Epirubicin or epirubicin and cisplatin as first-line therapy in advanced breast cancer. A phase III study.

Purpose: To compare the efficacy and toxicity of epirubicin to that of the combination of epirubicin and cisplatin in patients with advanced breast cancer.

Patients And Methods: A total of 155 patients were randomized to receive either epirubicin (70 mg/m2) days 1 and 8 every 4 weeks or epirubicin (60 mg/m2) days 1 and 8 plus cisplatin (100 mg/m2) day 1 every 4 weeks. Epirubicin was continued until disease progression or to a cumulative dose of 1000 mg/m2.

Long-term survival and development of secondary malignancies in patients with acute myeloid leukemia treated with aclarubicin or daunorubicin plus cytosine arabinoside followed by intensive consolidation chemotherapy in a Danish national phase III trial. Danish Society of Haematology Study Group on AML.

In 1991 we reported the results from a prospective randomised phase 3 trial comparing 7 days continuous infusion of cytosine arabinoside (ara-C) combined with either daunorubicin (DNR) or aclarubicin (ACR) as direct i.v. injection for 3 days as induction chemotherapy (CT) for patients with de novo acute myeloid leukemia (AML) followed by early intensive consolidation CT with two alternating cycles of high-dose ara-C and two cycles of amsacrine plus etoposide, and finally 3 days of daunomycin plus 7 days of ara-C as administered for induction of remission.

[Treatment of primary breast cancer. Consequences of mammographic screening in the municipality of Copenhagen].

In order to analyse changes in the pattern of primary treatment of breast cancer after introduction of mammography screening in the Copenhagen municipal area every second year, retrospective analyses of data from the Danish Breast Cancer Cooperative Group were performed. Newly diagnosed patients with breast cancer of the age of 50-69 years from the Copenhagen municipal area (1040 patients) were compared to a similar group of patients from the rest of Denmark (7353 patients). Parameters such as tumour size, lymph node status, grade of anaplasia, frequency of breast preserving surgery and adjuvant treatment were analysed.

Phase II study of gemcitabine in previously platinum-treated ovarian cancer patients.

Fifty-one patients with histologically confirmed epithelial stage III or IV ovarian cancer were entered into a study in which gemcitabine 800 mg/m2 was given as a 30 min intravenous infusion in a cycle once a week for 3 weeks followed by a week of rest. Patients were aged 58 years (range 23-70 years) with WHO performance status 0-2, and had received up to two different chemotherapy regimens. Thirty-eight patients had received only one prior platinum-containing chemotherapy regimen whereas 9 had received a first-line regimen on more than one occasion.

Phase II study of gemcitabine (2',2'-difluorodeoxycytidine) in previously treated ovarian cancer patients.

Background: Platinum-containing combination chemotherapy has resulted in improved survival rates in patients with advanced ovarian carcinoma, but the majority of the patients still die of their disease. It is therefore important to develop new non-cross-resistant drugs. Gemcitabine (2',2'-difluorodeoxycytidine) has shown a broad spectrum of antineoplastic activity in tumor cell cultures in vitro and in animal tumor models.

Inter-relationships between single carbon units' metabolism and resting energy expenditure in weight-losing patients with small cell lung cancer. Effects of methionine supply and chemotherapy.

The one-carbon unit metabolism was investigated in 8 weight-losing patients with small cell carcinoma of the lung (SCLC). At diagnosis, 6 of the 8 patients had elevated formiminoglutamic acid (FIGLU) excretion after a histidine load, suggesting a lack of one-carbon units. In accordance, a significant decrease of FIGLU excretion was observed in the patients after oral administration of DL-methionine for 4 days.

Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study.

Purpose: This study examined the effect of frequent nutritional counseling on oral intake, body weight, response rate, survival, and quality of life in patients with cancer of the lung (small-cell), ovary, or breast undergoing cyclic chemotherapy.

