TY - JOUR
T1 - Pemetrexed as second-line chemotherapy for castration-resistant prostate cancer after docetaxel failure
T2 - Results from a phase II study
AU - Caffo, Orazio
AU - Fratino, Lucia
AU - Barbieri, Roberto
AU - Perin, Alessandra
AU - Martini, Thomas
AU - Sava, Teodoro
AU - Segati, Romana
AU - Vaccher, Emanuela
AU - Bernardo Bassan, Franco
AU - Veccia, Antonello
AU - Pappagallo, Giovanni
AU - Galligioni, Enzo
PY - 2013/2
Y1 - 2013/2
N2 - Objective: Although there is no standard treatment after docetaxel failure in patients with castration-resistant prostate cancer (CRPC), second-line chemotherapy is increasingly required. Its mechanism of action and toxicity profile make pemetrexed suitable for testing in this setting. Methods and materials: Patients with docetaxel-resistant CRPC received pemetrexed 500 mg/m2 every 3 weeks for 6 courses. The usual premedication with vitamin supplementation and dexamethasone prophylaxis was regularly administered. The primary objective was to quantify the biochemical response rate. Results: The biochemical response rate was 10.5% (95% CI 1.3-33.1), with 2 patients showing a reduction in prostate specific antigen (PSA) of ≥50%. The null hypothesis that the PSA response rate would be less than 20% was therefore accepted, and patient accrual was stopped after the evaluation of the 19th patient. The 1-year overall survival rate was 61.5%, with a median survival of 14 months. A considerable proportion of the patients (36%) were withdrawn from the study because of hematologic and nonhematologic toxicity. Conclusions: Our experience with pemetrexed in CRPC patients appears discouraging in terms of activity and toxicity. No further studies of this drug should be performed in CRPC patients.
AB - Objective: Although there is no standard treatment after docetaxel failure in patients with castration-resistant prostate cancer (CRPC), second-line chemotherapy is increasingly required. Its mechanism of action and toxicity profile make pemetrexed suitable for testing in this setting. Methods and materials: Patients with docetaxel-resistant CRPC received pemetrexed 500 mg/m2 every 3 weeks for 6 courses. The usual premedication with vitamin supplementation and dexamethasone prophylaxis was regularly administered. The primary objective was to quantify the biochemical response rate. Results: The biochemical response rate was 10.5% (95% CI 1.3-33.1), with 2 patients showing a reduction in prostate specific antigen (PSA) of ≥50%. The null hypothesis that the PSA response rate would be less than 20% was therefore accepted, and patient accrual was stopped after the evaluation of the 19th patient. The 1-year overall survival rate was 61.5%, with a median survival of 14 months. A considerable proportion of the patients (36%) were withdrawn from the study because of hematologic and nonhematologic toxicity. Conclusions: Our experience with pemetrexed in CRPC patients appears discouraging in terms of activity and toxicity. No further studies of this drug should be performed in CRPC patients.
KW - Castration-resistance
KW - Pemetrexed
KW - Prostate cancer
KW - Second line chemotherapy
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U2 - 10.1016/j.urolonc.2010.11.012
DO - 10.1016/j.urolonc.2010.11.012
M3 - Article
C2 - 21803618
AN - SCOPUS:84875259992
VL - 31
SP - 180
EP - 186
JO - Urologic Oncology
JF - Urologic Oncology
SN - 1078-1439
IS - 2
ER -