received chemotherapy and radiation therapy plus living BCG vaccinations. After chemotherapy, inflammatory manifestations disappeared in 51% of cases. The mean of disease-free interval was 26 months and the overall survival mean 34 months. No difference in favor of the BCG treated group was noted. Lymph node involvement, age, hormonal status, response to tuberculin, and disappearance of inflammatory signs after 4 months of chemotherapy are of insignificant prognostic value.

Adult↗

[Chemotherapy of advanced head and neck cancer with a combination of bleomycin, vincristine, methotrexate and hydroxyuree or cis-dichloro-diamino-platinium. Analysis of local and general parameters of prognosis (author's transl)].

Sixty-six patients with advanced head and neck cancer 57 of whom had failed to respond to prior irradiation, were treated according to two protocols. Group I consisted of 41 patients in relapse who received a monthly combination of bleomycin, vincristin, methotrexate and hydroxyuera. The 16 patients (in relapse) of group II received a monthly combination of bleomycin, vincristin, methotrexate and cis-DDP. Nine patients in group III (patients never treated) received the same combination as in group II. Recurrences were local and/or regional in 37 cases out of 57. Before any chemotherapy, 62 p. 100 of the relapsing patients gave negative responses to delayed hypersensitivity skin tests to recall antigens. Fifty-one p. 100 showed evidence of a nutritional disturbance. Overall objective responses were 31 p. 100 (18/41) in group I and 43 p. 100 (7/16) in group II (this difference was not significant). In group III, 8 patients out of 9 were defined as objective responders. Overall mean survival in group I and II was 5.8 months and showed no difference between the two groups. Response rate and survival were dependent on skin test responses, nutritional status and sites of recurrence. Survival of patients with metastatic recurrence was significantly higher than survival in patients with local recurrence. Toxicity was essentially dependent upon local sequelae of prior irradiation. The results of this trial indicate that despite the effectiveness of such combinations of cytotoxic drugs, the indications for palliative chemotherapy must be discussed in the light of local and general prognostic parameters.

Bleomycin↗

[Effectiveness of VM 26, mitomycine C and methotrexate in advanced breast cancer refractory to a four drug combination (author's transl)].

56 patients with advanced breast carcinoma, primarily or secondarily resistant to a four drug combination including Adriamycine, Vincristine, Cyclophosphamide and 5 Fluoro-Uracile, entered a phase II trial using association of VM 26, Mitomycine C and Methotrexate. The tolerance was generally good, but 17 clinical manifestations of toxicity were observed out of 216 cycles of treatment (7,8%). THese mucosal and haematologic disorders have incitated to secondarily reduce of 20 per cent the current doses of Methotrexate. 28 patients out of 53 (53%) have objectively responded to treatment and in 16 of them, major responses (C.R + P.R. > 50%) were observed (30%). The median of survival responders was 11 months. The critical analysis of responses by site showed 53 per cent of objective regression of lung metastasis which appears higher than the incidence of response observed after treatment with drug combination including Adriamycine.

Adult↗

[Non resectable colonic cancer. Results from a test of chemotherapy with simultaneous prescription of VM26, methyl-CCNU and 5 fluoro-uracile (author's transl)].

Thirty nine patients with non resectable colonic carcinoma entered into a phase II combination chemotherapy trial. The patients were treated with a sequential cyclic combination of 3 drugs: VM 26 (60 mg/m2), methyl-C.C.N.U. (120 mg/m2) and 5 fluoro-uracile. Seventeen patients out of 39 (43.6%) are considered as good responders. The median survival time of the overall of this group is 12.6 months; it is of 15,6 months for good responders and of 7 months for non responders. The simultaneous application of B.C.G. do not change neither the level of responses nor the median of survival time. The good tolerance of this protocol let us to propose this combination as an adjuvant treatment for patients surgically treated for a Dukes'C colonic cancer.

Adult↗

[Non resectable squamous cell carcinoma of the bronchus. Study of the immunological status as prognosis factor and attempt at immunorestoration with B.C.G. (author's transl)].

Sixty-six patients with bronchus non resectable squamous cell carcinoma (stage III and 14) entered into a protocol of chemotherapy depending upon their initial immunological status. These patients with (+) skin tests to recall antigens were allocated to a chemotherapy programme; patients with initially (-) skin tests were submitted to a protocol of immunorestauration with B.C.G. After three weeks of B.C.G. applications on scarifications 17 patients out of 31 presented with (+) skin tests and were considered as immunocompetent patients. All the patients then were submitted to chemotherapy protocol. The comparison of different median of survival have demonstrated that immune status appears as the more fundamental prognosis factor; the B.C.G. is able to transitory restore the immunity of the patients without any modification of the tumour progress. The median of survival of patients with initially (+) skin tests was ten months, and only two months for patients with (-) skin tests. The median of survival of patients whom immunity was restored with B.C.G. was nine months. The results of this trial let us to propose new strategy for treatment of these patients.

Adult↗