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Biomedical subjects

G Bertelli

Publications and source records attributed to G Bertelli.

At least 55 records · Page 3Linked to original sources

Conservative treatment of postmastectomy lymphedema: a controlled, randomized trial.

A controlled, randomized trial was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve.

Aged↗

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↗

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↗

Colostomy irrigation in the elderly. Effective recovery regardless of age.

One hundred forty elderly cancer outpatients with colostomy in the authors' rehabilitation department were included in an analysis of the feasibility, effectiveness, and safety of periodic irrigation of remaining colon with lukewarm tap water with the aim of regaining full continence. Sixteen patients did not have a sufficiently long remaining bowel (cecostomy, transverse colostomy) and 17 were considered unsuitable to learn the technique because of advanced neoplastic disease with poor life expectancy, intercurrent disease, or stomal problems. One hundred seven patients were proposed to perform the irrigation: 17 refused to do so with the remaining 90 able to learn the method without problems. Nearly all patients achieved full continence for at least 24 hours. Three patients refused to continue, and nine interrupted for minor complications. The median duration of irrigation in the whole group is 257 days (range, 1 to 2669 days): 32 patients have been irrigating from one to five years, and 9 patients for more than 5 years. Based on these results, we recommend irrigation as standard rehabilitative treatment for elderly patients.

Age Factors↗

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↗

The fecal chymotrypsin photometric assay in the evaluation of exocrine pancreatic capacity. Comparison with other direct and indirect pancreatic function tests.

Fecal chymotrypsin (FCT) has been measured by a new photometric method (Monotest Chymotrypsin; Boehringer, Mannheim) in 78 patients: 44 with chronic pancreatitis and 34 not affected by any pancreatic disease. The results were compared with those from other tests of pancreatic secretory (secretin-cerulein test) and digestive [serum and urinary p-aminobenzoic acid (PABA) and pancreolauryl] capacity. When FCT values were severely reduced (below 6.7 U/g), from 90 to 100% of the patients also presented abnormal pancreatic secretory and digestive capacity. On the other hand, 87% of the patients with normal FCT (above 20 U/g) presented normal secretory and digestive capacity. Patients with intermediate FCT values (between 6.7 and 20 U/g) showed normal or abnormal pancreatic secretory and digestive capacity with the same probability. Therefore, FCT, carried out as a first test, seems to identify subjects that need no further pancreatic function tests (normal and severely impaired FCT) and patients who need other more complex functional investigations (intermediate FCT values).

Biomarkers↗

The role of surgery in the combined treatment of locally advanced breast cancer.

Sixty patients with stage IIIA and IIIB breast cancer have been treated with a combined modality approach including induction chemotherapy, surgery and adjuvant chemotherapy: 74.5% of patients achieved an objective response after 3 cycles of induction chemotherapy, and 98.3% of patients were rendered disease-free after induction chemotherapy and surgery or radiotherapy; at 4 years, actuarial survival and disease-free survival are 71.5% and 43%, respectively. These results are significantly better than our historical control, and locally advanced breast cancer must now be considered a curable disease when treated with an aggressive multimodal approach.

Adult↗

Cisplatin and 5-fluorouracil in refractory breast cancer patients: a phase II study.

24 patients with a median of 3 prior chemotherapy regimens were treated in our department with cisplatin 20 mg/m2 (with pre- and posthydration) and 5-fluorouracil 200 mg/m2 i.v. on day 1-5, every three weeks. 23 patients are evaluable; one had early death. 4 patients (17%) achieved a partial response, 8 had stable disease, and 11 progressed. Toxicity observed was moderate and no renal toxicity was noted. This study therefore shows tolerable toxicity but limited usefulness of adding cisplatin to 5-fluorouracil according to this schedule in these highly pretreated patients.

Adult↗

Adjuvant tamoxifen in primary breast cancer: influence on plasma lipids and antithrombin III levels.

The possible estrogenic effects of tamoxifen on plasma lipids and antithrombin III levels were investigated in 91 breast cancer patients. Mean values of total, HDL and LDL cholesterol, triglycerides, glucose, uric acid, and antithrombin III were evaluated in 55 patients on adjuvant tamoxifen for at least 3 months and compared with those found in 36 patients on no therapy. Total cholesterol, LDL cholesterol, and antithrombin III levels were significantly lower in treated patients (p less than 0.05). Our results support the hypothesis of a partial agonist action of this antiestrogen, although general clinical practice suggests that tamoxifen-related thrombotic events are rare.

Antithrombin III↗

Chemotherapy with estrogenic recruitment and surgery in locally advanced breast cancer: clinical and cytokinetic results.

