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Biomedical subjects

T Palangie

Publications and source records attributed to T Palangie.

At least 37 records · Page 2Linked to original sources
PubMed1991

[Phase I trial of a recombinant human interleukin 2. Results in patients with disseminated solid tumors].

A phase I trial of Roussel-Uclaf recombinant human interleukin 2 (IL 2) was performed on 31 cancer bearing patients of the Institut Gustave-Roussy, Villejuif, and the Institut Curie, Paris. This study allowed to define a schedule for administration of IL 2 in continuous infusion over 5 day cycles. This schedule is manageable in patients without major visceral failure. It is reproducibly feasible in conventional medical oncology units, without specialized intensive care facilities. Toxicities, although numerous, are acceptable for IL 2 doses below 24,000,000 IU/m2/day. There is a close relationship between secondary effect severity and IL 2 doses received. Main toxicities were: fever with chills, fatigue and general discomfort in 23 patients, nauseas and vomiting in 12, diarrhea in 10 and cutaneous rashes with erythema and dermal vascularitis in 13. One peculiar feature of this study was the minimal occurrence of manifestation related to leaky capillary syndrome prominant in other studies. Oliguria, functional renal failure and edema were observed in only 4 patients with functionally unique kidney. Five patients had severe anemia, 2 grade III thrombocytopenia, 1 grade IV hepatic cytolysis, 4 severe confusion episodes and 2 hypothyroidism with anti-thyroid microsome auto-antibodies. All these toxicities were reversible after withdrawal of IL 2 treatment. During this phase I trial, 3 therapeutic objective responses were observed, all 3 occurring in patients with metastatic melanoma treated with IL 2 doses equal to, or above 16,000,00 IU/m2/d. Recombinant IL 2 Roussel-Uclaf thus can be administered through a simple, manageable and efficient regimen.

Adolescent↗
PubMed1991

Neoadjuvant chemotherapy in operable breast cancer.

Primary chemotherapy in localised breast cancer may prevent tumour spread during surgical treatment and reduce proliferation of micrometastases. A randomised clinical trial, in 196 premenopausal and postmenopausal patients with operable (T2-3, N0-1b) breast cancer, was started in November 1983 at the Institut Curie to compare neoadjuvant and adjuvant regimens of chemotherapy with radiotherapy with or without surgery. The patients have been followed up for 35-70 months (median 54). A neoadjuvant group received two monthly cycles of intravenous doxorubicin/cyclophosphamide/5-fluorouracil before locoregional therapy and four cycles subsequently. Six monthly cycles following locoregional therapy were administered to the adjuvant group. Because of inclusion of postmenopausal and/or node-negative patients, compliance was less than optimal in 39 patients who were analysed separately according to actual dose received. Tumour response, evaluated after two cycles of neoadjuvant chemotherapy, was significantly associated with dose (P = 0.003). Survival showed a slight non-significant advantage for the neoadjuvant group. Survival plotted by actual dose was also similar. Neoadjuvant chemotherapy was safe and at least as effective as the adjuvant regimen. Patients have been accrued to a subsequent larger trial of chemotherapy as first-line treatment.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Acceleration of hemopoietic recovery after autologous bone marrow transplantation by low doses of peripheral blood stem cells.

Twenty patients with advanced malignant disease submitted to autologous bone marrow transplantation with marrow either unpurged (10 patients) or purged in vitro with mafosfamide (10 patients) after ablative chemotherapy, received simultaneously autologous peripheral blood stem cells (PBSC) collected during one to three 3 h cytapheresis procedures. The kinetics of the hematological recovery of these patients were compared to those of a group of patients suffering from similar diseases and grafted in the same institution with either unpurged marrow only (14 patients) or purged in vitro with mafosfamide (six patients). The median times to reach 10(9)/l leukocytes, 0.5 x 10(9)/l polymorphs, and 50 x 10(9)/l platelets were reduced by 10, 10, and 13 days, respectively, in patients transfused with both autologous bone marrow and peripheral blood stem cells as compared to those receiving bone marrow only. A reduction in the numbers of days spent in hospital post-transplantation (p less than 0.01), of days of fever greater than 38 degrees C (p = NS), and of platelet (p = 0.07) and of red blood cell transfusions (p less than 0.01) were also observed in the group of patients grafted with bone marrow and PBSC.

Adolescent↗
PubMed1989

[Metastatic breast cancer. Chemotherapy with adriamycin, vindesine, cyclophosphamide and 5 FU. Value of continuous 5 FU perfusion. Results of controlled trials].

