ISSN:
1569-8041
Keywords:
gemcitabine
;
gormone-refractory prostate cancer
;
pain
;
palliative endpoints
;
prostate specific antigen
;
quality of life
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Background:In a phase II trial, 43 patients withhormone-refractory prostate cancer were treated with gemcitabine at a dose of1200 mg/m2 over 2 hours (later decreased to 1000 mg/m2due to hematological toxicity) on days 1, 8 and 15 of a 28 day cycle. Patients and methods:Inclusion criteria were proven tumorprogression after hormonal treatment and increased PSA levels, a WHO PS ≤2,adequate bone marrow reserve, liver and renal function and age ≤80 years.Response criteria were based on PSA levels (CR: normalization of PSA, PR:〉50% decrease). Quality of life (QL) was assessed with the EORTCQLQ-C30 on day 1 of each treatment cycle and on day 8 of the first cycle(range of scales 0–100). Physician-rated pain intensity and use of painmedication were assessed at the same timepoints. Results:Hematological toxicity of gemcitabine led to adose-reduction in 48% of all cycles. Three of forty-three patients (RR= 7%) showed a PSA response: one CR and three PR with time to treatmentfailure of 8.7, 6.6 and ≥9.3 months. Seven patients (16%) had stabledisease (NC) for a median duration of 7.1 months (range 6.1–11.7months). There was one case with objective regression of lymph nodemetastases. Patients reported a considerably impaired health status/QL(n = 41, median = 50) and severe fatigue (n = 41, median =55.6) at baseline, with no change under treatment. Pain (QLQ-C30) was alsosevere at baseline (N=41, median=50) but was improved at the end of cycles 1(n = 33, median change = −16.7,P = 0.0002), 2(n = 19, median change = −33.3, P = 0.0006), 3(n = 14, median change = −16.7, P = 0.06) and 4(n = 9, median change = −33.3, P = 0.04).Patient-rated pain and use of analgesics as combined endpoint yieldedpalliation for at least 8 weeks in 14 patients (32%). Nine of thesepatients showed at least stable disease (CR/PR or NC by PSA level), fiveindicated a benefit in spite of progressive disease. Conclusions:Gemcitabine in the dose and schedule indicated abovehas a significant beneficial impact on pain in patients withhormone-refractory prostatic carcinoma despite its limited activity in termsof PSA response and considerable, especially hematological, toxicity.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008332724977
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