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Biomedical subjects

R Labianca

Publications and source records attributed to R Labianca.

At least 91 records · Page 5Linked to original sources
PubMed1994

Mediterranean Kaposi's sarcoma in the elderly. A randomized study of oral etoposide versus vinblastine.

BACKGROUND: This Phase III trial was performed to compare the roles of oral etoposide and intravenous (i.v.) vinblastine in the treatment of Mediterranean Kaposi's Sarcoma (MEKS) in elderly patients with severe disease (Stages II, Ac/B, III, and IV). PATIENTS AND METHODS: Sixty-five patients were randomized to receive either oral etoposide (60 mg/m2 on Days 1-3 during the first course; 60 mg/m2 on Days 1-4 during the second course, and 60 mg/m2 on Days 1-4 during the second course, and 60 mg/m2 on Days 1-5 during the third course; the courses were recycled every 3 weeks) or an i.v. bolus of vinblastine (3 mg/m2 weekly for 3 weeks, and then 6 mg/m2 every 3 weeks). RESULTS: No significant difference between the two drugs was observed in terms of response rates (etoposide, 73.5% vs. vinblastine, 58%; P = 0.3), duration of response, or survival (median not yet reached at a median follow-up of 38 months). Side effects of both treatments were limited, although myelotoxicity was more evident in the vinblastine arm. CONCLUSIONS: Although it is feasible and well tolerated, the oral administration of etoposide at these doses and in this regimen does not appear superior to vinblastine in the treatment of MEKS. Further evaluation of a more intensive schedule in large cooperative clinical trials is needed to establish the role of this drug in comparison with reference treatments.

Administration, Oral↗
PubMed1994

Double modulation of 5-fluorouracil in advanced colorectal cancer with low-dose interferon-alpha 2b and folinic acid. The "GISCAD" experience. Italian Group for the Study of Digestive Tract Cancer.

In advanced colorectal cancer the addition of folinic acid (FA) has been shown to lead to increased activity, at least in terms of response rate, in comparison with 5-fluorouracil (5FU) alone. Similarly, interferon-alpha (IFN) is able to potentiate 5FU, although high doses cause heavy toxicity. Given the different mechanisms of action of the two agents, the double modulation of 5FU deserves clinical evaluation. In a multicenter study (involving both primary care and referral institutions) 63 patients with advanced colorectal cancer, previously untreated with chemotherapy, received, in an outpatient setting, FA (200 mg/m2 i.v. bolus) + 5FU (400 mg/m2 i.v. in 15 min) for 5 consecutive days every 4 weeks + IFN 3 x 10(6) U on alternate days, starting 1 week before chemotherapy. During the 5 days of 5FU + FA, IFN was administered daily. The antitumour activity, the impact on response duration and survival and toxicity of the combination were evaluated according to WHO criteria. Of the 63 enrolled patients, 56 were evaluable: there were 2 complete responses (3%) and 13 partial responses (21%), giving an objective response rate of 24% (95% confidence interval 13-35%); no change was observed in 17 cases and progressive disease in 24. Median duration of response was 9 months and median survival (all patients) 13 months. Toxicity was acceptable, even though 4 patients presented reversible grade 4 side-effects (2 mucositis and 2 diarrhoea). With this schedule and these doses, addition of IFN did not lead to any increase in the activity of 5FU + FA. In colorectal cancer, further clinical studies with these drugs should be based on a deeper experimental knowledge of their mechanisms of interaction.

Adult↗
PubMed1994

Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma.

Between February 1991 and July 1992, 79 previously untreated patients with metastatic colorectal carcinoma were enrolled in a phase II study of combined 5-fluorouracil (5-FU) and l-folinic acid (FA). 5-FU 370 mg/m2/day was administered for 5 consecutive days as an intravenous (i.v.) bolus injection preceded by l-FA 100 mg/m2/day with the same administration modality. Treatment was given every 4 weeks until progression. 79 patients were evaluable for toxicity and 64 for response. 2 patients (3%) achieved a complete remission and 8 (12.5%) a partial remission, 33 (52%) had stable disease and 21 patients (33%) had progressive disease. Median duration of remission was 32.5 weeks and median survival for all evaluable patients was 64.5 weeks. Substantial to severe side-effects occurred in 39% of patients. Dose-limiting toxicity (grade 3-4) was mainly diarrhoea (18%) and mucositis (15%). Nausea/vomiting, cutaneous toxicity, leucopenia, alopecia and conjunctivitis of grade 3-4 occurred respectively in 6, 4, 2.5, 1 and 1% of cases. Toxicity appeared to be substantially similar to that characteristic of combined 5-FU and the chiral mixture of d,l-FA. Efficacy was within the range of that observed with the 5-FU/d,l-FA combination, although at the lower level.

Adult↗
PubMed1994

Stages I and II non-Hodgkin's lymphoma of the gastrointestinal tract. Retrospective analysis of 79 patients and review of the literature.

