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Biomedical subjects

J Renard

Publications and source records attributed to J Renard.

At least 55 records · Page 3Linked to original sources

Phase II study of iproplatin (CHIP, JM-9) in advanced squamous cell carcinoma of the head and neck.

A phase II study of iproplatin was conducted in advanced squamous cell carcinoma of the head and neck both in patients previously treated with chemotherapy or not. Iproplatin was given intravenously every 4 weeks at the dose of 240-300 mg/m2 without hydratation. A total of 101 4-week courses was given to 50 eligible patients. No antitumor activity was detected. Drug-induced toxicity consisted in moderate myelosuppression, frequent but mild nausea and vomiting, and occasionally diarrhea and stomatitis. This study demonstrates that iproplatin given in this dose and schedule is devoid of activity in advanced squamous cell carcinoma of the head and neck.

Adult↗

Chromosome aberrations in patients irradiated for pelvic tumours.

Peripheral blood lymphocytes of patients undergoing radiation therapy for pelvic tumours have been examined for the presence of dicentric and centric ring chromosomes. Blood samples were taken, by venipuncture, prior to the first radiotherapy session and 24 h after radiotherapy sessions to allow the mixing of the irradiated lymphocytes in the circulating blood. The yield of dicentrics and centric rings was best fitted by a straight line which, according the maximum likelihood method, corresponds to Y = 1.77 +/- 0.0003 10(-2) D. On this basis the dose inducing ten dicentrics or rings is 5.62 Gy at the target volume and, thus, is intermediate between the doses at the target volumes displaying the same effects in patients treated for mammary carcinoma (15 Gy) or for ankylosing spondylitis (2 Gy).

Adenocarcinoma↗

Phase II study of 5'-deoxy-5-fluorouridine (doxifluridine) in advanced malignant melanoma.

Forty-two patients with malignant melanoma were treated with doxifluridine, 4000 mg/m2 daily X 5, repeated every 3 weeks. The daily dose was reduced to 3000 mg/m2 in patients who had experienced severe myelosuppression with prior chemotherapy. A total of 35 patients were evaluable for response, and 25 of these received two or more courses. Two responses were observed. Toxicity mainly took the form of nausea, vomiting, stomatitis, dizziness, ataxia, and fatigue. Mild leukopenia was frequent (43%). Nadir counts less than 1.5 X 10(9)/l leukocytes or 50 X 10(9)/l platelets were seen in 7% and 2% of the courses respectively. Doxifluridine has no useful activity against malignant melanoma.

Drug Evaluation↗

Primary resistance of renal adenocarcinoma to 1,2,4-triglycidylurazol (TGU, NSC 332488), a new triexpoxide cytostatic agent--a phase II study of the EORTC early clinical trials group.

Fourteen patients with metastatic renal adenocarcinoma without prior chemotherapy were treated with 1,2,4-triglycidylurazol (TGU, NSC-332488), a new triepoxide alkylating agent. TGU was chosen for this study among other triepoxides because of its high antitumour activity in animal models, its relatively good water solubility and the expected favourable therapeutic index. The starting dose was 800 mg/m2 i.v. (600 mg/m2 for patients with prior extensive radiotherapy) every 4 weeks. No objective tumour regression was seen in this favourable group of patients. Leuko- and thrombocytopenia were the most important side-effects. Severe cumulative and prolonged thrombocytopenia was seen. Other toxicities observed were nausea with or without vomiting in all patients and local phlebitis in some.

Adenocarcinoma↗

Epirubicin in colorectal cancer. A phase II study of the early clinical trials group (EORTC).

Epirubicin, a stereoisomer of doxorubicin with suggested lower potential for cardiotoxicity in experimental animal tumor systems, was studied in a disease-oriented phase II trial in patients with advanced colorectal cancer. The drug was given as a direct iv injection of 90 mg/m2 q 3 weeks. No objective response was observed in 52 evaluable patients with colon (n = 34) and rectal (n = 18) carcinoma. Fourteen patients (27%) had stable disease for a median of four treatment courses. Leukopenia (88%), nausea and vomiting (71%) and alopecia (54%) were the most common toxic effects. We conclude that epirubicin at the present dose and schedule is an ineffective agent in patients with metastatic colorectal cancer.

