The role of lonidamine in the treatment of breast cancer patients.
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Adult↗
Biomedical subjects
P Pronzato
Publications and source records attributed to P Pronzato.
A randomized trial on tamoxifen continuation during second-line hormone therapy in breast cancer.
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Aminoglutethimide↗
Stimulation of human breast cancer in vivo. Experimental findings and clinical results.
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Antineoplastic Combined Chemotherapy Protocols↗
Lymphoblastoid interferon in advanced breast cancer: a phase II study.
Thirty-two metastatic breast cancer patients entered a phase II study in order to evaluate the toxicity and the clinical activity of lymphoblastoid interferon (IFN). The treatment was divided into two phases, induction and maintenance. During the first, patients were submitted to lymphoblastoid IFN at the dose of 3 MU die intramuscularly for 4-8 weeks; during maintenance treatment IFN was given at the same dosage, intramuscularly, every other day until progression. Five patients with inadequate follow-up were excluded from disease evaluation, thus 27 patients were evaluable for response. No complete response was observed; one patient achieved a partial response and 15 patients disease stabilization. Median time to progression in patients with partial response or stable disease was 11 weeks (range 2-32). Five patients with soft tissue metastases were biopsied before and after 1-2 months of treatment in order to perform Labelling Index and hormonal receptor status determinations. No significant modification was observed.
Adult↗
Impact of irradiation of residual breast on adjuvant chemotherapy dose intensity.
The chemotherapy dose intensity for breast cancer has been recently considered to be an important factor in determining clinical outcome. Many trials have shown routine postoperative irradiation to have a detrimental effect on the delivered dose of adjuvant chemotherapy. In this paper the impact of radiotherapy on the dose intensity of adjuvant chemo- or hormonotherapy was evaluated in 237 breast cancer patients. 177 patients had radical mastectomy and 60 quadrantectomy followed by radiotherapy. Chemotherapy comprised 6 cycles of FEC (5-fluorouracil, epidoxorubicin, cyclophosphamide) alternated to 6 cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil)+tamoxifen for 5 years. There were no significant differences in the adjuvant chemotherapy dose intensity in the mastectomy group compared to the radiotherapy group.
Antineoplastic Combined Chemotherapy Protocols↗
Second-line hormonotherapy for breast cancer. Uselessness of first-line continuation.
The hypothesis that the results of second line hormonotherapy for breast cancer may be ameliorated with continuation of the first line has been explored in a randomized trial. Patients progressing under tamoxifen were randomly allocated to aminoglutethimide and hydrocortisone acetate with or without tamoxifen continuation. No difference has been observed between the two arms in terms of response rate and progression-free overall survival.
Aged↗
Mitoxantrone and mitomycin C as second-line treatment for advanced breast cancer.
Forty-three evaluable patients with advanced breast cancer were treated with a combination of mitoxantrone 10 mg/sqm and mitomycin C 10 mg/sqm every 3 weeks. Two patients (4%) achieved objective responses lasting 3 and 16 months. The median duration of survival after protocol entry was 6 months (range 1-22) and the median progression-free survival was 3.5 (range 1-20). Only mild toxicities were observed. We concluded that the mitoxantrone and mitomycin C combination has limited toxicity but low activity and only brief disease palliation in advanced breast cancer.
Adult↗
Intensive chemotherapy with cisplatin, mitoxantrone, methotrexate and vincristine in metastatic breast cancer.
Eleven patients (pts) with advanced refractory breast carcinoma were treated with combination chemotherapy (Planovin) including mitoxantrone 10 mg/m2 on day 1, cisplatin 60 mg/m2 on days 1-2, methotrexate 200 mg/m2 on day 15, vincristine 2 mg on day 15, leucovorin 15 mg/m2 on days 15-16 every 3 weeks. Five patients (41%) achieved an objective response with one complete regression. The median duration of response was 4.5 months and the median duration of survival was 8 months. Drug related toxicity consisted mainly of leukopenia (8 pts), nausea and vomiting (6 pts), anemia (7 pts) and thrombocytopenia (4 pts).
Adult↗
Tamoxifen and alpha interferon in advanced breast cancer.
Thirteen pretreated advanced breast cancer patients received a combination of alpha interferon 5 million IU every 2 days, subcutaneously, plus tamoxifen 10 mg 3 times daily, until disease progression. The objective response rate was 15.4%: 1 patient achieved a complete response, 1 a partial response and 11 demonstrated stable disease; half of the patients were receptor negative and/or pretreated with hormonotherapy. Durations of response were 16 and 26 months for the CR and PR patients respectively; median progression-free survival was 4 months (range 0-26). Toxicities were registered according to WHO criteria: 4 patients stopped the treatment with interferon because of severe flu-like symptoms, while in the others the combination was generally accepted with good tolerance.
Adult↗
Continuous venous infusion of vinblastine in metastatic breast cancer.
In 19 patients with advanced pretreated breast cancer, vinblastine was administered by continuous venous infusion (2 mg/m2/24 h for 120 h every 3 weeks), using a totally implanted venous access and a portable pump. A total of 55 courses were given. Five objective responses were observed. Drug-related toxicity consisted mainly of leukopenia (4 patients), fever (4 patients) and nausea and vomiting (3 patients). Catheter-related toxicity was observed in 4 patients (21%) and consisted of infection of the skin pocket in 1 patient and dislodging of the needle with drug extravasation in 3 patients.
Adult↗
Oral chemotherapy with idarubicin plus cyclophosphamide in advanced breast cancer.
