Efficacy and Safety of Erlotinib in Previously Treated Advanced Non-Small Cell Lung Cancer

Abstract

Erlotinib is a potent inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, with single-agent antitumor activity which improves symptom control and quality of life compared with placebo in non-small-cell-lung cancer (NSCLC) patients. We aimed to determine the efficacy and safety of the second, third or fourth-line erlotinib in advanced NSCLC patients in Turkish population. Eighty patients (33 males and 47 females) were retrospectively evaluated. All patients had received a platinum-based regimen as the first-line metastatic therapy. Most of the patients (62.5%) had received erlotinib as the second-line treatment. None of the patients had EGFR mutation studied. One patient achieved a complete response, 10 patients partial response and 21 stable diseases. The overall response rate was 14% and disease control rate was 40%. The median progression-free survival (PFS) and overall survival (OS) were 12 months and 18 months, respectively. Although, there was no survival difference between male and female patients, the median PFS of females was significantly better than male patients (p=0.03). There was no significant difference in disease control rate in terms of age, smoking status, erlotinib line, performance status (PS), stage and skin rash. The most common adverse events were skin rash (56%), diarrhea (9%) and anorexia (8%). Sixteen patients (20%) developed grade 3 toxicities. Grade 4 toxicity or treatment related interstitial lung disease were not observed. Erlotinib showed an acceptable response rate, survival time and toxicity after disease progression with chemotherapy. It's an alternative therapy as a second or third-line therapy in patients with NSCLC. Prospective studies are needed to evaluate the efficiency of the treatment in Turkish population. Keywords:Non-small-cell lung cancer, Targeted therapy, Erlotinib, Epidermal growth factor receptor ÖZET Daha Önce Tedavi Edilmifl ‹leri Evre Küçük Hücreli D›fl› Akci¤er Kanserli Hastalarda Erlotinibin Güvenlik ve Etkinli¤iErlotinib tek bafl›na anti-tümör aktiviteye sahip olan güçlü bir epidermal büyüme faktör reseptörü tirozin kinaz inhibitörüdür ve küçük hücreli d›fl› akci¤er kanseri hastalar›nda plasebo ile karfl›laflt›r›ld›¤›nda semptom kontrolü ve yaflam kalitesini iyilefltirmektedir. Çal›fl-mam›zda, Türk popülasyonunda, ileri evre NSCLC hastalar›nda ikinci, üçüncü veya dördüncü s›ra erlotinib tedavisinin etkinlik ve gü-venirlili¤ini retrospektif olarak de¤erlendirmeyi amaçlad›k.

Retrospective Analysis of Clinical Efficacy of Erlotinib in Patients with Non-Small Cell Lung Cancer

“…Therefore, we were able to achieve a 58.9% disease control rate (ORR + SD). Side effects were predictable and manageable, similar to those seen in previous erlotinib clinical trials [8,[11][12][13][14][15]. The median PFS and OS of the study population were 242 and 377 days, respectively, which were similar to those reported in other similar studies [8,[11][12][13][14][15].…”

“…To the best of our knowledge, only two previous studies have investigated the efficacy of this agent in a Turkish population with previously treated advanced NSCLC (Table 3). Karaca et al [11] performed a multicenter retrospective study on the efficacy and safety of erlotinib in 80 advanced NSCLC patients. With an overall disease control rate of 40%, they reported that one patient had achieved CR, 10 patients had PR, and 21 patients had SD [11].…”

“…Karaca et al [11] performed a multicenter retrospective study on the efficacy and safety of erlotinib in 80 advanced NSCLC patients. With an overall disease control rate of 40%, they reported that one patient had achieved CR, 10 patients had PR, and 21 patients had SD [11]. The most common adverse effects reported were skin rash (56%), diarrhea (9%), and anorexia (8%).…”

“…A study on 95 resected pure SCC patients revealed that EGFR mutations are usually absent [17]. Karaca et al [11] detected that female patients had a marginally better disease control rate with erlotinib compared to male patients (49% vs 27%, p=0.052). They also found that female patients had significantly longer median PFS than male patients (18 vs 5 months, p=0.03).…”