HAMBURGPatients with poor-prognosis M1 prostate cancer who undergo orchidectomy have little to gain and much to lose from adjuvant mitomycin (Mutamycin) therapy, according to the findings of a phase III study from the EORTCs Genitourinary Tract Cancer Cooperative Group.
Dr. Sophie Fosså, of the Norwegian Radium Hospital, Oslo, presented the results at the Ninth European Cancer Conference (ECCO 9).
The 189 study participants were randomized after surgery to receive either mitomycin, 15 mg/m2 IV every 6 weeks for 9 months and every 3 months thereafter, or to a control group. The EORTC investigators had based their choice of drug on a phase II study that had shown a 29% response rate and acceptable toxicity for mitomycin in this setting.
Progression-free survival was the same in both study arms, although overall survival was actually shorter among mitomycin-treated patients, Dr. Fosså reported. Median follow-up in this study was 4 years.
We have to be careful in applying adjuvant chemotherapy in M1 prostatic cancer, Dr. Fosså said. She noted that mitomycin not only afforded no survival benefit but also negated the improvement in patients quality of life that resulted after orchidectomy.
Quality of life was measured using an abbreviated version of the EORTC C30 Quality of Life Questionnaire as well as a specially developed urinary function scale that assessed urinary frequency, urinary control, painful urination, and bladder emptying.
Patients who underwent surgery alone fared significantly better than their chemotherapy counterparts with respect to global quality of life, physical functioning, role functioning, fatigue, appetite, and dyspnea. Scores for pain and urinary function were similar in both groups, however.
This study showed that quality of life assessment is possible in a busy clinical setting if the clinician wants to do it, Dr. Fosså said. This is one of the first prospective studies in prostate cancer based on what patientsand not physiciansthink about quality of life.