Randomized, Placebo-Controlled, Phase II Study of Sequential Erlotinib and Chemotherapy As First-Line Treatment for Advanced Non–Small-Cell Lung Cancer

Abstract

Sequential administration of erlotinib following gemcitabine/platinum chemotherapy led to a significant improvement in PFS. This treatment approach warrants further investigation in a phase III study.

Synergistic antitumor activity of pro‐apoptotic agent PAC‐1 with cisplatinum by the activation of CASP3 in pulmonary adenocarcinoma cell line H1299

“…37,38 Based on these results, sequential chemotherapy with EGFR TKI was proposed for the FASTACT studies and was confirmed to be beneficial in the clinic. 39 In our study, PAC-1 was used as a targeted therapy, and it blocked cell cycle similarly to the EGFR TKIs but mainly at S phase with unknown mechanisms. Thus, concurrent Cis plus PAC-1 treatment had synergistic effects but became antagonistic with increased combination doses, and sequential Cis to PAC-1 was the best combination regimen evaluated, causing a high apoptotic rate in cancer cells.…”

Efficacy and Survival-associated Factors with Gefitinib Combined with Cisplatin and Gemcitabine for Advanced Non-small Cell Lung Cancer

“…Mok et al (Mok et al, 2009) used decitabine, cisplatin combined with erlotinib to treat advanced NSCLC and the response rate was 35.5%, with the median OS time being 7.2 and hazard ratio being 0.57. Guo et al (Guo et al, 2012) adopted gemcitabine combined cisplatin sequential to gefitinib in the treatment of advanced NSCLC and observed the efficacy and toxic and side effect, and the results showed that observational group (gemcitabine combined cisplatin sequential to gefitinib) had better effect than control group (gemcitabine plus cisplatin) (36.1%vs 14.3%).…”

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Versus Placebo as Maintenance Therapy for Advanced Non-small-cell Lung Cancer: A Meta-analysis of Randomized Controlled Trials

“…Furthermore, other excluded literatures were: one study covered the patients with Stage IIIA NSCLC (Kelly et al, 2008); one study (Miller et al, 2009) had the patients been treated with combined monoclonal antibody (bevacizumab) and placebo in the control group; one study (Takeda et al, 2010) had the patients been treated with platinum-based maintenance therapy as the controls and a study (Pérol et al, 2012) had the controls only received disease progression observation. As a result, only six studies (Herbst et al, 2005;Gatzemeier et al, 2007;Mok et al, 2009;Cappuzzo et al, 2010;Gaafar et al, 2011;Zhang et al, 2012) were included in the present study eventually (Figure 1). …”

“…In four studies (Herbst et al, 2005;Gatzemeier et al, 2007;Mok et al, 2009;Cappuzzo et al, 2010), Erlotinib was educated as the maintenance therapy; whereas Getifinib was used for maintenance therapy in the other two studies (Gaafar et al, 2011;Zhang et al, 2012). Different first-line treatment protocols were adopted in these studies, but all of these protocols were on a basis of the combined treatment of platinum with …”

“…A total of 3758 cases of patients with advanced-stage NSCLC have been investigated in the six studies, of which one was phase II clinical trial (Mok et al, 2009) and five were phase III clinical trail. In four studies (Herbst et al, 2005;Gatzemeier et al, 2007;Mok et al, 2009;Cappuzzo et al, 2010), Erlotinib was educated as the maintenance therapy; whereas Getifinib was used for maintenance therapy in the other two studies (Gaafar et al, 2011;Zhang et al, 2012).…”