ABSTRACT
AIM: Elective percutaneous coronary intervention (PCI) of left main coronary artery disease remains an important challenge in interventional cardiology. Nonetheless, this procedure is useful for patients with significant left main stenosis who are candidates for revascularization but unsuitable for coronary artery bypass graft. In this study the Authors sought to evaluate the safety and long-term mortality of PCI of left main coronary artery disease. Secondary endpoints were to analyse long-term mortality in various categories (patients<75 years vs patients<75 years, males vs females, drug eluting stents [DES] vs bare metal stents [BMS]). METHODS: Between January 2003 and December 2006, 131 patients who consecutively under-went PCI on left main stem were reviewed. The mean follow-up time was 14.0+/-10.8 months. Survival curves were plotted with the Kaplan-Meier method and compared with the Log-rank test. RESULTS: The Kaplan-Meier curves did not show statistically significant differences in terms of all-cause mortality at follow-up between protected and unprotected left main coronary disease (12% vs 14% respectively, P=0.67). In the protected left main group, there was a significantly higher use of DES compared with unprotected left main group (59% vs 43%, P=0.02). CONCLUSION: The data show that PCI for left main coronary disease is feasible, safe and with an acceptable long-term mortality rate in patients at high-surgical risk unsuitable for surgical revascularization.
Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease/mortality , Coronary Artery Disease/therapy , Myocardial Revascularization/methods , Aged , Aged, 80 and over , Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Drug-Eluting Stents , Elective Surgical Procedures/methods , Feasibility Studies , Female , Humans , Italy , Kaplan-Meier Estimate , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Stents , Survival AnalysisABSTRACT
BACKGROUND AND OBJECTIVE: The clinical and immunologic activities of interleukin-2 (IL-2) in cancer patients have been extensively studied and described; however, in most of these studies, IL-2 was administered by intravenous bolus or continuous infusion, while the immunologic effects of IL-2 given by the subcutaneous (s.c.) route have not yet been well studied. DESIGN AND METHODS: The present study was aimed at evaluating the effects of IL-2, given at very low doses s.c. to patients with advanced renal cell carcinoma (RCC), on a number of immunologic parameters: number of total lymphocytes, number of CD4-, CD8-, CD25-positive cells, number of natural killer (NK) cells, titers of IL-2 soluble receptor (sIL-2R) and of C4, eosinophils, eosinophilic cationic protein (ECP) and eosinophilic protein X (EPX). Finally, a logistic regression model was performed to identify early immunologic parameters that correlate with a favorable or unfavorable treatment outcome. RESULTS: Independently from the mere report of the changes induced by immunotherapy, the analysis showed that, within the pre-treatment model, a large eosinophil number predicts the failure of IL-2 treatment; in contrast, within the post-treatment model, high C4 serum titers and, again, a large number of circulating eosinophils predict immunotherapy failure. INTERPRETATION AND CONCLUSIONS: As far as concerns C4, its negative predictive value could be related to the fact that it is an indirect index of macrophage activation; thus, even though macrophages release substances with antitumor activity, they can also stimulate the release of sIL-2R, which may compete for exogenous IL-2. Some authors have postulated that macrophages may even stimulate tumor cell growth, or impair NK activity. Despite a great amount of uncertainty concerning the role of eosinophils, in our study, blood eosinophilia predicts a poor response to immunotherapy in patients with advanced RCC, thus supporting previous observations from our own group.
Subject(s)
Carcinoma, Renal Cell/drug therapy , Complement C4/metabolism , Eosinophils/cytology , Interferons/administration & dosage , Interleukin-2/administration & dosage , Kidney Neoplasms/drug therapy , Adult , Aged , Carcinoma, Renal Cell/diagnosis , Female , Humans , Immunotherapy , Injections, Subcutaneous , Interferons/blood , Interleukin-2/blood , Kidney Neoplasms/diagnosis , Logistic Models , Lymphocytes/cytology , Male , Middle Aged , Prognosis , Receptors, Interleukin-2/blood , Solubility , T-Lymphocyte Subsets/cytology , Treatment OutcomeABSTRACT
Twenty-one nephrectomized patients with metastatic renal cell cancer were treated with recombinant interleukin 2 (rlL-2) and interferon alpha (rIFN alpha). rIL-2 was administered s.c. at a dose of 1 x 10(6) IU m(-2) every 12 h on days 1 and 2, followed by 0.5 x 10(6) IU twice daily on days 3-5; rIFN alpha-2 was given i.m. as 1.8 x 10(6) IU m(-2) on days 3 and 5 of each week for 4 consecutive weeks. The cycle was regularly repeated at 4-month intervals and continued ad libitum in patients showing some response and in patients with progressing disease. Of 20 patients evaluable for treatment response, one (5%) had a complete response and three (15%) showed partial response. Three patients (15%) achieved stable disease and 13 (65%) were evaluated as having progressive disease. The estimated actuarial 44-month survival rate was 44%. Toxicity was limited to WHO grades 1 and 2 only.
