Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)

We conducted the Neo-LaTH study in which patients were randomized to different lengths of neoadjuvant induction anti-HER2 therapy with lapatinib and trastuzumab followed by weekly paclitaxel plus the anti-HER2 therapy, and in estrogen receptor (ER)-positive patients, with or without concurrent endoc...

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Main Authors: Eriko Tokunaga, Norikazu Masuda, Naohito Yamamoto, Hiroji Iwata, Hiroko Bando, Tomoyuki Aruga, Shoichiro Ohtani, Tomomi Fujisawa, Toshimi Takano, Kenichi Inoue, Nobuyasu Suganuma, Masahiro Takada, Kenjiro Aogi, Kenichi Sakurai, Hideo Shigematsu, Katsumasa Kuroi, Hironori Haga, Shinji Ohno, Satoshi Morita, Masakazu Toi
Format: Article
Language:English
Published: MDPI AG 2021-08-01
Series:Cancers
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Online Access:https://www.mdpi.com/2072-6694/13/16/4008
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author Eriko Tokunaga
Norikazu Masuda
Naohito Yamamoto
Hiroji Iwata
Hiroko Bando
Tomoyuki Aruga
Shoichiro Ohtani
Tomomi Fujisawa
Toshimi Takano
Kenichi Inoue
Nobuyasu Suganuma
Masahiro Takada
Kenjiro Aogi
Kenichi Sakurai
Hideo Shigematsu
Katsumasa Kuroi
Hironori Haga
Shinji Ohno
Satoshi Morita
Masakazu Toi
author_facet Eriko Tokunaga
Norikazu Masuda
Naohito Yamamoto
Hiroji Iwata
Hiroko Bando
Tomoyuki Aruga
Shoichiro Ohtani
Tomomi Fujisawa
Toshimi Takano
Kenichi Inoue
Nobuyasu Suganuma
Masahiro Takada
Kenjiro Aogi
Kenichi Sakurai
Hideo Shigematsu
Katsumasa Kuroi
Hironori Haga
Shinji Ohno
Satoshi Morita
Masakazu Toi
author_sort Eriko Tokunaga
collection DOAJ
description We conducted the Neo-LaTH study in which patients were randomized to different lengths of neoadjuvant induction anti-HER2 therapy with lapatinib and trastuzumab followed by weekly paclitaxel plus the anti-HER2 therapy, and in estrogen receptor (ER)-positive patients, with or without concurrent endocrine therapy. The use of endocrine therapy did not affect the response; comprehensive pathological complete response (CpCR) plus ypN0 rate was 57.6% and 30.3% in ER-negative and ER-positive patients, respectively. After surgery, patients received an anthracycline-based regimen based on physician’s choice, followed by trastuzumab for 1 year, and in ER-positive patients, endocrine therapy for 5 years. Here, we report the 5-year survival outcomes. Among the followed-up patients (<i>n</i> = 212), the 5-year disease-free survival (DFS), distant DFS, and overall survival rates were 87.8% [95% confidence interval (CI), 82.5–91.6%], 93.7% (95% CI, 89.3–96.3%), and 95.6% (95% CI, 91.7–97.7%), respectively, with no difference between ER-negative and ER-positive patients. The 5-year DFS rate was significantly higher in patients who had a CpCR plus ypN0 after neoadjuvant treatment than in those who did not (91.7% vs. 85.1%; <i>p</i> = 0.0387). The stratified analysis showed better survival outcomes in patients who had CpCRypN0 than in those who did not after neoadjuvant treatment, regardless of use of adjuvant anthracycline therapy.
