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Biomedical subjects

E Bajetta

Publications and source records attributed to E Bajetta.

At least 145 records · Page 8Linked to original sources

Preliminary 3-year results of 12 versus 6 cycles of surgical adjuvant CMF in premenopausal breast cancer.

In hope of reducing the duration of adjuvant treatment in premenopausal patients with operable breast cancer and histologically positive axillary lymph nodes, a prospective controlled study was started in September 1975. A total of 160 patients were randomized to receive 12 cycles of adjuvant CMF, while 165 were allocated to receive 6 cycles. At 3 years from radical mastectomy, the relapse-free survival was 85.4% in the 12-cycle group compared to 82.6% for the 6-cycle subset (P = 0.29). In both treatment groups, the incidence of treatment failure was directly proportional to the number of involved axillary nodes and to the clinical tumor size. Drug-induced amenorrhea as well as estrogen receptor status failed to significantly affect the results obtained. Treatment failures were more often documented in distant sites, while only 4--5% relapse was observed in local-regional areas. Overall survival was also similar for both treatment arms (86.2% vs. 85.1%, P = 0.49). Toxicity was moderate and reversible and no drug-induced neoplasms were so far observed. Present results achieved with 6 cycles of adjuvant CMF appear encouraging. However, they are still too preliminary to recommend the routine use of 6 cycles instead of the classical 12 cycles.

Adult↗

Combination chemotherapy as an adjuvant treatment in operable breast cancer.

Prolonged cyclic combination chemotherapy with cyclophosphamide, methotrexate and fluorouracil was evaluated as adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes. After 27 months of study, treatment occurred in 24 per cent of 179 control patients and in 5.3 per cent of 207 women given combination chemotherapy (P less than 10(-6)), the advantage appearing statistically significant in all subgroups of patients. Patients with four or more positive axillary nodes had a higher per cent of relapses than those with fewer nodes. The initial new clinical manifestations occurred in distant sites in 81.5 per cent of relapsed patients. Long-term chemotherapy produced an acceptable toxicity, thus allowing the administration of a high percentage of drug dosage. These results should be considered with caution, since, at present, the effect of this therapy on survival and possible long-term side effects remain unknown.

Adult↗

Combination chemotherapy with DTIC (NSC-45388) in advanced malignant melanoma, soft tissue sarcomas, and Hodgkin's disease.

The results of three controlled studies with multiple-drug regimens which included DTIC are reported for advanced melanoma, soft tissue sarcomas, and Hodgkin's disease. In malignant melanoma, no statistical difference was observed between (a) DTIC, BCNU, and vincristine, and (b) DTIC, BCNU, and actinomycin D in terms of response rate, median duration of response, and survival. In sarcomas, the combination of adriamycin and DTIC produced a higher incidence of complete plus partial responders when compared to cyclophosphamide, vincristine, and methotrexate. However, no significant difference was seen in the median duration of response or survival. In Hodgkin's disease, a new four-drug combination including adriamycin, bleomycin, vinblastine, and DTIC (ABVD) produced an incidence of complete remissions and a median duration of response comparable to that achieved with mechlorethamine, vincristine (Oncovin), predinisone, and procarbazine (MOPP). Preliminary data indicate that ABVD is not cross resistant to MOPP. It is concluded that DTIC can be successfully and safely employed in combination with conventional agents in susceptible neoplastic diseases.

Antineoplastic Agents↗

Laparoscopy and laparotomy combined with bone marrow biopsy in staging Hodgkin's disease.

The relative merits of laparoscopy with liver and spleen biopsy and staging laparotomy were studied in 91 unselected patients with Hodgkin's disease. Laparoscopy with liver and spleen biopsy were combined with needle biopsy of the bone marrow and laparotomy was combined with open bone marrow biopsy. In 65 untreated patients six out of seven with liver or marrow disease, or both, were shown to have extranodal lymphomas in these sites by laparoscopy plus needle marrow biopsy. Among 26 patients who had been treated this finding occurred in six out of 10 patients. Spleen biopsies during laparoscopy detected infiltration by lymphoma in 14 out of 37 (38%) patients with diseases spleens. Morbidity was higher after laparotomy than after laparoscopy. Laparoscopy produced abdominal bleeding secondary to splenic biopsy in two patients. All patients with Hodgkin's disease should be subjected to laparoscopy plus needle marrow biopsy before undergoing laparotomy.

