Journal ArticleDOI
Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial
Florian Lordick,Yoon-Koo Kang,Hyun Cheol Chung,Pamela Salman,Sang Cheul Oh,György Bodoky,G. Kurteva,Constantin Volovat,Vladimir Moiseyenko,Vera Gorbunova,Joon Oh Park,Akira Sawaki,Ilhan Celik,Heiko Götte,Helena Melezínková,Markus Moehler +15 more
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TLDR
Addition of cetuximab to capecitabine-cisplatin provided no additional benefit to chemotherapy alone in the first-line treatment of advanced gastric cancer in the EXPAND trial.Abstract:
Summary Background Patients with advanced gastric cancer have a poor prognosis and few efficacious treatment options. We aimed to assess the addition of cetuximab to capecitabine-cisplatin chemotherapy in patients with advanced gastric or gastro-oesophageal junction cancer. Methods In our open-label, randomised phase 3 trial (EXPAND), we enrolled adults aged 18 years or older with histologically confirmed locally advanced unresectable (M0) or metastatic (M1) adenocarcinoma of the stomach or gastro-oesophageal junction. We enrolled patients at 164 sites (teaching hospitals and clinics) in 25 countries, and randomly assigned eligible participants (1:1) to receive first-line chemotherapy with or without cetuximab. Randomisation was done with a permuted block randomisation procedure (variable block size), stratified by disease stage (M0 vs M1), previous oesophagectomy or gastrectomy (yes vs no), and previous (neo)adjuvant (radio)chemotherapy (yes vs no). Treatment consisted of 3-week cycles of twice-daily capecitabine 1000 mg/m 2 (on days 1–14) and intravenous cisplatin 80 mg/m 2 (on day 1), with or without weekly cetuximab (400 mg/m 2 initial infusion on day 1 followed by 250 mg/m 2 per week thereafter). The primary endpoint was progression-free survival (PFS), assessed by a masked independent review committee in the intention-to-treat population. We assessed safety in all patients who received at least one dose of study drug. This study is registered at EudraCT, number 2007-004219-75. Findings Between June 30, 2008, and Dec 15, 2010, we enrolled 904 patients. Median PFS for 455 patients allocated capecitabine-cisplatin plus cetuximab was 4·4 months (95% CI 4·2–5·5) compared with 5·6 months (5·1–5·7) for 449 patients who were allocated to receive capecitabine-cisplatin alone (hazard ratio 1·09, 95% CI 0·92–1·29; p=0·32). 369 (83%) of 446 patients in the chemotherapy plus cetuximab group and 337 (77%) of 436 patients in the chemotherapy group had grade 3–4 adverse events, including grade 3–4 diarrhoea, hypokalaemia, hypomagnesaemia, rash, and hand-foot syndrome. Grade 3–4 neutropenia was more common in controls than in patients who received cetuximab. Incidence of grade 3–4 skin reactions and acne-like rash was substantially higher in the cetuximab-containing regimen than in the control regimen. 239 (54%) of 446 in the cetuximab group and 194 (44%) of 436 in the control group had any grade of serious adverse event. Interpretation Addition of cetuximab to capecitabine-cisplatin provided no additional benefit to chemotherapy alone in the first-line treatment of advanced gastric cancer in our trial. Funding Merck KGaA.read more
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Current status of ramucirumab in gastroesophageal adenocarcinoma.
TL;DR: It is clear that paclitaxel and ramucirumab should be used if possible in the second-line setting of GEAC, and the placement of ramucIRumab may become less clear as the data from immune oncology trials in GEAC emerge.
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Novel Targeted Therapy for Advanced Gastric Cancer
Hui-yan Luo,Rui-hua Xu +1 more
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Does tumor profile in gastric and gastroesophageal (GE) junction cancer justify off-label use of targeted therapy?—a narrative review
TL;DR: This review will assess the current evidence for the use of targeted therapies utilizing biomarkers in the context of gastric and gastroesophageal (GE) junction cancers and demonstrate that what holds true in the metastatic setting does not necessarily apply to the adjuvant or neoadjuvant setting.
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Trends in Chemotherapy Patterns and Survival of Patients with Advanced Gastric Cancer over a 16-Year Period: Impact of Anti-HER2-Targeted Agent in the Real-World Setting.
TL;DR: The OS was improved over time with advancements in chemotherapy, particularly the introduction of the anti-HER2–targeted agent, which contributed to the increase in the number of long-term survivors and established the superiority of OS for the treatment of MRGC.
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Emerging biological drugs for the treatment of gastroesophageal adenocarcinoma.
TL;DR: In this article, the intrinsic characteristic of GC/GOJC from an epidemiological, molecular, and clinical perspective with an exhaustive evaluation of the reported and ongoing phase II/III clinical trials with targeted therapies was discussed.
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Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
Yung-Jue Bang,Eric Van Cutsem,A. Feyereislova,Hyun Cheol Chung,Lin Shen,Akira Sawaki,Florian Lordick,Atsushi Ohtsu,Yasushi Omuro,Taroh Satoh,G. Aprile,Evgeny Kulikov,Julie Hill,Michaela Lehle,Josef Rüschoff,Yoon-Koo Kang +15 more
TL;DR: Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
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Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer
Jan B. Vermorken,Ricard Mesia,Fernando Rivera,Eva Remenar,Andrzej Kawecki,Sylvie Rottey,Jozsef Erfan,Dmytro Zabolotnyy,Heinz Roland Kienzer,Didier Cupissol,Frederic Peyrade,Marco Benasso,Ihor Vynnychenko,Dominique De Raucourt,Carsten Bokemeyer,Armin Schueler,Nadia Amellal,Ricardo Hitt +17 more
TL;DR: Adding cetuximab to platinum-based chemotherapy with fluorouracil (platinum-fluorouracils) significantly prolonged the median overall survival and improved overall survival when given as first-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck.
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Capecitabine and oxaliplatin for advanced esophagogastric cancer.
TL;DR: Capecitabine and oxaliplatin are as effective as fluorouracil and cisplatin, respectively, in patients with previously untreated esophagogastric cancer, in a two-by-two design.
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