Laura Bobolts, PharmD, BCOP

Laura Bobolts, PharmD, BCOP

Miami-Fort Lauderdale Area
5K followers 500+ connections

About

Driven Board-Certified Oncology Pharmacist, specializing in oncology managed care…

Articles by Laura

Experience

  • OncoHealth Graphic

    OncoHealth

    Plantation, FL

  • -

    Ft. Lauderdale, FL

  • -

    Hollywood, FL

  • -

    Tampa, FL

  • -

    Tampa, FL

Education

Licenses & Certifications

  • Board Certified Oncology Pharmacist

    Board of Pharmacy Specialties

Publications

  • National Comprehensive Cancer Network: Petitions and Submissions

    2016 ASCO Quality Care Symposium

    Majority of NCCN petitions requesting a guideline/compendium change submitted from a company outside of the pharmaceutical industry come from Oncology Analytics, Inc., yet only account for a very small amount of requests in comparison to industry-driven requests.

    See publication
  • Community platinum use in neoadjuvant or adjuvant HER2- breast cancer.

    J Clin Oncol 33, 2015 (suppl; abstr e12029)

    Background: There is increasing evidence that platinum-based chemotherapy (PBC) is beneficial in breast cancer. Utilization of platinum agents are on the rise in potentially curable HER2-negative (HER2-) disease. This trend is particularly evident in triple negative breast cancer (TNBC), which lacks a specific molecular therapeutic target. Few data defines the optimal PBC regimen or candidates for these regimens. The aim of this study was to determine the frequency of PBC regimens selected in…

    Background: There is increasing evidence that platinum-based chemotherapy (PBC) is beneficial in breast cancer. Utilization of platinum agents are on the rise in potentially curable HER2-negative (HER2-) disease. This trend is particularly evident in triple negative breast cancer (TNBC), which lacks a specific molecular therapeutic target. Few data defines the optimal PBC regimen or candidates for these regimens. The aim of this study was to determine the frequency of PBC regimens selected in the community for HER2- non-metastatic breast cancer. Methods: This retrospective chart review tabulated PBC drug authorization requests across the US, from January 2014 to January 2015 for stages I-III HER2- breast cancer patients. We included 47 patients and recorded the following variables: age, stage, ER/PR, HER2, and BRCA status, planned chemotherapy and neoadjuvant versus adjuvant. Results: Carboplatin was the only platinum requested. The majority of PBC authorization requests were for triple negative breast (TNBC) patients (85%) age less than 60 (74%). Stage II disease predominated (43%), as did neoadjuvant PBC use (83%). Only 6% of cases were documented BRCA+, while 83% had no documented BRCA testing. Fifteen percent were ER/PR+ and HER2-. Neoadjuvant PBC was requested for stage I disease in two of these seven ER/PR+ patients. Paclitaxel qwk plus carboplatin q3wk with sequential ddAC was requested in 68%, with 94% in the neoadjuvant setting. Conclusions: Carboplatin is used with increasing frequency for the neoadjuvant therapy of early stage HER2- breast cancer, even in hormone receptor positive stage I disease. Further investigation is needed to determine whether this strategy prolongs overall survival and diminishes breast cancer-related mortality.

    Other authors
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  • Regulatory and clinical considerations for biosimilar oncology drugs.

    Lancet Oncology

    Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into…

    Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarize their regulatory frameworks, clinical experiences, and safety concerns.

    Other authors
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  • Off-label capecitabine, eribulin, or ixabepilone use in metastatic breast cancer (MBC)

    J Clin Oncol 31, 2013 (suppl; abstr e12034)

    Background: Anthracyclines and taxanes have proven to be the most effective treatments for MBC. The FDA indications for capecitabine, eribulin, and ixabepilone recommend prior anthracycline and taxane therapy, unless contraindicated. The proportion of patients who receive these drugs after having received an anthracycline and/or taxane is unknown. We retrospectively reviewed capecitabine, eribulin, and ixabepilone treatment requests to examine the utilization patterns, specifically in relation…

    Background: Anthracyclines and taxanes have proven to be the most effective treatments for MBC. The FDA indications for capecitabine, eribulin, and ixabepilone recommend prior anthracycline and taxane therapy, unless contraindicated. The proportion of patients who receive these drugs after having received an anthracycline and/or taxane is unknown. We retrospectively reviewed capecitabine, eribulin, and ixabepilone treatment requests to examine the utilization patterns, specifically in relation to prior anthracycline and/or taxane therapy. Methods: All capecitabine, eribulin, or ixabepilone requests for MBC from 2009 through January 2013 were reviewed. The proportion of requests for these agents with and without FDA stipulated prior therapies were contrasted, using Chi squared analyses. Results: 36 MBC requests were identified for capecitabine, eribulin, or ixabepilone. The majority (67%) of these occurred among patients who had no documentation of prior anthracycline therapy. 36% of all requests were not preceded by any documented taxane therapy. Anthracyclines were avoided more frequently than taxanes (p=0.011). All requests without documentation of prior taxane use (36%; 13/36) were also made without prior anthracycline use. Oncologists were more likely to initiate capecitabine without prior anthracycline and taxane, as compared to eribulin or ixabepilone (64% v 18% v 18%, respectively; p=0.042). Conclusions: In our sample, more than two thirds of MBC treatment requests for eribulin, capecitabine, or ixabepilone occurred prior to a request for an anthracycline, and more than a third prior to receiving a taxane. Since, in general, it is considered standard of care to use the most active drugs early in the course of disease, this trend could have negative effects upon the optimal control of MBC.

    Other authors
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  • Generic oncology drugs: are they all safe?

    Lancet Oncology. 2016 Nov;17(11):e493-e501. doi: 10.1016/S1470-2045(16)30384-9.

    Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin)…

    Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval.

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Projects

  • Peer reviewer for Clinical Genitourinary Cancer

  • Peer reviewer for the Board of Pharmacy Specialties, Board Certified Oncology Pharmacist Exam review materials focused on gynecological malignancies (ovarian cancer, uterine cancer, and cervical cancer)

    - Present

  • Peer reviewer for JAMA Oncology

    - Present

    One of 727 peer reviewers in 2015 for JAMA Oncology's inaugural year of publication, listed in a thank you editorial. I continue to review articles for JAMA Oncology upon request.

    See project
  • Exam question writer for the Board of Pharmacy Specialties, Board Certified Oncology Pharmacist (BCOP) Exam

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