Molecular heterogeneity and response to neoadjuvant human epidermal growth factor receptor 2 targeting in CALGB 40601, a randomized phase III trial of paclitaxel plus trastuzumab with or without lapatinib

Journal of Clinical Oncology

Volumn 34, Issue 6, 2016, Pages 542-549

  Carey, Lisa A ^a   Berry, Donald A ^c   Cirrincione, Constance T ^b   Barry, William T ^d   Pitcher, Brandelyn N ^b   Harris, Lyndsay N ^e   Ollila, David W ^a   Krop, Ian E ^d   Henry, Norah Lynn ^f   Weckstein, Douglas J ^g   Anders, Carey K ^a   Singh, Baljit ^h   Hoadley, Katherine A ^a   Iglesia, Michael ^a   Cheang, Maggie Chon U ⁱ   Perou, Charles M ^a   Winer, Eric P ^d   Hudis, Clifford A ^j  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b DUKE UNIVERSITY   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^f UNIVERSITY OF MICHIGAN   (United States)

^g University of Michigan ^*  (United States)

^h NEW YORK UNIVERSITY   (United States)

ⁱ MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^j INSTITUTE OF CANCER RESEARCH   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; MESSENGER RNA; PACLITAXEL; TRASTUZUMAB; ANTINEOPLASTIC AGENT; ERBB2 PROTEIN, HUMAN; ESTROGEN RECEPTOR; ESTROGEN RECEPTOR ALPHA; ESTROGEN RECEPTOR ALPHA, HUMAN; IMMUNOGLOBULIN G; PROGESTERONE RECEPTOR; PROTEIN P53; QUINAZOLINE DERIVATIVE;

ADULT; AGED; AMPLICON; ARTICLE; CANCER ADJUVANT THERAPY; CANCER PATIENT; CONTROLLED STUDY; DRUG WITHDRAWAL; FEMALE; GENE EXPRESSION; GENE MUTATION; GENE SEQUENCE; GENOMICS; HUMAN; LOADING DRUG DOSE; LUMINAL A BREAST CANCER; LUMINAL B BREAST CANCER; MAJOR CLINICAL STUDY; MINIMAL RESIDUAL DISEASE; MULTIPLE CYCLE TREATMENT; ONCOGENE NEU; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT RESPONSE; TUMOR MICROENVIRONMENT; TUMOR SUPPRESSOR GENE; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; CARCINOMA; CHEMISTRY; CLINICAL TRIAL; GENETICS; METABOLISM; MIDDLE AGED; NEOADJUVANT THERAPY; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA; ESTROGEN RECEPTOR ALPHA; FEMALE; GENE EXPRESSION; HUMANS; IMMUNOGLOBULIN G; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM, RESIDUAL; PACLITAXEL; QUINAZOLINES; RECEPTOR, ERBB-2; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; RNA, MESSENGER; TRASTUZUMAB; TREATMENT OUTCOME; TUMOR MICROENVIRONMENT; TUMOR SUPPRESSOR PROTEIN P53; YOUNG ADULT;

EID: 84964308576     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.62.1268     Document Type: Article

References (37)

