Single Agent Dexamethasone

Single Agent Dexamethasone

PEP Topic 
Chemotherapy-Induced Nausea and Vomiting—Adult
Description 

Dexamethasone is a corticosteroid. Corticosteroids, as single agents, are recommended as an antiemetic regimen in low-emetogenic chemotherapy (LEC) and have been examined for effect on fatigue.

Likely to Be Effective

Research Evidence Summaries

Hayashi, T., Ikesue, H., Esaki, T., Fukazawa, M., Abe, M., Ohno, S., … Oishi, R. (2012). Implementation of institutional antiemetic guidelines for low emetic risk chemotherapy with docetaxel: A clinical and cost evaluation. Supportive Care in Cancer, 20, 1805–1810.

doi: 10.1007/s00520-011-1278-6
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Study Purpose:

To evaluate the effect of implementation of institutional guidelines (12 mg dexamethasone alone) for low-emetic risk chemotherapy with docetaxel and to estimate the cost savings for all low-emetic risk chemotherapies in a year

Intervention Characteristics/Basic Study Process:

All patients with breast cancer received either four courses of FEC therapy  (500 mg/m5-fluorouracil, 100 mg/mepirubicin, and 500 mg/mcyclophosphamide) or EC therapy (100 mg/mepirubicin and 600 mg/mcyclophosphamide, every 21 days) followed by adjuvant docetaxel therapy (70–75 mg/m2) every 21 days for four cycles.

Before implementation of the institutional antiemetic guidelines, group one (41 patients, 151 courses) received 4 mg ondansetron plus 8 mg IV dexamethasone 30 minutes before treatment with docetaxel.

After implementation of the guidelines, group two (56 patients, 205 courses) received 12 mg dexamethasone only. In both groups, 4 mg oral dexamethasone was given twice a day on days 2 and 3 of docetaxel therapy for prevention of docetaxel-related fluid retention.

Effectiveness and adverse effects were compared between groups. With patients who received dexamethasone and ondansetron, investigators evaluated incidence of nausea, vomiting, and adverse reactions with docetaxel retrospectively in the medical records. 

Additionally, a cost minimization analysis was performed to assess the economic impact of implementing institutional antiemetic guidelines. The cost comparison looked at 4 mg ondansetron + 8 mg dexamethasone + 100 ml normal saline versus 12 mg dexamethasone + 100 ml normal saline plus the time to prepare the antiemetic guidelines, attending committee, and change order sets.

Sample Characteristics:

  • The study reported on 97 patients (41 in group one and 56 in group two).
  • The mean age in group one was 50.2 years (SD = 11.6 groups). The mean age in group two was 50.8 years (SD = 8.9 years).
  • The percentage of males and females was not indicated.
  • All patients were diagnosed with breast cancer.
  • No significant characteristic differences were observed between the groups before or after implementation of the institutional guidelines.

Setting:

This study was conducted at a single site, the National Hospital Organization Kyushu Cancer Center (NKCC) in Fukuoka, Japan.

Phase of Care and Clinical Applications:

All patients were in active treatment. This study has applications for late effects and treatment.

Study Design:

This was a retrospective cohort study.

Measurement Instruments/Methods:

The Common Terminology Criteria for Adverse Events, version 3.0, was used to grade adverse drug reactions.

Results:

  • Overall, 97 patients were observed during 356 treatments either before or after implementation of the institutional guidelines (ondansetron + 8 mg dexamethasone versus 12 mg dexamethasone alone).
  • Nausea (19.5% in group one versus 16.1% in group two) and vomiting (2.4% in group one versus 0% in group two) occurred in both groups; however, no significant differences in the incidence of emesis were found between the two groups.
  • Although anticipated to be higher in the dexamethasone group, no differences were found between the groups in incidence of constipation (34.1% in group one versus 30.4% in group two) or insomnia (17.1% in group one versus 17.9% in group two).
  • The cost of ondansetron + 8 mg dexamethasone ($68) decreased to $7.50 with 12 mg dexamethasone.
  • Considerable savings occurred between the two groups when ondansetron was eliminated from the low risk antiemetic guidelines.

Conclusions:

Dexamethasone alone (12 mg) appeared to be as effective in preventing nausea and vomiting as ondansetron and dexamethasone (8 mg) in low-risk emetic chemotherapy with docetaxel, and it was more cost effective.

