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S. Qin
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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
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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): S. Qin
- Abstract
- Presentation
Background:
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.
Methods:
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.
Results:
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.
Conclusion:
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.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-024 - An ENSURE Extension Study to Evaluate 2<sup>nd</sup> Line Erlotinib and Gemcitabine/Cisplatin Cross-Over Treatment for EGFR-Mutant Chinese NSCLC Patients (ID 1747)
09:30 - 17:00 | Author(s): S. Qin
- Abstract
Background:
ENSURE study shows that 1[st] line treatment with erlotinib provides longer PFS over gemcitabine/cisplatin (GP) for stage IIIB/IV NSCLC patients with EGFR mutations. Cross-over treatments after progression of disease (PD) was allowed in ENSURE study. However, post-study treatments might have significant impact on patient survival or other clinical benefits, which is insufficiently investigated. This trial in an extension of the ENSURE study, intended to evaluate PFS in 2[nd] line progression after cross-over treatments in ENSURE.
Methods:
Chinese patients who had PD after 1[st] line treatment in ENSURE were enrolled. Enrolled patients received cross-over treatment as 2[nd] line treatment after 1[st] line PD. The primary endpoint was PFS, defined as the time of randomization in ENSURE to disease progression or death while on 2[nd] line treatment. For patients who had already progressed after 2[nd] line therapy prior to entering this extension study, relevant information would be collected retrospectively. PFS from 1[st] line PD to 2[nd] line PD was also calculated. The study was approved by IRB and all patients signed informed consent. This study was registered in clinicalgrials.gov (NCT02000531). We also retrospectively analyzed the time to 2[nd] line treatment failure (TTF) defined as the time from randomization to discontinuation of 2[nd] line treatment for any reason.
Results:
Forty-five patients (21 from erlotinib arm and 24 from GP arm) were enrolled in the final analysis in this ENSURE extension study. Limited recruitment was mainly due to later initiation of this study (from January to December of 2014), many deaths at the beginning of this study, or unwillingness to sign informed consent by some patients. Age, sex, and ECOG at baseline in erlotinib group and GP group were balanced. Among 45 enrolled subjects, 33 (73.3%) subjects completed the study. There was no significant difference in median PFS from the date of randomization in ENSURE study to 2[nd] line PD for both arms 26.3 (95%CI: 19.8 , 34.0 ) months vs 23.4 (95%CI: 17.8, 39.0 ) months, HR=1.26 (95%CI: 0.61, 2.62), p=0.529). For 2[nd] line cross-over treatment, ORR in erlotinib and GP arms was 33.3% (7PR/21) and 66.7% (16PR/24) respectively (p=0.0377). In a retrospective analysis of 175 patients from the whole ENSURE study, 63.2% patients in erlotinib arm (n=87) received 2[nd] line chemotherapy and 86.4% patients in GP arm (n=88) received 2[nd] line targeted therapy. The median TTF in erlotinib and GP arm were 29.4 (95%CI: 24.7, 34.2) and 24.7 (95%CI: 21.9, 28.4) months respectively (HR=0.74(95%CI: 0.47, 1.17), p=0.192).The subgroup analysis (mutation type, ECOG performance status, gender) for TTF between erlotinib and GP arm showed similar trend to the primary analysis.
Conclusion:
Despite limitations, both median PFS (in prospective analysis) and TTF (in retrospective analysis) for erlotinib patients were numerically larger than that in GP arm. This first cross-over treatment ENSURE extension study further confirms benefits of erlotinib as standard 1[st] line treatment for EGFR mutant NSCLC. It also supports the importance of 1[st] and 2[nd] line treatment sequence of erlotinib and platinum-based chemotherapy for the treatment of EGFR mutant NSCLC.
