Pharmacodynamic stimulation of thrombogenesis by angiotensin (1-) in recurrent ovarian cancer patients receiving gemcitabine and platinum-based chemotherapy

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• 作者：Huyen Pham (1)
  Benjamin M. Schwartz (2)
  James E. Delmore (3)
  Eddie Reed (4)
  Scott Cruickshank (5)
  Leanne Drummond (6)
  Kathleen E. Rodgers (7)
  Kainoa J. Peterson (6)
  Gere S. diZerega (1) (6)
  
• 关键词：A(1-) ; Gemcitabine ; Carboplatin ; Cisplatin ; Thrombocytopenia ; Thrombocytosis
• 刊名：Cancer Chemotherapy and Pharmacology
• 出版年：2013
• 出版时间：April 2013
• 年：2013
• 卷：71
• 期：4
• 页码：965-972
• 全文大小：339KB
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• 作者单位：Huyen Pham (1)
  Benjamin M. Schwartz (2)
  James E. Delmore (3)
  Eddie Reed (4)
  Scott Cruickshank (5)
  Leanne Drummond (6)
  Kathleen E. Rodgers (7)
  Kainoa J. Peterson (6)
  Gere S. diZerega (1) (6)
  
  1. Livingston Laboratory, Keck School of Medicine at USC, 1321 N. Mission Rd., Los Angeles, CA, 90033, USA
  2. Schwartz Gynecologic Oncology, PLLC, 404 Potter Boulevard, Brightwaters, NY, 11718, USA
  3. Associates in Women’s Heath, 3232 E. Murdock, Wichita, KS, 67208, USA
  4. USA Mitchell Cancer Institute, 1660 Springhill Avenue, Mobile, AL, 36604, USA
  5. Cruickshank & Associates, 3109 Calle Cedro, Santa Barbara, CA, 93105, USA
  6. US Biotest, 231 Bonetti Drive, Suite 240, San Luis Obispo, CA, 93401, USA
  7. School of Pharmacy University of Southern California, 1985 Zonal Avenue, Los Angeles, CA, 90089, USA
  
• ISSN：1432-0843

文摘

Purpose This randomized, double-blind, placebo-controlled Phase 2 study evaluated safety and efficacy of A(1-) for reduction in Grade 3- thrombocytopenia in patients receiving myelosuppressive chemotherapy. Pharmacodynamic activity of A(1-) in platelet production and retention of scheduled dose intensity were also determined. Methods Thirty-four patients with ovarian, Fallopian tube, or peritoneal carcinoma receiving gemcitabine and carboplatin or cisplatin were evaluated. Patients were randomized to receive study drug subcutaneously at 100?mcg/kg (n?=?11), 300?mcg/kg (n?=?13), or placebo (n?=?10) following chemotherapy for up to six cycles. Hematologic variables were obtained throughout each treatment cycle. Results There were no drug-related safety issues. There were no instances of Grade 4 thrombocytopenia in patients who received 100?mcg/kg treatment compared to 6?% of chemotherapy cycles for patients receiving placebo (p?=?0.07). The maximal percentage increase in platelet concentration from baseline was higher for patients who received 100?mcg/kg A(1-) compared to placebo (p?=?0.02). This increase was accompanied by a reduction in the nadir absolute neutrophil count (p?=?0.04). Relative dose intensity for the combination chemotherapy was higher for patients who received 100?mcg/kg A(1-) compared to placebo (p?=?0.04). There were no differences in outcomes for patients receiving 300?mcg/kg dose compared to placebo. Conclusions A 100?mcg/kg dose of A(1-) was shown to produce pharmacodynamic effects on peripheral blood platelet counts, preserve planned dose intensity, and reduce Grade 3- thrombocytopenia following gemcitabine and platinum chemotherapy. These findings are consistent with A(1-)-induced stimulation of thrombogenesis in the bone marrow following marrow-toxic chemotherapy.