In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e16014-e16014
Abstract:
e16014 Background: Docetaxel (D) is standard first-line chemotherapy in patients (pts) with metastatic castration-resistant prostate cancer (CRPC). Cabazitaxel (C), a novel taxane developed to overcome D resistance, showed an overall survival improvement in second line CRPC in a three-weekly dose schedule. Its main toxicity is hematological with a risk of febrile neutropenia, especially in unfit patients. We aimed to evaluate efficacy and safety of weekly C/prednisone in "unfit" metastatic CRPC previously treated with D. Methods: Unfit pts (ECOG 2, dose reduction due to febrile neutropenia during treatment with D or radiation therapy affecting more than 25% of bone marrow reserve) with advanced CRPC progressing after D treatment with ECOG 〈 =2 and adequate bone marrow, liver and kidney functions were included. C 10 mg/m2 was administered on days 1, 8, 15 and 22 of 5-week cycles with daily prednisone 5 mg b.i.d. Radiological and PSA response was evaluated according to the PCCTWG II criteria and toxicity according NCI-CTC AE. Results: To date 28 pts have been enrolled and data are available for 21. Median age was 74 y (range 60-83), 13 (62%) pts had ECOG 2, 16 (76%) had bone metastases. Sixty-one cycles were administered (median: 3; range: 1-6) and 225 weekly administrations (median 10; range 1-24). Mean dose intensity was 94%. Most frequent related adverse events (AEs) of all grades as % of cycles were: asthenia (40%), anemia (34%), leukopenia (11%), thrombocytopenia (13%), diarrhea (10%), rash (8%), nauseas (8%), dysgeusia (8%), xerostomia (8%), anorexia (7%), mucositis (5%) and neuropathy (3%). Grade 3-4 AEs as % of cycles were: thrombocytopenia (8%), asthenia (7%), mucositis (2%), nausea (2%) and vomiting (2%). One patient discontinued the study due to asthenia G3. No grade III/IV diarrhea, neutropenia or febrile neutropenia were observed. Conclusions: Administration of weekly C (10 mg/m2) to unfit pts seems to be safe with no grade ≥3 neutropenia, diarrhea and febrile neutropenia reported. If confirmed in a larger scale, weekly C may represent an attractive option for unfit pts with mCRPC progressing after D treatment. Clinical trial information: NCT01518283.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.e16014
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
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