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Biomedical subjects

G Catalano

Publications and source records attributed to G Catalano.

At least 145 records · Page 8Linked to original sources

Recombinant human erythropoietin treatment in cisplatin-associated anemia: a randomized, double-blind trial with placebo.

PURPOSE: To evaluate the effect of exogenous recombinant human erythropoietin (rHuEPO) on the increase of hemoglobin levels and on the transfusion requirements in patients with cisplatin (CDDP)-induced anemia, we performed a double-blind randomized trial with placebo. PATIENTS AND METHODS: One hundred patients with CDDP-associated anemia (hemoglobin level < 90 g/L) were randomized to receive either placebo (saline solution) or rHuEPO (100 U/kg body weight subcutaneously) three times per week. The end points of this study were the increase in hemoglobin levels to greater than 100 g/L after 3, 6, and 9 weeks and the effect on transfusion requirements. RESULTS: Ninety-nine of 100 patients were assessable for response and toxicity. In the rHuEPO arm, mean hemoglobin levels were statistically significantly increased after the third, sixth, and ninth weeks of therapy (101.1 +/- 9.0, 102.4 +/- 6.6, and 105.1 +/- 9.4 g/L, respectively) compared with the mean baseline value (86.3 +/- 6.2 g/L). In the placebo arm, there were no increases in mean hemoglobin levels at the third, sixth, and ninth weeks (81.0 +/- 5.2, 81.3 +/- 9.2, and 81.2 +/- 11 g/L, respectively) compared with the mean baseline value (87.3 +/- 5.2 g/L). Furthermore only 20% of patients required blood transfusions in the rHuEPO arm versus 56% of patients in the placebo arm (P = .01), with a mean units of blood transfused per patient of 0.30 in the rHuEPO arm and 1.8 in the placebo arm (P = .01). Treatment was well tolerated, with no significant side effects. CONCLUSION: CDDP-induced anemia is corrected by rHuEPO, which results in reduced blood transfusion requirements.

Adult↗

Autologous bone marrow transplantation in Ki-1 lymphoma with poor prognosis. A case report.

The authors report a case of 17-years-old woman suffering from a Ki-1 lymphoma with retroperitoneal bulky disease, extranodal involvement, poor performance status and high level of LDH. Due to the unfavorable prognosis, after complete remission obtained with aggressive induction therapy, the patient received high dose of therapy based on busulfan and etoposide followed by autologous bone marrow transplantation (ABMT) as consolidation therapy. Toxicity was mild, particularly neutrophil recovery was hastened with G-CSF. After 22 months from ABMT she is alive without evidence of disease.

Adolescent↗

Expression cDNA cloning of a novel oncogene with sequence similarity to regulators of small GTP-binding proteins.

We generated a cDNA expression library from a human mammary epithelial cell line for detection of novel oncogenes by focus formation assay in NIH3T3 cells. A morphologically unique focus was identified and the transforming plasmid was isolated. The transforming gene, designated TIM, encoded a predicted protein species of 60 kDa containing a Dbl-Homology (DH) motif. This motif is also present in other growth regulatory molecules including Bcr, Cdc24, Vav, Ras-grf, and Ect2 which have been implicated as regulators of small GTP-binding proteins. NIH3T3 cells transfected with TIM expression plasmid showed altered growth properties in vitro and were tumorigenic when injected into nude mice. The 6.5 kilobasepair (kb) transcript of the TIM gene was mainly expressed in kidney, liver, pancreas, lung, and placenta. By analysing a panel of human-hamster somatic cell hybrids, we localized the TIM gene to human chromosome 7.

3T3 Cells↗

[Primary lymphoma of the parotid: a rare location].

Primary lymphoma of the parotid gland is uncommon: we report a case in an 82-year-old man, classified according to the Working Formulation as a low-grade lymphoma. After parotidectomy the patient was treated with radiation therapy and, subsequently, with polychemotherapy (endoxan, vincristine and prednisone) for six cycles. At follow-up examination one year after, the patient is in complete remission. The major problem encountered was the correct diagnosis that became possible only when the surgical specimen was available. The authors review the pathological features of this extranodal form of lymphoma and discuss the treatment.

Aged↗

A pilot clinical trial of postoperative adjuvant intraperitoneal cisplatin, 5-fluorouracil, 6S-leucovorin and interferon alpha 2b in patients with resected gastric cancer.

