Modeling and simulation of maintenance treatment in first-line non-small cell lung cancer with external validation

Table 1 Study summary

	SATURN [11, 12]	ATLAS [13]	AVAPERL [14, 15]
Investigational drug	Erlotinib	Erlotinib	Pemetrexed
N: run-in phase^a	1949	1145	376
N: maintenance phase^b	889	743	253
N: evaluable^c	837 (94 %)	697 (94 %)	231 (94 %)
BTS (cm)	6.99	6.1	5.21
Female^d	26 %	48 %	43 %
ECOG score >0^d	69 %	66 %	52 %
Age ≥ 55 years^d	70 %	77 %	72 %
Asian^d	15 %	13 %	12 %
Study number	BO18192	AVF3671g	MO22089
ClinicalTrials.gov Identifier	NCT00556712	NCT00257608	NCT00961415
Trial registration date^e	Nov 9, 2007	Nov 21, 2005	Aug 18, 2009
Retrospective registration	No	No	No

BTS baseline tumor size at randomization, ECOG Eastern Cooperative Oncology Group, TGI tumor growth inhibition
^aNumber of patients who received four cycles of first-line treatment (run-in phase)
^bNumber of patients whose disease did not progress during the run-in phase and who were randomized in the maintenance phase
^cNumber of evaluable patients, i.e. patients with at least two tumor size measurements in the maintenance phase (at least one tumor size measurement after randomization). The number in the parenthesis represents the percentage of evaluable patients out of the patients randomized
^dThe percentage of patients among evaluable patients
^eThe date of “First received” as displayed on ClinicalTrials.gov

ISSN: 1471-2407