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A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. Division of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan. hrmukai@east.ncc.go.jp. Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan. Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea. Division of Haematology and Oncology, Chang-Gung Memorial Hospital, Linko, Taoyuan, Taiwan. Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan. Center for Breast Cancer, National Cancer Center, Goyang, Korea. Division of Breast Oncology, Shizuoka Cancer Center, Shizuoka, Japan. Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan. Division of Breast and Endocrine Surgery, Department of Surgery, St. Marianna University School of Medicine, Kawasaki, Japan. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan. Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. Division of Hematology-Oncology, Samsung Medical Center, Seoul, Korea. Division of Hematology-Oncology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. Internal Medicine, College of Medicine, China Medical University, Taichung, Taiwan. Pharmaceuticals Group, Nippon Kayaku Co., Ltd., Tokyo, Japan.

British journal of cancer. 2019;(5):475-480
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Abstract

BACKGROUND NK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer. METHODS Patients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m2) or PTX (80 mg/m2) on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was progression-free survival (PFS), with a non-inferiority margin of 1.215. RESULTS A total of 436 patients were randomised and 211 patients in each group were included in the efficacy analysis. The median PFS was 8.4 and 8.5 months for NK105 and PTX, respectively (adjusted hazard ratio: 1.255; 95% confidence interval: 0.989-1.592). The median overall survival and overall response rates were 31.2 vs. 36.2 months and 31.6% vs. 39.0%, respectively. The two groups exhibited similar safety profiles. The incidence of peripheral sensory neuropathy (PSN) was 1.4% vs. 7.5% (≥Grade 3) for NK105 and PTX, respectively. The patient-reported outcomes of PSN were significantly favourable for NK105 (P < 0.0001). CONCLUSIONS The primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT01644890.

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