Giovanni 1996

Methods	Italy; RCT
Participants	Number of participants: 113 Number randomised: Experimental group (adoptive immunotherapy ± radiotherapy): 56 Control group (chemoradiotherapy): 57 Number evaluated: Experimental group: 56, age (year ± SD): 61± 7 years Control group: 57, age (year ± SD): 62 ± 8 years Diagnosis: patients with (completely or incompletely) surgically removed stage II, IIIa, or IIIb NSCLC. Inclusion: eligible patients should have: (1) histologically confirmed NSCLC; (2) preoperative assessment suggesting potentially resectable disease; (3) cardiopulmonary function adequate for planned surgery; (4) performance status (PS) from 0 to 1; (5) normal hematologic, renal, and hepatic function; (6) no prior therapy with biologic response modifiers (such as interferon (IF) or Interleukin (IL)); (7) negative serologic testing for HN and hepatitis B virus antibodies; (8) no previous treatment with antineoplastic therapy; and (9) no steroid therapy.
Interventions	Experimental group: Stage II participants underwent AI (tumour‐infiltrating lymphocytes and recombinant interleukin‐2); participants at Stage III received AI plus radiotherapy. Six to 8 weeks after surgery, TIL were infused i.v. (Day 0). A number of TIL ranging from 4 to 70 x 10⁹ cells was infused. rIL‐2 was administered subcutaneously (s.c.), starting from the day of TIL infusion and escalating from 2 to 16X10⁶ IU/m²/day, from Day 0 to Day 14. Each dose increment was 2 to 16X10⁶ IU/m²/ two days. Radiotherapy started 60 to 90 days from TIL infusion. Control group: Stage II participants received no treatment; participants at Stage III received chemotherapy plus radiotherapy. Chemotherapy consisted of vinblastine (5 mg/m² of body‐surface area given in an i.v. bolus weekly) and cisplatin (80 mg/m², given i.v. over 30 to 60 minutes on Day 1 and Day 22). The same radiation therapy regimen was used in both treatment arms. The radiation dose was 50Gy/25f over a 5‐week period for completely resected participants.
Outcomes	Duration of follow‐up: Range from 6 to 40 months OS (survival), adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised by the method of random number (how the random number was generated was not specified in the report)
Allocation concealment (selection bias)	Unclear risk	Not described
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	113 randomised participants were included in analysis (100%)
Selective reporting (reporting bias)	High risk	Prior protocol was unavailable, and no pre‐specified primary outcome was reported.
Other bias	Low risk	No obvious potential source of bias