Prescriber adherence to antiemetic guidelines with the new agent trifuridine-tipiracil

Daniel S. Childs, Alison C. Jacobson, Jessica L. Mitchell, Joleen M Hubbard, Harry H Yoon, Heidi Finnes, Axel F Grothey, Aminah Jatoi

Research output: Contribution to journalArticle

Abstract

Background: In 2015 alone, the US Food and Drug Administration approved 18 cancer drugs, but to our knowledge, few studies, if any, have examined prescribers' adherence to antiemetic guidelines as new chemotherapy agents become available. This issue is important because poor adherence to antiemetic guidelines has been shown in previous studies to have a negative impact on the control of nausea and vomiting. Here we report on antiemetic practices and outcomes for trifuridine-tipiracil, a drug newly approved in 2015. Objective: To test the hypothesis that patients prescribed a newly available chemotherapy agent, trifuridine-tipiracil, are at risk for chemotherapy-induced nausea and vomiting because of providers' poor adherence to antiemetic guidelines. Methods: All patients who received their first dose of trifuradine-tipiracil for metastatic colon cancer in 2015 were included in this retrospective, single-institution study of pretreated patients. The study time frame was the 2015 calendar year: 9 months before the drug was approved in September 2015, when patients received the medication through a compassionate-use program, and the 3 months immediately after drug approval. First-cycle antiemetic prescribing was examined for adherence to National Comprehensive Cancer Network Guidelines (v1.2015) and categorized as guideline adherent, non-guideline-adherent/aggressive (received more prophylaxis than called for), and non-guideline-adherent/less aggressive (including no antiemetics). Results: Of the 44 patients in this study, 28 (64%) had had nausea and vomiting with previous chemotherapy. With the first cycle of trifuridine-tipiracil, 25 patients (57%; 95% confdence interval [CI]: 42%, 70%) were prescribed prophylactic antiemetics in a guideline-adherent manner; 15 (34%; 95% CI: 22%, 49%) in a non-guideline-adherent/aggressive manner; and 4 (9%; 95% CI: 4%, 21%) in a non-guideline-adherent/less aggressive manner. In guideline-adherent patients, rates of nausea and vomiting were 52% and 24%, respectively. In non-guideline-adherent/aggressive patients, those rates were 33% and 27%, respectively. In both the aforementioned groups, a total of 2 patients received interim care for nausea and vomiting. No nausea or vomiting was reported among non-guideline-adherent/less aggressively managed patients. Limitations: Single-institution, retrospective study of a small group of patients Conclusions: Poor adherence to antiemetic guidelines was common. However, because adherence was not consistently associated with better control of nausea and vomiting, clinical judgment should complement guideline adherence when prescribing trifuridine-tipiracil and other newly approved cancer drugs.

Original languageEnglish (US)
Pages (from-to)e142-e146
JournalJournal of Community and Supportive Oncology
Volume15
Issue number3
DOIs
StatePublished - Jun 1 2017

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Antiemetics
Guidelines
Nausea
Vomiting
Drug Therapy
Pharmaceutical Preparations
Compassionate Use Trials
Guideline Adherence
Drug Approval
Neoplasms
United States Food and Drug Administration
Colonic Neoplasms
Retrospective Studies

ASJC Scopus subject areas

  • Hematology
  • Oncology

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Prescriber adherence to antiemetic guidelines with the new agent trifuridine-tipiracil. / Childs, Daniel S.; Jacobson, Alison C.; Mitchell, Jessica L.; Hubbard, Joleen M; Yoon, Harry H; Finnes, Heidi; Grothey, Axel F; Jatoi, Aminah.

In: Journal of Community and Supportive Oncology, Vol. 15, No. 3, 01.06.2017, p. e142-e146.

