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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, Y.-K. ; Ryu, M.-H. ; Park, S.H. ; Kim, J.G. ; Kim, J.W. ; Cho, S.-H. ; Park, Y.-I. ; Park, S.R. ; Rha, S.Y. ; Kang, M.J. ; Cho, J.Y. ; Kang, S.Y. ; Roh, S.Y. ; Ryoo, B.-Y. ; Nam, B.-H. ; Jo, Y.-W. ; Yoon, K.-E. ; Oh, S.C.

Annals of oncology, 2018-05, Vol.29 (5), p.1220-1226 [Periódico revisado por pares]

England: Elsevier Ltd

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Título:
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
Autor: Kang, Y.-K. ; Ryu, M.-H. ; Park, S.H. ; Kim, J.G. ; Kim, J.W. ; Cho, S.-H. ; Park, Y.-I. ; Park, S.R. ; Rha, S.Y. ; Kang, M.J. ; Cho, J.Y. ; Kang, S.Y. ; Roh, S.Y. ; Ryoo, B.-Y. ; Nam, B.-H. ; Jo, Y.-W. ; Yoon, K.-E. ; Oh, S.C.
Assuntos: Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Phytogenic - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - pharmacology ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; DHP107 ; Disease-Free Survival ; Drug Resistance, Neoplasm - drug effects ; Female ; gastric cancer ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - mortality ; Neoplasm Recurrence, Local - pathology ; non-inferiority ; oral paclitaxel ; Paclitaxel - administration & dosage ; progression free survival ; Response Evaluation Criteria in Solid Tumors ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - mortality ; Stomach Neoplasms - pathology ; Survival Analysis
É parte de: Annals of oncology, 2018-05, Vol.29 (5), p.1220-1226
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
ObjectType-News-3
content type line 23
Descrição: 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. Patients were randomized 1:1 to DHP107 (200mg/m2 orally twice daily days 1, 8, 15 every 4weeks) or i.v. paclitaxel (175mg/m2 day 1 every 3weeks). 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 6weeks. 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. 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%). 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. NCT01839773.
Editor: England: Elsevier Ltd
Idioma: Inglês

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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, Y.-K. ; Ryu, M.-H. ; Park, S.H. ; Kim, J.G. ; Kim, J.W. ; Cho, S.-H. ; Park, Y.-I. ; Park, S.R. ; Rha, S.Y. ; Kang, M.J. ; Cho, J.Y. ; Kang, S.Y. ; Roh, S.Y. ; Ryoo, B.-Y. ; Nam, B.-H. ; Jo, Y.-W. ; Yoon, K.-E. ; Oh, S.C.

England: Elsevier Ltd

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