Randomized, Open-Label, Phase III Study Comparing Irinotecan With Paclitaxel in Patients With Advanced Gastric Cancer Without Severe Peritoneal Metastasis After Failure of Prior Combination Chemotherapy Using Fluoropyrimidine Plus Platinum: WJOG 4007 Trial

Hironaka, Shuichi; Ueda, Shinya; Yasui, Hirofumi; Nishina, Tomohiro; Tsuda, Masahiro; Tsumura, Takehiko; Sugimoto, Naotoshi; Shimodaira, Hideki; Tokunaga, Shinya; Moriwaki, Toshikazu; Esaki, Taito; Nagase, Michitaka; Fujitani, Kazumasa; Yamaguchi, Kensei; Umemura, Takashi; Hamamoto, Yasuo; Morita, Satoshi; Okamoto, Isamu; Boku, Narikazu; Hyodo, Ichinosuke

doi:10.1200/jco.2012.48.5805

Cited by 465 publications

(363 citation statements)

References 21 publications

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“…PTX arm was longer in the Japanese population (11.5 months) than in the Western population (5.9 months) in our study. This is in accordance with previous studies in the first-line and second-line setting reporting better survival outcome in Asian/Japanese patients than in Western patients [3,4,7,18,19]. In the present study, there were differences between the Japanese and Western patients in some important baseline characteristics (such as ECOG PS, TTP with first-line therapy, and number of metastatic sites) indicating that the Japanese patients may have been healthier (with less tumor burden) at the start of the trial.…”

Section: Discussionsupporting

confidence: 82%

“…Neutropenia was one of the most frequently reported adverse events in both treatment arms, and the incidence in the PL ? PTX arm was within the range of that reported in other Japanese and Western trials with a similar paclitaxel dose and schedule [7,[11][12][13]. Neutropenia was commoner in the Japanese population, but this could be managed safely, as indicated by the longer median duration of therapy in the RAM ?…”

Section: Discussionsupporting

confidence: 59%

“…Recent randomized clinical trials exploring second-line or later single-agent chemotherapy versus best supportive care or comparing two single-agent chemotherapies in gastric cancer have suggested better survival outcome in Japanese patients in comparison with Western patients [3,4,7], although this is not a universal phenomenon in all Asian patients [5]. Differences in survival outcome between Japanese and Western patients with gastric cancer are well known, and the reasons have been widely speculated upon and include tumor biology, ethnicity, health care, insurance or reimbursement systems, and use of subsequent therapy [8,9].…”

Section: Introductionmentioning

confidence: 99%

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Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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Background We evaluated the safety and efficacy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients previously treated for advanced gastric or gastroesophageal junction adenocarcinoma in Japanese and Western subgroups from the RAINBOW trial. Methods Patients received ramucirumab at 8 mg/kg or placebo (days 1 and 15) plus paclitaxel at 80 mg/m 2 (days 1, 8, and 15 of a 28-day cycle). End points were compared between treatment arms within Japanese (N = 140) and Western (N = 398) populations. Results The incidence of adverse events of grade 3 or higher was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 83.8 % vs 52.1 %; Western population, 79.1 % vs 61.9 %). Neutropenia was the commonest adverse event of grade 3 or higher, with a higher incidence for ramucirumab plus paclitaxel (Japanese population, 66.2 % vs 25.4 %; Western population, 32.1 % vs 14.7 %). The incidence of febrile neutropenia was low and was similar between treatment arms in both populations. The overall survival hazard ratio was 0.88 (95 % Conclusions Safety profiles of the ramucirumab plus paclitaxel arm were similar between populations, though there was a higher incidence of neutropenia in Japanese patients. Progression-free survival and objective response rate improvements were observed for ramucirumab plus paclitaxel in both populations. ClinicalTrials.gov identifier: NCT01170663This

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Section: Discussionsupporting

confidence: 82%

Section: Discussionsupporting

confidence: 59%

Section: Introductionmentioning

confidence: 99%

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Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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“…A previous phase III study comparing irinotecan with paclitaxel in patients with AGC whose diseases progressed after first line chemotherapy reported median PFS as 3.6 months, an equivalent result to Bang' s study (23). The response rate presenting in the phase II trial was also consistent to the results on PFS.…”

supporting

confidence: 76%

Ataxia telangiectasia mutated (ATM), could it be another useful biomarker for the successful treatment with the poly (ADP-ribose) polymerase inhibitor?

