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Journal of Chinese Pharmaceutical Sciences ›› 2020, Vol. 29 ›› Issue (3): 192-198.DOI: 10.5246/jcps.2020.03.016

• Original articles • Previous Articles     Next Articles

Concomitant administration of gastric acid suppression might attenuates the clinical efficacy of gefitinib: a single cancer center retrospective study

Zihan Guo1,2#, Qiong Du1,2#, Xuan Ye1,2#, Feifei Gao1,2, Yufang You1,2, Bo Yu3*, Qing Zhai1,2*   

  1. 1. Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai 200032, China
    2. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
    3. Department of Pharmacy, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200336, China
  • Received:2019-12-28 Revised:2020-01-15 Online:2020-03-30 Published:2020-01-29
  • Contact: Tel.: +86-18017317070, E-mail: zhaiqing63@126.com, Tel.: +86-15821279851, E-mail: miguelboyu@msn.cn

Abstract:

Recent pharmacokinetic studies have demonstrated that gastric acid suppression (AS) reduces exposure of gefitinib. However, the clinical significance of this drug-drug interaction (DDI) has not been determined. We, therefore, evaluated it in this real-world study.A total of200 NSCLC patients who received gefitinib from 2016 to 2018 at Fudan University Shanghai Cancer Center (FUSCC) were randomly selected. The patients were divided into two groups according to whether AS was used. The clinical characteristics of the patients were collected, and the efficacy and safety of gefitinib were compared between the two groups. We showed that188 patients were considered eligible for this retrospective analysis, 49 received AS (AS user group), while 139 patients did not (AS non-user group). Objective response rate (ORR) and disease control rate (DCR) in the AS user group versus AS non-user group were 69.4% versus 73.4% (P = 0.591) and 89.8% versus 90.6% (P = 0.486), respectively, while the progression-free survival (PFS) were 9.7 versus 12.2 months (P = 0.0644). No significant difference in ORR, DCR or PFS was observed between the two groups. Further study showed that the PFS was related to the time of co-administration, and the patients receiving over 50% AS prescription overlap with gefitinib was significantly less compared with the other people (8.4 vs 12.6 months, P = 0.0004). The frequencies of rash (8.2% vs 15.1%,P = 0.281), diarrhea (4.1% vs 6.5%, P = 0.539) and elevated ALT or AST level (6.1% vs 10.1%, P = 0.407) were similar for both groups. Therefore, concomitant use of AS and gefitinib might affect the efficacy of gefitinib, which should be avoided if possible. 

Key words: Drug interactions, Gastric acid suppression, Gefitinib, Clinical impact

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