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G. Wu
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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 - 09:30 | Author(s): G. Wu
- 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.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-050 - A Interim Analysis of Randomized Phase III Trial of Nedaplatin or Cisplatin Combined with Docetaxel as First-Line Treatment for Advanced ASQC (ID 1225)
09:30 - 09:30 | Author(s): G. Wu
- Abstract
Background:
Cisplatin combined with docetaxel is one of the stand treatment in advanced squamous cell carcinoma(ASQC) of the lung. Nedaplatin combined with docetaxel has demonstrated potent activity in ASQC in phase II study. But until now there is no randomized phase III study comparing these 2 chemotherapy regimens. The aim of this study was to evaluate and compare the efficacy and safety between the combination chemotherapy of nedaplatin or cisplatin plus docetaxel in patients with ASQC.
Methods:
This is a multicentre, open-label, randomized, phase III study in China (NCT02088515). Chemo-naive stage IIIB/IV squamous NSCLC with Eastern Cooperative Oncology Group performance status 0/1 were randomized (1:1) to four cycles of nedaplatin (80 mg/m[2]) plus docetaxel(75 mg/m[2]) or cisplatin(75 mg/m[2]) plus docetaxel (75 mg/m[2]) . The primary endpoint was progression-free survival (PFS). Secondary end points were overall survival (OS), overall response rate (ORR), disease control rate (DCR) and quality of life.
Results:
From December 2013 to January 2015, 117 patients were accrued: nedaplatin plus docetaxel (n = 57) and cisplatin plus docetaxel (n = 60). The objective response rates were 27% and 31% and the disease control rate were 78.92 % and 82.67% in nedaplatin and cisplatin groups, respectively. There is no significance difference in nausea / vomiting(21% vs 30%) , diarrhea(3% vs 5%), liver dysfunction(12% vs 15%), neutropenia(60% vs 65%), thrombocytopenia(10% vs 12%), anemia(8% vs 7%) between the 2 arms. The renal dysfunction incidence is higher in the cisplatin group(3% vs 0%). Although there is no 3/4 grade toxicities difference between 2 arms including nausea / vomiting(0% vs 0%) , diarrhea(0% vs 1%), liver dysfunction(0% vs 0%), renal dysfunction(0% vs 0%) , neutropenia(4% vs 3%), thrombocytopenia(0% vs 0%), anemia(0% vs 0%) . This is an interim analysis and we haven't got the data of survival and quality of life.
Conclusion:
There is no ORR difference between the group of nedaplatin plus docetaxel and cisplatin plus docetaxel. But the toxicity of nedaplatin regiment is less toxicities, especially in renal toxicity,as first-line treatment for patients with advanced squamous NSCLC
