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Z. Chen



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    MINI 08 - Prognostic/Predictive Biomarkers (ID 106)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      MINI08.05 - A Survival Comparison Study of Chinese Patients with Primary Lung Adenocarcinoma Harboring ALK Rearrangements Detected in Different Methods with Crizotinib Treatment (ID 3227)

      17:15 - 17:20  |  Author(s): Z. Chen

      • Abstract
      • Presentation
      • Slides

      Background:
      EML4-ALK is a new driver gene of non-small cell lung cancer (NSCLC) and is associated with response to inhibition with crizotinib. ALK break apart fluorescence in situ hybridization (FISH) assay, Ventana immunohistochemistry (IHC), and reverse transcriptase polymerase chain reaction (RT-PCR) can all be used as the primary assay for detecting ALK fusion events in tumor samples of lung cancer patients with SFDA approval in China. The objective of this study was to analyze the association of ALK rearrangements with clinical outcomes in different ALK testing methods, including FISH, Ventana IHC, and RT-PCR.

      Methods:
      ALK status was assessed by FISH, IHC and RT-PCR in 75 patients with advanced ALK-positive lung adenocarcinoma who had received crizotinib treatment from 2011, May to 2014, Nov in China. Clinicopathologic data and survival outcomes were analyzed. Kaplan-Meier cumulative probability was used to assess different testing methods for survival.

      Results:
      Of all 75 ALK-positive lung adonocarcinoma, there are 23 FISH-positive ALK patients (23/75, 30.7%), 35 IHC-positive ALK patients (35/75, 46.7%) and 17 RT-PCR-positive ALK patients (17/75, 22.7%). 75 patients received crizotinib treatment with IHC-positive and FISH-positive had better progression-free survival (PFS) (P=0.049, Fig A), compared with those with RT-PCR-positive, but not for overall survival (OS) (P=0.074). The median PFS survival for all these 75 patients was 16m, 14m, 8m, respectively, based on the IHC, FISH, and RT-PCR test (Fig A). 23 patients received first-line crizotinib treatment with IHC-positive and FISH-positive had better PFS (P=0.030), compared with those with RT-PCR-positive, but not for OS (P=0.061), either. The median PFS survival for these 23 patients with first-line crizotinib treatment was 12m, 18m, 4.8m, respectively, based on the IHC, FISH, and RT-PCR test. Of all 17 RT-PCR-positive ALK patients, there are 10 E13:A20 fusion type (10/17, 58.8%), 4 E6:A20 fusion type (4/17, 23.5%), 2 E18:A20 fusion type (2/17, 11.8%), and 1 E2:A20 fusion type (1/17, 5.9%). 4 different fusion-type ALK-positive patients detected by RT-PCR received crizotinib treatment with no crizotinib-related PFS significant difference (P=0.312) and no OS difference (P=0.149).Figure 1



      Conclusion:
      ALK-positive patients confirmed by IHC and FISH assay, compared with RT-PCR, maybe have better crizotinib-related PFS. RT-PCR method needs to be further evaluated in clinical practice to identify its role in guiding targeted therapy using crizotinib. And there is no survival difference for different ALK fusion type detected by RT-PCR in our cohort, which need further validation in a large group.

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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
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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): Z. Chen

      • Abstract
      • Slides

      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

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    P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P3.03-017 - Interim Overall Survival of Neoadjuvant Erlotinib Intercalated with Gemcitabine/Cisplatin for IIIA N2 NSCLC Patients: A Phase II Study (ID 1743)

      09:30 - 09:30  |  Author(s): Z. Chen

      • Abstract

      Background:
      The optimal treatment for locally advanced stage IIIA non-small cell lung cancer (NSCLC) disease is not well established although neoadjuvant chemotherapy showed active results in stage IIIA N2 pts. A few case reports also indicate the advantages of neoadjuvant erlotinib. FASTACT II study showed that the regimen of erlotinib intercalated with chemotherapy improved PFS and OS in an unselected advanced NSCLC population of east Asian patients. Here we report the interim overall survival (OS) results of a phase II study which was to assess the efficacy and safety profile of erlotinib intercalated with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA N2 NSCLC pts.

      Methods:
      Patients with untreated stage IIIA bulky N2 NSCLC and ECOG PS 0/1 were enrolled to received up to 2 cycles of gemcitabine 1,000 mg/m[2] on days 1 and 8 and cisplatin 75 mg/m[2] on day 1 or carboplatin AUC=5 d1, followed by oral erlotinib (150 mg, once a day) on days 15 to 28 as neoadjuvant therapy. A repeat computed tomography (CT) scan evaluated the response after induction therapy and eligible patients would undergo surgical resection. The primary endpoint was ORR which was reported in 2013 WCLC. The secondary endpoints included pCR, resection rate, DFS (disease free survival) and OS (overall survival), safety, QoL and biomarker analyses.

      Results:
      Between March 2011 and December 2012, a total of 39 patients (29 male, median age 59.0 years; range 34.0 to 74.0 years) were enrolled in the study, in which 36 patients ( 92.3%) had completed 2-cycle erlotinib neoadjuvant treatment. For pathologic type, 13 pts were adenocarcinoma, 18 pts were squamous carcinoma, and 8 pts were other types. One patient withdrew from the study and one patient was lost in the follow-up. Twenty-two (56.4%, 22/39) patients underwent surgical resection after erlotinib neoadjuvant treatment. Till Jan 15, 2015, the median follow up duration was 24.4 mo (range 5.5 to 43.7 mo). To the cut-off date, 22 patients (56.4%) died. The median OS for total 39 patients was 29.0 mo (Figure 1A, range 3.4 to 43.7 mo). The median OS for those no surgery pts was 17.0 mo (range 6.1 to 39.8 mo) while the median OS is not matured ye for those pts who received surgery (Figure 1B).Figure 1



      Conclusion:
      Neoadjuvant erlotinib intercalated with gemcitabine/cisplatin brought clinical benefits by extending overall survival for stage IIIA N2 NSCLC pts.