Ninety-four patients with metastatic breast cancer were entered in a prospective randomised trial comparing 2 schedules of the same combination chemotherapy. Group I consisted of 46 patients, treated in a monthly three day course with adriamycin (ADM), cyclophosphamide (CPM), vindesine (VDS) and 5 fluoro-uracil (5 FU). Group II included 48 patients who received the same total monthly doses in 4 injections of ADM, CPM, VDS on days 2, 5, 16, 19 of each month together with a continuous infusion of 5 FU over a total of 10 days (days 1-5 and 15 and 19). Patient characteristics in the 2 groups as regards essential prognostic parameters were identical. We observed no difference in myelosuppression between the 2 groups. There were fewer gastrointestinal side effects in group II. Whereas complete alopecia occurred in 100% of patients in group I, only 33% of patients with the fractionated schedule totally lost their hair. The objective response rates at 8 months were 75 and 74% respectively, but the complete response rates (17.5 versus 28%) showed an advantage for group II. This advantage was not statistically significant. Durations of response were 15 months (group I) and 18 months (group II) and the median survival was 27 months in both. We conclude that prolonged low dose and fractionated administration of chemotherapy over 2 five day courses per month improves the therapeutic index and diminishes side effects.

Adult↗
PubMed1987

[Randomized trial comparing mitoxantrone with adriamycin in advanced breast cancer].

Between June, 1983 and December, 1984, 142 patients with metastatic breast cancer were enrolled in this controlled, multicentre trial. The patients were given cyclophosphamide (600 mg/m2) plus 5-fluorouracil (750 mg/m2) and either adriamycin (45 mg/m2) (CAF) or mitoxantrone (13 mg/m2) (CNF). All drugs were administered intravenously on the same day every 21 days. An objective response was obtained in 28 of the 66 assessable patients (42.8%) in the CAF group (with 9 complete responses) and in 30 of the 71 assessable patients (42.2%) in the CNF group (with 6 complete responses). At the moment, the median duration of response is 37+ weeks with CAF and 34+ weeks with CNF (n.s.). It is still too early to evaluate the duration of survival. The major toxicity was bone-marrow suppression which required delayed administration or dose reduction in 40-45% of the patients. Nausea and vomiting were of comparable frequency in both groups, but they appeared to be less severe with CNF. Alopecia was less frequent and less pronounced in the CNF group. Moderate and clinically non-significant reduction of left ventricular ejection fraction was observed at cardiac ultrasonography or scintigraphy in 6 (10%) CAF patients and 2 (3%) CNF patients. None of the patients developed heart failure. Our results show similar response rates and toxicity with CAF and CNF. However, the mitoxantrone-containing treatment had a slight advantage as regards alopecia and the severity of nausea and vomiting.

Adult↗
PubMed1987

Treatment of metastatic malignant melanoma with recombinant interferon alfa-2b.

Twenty-six patients with histologically proven metastatic malignant melanoma were included in a phase II trial of interferon alfa-2b (Intron A; Schering-Plough). Patients were given 10 X 10(6) IU/m2 of interferon alfa-2b subcutaneously three times a week until major intolerance or progression of disease. General signs of intolerance were seen in all patients; hematological toxicity with leukopenia (below 1,800/mm3) and/or thrombocytopenia (below 600/mm3) was seen in six patients and therapy was interrupted in one patient. Mild liver toxicity was seen in most patients after two weeks of treatment. These manifestations disappeared 1-2 weeks after treatment was discontinued. Twenty-four patients were evaluable for response. There were two complete responses; one skin and one lymph node going into remission for 12 and 12.5 months respectively. A partial response was observed in five cases lasting 1, 1.8, 2, 3 and 5 months respectively. These results indicate a potential role for interferon alfa-2b in treating patients with metastatic malignant melanoma, however, further trials are required to determine the optimum dose and schedule of administration and use of interferon alfa-2b in combination with cytotoxic drugs.

Drug Evaluation↗
PubMed1987

[Metastatic breast cancer. Modality of association of chemotherapy and hormonotherapy. Results of a controlled trial].

Two hundred forty-seven patients with metastatic breast cancer entered into the controlled trial. Its aim was to define the optimal modality of association between hormonotherapy and chemotherapy. Chemotherapy was given a monthly course of an association including: adriamycin: 45 mg/m2 on day 1; cyclophosphamide: 400 mg/m2 on days 1, 2, 3; 5 fluoro-uracil: 500 mg/m2 on days 1, 2, 3; methyl-prednisolone: 80 mg/m2 on days 1, 2, 3. Hormonotherapy was tamoxifen (TAM) at the daily dose of 30 mg. 82 patients in group I were given TAM alone for 4 months and then chemotherapy + TAM; 83 patients in group II were given simultaneously TAM + chemotherapy; 82 patients in group III were given chemotherapy alone for 8 months and then TAM + chemotherapy. The response rates in groups I, II and III were respectively of 59, 74 and 62%. The difference in favour of group II was marginally significant. The survival curves were significantly higher in group II and III than in group I (P = 0.04). This result appears as the consequence of the poor prognostic of the sub-group of 45% patients who did not respond to TAM. These results seem to emphasize that target cells of hormonotherapy are not target cells of chemotherapy and that this difference is persisting for long time under treatment, that others modalities of association between chemotherapy and hormonotherapy must be studied with the aim of reducing the kinetic's implication of chronic administration of TAM.

