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Biomedical subjects

R Labianca

Publications and source records attributed to R Labianca.

At least 109 records · Page 6Linked to original sources

Confirmed activity of FAM polychemotherapy in advanced gastric carcinoma.

During a 3-year period at our hospital, 54 consecutively observed patients with parametric, locally advanced, metastatic gastric carcinoma were treated with fluorouracil + adriamycin + mitomycin C. Of 47 evaluable patients, 44.6% had an objective response (complete + partial response) and 29.7% had stabilized disease. The median duration of response was 7.5 months. The median survival was 8.9 months for all patients. In particular, the survival of responders (greater than 12 months) and of patients with stabilized disease (8.6 months) was significantly longer than that of patients with progressive disease (4.5 months). Toxicity was limited and reversible, which allowed treatment also of patients in poor general condition (PS 3-4 of the Zubrod scale).

Adult↗

Cardiac toxicity of 5-fluorouracil: a study on 1083 patients.

The possible onset of cardiotoxic manifestations during chemotherapy with 5-fluorouracil (5-FU) was evaluated in 1083 patients treated with the drug for various kinds of neoplasm. We recognized 17 cases of 5-FU cardiopathy (usually anginous crises but also myocardial infarction). The comprehensive incidence was 1.6%, with a significantly greater risk (4.5% vs 1.1%) for patients with a positive anamnesis of previous cardiopathy. On the contrary, age and combination with other antiblastic drugs had no affect on the appearance of cardiopathy. We conclude that 5-FU cardiopathy, although rare, has to be taken into account in oncologic practice, chiefly in those patients already affected with cardiac diseases.

Aged↗

The meaning of bites on the vectorcardiogram: study in adriamycin cardiomyopathy.

We examined 106 VCGs of cancer patients receiving Adriamycin (ADM) to investigate the nature and meaning of bites. It is known that ADM causes patchy areas of myocardial degeneration and necrosis, the appearance of which is dose dependent. Thirty-eight cancer patients not yet receiving ADM were examined to provide controls. Patients were divided into six groups, according to total cumulative ADM dose received. The incidence of bites in the different groups was shown to be as follows: group 1 (controls, 38 patients) 13.1%; group 2 (1-100 mg/m2 of body surface ADM, 23 patients) 39.1%; group 3 (101-200 mg/m2, 33 patients) 42.2%; group 4 (201-300 mg/m2, 25 patients) 56%; group 5 (301-400 mg/m2, 15 patients) 66.6%; group 6 (greater than 400 mg/m2, 10 patients) 90%; groups 2-6 52.8%. These percentages show a trend which is highly correlated with the total cumulative dose of ADM (p=0.00005). The influence of age on the appearance of bites has been excluded by analyses of trends in patients below and over 50 years (p=0.08). In 80.35% of cases, bites appear on more than one plane and mostly close to the maximum vector (Vmax). We therefore think that these results favor the hypothesis that bites are the electrophysiologic expression of lesions, such as small fibrotic and necrotic areas, which interfere with the normal spread of the ventricular depolarization wavefront.

Adolescent↗

Cardiac toxicity from antitumor therapy.

A review is made concerning cardiac toxicity from antitumor agents. The pattern, clinical course and fate of cardiac drug-related phenomena are considered. Special attention is drawn to new attempts to better understand, and possibly prevent, such a treatment limiting side-effect.

Animals↗

Levamisole in cancer treatment: modifications in time of cellular immunity. (Preliminary report).

Some preliminary observations are reported on a restricted case-list of patients with neoplastic disease in remission, after suitable treatment (surgical and/or radiant and/or antiblastic), treated with levamisole. The results obtained, even if preliminary, stress the close relationship between the immunorestorative effect and the length of the administration. Besides, the restoration of the secondary delayed immunity turned out promptly, in comparison with the primary delayed immunity. Very scanty the side effects observed.

Adult↗

[Importance of the analysis of the carcinoembryonic antigen in clinical oncology].

