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Biomedical subjects

S Gundersen

Publications and source records attributed to S Gundersen.

At least 37 records · Page 2Linked to original sources
PubMed1992

Chemotherapy with or without high-dose medroxyprogesterone acetate in oestrogen-receptor-negative advanced breast cancer. Norwegian Breast Cancer Group.

In a randomised study 142 patients with advanced oestrogen-receptor-negative breast cancer in the tumour tissue received chemotherapy alone or chemotherapy combined with high doses (1000 mg daily) of oral medroxyprogesterone acetate (HD-MPA). Of the 126 fully evaluable for response, the response rates were 46% for chemotherapy alone and 73% for chemotherapy with HD-MPA (P = 0.005). There was no significant difference with regard to duration of response. Of the 138 patients evaluable for survival and toxicity, survival was shorter in the combined treatment group; median survival of 9 versus 13 months (P less than 0.05). Considerable toxicity was seen from HD-MPA, especially weight gain and fluid retention. The present study provides evidence that in concordance with preclinical studies an interaction between chemotherapy and HD-MPA may exist in breast cancer normally resistant to hormone therapy. The side-effects from MPA were substantial, however, and the survival data are of great concern.

Antineoplastic Agents↗
PubMed1992

Droloxifene--a new anti-estrogen. A phase II study in advanced breast cancer.

Twenty-six patients with advanced breast cancer were treated with a new anti-estrogen, Droloxifene (3-hydroxy-tamoxifen). They had all used tamoxifen either in the adjuvant or the advanced situation. The dose schedule was 100 mg orally daily. Partial remissions were observed in 4 (15%) of the patients, and in another 5 patients stable disease (greater than 24 weeks of duration) was observed. Three of the responders were resistant to tamoxifen. Fourteen of the 26 patients had no side-effect. In 2 patients therapy had to be stopped due to fatigue. Droloxifene seems to be an interesting new anti-estrogen which should be further exploited.

Adult↗
PubMed1991

Phase I/II study of carboplatin and 5-fluorouracil in patients with advanced head and neck carcinoma.

59 patients with histological verified squamous cell carcinoma of the head and neck, 39 with primary disease and 20 with relapse were given carboplatin and 5-fluorouracil (5-FU) in escalated carboplatin doses. The starting dose with carboplatin was 200 mg/m2 and the dose was escalated to 300 mg/m2, 350 mg/m2, 400 mg/m2 and thereafter by 20 mg/m2 per step. All patients received a dose of 1000 mg/m2 5-FU as a continuous infusion for 5 days. The myelotoxicity was moderate. No patients had grade 4 haemoglobin toxicity, while 7 patients had grade 3 toxicity. 2 patients had grade 4 leucocyte toxicity and 1 patient had grade 3. 4 patients were observed with a grade 4 platelet toxicity. 2 early deaths occurred at a dose level of 420 mg/m2. 18 out of 39 patients in primary treatment responded while 2 out of 20 patients treated for relapse responded. On the basis of the present study the maximum tolerable dose for carboplatin in combination with 5-FU 1000 mg/m2 is between 350 and 400 mg/m2.

Adult↗
PubMed1990

Toremifene, a new antiestrogenic compound in the treatment of metastatic mammary cancer. A phase II study.

Toremifene is a new antiestrogenic compound. Toremifene has definite antitumor effect in advanced breast cancer. The response rate in the present phase II study among postmenopausal women, mostly not pretreated with systemic therapy and with ER positive or not determined ER status in tumor tissue, was 11/23 (48%; 95% confidence interval 37-59%) including 6 complete responses. The toxicity profile was similar to that of tamoxifen. It is concluded that toremifene is at least as active as tamoxifen in advanced breast cancer and that a randomized study between these two antiestrogens is indicated.

Aged↗
PubMed1990

[Locally advanced breast cancer--primary treatment with tamoxifen].

