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Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy

Kang, YK | Ryu, MH | Park, SH | Kim, JG | Kim, JW | Cho, SH | Park, YI | Park, SR | Rha, SY | Kang, MJ | Cho, JY | Kang, SY  | Roh, SY | Ryoo, BY | Nam, BH | Jo, YW | Yoon, KE | Oh, SC
Annals of oncology, 29(5). : 1220-1226, 2018
Journal Title
Annals of oncology
BACKGROUND: Paclitaxel is currently only available as an intravenous (i.v.) formulation. DHP107 is a novel oral formulation of lipid ingredients and paclitaxel. DHP107 demonstrated comparable efficacy, safety, and pharmacokinetics to i.v. paclitaxel as a second-line therapy in patients with advanced gastric cancer (AGC). DREAM is a multicenter, open-label, prospective, randomized phase III study of patients with histologically/cytologically confirmed, unresectable/recurrent AGC after first-line therapy failure.
METHODS AND MATERIALS: Patients were randomized 1 : 1 to DHP107 (200 mg/m2 orally twice daily days 1, 8, 15 every 4 weeks) or i.v. paclitaxel (175 mg/m2 day 1 every 3 weeks). Patients were stratified by Eastern Cooperative Oncology Group performance status, disease status, and prior treatment: response was assessed (Response Evaluation Criteria in Solid Tumors) every 6 weeks. Primary end point: non-inferiority of progression-free survival (PFS): secondary end points: overall response rate (ORR), overall survival (OS), and safety. For the efficacy analysis, sequential tests for non-inferiority were carried out, first with a non-inferiority margin of 1.48, then with a margin of 1.25.
RESULTS: Baseline characteristics were balanced in the 236 randomized patients (n = 118 per arm). Median PFS (per-protocol) was 3.0 (95% CI 1.7-4.0) months for DHP107 and 2.6 (95% CI 1.8-2.8) months for paclitaxel (hazard ratio [HR] = 0.85: 95% CI 0.64-1.13). A sensitivity analysis on PFS using independent central review showed similar results (HR = 0.93: 95% CI 0.70-1.24). Median OS (full analysis set) was 9.7 (95% CI 7.1 - 11.5) months for DHP107 versus 8.9 (95% CI 7.1-12.2) months for paclitaxel (HR = 1.04: 95% CI 0.76-1.41). ORR was 17.8% for DHP107 (CR 4.2%: PR 13.6%) versus 25.4% for paclitaxel (CR 3.4%: PR 22.0%). Nausea, vomiting, diarrhea, and mucositis were more common with DHP107: peripheral neuropathy was more common with paclitaxel. There were only few Grade>/=3 adverse events, most commonly neutropenia (42% versus 53%): febrile neutropenia was reported infrequently (5.9% versus 2.5%). No hypersensitivity reactions occurred with DHP107 (paclitaxel 2.5%).
CONCLUSIONS: DHP107 as a second-line treatment of AGC was non-inferior to paclitaxel for PFS: other efficacy and safety parameters were comparable. DHP107 is the first oral paclitaxel with proven efficacy/safety for the treatment of AGC.
ClinicalTrials.gov: NCT01839773.
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Journal Papers > School of Medicine / Graduate School of Medicine > Hematology-Oncology
Ajou Authors
강, 석윤
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