| Study characteristics |
| Methods |
Italy; RCT |
| Participants |
Number of participants: 113
Number randomised
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 participants should have:
histologically‐confirmed NSCLC preoperative assessment suggesting potentially resectable disease cardiopulmonary function adequate for planned surgery performance status from 0 to 1 normal haematologic, renal, and hepatic function no prior therapy with biologic response modifiers (such as interferon or interleukin) negative serologic testing for HN and hepatitis B virus antibodies no previous treatment with antineoplastic therapy no steroid therapy
|
| Interventions |
Experimental group
Stage II participants underwent AI (tumour‐infiltrating lymphocytes and recombinant interleukin‐2) Stage III participants received AI plus radiotherapy. Six to 8 weeks after surgery, TIL were infused intravenously (day 0). A number of TIL ranging from 4 to 70 x 10⁹ cells were infused. rIL‐2 was administered subcutaneously, starting from the day of TIL infusion and escalating from 2 to 16 X 10⁶ IU/m²/day, from day 0 to day 14. Each dose increment was 2 to 16 X 10⁶ IU/m²/2 days. Radiotherapy started 60 to 90 days from TIL infusion.
Control group
Stage II participants received no treatment Stage III participants received chemotherapy plus radiotherapy. Chemotherapy consisted of vinblastine (5 mg/m² of body surface area given in an intravenous bolus weekly) and cisplatin (80 mg/m², given intravenously 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 50 Gy/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 prespecified primary outcome was reported |
| Other bias |
Low risk |
No obvious potential source of bias |
