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Biomedical subjects

N Rotmensz

Publications and source records attributed to N Rotmensz.

46 records · Page 3Linked to original sources
PubMed1986

Carminomycin versus doxorubicin in advanced breast cancer, a randomized phase II study of the E.O.R.T.C. Breast Cancer Cooperative Group.

Sixty-four patients with advanced progressive breast cancer resistant to conventional treatments were entered into the present study. They were randomized to receive either Carminomycin (CMM) 20 mg/m2 or Doxorubicin (DOX) 75 mg/m2, both drugs being administered by i.v. bolus every 3 weeks until progression of the disease. Five patients were not eligible and response could not be evaluated in another eight patients. Three patients had only one course due to disease-related early death. Among twenty-seven evaluable patients who received at least two courses of DOX one complete response and seven partial responses were observed for an overall response rate of 30%. CMM showed significantly lower (P = 0.04) antitumor activity with only one partial response (4%) among the 24 patients who received at least two courses of therapy. Median duration of response dating from the start of chemotherapy was 46 weeks on DOX (range 18-102+) and 30 weeks for the single partial response on CMM. Although the median time to progression for all patients receiving CMM (9 weeks) was significantly shorter (P = 0.04) than for those receiving DOX (30 weeks), patients on DOX had only a marginally longer duration of survival (P = .28) than those initially treated with CMM. Myelotoxicity was more severe in the CMM treated group than in the DOX group. Other toxicities such as alopecia, nausea and vomiting were slightly more severe in the DOX treated group. On the basis of this and other similar randomized studies, CMM cannot be recommended for further application in the treatment of advanced breast cancer.

Adult↗
PubMed1985

Combined cytotoxic and endocrine therapy in postmenopausal patients with advanced breast cancer. A randomized EORTC study of CMF vs CMF + tamoxifen.

Two hundred and sixty-three patients with advanced measurable breast cancer were randomized to receive cyclophosphamide, methotrexate and 5-fluorouracil (CMF) or CMF + tamoxifen (T). Each cycle of CMF (C, 100 mg/m2 p.o. days 1-14, M, 40 mg/m2 i.v. days 1 and 8, F, 600 mg/m2 i.v. days 1 and 8) was repeated every 4 weeks. Tamoxifen, 20 mg twice daily, was given continuously. The treatment results as assessed by external reviewing were as follows in the CMF and CMF + T groups, respectively: PD 24 and 10%, NC 27 and 15%, PR 29 and 44%, CR 20 and 31%. The difference between response (CR + PR) rates is highly significant (P = 0.0001). Derived from life-table analysis, the median duration of remission was 12 months in the CMF-treated group and 18 months in patients treated with CMF + T (P = 0.04). Median duration of survival was 19 and 24 months, respectively (P = 0.12), but in the group of responders CMF + T was significantly superior to CMF (32 months vs 21 months, P = 0.03). The addition of T was of benefit to all subgroups but the difference only reached statistical significance in patients with the dominant site of disease in viscera, in patients with a Karnofsky index of 100 and in patients of more than 60 years of age. The amount of CMF given was identical in two groups with a trend for a decrease in dose with increasing age. No relation between response rate and amount of dose given was observed. In conclusion, the addition of T to CMF improves the therapeutic results in patients with advanced breast cancer although the superiority of the combined treatment is statistically significant only in some subsets of patients.

Aged↗
PubMed1985

Aminoglutethimide and estrogenic stimulation before chemotherapy for treatment of advanced breast cancer. Preliminary results of a phase II study conducted by the E.O.R.T.C. Breast Cancer Cooperative Group.

While both endocrine therapy and chemotherapy are of proven value in the treatment of advanced breast cancer, the effects of combining these two methods or applying them consecutively have been relatively disappointing. This may be due to endocrine therapy suppressing cell division, in hormone-dependent tumors, whereas chemotherapy acts mainly on active-dividing cells. A trial protocol has therefore been devised which seeks to exploit the properties of both types of therapy. Oestrogen suppression is first obtained by aminoglutethimide (Orimeten) plus hydrocortisone; after 2 weeks, ethinyloestradiol is given to induce cell division and followed 24 h later by a combination of 3 cytotoxic agents given intravenously. This pattern of therapy, repeated at regular intervals, appears to be producing favorable clinical results. A phase-III study is being started among patients with hormone-dependent advanced breast cancer.

Adult↗
PubMed1985

Phase II trial of medroxyprogesterone acetate in advanced ovarian cancer: an EORTC Gynecological Cancer Cooperative Group Study.

