Table IIIa-BPatient Characteristics

StudyAgeRace (%)Disease StageDisease StagePerformance StatusHormone Receptor Status
Adjuvant Chemotherapy
Yang et al. 2003
rec. # 8840

(of n=107 tested for expression of various markers)
mnGrp1Grp2Scalenot reported
md51.9 yrsBIT <3cm31 (33%)ER+not reported
rng33–77 yrsWIIaT 3–5cm39 (41%)PR+
sdHIIbnot reportedT3 >5 cm24 (26%)
<50 yrs45 (47.9%)A100%IIIaN-41 (38%)
≥50 yrs49 (52.1%)OIIIbN+66 (62%)
IV
Gusterson et al. 2003; rec. # 43690

760 node- pts randomized to periop CMF vs no adj. Tx
HER2+HER2-Grp1Grp2Grp1Grp2HER2+HER2-Scalenot reportedHER2+HER2-
mnBIMn TER+36%51%
mdWnot reportedIIaT sizeER-41%32%
rngHIIbnot reported≤2cm41%57%unk23%17%
sdAIIIa>2cm53%40%PR+24%37.5%
menopausal status:OIIIbunk6%3%PR-50%37.5%
pre-52.5%53%IVN0100%100%unk26%25%
post-47.5%47%
Gusterson et al. 2003; rec. # 43690

746 node+ pts randomized to perioperative vs prolonged CMF
HER2+HER2-Grp1Grp2Grp1Grp2HER2+HER2-Scalenot reportedHER2+HER2-
mnBIMn TER+56%28%
mdWnot reportedIIaT sizeER-32%59%
rngHIIbnot reported≤2cmnot reportedunk12%13%
sdAIIIa>2cmPR+62%36%
menopausal status:OIIIb# positive nodes:PR-22%45%
pre-50%60%IV1–3+51%57%unk16%19%
post-50%40%≥449%43%
Moliterni et. al. 2003; rec. # 10210

RCT; CMF (Grp 1) versus CMF→A (Grp 2)
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
mnBIMn TER+59%52%
mdnot reportedWnot reportedIIaT stage distribution not reportedER-34%39%
rngHIIbnot reported~65% <2.1 cm diam.unk7%9%
sdAIIIaN0PR+53%53%
<51 yr69%67%OIIIbN1100%100%PR-38%34%
IVN2unk9%13%
Colozza et al. 2005; rec. # 3820

RCT; CMF (Grp 1) vs epirubicin (Grp 2); n=133 each tested for
HER2 status
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
age (years):BItumor diameter (cm):ER+56%55%
<40129Wnot reportedIIa≤245%46%ER-41%44%
40–503240HIIbnot reported2–550%48%unk4%2%
>505651AIIIa>51%0%PR+63%63%
menopausal status:OIIIbunk5%6%PR-33%35%
pre5353IVN020%23%unk4%2%
post4747N1–359%52%
N4–921%26%
Pritchard et al. 2006;
rec. # 1760

RCT; CMF versus CEF; n=163 FISH+
(Grp 1); n=465 FISH- (Grp2)
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
age (%)BIT135%40%ER+56%62%
≤29 yr41Wnot reportedIIaT252%49%ER-35%27%
30–392722HIIbnot reportedT35%5%unk9%12%
40–495460AIIIa# positive nodes:PR+not reported
≥50 yr1517OIIIb000
all pre-menopausal; ineligible if post-menopausalIV1–357%63%
4–1036%31%
≤107%7%
Knoop et al. 2005; rec. # 3450

