. Author manuscript; available in PMC: 2014 Aug 14.

Published in final edited form as: Clin Cancer Res. 2013 May 15;19(10):2646–2656. doi: 10.1158/1078-0432.CCR-12-2939

Table 2.

SWOG Trial Description

Study		Design							Observed Data
		N	Years		Control Arm Outcomes	Target HR_OS	α	Power	Accrual		Control Arm Outcomes	Stop Time	Result
	Disease	N	Accr	FUP	Control Arm Outcomes	Target HR_OS	α	Power	Years		Control Arm Outcomes	Stop Time	Result
S8797⁸²	Early stage cervical	240	5.5	4	5-yr OS: 60%	1.78	0.05	0.85	262	6.3	5-yr OS: 66%	Final	Positive
(GYN)	Early stage cervical	240	5.5	4	5-yr PFS: 56%	(1.5)^{^}	0.05	0.85	262	6.3	5-yr PFS: 62%	Final	Positive
S9008⁸¹	stomach or GI junction	550	5.5	2	Med OS: 30m	1.4	0.025	0.9	573	7	Med OS: 27m	Final	Positive
(GI)	stomach or GI junction	550	5.5	2	Med RFS: 20m	1.4	0.025	0.9	573	7	Med RFS: 19m	Final	Positive
S9308⁸⁷	Advanced NSCLC	400	2.5	1	Med OS: 6m	1.33	0.05	0.88	415	1.5	Med OS: 6m	Final	Positive
S9308⁸⁷	Advanced NSCLC	400	2.5	1	Med PFS: 2m	1.33	0.05	0.88	415	1.5	Med PFS: 2m	Final	Positive
S9313⁸⁰	high risk stage I/II	3000	3.75	5	5-yr OS: 93%	1.45^*	0.05	0.9	3126	3.1	5-yr OS: 88%	Final	Negative
(Breast)	high risk stage I/II	3000	3.75	5	5-yr DFS: 86%	1.45^*	0.05	0.9	3126	3.1	5-yr PFS: 80%	Final	Negative
S9321⁷⁵	Multiple myeloma	500⁺	4	3	Med OS: 3y	1.33	0.05	0.81	519	9.8	Med OS: 4.9y	Final	Negative
(Mmyel)	Multiple myeloma	500⁺	4	3	Med PFS: 1.3y	1.33	0.05	0.81	519	9.8	Med PFS: 1.8y	Final	Negative
S9415⁸⁵	high risk stage II and stage III colon	1500	6.5	3.5	Med OS: 9.3y	1.35	0.05	0.95	1004	5	Med OS: 10.9y	Interim	Negative
(GI)	high risk stage II and stage III colon	1500	6.5	3.5	Med DFS: 8.5y	1.35	0.05	0.95	1004	5	Med DFS: 9.4y	Interim	Negative
S9420⁷⁹	Colorectal	700	3.5	1.5	Med OS: 15m	1.33	0.025	0.9	723	4.1	Med OS: 13m	Final	Negative
(GI)	Colorectal	700	3.5	1.5	Med PFS: 6m	1.33	0.025	0.9	723	4.1	Med PFS: 5m	Final	Negative
S9438⁸⁶	Non-Hodkin	206⁺	5	2	2-yr OS: 40%	1.5	0.05	0.82	194	10	2-yr OS: 74%	Final	Negative
(Lymph)	Non-Hodkin	206⁺	5	2	2-yr DFS: 30%	1.5	0.05	0.82	194	10	2-yr DFS: 73%	Final	Negative
S9509⁷⁶	Advanced NSCLC	400	1.33	1	Med OS: 8m	1.5	0.025	0.94	415	1.8	Med OS: 9m	Final	Negative
(Lung)	Advanced NSCLC	400	1.33	1	Med PFS: 4m	1.5	0.025	0.94	415	1.8	Med PFS: 4m	Final	Negative
S9916⁸³	advanced refractory prostate	620	3.5	1	Med OS: 18m	1.33	0.025	0.8	716	3.3	Med OS: 16m	Final	Positive
(GU)	advanced refractory prostate	620	3.5	1	Med PFS: 4m	1.33	0.025	0.8	716	3.3	Med PFS: 3m	Final	Positive
S0001	glioblastoma and gliosarcoma	375	5	2	Med OS: 12m	1.4	0.05	0.925	179	4.2	Med OS: 10m	Interim	Negative
(Brain)	glioblastoma and gliosarcoma	375	5	2	Med PFS: 5m	1.4	0.05	0.925	179	4.2	Med PFS: 4m	Interim	Negative
S0003⁸⁸	Advanced NSCLC	500	1.67	1	Med OS: 8m	1.375	0.025	0.88	376	2	Med OS: 9m	Interim	Negative
(Lung)	Advanced NSCLC	500	1.67	1	Med PFS: 4m	1.375	0.025	0.88	376	2	Med PFS: 4m	Interim	Negative
S0023⁷⁷	Stage III, NSCLC	672⁺	3.5	2.5	Med OS: 21m	1.33	0.025	0.89	250	4.2	Med OS: 32m	Interim	Negative
(Lung)	Stage III, NSCLC	672⁺	3.5	2.5	Med PFS: 7m	1.33	0.025	0.89	250	4.2	Med PFS: 10m	Interim	Negative
S0124⁷⁸	Extensive stage 1^st line	620	4	1	Med OS: 10m	1.33	0.025	0.9	656	4.3	Med OS: 9m	Final	Negative
(Lung)	SCLC	620	4	1	Med PFS: 5m	1.33	0.025	0.9	656	4.3	Med PFS: 5m	Final	Negative
S0205⁸⁴	advanced pancreas	704	5	1	Med OS: 6m	1.33	0.0125	0.92	743	2.2	Med OS: 6m	Final	Negative
(GI)	advanced pancreas	704	5	1	Med PFS: 3m	1.33	0.0125	0.92	743	2.2	Med PFS: 3m	Final	Negative

S9313 had DFS as a primary endpoint with HR=1.3 and no interim futility testing. A trial with the same characteristics but OS as a primary endpoint would use HR=1.45.

^{^}

S8797 was powered for HR=1.78, but interim futility testing was based on HR=1.5.

⁺

Based on number randomized

NSCLC = Non-small cell lung cancer

GI = gastrointestinal

^17-29 Reference number – see bibliography