Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial

Moment of truth-adding carboplatin to neoadjuvant/adjuvant chemotherapy in triple negative breast cancer improves overall survival: An individual participant data and trial-level Meta-analysis

“…A total of 863 studies were identified in the literature search, of which 23 studies were selected for full text review after screening the titles and abstracts. Of these, eight studies [ 8 , 9 , [15] , [16] , [17] , [18] , [23] , [24] , [25] , [26] , [27] , [28] , [29] ] fulfilled the eligibility criteria and were included for qualitative synthesis and meta-analysis, with a total of 2425 patients. ( Fig.…”

“… Study (year) Phase Treatment arms TNBC patients, n Primary end point Relevant Secondary end points Neoadjuvant studies Loibl et al [ 8 , 23 ] (2018) III wkP + PM + bevacizumab + carboplatin wkP + PM + bevacizumab 158 157 pCR (ypT0/isN0) DFS,OS Sikov et al [ 9 , 24 ] (2016,2022 update) II wkP + Carboplatin→ddAC ± bevacizumab wkP→ddAC ± bevacizumab 221 212 pCR (ypT0/isNany). 5 year EFS, OS, toxicity, pCR (ypT0/isN0), which was used this analysis for pCR Zhang et al [ 25 ] (2016) II TP ET 47 44 pCR (ypT0/isN0) RFS, OS, safety Iwase et al [ 26 ] (2019) II CEF + Paclitaxel + carboplatin CEF + Paclitaxel 37 38 pCR (ypT0/isN0) DFS, safety Schneeweiss et al, 2022 [ 16 , 17 ] III wkPMwkP→ wkCb iddE→iddP→iddC 203 200 pCR (ypT0/isN0) iDFS, dDFS, LRRFI, OS,safety Geyer et al, 2022 a [ 15 , 18 ] III wkP + Cb→AC wkP→ AC 160 158 pCR pCR (ypT0/isN0) EFS,OS …”

“… HR 0.22 [95% CI 0.06–0.82], p = 0.024 93.9% vs 68.7%, HR 0.12 [95%CI 0.01–0.96] p = 0.046 23/37 vs 10/38 Ke Da Yu PATTERN [ 27 ] DFS: Time from random assignment to first relapse (local, regional and distant), contralateral breast cancer, second primary cancer (other than sqcc or basal cell ca of skin melanoma in situ or ca in situ) or death due to any cause. 5-year DFS, 86.5% vs 80.3%, HR 0.65 [95% CI, 0.44–0.96], p = 0.03 OS, 93.4% vs 89.8%, HR 0.71 [95% CI 0.42–1.22], p = 0.22 – Geyer et al, 2018, 2022 [ 15 , 18 ] Event free survival (EFS) was defined as the time from randomization to documentation of the first of the following events: failure to reach potential curative surgery; local, regional, or distant invasive recurrence of breast cancer following curative surgery; a new breast cancer or secondary malignancy; or death from any cause. 4 year EFS 79.3% vs 68.5%, HR 0.57 [95% CI 0.36–0.91], p = 0.02 16/160 (10%) deaths vs 22/158 (14%) deaths, HR 0.63 [95%CI 0.33–1.21], p = 0.17 92/160 (58%) vs 49/158 (31%), p < 0.0001 Schneeweiss et al, 2018, 2022 [ 16 , 17 ] iDFS was defined as time from randomization to event: any invasive locoregional (ipsilateral breast, locoregional lymph nodes) recurrence of disease, any invasive contralateral BC, any distant recurrence of disease, any secondary malignancy, or death as a result of any cause, whichever occurred first.…”

“…Qualitative and quantitative analyses of randomized controlled trials (RCTs) were performed. As per protocol, our completion date was June 30, 2021 (data extraction till April 28, 2021); however, in light of two critical studies [ 15 , 16 ] that published their updates in November 2021(GeparOcto-GBG 84, Schneeweiss et al [ 17 ]) and January 2022(BrighTNess, Geyer et al [ 18 ]), during our peer review, we extended our cut off till January 30, 2022 to include them in our analysis.…”

“…A literature search was conducted in Medline (via PubMed), Embase, and Cochrane library with the cut-off date of April 28, 2021. We extended our cut-off date to January 30, 2022 to include two important updates to prior publications of GeparOcto-GBG84 [ 17 ] and BrighTNness [ 18 ] studies. In addition, the annual conference presentations and abstracts were hand-searched from 2004 to 2020 for the following pertinent oncology conferences: the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO) congress, and the San Antonio Breast Cancer Symposium (SABCS).…”