AIMS AND BACKGROUND: The study was performed to assess the toxicity and impact on relapse pattern of postoperative intraperitoneal cisplatin, 5-fluorouracil, leucovorin and interferon therapy as adjuvant treatment for gastric cancer patients who are at high risk for recurrence after potentially curative resection (T2 N1-2; T3-4 N any Mo). PATIENTS AND METHODS: Starting 14 to 21 days after potentially curative resection of primary gastric cancers, 22 patients were given intraperitoneal cisplatin, 60 mg/m2; 5-fluorouracil, 1000 mg/m2; 6S-leucovorin, 250 mg/m2; interferon alpha 2b, 10 MU/m2; every other week for six times. RESULTS: After a median follow-up of 24 months, 63% of patients were alive and free of disease. Eight patients had recurred; five had an intraabdominal component, and 3 had extraabdominal failure. Toxicity was mild: no grade III-IV WHO toxicity was observed. CONCLUSIONS: Intraperitoneal cisplatin, 5-fluorouracil, 6S-leucovorin and interferon is a tolerable therapy in the postoperative setting for patients with resected gastric cancer. These data make this approach interesting for the development of new programs of adjuvant therapy of high-risk gastric cancer.

Adult↗

Breast cancer developing after therapy for Hodgkin's disease.

Two patients developed breast cancer 14 and 8 years after treatment of Hodgkin's disease. Both had received mediastinal irradiation and MOPP chemotherapy. Because of the increased risk of breast cancer in women treated for Hodgkin's disease, as reported in the literature, we suggest the early initiation of periodic screening for breast cancer, to detect possible neoplasms at a more treatable stage.

Adolescent↗

Cisplatin-associated anaemia treated with subcutaneous erythropoietin. A pilot study.

In 20 patients with cisplatin-associated anaemia (haemoglobin less than 90 gl-1), recombinant human erythropoietin was administered subcutaneously three times a week on an outpatient basis. The initial dose was 50 Units Kg-1 of body weight. If response was not achieved within 3 weeks, dose was increased to 75 Units Kg-1. Using the same criteria further escalation to 100 Units Kg-1 was performed. If there was no response erythropoietin was terminated. Fifteen patients obtained an increase in haemoglobin to above 100 gl-1 which was considered as a clinical response in this study, with a dose of 50 Units Kg-1; one patient needed an erythropoietin dose of 75 Units Kg-1 and one a dose of 100 Units Kg-1. Only three patients required haemotransfusions and were considered non responders. Haemoglobin increases occurred despite continuation of cisplatin chemotherapy. In conclusion subcutaneous low dose of erythropoietin seems to be effective and safe in the treatment of cisplatin-induced anaemia.

Aged↗

5-Fluorouracil, leucovorin and interferon alpha 2b in advanced pancreatic cancer: a pilot study.

BACKGROUND: On the basis of data suggesting the possibility of maximizing the efficacy of 5-FU by LV and IFN, a pilot clinical trial was initiated in advanced pancreatic cancer. PATIENTS AND METHODS: Twenty-four patients received weekly 5-FU 600 mg/m2 bolus 1 hour after the initiation of a 2-hour infusion of 500 mg/m2 of leucovorin. Three MU of interferon alpha 2b was administered subcutaneously three times a week. RESULTS: Two of 22 evaluable patients obtained partial responses (8%, confidence interval 3%-33%). Toxicity was severe. Diarrhea and stomatitis were the most common side effects, occurring in 50% and 25% of patients, respectively. CONCLUSION: Because of the presence of severe toxicity we suggest that further clinical trials in pancreatic cancer be attempted only after a better definition in preclinical studies of interactions among 5-FU, leucovorin and interferon.

Aged↗

Octreotide versus loperamide in the treatment of fluorouracil-induced diarrhea: a randomized trial.

