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C Garufi

Publications and source records attributed to C Garufi.

At least 37 records · Page 2Linked to original sources
PubMed1995

Chronomodulated 5-day infusion of floxuridine and L-folinic acid in patients with advanced malignancies: a feasibility and tolerability study.

The best schedule for administering floxuridine (FUDR) has not yet been established. Duration of infusion, need (and dosage) of leucovorin (folinic acid, FA), and circadian timing need to be further specified. Nevertheless, FUDR delivery according to circadian rhythms has allowed increase of dose intensity without enhancing the side effects. A 5-day infusional schedule combining FUDR and L-FA was devised as an attempt to increase dose intensity and to provide therapy every 3 weeks to patients with advanced cancer. An ambulatory programmable-in-time pump was used for this purpose. Fourteen patients entered this trial. Two dose levels (mg/kg x 5 days) were evaluated: 0.5 mg/kg/day in six patients and 0.525 mg/kg/day in eight patients. Both patient groups received a concurrent infusion of L-FA 10 mg/m2/day i.v. The delivery patterns of both FUDR and L-FA varied sinusoidally during the 24 hours with a maximum at 18.00 hours. Courses were repeated every 3 weeks. Of 35 courses, treatment produced mucosites greater than grade 2 in only two of them. No severe diarrhea, the dose-limiting toxicity of FUDR when infused over 14 days, was encountered at the dose levels tested. This 5-day chronotherapy schedule allowed delivery of a larger amount of FUDR than the flat delivery described in a previous report. A daily dose of 0.525 mg/kg FUDR, combined with 10 mg/mg2 L-FA, with intraindividual dose escalation according to tolerance, is recommended for future investigations of the activity of this chronotherapy schedule.

Adult↗
PubMed1995

Personality, inner experience and compliance in advanced cancer patients treated with external pumps.

The presence of portable pumps for protracted infusional chemotherapy in metastatic solid tumors at an advanced stage determines the need to evaluate psychologically the inner experience of the patients in relation to this therapeutic modality. The objective of the study were to analyze personality variables (coping and awareness), inner experience variables (acceptance and expectations) and the compliance of the patients during repeated courses of therapy. In addition we evaluated the influence of sex, age, level of education and response to treatment in relation to these variables. From February 1992 to March 1994 we evaluated 50 metastatic patients with a psycho-dynamic interview at the 1st, 3rd, 6th and the 9th course of therapy. The data obtained showed a positive trend for all the variables examined and in all the subgroups (age, sex, level of education, response) up to the 6th course. After the 6th course, personality variables remained stable, yet a drop in variables related to inner experience and compliance was observed in the whole group. While the personality variables remain constant in all patients, a decrease of acceptance and expectation was observed in patients non responding to therapy for their tumor, a trend which becomes significative at the 9th course regards expectation. The use of a psycho-dynamic interview allowed us to evaluate the effect of treatment on psychological variables and compliance to therapy. The length of treatment and the response to treatment seem to influence the more profound inner experiences of the patients.

Adaptation, Psychological↗
PubMed1994

Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid (leucovorin) in patients with colorectal cancer metastases: a randomized multi-institutional trial.

