Clinical Research Papers:
Efficacy of trastuzumab beyond progression in HER2 positive advanced gastric cancer: a multicenter prospective observational cohort study
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Qian Li1,*, Huiqin Jiang1,*, Hong Li1,*, Ruihua Xu2, Lin Shen3, Yiyi Yu1, Yan Wang1, Yuehong Cui1, Wei Li1, Shan Yu1, Tianshu Liu1
1Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China
2Department of Medical Oncology, Sun Yat-Sen University Cancer Center; State Key Laboratory of Oncology in South China, Guangzhou, China
3Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China
*These authors have contributed equally to this work
Tianshu Liu, email: [email protected]
Keywords: advanced gastric cancer, HER2, trastuzumab, treatment beyond progression
Received: March 18, 2016 Accepted: April 28, 2016 Published: July 07, 2016
Introduction: Trastuzumab plus chemotherapy is the standard first-line regimen in HER2 positive advanced gastric cancer (AGC), but lack of data in post-progression treatment. So, it is worth evaluating the efficacy of continuing trastuzumab after failure of the first-line trastuzumab based treatment.
Methods: 59 patients were enrolled from Zhongshan Hospital Fudan University, Sun Yat-sen University Cancer Center and Peking University Cancer Hospital between September 2012 and Oct 2015. Patients were divided into two groups according to the second line regimens: with or without trastuzumab. The primary endpoint was progression free survival of second line therapy (PFS2). Secondary end points included overall survival (OS), response rate, and adverse events (AEs).
Results: Baseline factors were well balanced between two groups. 32 patients treated with trastuzumab plus second line chemotherapy (group A) and 27 patients received chemotherapy alone (group B). The median follow-up time was 7.60 months (range 1.50-32.50). Longer median PFS2 was observed in group A than in group B (3.1 vs 2.0 months, P=0.008). There was no significant differences of median OS2 calculating from the second line therapy (10.5 vs 6.5 months, P=0.172) between two groups. Response rate was 9.3% in group A compared with 3.7% in group B (P=0.617). AEs were similar in two groups including cardiac safety. Subgroup analysis showed that factors of male, age<65, good performance status, HER2 immunohistochemical (IHC) 2+ and poor response to first line indicated superior PFS2 in patients continuing trastuzumab to those treated with chemotherapy alone.
Conclusion: Continuing treatment of trastuzumab beyond first line therapy progression showed effective and safe in AGC.
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