Abstract 5083
Background
DHP107 is a novel oral formulation composed of lipid based components and paclitaxel. DHP107 showed efficacy and safety comparable to IV paclitaxel in patients (pts) with AGC {Ann Oncol 2018}. DHP 107 was approved for marketing in 2016 for gastric cancer in Korea as first oral paclitaxel in the world. Another phase II clinical trial of DHP107 for PKs in breast cancer is ongoing in USA.
Methods
This trial is conducted using Simon’s optimal two stage design, and planned to proceed to stage 2, if ≥ 2 of 9 pts showed objective response in stage 1. DHP107 is considered adequately effective to proceed into phase III trial if ≥ 9 of 34 showed PR in stage 2. Subjects are eligible for the study regardless lines of endocrine therapy. Pts are administrated with DHP107 (200mg/m2 po bid D1, 8 & 15 q4wks) and response evaluation (RECIST v1.1) was done every 8wks (±1w). The primary tumor assessment was done by investigator’s review (IR). Independent central review (ICR) was followed for sensitivity analysis. Primary endpoint is objective response rate (ORR) and secondary endpoints are progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety.
Results
Total 36 subjects (including 11 TNBC pts) were enrolled during Dec 2017 until Oct 2018. Per Protocol set (PPS) was composed of 33 pts and 14 pts are still on treatment. Safety Analysis set (SAS) included 36 pts. ORR was 48.5% (CR 0%; PR 48.5%) by the IR vs 36.4% (CR 0%; PR 36.4%) by ICR. DCR was similar between the investigator’s decision (90.9%) and ICR (84.9%). Most common adverse events (AEs) were neutropenia; Gr. 3/4 Neutropenia (75%), Anemia (16.7%) and Peripheral neuropathy (5.6%). There were 2 SAEs related to Gr. 3/4 neutropenia without fever. One patient discontinued due to Gr 3 peripheral neurotoxicity. There was no treatment-related toxic death.
Conclusions
Based on confirmed PR (n = 16/33, 48.5%), DHP107 demonstrated adequate efficacy with manageable toxicity in the first line HER2 negative recurrent/metastatic breast cancer patients. Phase III trial in breast cancer is ongoing in Korea and China.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Daehwa Pharmaceuticals. Co. Ltd.
Funding
Daehwa Pharmaceuticals. Co. Ltd.
Disclosure
K.S. Lee: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Norvatis; Advisory / Consultancy: Lilly; Research grant / Funding (institution): Dong-A pharm. K. Lee: Advisory / Consultancy, Speaker Bureau / Expert testimony, Consulting role & Lecture fee: AstraZeneca; Advisory / Consultancy, Lecture fee: Bayer; Advisory / Consultancy, Lecture fee: Eisai; Advisory / Consultancy, Lecture fee: Ono Pharmaceuticals; Advisory / Consultancy, Speaker Bureau / Expert testimony, Consulting role & Lecture fee: Roche; Speaker Bureau / Expert testimony, Lecture fee: Eli Lilly; Advisory / Consultancy, Lecture fee: Samsung Bioepis. J. Sohn: Research grant / Funding (institution): MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Norvatis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): GSK; Research grant / Funding (institution): CONTESSA; Research grant / Funding (institution): Diichi Sankyo. S. Kim: Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Sanofi-Genzyme; Research grant / Funding (institution): Dongkook. All other authors have declared no conflicts of interest.
Resources from the same session
5747 - The routine use of sentinel lymph node biopsy in high risk DCIS lesions is not justified
Presenter: Fanny Preat
Session: Poster Display session 2
Resources:
Abstract
1837 - Oncological impact of re-excision for positive margin status after breast conserving surgery in invasive breast cancer
Presenter: Kenjiro Jimbo
Session: Poster Display session 2
Resources:
Abstract
4347 - Pneumonitis and fibrosis after breast cancer radiation.
Presenter: Jarle Karlsen
Session: Poster Display session 2
Resources:
Abstract
2280 - Prognosis of mastectomy with reconstruction after neoadjuvant chemotherapy: a nationwide study in Korean Breast Cancer Society
Presenter: Sungmin Park
Session: Poster Display session 2
Resources:
Abstract
804 - A negative prognosis of radiotherapy-induced lower lymphocyte to monocyte ratio in patients with breast cancer
Presenter: Chang-ik Yoon
Session: Poster Display session 2
Resources:
Abstract
2701 - Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Presenter: Francesco Giusti
Session: Poster Display session 2
Resources:
Abstract
1437 - A critical appraisal of quality indicators of breast cancer treatment in Belgium
Presenter: Didier Verhoeven
Session: Poster Display session 2
Resources:
Abstract
1534 - Predictors of adherence among post-menopausal women receiving adjuvant endocrine therapy for breast cancer in Ontario, Canada
Presenter: Phillip Blanchette
Session: Poster Display session 2
Resources:
Abstract
4363 - Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study
Presenter: Emilia Montagna
Session: Poster Display session 2
Resources:
Abstract
2679 - Baseline Quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): the French multicentric prospective CANTO cohort study
Presenter: Idlir Licaj
Session: Poster Display session 2
Resources:
Abstract