Citation

Kim SB, Seo JH, Ahn JH, Kim TY, Kang SY, Sohn J, Yang Y, Park KH, Moon YW, Lim S, Kang MJ, Yoon KE, Cho HJ, Lee KS. Therapeutic Advances in Medical Oncology 2021; 13.

Copyright

(Copyright © 2021)

DOI

10.1177/17588359211061989

PMID

unavailable

Abstract

BACKGROUND: Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer.

METHODS: This multicenter, phase II study using a Simon's two-stage design investigated the efficacy and safety of DHP107 200 mg/m2 administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer.

RESULTS: Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34-81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1-28) of DHP107 was administered.

OBJECTIVE response rate was 55% (17 patients), all partial responses, according to the investigator's decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator's decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2-12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2-10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade ⩾ 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis.

CONCLUSION: DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364). Trial registration: This trial was registered with ClinicalTrials.gov identifier: NCT03315364. © The Author(s), 2021.

Language: en

Keywords

adult; human; female; male; suicide attempt; clinical trial; middle aged; diarrhea; nausea; multicenter study; cardiovascular disease; alopecia; aspartate aminotransferase; electrocardiogram; paclitaxel; Article; hemoglobin; stomach cancer; overall survival; sensory neuropathy; febrile neutropenia; hypersensitivity; neutrophil count; estrogen receptor; metastatic breast cancer; anthracycline; clear cell carcinoma; DHP107; epidermal growth factor receptor 2; first-line; HER2-negative; oral mucositis; oral paclitaxel; progesterone receptor