BACKGROUND: This study was designed to evaluate toxicity and preliminary efficacy of 2 cycles of concomitant standard dose/schedule of (153)Sm-lexidronam plus Q 3 weeks schedule escalating doses of docetaxel in metastatic castration-resistant prostate cancer (mCRPC). METHODS: mCRPC patients with progressive bone metastases were treated in 4 cohorts. Docetaxel doses were escalated from 50, 50, 0 mg/m(2) (on days 1, 22, 43, per 12-week cycle) to 75, 75, 75 mg/m(2). (153)Sm-lexidronam was administered on days 2 (Q 12 weeks) at dose of 1 mCi/kg/cycle (maximum of 2 cycles). RESULTS: Thirteen patients received an average of 3.6 doses of docetaxel (range, 2-6 doses, median 4) and 1.5 doses of (153)Sm-lexidronam (range, 1-2, median 2). Toxicity was primarily hematologic. There were total 35 episodes grade 3/4 neutropenia with a median 7 (range 7-14) days to recovery to ≤grade 1. One dose limiting grade 3 thrombocytopenia occurred on cohorts 3 and 4. Eight of 13 (62%) patients had PSA > 50% decrease as best response during the treatment. Median time to bone disease progression was 5.2 months (range 91 days-10 months+); 6/13 (46%) patients had stable/improved bone scans at 6 months and 6/6 (100%) symptomatic patients had improvement in pain. CONCLUSIONS: Concurrent 6-month administration of 4 doses (75 mg/m(2)) of standard Q 3 weeks schedule of docetaxel with 2 Q 3 months infusions of 1 mCi/Kg (153)Sm-lexidronam is feasible with reversible bone marrow suppression, and deserves further testing in mCRPC patients with extensive bone metastasis.
BACKGROUND: This study was designed to evaluate toxicity and preliminary efficacy of 2 cycles of concomitant standard dose/schedule of (153)Sm-lexidronam plus Q 3 weeks schedule escalating doses of docetaxel in metastatic castration-resistant prostate cancer (mCRPC). METHODS: mCRPC patients with progressive bone metastases were treated in 4 cohorts. Docetaxel doses were escalated from 50, 50, 0 mg/m(2) (on days 1, 22, 43, per 12-week cycle) to 75, 75, 75 mg/m(2). (153)Sm-lexidronam was administered on days 2 (Q 12 weeks) at dose of 1 mCi/kg/cycle (maximum of 2 cycles). RESULTS: Thirteen patients received an average of 3.6 doses of docetaxel (range, 2-6 doses, median 4) and 1.5 doses of (153)Sm-lexidronam (range, 1-2, median 2). Toxicity was primarily hematologic. There were total 35 episodes grade 3/4 neutropenia with a median 7 (range 7-14) days to recovery to ≤grade 1. One dose limiting grade 3 thrombocytopenia occurred on cohorts 3 and 4. Eight of 13 (62%) patients had PSA > 50% decrease as best response during the treatment. Median time to bone disease progression was 5.2 months (range 91 days-10 months+); 6/13 (46%) patients had stable/improved bone scans at 6 months and 6/6 (100%) symptomatic patients had improvement in pain. CONCLUSIONS: Concurrent 6-month administration of 4 doses (75 mg/m(2)) of standard Q 3 weeks schedule of docetaxel with 2 Q 3 months infusions of 1 mCi/Kg (153)Sm-lexidronam is feasible with reversible bone marrow suppression, and deserves further testing in mCRPC patients with extensive bone metastasis.
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Authors: I Resche; J F Chatal; A Pecking; P Ell; G Duchesne; R Rubens; I Fogelman; S Houston; A Fauser; M Fischer; D Wilkins Journal: Eur J Cancer Date: 1997-09 Impact factor: 9.162
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Authors: Shi-Ming Tu; Paul Mathew; Franklin C Wong; Donnah Jones; Marcella M Johnson; Christopher J Logothetis Journal: J Clin Oncol Date: 2009-05-04 Impact factor: 44.544
Authors: Jatinder Goyal; Philipp Nuhn; Peng Huang; Prachi Tyagi; Daniel Oh; Michael A Carducci; Mario A Eisenberger; Emmanuel S Antonarakis Journal: BJU Int Date: 2012-06-15 Impact factor: 5.588
Authors: Oren Levy; W Nathaniel Brennen; Edward Han; David Marc Rosen; Juliet Musabeyezu; Helia Safaee; Sudhir Ranganath; Jessica Ngai; Martina Heinelt; Yuka Milton; Hao Wang; Sachin H Bhagchandani; Nitin Joshi; Neil Bhowmick; Samuel R Denmeade; John T Isaacs; Jeffrey M Karp Journal: Biomaterials Date: 2016-03-17 Impact factor: 12.479
Authors: Karen A Autio; Neeta Pandit-Taskar; Jorge A Carrasquillo; Ryan D Stephenson; Susan F Slovin; Dana E Rathkopf; Christina Hong; Glenn Heller; Howard I Scher; Steven M Larson; Michael J Morris Journal: Cancer Date: 2013-06-13 Impact factor: 6.860