Document Detail

Oral paricalcitol (19-nor-1,25-dihydroxyvitamin D2) in women receiving chemotherapy for metastatic breast cancer: a feasibility trial.
MedLine Citation:
PMID:  23760489     Owner:  NLM     Status:  MEDLINE    
The vitamin D hormone, [1,25(OH) 2D, calcitriol], inhibits proliferation and angiogenesis in breast cancer but its therapeutic use is limited by hypercalcemia. Synthetic analogs of 1,25(OH) 2D that are less calcemic, such as paricalcitol (19-nor-1,25-Dihydroxyvitamin D 2), are used to treat hyperparathyroidism associated with chronic kidney disease. We sought to determine the safety and feasibility of taking oral paricalcitol with taxane-based chemotherapy in women with metastatic breast cancer (MBC). Oral paricalcitol was considered safe if it did not result in excessive toxicity, defined as grade 3 or higher serum calcium levels. It was considered feasible if the majority of women could take eight weeks of continuous therapy in the first three months. Serum calcium was monitored weekly and the paricalcitol dose was adjusted based on its calcemic effect. Intact parathyroid hormone (iPTH) was monitored as a marker of paricalcitol activity. Twenty-four women with MBC were enrolled. Twenty women (83%) received eight weeks of continuous therapy. Paricalcitol was well-tolerated with no instances of hypercalcemia grade 2 or greater. Fourteen women (54%) were able to escalate the dose. The dose range of paricalcitol in the first 3 mo was 2-7 ug/day. Serum iPTH levels at baseline were significantly higher in women with serum 25-Hydroxyvitamin D (25-OHD) levels less than 30 ng/ml (96.4 ± 40.9 pg/ml) vs. 46.2 ± 20.3 pg/ml (p = 0 0.001) (iPTH reference 12-72 pg/ml). We conclude that paricalcitol is safe and feasible in women with MBC who are receiving chemotherapy.
Julia A Lawrence; Steven A Akman; Susan A Melin; L Douglas Case; Gary G Schwartz
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Cancer biology & therapy     Volume:  14     ISSN:  1555-8576     ISO Abbreviation:  Cancer Biol. Ther.     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-06-13     Completed Date:  2014-01-14     Revised Date:  2014-06-03    
Medline Journal Info:
Nlm Unique ID:  101137842     Medline TA:  Cancer Biol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  476-80     Citation Subset:  IM    
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MeSH Terms
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  pharmacology,  therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Dose-Response Relationship, Drug
Ergocalciferols / administration & dosage
Feasibility Studies
Hypercalcemia / chemically induced
Lymphatic Metastasis
Middle Aged
Taxoids / administration & dosage
Treatment Outcome
Grant Support
Reg. No./Substance:
0/Ergocalciferols; 0/Taxoids; 131918-61-1/paricalcitol

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