Coping with uncertainty: T1a,bN0M0 HER2-positive breast cancer, do we have a treatment threshold?

Annals of Oncology

Volumn 22, Issue 11, 2011, Pages 2387-2393

  Kelly, C M ^a   Pritchard, K I ^b   Trudeau, M ^b   Andreopoulou, E ^c   Hess, K ^c   Pusztai, L ^c  

^a WATERFORD REGIONAL HOSPITAL   (Ireland)

^b SUNNYBROOK RESEARCH INSTITUTE   (Canada)

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

Author keywords

Adjuvant therapy; Breast cancer; HER2 positive; Small HER2 positive cancers; T1a,bM0N0

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; TRASTUZUMAB;

ANALYTICAL PARAMETERS; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER SIZE; CANCER STAGING; CARDIOTOXICITY; CAUSE OF DEATH; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; COMORBIDITY; CONGESTIVE HEART FAILURE; DATA BASE; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG SAFETY; HEALTH CARE QUALITY; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; MEDICAL DECISION MAKING; MORTALITY; NUMBER NEEDED TO HARM; NUMBER NEEDED TO TREAT; OUTCOME ASSESSMENT; PREDICTION; PRIORITY JOURNAL; PROGNOSIS; PROTEIN ANALYSIS; PROTEIN EXPRESSION; RECURRENCE RISK; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SIDE EFFECT;

EID: 80155164070     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq786     Document Type: Article

References (38)

