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Table IIIa-ADesign, Enrollment and Treatment

StudyDesignTherapeutic Settingn, Enrolled (Randomized)n, Evaluatedn, Withdrawn (Lost to F/U)Treatment Regimen (Agents)
Adjuvant Chemotherapy
Yang et al. 2003 rec. # 8840single arm retrospective seriesadjuvant therapy post mastectomy94 (identically treated; 13 of 107 in series not given adj. chemo)94 (outcomes reported separately)0cyclophosphamide + methotrexate + fluorouracil (CMF)
Gusterson et al. 2003; rec. # 43690RCT; separate randomization by nodal statusadjuvant therapy: none versus one cycle peri-op versus prolonged1275 node-neg
1229 node-pos
760 node-neg
746 node-pos
515 node-neg
483 node-pos
(no samples)
node-neg: peri-op CMF versus no adj therapy; node-pos: peri-op versus continuous CMF
Moliterni et. al. 2003; rec. # 10210RCT retrospective analysis by HER2 statusadjuvant therapy post mastectomy or quadrantectomy with axillary dissect. (1–3 nodes+)55250646
(HER2 status unknown)
CMF alone (12 cycles) versus CMF for 8 cycles then doxorubicin for 4 cycles (CMF→(A)
Colozza et al. 2005; rec. # 3820RCT retrospective analysis by HER2 statuspost-operative adjuvant therapy; node- if ER/PR neg or node+ with ≤9 nodes involved34826682
(no tumor samples)
CMF for 6 cycles versus epirubicin weekly for 4 months
Pritchard et al. 2006; rec. # 1760RCT retrospective analysis by HER2 statusadjuvant therapy post mastectomy or lumpectomy with axillary dissection; all node+710634 (by IHC)
628 (by FISH)
71 (no tumor samples)
5 (IHC & FISH failed)
CMF (Cx) versus CEF (Tx); each given for 6 cycles; no endocrine therapy after adjuvant chemoTx
Knoop et al. 2005; rec. # 3450RCT (2 × 2) retrospective analysis by HER2 statusadjuvant therapy post mastectomy or lumpectomy with axillary dissection1,195
(980 Danes eligible)
773
(805 tested for HER2 status)
CMF: 79 of 500
CEF: 128 of 480
CMF (Cx) versus CEF (Tx); each given for 9 cycles ± pamidronate, daily for 4 years; no adjuvant tamoxifen
Dressler et al. 2005, rec. # 4280;
Thor et al. 1998, rec. # 40880

CALGB trial 8541 & lab companion study 8869
3-arm RCT retrospective analysis by HER2 statusadjuvant therapy post mastectomy or lumpectomy with axillary dissection; all node+1,549
(in CALGB 8541)
524
(of 993 in CALGB 8869)
1,025
(556 not in 8869 study + 469 not in Dressler et al.)
4 cycles high dose CAF (600/60/600 mg/m2) q4wk versus 6 cycles moderate dose CAF (400/40/400 mg/m2) q4wk versus 4 cycles low dose CAF (300/30/300 mg/m2) q4wk; similar proportions in each arm given 5 years of twice daily tamoxifen (41%, 40%, 34%) for ER+, post-menopausal disease
Del Mastro et al. 2004, 2005; rec. # 48020
GONO-MIG-1 trial
RCT retrospective analysis by HER2 statusadjuvant therapy for node- high-risk or node+ patients1,214731483
(specimens unavailable for HER2 testing)
6 cycles FEC21 regimen q3wk versus up to 9 cycles FEC14 regimen q2wk (same drug doses in each regimen; ER+ & PR+ patients in each arm received tamoxifen qd for 5 years
Tanner et al. 2006; rec. # 1820STD-dose arm of RCT; retrospective analysis by HER2 statusadjuvant therapy post mastectomy or lumpectomy with axillary dissection525
(251 to STD-dose arm)
391
(180 for STD-dose arm)
274
(71 from STD-dose arm; no samples)
FEC (9 cycles; individualized doses based on hematological toxicity) versus HDC/AuSCS using CTCb after 3–4 cycles of FEC (did not abstract data from HDC/AuSCS arm); loco-regional RTx + 5 years of tamoxifen for all patients
Hayes et al. 2007; rec. # 47610