We reviewed the medical records of 79 patients with primary gastrointestinal lymphoma (GI-NHL), defined according to the criteria of Dawson et al. (without involvement of liver, spleen, peripheral or mediastinal lymph nodes, or bone marrow), observed and treated in our institution between 1973-90. The most common disease site was the stomach (70 patients), followed by the small bowel (five patients) and the large bowel (four patients). The stage was IE in 36 cases and IIE in 43. Radical surgery or surgical debulking was the main therapeutic approach (67 patients); 12 patients received only chemotherapy, eight of whom had tumors considered unresectable at laparotomy. After surgery, most of the patients received chemotherapy; radiotherapy (RT) was given to only four patients. Surgically calculated overall survival (OS) rates at 5 years for the patients treated with surgery plus chemotherapy were 64% (radical surgery) and 46% (surgical debulking with microscopic lymphoma residue). For the 12 patients treated with chemotherapy alone, OS at 5 years was 0%. Our findings, in accordance with most published data, suggest that surgery, together with stage and tumor size, remains an important prognostic factor of survival in primary GI-NHL, especially when it is radical. In patients with negative prognostic factors (bulky disease, high-grade histologic type, microscopic residue, and stage II), postoperative chemotherapy and RT decrease the risk of distant failure and local recurrence.

Adult↗
PubMed1993

A phase II study of combination chemotherapy in advanced ovarian carcinoma with cisplatin and cyclophosphamide plus reduced glutathione as potential protective agent against cisplatin toxicity.

AIMS AND BACKGROUND: The clinical use of cisplatin (CDDP), one of the most active agents in advanced ovarian cancer, is limited by nephrotoxicity and cumulative neurotoxicity. In preclinical studies, reduced glutathione (GSH) demonstrated a protective action against CDDP nephrotoxicity. We treated 20 patients with advanced ovarian carcinoma, with polychemotherapy containing CDDP + GSH, to assess the protective action of GSH against CDDP nephrotoxicity. METHODS: Between January 1988 and December 1989, 20 patients, with advanced ovarian carcinoma (St. III-IV-FIGO), not pretreated received CDDP: 45 mg/m2 i.v., on day 1-2, + cyclophosphamide (CPA): 900 mg/m2 i.v. on day 2 + GSH 2500 mg i.v. in normal saline 100 ml (in 15 min), before CDDP, every 21-28 days. RESULTS: A pathologic complete response rate (PCR) of 55% (11/20) was observed (7/14 patients with bulky disease). Median survival was 26.5 months and 5 patients were still alive and disease free at 35 months. Toxicity was limited, without any case of nephrotoxicity. CONCLUSIONS: On the basis of our previous experience with the same regimen without GSH, this study suggests that also in the clinical setting, GSH has no negative interference on CDDP activity and that GSH might improve the therapeutic index of CDDP. However, our data need to be confirmed by large randomized clinical studies.

Adult↗
PubMed1992

High dose alpha-2b interferon + folinic acid in the modulation of 5-fluorouracil. A phase II study in advanced colorectal cancer with evidence of an unfavourable cost/benefit ratio.

The combination of folinic acid (FA) and 5-fluorouracil (5FU) is the most active systemic chemotherapy against advanced colorectal cancer. Experimental and clinical studies have suggested that the activity of 5FU can be improved by the addition of alpha-interferon (IFN). To evaluate the possibility of a double modulation of 5FU, a pilot study was conducted in the period July 1989-December 1989 with the following regimen: FA (200 mg/m2 i.v. bolus x 5 days) + 5FU (400 mg/m2 i.v. in 15 min x 5 days) + alpha-2b IFN (10 x 10(6) IU subcutaneously on alternate days). FA and 5FU administrations were repeated every 28 days; IFN was administered every week. In the 16 treated patients, 4 partial responses, 4 no changes, and 8 with progression of disease were observed, with an objective response rate of 25% (95% CI, 7.8%-55.1%). Median duration of response was 9.5 months, as was overall survival. Toxicity (fever, fatigue, neurotoxicity, stomatitis and diarrhea) was considerable and led to a reduction in IFN doses in 10/16 patients. Due to the unfavorable cost/benefit ratio, the study was closed and a new trial, with different doses and schedule of IFN, was started within the GISCAD (Italian Group for the Study of Digestive Tract Cancer).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the Study of Digestive Tract Cancer).

In a multicentre Phase III trial, 182 patients were randomized to either folinic acid (FA) (200 mg/sqm i.v. x 5 days) + 5-fluorouracil (5-FU) (400 mg/sqm i.v. in 15' x 5 days) every 4 weeks (Arm A), or to 5-FU alone at the same dosage (Arm B). Response rates were 20.6% (Arm A) and 10% (Arm B) with a significant (p = 0.046) advantage for FA + 5-FU. Median time to progression (6 and 6 months) and overall survival (11.5 and 11 months) were similar in the 2 groups of patients, while neither treatment was effective in reducing pain or improving performance status. Univariate analysis showed that no prognostic factors other than treatment influenced response, although survival was affected by the number and site of metastases, performance status, and the presence and degree of pain. Toxicity was acceptable and lower in comparison with other Phase II-III trials, with no significant difference between the 2 arms. However, in individual patients, grade 3-4 side effects (mainly stomatitis and diarrhoea) were observed, particularly in patients receiving FA: this led to interruption of the treatment in 7 cases. The superiority, in terms of objective response, of FA + 5-FU over 5-FU alone would seem to justify a large-scale evaluation of this combination in the adjuvant setting. Further improvements in relation to advanced disease (i.e., modifications to the schedule and/or introduction of other modulators) are warranted.

