PHILADELPHIA--Although the addition of chemotherapy to supportive
care with a corticosteroid provides no survival advantage for
patients with hormone-refractory prostate cancer, the combination
appears to achieve better pain control, compared with corticosteroid
The finding, from a phase III Cancer and Leukemia Group B (CALGB)
study comparing hydrocortisone with or without mitoxantrone (Novantrone),
supports earlier results from a pivotal phase III Canadian trial
comparing prednisone with or without mitoxantrone.
In his presentation of the CALGB preliminary results at the American
Society of Clinical Oncology (ASCO) annual meeting, Phillip W.
Kantoff, MD, of the Dana-Farber Cancer Institute, explained that
the two trials used different primary endpoints.
Palliation and Survival Endpoints
`The Canadian trial (J Clin Oncol 14:1756-1764, 1996), conducted
at 11 cancer centers with 161 patients, used palliative response
as the primary endpoint, whereas the CALGB trial, involving 242
patients at 62 cancer centers, used survival, with quality of
life, as measured by five different instruments, as a secondary
In the pivotal trial, clinical benefit, defined as reduced pain
or reduced analgesic use, was seen in 38% of the combination therapy
group versus 21% of the prednisone-alone group. Median duration
of pain relief was 8 months among patients who responded to combination
therapy versus 2 months in the single-agent group.
Immunex Corporation, the maker of Novantrone, has filed these
data with the Food and Drug Administration to receive priority
review for use of the drug in hormone-refractory prostate cancer.