De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer

被引:7
作者
Tanaka, Satoru [1 ]
Matsunami, Nobuki [2 ]
Morishima, Hirotaka [2 ]
Oda, Naofumi [2 ]
Takashima, Tsutomu [3 ]
Noda, Satoru [3 ]
Kashiwagi, Shinichiro [3 ]
Tauchi, Yukie [3 ]
Asano, Yuka [3 ]
Kimura, Kosei [4 ]
Fujioka, Hiroya [4 ]
Terasawa, Risa [4 ]
Kawaguchi, Kanako [4 ]
Ikari, Ayana [1 ]
Morimoto, Takashi [5 ]
Michishita, Shintaro [5 ]
Kobayashi, Toshihiro [6 ]
Sakane, Junna [6 ]
Nitta, Toshikatsu [7 ]
Sato, Nayuko [8 ]
Hokimoto, Norihiro [9 ]
Nishida, Yukihiro [10 ]
Iwamoto, Mitsuhiko [4 ]
机构
[1] Natl Hosp Org, Osakaminami Med Ctr, Dept Breast Surg, 2-1 Kidohigashi Cho, Kawachi Nagano, Osaka 5868521, Japan
[2] Osaka Rosai Hosp, Dept Breast Surg, Kita Ku, 1179-3 Nagasone Cho, Sakai, Osaka 5918025, Japan
[3] Osaka City Univ, Grad Sch Med, Dept Breast & Endocrine Surg, Abeno Ku, 1-4-3 Asahi Machi, Osaka 5458585, Japan
[4] Osaka Med Coll Hosp, Dept Breast & Endocrine Surg, 2-7 Daigaku Machi, Takatsuki, Osaka 5698686, Japan
[5] Yao Municipal Hosp, Dept Breast Surg, 1-3-1 Ryuge Cho, Yao, Osaka 5810069, Japan
[6] Red Cross Takatsuki Hosp, Dept Breast Surg, 1-1-1 Abuno Cho, Takatsuki, Osaka 5691045, Japan
[7] Shiroyama Hosp, Dept Breast Surg, 2-8-1 Habikino, Habikino, Osaka 5830872, Japan
[8] Saiseikai Suita Hosp, Dept Breast Surg, 1-2 Kawazono Cho, Suita, Osaka 5640133, Japan
[9] Red Cross Kochi Hosp, Dept Surg, 2-13-51 Shinhon Machi, Kochi, Kochi 7808562, Japan
[10] Nippon Life Hosp, Dept Breast Surg, Nishi Ku, 2-1-54 Enokojima, Osaka 5500006, Japan
关键词
Human epidermal growth factor receptor 2; Estrogen receptor negative; Neoadjuvant chemotherapy; Nanoparticle albumin-bound paclitaxel; Pathological complete response; ADJUVANT TRASTUZUMAB; OPEN-LABEL; CONCURRENT TRASTUZUMAB; PHASE-II; CHEMOTHERAPY; LAPATINIB; TRIAL; MULTICENTER; EPIRUBICIN; PERTUZUMAB;
D O I
10.1007/s00280-019-03836-z
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PurposeNeoadjuvant trastuzumab combined with anthracycline and taxane is now considered a standard regimen for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A less toxic, non-anthracycline regimen has been considered as a treatment option for patients with node-negative small tumors. Estrogen receptor-negative and HER2-positive (pure HER2) tumors are more likely to achieve a pathological complete response (pCR). This study evaluates the activity and safety of neoadjuvant nanoparticle albumin-bound paclitaxel (nab-PTX) plus trastuzumab for pure HER2 breast cancer in patients with low risk of relapse.MethodsWe treated patients with tumors measuring3cm, node-negative, pure HER2 breast cancer using neoadjuvant nab-PTX 260mg/m2 with trastuzumab every 3weeks for four cycles. The primary endpoint was the pCR rate. The secondary endpoints included the clinical response rate, disease-free survival, pathologic response rate (defined as pCR or minimal residual invasive disease only in the breast), breast-conserving surgery conversion rate, safety, and disease-free survival. Depending on the pathological findings of surgical specimens, the administration of adjuvant anthracycline could be omitted.ResultsEighteen patients were enrolled. No patient required dose delays or reductions; none showed disease progression, and all patients underwent surgery as scheduled. Of the 18 patients, 66.7% achieved pCR, and the adjuvant anthracycline regimen was omitted for all patients. The incidence of severe adverse events was quite low.ConclusionThis less toxic, anthracycline-free regimen appears to be a significantly effective neoadjuvant therapy for patients with pure HER2 breast cancer at low relapse risk.
