Soluble human epidermal growth factor receptor 2 (HER2) levels in patients with HER2-positive breast cancer receiving chemotherapy with or without trastuzumab: Results from North Central Cancer Treatment Group adjuvant trial N9831

Cancer

Volumn 119, Issue 15, 2013, Pages 2675-2682

  Moreno Aspitia, Alvaro ^a   Hillman, David W ^b   Dyar, Stephen H ^a   Tenner, Kathleen S ^b   Gralow, Julie ^c   Kaufman, Peter A ^d,g   Davidson, Nancy E ^e,f   Lafky, Jacqueline M ^b   Reinholz, Monica M ^b   Lingle, Wilma L ^b   Kutteh, Leila A ^b   Carney, Walter P ^b   Dueck, Amylou C ^b   Perez, Edith A ^a  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c SEATTLE CANCER CARE ALLIANCE   (United States)

^d DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^e UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^f Oncology Associates of Cedar Rapids   (United States)

^g Oncogene Science   (United States)

Author keywords

biomarker; breast cancer; extracellular domain; HER2 positive; human epidermal growth factor receptor 2; serum HER2

Indexed keywords

BIOLOGICAL MARKER; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; SOLUBLE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB; UNCLASSIFIED DRUG;

ADULT; AGE; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PROGNOSIS; CANCER STAGING; CONFIDENCE INTERVAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FEMALE; HAZARD RATIO; HORMONE RECEPTOR STATUS; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MENOPAUSE; MULTIPLE CYCLE TREATMENT; ONCOLOGICAL PARAMETERS; OVERALL SURVIVAL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; RECURRENT DISEASE; SHORT TERM SURVIVAL; STATISTICAL MODEL;

BIOMARKER; BREAST CANCER; EXTRACELLULAR DOMAIN; HER2-POSITIVE; HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2; SERUM HER2;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HUMANS; MIDDLE AGED; MULTIVARIATE ANALYSIS; NEOPLASM RECURRENCE, LOCAL; RECEPTOR, ERBB-2; TUMOR MARKERS, BIOLOGICAL; YOUNG ADULT;

EID: 84880569581     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28130     Document Type: Article

References (33)

