Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial

Ford, Hugo; Marshall, Andrea; Bridgewater, John; Janowitz, Tobias; Coxon, Fareeda Y.; Wadsley, Jonathan; Mansoor, Wasat; Fyfe, D.; Madhusudan, Srinivasan; Middleton, Gary; Swinson, Daniel; Falk, Stephen; Chau, Ian; Cunningham, David; Kareclas, Paula; Cook, Natalie; Blazeby, Jane M; Dunn, Janet A.

doi:10.1016/s1470-2045(13)70549-7

Cited by 527 publications

(417 citation statements)

References 26 publications

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“…The OS time of the TBP group was also equivalent to that of the non-TBP group in the subgroups with HER2 IHC 3+ (median, 11.3 vs. 8 Toxicity. The majority of adverse events associated with chemotherapy (Table II) were grade 1 or 2.…”

Section: Resultsmentioning

confidence: 83%

“…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%

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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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Section: Resultsmentioning

confidence: 83%

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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“…Currently, platinum-based and fluoropyrimidine-based combinations have been established worldwide as first-line regimens for treatment of advanced disease [2]. However, treatment options have been limited after failure of firstline therapy, resulting in short survival [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

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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“…Although cytotoxic agents have formed the backbone of systemic therapies for advanced/metastatic disease for many years [1], it is only recently that a survival advantage for second-line systemic therapy has been demonstrated [2][3][4][5]. Once a survival benefit in patients receiving first-line chemotherapy had been demonstrated for combinations of cytotoxics in the late 1990s [6][7][8], subsequent trials primarily built on this progress by substituting newer cytotoxic agents.…”

mentioning

confidence: 99%

“…A decade after the utility of first-line systemic therapy was established, the oral fluoropyrimidines were introduced into the treatment paradigm for gastric cancer [4,15]. Two large trials established the non-inferiority of capecitabine in comparison with 5-fluorouracil administered by continuous infusion when used in combination with either cisplatin or oxaliplatin.…”

mentioning

confidence: 99%

Gastric cancer: past progress and present challenges

Sjoquist

Zalcberg²

2014

Gastric Cancer

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Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial

Abstract: Cancer Research UK.

Cited by 527 publications

References 26 publications

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

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

Gastric cancer: past progress and present challenges

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