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 therapy alone.
The finding, from a phase III Cancer and Leukemia Group B (CALGB) study comparing hydrocortisone(Drug information on hydrocortisone) with or without mitoxantrone(Drug information on mitoxantrone) (Novantrone), supports earlier results from a pivotal phase III Canadian trial comparing prednisone(Drug information on 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 endpoint.
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.