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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

Fujiwara 2015.

Study characteristics
Methods Randomised, prospective, cross‐over, comparative study with 2 arms
  • comparison of aprepitant + palonosetron + dexamethasone vs aprepitant + granisetron + dexamethasone


Enrolment period: January 2011 to January 2012
  • 38 patients enrolled


Masking: open‐label
Baseline patient characteristics: reported
Follow‐up: n.r.
Participants Inclusion criteria
  • female patients older than 20 years of age with histologically confirmed gynaecological cancer scheduled to receive a TC regimen

  • ECOG performance status 0 to 2

  • meeting the following laboratory criteria: aspartate aminotransferase and alanine aminotransferase levels ≤ 2.5 × the ULN range at the facility; total bilirubin level ≤ 1.5 × the ULN range at the facility; and creatinine level ≤ 1.5 × the ULN range at the facility


Exclusion criteria
  • history of hypersensitivity to 5‐HT₃ receptor antagonists or dexamethasone

  • risk of vomiting for other reasons (e.g. symptomatic brain metastasis, active peptic ulcer, gastrointestinal obstruction)


Median age (range), years: 57.5 (36 to 76)
Gender: female (38)
Tumour/cancer type: gynaecological cancer (endometrial cancer, cervical cancer, ovarian or tubal cancer, double endometrial and ovarian cancer)
Chemotherapy regimen: TC regimen (paclitaxel and carboplatin)
Country: Japan (single centre)
Interventions Cross‐over study
Experimental: arm A: palonosetron
Day 1: aprepitant 125 mg p.o. + palonosetron 0.75 mg i.v. + dexamethasone 20 mg i.v.
Days 2 to 3: aprepitant 80 mg p.o. + dexamethasone 4 mg p.o.
Experimental: arm B: granisetron
Day 1: aprepitant 125 mg p.o. + granisetron 3 mg i.v. + dexamethasone 20 mg i.v.
Days 2 to 3: aprepitant 80 mg p.o. + dexamethasone 4 mg p.o.
Outcomes Primary endpoint
  • complete response rate during acute (Day 1, 0 to 24 hours) and delayed periods (Days 2 to 7)


Secondary endpoint(s)
  • change in dietary intake in both acute and delayed periods

Notes
  • this work was supported by a JSPS KAKENHI Grant, Number 25462621 (to Y. Terai)

  • "no potential conflict of interest relevant to this article was reported"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the group assignment was performed by simple randomization using a table of random numbers and patients were informed of which group (arm A or B) they were assigned"
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not reported
Blinding of participants and personnel (performance bias)
Blinding of participants High risk Quote: "... non‐blinded ..."
Blinding of participants and personnel (performance bias)
Blinding of personnel High risk Quote: "... non‐blinded ..."
Blinding of outcome assessment (detection bias)
Subjective outcomes (Patient reported outcomes) High risk Comment: patients and personnel were not blinded towards the intervention and therefore might influence subjective outcomes analysis
Incomplete outcome data (attrition bias)
Subjective outcomes (Patient reported outcomes) Low risk Quote: "the intent‐to‐treat population included 19 patients who received palonosetron on Day 1 (Arm A) and 19 patients who received granisetron on Day 1 (Arm B)"
Selective reporting (reporting bias) Low risk Comment: all outcome measures were reported in the results section
Other bias Low risk Comment: no information to suggest other sources of bias