Table 33Single-arm studies, summary time to event outcomes, KQ5, lung cancer

StudyTime to Event Outcomes
Cappuzzo et al., 2007;
gefitinib
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
TTPFISH+206.40.2
FISH-163.1
OSFISH+20not reached0.1
FISH-1610.4
Krug et al., 2005 docetaxel/paclitaxel + trastuzumab OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC+20~14~65~30~20~20NSIHC 2+/3+
IHC-45~16~59~33~16~10
Cappuzzo et al., 2005
gefitinib
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSFISH+2320.860.9~38LR0.056discrepancies
FISH-788.437.2~15
TTPFISH+239.0534.8LR0.02discrepancies
FISH-782.79.0~5
Hirsch et al., 2005
gefitinib
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSFISH+1716~64~26LR0.80Cox HER2 not entered
FISH-3913~61~35
Pelosi et al., 2005
surgery
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSFISH+5100~80~60~60~60LRNS
FISH-34094~88~80~72~70
DFSFISH+5~80~60~60~60~60LRNS
FISH-340~13 yrs~86~77~74~70~65
Saad et al., 2004
surgery
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSAC-IHC+19~24~81~50~18~0?signifCox: HER2 independent
AC-IHC-31~43~96~75~54~41
BAC-IHC+9~39~91~63~27~0~0?signifCox: HER2 independent
BAC-IHC-41~30~100~100~50~30~19
Langer et al., 2004 trastuzumab, paclitaxel and carboplatin OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC3+810.937.525LR0.77
IHC2+238.626.113.5
IHC1+2214.359.111.4
PFSIHC3+82.7-LR0.34
IHC2+233.8~9
IHC1+223.9~6
Cappuzzo et al., 2003
gefitinib
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
TTPIHC 2+/3+153.5LRNS
IHC 0 /1+283.7
OSIHC 2+/3+155.7LRNS
IHC 0 /1+286.8
Koukourakis et al., 1999; surgery OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC+LR0.51Cox HER2 not entered
IHC-
Koukourakis et al., 2000
surgery
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC+NS
IHC-
Graziano et al., 1998 cisplatin-etoposide (PE), surgery, PE, RT OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC+1010.5LR0.617
IHC-3717.5
Pfeiffer et al., 1996
surgery
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSIHC-none29~34~75~66~42~32~20LRNS
IHC-low108~24~58~50~38~33~25
IHC-high49~24~75~50~40~30~25

Abbreviations: AC: adenocarcinoma; BAC: bronchoalveolar carcinoma; DFS: disease-free survival; Grp: group; LR: log rank; NS: not significant; OS: overall survival; RT: radiation therapy; TTP: time to progression;

From: 3, Results and Conclusions

Cover of HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors
HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors.
Evidence Reports/Technology Assessments, No. 172.
Seidenfeld J, Samson DJ, Rothenberg BM, et al.

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