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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-02-12

AUTHORS

Yasuhiro Fujiwara, Hirofumi Mukai, Toshiaki Saeki, Jungsil Ro, Yung-Chang Lin, Shigenori E. Nagai, Keun Seok Lee, Junichiro Watanabe, Shoichiro Ohtani, Sung Bae Kim, Katsumasa Kuroi, Koichiro Tsugawa, Yutaka Tokuda, Hiroji Iwata, Yeon Hee Park, Youngsen Yang, Yoshihiro Nambu

ABSTRACT

BackgroundNK105 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.MethodsPatients 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.ResultsA 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).ConclusionsThe primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX.Clinical trial registrationClinicalTrials.gov: NCT01644890 More... »

PAGES

475-480

Journal

TITLE

British Journal of Cancer

ISSUE

5

VOLUME

120

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41416-019-0391-z

DOI

http://dx.doi.org/10.1038/s41416-019-0391-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112058397

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30745582


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26 schema:description BackgroundNK105 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.MethodsPatients 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.ResultsA 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).ConclusionsThe primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX.Clinical trial registrationClinicalTrials.gov: NCT01644890
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34 III non-inferiority trial
35 MethodsPatients
36 NCT01644890
37 NK105
38 PSN toxicity profile
39 Phase III non-inferiority trial
40 analysis
41 better PSN toxicity profile
42 breast cancer
43 breast cancer patients
44 cancer
45 cancer patients
46 cycle
47 day 1
48 delivery formulations
49 drug delivery formulations
50 efficacy
51 efficacy analysis
52 endpoints
53 formulation
54 group
55 incidence
56 margin
57 median overall survival
58 median progression-free survival
59 micelles
60 months
61 nanoparticle drug delivery formulation
62 neuropathy
63 non-inferiority margin
64 non-inferiority study
65 non-inferiority trial
66 novel nanoparticle drug delivery formulation
67 open-label phase III non-inferiority trial
68 outcomes
69 overall response rate
70 overall survival
71 paclitaxel
72 parallel
73 patient-reported outcomes
74 patients
75 peripheral sensory neuropathy
76 polymeric micelles
77 primary endpoint
78 profile
79 progression-free survival
80 rate
81 ratio
82 recurrent breast cancer
83 recurrent breast cancer patients
84 response rate
85 safety
86 safety of NK105
87 safety profile
88 sensory neuropathy
89 similar safety profile
90 study
91 survival
92 total
93 toxicity profile
94 trials
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