scholarly journals Oral Anticancer Drugs: How Limited Dosing Options and Dose Reductions May Affect Outcomes in Comparative Trials and Efficacy in Patients

2014 ◽  
Vol 32 (15) ◽  
pp. 1620-1629 ◽  
Author(s):  
Vinay Prasad ◽  
Paul R. Massey ◽  
Tito Fojo
Keyword(s):  
Clinical Trials ◽  
Anticancer Agents ◽  
Comparative Effectiveness ◽  
Clinical Effectiveness ◽  
Effectiveness Trials ◽  
Cancer Medicine ◽  
Poor Tolerability ◽  
Dose Reductions ◽  
Comparative Trials ◽  
Oral Anticancer Agents

Historically, cancer medicine has avoided the problem of unequal dosing by comparing maximum-tolerated doses of intravenous regimens with proportionate dose reductions for toxicity. However, in recent years, with the development of numerous oral anticancer agents, dosing options are arbitrarily and increasingly limited by the size of pills. We contend that an underappreciated consequence of pill size is unequal dosing in comparative clinical trials and that this can have an impact on outcomes. We discuss how comparative effectiveness trials can be unbalanced and how the use of doses that are not sustainable might affect outcomes, especially marginal ones. We further argue that because of their poor tolerability and their limited dosing options, which often result in large dose adjustments in response to toxicity, the real-world clinical effectiveness of oral anticancer agents may be diminished and may not emulate results achieved in registration trials.

Adherence reporting in phase III trials of approved oral anticancer agents: A systematic review.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20596-e20596
Author(s):  
R Donald Harvey ◽  
Trevor McKibbin ◽  
Madhusmita Behera ◽  
Suresh S Ramalingam
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medication Adherence ◽  
Anticancer Agents ◽  
Phase Iii ◽  
Investigational Agent ◽  
Adherence Data ◽  
Phase Iii Trials ◽  
Pubmed Search ◽  
Oral Anticancer Agents

e20596 Background: With the increasing number of orally administered anticancer agents, evaluation of treatment adherence is critical to assess efficacy and adverse events. When patients enrolled in registration clinical trials do not adhere to the investigational agent(s), conclusions made regarding efficacy and safety may be inaccurate and translate poorly to broader use. We performed a systematic review of adherence reporting in phase III trials of oral anticancer agents. Methods: We selected all oral anticancer agents approved by the FDA between 1996 and 2012. A PubMed search for generic name, with limits to "title" and "clinical trials", was performed. Publications from phase III trials were identified from the results. Medication adherence data were abstracted searching for the roots “compli” and “adher” and were categorized as follows: 1) mentioned or not, 2) methods described or not and 3) results reported or not. Results: Overall, publications or reports with 24 agents were identified. The search strategy yielded 5383 articles, of which 504 reporting on phase III trials were included for analysis. Of these, 106 (21%) mentioned either adherence or compliance to medications. Only 33 (7%) publications described methods of measuring adherence (e.g., diaries, interviews, pill counts), while 37 (7%) reported medication adherence results. Trials specifically identifying quantitative or qualitative rates of adherence in phase III trials involved abiraterone, anastrozole, capecitabine, dasatinib, exemestane, imatinib, lapatinib, letrozole, tamoxifen, thalidomide, topotecan, and toremifene (50% of agents). Within the 37 trials reporting adherence, 12 were qualitative (e.g., excellent, poor), 23 were quantitative, and 2 used pharmacokinetically-defined adherence measures. Conclusions: Medication adherence is infrequently reported in phase III trials of oral anti-cancer agents, leading to a knowledge gap in translation to clinical use. Our study underscores the need for standard metrics on measuring and reporting adherence to oral anticancer agents.

