Keat, C.H., Phua, G., Abdul Kassim, M.S., Poh, W.K., & Sriraman, M. (2013). Can granisetron injection used as primary prophylaxis improve the control of nausea and vomiting with low- emetogenic chemotherapy? Asian Pacific Journal of Cancer Prevention: APJCP, 14, 469–473.

DOI Link

Study Purpose

To examine differences in incidence and risk of chemotherapy-induced nausea and vomiting (CINV) among patients receiving low emetogenic chemotherapy (LEC) with or without prophylactic granisetron 

Intervention Characteristics/Basic Study Process

The first cohort of patients received 8 mg IV bolus dexamethasone or 10 mg metachloepramide. The second cohort also was given 3 mg IV bolus of granisetron.  Both groups were given dexamethasone (2-4 mg twice daily) or metochlopramide (10 mg three times daily) tablets to be taken for three days after chemotherapy. CINV was evaluated for 120 hours, days 1–5 after chemotherapy.

Sample Characteristics

  • The study consisted of 94 patients.
  • Mean age of patients was 53.4 years.
  • The sample was 51% male and 48% female.
  • Disease types were not described.
  • Drugs used in chemotherapy were gemcitabine, vinorelbine, fluorouracil, and docetaxel.
  • The percentage of patients who were chemotherapy naïve was 19% in both groups.

Setting

The study was conducted at a single outpatient site in Malaysia.

Phase of Care and Clinical Applications

All patients were in active, antitumor treatment.

Study Design

This was a two-group cohort, observational trial.

Measurement Instruments/Methods

  • Patients recorded emesis in diaries using a rating system adapted from the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool.
  • Complete control was defined as no nausea or vomiting and no use of rescue medication.

Results

Those who received granisetron had lower rates of acute and delayed nausea and emesis. The only significant difference between groups was in the prevalence of acute emesis; 3.9% of those who received granisetron experienced acute emesis versus 19% of those who did not receive granisetron (p = 0.017). No differences were found between groups in complete control rates in either the acute or delayed phases. With analysis controlling for covariates influencing CINV, those receiving granisetron had a lower risk of CINV (overall response [OR] = 0.1, 95% confidence interval [CI] = 0.02–0.85, p = 0.034).

Conclusions

Patients receiving granisetron in addition to antiemtic regimens recommended for LEC had a lower incidence of acute emesis, but no effect was found on delayed phase symptoms or acute nausea.

Limitations

  • The sample size was small with fewer than 100 patients.
  • A risk of bias exists because no blinding or random assignment was used.

Nursing Implications

Common recommendations for CINV prophylaxis with LEC do not include the use of neurokinin 1 (NK1) or 5-HT3 medications but, rather, rely primarily on the use of increased dexamethasone dosage for control. This study examined the addition of a 5-HT3 to an LEC antiemetic regimen and demonstrated a significant improvement in acute emesis. Granisetron is more costly than a single-agent antiemetic regimen such as dexamethasone, so additional antiemetic use is seen as controversial or “overtreatment.” Nurses can advocate for consideration of aggressive prevention of CINV to minimize the adverse patient experience with chemotherapy, balanced with recognition of potential cost burdens to the patient. As shown in many other studies, control of nausea (rather than emesis) remains challenging. The strength of findings in this study are limited by the study design. Further well-designed research in this area is warranted.