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Randomized Controlled Trial
. 2015 Jul 28:5:10648.
doi: 10.1038/srep10648.

Randomized, Multicenter Study of Gefitinib Dose-escalation in Advanced Non-small-cell Lung Cancer Patients Achieved Stable Disease after One-month Gefitinib Treatment

Cong Xue  1 , Shaodong Hong  1 , Ning Li  2 , Weineng Feng  3 , Jun Jia  4 , Jiewen Peng  5 , Daren Lin  6 , Xiaolong Cao  7 , Siyang Wang  8 , Weimin Zhang  9 , Hongyu Zhang  8 , Wei Dong  10 , Li Zhang  1
Affiliations
Randomized Controlled Trial

Randomized, Multicenter Study of Gefitinib Dose-escalation in Advanced Non-small-cell Lung Cancer Patients Achieved Stable Disease after One-month Gefitinib Treatment

Cong Xue et al. Sci Rep. .

Abstract

There is no consensus on the optimal treatment for patients with advanced non-small-cell lung cancer (NSCLC) and stable disease (SD) after gefitinib therapy. This randomized, open-label, multicenter study aimed to explore whether dose-escalation of gefitinib would improve response and survival in NSCLC patients who achieved SD after one-month of standard gefitinib dosage. Between May 2009 and January 2012, 466 patients were enrolled and 100 eligible patients were randomized (1:1) to receive either a higher dose (500 mg/d; H group) or to continue standard dose (250 mg/d; S group) of gefitinib. Objective response rate (ORR) was similar between the two groups (12.5% vs 12.5%, p = 1.000). There were no significant differences regarding progression-free survival (PFS) and overall survival (OS) between both arms (H group vs S group: median PFS, 5.30 months vs 6.23 months, p = 0.167; median OS, 13.70 months vs 18.87 months, p = 0.156). Therefore, dose-escalation of gefitinib does not confer a response or survival advantage in patients who achieve SD with one month of standard-dose gefitinib treatment.

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Conflict of interest statement

Li Zhang has received research support from Boehringer Ingelheim, Astra Zeneca, Lilly, and Roche. Other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Consort diagram of the disposition of participants. PR, partal response; PD, progressive disease; NA, unevaluable; SD, stable disease; TT, trial treatment.
Figure 2
Figure 2
Kaplan–Meier estimates of (A) progresion-free survival (PFS) and (B) overall survival (OS) in patients who received 500 mg/d (H group) or 250 mg/d (S group) gefitinib after achieving stable disease after one-month 250 mg/d gefitinib.
Figure 3
Figure 3
Kaplan–Meier estimates of (A) progression-free survival (PFS) and (B) overall survival (OS) in NSCLC patients, stratified by EGFR mutations status.
Figure 4
Figure 4
Kaplan–Meier estimates of (A) progression-free survival (PFS) and (B) overall survival (OS) in NSCLC in patients who received 500 mg/d (H group) or 250 mg/d (S group) gefitinib after achieving stable disease after one month of 250 mg/d gefitinib, stratified by EGFR mutations status.
Figure 5
Figure 5
Plasma gefitinib concentration at randomization and 60 days thereafter in patients who received 500 mg/d gefitinib or 250 mg/d gefitinib. PR, partal response; PD, progressive disease; SD, stable disease.
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References

    1. Siegel R., Ma J., Zou Z. & Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 64, 9–29 (2014). - PubMed
    1. Mok T. S. et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 361, 947–957 (2009). - PubMed
    1. Paez J. G. et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 304, 1497–1500 (2004). - PubMed
    1. Brugger W. et al. Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer. J Clin Oncol. 29, 4113–4120 (2011). - PubMed
    1. Zhang L. et al. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 13, 466–475 (2012). - PubMed

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