330 patients (126 with gastric neoplasms, 204 with large bowel carcinoma) were submitted to serial assays to evaluate the possible relations between C.E.A. levels, pathologic stage and histologictype of the neoplasm and to define the usefulness of the C.E.A. test in monitoring the followup of the patients with gastrointestinal neoplasms. From our experience it ensues that C.E.A. test positivity (C.E.A. greater than or equal to 5 ng/ml, according to the method employed) is higher in colon neoplasms in comparison with gastric neoplasms, in the adenocarcinomas compared with the anaplastic forms. Besides, the study of the relationship with the pathologic stage points out the scanty usefulness of the C.E.A. test in the early diagnosis of gastroenteric neoplasms (Dukes A-B-C1 = 29.2%; CH stage = 88.1%). The use of C.E.A. test during the follow up seemed us of fundamental importance. We observed that: a) after radical surgery, 72% of the patients showed a normalization of C.E.A. values; b) there is a significant relationship between clinical course and C.E.A. as it can predict, sometimes several months earlier, the occurrence of relapses and metastases; c) there is also a close relationship (P less than 0.001) between the modifications of the antigen under chemotherapy and the clinical response. At present, C.E.A. seems to play, above all, fundamental role in choosing a correct treatment after radical surgery or in modifying the chemotherapeutic treatment in non surgical cases or in non radically resected patients.

Carcinoembryonic Antigen↗

Clinical usefulness of CEA assay.

CEA is a normal constituent of fetal cells, which can reappear in entodermally-derived neoplasms, following a de-repression process. In order to evaluate the correlation between CEA serum levels, pathological stage and histological type of tumour, and to define the usefulness of CEA in monitoring the patients with gastroenteric neoplasms, 177 patients (62 with gastric heteroplasia and 115 with large bowel carcinoma) were tested for CEA; 83 patients had pre-surgical CEA tests. It was observed that CEA positivity (serum levels greater than or equal to 5 ng/ml, employing the technique here outlined), is higher in colonic than in gastric neoplasms, and in adenocarcinomas in comparison with undifferentiated forms, moreover depending on the pathologic stage. 108 patients were tested for CEA several times and a correlation between CEA variations and clinical evolution was observed. This investigation bears out the importance to monitor the patients with gastrointestinal neoplasms with CEA test, before and after surgery, to evaluate the usefulness of surgery and, when necessary, chemotherapy and, eventually, to adopt more suitable chemotherapeutic modalities.

Carcinoembryonic Antigen↗

Correlation between clinical course and CEA levels during chemotherapy.

In order to evaluate the correlation between clinical progress and CEA levels in gastroenteric tumours, particularly during chemotherapeutic treatment, CEA assay was performed on 330 patients (126 with gastric neoplasms, 204 with large bowel carcinoma). 175 out of these had a pre-operative assay. Moreover CEA test positivity (CEA larger than or equal to 5 ng/ml according to the technique employed by us) is higher in colon neoplasms compared with gastric neoplasms and in adenocarcinomas in comparison with undifferentiated forms; besides it depends on the pathologic stage. In colon tumours CEA test showed a higher positivity for left than for right forms (66.6% versus 38%). 240 patients were followed up with repeated CEA assays: the following observations were made: a - After radical surgery 72% of the patients shows normalized CEA values. b - In 198 patients who underwent radical surgery, not requiring chemotherapy, there was a close correlation between CEA levels and clinical evolution in 98% of the cases. c - 60 out of 68 patients (88%) submitted to chemotherapy for advanced neoplasms show a close correlation between CEA response to the chemotherapy and clinical response (p less than 0.001). These investigations stress, above all, the importance of CEA test to monitor the treatments performed (surgical and chemotherapeutic) and to adopt, eventually, more effective chemotherapeutic modalities.

Aged↗

Adjuvant treatment of colorectal cancer.

Colorectal cancer is one of the most frequent causes of cancer deaths. Survival for locoregional colorectal cancer is about 70% overall and 30-60% in stage III patients. Several randomized trials have shown that adjuvant chemotherapy can increase this survival rate. 5-Fluorouracil-based chemotherapy is strongly recommended in this context. There are still some questions about the setting in which patients should be treated as well as the optimal treatment. New data for different schedules and combinations are now available. Physicians have to choose between the different options now available to offer the best treatment to their patients. This Review analyses the current options for adjuvant therapy in colon and rectal cancer.

