IALT: trial | Bending the Curve: Trial by Trial

IALT

Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer

N = 1,867

Population

Patients with completely resected non-small-cell lung cancer: pathological stage I 36.5%, stage II 24.2%, stage III 39.3%.

Design

International Adjuvant Lung Cancer Trial: patients randomised to 3 or 4 cycles of cisplatin-based chemotherapy or to observation. Before randomisation each centre chose the pathological stages to include, its chemotherapy policy (dose of cisplatin and the drug combined with it) and its postoperative radiotherapy policy. Drug allocated with cisplatin: etoposide 56.5%, vinorelbine 26.8%, vinblastine 11.0%, vindesine 5.8%; 73.8% of the 932 patients assigned to chemotherapy received at least 240 mg/m2 of cisplatin. Main end point overall survival; median follow-up 56 months.

Primary endpoint

Arms

Observation (control): Observation after complete resection
Cisplatin-based chemotherapy (experimental, n = 932): 3 or 4 cycles of cisplatin-based chemotherapy; companion drug and cisplatin dose set by each centre

People

Arriagada R, International Adjuvant Lung Cancer Trial Collaborative Group

OSHR 0.86 (95% CI 0.76–0.98)Δ 60-month OS+4.1 pointsDFSHR 0.83 (95% CI 0.74–0.94)Δ 60-month DFS+5.1 points

Show the numbers

Results reported for IALT
Endpoint	Analysis	Cisplatin-based chemotherapy	Observation	Effect
OSRandomised patients (1867)	primarymedian follow-up 56 monthsArriagada 2004	44.5% at 5 y	40.4% at 5 y	HR 0.86 (95% CI 0.76–0.98)P<0.03469 deaths with chemotherapy and 504 with observation.
DFSRandomised patients (1867)	primarymedian follow-up 56 monthsArriagada 2004	39.4% at 5 y	34.3% at 5 y	HR 0.83 (95% CI 0.74–0.94)P<0.003518 events with chemotherapy and 577 with observation. Disease-free survival was not the main end point (overall survival was).
Toxic death rateChemotherapy group (denominator not stated in the abstract)	primaryArriagada 2004	0.8%	—	Seven patients died of chemotherapy-induced toxic effects.

Results reported for IALT
Endpoint	Analysis	Cisplatin-based chemotherapy	Observation	Effect
OSRandomised patients (1867)	primarymedian follow-up 56 monthsArriagada 2004	44.5% at 5 y	40.4% at 5 y	HR 0.86 (95% CI 0.76–0.98)P<0.03469 deaths with chemotherapy and 504 with observation.
DFSRandomised patients (1867)	primarymedian follow-up 56 monthsArriagada 2004	39.4% at 5 y	34.3% at 5 y	HR 0.83 (95% CI 0.74–0.94)P<0.003518 events with chemotherapy and 577 with observation. Disease-free survival was not the main end point (overall survival was).
Toxic death rateChemotherapy group (denominator not stated in the abstract)	primaryArriagada 2004	0.8%	—	Seven patients died of chemotherapy-induced toxic effects.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
OS	0.86	0.76–0.98
DFS	0.83	0.74–0.94

Appears in

2004 Adjuvant cisplatin after resection: IALT, JBR.10 and LACE

Sources

Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004;350(4):351-60.
PubMed DOI