1. Perez EA, Romond EH, Suman VJ, et al: Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: Planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol 32: 3744-3752, 2014
2. Baselga J, Corté s J, Kim SB, et al: Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 366:109-119, 2012
3. Blackwell KL, Burstein HJ, Storniolo AM, et al: Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: Final results from the EGF104900 study. J Clin Oncol 30:2585-2592, 2012
4. Prowell TM, Pazdur R: Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 366:2438-2441, 2012
5. Baselga J, Bradbury I, Eidtmann H, et al: Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): A randomised, openlabel, multicentre, phase 3 trial. Lancet 379: 633-640, 2012
6. Gianni L, Pienkowski T, Im YH, et al: Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): A randomised multicentre, open-label, phase 2 trial. Lancet Oncol 13:25-32, 2012
7. Robidoux A, Tang G, Rastogi P, et al: Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): An open-label, randomised phase 3 trial. Lancet Oncol 14:1183-1192, 2013
8. Piccart-Gebhart MJ, Holmes AP, Baselga J, et al: First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T-L), or their combination (T1L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol 32:4s, 2014 (suppl 15s; abstr LBA4)
9. Montemurro F, Prat A, Rossi V, et al: Potential biomarkers of long-term benefit from single-agent trastuzumab or lapatinib in HER2-positive metastatic breast cancer. Mol Oncol 8:20-26, 2014
10. Pogue-Geile KL, Kim C, Jeong JH, et al: Predicting degree of benefit from adjuvant trastuzumab in NSABP trial B-31. J Natl Cancer Inst 105: 1782-1788, 2013
11. Dave B, Migliaccio I, Gutierrez MC, et al: Loss of phosphatase and tensin homolog or phosphoinositol-3 kinase activation and response to trastuzumab or lapatinib in human epidermal growth factor receptor 2-overexpressing locally advanced breast cancers. J Clin Oncol 29:166-173, 2011
12. Berns K, Horlings HM, Hennessy BT, et al: A functional genetic approach identifies the PI3K pathway as a major determinant of trastuzumab resistance in breast cancer. Cancer Cell 12:395-402, 2007
13. Nagata Y, Lan K, Zhou X, et al: PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 6:17-27, 2004
14. Wang L, Zhang Q, Zhang J, et al: P13K pathway activation results in low efficacy of both trastuzumab and lapatinib. BMC Cancer 11:248, 2011
15. Loi S, Michiels S, Salgado R, et al: Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: Results from the FinHER trial. Ann Oncol 25:1544-1550, 2014
16. Bianchini G, Gianni L: The immune system and response to HER2-targeted treatment in breast cancer. Lancet Oncol 15:e58-e68, 2014
17. Wolff A, Hammond M, Schwartz J, 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 25:118-145, 2007
18. Iglesia MD, Vincent BG, Parker JS, et al: Prognostic B-cell signatures using mRNA-seq in patients with subtype-specific breast and ovarian cancer. Clin Cancer Res 20:3818-3829, 2014
19. Fan C, Prat A, Parker JS, et al: Building prognostic models for breast cancer patients using clinical variables and hundreds of gene expression signatures. BMC Med Genomics 4:3, 2011
20. Hoadley KA, Weigman VJ, Fan C, et al: EGFR associated expression profiles vary with breast tumor subtype. BMC Genomics 8:258, 2007
21. Herschkowitz JI, Simin K, Weigman VJ, et al: Identification of conserved gene expression features between murine mammary carcinoma models and human breast tumors. Genome Biol 8:R76, 2007
22. Hutti JE, Pfefferle AD, Russell SC, et al: Oncogenic PI3K mutations lead to NF-kappaBdependent cytokine expression following growth factor deprivation. Cancer Res 72:3260-3269, 2012
23. Hu Z, Fan C, Livasy C, et al: A compact VEGF signature associated with distant metastases and poor outcomes. BMC Med 7:9, 2009
24. Hammerman PS, Lawrence MS, Voet D, et al: Comprehensive genomic characterization of squamous cell lung cancers. Nature 489:519-525, 2012
25. Parker JS, Mullins M, Cheang MC, et al: Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol 27:1160-1167, 2009
26. Oh DS, Troester MA, Usary J, et al: Estrogenregulated genes predict survival in hormone receptor-positive breast cancers. J Clin Oncol 24: 1656-1664, 2006
27. Troester MA, Herschkowitz JI, Oh DS, et al: Gene expression patterns associatedwith p53 status in breast cancer. BMC Cancer 6:276, 2006
28. Alexe G, Dalgin GS, Scanfeld D, et al: High expression of lymphocyte-associated genes in nodenegative HER21 breast cancers correlates with lower recurrence rates. Cancer Res 67:10669-10676, 2007
29. Perou CM, Sørlie T, Eisen MB, et al: Molecular portraits of human breast tumours. Nature 406: 747-752, 2000
30. Weigelt B, Mackay A, A'Hern R, et al: Breast cancer molecular profiling with single sample predictors: A retrospective analysis. Lancet Oncol 11: 339-349, 2010
31. Hatzis C, Sun H, Yao H, et al: Effects of tissue handling on RNA integrity and microarray measurements from resected breast cancers. J Natl Cancer Inst 103:1871-1883, 2011
32. Guarneri V, Frassoldati A, Bottini A, et al: Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: Results of the randomized phase II CHER-LOB study. J Clin Oncol 30:1989-1995, 2012
33. Bellati F, Napoletano C, Ruscito I, et al: Cellular adaptive immune system plays a crucial role in trastuzumab clinical efficacy. J Clin Oncol 28: E369-e370, 2010; author reply e371
34. Ferris RL, Jaffee EM, Ferrone S: Tumor antigen-targeted, monoclonal antibody-based immunotherapy: Clinical response, cellular immunity, and immunoescape. J Clin Oncol 28:4390-4399, 2010
35. Gianni L, Bianchini G, Valagussa P, et al: Adaptive immune system and immune checkpoints are associated with response to pertuzumab (P) and trastuzumab (H) in the NeoSphere study. Cancer Res 72, 2012 (suppl 24; abstr s6-7)
36. Perez EA, Thompson EA, Ballman KV, et al: Genomic analysis reveals that immune function genes are strongly linked to clinical outcome in the North Central Cancer Treatment Group N9831 adjuvant trastuzumab trial. J Clin Oncol 33:701-708, 2015
37. Theriault RL, Carlson RW, Allred C, et al: Breast cancer, version 3.2013: Featured updates to the NCCN guidelines. J Natl Compr Canc Netw 11: 753-761, 2013