Abstract 1846
Background
CLEOPATRA study demonstrated the efficacy and safety of pertuzumab (P) + trastuzumab (T) + docetaxel (D) but efficacy results of Japanese subgroup weren’t consistent with the whole study results. A phase IV, multicenter, prospective, COMACHI study was conducted in Japan to re-confirm the efficacy and safety of P+T+D demonstrated in the CLEOPATRA study.
Methods
Patients (pts) with HER2-positive breast cancer who were diagnosed as Stage IV or recurred more than a year after (neo)adjuvant taxane chemotherapy completion were enrolled. Pts were administered study drugs intravenously every 3 weeks. Discontinuation of D was allowed after cycle 6. After discontinuation of D, pts were given maintenance by T+P, however not allowed to receive hormonal therapy for HR positive pts. We defined PFS as the primary endpoint. To demonstrate a median PFS of 12.4 months (mos) or more, which was observed in the placebo arm in the CLEOPATRA study.
Results
From November 2013 to September 2015, 132 pts were enrolled and all pts were treated with T+P at least once. The median age was 56.5 years old and 102 pts (77.3%) had not received prior HER2 therapy. Median cycles of T and P were both 24.0 (range 2.0-71.0) and that of D was 6.0 (range 0.0-65.0). Pts characteristics and subgroup analysis results are shown in the Table below.Table:
353P
Name | Level | Patients | Events | Time to event |
---|---|---|---|---|
[n (%)] | [n (%)] | [Median (95% CI)] | ||
All | n/a | 132 (100.0%) | 66 (50.0%) | 22.8 (16.9, 34.8) |
Prior (neo) adjuvant therapy(Excluding hormone therapy) | YES | 38 ( 28.8%) | 18 (47.4%) | 27.7 (12.4, NE ) |
NO | 94 ( 71.2%) | 48 (51.1%) | 20.8 (16.9, 38.8) | |
Age | < 65 | 96 ( 72.7%) | 49 (51.0%) | 22.8 (16.5, NE ) |
>- 65 | 36 ( 27.3%) | 17 (47.2%) | 33.1 (18.7, NE ) | |
Disease Type at Screening | VISCERAL DISEASE | 81 ( 61.4%) | 49 (60.5%) | 18.4 (13.8, 33.7) |
NON-VISCERAL DISEASE | 51 ( 38.6%) | 17 (33.3%) | NE (20.7, NE ) | |
ER/PgR Status | POSITIVE | 72 ( 54.5%) | 39 (54.2%) | 18.9 (14.7, 33.1) |
NEGATIVE | 60 ( 45.5%) | 27 (45.0%) | 33.7 (20.6, NE ) | |
HER2 Status IHC/ISH | IHC < = 2+ and ISH POSITIVE | 21 ( 15.9%) | 13 (61.9%) | 16.5 (10.4, 34.8) |
IHC 3+ | 111 ( 84.1%) | 53 (47.7%) | 22.9 (18.9, NE ) | |
Stage | < STAGE IV | 61 ( 46.2%) | 24 (39.3%) | 28.4 (22.8, NE ) |
STAGE IV | 71 ( 53.8%) | 42 (59.2%) | 18.9 (14.3, 33.7) |
Median PFS was 22.8 mos [95% CI, 16.9-34.8], and thereby a median PFS of 12.4 mos or more was confirmed. The incidence of typical Grade 3/4 adverse events were febrile neutropenia (31.1%), neutropenia (24.2%), leukopenia (10.6%), and diarrhea (4.5%), and these findings are consistent with the CLEOPATRA study except for febrile neutropenia. Febrile neutropenia lead to only one case of treatment discontinuation and it was manageable.
Conclusions
The efficacy and safety of P+T+D in Japanese pts were consistent with those of the CLEOPATRA study and we confirmed this treatment as a standard care at 1st line therapy for HER2-positive metastatic breast cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Chugai Pharmaceutical Co., Ltd.
Funding
Chugai Pharmaceutical Co., Ltd.