Tamoxifen was given as primary systemic treatment to 28 patients with locally advanced breast cancer. In all tumours, receptors for estrogen (ER) and/or progesterone (PGR) were positive. All patients (15) with high levels of hormone receptors (ER greater than or equal to 100 mumols/g protein and/or PGR greater than or equal to 200 mumols/g protein) were alive after two years of observation as against 60% of the patients (13) with lower hormone receptor values.

Adult↗
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

Cyclical use of tamoxifen and high-dose medroxyprogesterone acetate in advanced estrogen receptor positive breast cancer.

One-hundred and seventy patients with estrogen receptor positive (greater than or equal to 10 pmol/g protein) advanced breast cancer have been treated in a prospective randomized study either with continuous tamoxifen 30 mg x 1 daily (TAM), or with TAM 30 mg x 1 daily for 8 weeks alternating with medroxyprogesterone acetate 500 mg x 2 daily for 8 weeks (TAM/HD-MPA). The response rate was 62% in the group treated with cyclic TAM/HD-MPA versus 41% in the TAM alone group (p = 0.02). There was no significant difference in duration of remissions or survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Weekly Adriamycin vs. 4-epidoxorubicin every second week in advanced breast cancer. A randomized trial. The Norwegian Breast Cancer Group.

One hundred and sixty-six patients with advanced breast cancer previously not treated with chemotherapy for metastatic disease were randomly allocated to 20 mg Adriamycin i.v. weekly (Awkly) as bolus injection or 50 mg 4-epidoxorubicin biweekly over a 3-h infusion time (EPIbiwkly). Of the 149 patients evaluable for response, the response rate was 36% for Awkly vs. 22% for EPIbiwkly (P = 0.10). There was no difference in response duration or survival. The main difference between the two regimens was in toxicity. Seventy per cent of Awkly patients virtually had no side-effects vs. 15% in the EPIbiwkly group. Significant differences in favour of Awkly were observed both for nausea/vomiting and alopecia.

Breast Neoplasms↗
PubMed1989

Interferon in combination with vinblastine in advanced malignant melanoma. A phase I-II study.

Nineteen patients with advanced malignant melanoma were treated with a combination of recombinant alfa-interferon (alpha-IFN) and vinblastine (VBL). The alpha-IFN was administered subcutaneously daily at an initial dose of 3 X 10(6) IU escalating to a maximal dose of 9 X 10(6) U daily for the first 10 weeks followed by 3 X/week for 6 months. The VBL was given once every week at a dose of 0.025 mg/kg. Of the 19 patients 17 were evaluable for tumor response. Thirteen patients had received chemotherapy previously. Median performance status (World Health Organization) was 0, ranging from 0 to 2. One complete response and one partial response was observed. All patients experienced flu-like symptoms attributed to alpha-IFN. Leukopenia was observed in 12 patients and a planned dose escalation of VBL was undertaken for the patients only. It is concluded that combined alpha-IFN and VBL is only marginally effective in patients with advanced malignant melanoma who have had prior chemotherapy.

Adult↗
PubMed1989

Megestrol acetate versus aminoglutethimide for metastatic breast cancer.

In this prospective, randomized study the clinical response and toxicity of megestrol acetate (MA) and aminoglutethimide (AG) as second-line treatment in patients with metastatic breast cancer was compared. 176 patients were included, and 150 received treatment greater than 8 weeks and are evaluable for treatment response. The two groups did not differ with regard to prognostic factors. Response rate for the AG and MA groups were 34% and 31% respectively, with duration of response of 13.1 and 13.0 months. Stable disease was obtained in 33% and 35% respectively. No difference was observed in survival. Side effects occurred more frequently in the AG group (42%) than in the MA group (18%).

Aged↗
PubMed1989

TCNU (LS 2667), a new active drug in the treatment of advanced colorectal cancer. EORTC Early Clinical Trials Group.

