A Phase II Trial of Gefitinib Monotherapy in Chemotherapy-Naïve Patients of 75 Years or Older with Advanced Non-small Cell Lung Cancer

Abstract

Gefitinib monotherapy is effective and relatively well tolerated in chemotherapy-naïve elderly patients with advanced NSCLC. Gefitinib has potential as a first-line therapeutic option in elderly patients with advanced NSCLC.

Afatinib, Erlotinib and Gefitinib in the First-Line Therapy of EGFR Mutation-Positive Lung Adenocarcinoma: A Review

“…All of these trials reported an increase in ORR (13-43%) and PFS (4-5.9 months). Additional EGFR-mutational analyses revealed that the benefit was consistently highest in patients with tumors harboring the activating EGFR gene mutations [36,[43][44][45][46] [47][48][49][50]. Recently published meta-analyses consistently confirmed that EGFR mutations predict response to EGFR TKI with much higher sensitivity (0.78; 95% confidence interval (CI) 0.74-0.82) than do EGFR gene copy numbers or EGFR expression levels [51].…”

“…Anyhow, given that in many trials the HR for OS was slightly in favor of first-line EGFR TKI [52] and that the quality of life was maintained for much longer in TKI-treated patients [59], it is concluded that patients with EGFR-mutant tumors gain the greater benefit when TKIs are given early during the natural course of the disease [56]. Especially patients who are older or have a poor performance status will derive a greater benefit from first-line EGFR TKIs [46,60]. These trials also clearly show that proper selection of patients is absolutely crucial for treatment with EGFR-targeted agents in both directions.…”

Epidermal growth factor receptor tyrosine kinase inhibitors in elderly or poor performance status patients with advanced non-small cell lung cancer

“…EGFR mutations were detected in tumor tissues from seven patients, of which five had partial responses. Four patients had possible interstitial lung disease including two treatment-related deaths [29]. A phase II randomized trial, named INVITE (Iressa in NSCLC versus Vinorelbine Investigation in The Elderly), compared gefitinib with vinorelbine as first-line treatment of elderly advanced NSCLC patients.…”

First-line gefitinib treatment in elderly patients (aged ≥75 years) with non-small cell lung cancer harboring EGFR mutations

“…Interestingly, several previous clinical trials have examined the efficacy of gefitinib as a first-line treatment for elderly patients with NSCLC harboring sensitive EGFR mutations [15][16][17][18][19][20][21]. Their results suggest that first-line gefitinib is preferable to standard therapy in elderly patients.…”