Oncology Analytics Inc.

Plantation, FL, United States

Oncology Analytics Inc.

Plantation, FL, United States
Time filter
Source Type

Kaur K.,University of South Carolina | Fayad R.,University of South Carolina | Saxena A.,University of South Carolina | Frizzell N.,University of South Carolina | And 32 more authors.
Journal of Community and Supportive Oncology | Year: 2016

Background The 3 fuoroquinolone (FQ) antibiotics - ciprofoxacin, levofoxacin, and moxifoxacin - are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identifed through novel collaborations between FQtreated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists. Objective To conduct basic science and clinical investigations of a newly identifed adverse drug reaction, termed FQassociated disability. Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDAapproved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA's MedWatch program. Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identifed disability syndrome termed "FQ-associated disability" (FQAD). Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin. Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised. Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Effcacy. © 2016 Frontline Medical Communications.

Retsky M.,Public-i | Retsky M.,University College London | Rogers R.,Public-i | Demicheli R.,Fondazione IRCCS Instituto Nazionale Tumori | And 7 more authors.
Breast Cancer Research and Treatment | Year: 2012

To explain a bimodal relapse hazard among early stage breast cancer patients treated by mastectomy we postulated that relapses within 4 years of surgery resulted from something that happened at about the time of surgery to provoke sudden exits from dormant phases to active growth. Relapses at 10 months appeared to be surgeryinduced angiogenesis of dormant avascular micrometastases. Another relapse mode with peak about 30 months corresponded to sudden growth from a single cell. Late relapses were not synchronized to surgery. This hypothesis could explain a wide variety of breast cancer observations. We have been looking for new data that might provide more insight concerning the various relapse modes. Retrospective data reported in June 2010 study of 327 consecutive patients compared various perioperative analgesics and anesthetics in one Belgian hospital and one surgeon. Patients were treated with mastectomy and conventional adjuvant therapy. Follow-up was average 27.3 months with range 13-44 months. Updated hazard as of September 2011 for this series is now presented. NSAID ketorolac, a common analgesic used in surgery, is associated with far superior disease-free survival in the first few years after surgery. The expected prominent early relapse events are all but absent. In the 9-18 month period, there is fivefold reduction in relapses. If this observation holds up to further scrutiny, it could mean that the simple use of this safe and effective anti-inflammatory agent at surgery might eliminate most early relapses. Transient systemic inflammation accompanying surgery could be part of the metastatic tumor seeding process and could have been effectively blocked by perioperative anti-inflammatory agents. In addition, antiangiogenic properties of NSAIDs could also play a role. Triple negative breast cancer may be the ideal group with which to test perioperative ketorolac to prevent early relapses. © Springer Science+Business Media, LLC. 2012.

Bennett C.L.,University of South Carolina | Bennett C.L.,Dorn Medical Center | Bennett C.L.,Medical University of South Carolina | Chen B.,University of South Carolina | And 30 more authors.
The Lancet Oncology | Year: 2014

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 summarise their regulatory frameworks, clinical experiences, and safety concerns. © 2014 Elsevier Ltd.

Retsky M.,Public-i | Retsky M.,University College London | Demicheli R.,Fondazione IRCCS Instituto Nazionale Tumori | Hrushesky W.J.M.,Oncology Analytics Inc | And 7 more authors.
Current Medicinal Chemistry | Year: 2013

To explain a bimodal pattern of hazard of relapse among early stage breast cancer patients identified in multiple databases, we proposed that late relapses result from steady stochastic progressions from single dormant malignant cells to avascular micrometastases and then on to growing deposits. However in order to explain early relapses, we had to postulate that something happens at about the time of surgery to provoke sudden exits from dormant phases to active growth and then to detection. Most relapses in breast cancer are in the early category. Recent data from Forget et al. suggest an unexpected mechanism. They retrospectively studied results from 327 consecutive breast cancer patients comparing various perioperative analgesics and anesthetics in one Belgian hospital and one surgeon. Patients were treated with mastectomy and conventional adjuvant therapy. Relapse hazard updated Sept 2011 are presented. A common Non-Steroidal Anti-Inflammatory Drug (NSAID) analgesic used in surgery produced far superior disease-free survival in the first 5 years after surgery. The expected prominent early relapse events in months 9-18 are reduced 5-fold. If this observation holds up to further scrutiny, it could mean that the simple use of this safe, inexpensive and effective anti-inflammatory agent at surgery might eliminate early relapses. Transient systemic inflammation accompanying surgery could facilitate angiogenesis of dormant micrometastases, proliferation of dormant single cells, and seeding of circulating cancer stem cells (perhaps in part released from bone marrow) resulting in early relapse and could have been effectively blocked by the perioperative anti-inflammatory agent. © 2013 Bentham Science Publishers.

PubMed | Oncology Analytics Corporation
Type: | Journal: Methods in molecular biology (Clifton, N.J.) | Year: 2014

Circadian rhythms are biological rhythms that occur within a 24-h time cycle. Sleep is a prime example of a circadian rhythm and with it melatonin production. Stem cell systems also demonstrate circadian rhythms. This is particularly the case for the proliferating cells within the system. In fact, all proliferating cell populations exhibit their own circadian rhythm, which has important implications for disease and the treatment of disease. Stem cell chronobiology is particularly important because the treatment of cancer can be significantly affected by the time of day a drug is administered. This protocol provides a basis for measuring hematopoietic stem cell circadian rhythm for future stem cell chronotherapeutic applications.

PubMed | Oncology Analytics Inc.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

212 Background: Oncology Analytics, Inc. (OA) promotes evidence-based, guidelines-compliant cancer therapeutic decision-making on behalf of healthcare payers. The OA web-based 1,300 protocol treatment request system screens several hundred applications each month. Evidence-based requests are automatically approvable within seconds (Auto); those needing medical director (MD) review, within hours (Non-Auto). Some 10% of all requests require real-time consultation between OA board-certified medical oncologists/hematologists and the prescribing cancer specialist. Three-quarters of these non-compliant residual requests are rescinded by the treating oncologist. The remainder are either approved because of additional information while about 1% are recommended for an adverse determination.We hypothesize that OAs presence in a cancer market gradually improves the likelihood of evidence-based oncologist prescribing behavior. We tested this over 44 consecutive months of rapid growth, from May 2009 through December 2012, within a single southeastern US market. Since Auto requests are evidence- and guidelines-based, and Non-Auto requests are either not supported by evidence or have evidence support but with less toxic or less costly alternatives available, we reasoned that any sustained directional change in the ratio of Auto to Non-Auto represents a characteristic change in cancer specialist behavior over that span. The monthly ratios of Auto to Non-Auto were analyzed for trends by least squares and the slopes of each were contrasted by ANCOVA.During the first six months, Auto-processed requests approximately equaled Non-Auto-processed request numbers, for a baseline ratio of one. Over the next 38 months, this ratio rose to approximately 1.4, meaning that 40% more requests were eventually approved automatically each month than those requiring MD review. The slopes of this relationship between Auto and Non-Auto approvals are statistically distinct (F = 43.34; p<0.001).This progressive quality improvement reflects malleability of cancer doctor prescribing behavior, results in substantial savings, occurs quickly, persists and grows over time.

Loading Oncology Analytics Inc. collaborators
Loading Oncology Analytics Inc. collaborators