Senologie - Zeitschrift für Mammadiagnostik und -therapie 2021; 18(02): e14
DOI: 10.1055/s-0041-1730167
Abstracts
Senologie

IMpassion031: Efficacy, safety and patient (pts)-reported outcomes/quality of life (QoL) - Results from a Ph 3 study of neoadjuvant (neoadj) atezolizumab + chemo in early stage triple-negative breast cancer (eTNBC)

N Harbeck
1   Brustzentrum am Klinikum der LMU München, München, Deutschland
,
H Zhang
2   Memorial Sloan Kettering Cancer Center, New York, Vereinigte Staaten von Amerika
,
CH Barrios
3   Centro de Pesquisa em Oncologia HSL, PUCRS, Porto Alegre, Brasilien
,
S Saji
4   Fukushima Medical University, Fukushima, Japan
,
KH Jung
5   Asan Medical Center, Seoul, Korea, Republik
,
R Hegg
6   University of Sao Paolo, Sao Paolo, Brasilien
,
A Köhler
7   Gemeinschaftspraxis für Hämatologie und Onkologie, Langen, Deutschland
,
J Sohn
8   Yonsei Cancer Center, Seoul, Korea, Republik
,
H Iwata
9   Aichi Cancer Center Hospital, Nagoya, Japan
,
ML Telli
10   Stanford University School of Medicine, Stanford, Vereinigte Staaten von Amerika
,
C Ferrario
11   Jewish General Hospital, McGill University, Montreal, Kanada
,
K Punie
12   Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgien
,
F Penault-Llorca
13   Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, Frankreich
,
S Patel
14   Genentech Inc., South San Francisco, Vereinigte Staaten von Amerika
,
S Patel
14   Genentech Inc., South San Francisco, Vereinigte Staaten von Amerika
,
A Nguyen Duc
15   F. Hoffmann-La Roche, Basel, Schweiz
,
M Liste-Hermoso
15   F. Hoffmann-La Roche, Basel, Schweiz
,
V Maiya
14   Genentech Inc., South San Francisco, Vereinigte Staaten von Amerika
,
L Molinero
14   Genentech Inc., South San Francisco, Vereinigte Staaten von Amerika
,
SY Chui
14   Genentech Inc., South San Francisco, Vereinigte Staaten von Amerika
,
EA Mittendorf
16   Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, Vereinigte Staaten von Amerika
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Background IMpassion031 is a randomised, placebo-controlled Ph3 study in high-risk primary invasive eTNBC evaluating neoadj atezolizumab (A) or placebo (P) with nab-paclitaxel (nP) followed by A or P with dose-dense doxorubicin + cyclophosphamide.

Methods Pts with untreated stage II-III eTNBC > 2 cm were randomized to receive A 840 mg (n = 165) or P (n = 168) q2w + nP 125 mg/m2 qw for 6 doses followed by A 840 mg or P q2w + doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2 q2w for 4 doses of A before surgery. Pathologic complete response (pCR; ypT0/isN0) was assessed (stratified by PD-L1 expression on tumour-infiltration immune cells, cut-off 1 %). QoL was measured by EORTC-QLQ-C30 and single-item GP5 from the FACT-G questionnaire at baseline and day1 of each neo- and adjuvant cycle (C).

Results Median follow-up was 20.6 mos (A-chemo)/19.8 (P-chemo). pCR was seen in 57.6 % (A-chemo) and 41.1 % (P-chemo) (P = 0.0044). pCR benefit with A-chemo was observed regardless of PD-L1 status. In the neoadj phase, Grade 3/4 AEs were balanced, treatment (Tx)-related serious AEs occurred in 22.6 % (A-chemo) and 15.6 % (P-chemo). One pt/arm had an unrelated Grade 5 AE. QoL mean values were similar between arms across on-Tx assessments to C16 and through follow up. In both arms, HRQoL declined during neoadj therapy from C3-C5, rebounding in the adj period, and stabilizing from C6.

Conclusions In pts with eTNBC, atezolizumab + neoadj chemo significantly improved pCR rates independent of PD-L1 status with an acceptable safety profile, without added Tx burden to pts. (NCT03197935).



Publication History

Article published online:
01 June 2021

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