@article{oai:tsukuba.repo.nii.ac.jp:00054829,
 author = {坂東, 裕子 and BANDO, Hiroko and Masuda, Norikazu and Ohtani, Shoichiro and Takano, Toshimi and Inoue, Kenichi and Suzuki, Eiji and Nakamura, Rikiya and Ito, Yoshinori and Ishida, Kazushige and Yamanaka, Takashi and Kuroi, Katsumasa and Yasojima, Hiroyuki and Kasai, Hiroi and Takasuka, Tsuyoshi and Sakurai, Takaki and Kataoka, Tatsuki R. and Morita, Satoshi and Ohno, Shinji and Toi, Masakazu},
 issue = {1},
 journal = {Breast cancer research and treatment},
 month = {Feb},
 note = {Purpose
The standard of care in the neoadjuvant setting for human epidermal growth factor receptor 2 (HER2)-positive breast cancer is dual HER2-targeted therapy. However, a need to minimize treatment-related toxicity and improve pathological complete response (pCR) rates, particularly in luminal HER2-positive disease, exists.

Methods
Neopeaks, a randomized, phase 2 study, compared docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP; 6 cycles; group A), TCbHP (4 cycles) followed by trastuzumab emtansine + pertuzumab (T-DM1+P; 4 cycles; group B), and T-DM1+P (4 cycles; group C) regimens in HER2‐positive primary breast cancer patients; concurrent hormone therapy with T-DM1+P was administered in case of estrogen receptor positivity (ER+). Based on tumor shrinkage, nonresponders in group C were switched to 5-fluorouracil + epirubicin + cyclophosphamide (FEC; 4 cycles). Primary endpoint was pCR (comprehensive pCR ypN0 [ypT0-TisypN0]).

Results
Of 236 patients enrolled, 204 were randomized to groups A (n = 51), B (n = 52), and C (n = 101). In group C, 80 (79%) patients continued T-DM1+P following favorable response, whereas 21 (21%) nonresponders switched to FEC. pCR rate was numerically higher with the TCbHP →  T-DM1+P regimen (71%) versus the standard TCbHP (57%) and T-DM1+P (57%) regimens. The rate in group C was higher among responders continuing T-DM1+P (63%) versus nonresponders who switched to FEC (38%). pCR rates after initial 4 cycles of T-DM1+P (group C; 57%) and standard TCbHP regimen (57%) were equivalent. pCR rate in patients with ER+ was significantly higher in group B (69%) than groups A (43%) and C (51%), but was comparable in patients with ER− (67–76%). Compared with the T-DM1-based arm, the incidence of adverse events was higher in the taxane-based arms.

Conclusion
In the neoadjuvant setting, the pCR rate with the standard TCbHP →  T-DM1+P regimen was numerically better than the TCbHP regimen alone and significantly better in patients with ER+. Personalization of the T-DM1+P regimen could serve as a reasonable approach to minimize toxicity while maintaining efficacy.},
 pages = {135--146},
 title = {A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer},
 volume = {180},
 year = {2020},
 yomi = {バンドウ, ヒロコ}
}