Adolescent↗

The aromatase inhibitor letrozole in advanced breast cancer: effects on serum insulin-like growth factor (IGF)-I and IGF-binding protein-3 levels.

Serum insulin-like growth factor (IGF)-I and IGF-binding protein-3 levels were measured in two groups of postmenopausal women with advanced breast cancer, who received the aromatase inhibitor letrozole 0.5 or 2.5 mg p.o. once daily. Blood samples were obtained from 15 patients in each dose group at baseline, and one and three months after starting therapy. Circulating IGF-I and IGFBP-3 concentrations were determined by means of radioimmunoassay. In both dosage groups a statistically significant increase in the IGF-I levels was observed during three months of letrozole treatment (P=0.003). In addition, the multiple testing procedure yielded in the whole patient population a significant result in the comparison between mean IGF-I values after three months of therapy and those observed at baseline (P=0.004), the estimated average increase being of 24%. No significant result was obtained in the analysis for the dose effect (P=0.077) and for the time x dose interaction (P=0.208). Circulating IGFBP-3 levels did not appear to be affected by letrozole treatment in either of the dose groups. This is the first report concerning the short-term effects of letrozole on components of the IGF system in breast cancer patients; further investigations are warranted in order to confirm these preliminary data.

Aged↗

Goserelin in premenopausal advanced breast cancer: clinical and endocrine evaluation of responsive patients.

Medical ovariectomy with goserelin is an alternative to surgical oophorectomy. To evaluate the relationship between tumor regression and endocrine changes induced by therapy, 40 premenopausal patients with advanced breast cancer were given 3.6 mg of goserelin subcutaneously fortnightly for the first 4 doses and every 28 days thereafter. We have made a particular analysis of the clinical and endocrine profile of responsive patients. Objective responses were observed in 17 of the 38 evaluable patients (45%), 6 cases achieving complete remission. Serum estradiol was suppressed in castrated women, although there was a tendency towards an increase in serum follicle-stimulating hormone over time. No statistically significant difference was observed in the hormonal profiles of patients experiencing a complete or partial response. Our experience confirms that goserelin is as effective as oophorectomy and that there is a clear correspondence between clinical response and drug-induced estrogen suppression.

Adult↗

Home treatment with interleukin 2 and beta-interferon in patients with colorectal cancer and hepatocellular carcinoma.

Biological response modifiers have been extensively investigated in the management of patients with cancer, but few data are available on tumors of the gastrointestinal tracts. To evaluate the feasibility and activity of the combination of interleukin 2 (IL-2) and beta-interferon (beta-IFN), 15 patients with colorectal cancer and 10 patients with hepatocellular carcinoma were treated with the following outpatient schedule: beta-IFN 3 x 10(6) U i.m. 3 times weekly from day 1 to day 14; IL-2 4.5 x 10(6) U s.c. every 12 for 5 consecutive days a week from day 7 to day 21, the cycles being repeated every 28 days. All of the patients had been previously treated with chemotherapy; 7 unresectable locally advanced, and 18 had metastatic disease. All of the treatment courses were administered in an outpatient setting. No grade 4 side effects were recorded. The worst side effects were grade 3 fever (4 patients) and asthenia (2 patients) requiring treatment discontinuation in 4 cases. Twenty-four patients were evaluated for response (14 with colorectal cancer and 10 with hepatocellular carcinoma). One partial response, 4 stable disease, 9 progressive disease were recorded among the colorectal patients; 4 stable disease and 6 progressive disease among the hepatocellular carcinoma patients. The median duration of stable disease was 3 months for hepatocellular carcinoma and 4 months for colorectal cancer patients. Our results suggest that the schedule is feasible in an outpatient setting. Its limited hematological toxicity makes it suitable to be combined with cytotoxic drugs.

Adult↗