Lee

2016

Transl. Gastroenterol. Hepatol.

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“…Compared with the best supportive care, first-line chemotherapy for advanced gastric cancer (AGC) improves survival time and quality of life (2)(3)(4); however, the median overall survival (OS) time is short (9-13 months) (5)(6)(7). Several previous studies have demonstrated that second-line chemotherapy confers a significant survival benefit over best supportive care in AGC, with median OS time ranging from 4 to 9.5 months (8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Correlation between human epidermal growth factor receptor 2 expression level and efficacy of trastuzumab beyond progression in metastatic gastric cancer

Kadowaki¹,

Masuishi²,

Taniguchi³

et al. 2017

Oncology Letters

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Abstract. There is currently no clinical data regarding the efficacy of trastuzumab treatment for the progression of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) occurring during trastuzumab-based chemotherapy. The aim of this study was to retrospectively examine the clinical benefits of trastuzumab for HER2-positive AGC patients who progressed during first-line trastuzumab-based chemotherapy. Among the 108 patients treated with trastuzumab combined with fluoropyrimidine and cisplatin as first-line therapy, 46 HER2-positive AGC patients who received cytotoxic agents with or without trastuzumab subsequent to disease progression were included. Of these, the efficacy and safety outcomes of 26 patients who continued trastuzumab were compared with those of the 20 patients who discontinued trastuzumab. No difference in response rate (18.2 vs. 15.8%, P=1.00) was observed between the two groups. Progression-free survival (PFS) time was numerically longer in the chemotherapy combination with trastuzumab group than in the chemotherapy combination without trastuzumab group (median, 4.0 vs. 2.3 months), with no significance [hazard ratio (HR), 0.63; P=0.14]. In the subset analysis, continuation of trastuzumab significantly improved PFS time in selected subgroups of patients with tumors exhibiting HER2 expression scores of 3+ (HR, 0.41; P=0.04), intestinal-type histology (HR, 0.32; P<0.01), and a first PFS time of >6 months (HR, 0.44; P=0.04). The survival times for the trastuzumab beyond progression (TBP) and non-TBP groups were similar (HR, 1.06; P=0.88), with equivalent overall survival times in the subgroups with immunohistochemistry scores of 3+ (HR, 0.97; P=0.94), 0.53; P= 0.19), and a first PFS time of >6 months (HR, 0.62; P=0.31). There were no differences in the incidence rates of toxicity, including cardiac dysfunction, between the two groups. The study results suggest that selected HER2-positive AGC patients may benefit from trastuzumab continuation during first progression, and further prospective studies are warranted.

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Randomized, Open-Label, Phase III Study Comparing Irinotecan With Paclitaxel in Patients With Advanced Gastric Cancer Without Severe Peritoneal Metastasis After Failure of Prior Combination Chemotherapy Using Fluoropyrimidine Plus Platinum: WJOG 4007 Trial

Abstract: No statistically significant difference was observed between paclitaxel and irinotecan for OS. Both are reasonable second-line treatment options for advanced gastric cancer.

Cited by 465 publications

References 21 publications

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Ataxia telangiectasia mutated (ATM), could it be another useful biomarker for the successful treatment with the poly (ADP-ribose) polymerase inhibitor?

Correlation between human epidermal growth factor receptor 2 expression level and efficacy of trastuzumab beyond progression in metastatic gastric cancer

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