Research output: Contribution to journalArticle

Childs, Daniel S. ; Jacobson, Alison C. ; Mitchell, Jessica L. ; Hubbard, Joleen M ; Yoon, Harry H ; Finnes, Heidi ; Grothey, Axel F ; Jatoi, Aminah. / Prescriber adherence to antiemetic guidelines with the new agent trifuridine-tipiracil. In: Journal of Community and Supportive Oncology. 2017 ; Vol. 15, No. 3. pp. e142-e146.
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abstract = "Background: In 2015 alone, the US Food and Drug Administration approved 18 cancer drugs, but to our knowledge, few studies, if any, have examined prescribers' adherence to antiemetic guidelines as new chemotherapy agents become available. This issue is important because poor adherence to antiemetic guidelines has been shown in previous studies to have a negative impact on the control of nausea and vomiting. Here we report on antiemetic practices and outcomes for trifuridine-tipiracil, a drug newly approved in 2015. Objective: To test the hypothesis that patients prescribed a newly available chemotherapy agent, trifuridine-tipiracil, are at risk for chemotherapy-induced nausea and vomiting because of providers' poor adherence to antiemetic guidelines. Methods: All patients who received their first dose of trifuradine-tipiracil for metastatic colon cancer in 2015 were included in this retrospective, single-institution study of pretreated patients. The study time frame was the 2015 calendar year: 9 months before the drug was approved in September 2015, when patients received the medication through a compassionate-use program, and the 3 months immediately after drug approval. First-cycle antiemetic prescribing was examined for adherence to National Comprehensive Cancer Network Guidelines (v1.2015) and categorized as guideline adherent, non-guideline-adherent/aggressive (received more prophylaxis than called for), and non-guideline-adherent/less aggressive (including no antiemetics). Results: Of the 44 patients in this study, 28 (64{\%}) had had nausea and vomiting with previous chemotherapy. With the first cycle of trifuridine-tipiracil, 25 patients (57{\%}; 95{\%} confdence interval [CI]: 42{\%}, 70{\%}) were prescribed prophylactic antiemetics in a guideline-adherent manner; 15 (34{\%}; 95{\%} CI: 22{\%}, 49{\%}) in a non-guideline-adherent/aggressive manner; and 4 (9{\%}; 95{\%} CI: 4{\%}, 21{\%}) in a non-guideline-adherent/less aggressive manner. In guideline-adherent patients, rates of nausea and vomiting were 52{\%} and 24{\%}, respectively. In non-guideline-adherent/aggressive patients, those rates were 33{\%} and 27{\%}, respectively. In both the aforementioned groups, a total of 2 patients received interim care for nausea and vomiting. No nausea or vomiting was reported among non-guideline-adherent/less aggressively managed patients. Limitations: Single-institution, retrospective study of a small group of patients Conclusions: Poor adherence to antiemetic guidelines was common. However, because adherence was not consistently associated with better control of nausea and vomiting, clinical judgment should complement guideline adherence when prescribing trifuridine-tipiracil and other newly approved cancer drugs.",
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AU - Childs, Daniel S.

AU - Jacobson, Alison C.

AU - Mitchell, Jessica L.

AU - Hubbard, Joleen M

AU - Yoon, Harry H

AU - Finnes, Heidi

AU - Grothey, Axel F

AU - Jatoi, Aminah

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N2 - Background: In 2015 alone, the US Food and Drug Administration approved 18 cancer drugs, but to our knowledge, few studies, if any, have examined prescribers' adherence to antiemetic guidelines as new chemotherapy agents become available. This issue is important because poor adherence to antiemetic guidelines has been shown in previous studies to have a negative impact on the control of nausea and vomiting. Here we report on antiemetic practices and outcomes for trifuridine-tipiracil, a drug newly approved in 2015. Objective: To test the hypothesis that patients prescribed a newly available chemotherapy agent, trifuridine-tipiracil, are at risk for chemotherapy-induced nausea and vomiting because of providers' poor adherence to antiemetic guidelines. Methods: All patients who received their first dose of trifuradine-tipiracil for metastatic colon cancer in 2015 were included in this retrospective, single-institution study of pretreated patients. The study time frame was the 2015 calendar year: 9 months before the drug was approved in September 2015, when patients received the medication through a compassionate-use program, and the 3 months immediately after drug approval. First-cycle antiemetic prescribing was examined for adherence to National Comprehensive Cancer Network Guidelines (v1.2015) and categorized as guideline adherent, non-guideline-adherent/aggressive (received more prophylaxis than called for), and non-guideline-adherent/less aggressive (including no antiemetics). Results: Of the 44 patients in this study, 28 (64%) had had nausea and vomiting with previous chemotherapy. With the first cycle of trifuridine-tipiracil, 25 patients (57%; 95% confdence interval [CI]: 42%, 70%) were prescribed prophylactic antiemetics in a guideline-adherent manner; 15 (34%; 95% CI: 22%, 49%) in a non-guideline-adherent/aggressive manner; and 4 (9%; 95% CI: 4%, 21%) in a non-guideline-adherent/less aggressive manner. In guideline-adherent patients, rates of nausea and vomiting were 52% and 24%, respectively. In non-guideline-adherent/aggressive patients, those rates were 33% and 27%, respectively. In both the aforementioned groups, a total of 2 patients received interim care for nausea and vomiting. No nausea or vomiting was reported among non-guideline-adherent/less aggressively managed patients. Limitations: Single-institution, retrospective study of a small group of patients Conclusions: Poor adherence to antiemetic guidelines was common. However, because adherence was not consistently associated with better control of nausea and vomiting, clinical judgment should complement guideline adherence when prescribing trifuridine-tipiracil and other newly approved cancer drugs.

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