Comparison of CMF (cyclophosphamide, methotrexate, and 5-fluorouracil) with a rotational crossing and a sequential intensification regimen in advanced breast cancer: a prospective randomized study.

The Italian Oncology Group for Clinical Research tested two experimental chemotherapy strategies in an attempt to improve the results achievable with conventional chemotherapy in metastatic breast cancer. One hundred sixty-two patients were randomly allocated as follows: (a) to the conventional cyclophosphamide, methotrexate, 5-fluorouracil chemotherapy regimen (CMF); (b) to a rotational crossing program (ROT-CROSS); or (c) to a sequential intensification program (SEQ-INT). The same single agents (C, M, F, cisplatin, etoposide, and doxorubicin) were administered in both experimental arms, but following a different policy. The SEQ-INT program induced a significantly higher complete response (32% vs. 6%, p = 0.0006) and objective response rate (72% vs. 42%, p = 0.0047) than CMF did. There were no differences in survival between CMF and either experimental arm. A number of side effects were significantly more with both experimental chemotherapies than with CMF, but the treatments were generally tolerable. Although some caution is required when interpreting a significant advantage found between an entire chemotherapeutic strategy and a single conventional combination, this study documents the potential therapeutic advantage of administering different sequential chemotherapies, and changing each at the time of maximum result without waiting for a progression. The impressive cytoreductive effects achievable with this policy (SEQ-INT) in metastatic disease merit further investigation in the adjuvant setting.

[Adherence to dietetic treatment, the nutritional metabolic status and the progression of chronic kidney failure]. / Aderenza al trattamento dietetico, stato metabolico nutrizionale e progressione dell'insufficienza renale cronica.

Effects of two protein restricted diets on dietary compliance, nutritional and metabolic state, and progression of chronic renal failure (CRF) were investigated. Twenty-one patients with CRF were randomly assigned to either a conventional low protein diet (0.6 g of protein/kg b.w./day) or to a very low protein diet, providing 0.4 g of protein/kg b.w./day, supplemented with a mixture of essential amino acids which contained HIS, TYR and a high proportion of branched chain amino acids. Nutrition, assessed by body weight, anthropometry, serum protein levels and nitrogen balance studies, was maintained in all patients. Some metabolic abnormalities of CRF (i.e., secondary hyperparathyroidism, glucose intolerance) improved in both groups. The supplemented diet provided better adherence to protein prescription, corrected the depletion of VAL and LEU in muscle and was more effective than conventional diet in slowing the rate of progression of CFR.

Immediate- and late-hemodynamic coronary effects of tadalafil in men with erectile dysfunction and coronary artery disease.

We investigated whether coronary flow reserve (CFR) can be modified by tadalafil, a long-acting phosphodiesterase 5 (PDE5) inhibitor, in patients with documented coronary artery disease (CAD). CFR was non-invasively evaluated in 12 men with a positive history for erectile dysfunction (ED) and angiographically documented CAD, in the distal portion of the left anterior descending coronary artery, free from critical stenosis, with contrast enhanced echocardiography at time zero (T0). Then, after 20 mg tadalafil was orally administered CFR measurement was repeated after 2 h (T1) and after 24 h (T2). Doppler curves suitable for the analysis were obtained in all patients (CFR feasibility: 100%). The peak diastolic velocity after adenosine infusion increased from 71.3+/-14.3 cm/s at T0 to 82.5+/-24.0 at T1 (P=NS) and to 89.5+/-21.1 at T2 (P=0.0010). CFR after tadalafil increased significantly from 2.6+/-0.3 at T0 to 3.1+/-0.7 at T1 (P=0.0078) and a further increment was found at T2 (3.5+/-0.9; P=0.0010 vs T0). Our study shows that oral administration of tadalafil exerts a long standing, potentially beneficial effect on coronary microvasculature in patients with ED.

Left-to-right shunts. (Quantification, mathematical methods and their statistical comparison).

This work describes a non-traumatic technique for quantitative determination of left-to-right shunts. Various mathematical methods to evaluate the radioisotope concentration lung curve are considered. Data were collected with a gamma camera system connected to a computer. The first results were obtained from 18 patients at the Ospedali Riuniti in Parma, Italy. All the mathematical processes are described. The three methods used were based on: 1. the count ratio (C2/C1) between two pulmonary activity concentrations, 2. the gamma function fitting, 3. decreasing exponential. A comparison of the three methods shows that the gamma function method is the most reliable. In this kind of investigation the patient's radiation dose is low enough for it to be repeated so that the course of the disease can be followed.