Abstract
Purpose: 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 and Methods: Patients with HER2-positive advanced gastroesophageal adenocarcinoma were randomly assigned at a one-to-one ratio to CapeOx plus lapatinib 1,250mg or placebo daily. Primary end point was overall survival (OS) in patientswith centrally confirmed HER2 amplification in the primary efficacy population. Results: 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. Conclusion: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 443-451 |
| Number of pages | 9 |
| Journal | Journal of Clinical Oncology |
| Volume | 34 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2016 Feb 10 |
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All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research
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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. / Hecht, J. Randolph; Bang, Yung Jue; Qin, Shukui K.; Chung, Hyun C.; Xu, Jianming M.; Park, Joon O.; Jeziorski, Krzysztof; Shparyk, Yaroslav; Hoff, Paulo M.; Sobrero, Alberto; Salman, Pamela; Li, Jin; Protsenko, Svetlana A.; Wainberg, Zev A.; Buyse, Marc; Afenjar, Karen; Houè, Vincent; Garcia, Agathe; Kaneko, Tomomi; Huang, Yingjie; Khan-Wasti, Saba; Santillana, Sergio; Press, Michael F.; Slamon, Dennis.
In: Journal of Clinical Oncology, Vol. 34, No. 5, 10.02.2016, p. 443-451.Research output: Contribution to journal › Article
TY - JOUR
T1 - Lapatinib in combination with capecitabine plus oxaliplatin in human epidermal growth factor receptor 2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma
T2 - TRIO-013/LOGiC - A randomized phase III trial
AU - Hecht, J. Randolph
AU - Bang, Yung Jue
AU - Qin, Shukui K.
AU - Chung, Hyun C.
AU - Xu, Jianming M.
AU - Park, Joon O.
AU - Jeziorski, Krzysztof
AU - Shparyk, Yaroslav
AU - Hoff, Paulo M.
AU - Sobrero, Alberto
AU - Salman, Pamela
AU - Li, Jin
AU - Protsenko, Svetlana A.
AU - Wainberg, Zev A.
AU - Buyse, Marc
AU - Afenjar, Karen
AU - Houè, Vincent
AU - Garcia, Agathe
AU - Kaneko, Tomomi
AU - Huang, Yingjie
AU - Khan-Wasti, Saba
AU - Santillana, Sergio
AU - Press, Michael F.
AU - Slamon, Dennis
PY - 2016/2/10
Y1 - 2016/2/10
N2 - Purpose: 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 and Methods: Patients with HER2-positive advanced gastroesophageal adenocarcinoma were randomly assigned at a one-to-one ratio to CapeOx plus lapatinib 1,250mg or placebo daily. Primary end point was overall survival (OS) in patientswith centrally confirmed HER2 amplification in the primary efficacy population. Results: 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. Conclusion: 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.
AB - Purpose: 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 and Methods: Patients with HER2-positive advanced gastroesophageal adenocarcinoma were randomly assigned at a one-to-one ratio to CapeOx plus lapatinib 1,250mg or placebo daily. Primary end point was overall survival (OS) in patientswith centrally confirmed HER2 amplification in the primary efficacy population. Results: 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. Conclusion: 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.
UR - http://www.scopus.com/inward/record.url?scp=84958818670&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84958818670&partnerID=8YFLogxK
U2 - 10.1200/JCO.2015.62.6598
DO - 10.1200/JCO.2015.62.6598
M3 - Article
C2 - 26628478
AN - SCOPUS:84958818670
VL - 34
SP - 443
EP - 451
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 5
ER -