Advances in adjuvant systemic therapy for non-small-cell lung cancer

Table 1 Important randomised trials of adjuvant treatments for non-small cell lung cancer

Ref.	Size	Stage	1Chemotherapy regimen	OS	DFS
IALT[14]	1867	I-III	Pragmatic study of 3-4 cycles of cisplatin (80-100 mg/m2 on D1) with either: vindesine 3 mg/m2 weekly; vinblastine 4 mg/m2 weekly; vinorelbine 30 mg/m2 weekly; etoposide 100 mg/m2 D1-3	4.1% absolute benefit at 5 yr (HR, 0.86; P < 0.03)	5.1% absolute benefit at 5 yr (HR, 0.83; P < 0.003)
NCIC JBR.10[16]	482	Ib-II	4 cycles of: cisplatin 50 mg/m2 D1 + 8; vinorelbine 25 mg/m2 D1, 8, 15, 22 in a 4-wk cycle	15% absolute benefit at 5 yr (P = 0.04)	12% absolute benefit at 5 yr (P = 0.08)
ANITA[18]	840	Stage Ib-IIIa	4 cycles of: cisplatin 100 mg/m2 D1; vinorelbine 30 mg/m2 D1, 8, 15, 22 in a 4-wk cycle	8.6% absolute benefit at 5 yr (P = 0.17 for HR)	8.7% absolute benefit at 5 yr (P = 0.002 for HR)
JLCRG[24]	999	I	Daily UFT as tegafur 250 mg/m2 per day plus uracil, for 2 yr	3% absolute benefit at 5 yr (P = 0.04)	NR
NCIC BR19[30]	1242	Ib-IIIa	Gefitinib 250 mg daily for 2 yr	HR, 1.24 (P = 0.14)	HR, 1.22 (P = 0.15)
CALGB 9633[16]	344	Ib	4 cycles of carboplatin AUC 6 plus paclitaxel 200 mg/m2, every 3 wk	HR, 0.83 (P = 0.12)	HR, 0.80 (P = 0.065)

¹Control arms treated with observation. OS: Overall survival; DFS: Disease-free survival; HR: Hazard ratio; NR: Not reported.

Table 2 Incidence of treatment-related World Health Organization grade 3-4 toxicity from adjuvant cisplatin and vinorelbine

Trial	JBR.10 (%)[16]	ANITA (%)[18]
Anaemia	14	7
Thrombocytopenia	3	1
Neutropenia	85	73
Febrile neutropenia	9	7
Infection	11	1
Nausea/vomiting	27	10-171
Diarrhoea	2	< 1
Constipation	5	3
Anorexia	15	10
Asthenia/fatigue	28	15
Peripheral neuropathy	3	3-72
Creatinine elevation	(NR)3	< 1
Treatment-related mortality4	0.8	2

¹Separately documented as nausea (10%) and vomiting (7%) in publication;

²Separately documented as hearing loss (2%), sensory neuropathy (2%) and motor neuropathy (3%) in publication;

³NR: Not reported;

⁴No WHO grade.