Highlights
- •Achieving a pathologic complete remission is important in human epidermal growth factor receptor 2 (HER2)–positive breast cancer disease.
- •Achieving a pathologic complete remission translates into a better long-term outcome with regard to event-free survival (EFS) and overall survival (OS).
- •EFS and OS after 6 years did not differ significantly between the 3 treatment groups, although lapatinib + trastuzumab showed numerically higher EFS than trastuzumab in the hormone receptor–negative group.
Abstract
Background
Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel significantly increased
the pathologic complete response (pCR) rate compared with the anti–human epidermal
growth factor receptor 2 (HER2) agent alone plus paclitaxel. The event-free survival
(EFS) and overall survival (OS) by the treatment arms L + T vs. T and L vs. T and
the relationship between pCR and EFS/OS both in the whole study population and according
to hormone receptor–negative and hormone receptor–positive cohorts after a median
follow-up of 6.7 years were assessed.
Patients and methods
Four hundred fifty-five patients with HER2-positive early breast cancer randomly received
L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152)
for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel
weekly × 12. After surgery, patients received 3 cycles of fluorouracil, epirubicin
and cyclophosphamide. The primary end-point was pCR (ypT0/is; for current analysis,
it is ypT0/is ypN0), and the secondary end-points were EFS and OS.
Results
Six-year EFS rates were 67%, 67% and 74% with L, T and L + T, respectively (L vs T:
hazard ratio [HR], 0.98 [95% confidence interval {CI}, 0.64–1.51; P = .93]; L + T vs T: HR, 0.81 [95% CI, 0.52–1.26; P = .35]). Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively
(L vs T: HR, 0.85 [95% CI, 0.49–1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41–1.27; P = .26]). In landmark analyses, patients with a pCR had a significantly higher 6-year
EFS (77% and 65%) and OS (89% and 77%) compared with those without a pCR for both
overall and the hormone receptor–negative cohort.
Conclusion
Achieving a pCR is important in HER2-positive disease and translates into better long-term
outcome with regard to EFS and OS.
Keywords
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Article info
Publication history
Published online: August 01, 2019
Accepted:
April 27,
2019
Received in revised form:
April 16,
2019
Received:
January 22,
2019
Footnotes
☆The study has been presented in part at the annual meeting of the American Society of Clinical Oncology in 2017 in the poster discussion session.
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