1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM,. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010; 127: 2893-2917.
2. Cianfrocca M, Goldstein LJ,. Prognostic and predictive factors in early-stage breast cancer. Oncologist. 2004; 9: 606-616.
3. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235: 177-182.
4. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005; 353: 1673-1684.
5. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol. 1996; 14: 737-744.
6. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011; 29: 3366-3373.
7. Perez EA, Suman VJ, Rowland KM, et al. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005; 6: 425-432.
8. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007; 25: 118-145.
9. Codony-Servat J, Albanell J, Lopez-Talavera JC, et al. Cleavage of the HER2 ectodomain is a pervanadate-activable process that is inhibited by the tissue inhibitor of metalloproteases-1 in breast cancer cells. Cancer Res. 1999; 59: 1196-1201.
10. Sias PE, Kotts CE, Vetterlein D, et al. ELISA for quantitation of the extracellular domain of p185HER2 in biological fluids. J Immunol Methods. 1990; 132: 73-80.
11. Carney WP, Neumann R, Lipton A, et al. Potential clinical utility of serum HER-2/neu oncoprotein concentrations in patients with breast cancer. Clin Chem. 2003; 49: 1579-1598.
12. Hayes DF, Yamauchi H, Broadwater G, et al. Circulating HER-2/erbB-2/c-neu (HER-2) extracellular domain as a prognostic factor in patients with metastatic breast cancer: Cancer and Leukemia Group B Study 8662. Clin Cancer Res. 2001; 7: 2703-2711.
13. Lennon S, Barton C, Banken L, et al. Utility of serum HER2 extracellular domain assessment in clinical decision making: pooled analysis of 4 trials of trastuzumab in metastatic breast cancer. J Clin Oncol. 2009; 27: 1685-1693.
14. Lipton A, Leitzel K, Ali SM, et al. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011; 117: 5013-5020.
15. Perez EA, Suman VJ, Davidson NE, et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011; 29: 4491-4497.
16. Payne RC, Allard JW, Anderson-Mauser L, et al. Automated assay for HER-2/neu in serum. Clin Chem. 2000; 46: 175-182.
17. Bramwell VH, Doig GS, Tuck AB, et al. Changes over time of extracellular domain of HER2 (ECD/HER2) serum levels have prognostic value in metastatic breast cancer. Breast Cancer Res Treat. 2009; 114: 503-511.
18. Ludovini V, Gori S, Colozza M, et al. Evaluation of serum HER2 extracellular domain in early breast cancer patients: correlation with clinicopathological parameters and survival. Ann Oncol. 2008; 19: 883-890.
19. Witzel I, Loibl S, von Minckwitz G, et al. Monitoring serum HER2 levels during neoadjuvant trastuzumab treatment within the GeparQuattro trial. Breast Cancer Res Treat. 2010; 123: 437-445.
20. Witzel I, Loibl S, von Minckwitz G, et al. Predictive value of HER2 serum levels in patients treated with lapatinib or trastuzumab-a translational project in the neoadjuvant GeparQuinto trial. Br J Cancer. 2012; 107: 956-960.
21. Molina MA, Codony-Servat J, Albanell J, et al. Trastuzumab (Herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001; 61: 4744-4749.
22. Scaltriti M, Rojo F, Ocana A, et al. Expression of p95HER2, a truncated form of the HER2 receptor, and response to anti-HER2 therapies in breast cancer. J Natl Cancer Inst. 2007; 99: 628-638.
23. Loibl S, Bruey J, Von Minckwitz G, et al. Validation of p95 as a predictive marker for trastuzumab-based therapy in primary HER2-positive breast cancer: a translational investigation from the neoadjuvant GeparQuattro study [abstract]. J Clin Oncol. 2011; 29 (suppl). Abstract 530.
24. Perez EA, Dueck AC, Reinholz MM, et al. Effect of PTEN protein expression on benefit to adjuvant trastuzumab in early-stage HER2+ breast cancer in NCCTG adjuvant trial N9831 [abstract]. J Clin Oncol. 2011; 29 (suppl). Abstract 10504.
25. Cook JW, Paxinos E, Goodman LJ, et al. Mutations of the catalytic domain of PI3 kinase and correlation with clinical outcome in trastuzumab-treated metastatic breast cancer (MBC) [abstract]. J Clin Oncol. 2011; 29 (suppl). Abstract 582.
26. LoRusso P, Krop IE, Burris HA, et al. Quantitative assessment of diagnostic markers and correlations with efficacy in 2 phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy [abstract]. Proc Am Soc Clin Oncol. 2010; 28. Abstract 1016.
27. Burcombe RJ, Makris A, Wilson G, et al. Evaluation of topoisomerase II-alpha as a predictor of clinical and pathological response to neoadjuvant chemotherapy in operable breast cancer [abstract]. Proc Am Soc Clin Oncol. 2002; 21. Abstract 1785.
28. Pritchard KI, Messersmith H, Elavathil L, et al. HER-2 and topoisomerase II as predictors of response to chemotherapy. J Clin Oncol. 2008; 26: 736-744.
29. Esteva FJ, Hortobagyi GN,. Topoisomerase IIα amplification and anthracycline-based chemotherapy: the jury is still out. J Clin Oncol. 2009; 27: 3416-3417.
30. Harris LN, Broadwater G, Abu-Khalaf M, et al. Topoisomerase IIα amplification does not predict benefit from dose-intense cyclophosphamide, doxorubicin, and fluorouracil therapy in HER2-amplified early breast cancer: results of CALGB 8541/150013. J Clin Oncol. 2009; 27: 3430-3436.
31. Perez EA, Jenkins RB, Dueck AC, et al. C-MYC alterations and association with patient outcome in early-stage HER2-positive breast cancer from the North Central Cancer Treatment Group N9831 adjuvant trastuzumab trial. J Clin Oncol. 2011; 29: 651-659.
32. Yerushalmi R, Gelmon KA, Leung S, et al. Insulin-like growth factor receptor (IGF-1R) in breast cancer subtypes. Breast Cancer Res Treat. 2012; 132: 131-142.
33. Reinholz MM, Dueck AC, Chen B, et al. Effect of IGF1R protein expression on benefit to adjuvant trastuzumab in early-stage HER2+ breast cancer in NCCTG N9831 trial [abstract]. J Clin Oncol. 2011; 29 (suppl). Abstract 10503.