Clinical Trials as Topic↗

A cisplatinum-cyclophosphamide regimen in advanced ovarian cancer: reporting 5-year results.

The following paper reports the evaluation of 53 consecutive patients with advanced ovarian epithelial carcinoma (FIGO stage III-IV), treated between October 1984 and December 1987 with immediate or delayed cytoreduction surgery and chemotherapy. Combination chemotherapy consisted of cisplatinum 45 mg/m2 i.v. for 2 consecutive days and cyclophosphamide 900 mg/m2 i.v. on the second day, administered every 28 days for a maximum of 8 courses. Objective responses were observed in 35 of 50 evaluable patients (70%), 17 (34%) of whom were pathological complete remissions (pCR). For patients with minimal residual disease before chemotherapy a higher pCR rate was achieved (10/20 vs. 7/30; p = N.S.). Median survival time of all patients was 29 months; subjects with minimal residual disease and good performance status before treatment had higher survival (48 vs. 22 months-p < 0.05 and 29 vs. 9 months-p < 0.05, respectively). Median time to progression was 25 months. After a median follow-up of 60 months, 15 (28%) patients were alive, 14 of whom disease-free. Toxicity was moderate with a particularly low incidence of nephrotoxicity and no case of serious long-lasting neuropathy. These findings suggest that the described combination has an efficacy comparable to other CDDP-containing combinations, using 2, 3 or more drugs, with a low incidence of acute serious toxicities and of disabling delayed sequelae.

Adult↗

The value of oxaliplatin in combination with continuous infusion +/- bolus 5-fluorouracil and levo-folinic acid in metastatic colorectal cancer progressing after 5FU-based chemotherapy: a GISCAD (Italian Group for the Study of Digestive Tract) cancer phase II trial.

AIMS AND BACKGROUND: The phase II trial was designed to evaluate the activity of combined oxaliplatin (L-OHP), continuous infusion (CI) +/- bolus 5-fluorouracil (5FU) and levo-folinic acid (I-FA) in patients with metastatic colorectal cancer progressing after one or more lines of 5FU-based chemotherapy. PATIENTS AND METHODS: We designed two contemporary studies: in the former we enrolled patients previously treated with 1 line of chemotherapy, and in the latter, patients previously treated with 2, 3 and 4 lines. Seventy-six consecutive patients were enrolled: 45 received L-OHP (85 mg/m2 i.v. 2 h on day 1) + I-FA (100 mg/m2 i.v. 2 h on days 1 and 2) + 5FU i.v. bolus (400 mg/m2 days 1 and 2) + 5FU (600 mg/m2 CI 22 h days 1 and 2 (FOLFOX 4); 31 received L-OHP (100 mg/m2 i.v. 2 h on day 1) + I-FA (250 mg/m2 i.v. 2 h on days 1 and 2), followed by 5FU (1500 mg/m2 Cl 24 h days 1 and 2 (FOLFOX 2). The treatment was recycled every 2 weeks and continued until progression and/or unacceptable toxicity or patient preference. The primary end point was activity (tumor growth control [TGC]: partial response [PR] + stable disease [SD]); the secondary end points were time to progression (TTP), overall survival (OS) and toxicity. RESULTS: Forty-five patients in 2nd line (22 FOLFOX 4, 23 FOLFOX 2), 23 (17 FOLFOX 4, 6 FOLFOX 2) in 3rd, 4 in 4th and 1 in 5th line were assessable; 3 were lost to follow-up. In 15 patients (11 FOLFOX 4, 4 FOLFOX 2), disease involved the liver only. A total of 533 courses were administered with a range of 1-14 in FOLFOX4 and 1-12 in FOLFOX2; dose intensity was 92.85%, and the total dose of the administered L-OHP was 98.29%. As a 2nd line treatment, FOLFOX 4 achieved TGC in 72.8% of the patients (PR, 18.2%; SD, 54.6%), with a median TTP of 6 months and a median OS of 7 months, whereas in the FOLFOX 2 group these figures were 78.3% (PR 21.8%, SD 56.5%), and 5 and 9 months. As a 3rd line treatment, FOLFOX 4 produced TGC in 41.1% of patients (PR 23.5%, SD 17.6%), with a median TTP of 5 months and median OS of 7+ months, whereas FOLFOX 2 obtained respective values of 50% (PR 16.7%, SD 33.3%), 7 and 9 months. As a 4th line of treatment, TGC was achieved in 2 patients (1 PR, 1 SD); the patient in 5th line therapy obtained a SD. With "de Gramont" as the first-line regimen, patients assessable were 24 in FOLFOX 4 and 18 in FOLFOX 2. In the former population, TGC was 70.8% (PR 37.5%, SD 33.3%), with a TTP of 6 months and OS of 10 months, whereas with FOLFOX2 these values were 61.1% (PR 5.6%, SD 55.5), 5 and 7 months. In patients with liver involvement only, FOLFOX 4 obtained TGC in 63.6% of cases (with a TTP of 7 months and OS of 6+ months), FOLFOX 2 in 100% (with a TTP of 9.5 months and OS of 13.5+ months). Both schedules exhibited an acceptable toxicity: neurologic, hematologic and hepatic grade 3 side effects occurred in a limited number of patients, with a higher frequency in the FOLFOX 2 group. CONCLUSIONS: Treatment with L-OHP, CI +/- bolus 5FU and I-FA was well tolerated. The activity in terms of TGC was interesting and comparable with results reported in the literature for the standard treatment for 2nd line, i.e. irinotecan alone. Treatment was effective in 2nd line and in patients previously treated with more than two chemotherapy lines; in particular, treatment was active in patients with hepatic disease only. Although the two schedules seemed to achieve the same benefit with the same tolerance, we could not define from the study the better regime.