Limitations:

  • This was not a prospective, randomized, or blinded study
  • Outcomes were only evaluated with adjuvant docetaxel therapy for patients with breast cancer and not with other low-emetic risk drugs.
  • Adverse reactions caused from the antiemetics were evaluated from medical records.
  • Whether 12 mg of dexamethasone is optimal could not be determined from the study.

Nursing Implications:

The use of 12 mg dexamethasone alone for low-risk ematogenic antineoplastic therapies such as docetaxel is recommended in the literature, has shown reasonable effectiveness for preventing nausea and vomiting, and is economically advantageous.

Kawazoe, H., Motoki, Y., Takechi, Y., Shishino, Y., Ido, K., Suemaru, K., & Araki, H. (2010). Comparison of antiemetic efficacy between single and repeat treatment with dexamethasone in patients receiving carboplatin-based combination chemotherapy. Methods and Findings in Experimental and Clinical Pharmacology, 32(7), 499-505.

doi: 10.1358/mf.2010.32.7.1501438
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Study Purpose:

To assess the preventive effects of single and repeat treatment with dexamethasone on delayed nausea and vomiting in patients receiving carboplatin-based chemotherapy

Intervention Characteristics/Basic Study Process:

  • The study was carried out using the Ehime University Hospital electronic health record.
  • It consisted of 64 patients with various malignancies who had been treated with carboplatin-based combination chemotherapy. 
  • Chemotherapy-induced nausea and vomiting (CINV) assessment was conducted three times a day for the first five days after the chemotherapy cycle began, using the nausea and emesis score and food intake score.  
  • The frequency of need for rescue antiemetics also was assessed.

Sample Characteristics:

  • The study consisted of 64 patients.
  • The mean age was 59 years for the Repeat Treatment group and 62 years for the Single Treatment group. 
  • Race was not included in the sample description.
  • Just over half of the patients were male (57%).
  • Patients were diagnosed primarily with lung and ovarian cancers.
  • Patients were excluded if they had complications such as brain metastases that might induce nausea or vomiting, hepatic failure, or ulcerative diseases; were receiving drugs that affect nausea and vomiting (e.g., major or minor tranquilizers, corticosteroids given for other reasons than prevention of CINV); were receiving concomitant radiation therapy; or were receiving total parenteral nutrition (TPN).

Setting:

This was a single-site study conducted at an inpatient setting in Ehime, Japan.

Phase of Care and Clinical Applications:

  • All patients were in active treatment.
  • The study has applications for late effects and survivorship.

Study Design:

This was a retrospective, observational study.

Measurement Instruments/Methods:

  • Nausea and emesis was rated on a five-point scale (1 = absent,  3 = nausea, 5 = emesis).
  • Food intake was rated on a five-point scale (5 = complete intake, 3 = partial meal, 1 = missed meal because of nausea and vomiting).
  • Frequency of need for rescue antiemetics was recorded.

Results:

  • Demographic data was very different for the two groups. The Repeat Treatment Group was comprised of all women with gynecologic cancers. The Single Treatment group was mostly lung cancer, and 71% of the group were male. Data from both groups demonstrated that nausea and vomiting was well controlled on Day 1. The Single Treatment group received almost all placlitaxel, while the Repeat Treatment Group received docetaxel. No patients in the Single Treatment group experienced emesis, and only two subjects experienced emesis in the Repeat Treatment group.
  • A significant negative correlation was found between the total nausea and vomiting scores and food intake scores on days 2–5.
  • Almost half of the patients (45%) required antiemetics. The frequency of need for rescue antiemetics overall was significantly less in the Repeat Treatment group (26.9%) compared to the Single Treatment group (57.9%).
  • Overall response was 0.268 (CI = 0.091–0.789, p = 0.015).

Conclusions:

  • The authors stated that repeat treatment of dexamethasone may be more effective than single-dose dexamethasone for prevention of delayed CINV (after 24 hours) for patients treated with carboplatin-based combination chemotherapy.
  • The Repeat Treatment Group, which consisted of all women treated with multiple doses of dexamethasone, experienced less delayed CINV, as defined by the need for rescue antiemetics.
  • Results would need to be confirmed in a larger, prospective clinical trial.

Limitations:

  • This retrospective study design relied on the accurate documentation of events by others.
  • This study had a small sample size of 64 subjects, with even smaller groups for comparison study.
  • The groups were not heterogenous, making comparison difficult. The only constant was the use of carboplatin-based combination chemotherapy.
  • All patients were not chemotherapy naïve. History of previous CINV, smoking history, or motion sickness was not described.
  • Measurement scales combining nausea and vomiting are not precise enough to know magnitude of nausea.