Fifty-seven patients with advanced measurable or evaluable colorectal cancer not previously treated with chemotherapy and tumor manifestations from colorectal cancer were treated with tauromustine (TCNU), a new nitrosourea with a therapeutic index against murine tumors better to or equal to that of the established nitrosoureas. The dose was 130 mg/m2 orally q 5 weeks. There were one CR and seven PR, for an overall response rate of 14%. Responding sites included the liver (one CR and two PR), lung (four PR) and lymph nodes (two PR). The median duration of response was 33+ weeks (21+ to 34 weeks). The main dose limiting toxicity was myelosuppression which seemed to be cumulative. Subjectively, the drug was well tolerated although most patients experienced nausea and vomiting for some hours. It is concluded that TCNU is a well tolerated compound with limited, but definite antitumor activity against colorectal cancer and that further studies in this disease could be of interest.

Adenocarcinoma↗
PubMed1989

Regression analyses of prognostic factors in metastatic malignant melanoma.

Patients entered into phase II trials in metastatic malignant melanoma should be carefully selected in order to ensure that they live long enough to permit a meaningful evaluation of the efficacy of a given drug. In this selection emphasis has been put on performance status. However, also for patients with a good performance status, survival is often short. The purpose of this study has been to identify supplementary prognostic factors as these could be of help in the design of phase II trials. From 1978-1986, 177 consecutive patients were given various chemotherapy regimens for metastatic malignant melanoma in the Norwegian Radium Hospital. About 92% had a performance status of ECOG 0-2. Median survival was 4.0 months (0-30 months). Multivariate survival analysis selected lactate dehydrogenase (LDH) greater than 450 U/l, presence of brain metastases, leukocyte count greater than 10 x 10(9)/l, and erythrocyte sedimentation rate (ESR) greater than 15 mm/h as significant prognostic factors indicating short survival with low probability of surviving 3 months. Patients with normal values of LDH, leukocyte count, and ESR had a median survival of 11.5 months with 94% surviving 3 months. We conclude that this information could have an impact on the design of phase II trials.

Adolescent↗
PubMed1989

Colony forming ability of human breast carcinomas: lack of prognostic significance.

To study whether colony growth in vitro reflects the prognosis of breast cancer patients, specimens from a total number of 138 patients with primary breast carcinomas were cultivated in the Courtenay-Mills soft agar method. The plating efficiency (PE) values were related to various clinical and histopathological parameters. No significant correlation was found between colony forming ability and menopausal status, histopathology, TNM-status or steroid hormone receptor status. The crude survival of the patients was not significantly correlated to the in vitro growth of the tumours; neither was there any difference in relapse-free survival between patients whose tumours failed to grow in vitro and those having growing tumours (PE greater than 0). A multivariate survival analysis of 115 patients with primary tumours without distant metastases revealed that the PE was not a significant independent prognostic indicator, as it gave no additional prognostic information above that of node and ER status. It is concluded that routine measurement of colony formation in vitro is not warranted in the management of breast cancer.

Adult↗
PubMed1989

Weekly anthracycline in the treatment of advanced breast cancer.

In two consecutive prospective and randomized studies, very similar response rates (31 and 36% respectively) were obtained for weekly 20 mg doses of doxorubicin among 143 patients with advanced breast cancer. The treatment was well tolerated and most patients had only moderate, if any, complaints about this treatment.

Breast Neoplasms↗
PubMed1988

Phase II study of intravenous menogaril in patients with advanced breast cancer.

Menogaril was administered to 40 patients with advanced breast cancer who had not received anthracycline drugs previously. The drug was given iv as a 2-hour infusion, repeated every 4 weeks, at doses of 200 mg/m2 and 160 mg/m2 in good-risk and poor-risk patients. The overall response rate was 22% in patients with no prior chemotherapy and 10% in patients previously exposed to chemotherapy. Leukopenia was generally moderate and predictable. Phlebitis and erythema along the vein injected occurred in 34% and 17% of the cases, respectively. Menogaril is an active drug used in the treatment of patients with advanced breast cancer who have not had prior systemic therapy.

Adult↗