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Long-term outcomes of dual vs single HER2-directed neoadjuvant therapy in NSABP B-41.

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Citation: Breast Cancer Research & Treatment. 199(2):243-252, 2023 Jun.PMID: 36944848Department: Associate Dean for Research Development | MedStar HealthForm of publication: Journal ArticleMedline article type(s): Journal Article | Randomized Controlled TrialSubject headings: *Breast Neoplasms | Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | Breast Neoplasms/pa [Pathology] | Female | Humans | Neoadjuvant Therapy/ae [Adverse Effects] | Paclitaxel/tu [Therapeutic Use] | Receptor, ErbB-2 | Trastuzumab/tu [Therapeutic Use] | Treatment Outcome | Year: 2023 ISSN:

0167-6806

Name of journal: Breast cancer research and treatmentAbstract: BACKGROUND: The primary aim of this randomized neoadjuvant trial in operable, HER2-positive breast cancer, was to determine the efficacy on pathologic complete response (pCR) of substituting lapatinib (L) for trastuzumab (T) or adding L to T, in combination with weekly paclitaxel (WP) following AC. Results on pCR were previously reported. Here, we report data on planned secondary endpoints, recurrence-free interval (RFI) post-surgery, and overall survival (OS).CLINICAL TRIALS REGISTRATION: NCT00486668. Copyright © 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.CONCLUSIONS: Although pCR, RFI, and OS were numerically better with the dual combination and less with L, the differences were not statistically significant. However, achievement of pCR again correlated with improved outcomes, especially remarkable in the ER-negative subset.METHODS: All patients received standard AC q3 weeks x 4 cycles followed by WP (80 mg/m2) on days 1, 8, and 15, q28 days x 4 cycles. Concurrently with WP, patients received either T (4 mg/kg load, then 2 mg/kg) weekly until surgery, L (1250 mg) daily until surgery, or weekly T plus L (750 mg) daily until surgery. Following surgery, all patients received T to complete 52 weeks of HER2-targeted therapy. 522 of 529 randomized patients had follow-up. Median follow-up was 5.1 years.RESULTS: RFI at 4.5 years was 87.2%, 79.4% (p = 0.34; HR = 1.37; 95% CI 0.80, 2.34), and 89.4% (p = 0.37; HR = 0.70; 0.37, 1.32) for arms T, L, and TL, respectively. The corresponding five-year OS was 94.8%, 89.1% (p = 0.34; HR = 1.46; 0.68, 3.11), and 95.8% (p = 0.25; HR = 0.58; 0.22, 1.51), respectively. Patients with pCR had a much better prognosis, especially in the ER-negative cohort: RFI (HR = 0.23, p < 0.001) and OS (HR = 0.28, p < 0.001).All authors: Azar CA, Baez-Diaz L, Bandos H, Bear HD, Boileau JF, Brufsky AM, Geyer CE JrFiscal year: FY2023 Digital Object Identifier:

https://dx.doi.org/10.1007/s10549-023-06881-8

Date added to catalog: 06/01/2023

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Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	36944848	Available		36944848

BACKGROUND: The primary aim of this randomized neoadjuvant trial in operable, HER2-positive breast cancer, was to determine the efficacy on pathologic complete response (pCR) of substituting lapatinib (L) for trastuzumab (T) or adding L to T, in combination with weekly paclitaxel (WP) following AC. Results on pCR were previously reported. Here, we report data on planned secondary endpoints, recurrence-free interval (RFI) post-surgery, and overall survival (OS).

CONCLUSIONS: Although pCR, RFI, and OS were numerically better with the dual combination and less with L, the differences were not statistically significant. However, achievement of pCR again correlated with improved outcomes, especially remarkable in the ER-negative subset.

METHODS: All patients received standard AC q3 weeks x 4 cycles followed by WP (80 mg/m2) on days 1, 8, and 15, q28 days x 4 cycles. Concurrently with WP, patients received either T (4 mg/kg load, then 2 mg/kg) weekly until surgery, L (1250 mg) daily until surgery, or weekly T plus L (750 mg) daily until surgery. Following surgery, all patients received T to complete 52 weeks of HER2-targeted therapy. 522 of 529 randomized patients had follow-up. Median follow-up was 5.1 years.

RESULTS: RFI at 4.5 years was 87.2%, 79.4% (p = 0.34; HR = 1.37; 95% CI 0.80, 2.34), and 89.4% (p = 0.37; HR = 0.70; 0.37, 1.32) for arms T, L, and TL, respectively. The corresponding five-year OS was 94.8%, 89.1% (p = 0.34; HR = 1.46; 0.68, 3.11), and 95.8% (p = 0.25; HR = 0.58; 0.22, 1.51), respectively. Patients with pCR had a much better prognosis, especially in the ER-negative cohort: RFI (HR = 0.23, p < 0.001) and OS (HR = 0.28, p < 0.001).

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