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收藏
页码:1099 / 1104
页数:6
相关论文
共 27 条
[1]   Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: An update of the initial randomized study population and data of additional patients treated with the same regimen [J].
Buzdar, Aman U. ;
Valero, Vicente ;
Ibrahim, Nuhad K. ;
Francis, Deborah ;
Broglio, Kristine R. ;
Theriault, Richard L. ;
Pusztai, Lajos ;
Green, Marjorie C. ;
Singletary, Sonja E. ;
Hunt, Kelly K. ;
Sahin, Aysegul A. ;
Esteva, Francisco ;
Symmans, William F. ;
Ewer, Michael S. ;
Buchholz, Thomas A. ;
Hortobagyi, Gabriel N. .
CLINICAL CANCER RESEARCH, 2007, 13 (01) :228-233
[2]   Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial [J].
Buzdar, Aman U. ;
Suman, Vera J. ;
Meric-Bernstam, Funda ;
Leitch, A. Marilyn ;
Ellis, Matthew J. ;
Boughey, Judy C. ;
Unzeitig, Gary ;
Royce, Melanie ;
McCall, Linda M. ;
Ewer, Michael S. ;
Hunt, Kelly K. .
LANCET ONCOLOGY, 2013, 14 (13) :1317-1325
[3]   Dual Block with Lapatinib and Trastuzumab Versus Single-Agent Trastuzumab Combined with Chemotherapy as Neoadjuvant Treatment of HER2-Positive Breast Cancer: A Meta-analysis of Randomized Trials [J].
Clavarezza, Matteo ;
Puntoni, Matteo ;
Gennari, Alessandra ;
Paleari, Laura ;
Provinciali, Nicoletta ;
D'Amico, Mauro ;
DeCensi, Andrea .
CLINICAL CANCER RESEARCH, 2016, 22 (18) :4594-4603
[4]   Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015 [J].
Coates, A. S. ;
Winer, E. P. ;
Goldhirsch, A. ;
Gelber, R. D. ;
Gnant, M. ;
Piccart-Gebhart, M. ;
Thuerlimann, B. ;
Senn, H. -J. .
ANNALS OF ONCOLOGY, 2015, 26 (08) :1533-1546
[5]   Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis [J].
Cortazar, Patricia ;
Zhang, Lijun ;
Untch, Michael ;
Mehta, Keyur ;
Costantino, Joseph P. ;
Wolmark, Norman ;
Bonnefoi, Herve ;
Cameron, David ;
Gianni, Luca ;
Valagussa, Pinuccia ;
Swain, Sandra M. ;
Prowell, Tatiana ;
Loibl, Sibylle ;
Wickerham, D. Lawrence ;
Bogaerts, Jan ;
Baselga, Jose ;
Perou, Charles ;
Blumenthal, Gideon ;
Blohmer, Jens ;
Mamounas, Eleftherios P. ;
Bergh, Jonas ;
Semiglazov, Vladimir ;
Justice, Robert ;
Eidtmann, Holger ;
Paik, Soonmyung ;
Piccart, Martine ;
Sridhara, Rajeshwari ;
Fasching, Peter A. ;
Slaets, Leen ;
Tang, Shenghui ;
Gerber, Bernd ;
Geyer, Charles E., Jr. ;
Pazdur, Richard ;
Ditsch, Nina ;
Rastogi, Priya ;
Eiermann, Wolfgang ;
von Minckwitz, Gunter .
