Net Guides: Thrombocytopenia Supportive Care

Oncology Live®, February 2011, Volume 12, Issue 2

Useful Online Resources and Clinical Trials for Thrombocytopenia Supportive Care

//THE ONLINE ONCOLOGIST™

National Guideline Clearinghouse Includes Thrombocytopenia Entry

The National Guideline Clearing House is a Website run by the Agency for Healthcare Research and Quality, the health services research arm of the US Department of Health and Human Services. The site contains recommendations for the clinical management of many diseases and conditions, including thrombocytopenia. The “Guideline Summary” page for thrombocytopenia begins with the scope and methodology of the guidelines before listing the recommendations, the evidence supporting them, the potential benefits and harms of implementing them, and information on their source. The “Recommendations” section discusses the clinical approach to and basic rules about thrombocytopenia. It then covers the causes of thrombocytopenia (including reasons for decreased production and increased consumption), as well as the clinical approach to treating symptomless patients with various platelet counts, and patients with bleeding and idiopathic thrombocytopenic purpura.

http://guideline.gov/content.aspx?id=11048&search=Prednisolone

//THE EDUCATED PATIENT®

Cancer.Net Article Puts Focus on Side Effect

Cancer.Net is a Website hosted by the American Society of Clinical Oncology. The site is meant to serve as a resource for patients with cancer by providing information that has been reviewed and approved by a board of oncologists. An article on thrombocytopenia can be found on the website that discusses its definition, causes, signs and symptoms, diagnosis and treatments, and factors that patients with thrombocytopenia should consider. At the bottom of the article are links to other articles that patients with thrombocytopenia may find useful, which cover bleeding and clotting problems, managing side effects, and understanding blood test results. Cancer.Net also has a large number of cancer-related articles that, while not directly related to thrombocytopenia, may be helpful to patients. Articles are sorted in a range of categories, including cancer types, information for the newly diagnosed, risk factors and prevention, genetics, treatment, clinical trials, managing cost, coping, and survivorship. Visitors may also view Cancer.Net’s medical illustrations gallery, collection of medical dictionary resources, and library of publications. Cancer. Net is available in both English and Spanish.

http://bit.ly/i4Ogg8

//EABSTRACT

Dose Escalation Study of An antithrombocytopenic Agent in Patients With Chemotherapy-Induced Thrombocytopenia

Journal: BMC Cancer

Authors: Levin RD, Daehler M, Grutsch JF, Hall JL, Gupta D, Lis CG

Purpose: Preclinical studies have shown that small-chain RNA fragments can accelerate platelet recovery in animals that have been exposed to high doses of chemotherapeutic drugs. There are also anecdotal data supporting that small-chain RNA fragments may have the same use in humans. The purpose of this study was to determine the effect of administering small-chain RNA fragments on platelet recovery in patients with chemotherapy-induced thrombocytopenia (CIT). The study required patients to have solid tumors and post-chemotherapy thrombocytopenia with a nadir of < 80,000 platelets/ml, but made no exclusions based on Eastern Cooperative Oncology Group status, tumor type, tumor burden, or chemotherapeutic agents. Patients were given unique preparations of RNA derived from either E coli or yeast, which were self administered sublingually every other day while undergoing chemotherapy treatment. Ten patients per group received 20, 40, or 60 mg as a starting dose. Dosage was increased by 20 mg at the start of each cycle to a maximum dose of 80 mg as long as the nadir remained <80,000 platelets/ml. Patients would then continue taking the maximum dose for 3 cycles of chemotherapy. Participants in the study were required to keep a diary of RNA fragment and magnesium administration, as well as any side effects experienced.

Results: Of the 2 groups, patients receiving the E coli RNA fragments showed a faster recovery in platelet count and higher nadir platelet count. In addition, none of the patients receiving E coli RNA fragments needed a chemotherapy dose reduction due to CIT. Patients receiving yeast RNA fragments required chemotherapy dose reductions due to grades 3 and 4 CIT. The authors concluded that patients undergoing myelosuppressive chemotherapy demonstrated an improvement in platelet nadir and recovery time when receiving concurrent E coli RNA fragments as compared with patients receiving yeast RNA fragments, and that 60 and 80 mg doses of E coli RNA accelerated platelet recovery, with 80 mg being the optimal dose for minimizing CIT. The authors also noted that further clinical investigation is needed to establish the benefits of E coli RNA fragments in the management of CIT.

http://www.ncbi.nlm.nih.gov/pubmed/20955619

//CLINICAL TRIAL

Safety/Efficacy Study of a Drug to Reduce Rhrombocytopenia in Patients Receiving Chemotherapy for Ovarian, Fallopian Tube, or Peritoneal Cancer

Study Type: Interventional

Age/Sex Requirements: 18 years (Female)

Sponsor: US Biotest, Inc

ClinicalTrials.gov Identifier: NCT00771810

Purpose: This study will test the safety and efficacy of 2 different dose levels of a new experimental drug called TXA127, also known as angiotensin 1-7, in the management of CIT. The study will focus specifically on CIT caused by chemotherapy regimens of gemcitabine and carboplatin or gemcitabine and cisplatin for the treatment of ovarian, fallopian tube, or peritoneal cancer. There will be 3 arms to the study, with patients receiving either 100 ug/kg/day of TXA127, 300 ug/kg/day of TXA127, or placebo. The primary outcome measure of the study will be the severity and incidence of thrombocytopenia as determined by the number of patient chemotherapy cycles during which the platelet count is below 50,000/mm3. Secondary outcome measures will be the severity and incidence of thrombocytopenia as determined by the number of patients who experience a platelet count below 50,000/mm3, and as determined by absolute nadir and time to platelet count recovery for each cycle and study subject; the frequency and severity of serious adverse events; and the incidence and grade of toxicity experienced by each dose group. http://bit.ly/fl 4Vyk