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ORAL 32 - EGFR WT and MT Targeting (ID 144)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:K.J. O'Byrne, D.R. Gandara
- Coordinates: 9/09/2015, 16:45 - 18:15, Four Seasons Ballroom F3+F4
ORAL32.06 - Intercalating and Maintenance Use of Gefitinib plus Chemotherapy versus Chemotherapy Alone in Selected Advanced NSCLC: A Phase III Study (ID 2108)
16:45 - 18:15 | Author(s): C. Bai
This study investigated whether intercalating and maintenance use of gefitinib with chemotherapy improves clinical outcomes versus chemotherapy alone in selected, chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) after receiving two cycles of gemcitabine plus carboplatin with stable disease.
We undertook an open-label, randomized, phase III trial at 14 centres in China. Non-smoking patients with previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutation status unknown (tissue not available) firstly received two cycles of gemcitabine (1,250 mg/m2 days 1 and 8) plus carboplatin (AUC=5, day 1). The patients with stable disease and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive either gefitinib (250mg/d) on days 15 to 25 with a 4-week cycle of gemcitabine and carboplatin or a 4-week cycle of gemcitabine and carboplatin alone. A maximum of four cycles of chemotherapy was allowed in both arms after which time patients continued to receive gefitinib or observation until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. The trial is registered at ClinicalTrials.gov, number NCT01404260, and has completed enrolment; patients are still in follow-up.
From June 2011 to August 2014, 219 patients with stable disease were randomized to intercalating and maintenance use of gefitinib with chemotherapy (n=109) or chemotherapy alone (n=110). The number of PFS events is 84 cases for the gefitinib plus chemotherapy group and 93 cases for the chemotherapy alone group. PFS was significantly longer in the patients receiving gefitinib and chemotherapy than in those receiving chemotherapy alone (median 10.0 vs 4.4 months, respectively; hazard ratio 0.475, 95% CI 0.349-0.646; p<0.0001). The median follow-up duration for OS is 24.5 months; OS of maturity 34.7% was not statistically different between these two arms (32.2 vs 32.5 months, respectively; hazard ratio 1.01, 95% CI 0.64-1.58; p=0.97). The addition of gefitinib to chemotherapy was well tolerated, with no increase in haematologic toxicity and no treatment-related interstitial lung disease.
Intercalating and maintenance use of gefitinib with gemcitabine/carboplatin led to a significant improvement in PFS versus gemcitabine/carboplatin alone for Chinese nonsmoking patients with advanced pulmonary adenocarcinoma (EGFR mutation status unknown) who had previously achieved stable disease after receiving two cycles of gemcitabine/carboplatin; immature OS was not statistically different.
P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P3.04-127 - Correlation Between ApoA-I and Prognosis of Advanced NSCLC Patients (ID 341)
09:30 - 17:00 | Author(s): C. Bai
To investigate the correlation between apolipoprotein A-I(ApoA-I)and clinicopathological features, as well as the effect of ApoA-I on the prognosis of advanced non-small cell lung cancer (NSCLC) patients.
Retrospective analysis was performed for 117 cases with histologically confirmed IIIB and IV stage NSCLC patients in Changhai Hospital from January 2009 to December 2014. All patients were classified into two groups based on the value of baseline serum ApoA-I before treatment. The relationship between ApoA-I and clinicopathological features was studied. Univariate and multivariate analyses were performed to assess the prognostic effect of ApoA-I.
All patients were divided into two groups: low serum ApoA-I levels before treatment (≤1.2g/L, n=50,42.7%) and high serum ApoA-I levels before treatment (>1.2g/L, n=67,57.3%).ApoA-I was correlated with greatest tumor diameter（P=0.013), clinical stage(P=0.012),serum C-reactive protein before treatment（P=0.018),serum albumin(P<0.0001)and ECOG PS(P=0.024).The median survival time of low and high ApoA-I levels patients were10.1months and15.1 months, respectively,which indicated a statistically significant difference (χ2=7.027,P=0.008) between the two groups.Univariate analysis showed that smoking status（P=0.029), serum C-reactive protein before treatment（P=0.024),serum albumin（P=0.013),clinical stage(P=0.014),N stage（P=0.037）,ECOG PS（P=0.001)and serum ApoA-I levels before treatment（P=0.008).Multivariate analysis by using COX regression identified serum C-reactive protein before treatment（HR1.650，P=0.033),clinical stage（HR2.165，P=0.001), ECOG PS（HR0.451,P=0.008)and serum ApoA-I levels before treatment（HR0.487,P=0.005) as independent prognostic factors of all the patients.In addition, stratified analysis showed that the one-year survival rate of the low ApoA-I group was lower than that of the high ApoA-I group with or without distant metastasis, and the differences were statistically significant （χ2=12.053，P=0.001).
An decreased serum ApoA-I levels before treatment indicates poor prognosis in advanced NSCLC patients. ApoA-I could be a potential biological marker for advanced NSCLC patients.