BACKGROUND: In a previous phase II trial, circadian (chronomodulated) delivery of fluorouracil (5-FU), folinic acid (FA; leucovorin), and oxaliplatin (1-OHP; a new platinum complex with no renal and minor hematologic toxic effects) produced an objective response rate of 58% in 93 patients with metastatic colorectal cancer. PURPOSE: To determine whether chronomodulated drug delivery affects therapeutic activity, we again tested this regimen in another trial in patients with previously untreated metastatic colorectal cancer, this time comparing chronomodulated with constant-rate drug delivery. METHODS: Seven European centers participated in this trial. Ninety-two patients with metastatic colorectal cancer were enrolled and assigned to a treatment schedule by central randomization. Treatment courses consisted of the daily administration of 5-FU (600 mg/m2 per day), FA (300 mg/m2 per day), and 1-OHP (20 mg/m2 per day) for 5 days and were repeated every 21 days (16-day intermission) in ambulatory patients with the use of a programmable in-time pump. Drug delivery was kept constant over a 5-day period in schedule A (47 patients). It was chronomodulated in schedule B (maximum delivery of 5-FU and FA infusions at 0400 hours and maximum delivery of 1-OHP at 1600 hours; 45 patients). A risk of partial chemical inactivation of 1-OHP by its 2-hour exposure to the basic pH of the 5-FU solution in the catheter was documented in schedule A. RESULTS: Severe stomatitis (grade 3 or 4, World Health Organization [WHO] grading system), the dose-limiting toxic effect of 5-FU, occurred in five times as many patients on schedule A than on schedule B (89% versus 18%; chi 2 = 46; P < .001). The cumulative dose-limiting toxicity of schedule B was peripheral sensitive neuropathy (WHO grade 2). This side effect was reversible following 1-OHP withdrawal. Higher doses of 5-FU were administered in schedule B (median: 700 mg/m2 per day) compared with schedule A (median: 500 mg/m2 per day) (P < .0001; Mann-Whitney U test). On schedule B, 24 of 45 patients (53%; 95% confidence interval [CI] = 38%-68%) exhibited an objective response compared with 15 of 47 patients (32%; 95% CI = 18%-46%) on schedule A (chi 2 = 4.3; P = .038). The median progression-free survival was, respectively, 11 and 8 months (P = .19; logrank). The median survival was 19 months (95% CI = 14.8-23.2) on schedule B and 14.9 months (95% CI = 12.1-17.8) on schedule A (P = .03; logrank). CONCLUSION: This ambulatory treatment modality was both more effective and less toxic if drug delivery was chronomodulated rather than constant over time. IMPLICATION: The respective roles of 1-OHP dose and schedule and circadian peak time of drug delivery are being investigated with regard to the high activity of this three-drug, chronomodulated chemotherapeutic regimen.

Adult↗
PubMed1993

Medical oncology and home care in Italy.

AIMS AND BACKGROUND: Home care programs are designed to provide care for cancer patients in their homes. Aim of the study is to describe the activities of home care program, to examine the organization and efficiency of this type of care in Italy. METHODS: A questionnaire was sent to the regional representatives of the National Society of Medical Oncology and to the regional health departments. RESULTS: a) the home care program is uniformly distributed throughout the country; b) the number of personnel in the different centers varies greatly from one area to another; c) approximately 50% of the centers do not cover emergency situations (at night or on holidays); and d) there is little involvement of the public sector. CONCLUSIONS: In spite of these problems, the home care system is taking on a fundamental role, especially for advanced cancer patients.

Home Care Services↗
PubMed1993

Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous venous infusion at circadian rhythm modulated rate.

Oxaliplatin (L-OHP) is a non-nephrotoxic third generation platinum complex with proven antitumoral activity and minimal haematological toxicity. Circadian scheduling has allowed significant increases in L-OHP dosage and dose intensity and decreases in its toxicities. This phase II trial has tested the antitumour activity of a 5-day circadian schedule of continuous venous infusion of L-OHP against metastatic colorectal cancer. Initial dose was 150 mg/m2/course. An intrapatient dose escalation scheme by 25 mg/m2/course was planned up to 200 mg/m2/course, according to toxicity criteria. The delivery rate of L-OHP was sinusoidally modulated along the 24-h time scale, and was highest at 1600 h. A programmable-in-time ambulatory pump was used, so that all patients could receive their treatment at home. 29 of 30 patients registered were eligible. 25 had failed previous chemotherapy. Three objective responses were observed (response rate: 10%), in patients progressive while on chemotherapy with 5-fluorouracil and folinic acid. Toxicity was moderate. Dose-limiting toxicities were diarrhoea and peripheral sensitive neuropathy. The latter adverse effect appeared to be cumulative. L-OHP, as delivered under this circadian schedule, exhibits clinical antitumour activity against metastatic colorectal cancer. These results, which await further confirmation, support the place of L-OHP in combination regimens including 5-fluorouracil.

Adult↗
PubMed1993

Dynamic test with recombinant interferon-alpha-2b: effect on 90K and other tumour-associated antigens in cancer patients without evidence of disease.

We have previously shown that a short course of recombinant interferon-alpha-2b (rIFN-alpha-2b) (3 million units day for 5 days) for patients with primary gynaecologic malignancies was able to increase the circulating levels of a newly discovered tumour associated antigen, termed 90K. In this study, we have investigated the effects of the same modality of administration of rIFN-alpha-2b in 62 patients with breast and colorectal cancer whose primary tumour was surgically removed 1 month before and who were without evidence of disease (NED) at the time of the study. A significant increase of 90K serum concentration was already observed 24 h after the first r-IFN-alpha-2b injection and persisted throughout the investigational period. The increase was more pronounced in patients with a basal 90K-negative than a 90K-positive assay. Of 54 patients who started the test with a 90K negative assay, 17 (31%) shifted to a positive assay after rIFN-alpha-2b. Twenty-eight of 62 (45%) patients exhibited a 90K value above the mean increment of the whole population. The serum levels of CEA, CA-15-3, CA 19-9, and alpha-fetoprotein measured in the same serum samples were not modified. After 2 years of follow-up, ten patients relapsed. Six of them showed a 90K increase above the mean increment of the whole population. As with ovarian cancer, the increase of 90K following r-IFN-alpha-2b administration might be of importance for the early detection of disease recurrence in clinically NED breast and colon cancer patients.