RCT (n=773); CMF (Grp 1; n=421) vs CEF (Grp 2; n=352)
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
age in years (%)BIT size, cm (%)(%)(%)
<4016.4Wnot reportedIIa0–242.439.3ER+27.125
40–4947.6HIIbnot reported2.1–549.552.4ER-66.768.2
50–5922.0AIIIa>58.18.3PR+not reported
60–6914.0OIIIb# positive nodes (%)PR-
menopausal statusIV035.637.8
pre69.868.51–333.329.5
post30.231.5>331.332.7
Dressler et al. 2005, rec. # 4280;
Thor et al. 1998, rec. # 40880; Grp 1, n=542, Dressler analysis; Grp 2, n=469, rest of CALGB 88693
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
mn50.6 yr50.4 yrBIMn T2.962.86(%)(%)
mdWnot reportedIIa(cm)ER+68.264.8
rngHIIbnot reportedMn #4.624.68
pre-40.740.3AIIIaN+PR+59.155.7
OIIIb
IV
Del Mastro et al. 2004, 2005; rec # 48020
Grp 1: n=731, HER2 known
Grp 2: n=483 HER2 unknown
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
md5454BIT147.1%52.6%ER+54%49%
rng25–7026–70Wnot reportedIIaT246.2%42.2%ER-43%38%
<5035.8%43.1%HIIbnot reportedT3–45.3%4.4%ER?3%13%
50–5934.7%35.6%AIIIaT?1.4%0.8%PR+42%36%
>5929.5%21.3%OIIIbN+62.3%67.7%PR-50%44%
IVN-37.6%32.3%PR?8%20%
Tanner et al. 2006; rec. # 1820
(n=391 tested for HER2 status; 180 from FEC arm + 211 from CTCb arm)
HER2+HER2-Grp1Grp2Grp1Grp2nHER2+HER2-Scalenot reportedHER2+HER2-
<50 years of age:BItumor size:ER+ and/or PR+:
n=22730.8%69.2%Wnot reportedIIa<2 cm12627%73%yes (210)22%78%
≥50 years of ageHIIbnot reported2–5cm21336%64%no (148)49%51%
n=16435.4%64.6%AIIIa>5 cm3730%70%unk (33)27%73%
OIIIbunk1547%53%
IV# positive nodes:
5–76834%66%
8–910727%73%
≥1021635%65%
Hayes et al. 2007; rec. # 47610
Grp1, n=643
Grp2, n=679
each is random mix of patients from 6 RCT arms4
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2Scalenot reportedGrp1Grp2
age, years:B8%9%Itumor size (cm):ER+57%62%
<4020%20%W84%84%IIa≤233%35%ER-43%38%
40–4940%38%H5%4%IIbnot reported>266%64%PR+not reported
50–5927%30%A2%2%IIIaunk<1%<1%
≥6012%12%O1%1%IIIb# positive nodes:
menopausal status:IV1–348%46%
pre61%61%4–940%43%
post39%39%≥1012%11%
Martin et al. 2005; rec # 47650

Grp 1: DAC, n=745
Grp 2: FAC, n=746
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2ScaleGrp1Grp2Grp1Grp2
mnBIT140%43%100% had Karnofsky score ≥80%ER+ &/or
md4949Wnot reportedIIaT252%51%PR+76%76%
rng26–7023–70HIIbnot reportedT38%6%menopausal status:
sdAIIIaN000pre:56%55%
OIIIb1–3N+63%62%post:44%45%
IV≥4 N+37%38%
Neoadjuvant (Pre-operative) Chemotherapy
Learn et al. 2005; rec. # 47640
AC, n=50
AC+D, n=47
AC→D, n=47
pooled data on n=142 evaluated for clin. response
mn48 yrsBI23.6%clinical tumor diameterScalenot reportedOf n=121 with biopsy specimens available for IHC:
md47 yrsWIIa39.6%≤2 cm28.2%ER+60.3%
rng27–73 yrsH71%IIb30.6%>2-≤5 cm47.2%ER-39.7%
sdAIIIa6.3%>5 cm24.6%PR+57.9%
OIIIb0N061.3%PR-42.1%
not reported29%IV0N138.7%
N≥20
Arriola et al. 2006; rec # 950