Adult↗

Evaluation of clinical efficacy of new medical treatments in advanced colorectal cancer. Results of a workshop organized by the EORTC GITCCG. European Organization for Research and Treatment of Cancer. Gastrointestinal Tract Cancer Cooperative Group.

During the last few years several factors have contributed to an increasing change in the medical treatment of advanced colorectal cancer. Among them are the more general acceptance of the impact of chemotherapy on quality of life and survival in first as well as in second-line treatment, the introduction of new drugs and the definition of novel endpoints which can roughly be defined as "patient benefit". For this reason the European Organization for Research and Treatment of Cancer (EORTC) Gastrointestinal Tract Cancer Cooperative Group (GITCCG) felt it was appropriate to organize a workshop with experts from different countries and national groups to discuss in depth several aspects concerning the treatment of patients with advanced colorectal cancer.

Clinical Trials as Topic↗

[5-fluorouracil and colorectal tumors: use in clinical practice and the "MISURA" project].

5-fluorouracil, an antimetabolite inhibiting timidilate synthetase, is one of the most used drugs in the treatment of many solid tumor types. In particular it is still central in the treatment of colorectal cancer. Nevertheless 5-FU efficiency is limited, this is due to the rapidity of its metabolism (T1/2 10 min). Many attempts have been done to increase its efficiency: 1) combinations with other antitumor drugs have been tested, but no one showed improved response rates with respect to 5-FU alone; 2) use of biological modifiers such as folinic acid and methotrexate. They interact with the biological actions of 5-FU improving its therapeutic effects. These combinations appear to be more effective than 5-FU alone; 3) continuous infusion increases the percentage of susceptible tumor cells, it makes possible the use of a high intensity dose which is active in patients resistant to 5-FU administered as bolus-injection. There are many schedules and methods of administration of 5-FU in the treatment of CRC, each of them showing different types of toxicities. This explains why there is the need to obtain a profile of 5-FU in clinical practice. The project called MISURA is though to give us this kind of information. It will be a collection of data regarding patients affected by colorectal cancer and treated with 5-FU. The collected information will be about diagnosis; ways of use, schedules, doses and tolerability of the drug; obtained responses. The aims of the study are: 1) to evaluate the use of 5-FU in clinical practice; 2) to collect data about the use of supportive therapy; 3) to know the effective incidence and prevalence of CRC in Italy. The study is retrospective, the sample consists of all patients from the oncological departments chosen to represent the national territory. The analysis of the data will be descriptive.

Antimetabolites, Antineoplastic↗