C. Jouannaud (Reims, France)

Institut de Cancérologie Jean-Godinot

Author Of 1 Presentation

 Conference Calendar
Proffered Paper session 1 Proffered paper

63O - Letrozole and palbociclib versus 3rd generation chemotherapy as neoadjuvant treatment in luminal breast cancer: survival results of the UNICANCER-NeoPAL study (ID 239)

Presentation Number
63O
Lecture Time
14:16 - 14:26
Speakers
Session Name
Proffered Paper session 1
Room
Channel 2
Date
Fri, 07.05.2021
Time
14:15 - 15:30

Abstract

Background

The NeoPAL trial compared letrozole-palbociclib (LETPAL) combination to standard chemotherapy (CT) as neoadjuvant treatment in patients with high-risk LBC. Both LETPAL and CT were associated with poor pathological response, and equivalent clinical responses, while LETPAL let to encouraging biomarker responses in Prosigna®-defined high-risk LBC. We now evaluate the survival outcomes of both groups.

Methods

NeoPAL (UCBG104, NCT02400567) is a randomized, parallel, non-comparative phase II study. Postmenopausal women with ER-positive, HER2-negative, Prosigna®-defined luminal B, or luminal A and node-positive, stage II-III BC, were randomly assigned to either letrozole (2.5 mg daily) and palbociclib (125 mg daily, 3 weeks/4) during 19 weeks (LETPAL), or to FEC100 (5FU 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) x3 21-day courses followed by docetaxel 100 mg/m2 x3 21-day courses (CT). Secondary endpoints included progression-free survival (PFS) and invasive-disease free survival (iDFS), all measured from the date of randomization. Exploratory objectives aimed at evaluating the impact of PEPI score and residual cancer burden (RCB) on survival outcomes in both arms.

Results

53 pts were randomized in each arm. 23 of the 53 pts in the LETPAL arm received postoperative adjuvant chemotherapy. Median follow-up is 40.4 months [0-56.6]. 11 progressions have been observed, of which 3 were in the LETPAL and 8 in the control arm. Two additional iDFS events were observed in the LETPAL arm (secondary malignancies). PFS (HR = 1.01; 95%CI [0.36; 2.90], p=0.98) and iDFS (HR= 0.83; 95%CI [0.31; 2.23], p=0.71) did not differ between both arms. 40 months PFS rate is 86.7% (78.0-96.4) and 87.2% (78.1-97.4) in LETPAL and CT arms respectively. PEPI (PEPI II/II vs I: HR 0.80, 95%CI 0.18-3.67) and RCB scores (RCB II/III vs 0/I: HR 1.36; 95%CI 0.17-10.6) did not appear as independent predictors of PFS or iDFS.

Conclusions

Despite its small size, NeoPAL suggests that a neoadjuvant LETPAL strategy, together with selected postoperative administration of chemotherapy, may spare chemotherapy in some pts with LBC while allowing good long-term outcomes.

Clinical trial identification

NCT02400567.

Legal entity responsible for the study

UNICANCER.

Funding

Pfizer, NanoString Technologies.

Disclosure

S. Delaloge: Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Orion; Research grant/Funding (institution): Daiichi; Research grant/Funding (institution): Puma; Research grant/Funding (institution): Pierre Fabre. H. Manduzio, J. Lemonnier, P.H. Cottu: Research grant/Funding (institution): Pfizer. All other authors have declared no conflicts of interest.

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Author Of 1 Presentation

 On-Demand ePoster Display

102P - Breast cancer patients treated with intrathecal therapy for leptomeningeal metastases: characteristics and validation of prognostic models in a large real-life database

Abstract

Background

Leptomeningeal metastasis (LM) is a rare complication of metastatic breast cancer (MBC), with high rates of morbidity/mortality. Large cohorts are scarce. Our study aimed to describe the largest-to-date real-life population of MBC patients treated with intrathecal (IT) therapy and to evaluate prognostic models.

Methods

ESME MBC database (NCT03275311) includes all consecutive patients having started treatment for MBC since 2008. Overall survival (OS) of patients treated with IT therapy was estimated using the Kaplan-Meier method. Prognostic models were constructed using Cox proportional hazards models. Performance was evaluated using C-index and calibration plots.

Results

Of 22,266 female patients included in the ESME database covering 2008-2016, 312 were IT-treated with methotrexate, cytarabine or thiotepa and included in our analysis (15 patients have been excluded because of lack of data on the treatment line). Compared with non-IT treated ones, these were younger at MBC relapse (median age 52 years vs 61 years) and had more often lobular histology (23.4% vs 12.7%) or triple-negative subtype (24.7% vs 13.3%) (all p<0.001). Median OS was 4.5 months (95% CI 3.8-5.6) and 1-year survival rate was 25.6%. In case of IT therapy, significant prognostic factors associated with worse outcome by multivariable analysis were triple-negative subtype (HR=1.81 [95%CI 1.32-2.47]), treatment line ≥ 3 (HR=1.88 [95% CI 1.30-2.73]), ≥ 3 other metastatic sites (HR=1.33 [95%CI 1.01-1.74]), and IT cytarabine or thiotepa vs methotrexate (HR=1.68 [95%CI 1.28-2.22]), while concomitant systemic therapy was associated with better OS (HR=0.47 [95%CI 0.35-0.62]) (all p<0.001). We validated two previously published prognostic scores, the Curie score and the breast graded prognostic assessment, both with C-index of 0.57.

Conclusions

MBC patients with LM treated with IT therapy have a poor prognosis. However, in this large series, we could identify a subgroup of patients with better prognosis, when concomitant systemic therapy and IT methotrexate were used.

Clinical trial identification

NCT03275311.

Legal entity responsible for the study

UNICANCER.

Funding

UNICANCER. The ESME MBC database receives financial support from an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai and Daiichi Sankyo). Data collection, analysis and publication are managed entirely by R&D UNICANCER independently of the industrial consortium.

Disclosure

M. Campone: Honoraria (self): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy: GT1. All other authors have declared no conflicts of interest.

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