CHICAGOA Canadian study has shown that men with
hormone-resistant prostate cancer have improved global and social
function, fewer symptoms, and a greater improvement in quality of
life (QOL) measures over time when mitoxantrone (Novantrone) is added
to prednisone. A subset of patients who crossed over to mitoxantrone
after prednisone therapy had failed also experienced significantly
greater improvement in quality of life measures.
These are interesting results, David Osoba, MD, said at a
quality of life and outcomes symposium sponsored by Northwestern
University and Evanston Northwestern Healthcare. Although in the
crossover protocol, mitoxantrone was not added until 6 weeks after
prednisone had failed, men in the crossover treatment group still
showed improvement, indicating that mitoxantrone alone may have
an effect, said Dr. Osoba, clinical professor, British Columbia
Cancer Agency, Vancouver.
This randomized study of 161 men focused on health-related quality of
life outcomes rather than standard outcomes such as survival. The
study assessed quality of life in five functional domains using the
30-item EORTC QLQ-C30 instrument.
The researchers also used a linear analog self-assessment scale
(PROSQOL1) and a prostate-cancer-specific quality of life module
comprised of 14 items (QLM-P14).
The primary endpoint of the study was reduction in pain without the
need to increase analgesic use over a 3-week period. The results,
published in the Journal of Clinical Oncology in 1996, showed
that 29% of men who received the drug combination had a reduction in
pain, compared with 12% of men receiving prednisone alone. The
duration of the response also was longer in the
mitoxantrone-prednisone group (11 months vs 5 months).
Results involving other domains of quality of life were discussed at
the symposium. Scores on quality of life instruments were obtained at
6-, 12-, and 18-week intervals. These scores were subtracted from
pretreatment, baseline measurements, and average treatment
differences were computed.
Men who received mitoxantrone and prednisone had significantly better
global, physical, and social functioning at all three time intervals.
In addition, there was also improvement in emotional and role
functioning. These men had significantly less fatigue and anorexia at
12 and 18 weeks, and they experienced less pain, which confirmed the
findings presented in the published report of the study.
On the prostate-cancer-specific questionnaire involving 14 items in
three domains related to daily functioning, men in the
mitoxantrone-prednisone group had less drowsiness and confusion and
less difficulty with nocturia interfering with sleep. Statistical
significance for all these aspects of quality of life was at the P =
Findings also were considered to be significant if a change of 10
points or more was documented between one time period and another on
a 0 to 100-point scale using the SF-36 instrument. This degree of
change was achieved in social function, insomnia, drowsiness, and
pain relief, and it lasted two to three times longer for men in the
Patients who crossed over to mitox-antrone also did significantly
better than those who had prednisone alone, Dr. Osoba said.
The study showed, therefore, that mitoxantrone plus prednisone not
only improved pain management in men with hormone-resistant prostate
cancer but also improved other aspects of quality of life, Dr. Osoba