Patients And Methods: Of 105 assessable patients, 57 were randomized to receive nutritional counseling, and 48 to receive no nutritional counseling and consumption of an ad lib oral intake. The intervention group was counseled to achieve a daily energy and protein intake according to recommended dietary allowances.

Second-look laparotomy in the management of patients after radical surgery for ovarian cancer.

Background: Radically excised ovarian cancers present an unsolved problem with regard to the value of routine second-look operation. This study presents the outcome of second-look operations in an effort to help elucidate this problem.

Patients And Methods: Twenty-eight patients who underwent radical surgery for ovarian cancer stage IC-IIIA were given adjuvant chemotherapy with cyclophosphamide 500 mg/m2 i.

Ceftriaxone versus latamoxef in febrile neutropenic patients: empirical monotherapy in patients with solid tumours.

121 patients with 132 febrile episodes were randomised to ceftriaxone or latamoxef monotherapy in order to compare antibiotic efficacy in neutropenic patients treated with cytotoxic chemotherapy for solid tumours. In 80 evaluable episodes no significant differences were observed between the two groups with respect to efficacy and fatal failure rates. Of episodes treated with ceftriaxone, 67% showed a favourable clinical response vs.

Teniposide in advanced breast cancer. A phase II trial in patients with no prior chemotherapy.

The objective response rates were determined using teniposide as first-line chemotherapy for patients with recurrent breast cancer. Twenty-seven evaluable patients with advanced disease received teniposide 70 mg/m2 i.v.

Combination therapy with carboplatin/cisplatin/ifosfamide/etoposide in ovarian cancer.

In 1987 a phase II study of combined high-dose platinum (carboplatin 300/mg/m2 day 1, cisplatin 50 mg/m2 days 2 and 3 q4wk) was carried out in 42 previously untreated ovarian cancer patients with residual disease. Since then, another phase II study of combined high-dose platinum and ifosfamide (1,500 mg/m2 days 1 to 3) has been carried out in 37 patients, while a third study of combined high-dose platinum and etoposide (70 mg/m2 intravenously days 1 to 5) is ongoing. Pathologic complete response (CR) and partial response (PR) rates in the first two studies were 62% in 37 evaluable patients, and 58% in 36 patients, 22% and 42% of whom were CRs, respectively.

Increased myelosuppression during cytostatic treatment and pleural effusion in patients with small cell lung cancer.

30 patients with small cell lung cancer (SCLC) and malignant pleural effusion were compared with 30 matched patients with SCLC but without pleural effusion. In the 30 with pleural effusion, white blood cell and platelet counts fell significantly after initial chemotherapy, necessitating dose reduction. Of the patients with pleural effusion, 16 developed severe (WHO grade IV) leukopenia, 7 had severe thrombocytopenia, and 2 patients died of infection.

Aclarubicin plus cytosine arabinoside versus daunorubicin plus cytosine arabinoside in previously untreated patients with acute myeloid leukemia: a Danish national phase III trial. The Danish Society of Hematology Study Group on AML, Denmark.

A regimen of aclarubicin (ACR) of 75 mg/m2 daily for 3 days plus a continuous intravenous infusion of cytosine arabinoside (ara-C) of 100 mg/m2 per day for 7 days was compared with daunorubicin (DNR) 45 mg/m2/day for 3 days plus ara-C for 7 days as first-line chemotherapy of de novo acute myeloid leukemia (AML) in a randomized, nationwide Danish study. A total of 180 patients aged between 17 and 65 years were entered onto the protocol. Patients who achieved complete remission (CR) were given five courses of intensive consolidation therapy consisting of two courses of high dose ara-C, two courses of amsacrine plus etoposide, and one course of DNR plus ara-C.

Combined high-dose carboplatin and cisplatin, and ifosfamide in previously untreated ovarian cancer patients with residual disease.