The intravenous to oral switch of taxanes: strategies and current clinical developments

2020 ◽  
Author(s):  
Marit AC Vermunt ◽  
Andries M Bergman ◽  
Eric van der Putten ◽  
Jos H Beijnen
Keyword(s):  
Clinical Trials ◽  
Anticancer Agents ◽  
Hospital Care ◽  
Oral Treatment ◽  
Chemotherapy Treatment ◽  
Intravenous Treatment ◽  
Improve Cost Effectiveness ◽  
Oral Switch ◽  
Tumor Types ◽  
Improve Cost

The taxanes paclitaxel, docetaxel and cabazitaxel are important anticancer agents that are widely used as intravenous treatment for several solid tumor types. Switching from intravenous to oral treatment can be more convenient for patients, improve cost–effectiveness and reduce the demands of chemotherapy treatment on hospital care. However, oral treatment with taxanes is challenging because of pharmaceutical and pharmacological factors that lead to low oral bioavailability. This review summarizes the current clinical developments in oral taxane treatment. Intravenous parent drugs, strategies in the oral switch, individual agents in clinical trials, challenges and further perspectives on treatment with oral taxanes are subsequently discussed.

scholarly journals Real-World Utilization of Oral Anticancer Agents Costs in Older Adults with Metastatic Renal Cell Carcinoma in the United States

Kidney Cancer ◽  
2021 ◽  
pp. 1-13
Author(s):  
Lauren E. Wilson ◽  
Lisa Spees ◽  
Jessica Pritchard ◽  
Melissa A. Greiner ◽  
Charles D. Scales ◽  
...  
Keyword(s):  
United States ◽  
Anticancer Agents ◽  
Patient Characteristics ◽  
The United States ◽  
Socioeconomic Indicators ◽  
Economic Implications ◽  
Southern Us ◽  
Race Ethnicity ◽  
Nationally Representative ◽  
Oral Anticancer Agents

Background: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population. Methods: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007–2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars. Results: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (>  80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient’s first OAA prescription nearly doubled from $3864 in 2007 to $7482 in 2015, while patient out-of-pocket cost decreased from $2409 to $1477. Conclusion: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine.

scholarly journals Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis

2021 ◽  
Vol 15 ◽  
pp. 175346662110280
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González-Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
David Gómez Martínez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Risk Of Bias ◽  
Hospitalized Patients ◽  
Low Risk ◽  
Controlled Clinical Trials

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.

scholarly journals The Metabolic Syndrome and Mind-Body Therapies: A Systematic Review

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Joel G. Anderson ◽  
Ann Gill Taylor
Keyword(s):  
Systematic Review ◽  
Metabolic Syndrome ◽  
Clinical Trials ◽  
Tai Chi ◽  
Clinical Trial Data ◽  
Clinical Effectiveness ◽  
The Metabolic Syndrome ◽  
Worldwide Population ◽  
Increased Risk

The metabolic syndrome, affecting a substantial and increasing percentage of the worldwide population, is comprised of a cluster of symptoms associated with increased risk of type 2 diabetes, cardiovascular disease, and other chronic conditions. Mind-body modalities based on Eastern philosophy, such as yoga, tai chi, qigong, and meditation, have become increasingly popular worldwide. These complementary therapies have many reported benefits for improving symptoms and physiological measures associated with the metabolic syndrome. However, clinical trial data concerning the effectiveness of these practices on the syndrome as a whole have not been evaluated using a systematic and synthesizing approach. A systematic review was conducted to critically evaluate the data from clinical trials examining the efficacy of mind-body therapies as supportive care modalities for management of the metabolic syndrome. Three clinical trials addressing the use of mind-body therapies for management of the metabolic syndrome were identified. Findings from the studies reviewed support the potential clinical effectiveness of mind-body practices in improving indices of the metabolic syndrome.

scholarly journals Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US

2015 ◽  
Vol 16 (6) ◽  
pp. 207-218 ◽  
Author(s):  
Pamela P. Pei ◽  
Milton C. Weinstein ◽  
X. Cynthia Li ◽  
Michael D. Hughes ◽  
A. David Paltiel ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Value Of Information ◽  
Brand Name ◽  
The Us ◽  
Effectiveness Trials

scholarly journals Novel Marine Compounds: Anticancer or Genotoxic?

