NCT00950300.

LV and LG seem to be active combinations in patients with HER2(+) MBC after taxane failure. The overall toxicity was manageable in all regimens.

Background: The achievement of pCR (breast and axilla) is strongly prognostic for event-free (EFS) and overall survival (OS) in EBC (Cortazar 2014), and modulation of therapy improves long-term outcomes for patients with HER2-positive disease not achieving pCR (Von Minckwitz 2019). We sought to investigate prognostic factors for EFS and OS among patients with and without pCR following neoadjuvant systemic treatment consisting of chemotherapy plus anti-HER2 therapy. Methods: We used individual data from 3,710 patients randomized in 11 neoadjuvant trials for HER2-positive EBC with N≥100 patients enrolled, available data for pCR, EFS, and OS, and follow-up ≥3 years. We assessed baseline clinical tumor size (cT) and clinical nodal status (cN) as prognostic factors using stratified (by trial and treatment) Cox models separately for hormone-receptor (HR)-positive vs. HR-negative disease, and for patients who achieved pCR (pCR+; ypT0/is, ypN0) vs. patients who did not achieve pCR (pCR-). Results: The median follow-up overall was 61.2 months. The table shows hazard ratios and 5-year Kaplan-Meier estimates of OS (5yr OS) according to HR and pCR. Comparable results were observed for EFS. Both cT (1-2 vs. 3-4) and cN (cN- vs. cN+) were independent prognostic factors for OS in most subsets, including in pCR+ patients. Conclusions: These results confirm that patients achieving pCR have far better long-term outcomes than patients who do not, and that traditional poor prognostic features namely tumour size and nodal status remain important even after a pCR, with no clear evidence that the relative impact of unfavourable (cT3-4 or cN+) features is different in patients who achieve a pCR than in those who did not. Key words: neo-adjuvant therapy, HER2-targeted therapy, pathological complete response, prognostic factors, overall survival Funding: German Breast Group HR pCRBaseline cT/cN DeathsPatients5yr OS (%)Hazard ratio* [95% CI]HR+ pCR+cT1-2/cN-521298.6%1.0 (reference)(N= 637)cT3-4/cN-46592.9%0.49 [0.21-1.14]cT1-2/cN+720095.1%0.82 [0.34-1.99]cT3-4/cN+1016094.0%0.40 [0.13-1.25]HR+ pCR-cT1-2/cN-1737796.3%1.0 (reference)(N=1399)cT3-4/cN-2514381.8%0.51 [0.36-0.73]cT1-2/cN+4844888.9%0.71 [0.49-1.03]cT3-4/cN+6443184.9%0.36 [0.23-0.58]HR- pCR+cT1-2/cN-319698.1%1.0 (reference)(N=860)cT3-4/cN-89090.4%0.56 [0.32-0.98]cT1-2/cN+1928092.4%0.49 [0.24-0.98]cT3-4/cN+3029489.5%0.27 [0.12-0.64]HR- pCR-cT1-2/cN-2114083.2%1.0 (reference)(N=814)cT3-4/cN-207871.4%0.46 [0.34-0.64]cT1-2/cN+4225181.6%0.76 [0.53-1.09]cT3-4/cN+11634561.9%0.35 [0.22-0.56]*Hazard ratio cT1-2/cN- vs. higher risk cohorts Citation Format: Sibylle Loibl, Michael Untch, Marc Buyse, André Robidoux, Luca Gianni, Andreas Schneeweiss, Pierfranco Conte, Martine Piccart, Hervé Bonnefoi, Christian Jackisch, Valentina Nekljudova, Joseph Costantino, Pinuccia Valagussa, Colin Neate, Richard Gelber, Coralie Poncet, Pierre Squifflet, Everardo Saad, Dominik Heinzmann, Carsten Denkert, Charles E Geyer, Javier Cortes, Valentina Guarneri, Evandro de Azambuja, David Cameron, Gustavo Ismael, Gunter von Minckwitz, Norman Wolmark, Patricia Cortazar. Pathologic complete response (pCR) and prognosis following neoadjuvant chemotherapy plus anti-HER2 therapy of HER2-positive early breast cancer (EBC) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-06-02.

Background Randomised clinical trials (RCT) are considered a gold standard generating efficacy and safety data supporting drug approval. However, real world data (RWD) reflecting health care delivery is becoming increasingly important. RWD on patient profiles and patterns of care in MBC are scarce in developing countries. As an example, observational studies suggest that despite guideline recommendations clearly indicating ET for hormone receptor positive MBC, a considerable proportion of patients in clinical practice begin chemotherapy in early lines of therapy. This pragmatic information addresses the uptake and applicability of the RCT results and should be able to help informing health care planning complementing RCT generated data. The objective of this study is to describe patient characteristics and evaluate actual physician-reported treatments for MBC in Brazil. Methods This analysis addresses the first 362 patients included in LACOG-0312, a retrospective study planning to recruit over 700 patients (cut-off date April 30th 2016) with recurrent locally advanced or MBC diagnosed in 2012 in 18 institutions across Brazil. Patient characteristics, type of health insurance coverage, treatment and survival outcome were analysed. Results Median age at BC diagnosis was 53 years and 37% were premenopausal. Regarding the educational level, 63.2% had completed elementary (primary) schooling, 75.7% were covered by the public health system while 24.3% had some form of private coverage. 70% of patients had hormone receptor positive (HR+) and 18% had HER2 positive tumors. Median disease free survival time from surgery was 29 months. Interestingly, 30% of patients underwent a biopsy of a metastatic site. Of the 362 patients, 349 (96.9%) received some form of palliative systemic therapy. Median time from diagnosis of metastatic disease to first-line therapy initiation was 46 days but a significant difference was noted between patients with public versus private health insurance (50 vs. 33 days p=0.012). Half of the patients received at least 3 lines of therapy (chemo or endocrine) to a maximum of 9 lines. In patients with HR+ tumors, endocrine therapy was administered in 47% in first, 65% in second and 61% in third-line, respectively. Median overall survival (OS) from diagnosis of metastatic disease was 34 months (CI 95%: 25.7-44.3) and no differences in OS were observed between patients with public or private coverage (34 months vs. 35 months p=0.808). Causes of death were cancer in 85.2% of patients and treatment toxicity in 3.6%. Conclusion Our study included a population with predominantly low educational level and mostly public health insurance. This likely corresponds to the majority of cases and reflects cancer care patterns in Brazil and many developing countries. A considerable proportion of patients were premenopausal at MBC diagnosis. More than half of HR+ patients received at least 3 lines of endocrine therapy although 54% of them had chemotherapy as the first systemic treatment. Patients from the public health system experienced a delay in starting first-line therapy but this didn't seem to jeopardize cancer outcomes in this setting. Citation Format: Barrios CH, Uema D, Cronenberger E, Lima V, Bines J, de Sant'ana RO, Batista ML, Dybal V, Liedke P, Beato C, Nerón YV, Giacomazzi J, dos Santos L, Ismael G, Azambuja A, Andrade D, Rosa DD, Borges G, Mano M, Martinez-Mesa J, Zaffaroni F, Werutsky G. Real World data and patterns of care of metastatic breast cancer (MBC) in Brazil: First results of LACOG 0312 retrospective study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-16-04.

No abstract