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Table 10Summary design, treatment, patient characteristics, KQ3a

Study/DesignTreatmentsAge or Menopause StatusExtent of Disease(% of pts analyzed by HER2 status)
ER+PR+HER2+HER2-
Adjuvant chemotherapy for resected early breast cancer
Yang et al., 2003
series
cyclophosphamide + methotrexate + fluorouracil (CMF; n=94)≥50 yr:≥3 cm: 67%NRNRIHC only:36%64%
52.1%N+: 62%
Gusterson et al., 2003; stratified RCT perioperative CMF (one cycle)post: 47% of n=760 of 1275 N- patients randomized >2 cm: 53%, HER2+of HER2+:IHC only:12.8%87.2%
40%, HER2-36%24%
no adjuvant therapyof HER2-:IHC only:20.8%79.2%
100% N0 51%38%
Multiple cycles of CMFpost: 45% of n=746 of 1229 N+ patients randomizedT size, NR; 100%of HER2+:IHC only:17.3%82.7%
node+; ≥4 nodes +:32%22%
perioperative CMF (one cycle)49%, HER2+of HER2-:
43%, HER2- 59%45%IHC only:21.6%78.4%
Moliterni et al., 2003; RCT 8 cycles CMF + 4 cycles doxorubicin (CMF → A; n=248 of 277 randomized)≥52 yr:~65%, <2.1 cmonly reported for all randomized to each armIHC only:18.1%81.9%
67% 100% N1
12 cycles of CMF alone
(n=258 of 275 randomized)
≥52 yr:IHC only:19.4%80.6%
69%
Colozza et al., 2005;
RCT
epirubicin(E), weekly for 4 months
(n=133 of 166 randomized)
>50 yr:≤2 cm: 46%55%63%IHC only:40.6%59.4%
51% 1–3 N+: 52%
6 cycles CMF
(n=133 of 174 randomized)
>50 yr:≤2 cm: 45%56%63%IHC only:27.8%72.2%
56%1–3 N+: 59%
Pritchard et al. 2006; RCT 6 cycles of CEF
(n=312 of 351 randomized)
100% pre FISH:posneg62% NR by FISH: 24.0% 76.0%
6 cycles of CMF
(n=316 of 359 randomized)
T252%49%
100% pre1–3 N+57%63%56%NRby FISH:27.8%72.2%
Knoop et al., 2005; RCT 9 cycles of CEF
(n=352 of 480 randomized)
post: 31.5%T≥2.1 cm: 60.7%25%NRIHC 3+ or
1–3 N+: 29.5% FISH+ 32.5% 67.5%
9 cycles of CMF
(n=421 of 500 randomized)
post: 30.2%T≥2.1 cm: 57.6%27%NRIHC 3+ or
1–3 N+: 33.3% FISH+32.8%67.2%
Dressler et al., 2005, Thor et al., 1998; 3-arm
RCT
(CALGB 8541)
4 cycles high-dose CAF (n=179 of 519 randomized)a (A=doxorubicin)mn, 50.1 yrsmn T size, 2.91 cm68%54%FISH+17.3%82.7%
42.5% pre mn # N+, 4.51 IHC+24.8% 75.2%
6 cycles moderate-dose CAF (n=167 of 513 randomized)amn, 51.4 yrsmn T size, 2.88 cm71%65%FISH+20.7%79.4%
38.3% pre mn # N+, 4.43 IHC+25.7% 74.3%
4 cycles low-dose CAF (n=178 of 518 randomized)amn, 50.4 yrsmn T size, 3.07 cm66%58%FISH+18.8%81.2%
41.1% premn # N+, 4.92 IHC+22.9%77.1%
Del Mastro et al. 2004, 2005; RCT (GONO-MIG-1) up to 9 cycles FEC14 regimen (q2wk; n=370 of ~607 randomized)IHC 3+
T1: 47% N+: 62%CB1150 (13.5%)320
median, 54 yrsT2: 46% N-: 38%54%(86.5%)
6 cycles FEC21 regimen (q3wk; n=361 of ~607 randomized)range, 25–70T3–4: 5%42%IHC 3+
T? 1%CB1153 (14.7%)308
(85.3%)
Tanner et al., 2006; control arm from RCT 9 cycles of FEC (n=180 of 251 randomized; n=211 from HDC/AuSCS arm excluded)≥50 yr:HER2:posnegonly reported pooled data for both study armsCISH
42% of all testedT:2–5cm60%52%only:31.1%68.9%
5–9 N+41%47%
≥10 N+59%53%
Hayes et al., 2007; RCT
(randomly selected 2 groups of 750 ea)
4 cycles AC → paclitaxel (n=1,570 randomized)post: 38%Grp1Grp157%not reported
Grp2
T>2cm66%64%NR
4 cycles AC → observation
(n=1551 randomized)
