BIG research at ASCO 2018 (June 1-5, Chicago, USA)

Several abstracts with updates or follow-on analyses from BIG trials were selected for presentation at the upcoming ASCO Annual Meeting, which will take place from 1 to 5 June 2018 in Chicago.
Here is a peek at some of them.
APHINITY (BIG 4-11), of which the primary results were published in the New England Journal of Medicine in 2017, reports one of its secondary analyses, namely patient-reported health-related quality of life (HRQoL). It is one of the largest HRQoL data sets available to date in HER2-positive early breast cancer.
Trial information: NCT01358877
- Patient (pt)-reported function and symptoms in APHINITY: A randomized comparison of chemotherapy (C) + trastuzumab (H) + placebo (Pla) versus C + H + pertuzumab (P) as adjuvant therapy in pts with HER2-positive early breast cancer (EBC).
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Jose Baselga, MD, PhD, FASCO
ALTTO / NeoALTTO (BIG 2-06 / 1-06)
Trial information: NCT00898898 and NCT00553358
Dr Matteo Lambertini, research fellow at the Institut Jules Bordet, Brussels, Belgium, presents further analyses from the NeoALTTO and ALTTO trials that aimed to evaluate the outcome of pregnancies occurring during or following trastuzumab and/or lapatinib, as well as the prognostic effect of having a pregnancy in HER2-positive early breast cancer patients.
Dr Lambertini is one of the recipients of the 2018 Conquer Cancer Merit Awards, which support early-career oncology professionals who are first authors on selected abstracts. This award recognises their important research findings in their respective fields within the cancer care continuum.
- Pregnancies during and following trastuzumab (T) and/or lapatinib (L) in patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials.
- Session: Patient and Survivor Care; Monday 4 June, 2018 (poster)
- First author: Matteo Lambertini, MD
Other abstracts related to ALTTO and NeoALTTO:
- A RB-1 loss of function gene-signature (RBsig) as a tool to predict response to neoadjuvant chemotherapy (CT) plus anti-HER2 agents (H): A substudy of the NeoALTTO trial (BIG 1-06).
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Emanuela Risi, MD
- Association between adaptive immune signature and outcome in HER2-positive breast cancer treated with trastuzumab and lapatinib in the NCCTG-N9831 (Alliance) and NeoALTTO trials.
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Saranya Chumsri, MD
- Impact of body mass index (BMI) and weight change after treatment in patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Secondary analysis of the ALTTO BIG 2-06 trial.
- Session: Patient and Survivor Care; Monday 4 June, 2018 (poster)
- First author: Samuel Martel, MD
SOLE (BIG 1-07): The study investigators report the results of molecular analyses performed on 499 primary tumour samples from the patients enrolled in the main trial. The primary results of SOLE were published in the Lancet in January 2018.
Trial information: NCT00553410
- Molecular alterations and late recurrence in postmenopausal women with hormone receptor-positive node-positive breast cancer (BC): Results from the “SOLE” trial.
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster discussion)
- First author: Elena Guerini Rocco
POSITIVE (BIG 8-13) / the BIG Time for Baby study
Dr Ann H. Partridge presents an update of the POSITIVE trial and its psycho-oncological companion study, which have both reached about half of their respective target accrual.
Trial information: NCT02308085
- POSITIVE (IBCSG 48-14/BIG 8-13/A221405): Evaluating outcomes after interrupting endocrine therapy (ET) for women with endocrine responsive (ER+) early breast cancer (BC) who desire pregnancy.
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Ann H. Partridge, MD, MPH, FASCO
Other abstract related to POSITIVE:
- Estimation of historical control rate for a single arm de-escalation study: Application to the POSITIVE trial.
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Zhuoxin Sun, PhD
TEXT and SOFT (BIG 3-02 / 2-02)
Researchers report their conclusions on distant recurrence-free interval (DRFI) after 8.5 years median follow-up.
Trial information: NCT00066690, NCT00066703
- Absolute improvements in freedom from distant recurrence with adjuvant endocrine therapies for premenopausal women with hormone receptor-positive (HR+) HER2-negative breast cancer (BC): Results from TEXT and SOFT.
- Session: Breast Cancer – Local/Regional/Adjuvant; Monday 4 June, 2018 – oral abstract)
- First author: Meredith M. Regan
MA32 (BIG 5-11)
Trial information: NCT01101438
- CA15-3/MUC1 in CCTG MA-32 (NCT01101438): A phase III RCT of the effect of metformin vs. placebo on invasive disease free and overall survival in early stage breast cancer (BC).
- Session: Breast Cancer – Local/Regional/Adjuvant; Saturday 2 June, 2018 (poster)
- First author: Ryan JO Dowling, PhD
Every year, the ASCO Annual Meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.
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