prospective single-arm series; n=232
mn47 yrsBIT230%Scalenot reportedER+67%
mdWIIaT370%ER-29%
rngHnot reportedIIbnot reportedN060%unk4%
sdAIIIaN140%PR+52%
OIIIbPR-43%
IVunk5%
Park et al. 2003; rec # 9960
retrospective single-arm series; n=67
yearsBItumor size (cm):
<5082%WIIa5–1091%Scalenot reportedER+46%
≥5018%Hnot reportedIIbnot reported>109%ER-54%
0IIIaPR status not reported
IV
Zhang et al. 2003; rec # 9820
retrospective single-arm series; n=97
md44.5 yrBIT113%Scalenot reportedER+65%
rng25–74 yrWnot reportedIIaT253%PR+56%
sdHIIbnot reported≥T334%
≥5044%AIIIaN-33%
<5056%OIIIbN+67%
IV
Tulbah et al. 2002; rec # 11560 HER2+HER2-BHER2+HER2-HER2+HER2-Scalenot reportedHER2+HER2-
age (yr)Wnot reportedI00T237ER+1216
≥502027HIIa13T3916ER-911
>5025AIIb69T4109unk15
menopausal status:OIIIa510N089PR+1111
pre2025IIIb1010N11218PR-1016
post27IV00N225unk15
Tinari et al. 2006; rec # 2300

retrospective single-arm series; n=77
mnBItumor size (cm):ER+62%
md46.1 yrsWnot reportedIIa2–575%Scalenot reportedER-38%
rng25.5–73.7 yrsHIIbnot reported>525%PR+45%
sdAIIIaPR-55%
OIIIb
IV
Chemotherapy for Advanced or Metastatic Disease
Harris et al 2006; rec. # 390 AllAllAllAllScaleAllAll
mnB20.6IT1ECOG performance status of 0,1,2=100ER+ and/or PR+=58
md54.9WIIT2
rngHIIInot reportedT3
sdAIVT4
preOUnkN0
postN1
N2
N3
median # mets: 1
Di Leo et al 2004; rec. # 5970

Grp 1: A, n=91
Grp 2: T, n=85
patients with tumor blocks tested for HER2 status
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2ScaleGrp1Grp2Grp1Grp2
mnBnot reportedI≥3 sites46%51%KarnofskyER+not reported
md54 yr51yrWIIVisceral Involvement79%76%all w specimens:PR+not reported
rngHIII60–70:15%15%reported (data not shown) other factors similar in HER2 status subgroups of each arm
sdAIV100%100%≥8085%85%
preOUnkHER2+ subgroup:
post60–70:33%0
Konecny et al 2004; rec. # 6740

Grp 1: EC, n=137
Grp 2: ET, n=138

data are for subgroups with known HER2 status
Grp1Grp2Grp1Grp2Grp1Grp2Grp1Grp2ScaleGrp1Grp2Grp1Grp2
Mn5555BINuclear GradeKarnofskyER+52.660.9
mdWNot reportedII12.22.9>60100100ER-37.232.6
rng31–7429–75HIII241.637.0Prior adj chemounk10.26.5
sdAIV100%100%338.746.3Yes40.232.6PR+48.949.3
preOUnkUnk17.513.8No59.165.9PR-40.142.7
post# of met sitesunk0.71.5unk11.08.0
135.831.9Prior palliative hormone therapy
221.221.0
≥342.342.0Yes14.613.8
Unk0.75.1No84.786.2
unk0.70
3

Also showed patient populations were similar in 3 CAF dose arms (high, moderate, low); data not abstracted here.

4

Also reported data comparing groups 1 and 2 with 1799 patients from CALGB 9344 not included in biomarker analysis; data showed similar baseline characteristics and 5-year outcomes.

*

p<.05;

characteristics of subset with biomarker data, n=165, similar to those of patients w/o biomarker measurements, n=299

From: Appendix C. Evidence Data Abstraction Tables

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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