Quality of life analyses from vinorelbine (Navelbine) clinical trials of women with metastatic breast cancer.

The effect of therapy on a patient's quality of life (QOL) is an important factor in choosing a treatment, especially when the primary intent of therapy is palliation of symptoms. An increasing recognition of the importance of QOL prompted inclusion of QOL assessments in a number of clinical trials of women with breast cancer. This report describes two clinical trials in which women with metastatic breast cancer were treated with intravenous (IV) vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France). In a randomized trial, IV vinorelbine was compared with IV melphalan (Alkeran; Burroughs Wellcome Co) as second- or third-line treatment in patients with anthracycline-refractory breast cancer. In a second, nonrandomized study, vinorelbine was used as first- or second-line treatment in patients who had not received doxorubicin previously. Both studies assessed the QOL dimensions of physical functioning, symptom status, role functioning, and global QOL. In the randomized trial, analyses of linear time trends indicated that patients treated with vinorelbine compared with patients receiving IV melphalan had better physical functioning throughout most of the study. Differences between the two treatment groups in other QOL dimensions were not significant. In the nonrandomized study, patients who received vinorelbine as first-line therapy had worse role functioning and somewhat worse physical functioning than those who received the drug as second-line treatment. Overall, these studies suggest that patients who receive IV vinorelbine treatment maintain a reasonable QOL and that this agent is comparable to or better in some respects than IV melphalan.

Cerebral arterial spasm--a controlled trial of nimodipine in patients with subarachnoid hemorrhage.

We enrolled 125 neurologically normal patients with intracranial aneurysms in a multi-institution, prospective, double-blind, randomized, placebo-controlled trial within 96 hours of their subarachnoid hemorrhage, to determine whether treatment with the calcium blocker nimodipine would prevent or reduce the severity of ischemic neurologic deficits from arterial spasm. A deficit from cerebral arterial spasm that persisted and was severe or caused death by the end of the 21-day treatment period occurred in 8 of 60 patients given placebo and in 1 of 56 given nimodipine (P = 0.03, Fisher's exact test). Analysis of the amount of basal subarachnoid blood on pre-entry CAT scans in patients with deficits from spasm showed that an increase in subarachnoid blood was not associated with a worse neurologic outcome among patients who received nimodipine, unlike the situation in patients given a placebo. There were no side effects from nimodipine. We conclude that nimodipine should be given to patients who are neurologically normal after subarachnoid hemorrhage in order to reduce the occurrence of severe neurologic deficits due to cerebral arterial spasm.