PurposeTo describe the clinical features and outcomes of estrogen receptor negative (ER-) and progesterone receptor positive (PgR+) breast cancer.MethodsWe retrospectively reviewed a well-characterized database of sequential patients diagnosed with early stage invasive breast carcinoma. Outcomes of interest were time to relapse (TTR) and overall survival (OS). Multivariable Cox proportional hazards analysis was conducted to assess the association of ER-/PgR+ with TTR and OS in comparison to ER+ and to ER- and PgR negative (ER-/PgR-) tumors irrespective of HER2 status. ER and PgR expression was conservatively defined as 10% or greater staining of cancer cells.Results815 patients were followed for a median of 40.5 months; 56 patients (7%) had ER-/PgR+, 624 (77%) had ER+ and 136 (17%) had ER-/PgR- phenotypes. Compared with ER+ tumors, ER-/PgR+ tumors were associated with younger age (50 versus 59 years, p=0.03), high grade (50% versus 24%, p<0.001) and more frequent HER2 overexpression/amplification (43% versus 14%, p<0.001). TTR for ER-/PgR+ was intermediate between ER+ and ER-/PgR- tumors, but was not significantly different from ER+ tumors. Recurrences in the ER-/PgR+ and ER-/PgR- groups occurred early in follow-up while in ER+ tumors recurrences continued to occur over the duration of follow-up. OS of ER-/PgR+ was similar to ER+ tumors and better than that of ER-/PgR- tumors.ConclusionsThe ER-/PgR+ phenotype is associated with higher grade with HER2 overexpression/amplification and occurs more commonly in younger women. Risk of relapse and death more closely resembles ER+ than ER-/PgR- tumors suggesting this phenotype represents a group of more aggressive hormone receptor positive tumors.

The objective was to compare the performance of the updated Charlson comorbidity index (uCCI) and classical CCI (cCCI) in predicting 30-day mortality in patients with Staphylococcus aureus bacteraemia (SAB). All cases of SAB in patients aged ⩾14 years identified at the Microbiology Unit were included prospectively and followed. Comorbidity was evaluated using the cCCI and uCCI. Relevant variables associated with SAB-related mortality, along with cCCI or uCCI scores, were entered into multivariate logistic regression models. Global model fit, model calibration and predictive validity of each model were evaluated and compared. In total, 257 episodes of SAB in 239 patients were included (mean age 74 years; 65% were male). The mean cCCI and uCCI scores were 3.6 (standard deviation, 2.4) and 2.9 (2.3), respectively; 161 (63%) cases had cCCI score ⩾3 and 89 (35%) cases had uCCI score ⩾4. Sixty-five (25%) patients died within 30 days. The cCCI score was not related to mortality in any model, but uCCI score ⩾4 was an independent factor of 30-day mortality (odds ratio, 1.98; 95% confidence interval, 1.05-3.74). The uCCI is a more up-to-date, refined and parsimonious prognostic mortality score than the cCCI; it may thus serve better than the latter in the identification of patients with SAB with worse prognoses.

Background: Eribulin is the only cancer agent that has demonstrated a significant prolongation in overall survival on previously treated breast cancer patients. To date, no biomarker exists to prospectively select patients who will derive the maximum benefit from this chemotherapeutic. In the SOLTI1007-NeoEribulin study, we explored, in a prospective clinical trial, the efficacy and the association of pre-treatment expression of RNA in patients with HER2-negative breast cancer treated with neoadjuvant eribulin. Methods: SOLTI1007 is a phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for stage I-II HER2-negative breast cancer (planned n=100 hormonal receptor-positive [HR+] and n=100 HR-negative). Patients received 1.4 mg/m2 of eribulin intravenously on Days 1 and 8 every 21-day cycle, for 4 cycles. Baseline and post-treatment (surgical) formalin-fixed, paraffin-embedded tissue samples were collected and gene expression profiled. PAM50 intrinsic subtype and the Risk of Relapse based on subtype and proliferation (ROR-P) were evaluated in each time-point. The association of each PAM50 signature and pathological complete response in the breast (pCRB) was evaluated using univariate logistic regression models. Results: Between September 2012 and October 2015, one hundred and seventy-four patients (TNBC n=73 and HR+ n=101) were recruited. Mean age (55.5), stage II (90%), negative axilla (78% and 67%), grade 3 (62% and 26%), mean tumor size (3 cm and 3.6 cm) and mean Ki-67 (61% and 31%). Completion of 4 cycles of eribulin was achieved by 85% of the patients. Grade 3-4 toxicities were observed in 19.54%, mostly due to neutropenia (5.1%) and alopecia (4.02%). The overall pCRB was 5.4%. No significant differences were observed between HR+ and TNBC disease. Distribution of the PAM50 intrinsic subtypes was as follows: Luminal A (n=43, 27.7%), Luminal B (n=42, 27.1%), Basal-like (n=63, 40.6%) and HER2-enriched (n=7, 4.5%). pCRB rates by subtype were the following: HER2-enriched (28.6%, 2/7), Luminal B (7.1%, 3/42), Basal-like (4.8%, 3/63), Luminal A (2.3%, 1/43). pCRB rates significantly (p=0.047) differed when HER2-enriched was compared to the other subtypes (odds ratio = 8.06, 95% CI 1.32-49.1). pCRB rate differed significantly by ROR-P (p=0.006): ROR-P high (17.1%, 6/35), ROR-P med (2.7%, 2/75), ROR-P low (2.2%, 1/45). Ki67 % by IHC did not predict pCRB (p=0.918). Subtype change at surgery occurred in 60% (3/5) HER2-enriched, 44.1% (15/34) of Luminal Bs, 10.3% (4/39) of Luminal A and 5.4% (2/37) of Basal-like tumors. 100% of subtype changes in Luminal B disease were to Luminal A. Conclusions: From a response and biological perspective, patients with HER2-enriched and Luminal B disease may benefit the most from eribulin therapy. Mechanistically, our gene expression data further supports previous preclinical evidence suggesting that eribulin triggers a phenotypic conversion. Citation Format: Prat A, Ortega V, Villagrasa P, Paré L, Galván P, Oliveira M, Nucíforo P, Lluch A, Morales S, Amillano K, Lopez R, Gonzalez R, Manso L, Martinez J, Llombart A, De la Peña L, Di Cosimo S, Rubio IT, Harbeck N, Baselga J, Cortés J. Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer [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 P1-09-09.

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