Biomedical subjects
Publications and source records attributed to V Adamo.
Serum copper levels (SCL) and serum zinc levels (SZL) were measured in two groups of lung cancer patients divided according to disease extension. SCL was higher, SZL was lower and SCL/SZL ratio was more raised in patients extensively affected by the disease. It is confirmed that SCL, SZL and the SCL/SZL ratio play an important role in indicating the stage of lung cancer development.
Serum sialic acid levels were measured at two different stages of neoplasia (active and non-active phases). CEA levels were also assayed at the same time. 98 patients suffering from different neoplastic diseases and a group of healthy controls were studied. Serum sialic acid levels were always significantly higher in the neoplastic patients. When neoplastic disease were divided into active and non-active groups, it was observed that the level of this glycoprotein was specific in the non-active (NA) phase only for breast tumours and lymphomas. Correlation with CEA levels was also significant in these cases. It is concluded that serum sialic acid assay may be useful only for melanomas, breast tumours and lymphomas where the level of this membrane protein undergoes significant changes according to the stage of the tumour.
Thirty patients with local recurrent and/or distant metastatic cervical carcinoma were treated by combined chemotherapy with methotrexate, adriamycin and bleomycin (MAB). Among the 25 evaluable patients 1 CR (4%), 5 PR (20%), 9 SD (36%) and 10 PD (40%) were obtained. A high incidence of cardiotoxicity (20%) and alopecia (32%) was observed. Both phenomena are linked to the anthracyclinic component of the regimen. As the results are not better than those reported by using only methotrexate and bleomycin, the authors did not find it useful to insert adriamycin in this regimen.
By scanning and transmission electron microscopy the Authors studied four cases of endometrial adenocarcinoma (stage I, G1) after 15-days treatment with Tamoxifen (20 mg X 2) before surgery. The ultrastructural findings, similar to those observed in untreated adenocarcinomas but quite different from those obtained in MAP-responsive cases - as other Authors reported too - seem to indicate an almost complete absence of secretory or cytotoxic induction at least as far as 15-days treatment is concerned. According to the Authors this study raises many doubts about the usefulness of a first-instance therapeutical protocol based on Tamoxifen alone. However they believe that Tamoxifen can be utilized combined with a progestational agent in a simultaneous or sequence treatment.
Thirty non diabetic women with breast cancer and five with benign breast disease have been evaluated by oral glucose tolerance test. 40% showed a diabetic-like curve. The positive women had a metastatic disease. The positive correlation between a pathologic glucose tolerance and the metastatic disease are stressed. The conclusion is drawn that the research of a latent glycidic alteration as monitor of breast cancer evolution is useful.
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BACKGROUND: Following the demonstration that vinorelbine improves survival and quality of life compared with best supportive care in elderly patients with advanced non-small-cell lung cancer (NSCLC), we started the three-arm prospective Multicenter Italian Lung Cancer in the Elderly Study (MILES) trial of vinorelbine, gemcitabine and gemcitabine + vinorelbine. DESIGN: Within the randomized phase 3 trial, pilot single-stage phase 2 studies were planned for gemcitabine and for gemcitabine + vinorelbine. Eligible patients are aged 70 or more, with stage IV or IIIb (with metastatic supraclavear nodes or malignant pleural effusion) NSCLC. Single-agent gemcitabine is given at 1200 mg/m(2) on days 1 and 8; in the combination, gemcitabine is given at 1000 mg/m(2) and vinorelbine at 25 mg/m(2), both on days 1 and 8, every 3 weeks. RESULTS: As planned 49 patients were enrolled in each group. Median age was 74 in both groups. Two-thirds of patients had stage IV disease. The response rate was 18.4% (95% exact CI 8.8-32.0) with both treatments. With single-agent gemcitabine main toxicities were grade 4 thrombocytopenia and grade 2 hepatic toxicity, in one patient each, and grade 2 pulmonary toxicity in two patients. With gemcitabine + vinorelbine combination there were grade 4 neutropenia and thrombocytopenia (one patient each), grade 3 anemia requiring red blood cell transfusion (two patients), and grade 4 fever in two patients. Four patients, with severe cardiac comorbidities, suffered grade 3 heart toxicity with atrial flutter or fibrillation, followed by congestive heart failure responsive to treatment. CONCLUSION: Both single-agent gemcitabine and the gemcitabine + vinorelbine combination are sufficiently active and tolerable to allow continuation of the MILES study.
