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Biomedical subjects

M Clavel

Publications and source records attributed to M Clavel.

At least 73 records · Page 4Linked to original sources
PubMed1991

Intravenous interleukin-2 just after high dose BCNU and autologous bone marrow transplantation. Report of a multicentric French pilot study.

This multicentric pilot study was conducted in order to evaluate the feasibility of early interleukin-2 (IL2) after high dose chemotherapy requiring autologous bone marrow transplantation (ABMT). BCNU at 800 mg/m2 was followed, 3 days later, by the reinjection of the bone marrow cells. At day 4, IL2 at 18 x 10(6) i.u./m2/day was given as a continuous infusion during a minimum of 6 days (first phase of study) or for 6 more days after 1 day break (second phase of the study). Twenty patients were included. Toxicity was not negligible, with one toxic death, but IL2 therapy does not damage the haematological recovery of most patients. However, a 6-day IL2 treatment period only appears tolerable. In 18 evaluable patients, three responses were observed: one complete response (CR) of short duration in a non-Hodgkin's lymphoma, one CR (24 months +) and one partial response (PR) (6 months) in two patients with metastatic gastric adenocarcinoma. This study confirms that IL2, restricted to a 6-day treatment period, is feasible immediately after high-dose chemotherapy requiring ABMT without haematological problem in most patients. The response rate was unexpected for a pilot study and this combined therapy obviously requires further study.

Adult↗
PubMed1990

Toxic dermatitis induced by 10-ethyl-10-deaza-aminopterin (10-EdAM), a novel antifolate.

A new methotrexate analog, 10-ethyl-10-deaza-aminopterin (10-EdAM), was found to induce a particular form of skin toxicity different than the skin rash reported to result from methotrexate. At histologic examination, it was found to be a toxic dermatitis that clinically most often first appears on the lower legs but can occur anywhere in the body, especially if treatment is continued. Nine cases are reported. A specific risk factor could not yet be identified. Discontinuation of 10-EdAM administration leads to complete healing; concomitant corticosteroid treatment also induces healing.

Aged↗
PubMed1990

[Small cell lung carcinoma. Value of the evaluation of extension for the therapeutic strategy].

Small-cell lung carcinoma can be distinguished from other histological types of lung cancer because of its high metastatic potential. Initial staging procedures divide the patients into two main prognostic groups: the so-called "limited" (to the thorax) and the extensive disease patients. Based on the results of a prospective pilot study involving 182 patients and on a review of the literature, the authors discuss the usefulness of initial staging in increasing the number of detectable metastases, assessing tumour burden, evaluating treatment results and identifying prognostic factors. Complete tumour staging at the time of diagnosis appears to be very helpful for a better knowledge of the disease and better therapeutic decisions.

Adrenal Gland Neoplasms↗
PubMed1990

Phase II trials with flavone acetic acid (NCS. 347512, LM975) in patients with advanced carcinoma of the breast, colon, head and neck and melanoma.

Phase II trials of flavone acetic acid have been performed in a total of 87 patients including 17 with advanced breast cancer, 23 with advanced colorectal cancer, 25 with advanced malignant melanoma and 22 with advanced head and neck cancer. Patients with colorectal cancer and melanoma had received no prior chemotherapy; in breast and head and neck cancer patients prior chemotherapy had been given with a median of 5 and 2 drugs respectively. The schedule used was a once-weekly regime, with a dose of 4.8 gms/m2 given as a 1 hour infusion, together with alkalinization (with i.v. sodium bicarbonate) given before and after FAA. Reassessment was performed after 6 weekly doses, although in 23 patients fewer than 6 doses were given, because of early disease progression in 15, and undue toxicity in 5. An additional 3 patients died within 72 hours of having received FAA and, although the precise cause of death in each case was not established, FAA toxicity could not be excluded. Treatment was generally manageable, the major manifestations of toxicity comprising uncomfortable warmth and flushes, nausea, diarrhoea, and visual complaints. Hypotension was also documented in 8 patients. No objective responses were seen in any of the patient sub-groups, although disease-stabilization was seen in 3 patients with breast cancer, 1 patient with advanced colorectal cancer, 2 patients with advanced melanoma and 4 patients with head and neck cancer. Further Phase II studies, using a higher dose of 8.6 gm/m2 over 6 hours once weekly, are currently in progress in Europe.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

Phase II study of recombinant human interferon-gamma in metastatic renal cell carcinoma.

The efficacy of a low-dose regimen of human recombinant interferon-gamma was studied in 40 patients with metastatic or locally advanced renal cell carcinoma. Patients received 100 micrograms/m2/day as an infusion over 4 h. The intention was to find an active but tolerable regimen as a basis for future combination treatments with other cytokines or cytotoxic drugs. Activity of this low-dose schedule had been reported. In the absence of rapid progression, treatment was given for at least 3 months, and in case of stable disease it was continued for prolonged periods in order not to miss late remissions. Toxicity was generally mild, with fever and constitutional symptoms predominating. Therapeutic efficacy was low with only one partial remission. Three patients had stable disease over 6, 9, and 15 months. This low-dose schedule cannot be recommended for the treatment of renal cell cancer.

Adult↗
PubMed1990

[Prognostic factors in the response of a first line chemotherapy in advanced breast cancer].

Anthracyclines containing regimen are widely used in advanced breast cancer. The response to first line chemotherapy varies according to many individual factors and the theoretical response to a given protocol cannot predict the response of a patient. A randomized clinical trial (ERASME) was initiated in order to evaluate the more appropriate first line chemotherapy scheme in advanced breast cancer. Prognostic factors were included in a multiple logistic regression to explain the response after the first 3 chemotherapy courses (monthly FEC). Three factors were found to be statistically significant: adjuvant hormonotherapy, loco-regional metastases, adjuvant adriamycin containing regimen (pejorative prognostic factor). By combining these factors, this statistical model enables us to predict a response rate to a first line chemotherapy from 27 to 87%. Such a model can be taken into account in a decision-making procedure of first line chemotherapy in advanced breast cancer.