1. McNeil BJ. Shattuck Lecture-hidden barriers to improvement in the quality of care. N Engl J Med 2001; 345: 1612-1620.
2. Burstein HJ, Winer EP. Refining therapy for human epidermal growth factor receptor 2-positive breast cancer: T stands for trastuzumab, tumor size, and treatment strategy. J Clin Oncol 2009; 27: 5671-5673.
3. Petrelli F, Barni S. Should adjuvant trastuzumab be offered in very early-stage (pT1a/bN0M0) HER2-neu-positive breast cancer? A current debate. Med Oncol 2010. [Epub ahead of print] doi:10.1007/s12032-010-9460-0.
4. Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005; 353: 1659-1672.
5. 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.
6. Slamon D, Eiermann W, Robert N et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2neu positive early breast cancer patients: BCIRG 006 study. Presented at the 32nd Annual San Antonio Breast Cancer Symposium, San Antonio, TX, 9-13 December 2009.
7. Joensuu H, Bono P, Kataja V et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol 2009; 27: 5685-5692.
8. Spielmann M, Roche H, Delozier T et al. Trastuzumab for patients with axillarynode-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol 2009; 27: 6129-6134.
9. Hanrahan EO, Gonzalez-Angulo AM, Giordano SH et al. Overall survival and cause-specific mortality of patients with stage T1a, bN0M0 breast carcinoma. J Clin Oncol 2007; 25: 4952-4960.
10. Curigliano G, Viale G, Bagnardi V et al. Clinical relevance of HER2 overexpression/amplification in patients with small tumor size and node-negative breast cancer. J Clin Oncol 2009; 27: 5693-5699.
11. Gonzalez-Angulo AM, Litton JK, Broglio KR et al. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller. J Clin Oncol 2009; 27: 5700-5706.
12. Park YH, Kim ST, Cho EY et al. A risk stratification by hormonal receptors (ER, PgR) and HER-2 status in small (< or = 1 cm) invasive breast cancer: who might be possible candidates for adjuvant treatment? Breast Cancer Res Treat 2010; 119: 653-661.
13. Harris L, Fritsche H, Mennel R et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2007; 25: 5287-5312.
14. Yamauchi H, Stearns V, Hayes DF. When is a tumor marker ready for prime time? A case study of c-erbB-2 as a predictive factor in breast cancer. J Clin Oncol 2001; 19: 2334-2356.
15. Edge SB, Byrd DR, Compton CC et al. (eds). AJCC Cancer Staging Manual, 7th edition. New York: Springer 2009.
16. National Comprehensive Cancer Network. Practice guidelines in oncology-V.2.2010. Breast Cancer 2010; http://www.nccn.org (31 March 2010, date last accessed).
17. Ewer MS, Lippman SM. Type II chemotherapy-related cardiac dysfunction: time to recognize a new entity. J Clin Oncol 2005; 23: 2900-2902.
18. Hayes DF, Picard MH. Heart of darkness: the downside of trastuzumab. J Clin Oncol 2006; 24: 4056-4058.
19. Albini A, Pennesi G, Donatelli F et al. Cardiotoxicity of anticancer drugs: the need for cardio-oncology and cardio-oncological prevention. J Natl Cancer Inst 2010; 102: 14-25.
20. Telli ML, Hunt SA, Carlson RW et al. Trastuzumab-related cardiotoxicity: calling into question the concept of reversibility. J Clin Oncol 2007; 25: 3525-3533.
21. Dahabreh IJ, Linardou H, Siannis F et al. Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist 2008; 13: 620-630.
22. Bria E, Cuppone F, Fornier M et al. Cardiotoxicity and incidence of brain metastases after adjuvant trastuzumab for early breast cancer: the dark side of the moon? A meta-analysis of the randomized trials. Breast Cancer Res Treat 2008; 109: 231-239.
23. Chia S, Norris B, Speers C et al. Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of nodenegative breast cancers. J Clin Oncol 2008; 26: 5697-5704.
24. Joensuu H, Isola J, Lundin M et al. Amplification of erbB2 and erbB2 expression are superior to estrogen receptor status as risk factors for distant recurrence in pT1N0M0 breast cancer: a nationwide population-based study. Clin Cancer Res 2003; 9: 923-930.
25. Slamon D, Eiermann W, Robert N et al. BCIRG 006 phase III trial comparing AC/T with AC/TH and with TCH in the adjuvant treatment of HER2-amplified early breast cancer patients: third planned efficacy analysis. Presented at San Antonio Annual Breast Cancer Symposium, San Antonio, TX, 10-13 December 2009.
26. Untch M, Gelber RD, Jackisch C et al. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial. Ann Oncol 2008; 19: 1090-1096.
27. Perez EA, Suman VJ, Davidson NE et al. Interim cardiac safety analysis of NCCTG N9831 Intergroup adjuvant trastuzumab trial. J Clin Oncol 2005; 23: 556 (Meeting Abstr).
28. Rastogi P, Jeong J, Geyer CE et al. Five year update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)/paclitaxel (T) vs. AC/T with trastuzumab(H). J Clin Oncol 2007; 25 (Suppl 18): (Abstr LBA513). ASCO Annual Meeting Proceedings Part I.
29. Smith I, Procter M, Gelber RD et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007; 369: 29-36.
30. Procter M, Suter TM, de Azambuja E et al. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. J Clin Oncol 2010; 28: 3422-3428.
31. Slamon D, Eiermann W, Robert N, Pienkowski T. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study. Breast Cancer Res Treat 2006; 100 (Suppl 1): 52.
32. Tan-Chiu E, Yothers G, Romond E et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol 2005; 23: 7811-7819.
33. Parmar M, Machin D. Survival Analysis: A Practical Approach. Chichester, UK: Wiley 1995.
34. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318: 1728-1733.
35. Adjuvant! Online. http://www.adjuvantonline.com/ (31 May 2010, date last accessed).
36. American College of Cardiology. CardioSmart Heart Disease Risk Assessment. http://www.cardiosmart.org/ (12 May 2010, date last accessed).
37. American Heart Association. Heart Attack Risk Calculator. https://www.americanheart.org/gglRisk/locale/en_US/ (12 May 2010, date last accessed).
38. Knauer M, Cardoso F, Wesseling J et al. Identification of a low-risk subgroup of HER-2-positive breast cancer by the 70-gene prognosis signature. Br J Cancer 2010; 103: 1788-1793.