Adenocarcinoma↗
PubMed1990

Quality of care of colorectal cancer patients in general hospitals: diffusion and impact of management guidelines.

Over the last ten years the Italian National Research Council (C.N.R.) has launched an educational program aimed at favoring the delivery of the most up to date care for cancer patients in community hospitals. Among various tumors for which this effort was undertaken, management guidelines for colorectal cancer were developed in 1978 by a multidisciplinary team of national experts and reported in booklets distributed nationwide under the aegis of the Colorectal Cancer Task Force. In 1988, the C.N.R. funded an evaluation to learn whether: a) the guidelines were widely diffused in the target physician populations; b) their content was accepted by those who received them and, c) practice patterns were consistent with the recommendations in the guidelines. Overall results indicate only a limited effect. Despite clear evidence of a positive self-selection in the physicians' survey, guidelines were familiar to only 47% of responders. Although acceptance of at least some specific recommendations was good among doctors aware of the guidelines (greater than or equal to 60% responders), this finding loses relevance since a not negligible proportion of those not aware of them had the same convictions. Finally, analysis of practice patterns showed serious deficiencies (mostly in terms of thoroughness of operative staging) even in centers where more widespread knowledge of the guidelines should have led to better quality of care. The paper also discusses the comparability of our findings to results of a similar evaluation carried out in the U.S.A. Our results underscore the importance of analyzing the process of diffusion in any assessment of interventions based on knowledge dissemination.

Adult↗
PubMed1988

Cisplatin + 5-fluorouracil versus 5-fluorouracil alone in advanced colorectal cancer: a randomized study.

Sixty patients with advanced colorectal cancer were randomized between cisplatin (60 mg/mq i.v. every 3 weeks) + 5-fluorouracil (600 mg/mq i.v. bolus/weekly) and 5-fluorouracil alone (same schedule). In the 54 evaluable patients, no CR was observed. PR rate was 19.2% for the combination, and 14.5% for the monochemotherapy. Also the overall median survival time was similar for the two arms (10 and 13 months, respectively). Toxicity was acceptable, with more side-effects in the combination arm. Both treatments are of limited activity in advanced colorectal cancer and no advantage comes out from the use of this polychemotherapy.

Adult↗
PubMed1987

[Current status of the use of vitamins (A, E, C, D), folates and selenium in the chemoprevention and treatment of malignant tumors].

The role of vitamins A, E, C, D, folates and selenium in the chemical prevention of tumours and/or precancerous conditions is examined in the light of epidemiological studies and experimental observations. Particular mention is made of significant clinical studies that provide valuable indications about the use of vitamin A and its derivates in particular for the treatment of precancerous and cancerous conditions. Vitamin A and its derivates apparently play a fundamental role not only in the treatment of proliferating malignancies of the skin (carcinomas, severe aclinic keratosis) or involving the skin (fungoid mycosis, skin metastases of solid tumours) but also in the prevention of recurring bladder tumours and the treatment of several bronchial dysplasias.

Ascorbic Acid↗
PubMed1987

Epirubicin treatment of advanced breast carcinoma with the weekly low-dose regimen.

Authors describe the results obtained with weekly low-dose (20 or 30 mg/total) of intravenous bolus epirubicin, used as second line chemotherapy, after CMF, in 29 advanced breast carcinoma patients. 29% objective response rate (1 complete + 6 partial responses) has been observed in 24 evaluable patients, with median response duration of 4 months (range 1-7+). The discrete response rate and the minimal incidence of side effects call for further studies and more extensive evaluation of epirubicin given alone or in combination through this new treatment schedule.

Adult↗
PubMed1987

[Cardiotoxicity of 5-fluorouracil. Personal cases and review of the literature].

Two cases of 5-Fluorouracil (5FU) cardiotoxicity, chest pain with changes in ECG the former, and myocardial infarction the latter, are described. Review of literature shows the existence of 49 cases of cardiotoxicity due to 5FU (38 angina = 77.5% 8 myocardial infarction = 16.3%). This complication seems due to a "coronary toxicity" whose onset is very precocious and not dose-dependent. Since 5FU therapy could result very dangerous when cardiotoxicity occurs, it is strictly advisable to withdraw further administration of the drug. As a matter of fact 18 patients out of 21 who again were treated with 5FU, had more serious complications which resulted in 3 myocardial infarctions (2 deaths).

Aged↗