Antigens, Tumor-Associated, Carbohydrate↗
PubMed1991

Phase II study of mitomycin C, etoposide and vindesine in metastatic stage IV non-small-cell lung cancer.

A total of 72 patients with metastatic stage IV non-small-cell lung cancer (NSCLC) were treated with combination chemotherapy comprising the MEV regimen (mitomycin C, 8 mg/m2 given i.v. on day 1; etoposide, 100 mg/m2 given i.v. on days 1-3; and vindesine, 3 mg/m2 given i.v. on day 1; treatment repeated every 3 weeks). In 65 evaluable patients, the objective response rate was 37% (complete responses, 4.7%; partial responses, 32.3%). The median survival was 7.6 months for all patients. The treatment was very well tolerated. MEV proved to be an active and non-toxic regimen for the treatment of metastatic NSCLC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Hepatocarcinoma in cirrhosis. Is antithrombin III a neoplastic marker?

It has been reported that hepatoma (HCC) cells produce abnormal proteins such as erytropietin, fibrinogen, prothrombin, and, recently, antithrombin III (AT III). In a preliminary report, we reported increased AT III levels in patients bearing HCC independent of their clinical liver status. The present study was performed to assess antithrombin III levels and other serological data present in patients with cirrhosis and in patients with cirrhosis and clinical findings of neoplastic disease. In 70 well-matched patients (47 with cirrhosis and 23 with cirrhosis and proven HCC) serum total cholesterol, albumin, prothrombin, alkaline phosphatase, AFP, aminotransferases, and AT III were determined. Together with AFP and alkaline phosphatase, patients with HCC had higher values of AT III (88 +/- 7%) and total cholesterol (184 +/- 17 mg/100 ml), as compared with cirrhotic patients (AT III 56 +/- 3.6%; total cholesterol 113 +/- 5 mg/100 ml) (P less than 0.001). No difference was observed between these two groups for albumin, prothrombin, and aminotransferases. In HCC patients, AT III levels were related to the total cholesterol level (R2 = 0.317), whereas in the cirrhotic patients it correlated with the prothrombin level (R2 = 0.274). These data suggest that in HCC patients a greater rate of synthesis of AT III occurs, whereas in cirrhotic patients lower levels of AT III occur due to impaired synthesis or increased catabolism of the protein. The serial determination of AT III in cirrhotic patients as a means of detecting neoplastic transformation is suggested.

Adult↗
PubMed1991

5-Fluorouracil (FU) and mitomycin C (MMC) in the management of colorectal carcinoma. Part II. In vitro activity of the two drugs in short-term tumor cultures.

Eighty-seven colorectal adenocarcinomas from untreated patients were investigated by short term tumor cultures to test in vitro sensitivity to 5-fluorouracil and mitomycin C. This study reports the preliminary results of a multistep program aimed at the prospective clinical application of the assay. At present this in vitro experience was performed in parallel with a clinical trial carried out with the same drugs. The in vitro activity of the two anticancer agents is in agreement with the response rate reported in monochemotherapy; our data would suggest an increase of responses using the combination of fluorouracil and mitomycin in comparison to single drug therapy. A low cosensitivity rate and a high number of cases sensitive to one drug but resistant to the other, account for the use of this test as screening of active drugs in the individual patient.

Adenocarcinoma↗
PubMed1991

Association of epirubicin, etoposide and cisplatin in gastric cancer. A phase II study.

Cisplatin-based drug combinations are now currently investigated in an attempt to surpass the results obtainable by 5-FU alone or by 5-FU-containing regimens. We evaluated 29 patients with advanced and measurable gastric adenocarcinoma treated with etoposide, epirubicin and cisplatin. One patient had complete response (3 +/- 7%); 9 patients had partial response (31 +/- 17%); 5 patients (17 +/- 14%) were considered stable (S) and 14 (48 +/- 18%) were classified as progressive. The average survival time for the entire group was 11 months with 25% of the patients alive at 24 months. We feel that cisplatin-containing regimens are promising and deserve further investigations. To clearly explore the potential innovative role of these regimens randomized trials versus FAM or 5-FU alone are mandatory.

