Phase II Trial of Docetaxel in Asian Patients with Inoperable Stage III Non-Small Cell Lung Cancer

Goh, Boon Cher; Lehnert, Manfred; Lim, Hong Liang; Ng, Alan; Chan, Choong C.; Kong, Hwai Loong; Lee, Soo C.; Wee, Joseph; Chua, Eu Tiong; Wong, John

doi:10.1080/028418600430824

Cited by 18 publications

(2 citation statements)

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“…In addition, according to several studies, adverse events (AEs), predominantly hematological AEs, are higher in Asians than in Caucasians receiving docetaxel [21,22], with neutropenia being the predominant toxicity [22]. Studies in East Asian patients with NSCLC have indicated the need to decrease the dose of docetaxel or use the prophylactic support of growth factors in this ethnic group [22]. In a Japanese study, a reduction in the starting dose of docetaxel from 75 to 60 mg/m 2 was associated with an improved safety profile and a reduction in the incidence of neutropenia and febrile neutropenia in Japanese patients [23].…”

Section: Discussionmentioning

confidence: 99%

East Asian Subgroup Analysis of a Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL)

Park¹,

Kim²,

Cho³

et al. 2016

Cancer Res Treat

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PurposeREVEL demonstrated improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) with docetaxel+ramucirumab versus docetaxel+placebo in 1,253 intent-to-treat (ITT) stage IV non-small cell lung cancer patients with disease progression following platinum-based chemotherapy. Results from the East Asian subgroup analysis are reported.Materials and MethodsSubgroup analyses were performed in the East Asian ITT population (n=89). Kaplan-Meier analysis and Cox proportional hazards regression were performed for OS and PFS, and the Cochran-Mantel-Haenszel test was performed for response rate.ResultsIn docetaxel+ramucirumab (n=43) versus docetaxel+placebo (n=46), median OS was 15.44 months versus 10.17 months (hazard ratio [HR], 0.762; 95% confidence interval [CI], 0.444 to 1.307), median PFS was 4.88 months versus 2.79 months (HR, 0.658; 95% CI, 0.408 to 1.060), and ORR was 25.6% (95% CI, 13.5 to 41.2) versus 8.7% (95% CI, 2.4 to 20.8). Due to increased incidence of neutropenia and febrile neutropenia in East Asian patients, starting dose of docetaxel was reduced for newly enrolled East Asian patients (75 to 60 mg/m2, n=24). In docetaxel+ramucirumab versus docetaxel+placebo, incidence of neutropenia was 84.4% versus 72.7% (75 mg/m2) and 54.5% versus 38.5% (60 mg/m2). Incidence of febrile neutropenia was 43.8% versus 12.1% (75 mg/m2) and 0% versus 7.7% (60 mg/m2).ConclusionResults of this subgroup analysis showed a trend favoring ramucirumab+docetaxel for median OS, PFS, and improved ORR in East Asian patients, consistent with ITT population results. Reduction of starting dose of docetaxel in East Asian patients was associated with improved safety.

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Section: Discussionmentioning

confidence: 99%

East Asian Subgroup Analysis of a Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL)

Park¹,

Kim²,

Cho³

et al. 2016

Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…A single center retrospective analysis in China showed that the incidence of myocarditis was 1.06% when using ICIs alone or in combination with chemotherapy [ 16 ]. In this case, for drug-induced myocarditis, although he was combined with docetaxel and other chemotherapy drugs, a number of clinical trials about Docetaxel and Cisplatin in Advanced NSCLC showed that the rate of cardiotoxicity was low [ 17 , 18 ]. A meta-analysis of docetaxel versus docetaxel plus cisplatin in the treatment of advanced NSCLC showed that the major toxic side effects were anemia, nausea vomiting, thrombocytopenia, mucositis and nephrotoxicity, no cardiac toxicity has been reported [ 19 ].…”

Section: Discussionmentioning

confidence: 99%