2004 ◽  
Vol 2004 (2) ◽  
pp. 93-98 ◽  
Author(s):  
Jamal M. Arif ◽  
Amal A. Al-Hazzani ◽  
Muhammed Kunhi ◽  
Fahad Al-Khodairy
Keyword(s):  
Clinical Trials ◽  
Anticancer Agents ◽  
Screening Tests ◽  
Tumor Xenograft ◽  
Anticancer Compounds ◽  
Early Exit ◽  
Marine Compounds ◽  
Xenograft Models ◽  
Pharmaceutical Industries ◽  
Carcinogenesis Models

In the past several decades, marine organisms have generously gifted to the pharmaceutical industries numerous naturally bioactive compounds with antiviral, antibacterial, antimalarial, anti-inflammatory, antioxidant, and anticancer potentials. But till date only few anticancer drugs (cytarabine, vidarabine) have been commercially developed from marine compounds while several others are currently in different clinical trials. Majority of these compounds were tested in the tumor xenograft models, however, lack of anticancer potential data in the chemical- and/or oncogene-induced pre-initiation animal carcinogenesis models might have cost some of the marine anticancer compounds an early exit from the clinical trials. This review critically discusses importance of preclinical evaluation, failure of human clinical trials with certain potential anticancer agents, the screening tests used, and choice of biomarkers.

Primary care oncology model (PCOM): Implementation of a model integrating primary and oncology care for patients taking oral anticancer agents.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS1587-TPS1587
Author(s):  
Emily R. Mackler ◽  
Karen B. Farris ◽  
Katie S. Gatwood ◽  
Amna Rizvi-Toner ◽  
Alex Wallace ◽  
...  
Keyword(s):  
Primary Care ◽  
Anticancer Agents ◽  
Chronic Conditions ◽  
Lymphocytic Leukemia ◽  
Chronic Obstructive ◽  
Multiple Chronic Conditions ◽  
Hiv Intervention ◽  
Patient Reported ◽  
Chronic Medications ◽  
Oral Anticancer Agents

TPS1587 Background: Non-adherence to oral anticancer agents (OAA) has been reported among 30% of individuals. Often, individuals with cancer are not just managing their new OAA but also medications to treat multiple chronic conditions (MCC). Multiple factors contribute to the extent patients on OAAs and MCC medications adhere to therapy. The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and MCC through care coordination between pharmacists. Methods: Design. This is a multi-center prospective single arm pilot study at two academic medical centers in Michigan and Tennessee. Subjects. Ninety participants will be recruited, 60 from site 1 and 30 from site 2. Inclusion criteria are: adults > 18 years, diagnosed with and initiating oral treatment for chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma, diagnoses of at least 2 chronic conditions, where one is type 2 diabetes, hypertension, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, hyperlipidemia, or chronic obstructive pulmonary disease, taking at least two chronic medications, and able to provide electronic consent. Exclusion criteria are: inability to speak English, and diagnosis of type 1 diabetes or HIV. Intervention. Participants will complete two Patient Reported Outcome Measures (PROMs) for their OAA that will be reviewed by the oncology pharmacist, with follow-up to the care team if needed. Participants will be scheduled for a Comprehensive Medication Review with a primary care pharmacist for up to two visits for their chronic medications. The intervention over 2 months, and the oncology and primary care pharmacists communicate via electronic health record about medications, symptoms, and disease control. Outcomes. The primary endpoints are (a) dose-adjusted adherence by proportion days covered (PDC) for the OAA and (b) PDC for chronic condition medications, assessed using 6 months of prescription claims. Data will be collected from patients using REDCap surveys and abstracted data will be entered into REDCap. Implementation by pharmacists and patient acceptability will be examined. Analysis. The association of OAA and chronic medication adherence (PDC) will be examined via correlation. Participant demographics,clinical characteristics, and the symptom experience from the PROM will be described. Using CMR results, medication problems, recommendations, and changes will be provided. Program implementation will be assessed and patient perceptions obtained from post-CMR interviews. A joint display for the quantitative and qualitative data for feasibility, appropriateness, and acceptability from pharmacists will be completed. Results: Screening and recruitment has begun. Clinical trial information: NCT04595851 and NCT04663100.

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