Adult↗

Enzyme-antigen immunoassay for human placental alkaline phosphatase in serum and tissue extracts, and its application as a tumor marker.

In this enzyme-antigen immunoassay for human placental alkaline phosphatase (hPLAP; EC 3.1.3.1.) in serum and tissue extracts, polyclonal rabbit antiserum to mouse IgG2b is adsorbed to the wells of a microtiter plate, its excess binding sites are blocked, then it is incubated with murine monoclonal anti-hPLAP and mixed with serially diluted standard or sample antigen. The amount of antigen bound is determined by measuring its enzymic activity. The standard curve is linear for hPLAP concentrations of 0.2 to 1 U/L. The mean within-assay CV was 3.8% (SD 0.9%) for a serum sample and 6.1% (SD 3.0%) for a tissue extract. The respective mean between-assay CVs were: 6.7% (SD 2.0%), and 7.0% (SD 2.0%). Serum hPLAP concentrations, determined in four different dilutions, had a CV of 5.5%. We evaluated the method by standard additions and by comparing dilution curves for purified hPLAP, hPLAP in serum, and hPLAP in tissue extracts. The upper limit of activity in normal subjects was 0.1 U/L for serum samples, and 1.0 mU/g wet weight of tissue for tissue extracts. hPLAP activity was increased in 9.8% of all cancer patients, and in 40% of ovarian cancer patients. Almost half of the tumor biopsies were positive for hPLAP activity, and 94% of the biopsies from ovarian neoplasia had an increased activity of this isoenzyme. Of the nonmalignant tissues examined, normal lung tissue had the highest hPLAP activity.

Alkaline Phosphatase↗

An EORTC phase II study of mitoxantrone in solid tumors and lymphomas.

Mitoxantrone is an anthracenedione, showing structural similarities to doxorubicin. This drug has been proved active against several tumor systems, including some tumors resistant to doxorubicin, and also against human breast xenografts. It is also less cardiotoxic than doxorubicin. Mitoxantrone has been given to 335 patients in an i.v. perfusion of 12 mg/m2 or 14 mg/m2 every 3 weeks. Two hundred and sixty-three patients with advanced disease were evaluable for response: breast (94 patients), head and neck (40), kidney (20), bronchial (19), lymphomas (13) and various sites (77). Most of the patients had been previously treated with radiotherapy and chemotherapy, including/not including doxorubicin. In breast cancer three complete remissions (CR) and 16 partial remissions (PR) have been achieved (20%). The therapeutic activity was higher in patients who had not received any prior chemotherapy: 35 vs 15% (P = 0.06). The response rate observed at 14 mg/m2 (32%) was superior to the response rate observed at 12 mg/m2 (15%). However, no response has been reported in lung metastases (0/22). The median duration of response is 8 months. Mitoxantrone shows borderline activity in head and neck tumors (one CR and two PR out of 40 patients) but no activity in squamous cells of the lung (0/19). One CR and three PR have been seen out of 13 malignant lymphomas (four Hodgkin's disease and nine non-Hodgkin's lymphomas). The duration of response ranges from 10 to 24+ months. Myelosuppression was moderate and no severe leukopenia has been reported. Nausea and vomiting were seen in 50% of the patients. Four patients presented cardiac events associated with mitoxantrone, such as reversible congestive heart failure or a significant decrease in the ventricular ejection fraction. Alopecia was observed in 17 and 48% of the patients treated with 12 and 14 mg/m2 respectively. Due to its anti-tumoral activity, mainly in breast cancer, and its low hematological and cardiac toxicity, mitoxantrone must be considered as a major antimitotic.

Adolescent↗

Phase II study of amsacrine in refractory lymphomas. A report of the EORTC Early Clinical Trials Group.

