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. 2021 Dec 6;2021(12):CD011300. doi: 10.1002/14651858.CD011300.pub3

Fujisawa 1996.

Study characteristics
Methods Japanese RCT
Participants Number of participants: 82 (between 1986 and 1990)
Number randomised
  • Experimental group (surgery + TF + N‐CWS): 41

  • Control group (surgery only): 41


Number evaluated
  • Experimental group: 41

  • Control group: 41


Diagnosis: patients with NSCLC who had undergone a complete resection and mediastinal lymph node dissection
Inclusion: the eligibility criteria was:
  • non‐small cell carcinoma;

  • pathologic stage T1N0M0 or T2N0M0 disease;

  • compIete resection;

  • age younger than 75 years;

  • Karnofsky performance status of 90% or greater;

  • no other active malignancy;

  • no hepatorenal dysfunction;

  • no severe complications.

Interventions Experimental group: TF and N‐CWS: 1 vial of TF, equivalent to 5 x 10⁸ peripheral lymphocytes, was administered subcutaneously every 4 weeks, and N‐CWS (200 mg) was administered subcutaneously every 2 weeks, beginning 1 month after resections, and continuing for 1 year
Control group: participants received surgery alone without any particular treatment until recurrence
Outcomes Duration of follow‐up (median): experimental group: 99 months, control group: 83 months
  • Overall survival

  • Disease‐specific survival

  • Recurrence‐free survival

Notes Supported in part by grants‐in‐aid for scientific research 05453481 from the Ministry of Education and Culture of Japan
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk The author reported "Patients were randomised into two groups, TF + N‐CWS or control, by closed envelope", without detailed information about how the envelope was generated and kept.
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label design
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias)
All outcomes Low risk 82 randomised participants were included in analysis (100%)
Selective reporting (reporting bias) High risk Prior protocol was unavailable, and no prespecified primary outcome was reported
Other bias Low risk No obvious potential source of bias