A single center, single arm and Phase II clinical trail: the study of efficacy a
PUBLISHED: 2015-11-26  451 total views, 1 today

Yanzhe Zhu, Hu Liu, YingyingDu, Yuanyuan Shen

1Oncology, The FirstAffiliated Hospital of Anhui Medical University,

 

Objective:To observe the efficacy and safety ofpulsatile administration of high-dose gefitinib or erlotinib for advancednon-small cell lung cancer patients with secondary drug resistanceto standarddose of TKI treatment. Method: 42 cases of non-small cell lung cancerpatients with drug resistance after 1-year conventional treatment of gefitinibor erlotinib wererecruited in this study in our hospital from August of 2013 toDecember of 2014. The gefitinib group, including 29 cases, received one dose of1000mg gefitinib every four days. The erlotinib group, including 13 cases,received one dose of 450mg erlotinib everythree days. Treatments continued tilldisease progression according to RECIST 1.1 criteria or developmentofintolerable toxicity. Result: The median PFS of the total 42 cases was30months, the gefitinib group 31 months and erlotinib group 24 months, respectively.No statistically significant difference was observed (P>0.05). Afterthe high-dose pulsatile administration, total group had 8 cases of PR, 11 casesof SD and 23 case of PD, Meanwhile, RR was 19.0%, CDR was 45.2%, the median PFSwas 6 months. The gefitinib group had 0 case of CR, 6 cases of PR, 9 cases ofSD and 14 cases of PD; The erlotinibgroup had 0 case of CR, 2 cases of PR, 2cases of SD and 9 cases of PD. The median PFS of gefitinib and erlotinib groupswere 8 months and 6 months, respectively, with no significant difference (P>0.05).All cases were divided to 2 groups according to the mutation of EGFR exon. Exon19 mutationgroup had 0 case of CR, 4 cases of PR, 6 cases of SD and 17 cases ofPD. Exon 21 mutation group had 0 case of CR, 4 cases of PR, 5 cases of SD and 6cases of PD. The median PFSs of two groups were 6 months and 7 months, respectively,with nosignificant difference (P>0.05). Adverse reactions, such asrash, fatigue, anorexia and dry skin were observed, without presence of severeside effects. Conclusion: For advanced NSCLC patients who have previouslyundergone a standard dose treatment of gefitinibor erlotinib, high-dose TKIpulsatile treatment is safe and efficient, and canimprove prognosis of aportion of the patients.

 

Key Words: gefitinib  erlotinib pulsatile administration


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