Adenocarcinoma↗
PubMed1990

Role of immunoscintigraphy in clinical assessment of gastrointestinal tumors.

From June 1986 until April 1989 31 patients with gastrointestinal tumors were studied at follow-up for recurrences by immunoscintigraphy (IS) using F(ab)2 fragments of monoclonal antibodies anti CEA and anti CA 19-9. IS was employed to confirm the presence of metastases already found (group A) and to verify metastases suspected following physical and instrumental examinations and/or increases in CEA and/or CA 19-9 (group B). Thirty-four IS findings have been evaluated to date: 19 in group A, with 18 true positive and 1 false negative results; 15 in group B. In these patients there were 12 cases of pathologic high fixation: 6 were confirmed using standard examinations after a median follow-up of 1 month (range 1-12); 6 cases had no metastatic evolution at the suspected site after a follow-up of 5-28 months. In 3 cases IS was negative, these patients are disease free at 13, 14 and 24 months. In group B, 5 of 8 abdominal intense fixations were early diagnoses of local or peritoneal recurrences. The overall accuracy was 79.4% and it was not affected by circulating CEA levels; sensitivity was 96%. IS can be considered useful as a primary diagnostic examination in the follow-up of patients with suspected abdominal metastases.

Adult↗
PubMed1990

Advanced colon cancer: staging and prognosis by CEA test.

The carcinoembryonic antigen (CEA) test was studied in 54 patients with advanced stages of colon cancer which was treated with high doses of folinic acid + fluorouracil. The CEA test correlates evaluated included: prognostic value, performance status, metastatic pattern, histologic grading, predictive value for response to chemotherapy, and value differences in cases with partial response to therapy. CEA levels less than 5 ng/ml corresponded to a greater survival time than did levels greater than 5 ng/ml. A correlation of CEA with performance status and with metastatic pattern was demonstrated. A progressive increase in average CEA values corresponded to increases in neoplastic mass. Although CEA levels were not found to be an index for predicting the response to chemotherapy, there was a significant different between pre- and posttreatment levels for partial response. The results suggest that CEA offers an additional criterion for evaluating the response of colon cancer to chemotherapy and it also has a role in the staging of advanced disease.

Adult↗
PubMed1989

A response in advanced post-menopausal breast cancer during treatment with the luteinising hormone releasing hormone agonist--Zoladex.

Luteinising hormone releasing hormone (LHRH) agonists are currently undergoing clinical trials in the treatment of advanced breast cancer in pre-menopausal women. Clinical responses are attributed to the suppression of the pituitary-ovarian axis, with a reduction in circulating levels of gonadal steroids similar to that produced by castration. In the present case report, we report a partial response to a LHRH analogue in a post-menopausal woman refractory to other endocrine treatments. This response cannot be explained with a chemical castration and confirms the possible direct anti-tumor effect of Zoladex.

Aged↗
PubMed1987

High-dose folinic acid (HDFA) combined with 5-fluorouracil (5-FU) in first line chemotherapy of advanced large bowel cancer.

The therapeutic activity of 5-FU in large bowel cancer is enhanced by increasing the intracellular pool of reduced folates. We treated 45 patients with advanced colon cancer with HDFA and 5-FU for 5 consecutive days. None had been given previous radio- or chemotherapy. All had measurable disease. Not one complete response was observed. Thirteen of the 39 evaluable patients showed partial response. Median duration of response was 9+ months. The probability of 50% survival was 15 months for all evaluable patients. There was no case of severe toxicity and the principal toxic effects were oral mucositis and diarrhea. To date, HDFA + 5-FU is one of the most effective treatments for large bowel cancer.

Adult↗
PubMedDate not supplied

ACTH 1-17 effects in the chemotherapy of advanced solid tumors.

The effect of administration of a synthetic ACTH analogue (ACTH 1-17, Synchrodyn) in the chemotherapy of advanced-phase solid tumors was studied. In this preliminary report the following data are evaluated: response rate; occurrence of toxic effects; performance status of patients; several immunological parameters. The administration of Synchrodyn seems mainly to influence the lymphocyte subpopulations and the occurrence of toxic effects. A final evaluation of the role that may be played by chronotherapy in the treatment of tumors must await further studies on the clinical response and tolerance.

Adrenocorticotropic Hormone↗
PubMedDate not supplied

[Chronochemotherapy].

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Antimetabolites, Antineoplastic↗