IBCSG is proud to contribute nine abstracts to the upcoming San Antonio Breast Cancer Symposium which will be held on December 6 through 10:
The IBCSG 42-12 / BIG 2-12 SNAP trial enrolled 258 women from April 2013 to Aug 2015. Now the final results are available, and Alessandra Gennari will present “Randomized phase II study evaluating different schedules of nab-Paclitaxel in metastatic breast cancer (MBC): results of the SNAP study” on Thursday Dec 9 as poster P5-15-05 in the session of 5:00-7:00pm. The SNAP trial was designed to improve the tolerability of prolonged chemotherapy studying alternative treatment schedules. All eligible patients were randomized to one of three arms. In each arm, patients were assigned the same induction chemotherapy based on 3 cycles of nab-Paclitaxel. The schedules of nab-Paclitaxel in maintenance therapy in the three arms are different.
Beat Thürlimann and colleagues will present „12 years’ median follow up (MFU) of BIG 1-98: adjuvant letrozole, tamoxifen and their sequence for postmenopausal women with endocrine responsive early breast cancer“. Previous publications demonstrated a significant DFS benefit favoring letrozole compared with tamoxifen, and updated results published in 2011 at 8.1 years MFU showed OS benefit. Industry-sponsorship of the original BIG 1-98 ended in 2010; IBCSG launched an observational, non-interventional long-term follow up study (BIG 1-98 LTFU) to collect survival, disease status and adverse events for an additional 5 yrs. The LTFU study has now come to a close, and we will report the results on Thursday Dec 8, 7:30-9:00am on poster P2-09-05.
In the General Session on Wednesday Dec 7 at 11 am, Sherene Loi will present “Clinical implications of somatic mutations in post-menopausal early-stage estrogen receptor (ER)-positive HER2-negative breast cancer (BC): Results from the BIG 1-98 study“. Next generation sequencing (NGS) has revealed that ER+/HER2- BCs have diverse somatic copy number and mutation profiles but thus far the clinical relevance of such findings is unknown. NGS was used to genotype DNA from archival primary tumor blocks for 286 cancer-related genes. From 2706 available eligible samples (confirmed ER+, excluding HER2-positivity or neoadjuvant treatment, adequate DNA quality/quantity), a case-cohort design selected 764 samples: all distant relapses and a stratified sampling of non-relapses after 8yr median follow-up. The prognostic relevance of oncogenic mutations in ER+/HER2- postmenopausal early-stage BCs from a clinical trial population will be shown.
Steve Buechler and Kathryn Gray have performed an “Independent validation of EarlyR gene signature in BIG 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer”, and will present the results on poster P4-12-01 on Thursday, Dec 9 at 7:30-9:00am. EarlyR is a prognostic gene signature score in ER+ breast cancer (BC) computed from the expression values of ESPL1, SPAG5, MKI67, PLK1 and PGR using a novel algorithm. EarlyR scores and pre-specified risk strata (≤25=low, 26-75=intermediate, >75=high) have been computed in 1174 ER+ patients. These strata will be correlated with clinical outcome to assess the prognostic significance of the EarlyR signature.
Karin Ribi and colleagues have investigated “The effects of treatment-induced symptoms, depression and age on sexuality in premenopausal women with early breast cancer receiving adjuvant endocrine therapy” in the SOFT and TEXT trials and will present the results as poster P2-09-09 on Wednesday Dec 8, 7:30-9:00am. A subset of patients enrolled by centers with English as primary language to TEXT (1027 of 2672 pts) and SOFT (1260 of 3066 pts) completed a questionnaire consisting of global and symptom-specific quality of life indicators, the CES-Depression (CES-D) and the MOS - Sexual Problems (MOS-SP) measures at baseline, 6, 12 and 24 months. The evaluation focused on effect of changes in several quality of life indicators on changes in sexual problems.
First results of the TEXT and SOFT trials were practice-changing, indicating that: i) 5 years adjuvant exemestane+ovarian function suppression (E+OFS) reduces recurrence risk relative to tamoxifen(Tam)+OFS or to Tam alone, ii) Tam+OFS reduces recurrence risk vs Tam in women who are at sufficient risk to warrant chemotherapy and remain premenopausal afterwards, and iii) Tam alone remains appropriate for some premenopausal women. However, median follow-up was only 5.5 years and <5% pts had died. Follow-up is immature given the long natural history of HR+ disease and EBCTCG overviews showing overall survival improvements for Tam vs no-Tam emerged during 5-15 years. It is crucial to establish if changing standard adjuvant endocrine therapy from Tam improves survival and if there are associated late toxicities. On poster OT3-02-03 Prue Francis presents the ongoing effort of „Long-Term Follow-Up of TEXT and SOFT Trials of Adjuvant Endocrine Therapies for Premenopausal Women with HR+ Early Breast Cancer“ on Thursday Dec 9, 5:00-7:00pm
The IBCSG, in collaboration with Dana-Farber Cancer Institute, conducts the European cohort of the Helping Ourselves Helping Others (HOHO) study. HOHO is a prospective longitudinal cohort study investigating short and long-term treatment and fertility concerns in young women with breast cancer. Olivia Pagani and Monica Ruggeri will present PD6-04 “HOHO study: how European and US young women cope with breast cancer and fertility concerns” in the poster discussion on Wednesday Dec 8, 5:00-7:00pm. Many young women with newly diagnosed breast cancer have concerns about fertility, which may affect their treatment decisions. The POSITIVE Trial (IBCSG 48-14/ALLIANCE 221405) will address safety and outcome of pregnancy after BC.
Olivia Pagani and Monica Ruggeri will present the ongoing trial “POSITIVE: A study evaluating pregnancy and disease outcome and safety of interrupting endocrine therapy for young women with endocrine-responsive breast cancer who desire pregnancy (IBCSG 48-14/BIG 8-13)“ in the OT3 session on Friday Dec 7, 5:00 – 7:00pm. The trial has been activated in the meantime in 93 sites from 13 countries, and the poster is meant to further stimulate the interest in this unique trial.
IBCSG and BIG currently conduct “PYTHIA: A Phase II Study of Palbociclib plus Fulvestrant versus Placebo plus Fulvestrant for pretreated patients with ER+/HER2- Metastatic Breast Cancer”. In the poster session on Saturday, Dec 10, 7:30 – 9:00am, Dimitrios Zardavas will present the ongoing trial poster P6-11-16 which is conducted in conjunction with the BIG AURORA program, a longitudinal cohort study incorporating extensive molecular characterization of matched primary and metastatic breast cancer samples. PYTHIA results should eventually help to inform the treatment choice in this patient population.