Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial

Yoon, Harry H.; Bendell, Johanna C.; Braiteh, Fadi; Firdaus, Irfan; Philip, P. A.; Cohn, Allen Lee; Lewis, Nancy; Anderson, D. Mark; Arrowsmith, Edward; Schwartz, Jonathan D.; Gao, Ling; Hsu, Yanzhi; Xu, Yihuan; Ferry, David; Alberts, Steven R.; Wainberg, Zev A.

doi:10.1093/annonc/mdw423

Cited by 127 publications

(106 citation statements)

References 16 publications

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“…Conversely, combination therapies between platinum-based chemotherapy and anti-angiogenic agents in first-line treatment of GC have failed to show significant survival benefit [40,41,51]. Additionally, the first report on ramucirumab in combination with a platinum compound, such as oxaliplatin, did not meet its primary endpoint [50]. Therefore, a randomized, double-blind, placebo-controlled phase III study of cisplatin plus a fluoropyrimidine with or without ramucirumab as first-line therapy in patients with metastatic GC or GEJ adenocarcinoma (RAINFALL, NCT02314117) is currently recruiting participants, and the final results of this trial are awaited to make definitive conclusions about platinumbased chemotherapy and antiangiogenic agents in first-line treatment of GC.…”

Section: Discussionmentioning

confidence: 99%

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Angiogenesis inhibitors in gastric and gastroesophageal junction cancer

et al. 2015

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Despite significant improvements in systemic chemotherapy during the past two decades, the prognosis of patients with advanced gastric and gastroesophageal junction adenocarcinoma remains poor. Because of molecular heterogeneity, it is essential to classify tumors based on the underlying oncogenic pathways and to develop targeted therapies acting on individual tumors. Unfortunately, although a number of molecular targets have been studied, very few of these agents can be used in a clinical setting. In this review, we summarize the available data on anti-angiogenic agents in advanced/metastatic gastric cancer.

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Section: Discussionmentioning

confidence: 99%

“…In a doubleblind, phase II trial, 168 patients with previously untreated unresectable locally advanced or metastatic esophageal, GC, or EGJ adenocarcinoma were randomized to receive mFOLFOX6 plus ramucirumab or placebo [50]. One hundred sixty-eight patients were enrolled (84 in the experimental arm vs. 84 in the chemotherapy ?…”

Section: Ramucirumabmentioning

confidence: 99%

Angiogenesis inhibitors in gastric and gastroesophageal junction cancer

et al. 2015

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“…По результатам рандомизированных исследований III фазы оба препа-рата зарегистрированы только в сочетании с режимом FOLFIRI во второй линии терапии [19,20]. Эффектив-ность данных моноклональных антител в первой линии или в комбинациях с оксалиплатин-содержащими режи-мами не доказана [21][22][23][24].…”

Section: какой режим химиотерапии лучше комбинировать с таргетным преunclassified

Optimal Sequences and Combination of Chemotherapy and Monoclonal Antibodies in the Treatment of Patients With Metastatic Colorectal Cancer

Федянин¹,

Тюляндин²

2018

Zlokač. opuholi

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In this review we analyzed results of studies concerning the choice of first and subsequent lines of therapy in patients with metastatic colon cancer. We discussed data of various combinations of monoclonal antibodies with different chemotherapeutic regimens. Also we discussed modern preclinical and clinical trials concerning strategy of choice of targeted therapy sequence in patients with metastatic disease. We considered the impact of various molecular and clinical factors on the effectiveness of drugs and determined their application for therapy choice for colon cancer.

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“…[25][26][27][28][29][30][31][32][33][34][35][36][37]44,[51][52][53][54][55][56][57][58][59] The TYTAN trial missed data about PFS. One trial missed results about OS.…”

Section: Studies Selectionmentioning

confidence: 99%

A systematic review and meta-analysis of randomized trials on the role of targeted therapy in the management of advanced gastric cancer: Evidence does not translate?

Ciliberto

Staropoli

Caglioti

et al. 2015

Cancer Biology & Therapy

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It is still uncertain if targeted therapy-based regimens in advanced gastric cancer actually produce survival benefit. To shed light on this important question, we performed a systematic review and meta-analyses on each relevant targeted-pathway. By searching literature databases and proceedings of major cancer meetings in the time-frame 2005-2014, 22 randomized clinical trials exploring targeted therapy for a total of 7022 advanced gastric cancer patients were selected and included in the final analysis. Benefit was demonstrated for antiangiogenic agents in terms of overall survival (HR 0.759; 95%CI 0.655-0.880; p < 0.001). Conversely no benefit was found for EGFR pathway (HR 1.077; 95%CI 0.847-1.370; p D 0.543). Meta-analysis of HER-2 pathway confirmed improvement in terms of survival outcome, already known for this class of drugs (HR 0.823; p D 0.004). Pooled analysis demonstrated a significant survival benefit (OS: HR 0.823; PFS: HR 0.762) with acceptable tolerability profile for targeted-based therapies as compared to conventional treatments. This finding conflicts with the outcome of most individual studies, probably due to poor trial design or patients selection. In conclusion, our findings demonstrate a significant survival benefit for targeted therapy in its whole, which can be ascribed to anti-angiogenic and anti-HER2 agents.

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Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial

Abstract: NCT01246960.

Cited by 127 publications

References 16 publications

Angiogenesis inhibitors in gastric and gastroesophageal junction cancer

Angiogenesis inhibitors in gastric and gastroesophageal junction cancer

Optimal Sequences and Combination of Chemotherapy and Monoclonal Antibodies in the Treatment of Patients With Metastatic Colorectal Cancer

A systematic review and meta-analysis of randomized trials on the role of targeted therapy in the management of advanced gastric cancer: Evidence does not translate?

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