PURPOSE: Diarrhea is a prominent feature of fluorouracil (5FU) gastrointestinal toxicity, especially when 5FU is combined with leucovorin (LV) or interferon (IFN). No treatment for this condition has been well defined, although drugs, such as diphenoxylate or loperamide, generally are used. The efficacy of octreotide in the treatment of 5FU-induced diarrhea recently has been reported. We performed a randomized trial that compared octreotide with loperamide, the drug most commonly used for therapy for this disorder. PATIENTS AND METHODS: Forty-one patients with grade 2 (four to six stools per day) or grade 3 (seven to nine stools per day; National Cancer Institute toxicity criteria) diarrhea after chemotherapy with a 5FU-containing regimen for colorectal cancer in 28 cases, gastric cancer in six cases, pancreatic cancer in five cases, and breast cancer in two cases, were entered onto the study. Twenty-one patients received octreotide at a dosage of 0.1 mg subcutaneously twice per day for 3 days, and 20 patients received loperamide 4 mg orally initially and then 2 mg every 6 hours for 3 days. The two arms were comparable for age, sex, and primary tumor. Patients were evaluated for response each treatment day; all patients were assessable. RESULTS: Diarrhea resolved in 19 patients in the octreotide arm (one within the first day; four within the second day; and 14 within the third day) versus only three (all after the third day of therapy) in the loperamide arm (P < .005). Median frequency of stools in the 3 days of therapy was four, three, and zero in the octreotide arm and five, five, and five in the loperamide arm. No side effects were observed in both arms. Ten patients on the loperamide arm and only one on the octreotide arm required hospitalization for parenteral replenishment of fluids and electrolytes. CONCLUSION: Octreotide seems to be more effective than loperamide in control of diarrhea and elimination of the need for replenishment of fluids and electrolytes.

Adult↗

Control of chemotherapy-induced diarrhoea with octreotide in patients receiving 5-fluorouracil.

Chemotherapy treatment with combination of 5-fluorouracil and leucovorin or interferon alpha determined an incidence of severe diarrhoea of 10 and 20%, respectively. Up to date no treatment for this condition has been defined. 21 patients affected by advanced colorectal cancer and 6 patients affected by advanced pancreatic cancer received octreotide as treatment for severe diarrhoea following chemotherapy with 5-fluorouracil/leucovorin (Machover's regimen) or 5-fluorouracil/interferon (Wadler's regimen) combination. Octreotide was administered by subcutaneous injection of 50 micrograms twice daily on the first day and 100 micrograms twice daily on the second and third day. 26 patients had total cessation of diarrhoea: 4 patients within the first day, 6 within the second day and 16 within the third day. 1 patient had no change and after the last administration of octreotide he was treated with loperamide and intravenous hydration. Side effects have been mild. In summary octreotide seems to be an effective agent in the management of chemotherapy related diarrhoea.

Aged↗

Salvage chemotherapy in colorectal cancer patients with good performance status and young age after failure of 5-fluorouracil/leucovorin combination.

Forty-one patients with metastatic colorectal cancer were treated every four weeks with methotrexate 25 mg/m2 i.v. days 1, 8, 15; vincristine 1 mg/m2 i.v. day 1; lomustine 100 mg/m2 p.o. day 1. Inclusion criteria were: failure of previous 5-fluorouracil/leucovorin treatment; performance status (ECOG) 0-2; age less than 60 years; presence of symptoms; absence of concomitant diseases. Metastatic sites were: liver 30, lung 4, abdominal/pelvic mass 7. Three patients achieved partial responses (2 liver, 1 lung metastases); 4 showed stable disease and 34 progressed on therapy. The median survival of patients with partial response, stable disease and progression was comparable (24, 21, 22 weeks respectively). The most common toxicity was hematologic (thrombocytopenia and leukopenia). Other side effects included nausea and vomiting, stomatitis and diarrhea. Symptoms were not affected by treatment. We conclude that salvage chemotherapy is not recommended in colorectal cancer after 5-fluorouracil/leucovorin treatment even in patients with generally considered favorable characteristics for response to chemotherapy.

Adenocarcinoma↗

Treatment of elderly advanced gastric cancer patients with 5-fluorouracil and leucovorin combination.

In September 1987 a phase II study was begun to verify if elderly symptomatic patients affected by advanced gastric cancer could benefit from a combination of 5-fluorouracil (5FU) and leucovorin (LV). We employed Machover's regimen: 5FU 370 mg/m2 i.v. infusion daily for 5 days; LV 200 mg/m2 i.v. bolus daily for 5 days; cycles were repeated every 3 weeks. 23 patients entered the study and 22 were evaluable for response and toxicity. We obtained only one partial response; 9 had stable disease and 12 progressed on therapy. The median duration of survival was 6 months. Symptoms were not affected by treatment. These data reflect the absence of significant improvement in the quality of life, which was further lessened by the presence of treatment side effects. Because of this we think that this regimen cannot be recommended for the treatment of elderly advanced gastric cancer patients.