Adult↗
PubMed1987

[Adriamycin and chemotherapy of breast cancer. Personal experience].

The clinical results achieved for more than 10 years in patients with metastatic breast cancer have clearly demonstrated the efficacy of chemotherapy programs including Adriamycin. This therapeutic effect was confirmed when it is given in protocols of adjuvant chemotherapy. Some complementary studies have demonstrated 4 points in order to define the better modality of application of Adriamycin: the results of induction chemotherapy's protocols are not better if the treatment is given beyond 6 months, the alternative administration of 2 noncross resistant programs of chemotherapy is no more efficient than the continuous administration of a program of chemotherapy including Adriamycin, the increase of the doses of cytotoxic chemotherapy does not change the median of survival of the patients, the fractionated administration of Adriamycin is as effective as the conventional administration of the same total dose.

Adult↗
PubMed1986

Clinical phase II trial of recombinant DNA interferon (interferon alpha 2b) in patients with metastatic malignant melanoma.

Twenty-four patients with histologically proven metastatic malignant melanoma were included in a Phase II trial of human DNA recombinant interferon (rDNA IFN alpha 2). They were given 10 X 10(6) IU of IFN alpha 2 subcutaneously three times a week until progression of disease or major intolerance developed. Twenty-two patients were evaluable for toxicity and response. General manifestations of intolerance were seen in all the patients. Hematologic toxicity was seen in six patients and therapy had to be interrupted in one patient. Mild liver toxicity was seen in most patients after 2 weeks of treatment. These manifestations disappeared within 2 weeks after treatment was discontinued. A partial response was seen in four cases lasting 2, 4, 4, and 5 months, respectively. There were two complete responses (one skin, one lymph node metastasis) lasting 20 and 6 weeks, respectively. These results indicate a potential role for rDNA IFN alpha 2 in treating patients with metastatic malignant melanoma. However, further trials are required to determine the optimal dose and schedule of administration and modalities of combination.

Adult↗
PubMed1986

[Breast cancer. Development of the concentration of hormonal receptors under cytotoxic chemotherapy].

38 patients with locally advanced breast cancer, were treated with a program of cytotoxic chemotherapy including Adriamycin, Cyclophosphamide, 5 Fluoro-uracile and Prednisone. The concentration of hormonal receptors (Estrogen ER and Progesterone receptor PR) in the tumor were studied before starting the chemotherapy and after one to 9 courses of chemotherapy. This therapeutic response rate was not related to the initial level of ER and PR. After chemotherapy, we observed an increase of ER level in 14 cases out of 29 (59%), of PR level in 17 out of 32 cases (53%); A therapeutic response is observed in 11 cases out of 17 when the PR concentration is increased and in 3 cases out of 15 when the PR concentration was either stable or decreased. These observations let us to suppose a selective initial activity of chemotherapy on lesser differentiated tumor cells.

Adult↗
PubMed1986

[Phase II trial of an ambulatory treatment with 5-fluorouracil administered by continuous perfusion combined with vindesine and cyclophosphamide].

Thirty-four patients with histologically proven metastatic breast cancer, were included in this phase II trial. They were given a five day course of continuous infusion of 5 fluoro-uracile at the daily dose of 500 mg/m2 associated with vindesine 2 mg/m2 on day 2 and 5, cyclophosphamide 300 mg/m2 on day 2 and 5. The treatment was repeated every 15 days after haematological and biological assay. Twenty-six patients were objectively resistant to previous cytotoxic chemotherapy including adriamycin and 6 patients had recently received adjuvant therapy. A major objective response was observed in 17 cases (50%) (4 complete responses, 13 responses greater than 50%) and a response less than 50% in 7 cases. The median duration of response is over 8 months. After 8 months of median follow-up, the median of survival is not defined.

Adult↗
PubMed1986

[Advanced cancer of the prostate: chemotherapy].

For patients with advanced prostatic carcinoma who have become resistant to hormone therapy, chemotherapy is probably the most appropriate treatment. Several drug administration modalities and associations with hormonotherapy are analyzed. In a multiple drug (adriamycin, VM 26, 5-fluoro-uracile and cyclophosphamide) chemotherapy trial, 25 out of 31 hormone resistant patients showed objective as well as subjective responses. Survival was significantly higher in this group of patients than in patients who did not respond to this chemotherapy association.

Antineoplastic Combined Chemotherapy Protocols↗