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spelling doaj.art-52f3620ddc4f4583ba63afb88f59ca1a2023-11-22T07:02:27ZengMDPI AGCancers2072-66942021-08-011316400810.3390/cancers13164008Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)Eriko Tokunaga0Norikazu Masuda1Naohito Yamamoto2Hiroji Iwata3Hiroko Bando4Tomoyuki Aruga5Shoichiro Ohtani6Tomomi Fujisawa7Toshimi Takano8Kenichi Inoue9Nobuyasu Suganuma10Masahiro Takada11Kenjiro Aogi12Kenichi Sakurai13Hideo Shigematsu14Katsumasa Kuroi15Hironori Haga16Shinji Ohno17Satoshi Morita18Masakazu Toi19Department of Breast Oncology, National Hospital Organization Kyushu Cancer Center, 3-1-1 Notame Fukuoka Minami-ku, Fukuoka-shi 811-1395, Fukuoka, JapanDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka-shi 540-0006, Osaka, JapanDivision of Breast Surgery, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba-shi 260-8717, Chiba, JapanDepartment of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya-shi 464-8681, Aichi, JapanBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba-shi 305-8575, Ibaraki, JapanDepartment of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 18-22, Honkomagome 3-chome, Bunkyo-ku, Tokyo 113-8677, JapanDivision of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi 730-8518, Hiroshima, JapanDepartment of Breast Oncology, Gunma Prefectural Cancer Center, 617-1 Takabayashi Nishimachi, Ohta-shi 373-8550, Gunma, JapanDepartment of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JapanDivision of Breast Oncology, Saitama Cancer Center, 780 Komuro Inamachi, Kitaadachi-gun, Saitama 362-0806, JapanDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama-shi 241-8515, Kanagawa, JapanBreast Cancer Unit, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin Sakyo-ku, Kyoto-shi 606-8507, Kyoto, JapanDepartment of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou Minamiumemotomachi, Matsuyama-shi 791-0280, Ehime, JapanBreast and Endocrine Surgery, Nihon University Itabashi Hospital, 30-1 Oyaguchikamicho Itabashi-ku, Tokyo 173-8610, JapanDepartment of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1 Aoyamacho, Kure-shi 737-0023, Hiroshima, JapanDepartment of Breast Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital, 4-5-10 Higashiyukigaya, Ota-ku, Tokyo 145-0065, JapanDepartment of Diagnostic Pathology, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-shi 606-8507, Kyoto, JapanBreast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JapanDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-shi 606-8507, Kyoto, JapanBreast Cancer Unit, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin Sakyo-ku, Kyoto-shi 606-8507, Kyoto, JapanWe conducted the Neo-LaTH study in which patients were randomized to different lengths of neoadjuvant induction anti-HER2 therapy with lapatinib and trastuzumab followed by weekly paclitaxel plus the anti-HER2 therapy, and in estrogen receptor (ER)-positive patients, with or without concurrent endocrine therapy. The use of endocrine therapy did not affect the response; comprehensive pathological complete response (CpCR) plus ypN0 rate was 57.6% and 30.3% in ER-negative and ER-positive patients, respectively. After surgery, patients received an anthracycline-based regimen based on physician’s choice, followed by trastuzumab for 1 year, and in ER-positive patients, endocrine therapy for 5 years. Here, we report the 5-year survival outcomes. Among the followed-up patients (<i>n</i> = 212), the 5-year disease-free survival (DFS), distant DFS, and overall survival rates were 87.8% [95% confidence interval (CI), 82.5–91.6%], 93.7% (95% CI, 89.3–96.3%), and 95.6% (95% CI, 91.7–97.7%), respectively, with no difference between ER-negative and ER-positive patients. The 5-year DFS rate was significantly higher in patients who had a CpCR plus ypN0 after neoadjuvant treatment than in those who did not (91.7% vs. 85.1%; <i>p</i> = 0.0387). The stratified analysis showed better survival outcomes in patients who had CpCRypN0 than in those who did not after neoadjuvant treatment, regardless of use of adjuvant anthracycline therapy.https://www.mdpi.com/2072-6694/13/16/4008anti-HER2 therapyHER2-positive breast cancerlapatiniblong-term prognosisneoadjuvant chemotherapypaclitaxel
spellingShingle Eriko Tokunaga
Norikazu Masuda
Naohito Yamamoto
Hiroji Iwata
Hiroko Bando
Tomoyuki Aruga
Shoichiro Ohtani
Tomomi Fujisawa
Toshimi Takano
Kenichi Inoue
Nobuyasu Suganuma
Masahiro Takada
Kenjiro Aogi
Kenichi Sakurai
Hideo Shigematsu
Katsumasa Kuroi
Hironori Haga
Shinji Ohno
Satoshi Morita
Masakazu Toi
Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
Cancers
anti-HER2 therapy
HER2-positive breast cancer
lapatinib
long-term prognosis
neoadjuvant chemotherapy
paclitaxel
title Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
title_full Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
title_fullStr Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
title_full_unstemmed Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
title_short Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study)
title_sort long term outcomes of a randomized study of neoadjuvant induction dual her2 blockade with trastuzumab and lapatinib followed by weekly paclitaxel plus dual her2 blockade for her2 positive primary breast cancer neo lath study
topic anti-HER2 therapy
HER2-positive breast cancer
lapatinib
long-term prognosis
neoadjuvant chemotherapy
paclitaxel
url https://www.mdpi.com/2072-6694/13/16/4008
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