Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-gamma after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer.

High-risk primary breast cancer patients treated with high-dose chemotherapy (HDC) and stem cell support (SCS) have shown prolonged disease-free survival (DFS) in many studies; however, only one trial has demonstrated an overall survival benefit (OS). We hypothesize that the period following myeloablative therapy is ideal for immunologic manipulation and studied the effects of two different methods of immunotherapy following HDC with SCS aimed at the window of immune reconstitution. Seventy-two women with high-risk stage II or III breast cancer were randomized following HDC to receive either interleukin 2 (IL-2) at 1 million units/m(2) SQ daily for 28 days or combined cyclosporine A (CsA) at 1.25 mg/kg intravenously daily from day 0 to +28 and interferon gamma (IFN-gamma) 0.025 mg/m(2) SQ every 2 days from day +7 to +28. At a median follow-up of 67 months, no significant difference was observed in DFS or OS between the two treatment groups. The IL-2 arm had a 59% DFS (95% CI (0.45, 0.78)) and a 72% OS (95% CI (0.58, 0.88)) at 5 years. The CsA/INF-gamma arm had a similar outcome with a 55% DFS (95% CI (0.40, 0.76)) and a 78% OS (95% CI (0.65, 0.94)) at 5 years. Treatment was well tolerated, without increased toxicity.

Age-related changes of the insular cortex and lateral ventricles: conventional MRI volumetric measures.

Preliminary data suggest that the insular region may be atrophied in patients with Alzheimer's disease when compared with healthy, age-matched control subjects. Therefore, normative data on age-related changes of the insular cortex were gathered and compared with age-related changes in the bodies of the lateral ventricles, which have been studied previously. Cerebrospinal fluid (CSF) volume of the lateral ventricles and insular cortical regions were measured on T1-weighted axial magnetic resonance images in 93 healthy subjects (age 21 to 84 years). Age-related changes were found in the lateral ventricles (r = 0.57, p < 0.0001) and in the CSF insular space (r = 0.42, p < 0.0001). Increasing age accounted for a significant amount of the variance for the lateral ventricle (pc = 0.45, p < 0.0001), but not for the insula (pc = 0.15, p = 0.14). Although there was a continuous linear increase in lateral ventricular volume with age, the CSF insular space increased linearly until the fourth decade, then plateaued until the seventh decade, with a linear increase thereafter. These data suggest that age-related changes occur in the region of the insular cortex, but differ from age-related changes of the lateral ventricles.