Erlotinib versus vinorelbine therapy in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer and EGFR mutation: a randomized, controlled trial / 中华老年医学杂志

ABSTRACT

Objective To compare the efficacy and adverse effects of erlotinib versus vinorelbine naive patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutation.Methods Totally 46 elderly patients with histologically confirmed advanced NSCLC and EGFR mutations (exon 19 dclction or L858R point mutation) were enrolled.Patients were randomly divided into two groupserlotinib group (43 cases,150mg per day until disease progression or unacceptable toxicities) and control group (21 cases,vinorelbine-based chemotherapy,single vinorelbine chemotherapy or vinorelbine-based double chemotherapy).Results Response rates and disease control rates were significantly improved with erlotinib compared with vinorelbine (78.6％ and 88.1％ vs.38.1％ and 61.9％,respectively,P＜ 0.05).There was a significant difference in median progression-free survival (11.6 months vs.5.6 months,P＜0.05),while no statistical difference in median overall survival with erlotinib compared with vinorelbine (19.0months vs.16.5 months,P=0.193).The most frequent adverse effects were grade Ⅰ or Ⅱ and no patients stopped treatment due to adverse effects and no drug-relatcd death.The primary adverse effects were skin rash (71.4％),diarrhea (31.0％)and liver dysfunction (23.8％) in the erlotinib group and neutropenia (66.7％),nausea or vomit (47.6％),anemia (42.9％),platelet decline (33.3％),constipation (33.3％) and peripheral neuritis (23.8％) in the vinorelbine group.Vinorelbine group versus erlotinib group have more 3-4 level adverse reactions (15/21 vs.7/42)(x2=1.69,P=0.193).Conclusions Erlotinib treatment has advances in PFS,ORR and DCR and tolerability compared with vinorelbine-based chemotherapy in elderly patients with advanced NSCLC and EGFR mutation,while overall survival is in no difference.Erlotinib may be a reasonable first-line treatment option for elderly patients with advanced NSCLC and sensitive EGFR mutation.