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Ref Type Journal Article
PMID (26628478)
Authors Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houé V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D
Title Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial.
Journal Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Vol 34
Issue 5
Date 2016 Feb 10
URL
Abstract Text To evaluate the efficacy of adding lapatinib to capecitabine and oxaliplatin (CapeOx) in patients with previously untreated human epidermal growth factor receptor 2 (HER2) -amplified advanced gastroesophageal adenocarcinoma.Patients with HER2-positive advanced gastroesophageal adenocarcinoma were randomly assigned at a one-to-one ratio to CapeOx plus lapatinib 1,250 mg or placebo daily. Primary end point was overall survival (OS) in patients with centrally confirmed HER2 amplification in the primary efficacy population.A total of 545 patients were randomly assigned, and 487 patients comprised the primary efficacy population. Median OS in the lapatinib and placebo arms was 12.2 (95% CI, 10.6 to 14.2) and 10.5 months (95% CI, 9.0 to 11.3), respectively, which was not significantly different (hazard ratio, 0.91; 95% CI, 0.73 to 1.12). Median progression-free survival in the lapatinib and placebo arms was 6.0 (95% CI, 5.6 to 7.0) and 5.4 months (95% CI, 4.4 to 5.7), respectively (hazard ratio, 0.82; 95% CI, 0.68 to 1.00; P = .0381). Response rate was significantly higher in the lapatinib arm: 53% (95% CI, 46.4 to 58.8) compared with 39% (95% CI, 32.9 to 45.3) in the placebo arm (P = .0031). Preplanned exploratory subgroup analyses showed OS in the lapatinib arm was prolonged in Asian and younger patients. No correlation was observed between HER2 immunohistochemistry status and survival. There were increased toxicities in the lapatinib arm, particularly diarrhea.Addition of lapatinib to CapeOx did not increase OS in patients with HER2-amplified gastroesophageal adenocarcinoma. There were clear differences in the effect of lapatinib depending on region and age. Future studies could examine this correlation.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 amp gastroesophageal junction adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastroesophageal junction adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478
ERBB2 amp esophagus adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in esophagus adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478
ERBB2 amp gastric adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastric adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478