Forty-three patients with advanced measurable lymphoma, progressive after conventional therapy, were entered into a phase II study of m-AMSA 90-120 mg/m2 every 3 weeks. Five patients were ineligible and response could not be evaluated in four patients. For HD there were two partial responses (14%), lasting 6 and 41 weeks, in 14 evaluable patients. Among 20 evaluable patients with NHDL three (15%) achieved partial remission, but duration of response could not be evaluated. One patient with diffuse histiocytic lymphoma died of infection at 4 weeks, a second with lymphoblastic lymphoma was given high-dose steroids commencing at 6 weeks, and the third patient with nodular poorly differentiated lymphocytic lymphoma refused further treatment after one course. Leucopenia was more marked in patients with NHDL (WBC nadir X 10(9)/l, median 2.2, range 0.2-4.3) than in HD (WBC nadir X 10(9)/l, median 2.8, range 0.85-7.2), as was thrombocytopenia. There was one toxic death and one life-threatening infection, both secondary to myelosuppression. Non-haematological toxicity was mild. m-AMSA has marginal activity in previously treated lymphomas and causes considerable myelosuppression.

Adolescent↗

Phase II trial of epirubicin in advanced squamous, adeno- and large cell carcinoma of the lung.

Epirubicin , a stereoisomer of doxorubicin with suggested lower potential for cardiotoxicity in animal tumor systems, was evaluated in a disease-oriented phase II trial in non-small cell lung cancer. The drug was given as a direct i.v. injection of 90 mg/m2 repeated every 3 weeks. Four partial remissions were observed among 75 evaluable patients. Forty-two of the 75 patients had received no prior chemotherapy. The predicted true response rate is equal to 5% (0.2-10%). Leucopenia (75% of patients), gastrointestinal disturbances (76% of patients) and alopecia (53% of patients) were common side-effects observed. Four patients had cardiac abnormalities after treatment with epirubicin (one sinustachycardia , two premature beats, one biopsy-proven cardiomyopathy with congestive heart failure). One patient developed a peripheral neuropathy possibly related to epirubicin . We conclude that epirubicin in the present dose and schedule is an inactive agent in patients with non-small cell lung cancer.

Adenocarcinoma↗

[Case of a rare maxillary tumor: osteocementofibroma].

A 17-year-old young girl presented with a rare maxillary tumor, an osteocementoblastoma, which from the ectopic type of position of the wisdom tooth had apparently been present for many years pathologic findings are reported. Post-operative course was normal but regular follow-up is necessary because of the tendency for recurrence of the few cases reported in the literature of this benign tumor.

Adolescent↗

Phase II study of amsacrine in solid tumors: a report of the EORTC Early Clinical Trial-Group.

A total of 239 patients with advanced solid tumors were treated in this phase II trial. Amsacrine was administered as a single i.v. dose of 120 mg/m2 repeated at 21-day intervals. The initial dose was reduced to 90 mg/m2 in the case of extensive prior therapy. Some antitumor activity was detected in head and neck cancer but the drug appears to lack significant efficacy in epidermoid lung cancer as well as in carcinoma of the breast, melanoma, renal cell cancer, colorectal cancer and non-seminomatous testicular cancer. Leukopenia was the major toxic effect encountered in this trial and was similar at 90 and 120 mg/m2.

Adult↗

Quality of institutional participation in multicenter clinical trials.

We studied the relation between an institution's degree of participation in a multicenter clinical trial and the quality of its participation. The quality of participation was judged on the basis of the percentage of patients entered into the trial who were in fact eligible, who were treated in accordance with the protocol, and for whom the appropriate forms were received. Those who satisfied these criteria were termed "valid" patients. Institutions were divided into two groups, "major participants" and "minor participants," according to the number of patients they entered in the trial. In a detailed analysis of a multicenter trial of chemotherapy for soft-tissue sarcoma, we found that major participants had a significantly higher percentage of valid patients than did minor participants (81 per cent vs. 39 per cent) and that the minor participants were actually detrimental to the study from both scientific and administrative viewpoints. These results suggest that institutions should not participate in multicenter studies unless they can enter some predetermined minimal number of patients per year.

Antineoplastic Agents↗