Preliminary results of a randomized phase II trial of first-line treatment of gemcitabine (G) versus erlotinib (E) versus gemcitabine and erlotinib (GE) in patients 70 years or older with advanced non-small cell lung cancer (NSCLC).

Stinchcombe, Tom; Bradford, Daniel S.; Lee, C. B.; Moore, Dominic T.; Bakri, Kamal; Taylor, Marianne; Crane, Jeffrey M.; Schwartz, Gary N.; Hensing, Thomas A.; Socinski, Mark A.

doi:10.1200/jco.2010.28.15_suppl.7576

Cited by 2 publications

(3 citation statements)

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“…A recently reported analysis confirmed that IPD and literature abstract-based metaanalyses did not differ substantially in their outcome [33]. Second, although we included 14 trials, there were only one to three trials in each subgroup [34][35][36][37][38][39]. However, all the 14 trials were RCTs, and all the results except for adverse events were based on ITT analysis.…”

Section: Discussionmentioning

confidence: 85%

Efficacy of erlotinib in patients with advanced non-small cell lung cancer

Gao¹,

Ding

Dong³

et al. 2011

Anti-Cancer Drugs

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Erlotinib is a potent reversible HER1/epidermal growth factor receptor tyrosine kinase inhibitor with single-agent activity in patients with non-small cell lung cancer. The aim of this study was to evaluate the efficacy of erlotinib for treating advanced non-small cell lung cancer by carrying out a pooled analysis of randomized controlled trials that compared erlotinib-based regimens with other agent-based regimens between January 1997 and 2011. Outcomes analyzed were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events. Fourteen trials including 7974 patients were identified. As first-line therapy was compared with chemotherapy, there was a similar ORR [OR: 0.33; 95% confidence interval (CI): 0.64-17.36; P=0.15], but decreased PFS [hazard ratio (HR): 1.55; 95% CI: 1.24-1.93; P<0.01] and OS (HR: 1.39; 95% CI: 0.99-1.94; P=0.05). As maintenance therapy was compared with placebo, erlotinib-based regimens significantly increased ORR (OR: 0.47; 95% CI: 0.31-0.70; P<0.01), prolonged PFS (HR: 0.71; 95% CI: 0.60-0.83; P<0.01), but did not improve OS (HR: 0.87; 95% CI: 0.68-1.11; P=0.22). As second/third-line therapy was compared with placebo, erlotinib-based regimens also significantly increased ORR (OR: 0.10; 95% CI: 0.02-0.41; P<0.01), prolonged PFS (HR: 0.61; 95% CI: 0.51-0.73; P<0.01), and improved OS (HR: 0.70; 95% CI: 0.58-0.84; P<0.01). However, as second/third-line therapy was compared with chemotherapy, the outcomes were similar between the two arms. When compared with PF299804, there was a decreased ORR (OR: 3.87; 95% CI: 1.27-11.81; P=0.02), and shortened PFS (HR: 0.58; 95% CI: 0.49-0.95; P=0.02). Meanwhile, erlotinib-based regimens showed no significant difference in adverse events, except for diarrhea, rash, and anemia. Erlotinib-based regimens significantly increased ORR and improved PFS as a first-line maintenance therapy or as a second/third-line therapy when compared with placebo.

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Section: Discussionmentioning

confidence: 85%

Efficacy of erlotinib in patients with advanced non-small cell lung cancer

Gao¹,

Ding

Dong³

et al. 2011

Anti-Cancer Drugs

View full text Add to dashboard Cite

show abstract

“…In contrast to the study reported here, out of the 144 patients enrolled, ~27% were PS 2 across the three study arms. The concurrent administration of erlotinib plus gemcitabine, in this study did not provide additional benefit relative to monotherapy with either agent (19). …”

Section: Discussionmentioning

confidence: 65%

“…Recently, the concurrent administration of gemcitabine plus erlotinib was also assessed in a phase II trial (19) that enrolled chemotherapy-naïve, stage IIIB or IV NSCLC patients, 70 years or older and PS ≤2. Patients were randomised to gemcitabine monotherapy (1250 mg/m 2 , days 1 and 8), erlotinib monotherapy (150 mg po daily) or the combination (1000 mg/m 2 days 1 and 8 and 100 mg po daily, respectively).…”

Section: Discussionmentioning

confidence: 99%