A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer.

BACKGROUND: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. PATIENTS AND METHODS: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvic radiotherapy) was combined with EMP at 280 mg orally tds for 3 days (the day before, the day of and the day after vinorelbine infusion). After 8 weeks of therapy the combination was given every other week. RESULTS: From February 1998 to February 1999, 23 men were enrolled with a median age of 69 years (range 50-83 years). The median prostate-specific antigen (PSA) at entry was 160 ng/ml (range 0-802 ng/ml). A median of 13 weeks of therapy was administered and the median follow-up was 14.8 months. Eleven patients (48%) had lower extremity edema requiring diuretic therapy, two (9%) had grade 2 granulocytopenia and four patients [17%; 95% confidence interval (CI) 5% to 39%] had a thromboembolic episode. There was no treatment-related mortality. Fifteen of 21 patients (71%; 95% CI 49% to 89%) had at least a 50% decrease in the PSA for at least 2 months with a median time to serologic progression of 3.5 months (range 0.75-10.5 months). One of eight patients (12.5%; 95% CI 0% to 53%) with measurable disease had a confirmed partial response. The estimated median survival was 15.1 months and the actual one year overall survival was 71% (95% CI 51% to 88%). CONCLUSIONS: Weekly vinorelbine with short course oral EMP is an active regimen as evaluated by rate of PSA response, time to progression and median survival. However, the toxicities of EMP, even when given as a short course, are still problematic.

A bench test evaluation of a neonatal closed tracheal suction system.

We tested the hypothesis that a possible mechanism for reduced hypoxia during suctioning with closed tracheal suction systems (CTSS) is the provision of uninterrupted gas delivery and the maintenance of airway pressures. This was accomplished by using a neonatal ventilator and test lung model to permit the insertion of a CTSS (with and without suction applied), measurements of inspiratory and end-expiratory airway pressures proximal and distal to the endotracheal tube (ETT) and measurements of inspired and expired tidal volumes (sampled distal to the ETT). An 8 Fr CTSS was evaluated with 4.5, 4.0, and 3.5 mm ETT, and a 6 Fr CTSS with a 3.5, 3.0, and 2.5 mm ETT. We found that catheter placement without suction caused no changes in proximal airway pressures but distal peak inspiratory pressures decreased as the relationship between suction catheter size and ETT lumen increased, while distal end-expiratory pressures were unchanged. Similarly, distal tidal volumes progressively decreased as the size of the suction catheter occupied more of the ETT lumen. During suctioning with the 6 Fr catheter, proximal airway pressures were virtually unchanged; however, as ETT size decreased, distal airway pressures also decreased. The application of suction only modestly augmented the substantial decrement in measured tidal volumes when compared to catheter insertion alone. For the 8 Fr catheter, suction markedly reduced both proximal and distal airway pressures and tidal volumes. We conclude that the use of the CTSS tested in this neonatal ventilator/test lung model does not preserve continuity of volume or pressure delivery during suction procedures; therefore these cannot be the sole explanation for the reported reduction in suction related hypoxia.

Evaluation of a mainstream capnometer and end-tidal carbon dioxide monitoring in mechanically ventilated infants.

We evaluated a new lightweight capnometer with a less than 1 mL deadspace neonatal airway adapter and endotracheal tube connector unit (NAC) for use in mechanically ventilated neonates. The evaluation consisted of: 1) a bench test comparison of air flow resistance between the standard endotracheal tube and connector with the new NAC (flow rates, 1.5 to 12.8 L/min); 2) a determination of the effect of NAC placement on Paco2; 3) pre- and post-NAC pulmonary mechanics; and 4) analysis of paired PetCO2 and PACO2 in 16 infants requiring mechanical ventilation. Paired t test of the slopes of the resistance curves was significant (P = 0.002) while analysis of variance of differential pressures was not (P = 0.29). All post-NAC placement Paco2 were smaller than pre-placement values; there were no differences in pulmonary mechanics, and Petco2 correlated closely with Paco2 (n = 132, r = 0.79) defined as Petco2 = 0.68.Paco2 + 5.52; means +/- 1 SD, Paco2 -Petco2 was 4.7 +/- 4.7 torr and Petco2/Paco2 was 0.86 +/- 0.14.