Adenocarcinoma↗

Double biochemical modulation of 5-fluorouracil by leucovorin and cyclic low dose interferon alpha 2b in advanced colorectal cancer patients.

Because of the different sites and mechanisms of biochemical interaction among 5-fluorouracil (5-FU), leucovorin (LV) and interferon (IFN), we hypothesized that the concomitant use of IFN could increase the activity of the 5-FU/LV combination in colorectal cancer patients. Forty-five patients were included in the study and all were evaluable for response and toxicity. They were treated with 5-FU 370 mg/sqm i.v. d 2-6; LV 200 mg/sqm i.v. d 2-6; IFN alpha 2b 3 million U im d 1-7 every 21 days. Six patients achieved complete responses, 17 partial responses, 14 had stable disease and 8 progressed on therapy for an overall response rate of 51%. Median survival has not been reached. At a median follow-up of 14 months 33 of 45 patients remain alive. Nine patients experienced toxicity grade 3 (6 diarrhea and 3 stomatitis). Our results seem to suggest that IFN could increase 5-FU/LV activity and that this combination is well tolerated.

Adult↗

Experience with intrapleural natural beta interferon in the treatment of malignant pleural effusions.

Malignant pleural effusion is a common complication of cancer. Intrapleural beta interferon has been recently tested, and responses were obtained in about 1/3 of the patients without considerable side effects. We treated 22 patients with recurrent symptomatic malignant pleural effusions with intrapleural beta interferon at increasing doses (5-15 million units) for a maximum of three courses and obtained only two responses. In our opinion, this schedule cannot be recommended for routine use.

Aged↗

5-Fluorouracil dose intensity increase in 5-fluorouracil and leucovorin combination: results of a phase II study.

It was our intention to verify if in the combination of 5-fluorouracil and leucovorin, the fluoropyrimidine dose intensity is an important determinant of response as noted by Hryniuk when 5-fluorouracil was given alone. By employing the Machover regimen but with cycles repeated every three weeks, a 5-fluorouracil projected dose intensity of 616 mg/m2/wk was obtained. It approximates the maximum tolerated dose for this drug when used alone by i.v. bolus. 50 patients entered this study and 48 were evaluable for response and toxicity. The overall response rate was 29% (five complete responses and nine partial responses). The dose limiting toxicity was gastrointestinal rather than myelosuppression. 5-fluorouracil dose reduction was needed in seven patients. The mean delivered dose intensity of 5-fluorouracil was 610 mg/m2/wk (582 mg/m2/wk in patients in whom 5-fluorouracil was reduced for toxicity and 616 mg/m2/wk in the others). Our results do not seem to show any advantage in the maximization of 5-fluorouracil dose intensity. Furthermore, in an analysis of data from the literature we did not find any difference in response rate in relation to dose intensity in the 5-fluorouracil/leucovorin combination.

Antineoplastic Combined Chemotherapy Protocols↗

Gastric metastases from breast cancer: a case report.

We describe a case of a 50 year old woman with a secondary involvement of the stomach from breast carcinoma. She complained of nausea, vomiting and epigastric pain resistant to gastroprotective drugs. Initially symptoms were attributed to the side effects of chemotherapeutic agents. Correct diagnosis led to effective treatment of gastrointestinal symptoms with consequent improvement in her quality of life.

Breast Neoplasms↗

[Biological tumor markers].

The classification of tumor markers can at present be only provisional since in this field new acquisitions are reported daily. Nevertheless, during the last few years, a number of monographs and chapters in oncology texts have become available for students and physicians in which certain parameters (sensitivity, specificity, predictive value of individual markers) are illustrated, thus allowing for a more accurate evaluation of their diagnostic efficacy and offering indications as to which of these markers are most useful in relation to the site of the tumor. Although tumor markers are present throughout the organism, the above review is limited to those found in blood. Clinical results obtained to far have already lead to the conclusion that tumor markers are useful above all for the diagnostic and therapeutic follow-up of patients rather than for the diagnosis of tumors. The present tendency is for the association of several markers since a higher percentage of positive results is achieved both for diagnostic purposes and for the detection of residual foci after apparently successful treatments and for the precocious detection of recurrences, as well as for the evaluation of the efficacy of ongoing therapies.

Adult↗