Oral Chemotherapy Food and Drug Interactions: A Comprehensive Review of the Literature

Segal, Eve M; Flood, Megan R.; Mancini, Robert; Whiteman, Robert T.; Friedt, Gregory A.; Kramer, Adam R.; Hofstetter, Mark A.

doi:10.1200/jop.2013.001183

Cited by 83 publications

(51 citation statements)

References 23 publications

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“…In recent year, there has been a remarkable growth in the approvals of oral anticancer drugs, which are increasingly making up a larger proportion of oncology drug use in the real world . In light of this growing trend it is important to understand factors associated with oral therapy and clinical response, such as food‐drug interaction, drug‐drug interaction, variable bioavailability, therapeutic window, and patient adherence to anticancer therapies . With this in mind, by analyzing the results of food bioavailability studies and pivotal clinical trial dosing conditions (ie, fasting vs fed), we were able to draw some generalizations of how these 2 factors converge and influence the eventual labeling decisions of oral oncology drugs by the FDA (Figure ).…”

Section: Discussionmentioning

confidence: 99%

“…18 In light of this growing trend it is important to understand factors associated with oral therapy and clinical response, such as food-drug interaction, drug-drug interaction, variable bioavailability, therapeutic window, and patient adherence to anticancer therapies. [19][20][21][22] With this in mind, by analyzing the results of food bioavailability studies and pivotal clinical trial dosing conditions (ie, fasting vs fed), we were able to draw some generalizations of how these 2 factors converge and influence the eventual labeling decisions of oral oncology drugs by the FDA (Figure 2). Furthermore, the rationales for these labeling decisions as found in regulatory submission documents at Drugs@FDA or related literature are listed in Supplementary Tables 1 and 2.…”

Section: Discussionmentioning

confidence: 99%

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To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs

Deng

Brar

Lesko

2017

Clinical Pharm in Drug Dev

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There has been controversy regarding whether bioavailability of certain oral oncology drugs should be maximized by taking these medications with food, irrespective of label instructions in the dosing and administration section. To provide insight into this controversy, we conducted an in-depth analysis for oral antineoplastic drugs approved by the Food and Drug Administration in 2000-2016 and identified important issues influencing food labeling decisions. Furthermore, a case study involving sonidegib, a drug approved for locally advanced basal cell carcinoma with a significant food effect on exposure, was used to demonstrate the consequences of failure to adhere to food label recommendations using drug-specific population pharmacokinetic and exposure-toxicity models. In 2000-2009, 80% (4 out of 5) of all approved oral antineoplastics with increased bioavailability in the fed state were labeled as "take on empty stomach." In contrast, we found that in 2010-2016 there is a greater diversity in food recommendations for drugs with increased bioavailability in the fed state. Currently, many oral oncology drugs are given with food to maximize their bioavailability; however, as seen from our case study of sonidegib, failure to fully adhere to label recommendations to either take with food or not could lead to adverse consequences in terms of safety and efficacy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs

Deng

Brar

Lesko

2017

Clinical Pharm in Drug Dev

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“…Food and drug interactions play a more significant role in treatment with OAA than with intravenous chemotherapy (Segal et al 2014). In fact, interactions are the most frequent drug-related problems in OAA (Bulsink et al 2013).…”

Section: Discussionmentioning

confidence: 99%

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents

et al. 2016

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We assessed the impact of a pharmacotherapy follow-up programme on key safety points [adverse events (AE) and drug administration] in outpatients treated with oral antineoplastic agents (OAA). We performed a comparative, interventional, quasi-experimental study of outpatients treated with OAA in a Spanish hospital to compare pre-intervention group patients (not monitored by pharmacists during 2011) with intervention group patients (prospectively monitored by pharmacists during 2013). AE data were collected from medical records. Follow-up was 6 months, and 249 patients were included (pre-intervention, 115; intervention, 134). After the first month, AE were detected in 86.5% of patients in the pre-intervention group and 80.6% of patients in the intervention group, P = 0.096. During the remaining months, 79.0% patients had at least one AE in the pre-intervention group compared with 78.0% in the intervention group, P = 0.431. AE were more prevalent with sorafenib and sunitinib. In total, 173 drug interactions were recorded (pre-intervention, 80; intervention, 93; P = 0.045). Drug interactions were more frequent with erlotinib and gefitinib; food interactions were more common with sorafenib and pazopanib. Our follow-up of cancer outpatients revealed a reduction in severe AE and major drug interactions, thus helping health professionals to monitor the safety of OAA.

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“…FDI can occur frequently specially if neglected or no resolved immediately because may be lead to adverse reactions or therapeutic failure can occur [18]. The most people who exposed to this interaction are the elderly patient because most of them have more than two drugs and in can lead to serious situation for them [19]. Several numbers of prescribed medication to patients is usually high in Intensive care units; and most of them supplied food by naso gastric tube because they cannot take food by mouth, in the same time they have drugs too and can lead to serious changes such as problems of incompatibility between food and medication or toxicity can be occur.…”

Section: Literature Reviewmentioning

confidence: 99%

Nurses’ Knowledge Regarding FoodDrug Interaction in the Intensive Care and Emergency Hospitals

Lafi

Kamali

Sharif

2019

KJAR

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Usually supplement is essential and fundamental components for ensure and creating the human body, also drugs seem to survey the life of each individual and ensure the wellbeing for a long life aimed most of illness, but in case nourishment sedate interaction ignored since of information shortage almost it or any reason maybe lead to futile of medicine for the patients or cause life threatening condition because of that, one of the most significant ethical point in every health care setting in the world is patient's safety; and the care for patients must be improved in every country to prevent complication of interaction between food and drug. The main objective of this cross-sectional study has been conducted to assess the nurses' knowledge regarding food-drug interaction (FDI) at the intensive care in both of Shar and emergency hospitals in the Slemani city, the data were collected during the period of October up to the end of December. Non-probability, (purposive sample) of 78 nurses at both hospitals, a questionnaire was designed according to literatures and books regarding FDI which contained 25 items, 8 items for demographic characteristics, and 17 items concerning FDI. The validity of the questionnaire was given to a panel of 7 experts, a pilot study was carried out to check the reliability of the questionnaire which determined through the use of stability reliability (test-retest) approach which was estimated as r = 0.81. The data were collected through the interviewing of the study sample and analyzed through the using of the Statistical Package for Social Sciences SPSS, version 23, and analyzed through the application of descriptive and inferential statistical analysis. The findings of the present study conclude that more than half of nurses had low knowledge and none of them had high level of knowledge, also there is no significant association between the levels of knowledge with age, gender, educational level, years of experience and working place. The study suggested extends the knowledge of nurses regarding the FDI, by training courses from clinical pharmacologists.

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Oral Chemotherapy Food and Drug Interactions: A Comprehensive Review of the Literature

Cited by 83 publications

References 23 publications

To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs

To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents

Nurses’ Knowledge Regarding FoodDrug Interaction in the Intensive Care and Emergency Hospitals

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