PMID- 19884543 OWN - NLM STAT- MEDLINE DCOM- 20091223 LR - 20220318 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 27 IP - 34 DP - 2009 Dec 1 TI - 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. PG - 5700-6 LID - 10.1200/JCO.2009.23.2025 [doi] AB - PURPOSE: To evaluate the risk of recurrence in women diagnosed with T1a and T1b, node-negative, human epidermal growth factor receptor 2 (HER2) -positive breast cancer. METHODS: We reviewed 965 T1a,bN0M0 breast cancers diagnosed at our institution between 1990 and 2002. Dedicated breast pathologists confirmed HER2 positivity if 3+ by immunohistochemistry or if it had a ratio of 2.0 or greater by fluorescence in situ hybridization (FISH). Patients who received adjuvant chemotherapy or trastuzumab were excluded. Kaplan-Meier product was used to calculate recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were fit to determine associations between HER2 status and survival after adjustment for patient and disease characteristics. Additionally, 350 breast cancers from two other institutions were used for validation. RESULTS: Ten percent of patients had HER2-positive tumors. At a median follow-up of 74 months, there were 72 recurrences. The 5-year RFS rates were 77.1% and 93.7% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). The 5-year DRFS rates were 86.4% and 97.2% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). In multivariate analysis, patients with HER2-positive tumors had higher risks of recurrence (hazard ratio [HR], 2.68; 95% CI, 1.44 to 5.0; P = .002) and distant recurrence (HR, 5.3; 95% CI, 2.23 to 12.62; P < .001) than those with HER2-negative tumors. Patients with HER2-positive tumors had 5.09 times (95% CI, 2.56 to 10.14; P < .0001) the rate of recurrences and 7.81 times (95% CI, 3.17 to 19.22; P < .0001) the rate of distant recurrences at 5 years compared with patients who had hormone receptor-positive tumors. CONCLUSION: Patients with HER2-positive T1abN0M0 tumors have a significant risk of relapse and should be considered for systemic, anti-HER2, adjuvant therapy. FAU - Gonzalez-Angulo, Ana M AU - Gonzalez-Angulo AM AD - Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030-4009, USA. agonzalez@mdanderson.org FAU - Litton, Jennifer K AU - Litton JK FAU - Broglio, Kristine R AU - Broglio KR FAU - Meric-Bernstam, Funda AU - Meric-Bernstam F FAU - Rakkhit, Ronjay AU - Rakkhit R FAU - Cardoso, Fatima AU - Cardoso F FAU - Peintinger, Florentia AU - Peintinger F FAU - Hanrahan, Emer O AU - Hanrahan EO FAU - Sahin, Aysegul AU - Sahin A FAU - Guray, Merih AU - Guray M FAU - Larsimont, Denis AU - Larsimont D FAU - Feoli, Francesco AU - Feoli F FAU - Stranzl, Heidi AU - Stranzl H FAU - Buchholz, Thomas A AU - Buchholz TA FAU - Valero, Vicente AU - Valero V FAU - Theriault, Richard AU - Theriault R FAU - Piccart-Gebhart, Martine AU - Piccart-Gebhart M FAU - Ravdin, Peter M AU - Ravdin PM FAU - Berry, Donald A AU - Berry DA FAU - Hortobagyi, Gabriel N AU - Hortobagyi GN LA - eng GR - K23 CA121994/CA/NCI NIH HHS/United States GR - 1K23 CA121994-01/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20091102 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM CIN - J Clin Oncol. 2009 Dec 1;27(34):5671-3. PMID: 19884535 CIN - J Clin Oncol. 2010 Jun 10;28(17):e281; author reply e282-3. PMID: 20368535 CIN - J Clin Oncol. 2010 Jun 10;28(17):e279-80; author reply e282-3. PMID: 20406920 MH - Adult MH - Aged MH - Aged, 80 and over MH - Breast Neoplasms/*chemistry/*pathology MH - Disease-Free Survival MH - Female MH - Humans MH - Lymphatic Metastasis MH - Middle Aged MH - Neoplasm Metastasis MH - Neoplasm Recurrence, Local MH - Prognosis MH - Receptor, ErbB-2/*analysis/*metabolism MH - Receptors, Estrogen/analysis/metabolism MH - Receptors, Progesterone/analysis/metabolism MH - Risk Factors PMC - PMC2792998 COIS- Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. EDAT- 2009/11/04 06:00 MHDA- 2009/12/24 06:00 PMCR- 2010/12/01 CRDT- 2009/11/04 06:00 PHST- 2009/11/04 06:00 [entrez] PHST- 2009/11/04 06:00 [pubmed] PHST- 2009/12/24 06:00 [medline] PHST- 2010/12/01 00:00 [pmc-release] AID - JCO.2009.23.2025 [pii] AID - 32025 [pii] AID - 10.1200/JCO.2009.23.2025 [doi] PST - ppublish SO - J Clin Oncol. 2009 Dec 1;27(34):5700-6. doi: 10.1200/JCO.2009.23.2025. Epub 2009 Nov 2.