Furukawa, N., Kanayama, S., Tanase, Y., & Ito, F. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin. Supportive Care in Cancer, 23, 3317–3322. 

DOI Link

Study Purpose

To evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 versus 3 of Decadron in patients with gynecologic cancer receiving carboplatin and paclitaxel (TC); to evaluate the efficacy of a one-day versus three-day Decadron regimen (primary endpoint was complete response in the delayed phase)

Intervention Characteristics/Basic Study Process

All patients received an intravenous prophylactic of Decadron at 20 mg within 15 minutes of a PAL dose of 0.75 mg 30 minutes before chemotherapy. Patients in the DEX1 arn received no further Decadron. Patients in the DEX3 arm received Decadron on days 2 and 3 at 8 mg.

Sample Characteristics

  • N = 88  
  • AVERAGE AGE = 59 years (DEX1), 62 years (DEX3)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian, cervical, and endometrial cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were receiving paclitaxel and carboplatin. All participants were chemotherapy-naïve.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care and palliative care 

Study Design

Single-institution, prospective, randomized, open-label study

Measurement Instruments/Methods

  • Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) for data collection in the first cycle
  • The primary endpoint was complete response (CR) defined as no emetic episodes and no rescue medication in the delayed phase of the first cycle.
  • The secondary endpoint was CR in the acute and in all phases of chemotherapy-induced nausea and vomiting (CINV). Complete control (CC) defined as no emetic episodes, no use of rescue medications, and no significant nausea defined as a MAT score less than 3.

Results

The authors noted that there was no significant difference between groups in complete response, complete control, or total CINV in the acute and delayed phases. There was no significant difference between groups in the rate of severe nausea. The CR rates in the delayed phase were not statistically different in the three-day group (76.9%) versus the one-day group (69.8%). The use of palonosetron and Decadron appears to be equally effective in treatment of delayed CINV for patients receiving paclitaxel and carboplatin.

Conclusions

The use of Decadron was effective with one-day use compared to three-day use. The side effect profile of steroids is very robust, meaning that fewer days of their usage with good control could improve patients' quality of life.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding) 
  • Risk of bias(sample characteristics)
  • Findings not generalizable
  • Other limitations/explanation: The homogenous population in Japan would affect drug metabolism.

Nursing Implications

Based on the results of this study, dexamethasone is effective after only one day of use compared to three days of use. The side effect profile of steroids is robust, so fewer days of their use with adequate CINV control could improve patients' quality of life.