Deauna-Limayo, D., Aljitawi, O.S., Ganguly, S., Abhyankar, S., Wick, J.A., & McGuirk, J.P. (2014). Combined use of multiday palonosetron with aprepitant and low-dose dexamethasone in prevention of nausea and emesis among patients with multiple myeloma and lymphoma undergoing autologous hematopoietic stem cell transplant: A pilot study. Journal of Oncology Pharmacy Practice, 20, 263–269.

DOI Link

Study Purpose

To assess emetic responses to multiday palonosetron, aprepitant, and low-dose dexamethasone among patients treated with pretransplant regimens for multiple myeloma and lymphoma prior to undergoing stem cell transplantation

Intervention Characteristics/Basic Study Process

Oral aprepitant with IV dexamethasone and palonosetron was administered on days -3, -2, -1 for multiple myeloma and days -7 through -5 for patients with lymphoma. The patients with lymphoma also received IV dexamethasone and palonosetron on days -4 and -3.  Palonosetron was repeated on third post transplant day. Patients with multiple myeloma were given melphalan, and patients with lymphoma received BCNU, etoposide, cytarabine, and melphalan with or without rituximab. Patients with multiple myeloma completed questionnaires on days -2, -1, +3, and +7. Patients with lymphoma completed questionnaires on days -6 through -2 and on days +3 and +7. The Common Terminology Criteria for Adverse Events version 3 wascused to evaluate nonhematologic toxicities.

Sample Characteristics

  • N = 18  
  • AVERAGE AGE = Multiple myeloma group: 60 years (range = 53–66 years), lymphoma group: 48 years (range = 35–60 years)
  • MALES: 61%, FEMALES: 39%
  • KEY DISEASE CHARACTERISTICS: Six out of nine patients with multiple myeloma reported using pain medications at time of transplantation.
  • OTHER KEY SAMPLE CHARACTERISTICS: Most subjects were Caucasian with Karnofsky Performance statuses greater than 60. 

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University of Kansas Medical Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Nonrandomized, prospective, descriptive cohort design

Measurement Instruments/Methods

  • Emetic response was assessed by daily patient diaries and the MASCC Antiemesis Tool (MAT).
  • Nausea was measured by a 10-point Visual Analog Scale (VAS)
  • The Osoba modules were modified by removing retching from the nausea module and adding it to the emetic module.  
  • The modified Osoba modules were used to assess impact of CINV on overall quality of life.

Results

Complete control (CC) was achieved in the acute phase by 55% of patients with multiple myeloma and 100% of patients with lymphoma for a combined acute phase CC of 78%. In the delayed phase, CC fell to 22% in the multiple myeloma group and 44% in the lymphoma group. In the extended phase, CC fell to 11% and 22%, respectively. No complete emetic response was noted in either group, and no patients experienced more than five emetic episodes with a 24-hour period. They reported no significant nausea in the acute phase although they could not report on nausea in the delayed and extended phases because of missing data. Overall nausea remained a major problem with 78% of all patients developing some level of nausea.

Conclusions

Nausea and vomiting continued to be problematic for both groups in the post-transplant period, and these data were correlated with worsening Osoba scores. This drug combination was safe, feasible, and effective in the acute phase of CINV. However, other strategies are needed to treat patients scheduled for stem cell transplants.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)

 

Nursing Implications

The results of this study were not strong enough to influence treatment protocols. However, the study did underscore the need to assess patients receiving stem cell transplantations for at least a week for CINV.