No abstract

This study raises questions regarding the following: (1) the perceived generalizability of trial findings, (2) the role of end points other than survival for clinical trials, (3) the consequences of physician overestimation of patient accrual, and (4) the impact of randomized trials on the behavior of clinicians. Further investigation into these critical issues will provide meaningful recommendations to enhance the future design, implementation, and conduct of randomized clinical trials in cancer.

No abstract

To determine whether impaired diastolic function may be an early sign of doxorubicin cardiotoxicity, a retrospective study was performed in 12 patients who had undergone serial radionuclide angiography and were found to have a left ventricular ejection fraction of 55% or more before doxorubicin (Adriamycin) treatment and during follow-up. Average rapid filling velocity and slow filling velocity were both significantly reduced after doxorubicin treatment. Rapid filling velocity decreased from 5.17 +/- 1.52 to 4.18 +/- 0.96 units/s (p less than 0.01), and slow filling velocity decreased from 2.20 +/- 1.32 to 1.42 +/- 0.62 units/s (p less than 0.05). There were no significant changes in filling volume ratio, total diastolic time or diastolic time ratio. Because a change in left ventricular diastolic function can occur before ejection fraction falls to subnormal levels, diastolic function as well as systolic function should be examined for the early detection of doxorubicin cardiotoxicity. The clinical implications of our observations can only be established by a longer-term prospective analysis of left ventricular function in patients receiving doxorubicin therapy.