Oyama, K., Fushida, S., Kaji, M., Takeda, T., Yabushita, K., Nezuka, H., . . . Ohta, T. (2015). Evaluation of the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with gastric cancer treated with S-1 plus cisplatin. International Journal of Clinical Oncology, 21, 483–490. 

DOI Link

Study Purpose

To examine the efficacy of palonosetron, dexamethasone, and aprepitant to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with gastric cancer receiving S-1 (oral 5-fluorouracil analog) and cisplatin

Intervention Characteristics/Basic Study Process

  • Day 1: 125 mg aprepitant PO 60 minutes prior to chemotherapy, then 9.9 mg dexamethasone IV and 0.75 mg palonosetron IV 30 minutes prior to chemotherapy
  • Days 2 and 3: 80 mg aprepitant PO QAM and 8 mg dexamethasone PO BID
  • Day 4: 8 mg dexamethasone PO BID
  • Throughout observation: Rescue antiemetic as needed
  • Vomiting, retching, changes in dietary intake, and impact on quality of life were measured for 120 hours post administration of cisplatin.

Sample Characteristics

  • N = 72, 70 patients completed Functional Living Index-Emesis (FLIE) questionnaires   
  • AGE = 50–81 years
  • MEDIAN AGE = 65 years
  • MALES: 80.6%, FEMALES: 19.4%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Gastric cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Sixty-five patients had received previous chemotherapy, and no patients had a history of CINV.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • This was a prospective, observational, noncomparative study.

Measurement Instruments/Methods

From the administration of cisplatin until 120 hours post administration, patients kept a diary, recording frequency and timing of vomiting or retching, frequency and timing of rescue antiemetics, and the degree of nausea. On days 1–5, patients also recorded dietary intake as a percent volume of diet compared to dietary intake prior to chemotherapy administration. 
 
To assess the impact of CINV on their daily lives, patients completed the FLIE questionnaire daily on days 1–5. The FLIE is an 18-item visual analog scale with separate domains for nausea and vomiting. Each question is rated from 7–1, with a higher score indicating no impact on daily function. A total score greater than 108 or a domain score greater than 54 indicates minimal or no affect of CINV on quality of life.

Results

Fifty-five patients (78.6%) had a total FLIE score greater than 108, indicating no or minimal affect of CINV on quality of life. Fifty-four patients (77.1%) had a nausea domain score greater than 54, and sixty-six patients (91.6%) had a vomiting domain score greater than 54, indicating little to no affect on quality of life.
 
Complete response (CR), defined as the absence of emesis and nonuse of anti-emetics, was observed in 97.2% of patients 0–24 hours post administration of cisplatin and 91.6% of patients 24–120 hours post administration of cisplatin. Complete protection, defined as nonsignificant nausea and nonuse of anti-emetics, was observed in 84.7% of patients 0–24 hours post administration of cisplatin and 68.1% of patients 24–120 hours post administration of cisplatin.
 
Dietary intake decreased each day, with some degree of anorexia seen in almost half the patients. By day 5, only 44.4% of patients were consuming 70%–100% of normal dietary intake and 5.6% of patients did not consume any food or drink.

Conclusions

Patients with gastric cancer who received S-1 and cisplatin tolerated palonosetron and dexamethasone. When compared to a previous study in a similar population who received aprepitant, granisetron, and dexamethasone, no significant differences existed in the CR rate, complete protection, dietary intake, or quality of life.

Limitations

  • Small sample (< 100)

 

Nursing Implications

The CR rate and complete protection were observed in the majority of patients with gastric cancer on S-1 and cisplatin who received antiemetic prophylaxis with palonosetron and dexamethasone. Although CINV did not significantly affect the quality of life in most patients, dietary intake decreased during the five-day observation time.