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

Ando 2016.

Study characteristics
Methods Randomised, controlled study with 2 arms
  • comparison of aprepitant + palonosetron or granisetron or azasetron + dexamethasone vs fosaprepitant meglumine + palonosetron or granisetron or azasetron + dexamethasone


Recruitment period: January 2013 to March 2014
  • 101 patients enrolled

  • 93 patients randomised


Masking: open‐label
Baseline patient characteristics: reported
Follow‐up: n.r.
Participants Inclusion criteria
  • Japanese patients who started to receive chemotherapy including cisplatin (CDDP) (≥ 60 mg/m²)


Exclusion criteria
  • nausea or vomiting within 24 h before start of administration of antineoplastic drugs

  • could not receive a drug orally

  • could not answer the questionnaire

  • did not provide consent

  • considered unsuitable for this study


Mean age ± SD, years: 61.7 ± 11.7 in aprepitant group, 65.4 ± 10.0 in fosaprepitant group
Gender: male (74) + female (19)
Tumour/cancer type: malignant tumour (lung cancer, gastric cancer, oesophageal cancer, head and neck cancer)
Chemotherapy regimen: CDDP (60 mg/m² or higher)
Country: Japan (single centre)
Interventions Experimental: arm A: aprepitant
Day 1: aprepitant 125 mg + palonosetron 0.75 mg or granisetron 3 mg or azasetron 10 mg + dexamethasone 6.6 to 9.9 mg
Days 2 to 4: aprepitant 80 mg + dexamethasone 3.3 to 6.6 mg
Day 5: aprepitant 80 mg
Experimental: arm B: fosaprepitant
Day 1: fosaprepitant meglumine 150 mg + palonosetron 0.75 mg or granisetron 3 mg or azasetron 10 mg + dexamethasone 6.6 to 9.9 mg
Days 2 to 4: dexamethasone 3.3 to 6.6 mg
Outcomes Primary endpoint
  • complete response rate


Secondary endpoint(s)
  • complete control rate

Notes
  • no funding for this work was received

  • study authors declare that they have no conflicts of interest

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomised trial but method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Comment: no allocation concealment reported
Blinding of participants and personnel (performance bias)
Blinding of participants High risk Quote: "... open‐label ..."
Blinding of participants and personnel (performance bias)
Blinding of personnel High risk Quote: "... open‐label ..."
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 Comment: all randomised patients were included in the analysis
Selective reporting (reporting bias) Unclear risk Comment: in the results section, palonosetron, granisetron, and azasetron were not separately reported
Other bias Low risk Comment: no information to suggest other sources of bias