Nursing Implications:

Patients treated with carboplatin-based combination chemotherapy may benefit from a daily dose of dexamethasone for three days following initiation of chemotherapy.

Tsukuda, M., Ishitoya, J., Mikami, Y., Matsuda, H., Katori, H., Horiuchi, C., … Toth, G. (2009). Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: Dexamethasone dosage verification trial. International Journal of Clinical Oncology, 14, 337–343.

doi: 10.1007%2Fs10147-008-0874-z
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Study Purpose:

To determine the optimal dose of dexamethasone in combination with granisetron for chemotherapy-induced nausea and vomiting (CINV) control with cisplatin-containing chemotherapy

Intervention Characteristics/Basic Study Process:

Patients were randomized to either receive 8 mg dexamethasone before chemotherapy and 24, 48, and 72 hours after chemotherapy during cycle 1, and 16 mg dexamethasone at the same time periods with cycle 2 of chemotherapy (8 mg antecedent group), or dosing of dexamethasone in the opposite sequence. All patients also received 3 mg granisetron with each dexamethasone administration. Physicians had discretion to provide addition treatment in cases of extreme nausea or vomiting. Symptoms were evaluated daily for 5 days.

Sample Characteristics:

  • The study consisted of 36 participants.
  • Age was not reported.
  • The sample was 33% female and 77% male.
  • All patients had head and neck cancers, with the most prevalent being hypopharyngeal.
  • The majority of patients (83%) were chemotherapy naïve.

Setting:

The study was conducted at a single site in Japan.

Phase of Care and Clinical Applications:

All patients were in active treatment.

Study Design:

This was a randomized crossover trial.

Measurement Instruments/Methods:

  • The National Cancer Institute's (NCI) Common Terminology Criteria (CTC) version 2.0 for appetite loss was used.
  • Nausea grade was defined in terms of number of vomiting episodes and ability to ingest liquids.
  • Complete response was defined as no occurrence of nausea and zero instances of vomiting or retching.

Results:

Overall efficacy rates ranged from 47.2% on day 5 to 88.9% on day 1. No differences were found at any time point between groups.

Conclusions:

No difference was found in antiemetic effect between 8 mg and 16 mg dexamethasone dosing.

Limitations:

  • The sample size was small.
  • The antiemetic regimen did not contain all recommended medications.
  • Use of rescue medications was not discussed nor included in the definition of complete response.
  • Whether the study team conducted nausea grading or it was based on patient reports was not clear.
  • Nausea was defined in terms of vomiting rather than a symptom itself.

Nursing Implications:

The study suggests that lower dosages of dexamethasone may be as effective as higher doses for CINV management. Further research in this area is needed. Lower dosing may help to reduce potential side effects of steroids.

Guideline/Expert Opinion

Olver, I., Clark-Snow, R.A., Ballatori, E., Espersen, B.T., Bria, E., & Jordan, K. (2011). Guidelines for the control of nausea and vomiting with chemotherapy of low or minimal emetic potential. Supportive Care in Cancer, 19(Suppl 1), S33–S36.

doi: 10.1007/s00520-010-0985-8
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Purpose & Patient Population:

To review the Multinational Association of Supportive Care in Cancer (MASCC) guidelines for low- or minimal-emetic potential anticancer agents

Type of Resource/Evidence-Based Process:

Experts from MASCC met in Perugia in 2009 to revise the MASCC consensus guideline.

Searched keywords were antiemetic, low, minimal, guidelines, chemotherapy, dexamethasone, 5-HT3 receptor antagonists, and dopamine receptor antagonists

Studies were included in the review if they involved chemotherapeutic agents with low or minimal emetic potential.

Studies were excluded from the review if they involved agents with moderate or high emetic potential.

Phase of Care and Clinical Applications:

The guidelines apply to multiple phases of care.

This review has applications for elderly and palliative care.

Guidelines & Recommendations:

For chemotherapy with minimal emetic potential, the following is recommended.

  • No antiemetic prophylaxis should be given in patients with no prior history of nausea and vomiting.
  • Single-agent dexamethasone, 5-HT3, or dopamine receptor antagonists should be given for nausea and vomiting.


For chemotherapy with low emetic potential, single-agent dexamethasone, 5-HT3, or dopamine receptor antagonists should be administered.

Nursing Implications:

More data is needed on the emetic potential and outcomes related to newer agents in oncology. A lack of clinical data is available on the emetic potential of some agents (e.g., cytotoxics, newer targeted agents), and the emetic potential has not been divided into acute or delayed.


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