Progestin therapy of ovarian carcinoma in the past has been reported to lead to varying response rates. A multicenter phase II study of high-dose MPA was conducted in 53 patients with epithelial ovarian cancer who had received adequate trials of conventional therapy with cytotoxic agents. Forty-one patients were included for response and toxicity evaluations. Only one partial response has been recorded with a duration of 20 weeks. Stabilization of disease was observed in 7 patients. The present investigation shows that MPA given at the present high dose is not effective in patients extensively pretreated with chemotherapy.

Adenocarcinoma↗
PubMed1985

Cisplatin plus vindesine in advanced breast cancer: a phase II trial of the EORTC Breast Cancer Cooperative Group.

This phase II clinical trial was conducted in a series of patients with advanced breast cancer, refractory to conventional chemotherapy. The therapeutic regimen consisted of a combination of cisplatin 100 mg/m2, given as a 24-hr infusion on day 1 and vindesine (VDS) 2 mg/m2, i.v. bolus on days 1 and 8. VDS injection was omitted on day 8 in patients with poor bone marrow reserves (prior extensive irradiation). Courses were repeated at 4-week intervals until documented disease progression. Among 46 evaluable patients, there were two complete and seven partial remissions for an overall response rate of 20%. These responses lasted for a median of 21 weeks (range 8-89 weeks). Remission rates according to the predominant metastatic site were as follows: soft tissue, 3/8 (38%); bone, 0/6 (0%); viscera, 6/32 (19%). Transient myelosuppression and gastrointestinal intolerance were almost universal. Renal function impairment and neurologic manifestations were frequently encountered but these adverse reactions were generally mild. Significant antineoplastic activity in far-advanced and heavily pretreated patients warrants further evaluation of this regimen at an earlier stage of the disease.

Adult↗
PubMed1985

Combined cytotoxic and endocrine therapy in postmenopausal patients with advanced breast cancer. A randomized study of CMF vs CMF plus tamoxifen.

In this study 263 patients with advanced measurable breast cancer were randomized to receive cyclophosphamide, methotrexate and 5-fluorouracil (CMF) or CMF + tamoxifen (T). Each cycle of CMF (C, 100 mg/m2 p.o. days 1-14, M 40 mg/m2 i.v. days 1 and 8, F, 600 mg/m2 i.v. days 1 and 8) was repeated every 4 weeks. Tamoxifen, 20 mg twice daily, was given continuously. The treatment results have been assessed by external review for the 220 evaluable patients and were the following for the CMF and CMF + T groups, respectively: PD: 24 and 10%; NC: 27 and 15%; PR: 29 and 44%; and CR: 20 and 31%. The difference between response (CR + PR) rates is highly significant (P = 0.0001). The median duration of remission was 12 months in the CMF-treated group and 18 months in patients treated with CMF + T (P = 0.09). The median duration of survival was 19 months and 24 months respectively (P = 0.07). However, in the group of responders patients receiving CMF + T survived significantly longer than those who received CMF alone (32 months vs 21 months, P = 0.005). The addition of T appeared to be of benefit in all subgroups. The largest differences were seen in patients with the dominant site of disease in the viscera, in patients with a Karnofsky index of 100, and in patients of more than 60 yr of age. The amount of CMF given was identical in the two treatment groups and there was a trend toward a decrease in dose with increasing age. No relationship between response and dose given was observed. In conclusion, the simultaneous use of T and CMF improves the therapeutic results in patients with advanced breast cancer.

Adult↗
PubMed1985

Phase II trial of bleomycin in patients with advanced ovarian cancer: an EORTC Gynecological Cancer Cooperative Group Study.

Bleomycin was administered by continuous i.v. infusion at a dose of 20 mg/m2/day for 7 days to 18 evaluable patients with advanced ovarian epithelial cancer resistant to conventional chemotherapy. The toxicity pattern was no different from that known from earlier studies using continuous infusion of bleomycin with the exception of the occurrence of a life-threatening allergic reaction in one patient, which led to discontinuation of treatment after 3 days. Only one patient showed a partial response for 2 months (5.5%), indicating that the drug has no significant activity in this unfavorable group of patients.

Adult↗
PubMed1982

N-(phosphonacetyl)-L-aspartate (PALA) in advanced breast cancer: a phase II trial of the EORTC breast cancer cooperative group.

Twenty-nine evaluable patients with extensively pretreated breast cancer received PALA, a new pyrimidine antimetabolite. The drug was given by intravenous infusion over 60 min, at a daily dose of 2.5 g/m2 for 2 consecutive days. Courses were repeated at 2-week intervals and doses were escalated to toxicity. Two objective partial remissions were observed, lasting for 3 and 4.5 months respectively. Toxic effects were dose-related and consisted mainly of mucocutaneous manifestations, i.e., skin rashes, stomatitis, diarrhea, conjunctivitis and corneal ulcerations. Evidence of antitumor potential in far-advanced disease and lack of myelosuppression point to the need for additional trials of PALA in a more favorable selection of patients with breast cancer.

Adult↗