Thirty-nine patients with locally advanced breast cancer (T3b-4, N1-3 or inflammatory carcinoma) received 3 cycles of induction chemotherapy with estrogenic recruitment before surgery. The therapeutic regimen consisted of diethylstilbestrol (DES) orally on days 1-3, 5-Fluorouracil + Doxorubicin + Cyclophosphamide on day 4 q 21 days (DES-FAC). After surgery 6 additional cycles of chemotherapy (3 DES-FAC alternating with 3 DES-CMF with Methotrexate + F and C as in FAC) were administered. The objective response rate was 71.8% with 15.4% CR, and 56.4% PR; after surgery 36/39 (92.3%) patients were rendered disease-free. So far, 13 of 26 patients in stage IIIb have relapsed (9 of 13 with inflammatory carcinomas). Three-year survival and progression-free survival are 60% and 53.5%, respectively. Twenty-three of the 39 patients were subjected to serial tumor biopsies during the first DES-FAC regimen to allow for tumor-cell kinetic studies during DES and chemotherapy. A significant estrogenic recruitment occurred in 16 patients (69.6%), irrespective of estrogen-receptor status. At surgery, 3-4 weeks after induction chemotherapy, tumor proliferative activity was significantly depressed in comparison to basal values. These results indicate that breast cancer cells can be recruited in vivo with DES and that chemotherapy following estrogenic stimulation is effective and feasible with acceptable toxicity.

Adult↗

Sequential administration of cyclophosphamide, methotrexate, 5-fluorouracil, and folinic acid as salvage treatment in metastatic breast cancer.

Experimental data show that sequencing methotrexate (MTX) and 5-fluorouracil (5-FU) may result in synergistic antitumor activity. Moreover, the effect of 5-FU is increased by folinic acid (FA), and finally, cyclophosphamide (CPA) produces an expansion of tumor growth fraction, suggesting an increased cytotoxic effect of cycle-specific drugs subsequently administered. Based on these premises, we have performed a Phase II study with CPA (600 mg/m2 i.v., day 1), MTX (200 mg/m2 1-h i.v. infusion, day 7), 5-FU (600 mg/m2 i.v., day 8), and FA (500 mg/m2 2-h i.v. infusion, day 8 plus 15 mg p.o. every 6 h on days 8 and 9) administered every 3 weeks. Thirty-six patients with metastatic breast cancer were admitted into the study. Median age was 52 years, and all but two patients were postmenopausal. Dominant sites of metastases were soft tissues in 10 patients, bones in 7 patients, and viscera in 19 patients. All patients were pretreated with chemo- and/or hormone therapy. Sixteen patients achieved an objective response (44.5%: 1 complete response and 15 partial responses), 8 had stable disease (SD) (22.2%), and 12 progressed (33.3%). Twenty-one patients had previously received conventional CMF in an adjuvant setting (15 patients) or for metastases (6 patients): 1 complete response (CR) and 7 partial responses (PR) were obtained in the first group and 1 in the second. Major toxic effects were hair loss (56.4%), nausea and vomiting (72%), mucositis (52.5%), and leukopenia (61%). A randomized study could be useful to assess the role of sequential CMF versus conventional CMF in metastatic breast cancer patients.

Adult↗

A phase II study with danazol in metastatic breast cancer.

Danazol is a synthetic steroid that inhibits the gonadotropin secretion. Its efficacy was tested in 27 patients with metastatic breast cancer at the dose of 200 mg three times daily. Characteristics of patients were as follows. The median age was 57 years (range, 44-85). All patients were postmenopausal, and all had previously received a median of two (range, 1-3) endocrine therapies. Estrogen receptor status was known in 12 (positive in five of 12; negative in seven of 12). Dominant sites of metastases were lung in seven, bone in ten, liver in three, and soft tissue in seven. Six of 27 patients were unevaluable for response (early death, four; lost to follow-up, two). Three of 21 patients showed an objective response, eight of 21 obtained stabilization of disease, and eight progressed. The therapy was well tolerated in the majority: gastric pain was observed in three and nausea in two. Danazol could have a role in the treatment of metastatic breast cancer as an alternative regimen when other treatment has failed.

Adult↗

Multimodality treatment of locally advanced breast cancer.

From 1976 to 1985, 61 consecutive patients with locally advanced breast cancer were treated with multimodality therapy. Overall 5-year survival was 30% with a median survival of 36 months. 50% of patients relapsed within 13 months. Other factors such as menopausal status, side of illness (right or left breast), responses to systemic or to local treatment, survival and progression-free survival in responders and non-responders have been analyzed.

Adult↗