CALGB 9344
subset from 3 X 2 RCT; retrospective analysis by HER2 statusadjuvant therapy for node+ patients after surgery with negative margins1500
(2 groups, 750 each, randomly selected from 3121 in RCT)
1322178 (no tumor specimens;
1621 RCT patients not analyzed by HER2 status)
4 cycles of AC (randomized to 1 of 3 doxorubicin doses) followed by 4 cycles of paclitaxel or observation (a second; separately reported doxorubicin dose did not change outcomes
Martin et al. 2005; rec # 47650RCT pre-planned subgroups; 2nd interim analysis of ongoing trialadjuvant therapy for node+ patients after surgery with negative margins14911262229
(no tumor specimens
6 cycles (3 wks each) of docetaxel + doxorubicin + cyclophosphamide (DAC) versus flluorouracil + doxorubicin + cyclophosphamide (FAC); equal proportion (ER or PR)+ patients, each arm took qd tamoxifen for 5 years
Neoadjuvant (Pre-operative) Chemotherapy
Learn et al. 2005; rec. # 476403 arm RCT; retrospective analysis by HER2 statuspre-operative chemotherapy for operable breast cancer (T1–3, N0–1, M0)14410440
(no tumor specimen, 23; HER2 status unknown, 17)
4 cycles AC ± docetaxel (D) q3wk, followed by surgery; 3rd arm given AC + post-surgery D (pooled with AC alone controls for analysis by HER2 status); all patients given 5 yrs of TAM qd
Arriola et al. 2006; rec # 950prospective single-arm seriesprimary chemotherapy for T2–3 N0–1 operable breast cancer2322320doxorubicin (75 mg/m2) 4 cycles, q3wk, then lumpectomy or mastectomy + 3-level axillary dissect.
Park et al. 2003; rec # 9960retrospective single-arm seriespre-operative chemotherapy for locally-advanced disease67670doxorubicin (50 mg/m2) 4 cycles, q3wk, prior to breast conservation or mastectomy
Zhang et al. 2003; rec # 9820retrospective single-arm seriespre-operative chemotherapy for operable breast cancer97970FAC q3wk (6 cycles for 7 patients, 5 cycles for 1, 4 cycles for 81, and 3 cycles for 8)
Tulbah et al. 2002; rec # 11560retrospective single-arm seriespre-operative chemotherapy for locally-advanced, non-inflammatory breast cancer54540paclitaxel + cisplatin, q3wk, for 3 or 4 cycles
Tinari et al. 2006; rec # 2300retrospective single-arm seriespre-operative chemotherapy for operable breast cancer77
(selected; 16 ineligible of 93 consecutive)
770FEC q3wk (median 4 cycles; range 3–6 cycles)
Chemotherapy for Advanced or Metastatic Disease
Harris et al 20061; rec. # 390, no data on no. of sites, 1994-?RCT/RET; CALGB 9342Advanced (Stage IV or inoperable); first or second line Tx. No concurrent hormonal therapy474165
(of n=175 w adequate tumor blocks; n= 10, all bio-marker tests unsuccessful)
299
(n=273, no blocks; n=26, blocks inadequate); similar characteristics & outcomes, w/wo blocks, except DFS
Paclitaxel; compared 3 doses—175, 210, or 250 mg/m2 q3wk to failure (progression or intolerable toxocity)—but data combined for this analysis)
Di Leo et al 2004; rec. # 5970; 29 of 41 sites in original trial, 7/94–1/972Phase III RCT (not blinded); TAX 303 trial; secondary analysisMetastatic disease; first or second line therapy; prior CMF required (adj or for mets); prior anthraciclines or taxanes excluded326176150

(n=74, Grp1; n=76, Grp 2)
Grp 1: doxorubicin (75 mg/m2) (A; n=91) vs Grp 2: docetaxel (100 mg/m2) (T; n=85) every 3 wks; max 7 cycles absent progression or toxicity. No stat sig differences between populations with versus without specimens for HER2 analysis.
Konecny et al 2004; rec. # 6740; ~71 sites, Germany, 10/96–12/99RCT; secondary analysisMetastatic; no prior chemo for metastatic disease, no metastasis to CNS or to bone only. Stratified by 0 vs 1 prior hormonal Tx for metastatic disease.579 enrolled; 516 eligible were randomized & treated275241
(n=219, no block; n=17, technically inadequate; n=5, no invasive cancer; no SS diffs between pts w/wo known HER2 status.
Grp 1: epirubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (EC, n=137); Grp 2: epirubicin (60 mg/m2) and paclitaxel (175 mg/m2)(ET, n=138). Chemo given q3 wks for max of 10 cycles; median=6 cycles.
1

Some data from: Winer EP. Berry DA. Woolf S. Duggan D. Kornblith A. Harris LN. Michaelson RA. Kirshner JA. Fleming GF. Perry MC. Graham ML. Sharp SA. Keresztes R. Henderson IC. Hudis C. Muss H. Norton L. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 22(11):2061–8, 2004 Jun 1.

2

Some data from: Chan S, Friedrichs K, Noel D et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999;17(8):2341–54.

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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