Aged↗
PubMed1989

A phase II study of spirogermanium in patients with advanced malignant lymphoma.

Spirogermanium was given as a 90 minute infusion to 47 eligible patients with refractory Hodgkin's (9 patients) or non-Hodgkin's lymphoma (38 patients). The schedule was 80 mg/m2 three times a week for the first two weeks and 100 mg/m2, 3 times a week, for the two subsequent weeks. In case of response or stable disease, the treatment was continued with biweekly infusions of 100 mg/m2 until tumor progression. In 64% of cases, three or more combinations had been previously administered; 66% of patients presented an extra-lymphatic spread of disease. Two patients with Hodgkin's disease showed a partial response of 11 and 23 weeks and two patients with non-Hodgkin's lymphoma achieved a complete response of 12 and 24 weeks. Overall, 14 patients showed a tumor progression within the first month of treatment. The main toxicity was neurological, with dizziness and lethargy during the infusion in 50% of cases. Hematologic toxicity was almost absent. Spirogermanium is ineffective in heavily pretreated patients with non-Hodgkin's lymphoma. The confirmed lack of activity in patients with refractory malignant lymphoma and the need of repeated and prolonged infusions definitely discourage the clinical use of the drug.

Adult↗
PubMed1989

[Chemotherapy of cancer of the breast in the metastatic phase].

Metastatic breast adenocarcinoma is a very chemosensitive tumor. Polychemotherapy (CT) is more active than mono-CT inducing a 50-60% response rate in naive chemotherapy patients. The response rate is increased by adding hormonotherapy (HT) to CT in hormone-receptors positive patients. Whether or not HT and CT should be concomitant or consecutive is still questionable. The overall survival remains poor (22-30 months) and no improvement happened during the last decades. A hope for the future is possible from 2 different concepts: high dose chemotherapy or intermittent CT with successive short inductions treatment and no maintenance therapy.

Adenocarcinoma↗
PubMed1988

[Cardiac toxicity of 5-fluorouracil. Review of the literature, 5 new cases].

The toxic effects of 5-fluorouracil - an antimitotic drug widely used in the treatment of cancer - mainly affect the digestive tract and the blood. The 5 new cases presented here may be added to the 57 cases of cardiotoxicity reported in the literature. The clinical manifestations always consist of constrictive chest pain resembling angina pectoris and associated with disorders of repolarization on electrocardiographic tracing recorded during the painful episodes. The outcome is usually favourable after discontinuation of treatment, but it may also be fatal. Reintroduction of the drug in 28 patients resulted in myocardial necrosis in 4 cases and in death due to cardiogenic shock in 4 cases. The frequency of such side-effects does not seem to be influenced by age, sex, route of administration and previous pathology including cardiovascular diseases. They usually occur at the beginning of treatment irrespective of the dose administered. The mechanism through which 5-fluorouracil exerts its cardiotoxic effects is unknown, and 3 hypothesis have been put forward: an immunoallergic reaction after a sensitization period, a coronary spasm directly induced by the drug or due to the release of a vasopressive substance, or a direct toxic effect on the myocardium and pericardium.

Arrhythmias, Cardiac↗
PubMed1988

Phase II study of iproplatin (CHIP, JM-9) in advanced testicular cancers progressing after prior chemotherapy.

Twenty-two patients with advanced testicular cancer received iproplatin at a dose of 180-240 mg/m2 every 4 weeks. All the patients progressed or recurred after chemotherapy including cisplatin. The most severe toxicity was thrombocytopenia with two toxic deaths after a first cycle of 240 and 180 mg/m2 respectively. Nausea and vomiting were almost universal but mild in intensity. One renal failure occurred 6 weeks after the first cycle while the tumor was progressing. No antitumor activity was observed in this heavily pretreated population of patients.

Adult↗
PubMed1988

Iproplatin and carboplatin induced toxicities: overview of phase II clinical trial conducted by the EORTC Early Clinical Trials Cooperative Group (ECTG).

Data of five phase II clinical trials on iproplatin and carboplatin, conducted by the ECTG, have been pooled in order to evaluate the extent of toxicities of these compounds. One hundred and seventy patients treated with iproplatin and 65 patients treated with carboplatin were evaluable. Most of them (81%) had been previously treated with chemotherapy. Doses ranged from 180 to 300 mg/m2 every 4 weeks for iproplatin, and from 350 to 450 mg/m2 every 5 weeks for carboplatin, according to the initial status of the patient. WHO criteria were used to grade toxic effects. Weekly blood counts were performed, and lowest observed counts were analysed by non-parametric methods. Censored data were analysed by actuarial methods. Thrombocytopenia was the dose-limiting toxicity and was dose related. Leucopenia was less severe. The risk of thrombocytopenia varied largely amongst patients, and could be predicted from the initial platelet count, the initial creatinine level and prior therapy with alkylating agents. The cumulative risk increased with the total dose, but with a decreasing hazard rate, and without additional delay to platelet recovery. Nausea, vomiting and diarrhoea were the most frequently observed non-haematological side-effects, and were more severe with iproplatin than with carboplatin. Peripheral neuropathy was observed in some cases, but could be due to prior treatments. Renal toxicity did not cause major problems. Our results confirm the findings of the phase I trials: thrombocytopenia is dose-limiting for both drugs, and renal side-effects are negligible. The risk model of thrombocytopenia, consistent with Egorin's model for carboplatin, could serve as a basis for dose adjustment. The feasibility of the scheme could be insufficient for prolonged treatment.

Adult↗