First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F18%3A00070314" target="_blank" >RIV/65269705:_____/18:00070314 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1007/s10549-017-4658-x" target="_blank" >http://dx.doi.org/10.1007/s10549-017-4658-x</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s10549-017-4658-x" target="_blank" >10.1007/s10549-017-4658-x</a>
Alternative languages
Result language
angličtina
Original language name
First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
Original language description
Purpose The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL). Methods Postmenopausal women (N = 668) with HR+, HER2-ABC and no prior systemic therapy for ABC were randomized to RIB (600 mg/day; 3 weeks on/1 week off) plus LET (2.5 mg/day; continuous) or placebo (PBO) plus LET. Primary end point was PFS; HRQoL was the secondary end point; DoR was exploratory end point and PFS by TFI was post hoc analysis. Results Of 501 pts with measurable disease and confirmed complete or partial response, median DoR was 26.7 months (95% CI, 24.0-NR) in the RIB arm versus 18.6 months (95% CI, 14.8-23.1) in the PBO arm. At 8 weeks, more pts in the RIB arm (32%) versus the PBO arm (17%) experienced best percentage change >= 60%. The average pain reduction was greater in the RIB arm (26%) versus the PBO arm (15%). PFS benefit was seen with RIB vs PBO, irrespective of TFI. Conclusion RIB plus LET versus PBO plus LET is associated with earlier and more durable tumor response, greater degree of tumor shrinkage and pain reduction, and PFS benefit irrespective of TFI. These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+, HER2-ABC.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Breast Cancer Research and Treatment
ISSN
0167-6806
e-ISSN
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Volume of the periodical
169
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
469-479
UT code for WoS article
000432317800008
EID of the result in the Scopus database
2-s2.0-85045047244