Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C - Results from the EORTC phase-III Trial 30893
Sd. Fossa et al., Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C - Results from the EORTC phase-III Trial 30893, EUR UROL, 37(5), 2000, pp. 541-551
Objectives: To compare the quality of life (QL) of patients with poor progn
osis M1 prostate cancer treated with orchiectomy alone (ORCH) or orchiectom
y combined with adjuvant mitomycin C (MMC; 15 mg/m(2) i.v. q 6 weeks: ORCH
+ MMC; EORTC trial 30893).
Methods: Patients with newly diagnosed M1 poor prognosis prostate cancer co
mpleted a truncated version of the EORTC OLQ-C30 (V 1.0) at randomization (
baseline) and every 6-12 weeks thereafter until going off the protocol. Fiv
e ad hoc questions assessing lower urinary tract symptoms were included in
the QL questionnaire.
Results: At least one OL form was completed by 177 of the 189 patients incl
uded in the trial, with baseline questionnaires available for 113 patients
(ORCH n = 52; ORCH + MMC n = 61). In both arms, pain and urinary dysfunctio
n improved during treatment. Compared with patients from the ORCH arm, the
use of adjuvant MMC was associated with a significant reduction in global h
ealth status/QL and with impairment in 7 of 11 QL dimensions covered by the
questionnaire. Some improvement in QL was observed after discontinuation o
f MMC. A survival benefit was not observed in the ORCH + MMC arm.
Conclusions: Intravenous MMC (15 mg/m(2) q 6 weeks) cannot be recommended a
s adjuvant treatment in M1 poor prognosis prostate cancer due to its negati
ve impact on QL and lack of efficacy. In general, QL assessments should be
mandatory when adjuvant chemotherapy is evaluated in patients with metastat
ic prostate cancer. Copyright (C) 2000 S. Karger AG. Basel.