Carboplatin 200 mg/m2 day 1, cisplatin 50 mg/m2 days 2 and 3, ifosfamide 1,500 mg/m2 days 1 to 3, and mesna 900 mg/m2 days 1 to 3 every 4 weeks for six cycles were given to 37 previously untreated ovarian cancer patients with residual disease after the primary laparotomy. The median observation time was 17+ months (range, 9+ to 24+ months). Of all the patients, 81% had primary residual disease larger than 2 cm.

Phase II study of teniposide in advanced breast cancer.

In a phase II study, 19 patients with previously treated, advanced breast cancer received 50 mg/m2 teniposide (VM-26) i.v. on days 1-5 every 3 weeks.

High-dose platinum consisting of combined carboplatin and cisplatin in previously untreated ovarian cancer patients with residual disease.

A phase II trial of carboplatin, 300 mg/m2 day 1, and cisplatin, 50 mg/m2 days 2 and 3 every 4 weeks for six cycles, was performed in 42 previously untreated patients with residual disease after primary laparotomy. Overall, 79% of patients had primary residual tumor larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 37 evaluable patients was 62%, and in PCRs was 22%.

Phase III study of intermittent 5-drug regimen (VBCMP) versus intermittent 3-drug regimen (VMP) versus intermittent melphalan and prednisone (MP) in myelomatosis.

A prospective randomized trial in 96 patients with previously untreated myelomatosis was performed comparing 3 regimens of chemotherapy: (i) Intermittent vincristine, BCNU, cyclophosphamide, melphalan, and prednisone (VBCMP) to (ii) intermittent vincristine, melphalan and prednisone (VMP) to (iii) intermittent melphalan and prednisone (MP). Induction response rates and survival were similar in all 3 regimens. An improvement in relapse-free survival was observed by adding vincristine to MP, but this did not achieve statistical difference (p = 0.

A methodological evaluation of 14 controlled clinical trials in myelomatosis.

A methodological evaluation of the 14 randomized clinical controlled trials so far published on myelomatosis was performed. A quite large heterogeneity was observed among the trials, especially in their presentation of patients included and in the criteria applied for therapeutic response. Additionally, none of the studies accounted for the randomization procedure - and particularly whether the randomizations were performed consecutively.

Classification and prognostic variables in myelomatosis.

It is difficult to compare the results of treatment obtained in different trials in myelomatosis because different sets of diagnostic criteria are used, and because the criteria by which patients are deemed eligible for entry vary. Thus the composition of different series of patients varies considerably. Furthermore, the outcome of treatment is recorded in different ways.

Primary hemangiosarcoma of the spleen with angioscintigraphic demonstration of metastases.

A case of primary hemangiosarcoma of the spleen in a 48-year-old woman is presented. Twenty-eight months after splenectomy the patient developed a severe anemia of the microangiopathic type, thrombocytopenia, and a leukoerythroblastic peripheral blood picture. In contrast to x-ray and conventional 99mTc-methylene-diphosphonate (MDP) bone scintigraphy, which showed only a few minor focal changes in the spine and ribs, angioscintigraphy with in vitro labeled 99mTc-erythrocytes revealed extensive pathologic accumulations throughout the spine, femurs, and the liver, indicating the presence of extremely vascular metastases.

Red-cell sensitization in myelofibrosis.

Using an enzyme-linked immunosorbent assay (ELISA), elevated RBC-Ig of the IgG and IgM class were found in 8 of 14 patients with idiopathic myelofibrosis. In 2 patients with high levels of RBC-Ig the direct Coombs' test was positive. It is supposed that immune haemolysis may contribute to the anaemia in some patients with idiopathic myelofibrosis.

Simultaneous quantification of red cell and platelet surface-bound IgG & IgM by an ELISA technique.

In vivo red cell-bound (RBC-) and platelet-bound (P-) IgG and IgM were measured by an enzyme-linked immunosorbent assay (ELISA) using washed cells as solid phase and alkaline phosphatase conjugated antiglobulins (Fc-specific). With this technique cells from normal donors had small amounts of RBC-IgG ranging from 0.02 to 0.