post: 38%1–3 N+48%46%Grp262%not reported
4–9 N+40%43%NR
Martin et al., 2005b;
RCT
6 cycles DAC (n=630 with known HER2 status of 745 randomized) (D=docetaxel)median, 49 yrsT1: 40% 1–3N+: 63%155 (24.6%)475
range, 26–70T2: 52% ≥4N+: 37%ER+ &/or PR+: 76%(75.4%)
pre, 56% T3: 8%
6 cycles FAC (n=632 with known HER2 status of 746 randomized)median, 49 yrsT1: 43% 1–3N+: 62%164 (26.0%)468
range, 23–70T2: 51% ≥4N+: 38%ER+ &/or PR+: 76%(74.0%)
pre, 55%T3: 6%
Neoadjuvant (preoperative) chemotherapy for locally advanced breast cancer
Learn et al., 2005c; 3-arm RCT 4 cycles AC ± D (concurrent or after resection) (n=104 of 144 randomized)mean, 48 yrsT ≤ 2 cm: 28% N0:61%only reported data for n=121 with biopsy specimensTAB 250 (n=104 classified)
median, 47 yrsT 2–5 cm:47% N1:39%IHC+41 (39%)63 (61%)
range, 27–73T >5 cm: 25% N2: 0
Arriola et al., 2006; series 4 cycles of doxorubicin followed by surgery (n=232)mean, 47 yrsT3: 70%67%52%IHC + FISH
N1: 40% then CISH18%82%
Park et al., 2003; series 4 cycles of doxorubicin followed by surgery (n=67)≥50 yrs, 18%5–10 cm91%
>10 cm9%46%NRCISH only:46%54%
N statusNR
Zhang et al., 2003; series 3–6 cycles of FAC followed by surgery
(n=97)
T253%
≥50 yrs, 44%≥T334%65%56%IHC 3+
N-33%or FISH+28%72%
N+67%
Tulbah et al., 2002; series 3–4 cycles of paclitaxel + cisplatin followed by surgery (n=54)HER2+ HER2-HER2+of HER2+:
≤50 91% 84%HER2-55%50%IHC 3+41%59%
pre 91% 78%≥T386%78%
N036%28%of HER2-:
N155%56%50%34%
N29%16%
Tinari et al., 2006; series median 4 (range, 3–6) cycles FEC, q3wk followed by surgery (n=77)median, 46 yrsT 2–5 cm: 75%62%IHC 3+
range, 25–74T >5 cm: 25% 45%or 2+ & FISH+20 (26%)57 (74%)
First- or second-line chemotherapy for advanced or metastatic breast cancer
Harris et al., 2006; RCT paclitaxel (n=165 of 474 randomized to 3 dose arms, but pooled for HER2 analysis)median: 54.9 yr# metastatic sites:ER+ &/or PR+:FISH26%74%
median, 158%CB1120%80%
Hercep. 3+21%79%
Di Leo et al., 2004; RCT doxorubicin (A; n=91 of 165 randomized)54 yr≥3 sites:46%NRIHC+ ≥1% & FISH+:
visceral: 79% 16% 69%
docetaxel (T; n=85 of 161 randomized)51 yr≥3 sites:51%NRIHC+ ≥1% & FISH+:
visceral:76%25%59%
Konecny et al., 2004; RCTepirubicin + cyclophosphamide (EC; n=137 of 254 randomized)mean: 55 yr1–2 sites:57%52.6%48.9%FISH only36%64%
(31–74) ≥3 sites: 42%
epirubicin + paclitaxel (ET; n=138 of 262 randomized)mean: 55 yr1–2 sites:53%60.9%49.3%FISH only35%65%
(29–75)≥3 sites:42%
a

Data on eligible patients randomized to each arm are from Budman, Berry, Cirrincione, et al., 1998.

b

Except for HER2 status, data shown compare all patients randomized to TAC versus all patients randomized to FAC

c

Except for ER, PR and HER2 status, data shown pool evaluable patients (n=142) randomized to AC, AC+D, or AC→adjuvant D

Abbreviations: Please refer to the text or list of abbreviations at the end of the report for definition of specific chemotherapy regimens/agents.

Grp: group; IHC: immunohistochemistry; FISH: fluorescent in situ hybridization; mn: mean; q wk: every week; q3wk: every 3 weeks;

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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