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Biomedical subjects

R Sylvester

Publications and source records attributed to R Sylvester.

At least 163 records · Page 9Linked to original sources
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

Mitomycin C (MCC) in advanced soft tissue sarcoma: a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group.

Mitomycin C at a dose of 12 mg/m2 i.v. q 3 weeks was administered to 34 patients with measurable progressive advanced soft tissue sarcomas. No objective response was observed although in one of the 12 patients with overall stabilisation of disease a partial response was reported in lung lesions. The side-effects observed in this group of patients were generally mild. On the basis of this result the application of mitomycin C in this disease cannot be recommended.

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 study of cisplatin in advanced osteogenic sarcoma. European Organization for Research on Treatment of Cancer Soft Tissue and Bone Sarcoma Group.

The activity of cisplatin (CDDP) against advanced osteogenic sarcoma was evaluated in 37 of 50 patients registered by the members of the European Organization for Research on Treatment of Cancer Soft Tissue and Bone Sarcoma Group between 1979 and 1982. All patients had measurable lung metastases. Thirty-one patients (84%) had received previous chemotherapy consisting mainly of high-dose methotrexate, doxorubicin, and vincristine. CDDP (100 mg/m2) was given as a 24-hour continuous infusion every 3 weeks for a minimum of two cycles, with appropriate fluids and diuretics. In the absence of impairment of the renal function and/or myelosuppression, the dose could be escalated by 20%. The overall response rate was 19% (seven responses among 37 patients), with one complete remission for 51 weeks and six partial remissions from 12 to 26 weeks. The median number of courses of CDDP administered was three, ranging from two to 11. Of 143 courses administered, only 18 (12%) had to be modified because of toxicity. In 16% of the patients some transient impairment of the renal function was observed. CDDP adds to the limited number of chemotherapeutic agents with useful properties in osteogenic sarcoma, and CDDP-containing combination chemotherapy regimens should be actively investigated.

Adolescent↗
PubMed1984

Mitoxantrone in advanced renal cancer: a phase II study in previously untreated patients from the EORTC Genito-Urinary Tract Cancer Cooperative Group.

Mitoxantrone at a dose of 15 mg/m2 i.v. q 3 weeks failed to produce responses in 29 adequately treated patients with measurable advanced renal cell carcinoma. The side-effects observed in this group of patients with a good performance status were generally mild. On the basis of this negative result, the application of mitoxantrone in this disease is not recommended.

Adult↗
PubMed1983

Carminomycin vs adriamycin in advanced soft tissue sarcomas: an EORTC randomised phase II study.

Eighty-three patients with advanced soft tissue sarcoma who had received no prior chemotherapy entered a randomised phase II study comparing carminomycin (CMM) 20 mg/m2 with adriamycin (ADM) 75 mg/m2, both administered i.v. bolus every 3 weeks. Six patients were ineligible and response could not be evaluated in 6 additional patients. Thirty-eight evaluable patients received ADM and 33 received CMM. There was one complete response to ADM and 10 partial responses, an overall response rate of 29%. CMM showed significantly (P = 0.01) lower antitumour activity--one partial response (3%). Stabilisation of disease was similar in both arms (47 and 45%), but fewer patients progressed on ADM (24 compared to 52%). Durations of response dating from the start of chemotherapy were 5 months for complete remission on ADM, a median of 7 months (range 4-17) for partial response on ADM and 14 months for the one partial remission on CMM. Although the median time to progression for all patients receiving CMM (2 months) was significantly (P = 0.001) shorter than for those receiving ADM (5 months), patients on ADM had only a marginally significant longer duration of survival (P = 0.06) than the patients receiving CMM. A leucocyte nadir less than 2.0 X 10(9)/l occurred in 38% of patients receiving ADM and 43% receiving CMM. Anaemia and thrombocytopoenia were uncommon. Other toxicities such as nausea, vomiting, anorexia and alopecia were more severe in the ADM group. There was one infective death secondary to leucopoenia in the ADM arm, and one patient who had received 109 mg/m2 CMM + 255 mg/m2 ADM developed progressively fatal cardiomyopathy.

Adolescent↗
PubMed1983

Prognostic factors in superficial bladder tumors. A study of the European Organization for Research on Treatment of Cancer: Genitourinary Tract Cancer Cooperative Group.

A randomized clinical trial was performed on 308 patients with stage T1 carcinoma of the bladder to compare the efficacy of transurethral resection alone or followed by bladder instillations of thiotepa or VM-26 (teniposide) for 1 year. With the recurrence rate as the primary end point of interest the data from this trial were used to assess the prognostic importance of the following factors at entry into the study: number of tumors, prior recurrence rate, tumor size, grade, age, treatment group assigned and, finally, the interval between transurethral resection at entry into the study and the start of intravesical treatment. Using multivariate statistical techniques we found that the number of tumors at presentation was the most important prognostic factor followed by, in order of importance, the recurrence rate at entry and the size of the largest tumor. Of particular note was the discovery that patients with less than 1 recurrence per year at entry had a prognosis similar to patients with primary tumors, while those with a higher recurrence rate did uniformly poorly. These results show that patients with stage T1 carcinoma of the bladder form a heterogeneous group and that more aggressive therapy should be considered for patients with a poor prognosis.

Humans↗
PubMed1983

Change in white cell count during treatment of advanced cancer of the prostate with estramustine phosphate and with stilboestrol.

Patients with locally advanced (category T3-4 of the TNM system) and metastatic prostatic cancer, not previously treated, seen by one of the authors (P.H.S.) have been entered into EORTC Protocol 30762 which has compared the therapeutic effects of estramustine phosphate (Estracyt) and of diethyl-stilboestrol (DES) as primary treatment. A gradual and as yet unexplained rise in the total leucocyte count was seen in patients treated with estramustine phosphate. This was always apparent within 2 months of starting treatment and did not change significantly thereafter unless treatment was stopped, when the raised values soon returned to normal. In four patients in whom the white cell count rose to levels above the normal range a neutrophil leucocytosis was always reported. The cause of this is not yet understood.

Clinical Trials as Topic↗
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↗