Disclosure
N. Masuda: Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli-Lilly; Speaker Bureau / Expert testimony: Takeda; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Kyowa-Kirin; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Daiichi Sankyo; Officer / Board of Directors: Japan Breast Cancer Research Group Association. S. Ohtani: Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: Eisai; Speaker Bureau / Expert testimony: AstraZeneca. S. Nagai: Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli-Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd. Y. Komoike: Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Eli-Lilly; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Taiho; Speaker Bureau / Expert testimony, the publisher, for writing atricle: Nikkei Business Publications, Inc. Y. Ito: Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Speaker Bureau / Expert testimony, Research grant / Funding (self): Taiho; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli-Lilly; Speaker Bureau / Expert testimony, Research grant / Funding (self): Eisai; Research grant / Funding (institution): Covance; Research grant / Funding (institution): IQVIA; Research grant / Funding (institution): MSD; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): A2healthcare; Research grant / Funding (institution): Parexel; Research grant / Funding (institution): Kyowa-Kirin. M. Ikeda: Advisory / Consultancy, Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Eisai; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Daiichi Sankyo; Speaker Bureau / Expert testimony: Asahi Kasei Pharma Corporation; Speaker Bureau / Expert testimony: Kyowa-Kirin; Speaker Bureau / Expert testimony: Ono; Speaker Bureau / Expert testimony: Mundipharma; Speaker Bureau / Expert testimony: Taiho; Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony: Nippon Kayaku; Research grant / Funding (institution): Hisamitsu; Officer / Board of Directors, engaged in the project of medical practice guidline: Japanese Breast cancer society; Officer / Board of Directors, the leader of clinical trial comittee: Setouchi Breast Project Comprehensive Support Organization. K. Ishida: Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Eisai; Speaker Bureau / Expert testimony: Nippon Kayaku. T. Nakayama: Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Eli-Lilly; Speaker Bureau / Expert testimony: Novartis. T. Takashima: Speaker Bureau / Expert testimony, Officer / Board of Directors: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony, Officer / Board of Directors: AstraZeneca; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Takeda; Speaker Bureau / Expert testimony: Eisai; Speaker Bureau / Expert testimony: Kyowa-Kirin; Speaker Bureau / Expert testimony: Eli-Lilly. T. Asakawa: Full / Part-time employment: Chugai Pharmaceutical Co., Ltd. S. Matsumoto: Full / Part-time employment: Chugai Pharmaceutical Co., Ltd. D. Shimizu: Full / Part-time employment: Chugai Pharmaceutical Co., Ltd. M. Takahashi: Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eisai; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Eli-Lilly; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Kyowa-Kirin; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Taiho; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Daiichi Sankyo; Speaker Bureau / Expert testimony: Allergan; Speaker Bureau / Expert testimony, Research grant / Funding (institution): FUJIFILM Toyama Chemical; Speaker Bureau / Expert testimony: Nihon Medi-Physics; Honoraria (self), for wrtitin article: The Asahi Shimbun Company. All other authors have declared no conflicts of interest.
Resources from the same session
2840 - Effects of Aerobic and Resistance Exercise on Android:Gynoid Fat Ratio in Breast Cancer Survivors
Presenter: Christina Dieli-Conwright
Session: Poster Display session 2
Resources:
Abstract
869 - Impact of Education for Breast self examination in Rural Indian Women on Early Detection - results of POC study
Presenter: Sneha Parchuri
Session: Poster Display session 2
Resources:
Abstract
1951 - Breast cancer incidence and survival in renal transplant patients: 35-year experience
Presenter: Michalis Kontos
Session: Poster Display session 2
Resources:
Abstract
2017 - The changing landscape of breast cancer incidence after treatment for Hodgkin’s disease
Presenter: Amelia Benjamin
Session: Poster Display session 2
Resources:
Abstract
1780 - Number of deliveries as a prognostic factor in different breast cancer subtypes
Presenter: Anniina Jääskeläinen
Session: Poster Display session 2
Resources:
Abstract
4650 - Effects of supervised and adapted exercise program in the quality of life and strength of breast cancer survivors: MAMA MOVE Gaia trial
Presenter: Ana Joaquim
Session: Poster Display session 2
Resources:
Abstract
4962 - Study On the Socioeconomic and Clinical Factors Affecting the Proportion of Breast Conserving Surgery in Chinese Women Breast Cancer
Presenter: Jin Zhang
Session: Poster Display session 2
Resources:
Abstract
5451 - Clinical decision making and multidisciplinary team meetings (MDMs) in early breast cancer. Is the agreement between planned and applied therapeutic program?
Presenter: Marco Giavarra
Session: Poster Display session 2
Resources:
Abstract
888 - The value of genetic counselling in breast cancer genetic testing and clinical management
Presenter: Vicki Kiesel
Session: Poster Display session 2
Resources:
Abstract
4005 - Elderly patients in the Japanese Breast Cancer Registry
Presenter: Masataka Sawaki
Session: Poster Display session 2
Resources:
Abstract