An oral chemotherapy schedule based on idarubicin and cyclophosphamide was evaluated in 31 advanced breast cancer patients. Out of 27 patients evaluable for response, 1 (3.7%) achieved a complete response and 5 (18.5%) a partial response, with an objective response rate of 22.2% (95% confidence limits 8.6-42.3%). The median time to progression was 7 months (range 3-12). Fourteen patients (51.9%) showed a disease stabilization, and 7 progressed (25.9%). Toxicity was mild. Considering the low response rate, but also the advantages of oral chemotherapy and the mild toxicity observed, oral idarubicin plus cyclophosphamide can be considered as a second-choice regimen in advanced breast cancer.
Administration, Oral↗
[Computerized management of therapy protocols in oncology. Evaluation of a decision support for breast carcinoma].
A computerized system for assisted clinical decisions in breast cancer was evaluated, comparing the therapeutic strategies suggested bt the program with those actually used in an oncology Division. One hundred patients treated at the Medical Oncology Department of the National Institute for Cancer Research of Genoa, Italy, were entered into the study. Results, showing a 95% concordance, are discussed.
Adult↗
Lonidamine in metastatic breast cancer.
Lonidamine belongs to a new class of antineoplastics agents, since it does interfere with cell energy processes. When administered as single agent in metastatic breast cancer, it produces moderate therapeutic effects. The pattern of toxicity includes myalgias, asthenia, testicular pain, and gastrointestinal discomfort. No myelosuppression was demonstrated in phase I-II studies. Since the peculiar mechanism of action and side effects are not overlapping with those of standard chemotherapeutic agents, combination of lonidamine with chemotherapy is currently under investigation in advanced breast cancer. Moreover, the potentiation of radiotherapy by lonidamine could be of interest in palliating symptomatic lesions from breast cancer.
Antineoplastic Agents↗
In vivo manipulation of human breast cancer growth by estrogens and growth hormone: kinetic and clinical results.
Since 1983, a series of experimental and clinical studies have been carried out on the possibility of enhancing the chemotherapy effectiveness in breast cancer by expanding the fraction of cycling cells. Theoretically estrogens should recruit breast cancer cells and this fact should result in a higher killing efficiency of antiproliferative drugs. Actually it has been clearly shown, by means of the thymidine labeling index and primer-dependent alpha-DNA polymerase assay, that low doses of diethylstilbesterol are able to increase the tumor proliferative activity of human breast cancer in vivo (estrogenic recruitment). Three randomized trials have been carried out (one in locally advanced and two in metastatic breast cancer) comparing conventional polychemotherapy vs chemotherapy with estrogenic recruitment. Only limited advantages have been observed in these trials. Searching for new modalities of kinetic manipulation of tumors, recombinant human growth hormone has been employed in a pilot study: the preliminary results indicate that it largely enhances tumor proliferative activity, suggesting the possibility of employing a growth factor system to increase chemosensitivity.
Antineoplastic Combined Chemotherapy Protocols↗
Megestrol acetate: phase II study of a single daily administration in advanced breast cancer.
A new formulation of megestrol acetate, a semisynthetic oral progestin used in the hormonal treatment of breast cancer, allows the administration of 160 mg of the drug in a single daily dose. Sixty-nine postmenopausal patients with advanced breast cancer have been treated with this regimen: five patients received megestrol acetate as first-line treatment of their metastatic disease, while all the others had been previously treated with one or more regimens of chemotherapy and/or hormone therapy. The median duration of the treatment for evaluable patients was 3 months (range 1-13+). Among 65 evaluable patients 2 complete responses and 12 partial responses (objective response rate 21.5%; 95% confidence limits 12.31%-33.49%) were observed. Median duration of response was 7 months (range 2-12+). Responses were observed both in visceral and in non-visceral sites of disease. Twenty-nine patients obtained a stabilization of disease (44.7%), and twenty-two progressed (33.8%). Median duration of stabilization was 4 months (range 3-13+). Median survival for all patients from the start of megestrol acetate was 9 months (range 1-22+). The most common side effect of therapy was weight gain, occurring in 36% of patients. Megestrol acetate on a single-daily-dose schedule can be considered as an interesting hormonal treatment for advanced breast cancer, especially in the clinical instance of patients who, after having obtained a remission or stabilization of disease with tamoxifen, need further palliative treatment.
Body Weight↗
Cisplatin and recombinant alpha interferon in advanced breast cancer.
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Breast Neoplasms↗
Phase II study of lonidamine in metastatic breast cancer.
Thirty patients with previously treated metastatic breast cancer were entered in a phase II study with oral lonidamine. Twenty-eight patients are evaluable for toxicity and 25 for response. A partial remission was obtained in four patients (16%) and disease stability in 11 (44%): 10 patients progressed (40%). Toxicity was acceptable, consisting mainly of myalgias (39% of patients) and asthenia (21.4%). No myelotoxicity was observed. The drug is active in previously treated metastatic breast cancer and, because of its peculiar pattern of action and toxicity, deserves to be evaluated in combination with cytotoxic chemotherapy.
Adult↗
Impact of administration-related factors on outcome of adjuvant chemotherapy for primary breast cancer.
The survival of 229 patients treated with adjuvant i.v. cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) after surgery for primary breast cancer was analyzed according to three administration-related factors: total number of cycles received, time elapsed between surgery and start of chemotherapy, and dose intensity of treatment. All parameters were found to be significantly associated with survival of patients in a univariate analysis. Multivariate analysis confirmed the independent prognostic importance of dose intensity and time between surgery and chemotherapy. Although prospective studies are needed to confirm such results, clinicians should be aware that unnecessary treatment delays or dose reductions in adjuvant chemotherapy for breast cancer are probably detrimental to patient survival.
Adult↗