Newer agents and combinations are needed in order to improve current results in ovarian cancer treatment. Gemcitabine is a novel agent that has shown consistent activity as a single agent in the treatment of platinum-resistant ovarian cancer and a favorable toxicity profile. Because of its clinical and preclinical synergism with platinum analogs, gemcitabine has been combined with carboplatin as a convincing approach in the treatment of platinum-sensitive recurrent ovarian cancer patients. Further combination of gemcitabine and other agents, including paclitaxel, is also feasible and has been actively studied in order to establish the role of gemcitabine in the management of treated and untreated ovarian cancer patients.
BACKGROUND: In phase II trials gemicitabine proved to be an active agent in NSCLC, producing a clinical benefit, often higher than response rate. PATIENTS AND METHODS: We assessed the impact of gemcitabine treatment on response rate and quality of life in 21 untreated elderly patients (aged > 70 years) with NSCLC. Gemcitabine (1250 mg/sm) was administered days 1-8 every 21 days. Response and toxicity were analyzed according to WHO criteria. The assessment of quality of life was performed by analysing a disease symptom related questionnaire completed by the patient. RESULTS: All the patients were evaluable: we found 7 PR (33%), 5 SD (24%) and 9 PD; the median duration of response was 24 weeks; the median overall survival 32 weeks; WHO grade 2 leukopenia (in 4 patients) and thrombocytopenia (grade 3 in 1 patient and grade 2 in two patients) were the main toxic effects. A clinical benefit was demonstrated in all 12 patients with PR or SD and in 3 patients with PD. CONCLUSIONS: These data confirm that gemcitabine is a well tolerated and active therapeutic approach in elderly non small cell lung cancer patients.
Treatment of gastrointestinal stromal tumors (GIST) has been revolutioned by the recently discovered molecular mechanism responsible for the oncogenesis of this disease. In addition, due to the rapid progress at molecular and clinical level observed in the last few years, there is a need to review the current state of the art in order to delineate appropriate guidelines for the optimal management of these tumors. A panel of experts from several specialities, including medical oncology, surgery, pathology, molecular biology and imaging, were invited to participate in a meeting to present and discuss a number of pre-selected questions, and to achieve a consensus according to the categories of the National Comprehensive Cancer Network (NCCN) and the Standard Options Recommandations (SOR) of the French Federation of Cancer Centers. Generally, consensus points were from categories 2A of the NCCN and B2 of the SOR. Conventional histologic examination with immunohistochemistry for CD117, CD34, SMA, S-100 and desmin is considered standard. Molecular analysis for the identification of KIT and PDGFRA mutation may be indicated in CD117-negative GIST. Complete tumor resection with negative margins is the optimal surgical treatment. Adjuvant imatinib should be considered an experimental approach. Neoadjuvant imatinib is also experimental, although its use may be justified in unresectable or marginally resectable GIST. Imatinib should be started in metastatic or recurrent disease, and should be continued until progressive disease or drug intolerance. In these cases, sunitinib can be used. The optimal criteria for the assessment and monitoring of GIST undergoing imatinib therapy are not well known, but they should include reduction in tumor size and disease stabilization, as well as reduction of tumor density on CT scan and metabolic activity on PET scan.
We have retrospectively examined 94 evaluable patients with metastatic osteolysis from breast cancer (BC) and non-small cell lung (NSCLC) cancer, who received RT from Nov. 88 to Nov. 89.27 (15 BC and 12 NSCLC) were in treatment with Clodronate for at least 3 days from the beginning of RT; of the remaining 67 treated with RT alone, 31 had NSCLC and 36 BC. We have evaluated: increase in pain (IP) occurring on the first days of RT, percentages of complete pain relief (CPR) at the end of RT and 4-6 weeks after. A decreased occurrence of IP was observed more in NSCLC patients receiving RT + Clodronate compared to those treated with RT alone (33.3% vs 41.9%). Both at the end of RT and 4-6 weeks after, we registered a significant difference in the percentages of CPR in the RT + Clodronate group (40.7 vs 20.9 and 70.3% vs 53.7%). We believe the points of interest focused in this paper-greater precision in centering and defining the target volume, decreased occurrence of IP during the first days of RT, increase in percentage of CPR--need a prospective confirmation.