LANCET, 2014, 384 (9938) :164-172
[6]   Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response [J].
de Azambuja, Evandro ;
Holmes, Andrew P. ;
Piccart-Gebhart, Martine ;
Holmes, Eileen ;
Di Cosimo, Serena ;
Swaby, Ramona F. ;
Untch, Michael ;
Jackisch, Christian ;
Lang, Istvan ;
Smith, Ian ;
Boyle, Frances ;
Xu, Binghe ;
Barrios, Carlos H. ;
Perez, Edith A. ;
Azim, Hatem A., Jr. ;
Kim, Sung-Bae ;
Kuemmel, Sherko ;
Huang, Chiun-Sheng ;
Vuylsteke, Peter ;
Hsieh, Ruey-Kuen ;
Gorbunova, Vera ;
Eniu, Alexandru ;
Dreosti, Lydia ;
Tavartkiladze, Natalia ;
Gelber, Richard D. ;
Eidtmann, Holger ;
Baselga, Jose .
LANCET ONCOLOGY, 2014, 15 (10) :1137-1146
[7]   5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial [J].
Gianni, Luca ;
Pienkowski, Tadeusz ;
Im, Young-Hyuck ;
Tseng, Ling-Ming ;
Liu, Mei-Ching ;
Lluch, Ana ;
Staroslawska, Elzbieta ;
de la Haba-Rodriguez, Juan ;
Im, Seock-Ah ;
Pedrini, Jose Luiz ;
Poirier, Brigitte ;
Morandi, Paolo ;
Semiglazov, Vladimir ;
Srimuninnimit, Vichien ;
Bianchi, Giulia Valeria ;
Magazzu, Domenico ;
McNally, Virginia ;
Douthwaite, Hannah ;
Ross, Graham ;
Valagussa, Pinuccia .
LANCET ONCOLOGY, 2016, 17 (06) :791-800
[8]   Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort [J].
Gianni, Luca ;
Eiermann, Wolfgang ;
Semiglazov, Vladimir ;
Manikhas, Alexey ;
Lluch, Ana ;
Tjulandin, Sergey ;
Zambetti, Milvia ;
Vazquez, Federico ;
Byakhow, Mikhail ;
Lichinitser, Mikhail ;
Angel Climent, Miguel ;
Ciruelos, Eva ;
Ojeda, Belen ;
Mansutti, Mauro ;
Bozhok, Alla ;
Baronio, Roberta ;
Feyereislova, Andrea ;
Barton, Claire ;
Valagussa, Pinuccia ;
Baselga, Jose .
LANCET, 2010, 375 (9712) :377-384
[9]   2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial [J].
Goldhirsch, Aron ;
Gelber, Richard D. ;
Piccart-Gebhart, Martine J. ;
de Azambuja, Evandro ;
Procter, Marion ;
Suter, Thomas M. ;
Jackisch, Christian ;
Cameron, David ;
Weber, Harald A. ;
Heinzmann, Dominik ;
Dal Lago, Lissandra ;
McFadden, Eleanor ;
Dowsett, Mitch ;
Untch, Michael ;
Gianni, Luca ;
Bell, Richard ;
Koehne, Claus-Henning ;
Vindevoghel, Anita ;
Andersson, Michael ;
Brunt, A. Murray ;
Otero-Reyes, Douglas ;
Song, Santai ;
Smith, Ian ;
Leyland-Jones, Brian ;
Baselga, Jose .
LANCET, 2013, 382 (9897) :1021-1028
[10]   Prospective Biomarker Analysis of the Randomized CHER-LOB Study Evaluating the Dual Anti-HER2 Treatment With Trastuzumab and Lapatinib Plus Chemotherapy as Neoadjuvant Therapy for HER2-Positive Breast Cancer [J].
Guarneri, Valentina ;
Dieci, Maria Vittoria ;
Frassoldati, Antonio ;
Maiorana, Antonino ;
Ficarra, Guido ;
Bettelli, Stefania ;
Tagliafico, Enrico ;
Bicciato, Silvio ;
Generali, Daniele Giulio ;
Cagossi, Katia ;
Bisagni, Giancarlo ;
Sarti, Samanta ;
Musolino, Antonino ;
Ellis, Catherine ;
Crescenzo, Rocco ;
Conte, PierFranco .
ONCOLOGIST, 2015, 20 (09) :1001-1010