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BACKGROUND: Most chemotherapic treatments are carried out on an outpatient basis. In such patients the prevention and control of emesis is important. Granisetron is a specific and extremely potent 5-HT3 antagonist available as an oral formulation. We have carried out an open randomized crossover study in patients receiving moderately emetogenic chemotherapy. MATERIALS AND METHODS: 30 patients were randomized to receive one of the two oral dose regimens of GRAN. Treatment A = 1 mg of GRAN initially and 12 hours after the first; treatment B = a single 2 mg dose of GRAN. RESULTS. An overall good response for vomiting was reached in 70% and 86.7% respectively of patients receiving treatments A and B (p = 0.0625). Good response to nausea was reached in 73.3% of the patients with treatment A and in 76.7% with treatment B (p = 1). 68.3% of patients did not record chemoinduced emesis. CONCLUSION: We believe that oral GRAN alone is an active and safe drug for the prevention of acute chemoinduced emesis.
BACKGROUND: Supraclavicular lymph node metastases (SLM) as the only site of metastatic disease from breast cancer is a rare and a poor prognostic event. In order to evaluate the role of Radiotherapy (RT) with "radical dose" to the supraclavicular fossa, we carried out a non randomized clinical trial comparing systemic therapy alone to integrated and aggressive treatment (systemic therapy plus radiotherapy). The primary end-point was time to progression (TTP). The second end-point was the overall survival (OS). METHODS: From 1/1/1989 to 31/12/1994 37 patients (with or without the presence of locoregional disease) were enrolled into two arms, of the study, but were allowed, when giving their consent, to change the arm of the study which they had been originally allotted to. Arm A, 18 patients, 15 evaluable: chemo +/- hormonotherapy for 6 courses; after the second course, if local progression disease was present, the pts. were submitted to RT and removed from the study (3 patients). Arm B, 19 patients all evaluable: chemo +/- hormonotherapy for 3 courses followed by RT with "radical" dose. Results were analyzed on 30/11/1995 and no interim analysis was performed. The potential median follow up for all patients was 56.5 months (range 11-83 months): for Arm A 61 months (range: 12-82); for Arm B 53 months (range: 11-83). The two groups were homogeneous and balanced, without statistical differences. RESULTS: Median TTP was 12.5 months in Arm A and 19.5 months in Arm B (p = 0.064). Median overall survival (OS) was 27.5 months in Arm A and 48 months in Arm B. T-status to the time of the diagnosis was found to be independent prognostic factor for TTP (p = 0.0029). Disease-free interval from diagnosis to recurrence was found to be a significant prognostic factor for OS (p = 0.009). CONCLUSION: The results in Arm B demonstrated the opportunity of a long term control in this subset of patients. Therefore we suggest the start of a wider multicenter study in order to define the biological significance of SLM, its importance in staging breast cancer and to consider the optimum treatment.
BACKGROUND: Vinorelbine is active in a variety of malignancies. The most common side effects are leukopenia and granulocytopenia, moreover Vinorelbine is a vescicant and venous irritant, the incidence of the latter being 10-26% in patients who received VNB as a 20-30 minute peripheral infusion. To prevent venous toxicity we have carried out a study in order to evaluate the efficacy of Defibrotide in this issue. MATERIALS AND METHODS: 41 patients were enrolled in the study, the experimental schedule was: Defibrotide 400 mg on 250 cc of normal saline iv, after 15 minutes of infusion, we delivered quick, brief and repeated pulses of Vinorelbine through the plastic tube followed by remaining Defibrotide: For grading venous irritation we used the scale by Rittenberg et al. RESULTS: A total of 360 infusion were delivered, the incidence of any venous irritation was 5% and maximum grade 2. No severe toxicity was recorded. CONCLUSION: These data show that Defibrotide might serve as a therapeutic drug to prevent vascular toxicity by Vinorelbine.