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N. Xu



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    MO12 - Prognostic and Predictive Biomarkers III (ID 96)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO12.03 - Biomarker analysis of a randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gmcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer (ID 3483)

      10:40 - 10:45  |  Author(s): N. Xu

      • Abstract
      • Presentation
      • Slides

      Background
      The platinum-based doublet regimen was standard of care in advanced non-small cell lung cancer (NSCLC), but the biomarkers to predict the efficacy of first-line chemotherapy is still controversial.

      Methods
      We collected 239 tumor samples (83.0%) from a a randomized, controlled, multicenter clinical trial, which enrolled 288 treatment naïve nonsquamous NSCLC patients who were randomly assigned (1:1) to experimental group to receive cisplatin plus pemetrexed (PC) or the control group to receive gemcitabine plus cisplatin (GC) every 3 weeks for up to 6 cycles. We evaluated the EGFR mutation by Amplification Refractory Mutation System(ARMS) method and EML4-ALK fusion by real-time PCR. Meanwhile, the mRNA expression of excision repair cross complementation 1 (ERCC-1), thymidylate synthase (TS), ribonucleotide reductase M1(RRM-1), and folatereceptor 1(FR-1) was tested by real-time PCR. All of the EGFR mutation, ALK fusion and mRNA expression were analyzed for the correlation with progression free survival, the primary endpoint in the tiral.

      Results
      The EGFR mutation rate was 46.6%(110/236) in the overall population and the ALK fusion rate was 12.0%(29/233). The median PFS was similar between the EGFR mutated patients and wild-type patients(6.0m vs 5.7m,p=0.85), however, the patients of EGFR wild-type had better PFS in the PC group compared with GC group (5.7m vs 3.5m, p=0.03). There are no significant difference between groups in EGFR mutated patients(5.6m vs 6.1m, p=0.59). The patients with ALK fusion seem to have better PFS compared with fusion negative patients (7.7m vs 5.7m), but the difference is not significant(p=0.48). The mRNA expression level was available in 225 patients(94.1%) and we determined the median expression as the cutoff value. The TS expression is significantly correlated with ERCC-1(r=0.67,p<0.001) and negatively correlated with FR-1 expression(r=-0.21,p=0.002). EGFR mutation correlated with lower TS expression(p=0.034) and ALK fusion correlated with higher FR-1 expression(p=0.017). The differences of PFS between the high and low expression of ERCC-1, TS, RRM-1and FR-1 was not significant, in both PC group and GC group.

      Conclusion
      The expression level of ERCC-1, TS, RRM-1and FR-1 could not effectively predict the progression free survival of NSCLC patients receiving platinum-based doublet regimen. The pemetrexed plus cisplatin regimen should be the priority choice for EGFR wild type patients compared with gemcitabine plus cisplatin regimen.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-046 - Patients with advanced non-small cell lung cancer(NSCLC) received multi-line treatments had better efficacy (ID 2804)

      09:30 - 09:30  |  Author(s): N. Xu

      • Abstract

      Background
      Efficacy of advanced non-small cell lung cancer treatment has been in platform. How to integrate the limited drugs and design the sequence of regimens is the key point in clinical practice.

      Methods
      Clinical data of 215 patients of pathologically confirmed advanced non-small cell lung cell from January 2010 to December 2012 was analyzed retrospectively. The clinical features, pathological diagnosis, numbers of treatment lines and the efficacy were analyzed. Efficacy and adverse events were evaluated according to the RECIST 1.1 Criteria, NCI Common Terminology Criteria v3.0, respectively.

      Results
      Among 215 patients treated in our cancer center, 135 were men and 84 were women. The squamous cell carcinoma and adenocarcinoma was 50 and 74 in man ; 8 and 70 in women, respectively. 111 cases had 1 line treatment, 53 had 2 lines, 31 had 3 lines, 10 had 4 lines and 9 had more than 4 lines. In all lines, patients with adenocarcinoma compared to the squamous cell carcinoma had more opportunities to receive more drugs(P<0.05). The therapy regimen was decided by the Chinese medical insurance. Combined with platinum, gemcitabine was 29.3% and Taxanes was 26.5%. Either of these two regimens was the preferred choice. Tyrosine kinase inhibitors(TKI) including those offered by clinical trail and pemetrexed which were paid at patients’ own expense were 14%, 22.8%, respectively. In patients received 1, 2 and multi-line therapy(more than 2 lines), the partial response rate was 14.4%, 3.8%, 0, respectively. The stable disease rate was 28.8%, 32.1%, 30%, respectively. OS of patients with multi-line therapy(more than 2 lines) was longer than those with 1 and 2 lines treatment but the data was not mature.

      Conclusion
      Patients with advanced non-small cell lung cancer had multi-line treatment had better disease control. Their regimens mainly covered the chemotherapy and TKIs. Limited of the Chinese medical insurance, the first choice was gemcitabine/taxanes combined with platinum. Tailored therapy may explore the rational therapy sequence to get much better efficacy.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-015 - An open label, dose escalation, phase I trial to evaluate the tolerability and antitumor activity of icotinib in patients with advanced non-small-cell lung cancer (ID 1499)

      09:30 - 09:30  |  Author(s): N. Xu

      • Abstract

      Background
      A phase I, dose escalation study was conducted to evaluate the safety and antitumor activity of icotinib, an oral epidermal growth factor receptor inhibitor which was approved for treating advanced non-small-cell lung cancer (NSCLC) in China, and to explore its tolerable and effective dose range, and the maximum tolerated dose (MTD) in patients with advanced NSCLC.

      Methods
      Patients were enrolled into sequential dose-escalating cohorts to receive icotinib orally three times daily (tid) from 225 mg/day to 1875 mg/day for at least 28 days. Escalation of icotinib was based on toxicities observed in the preceding dose cohort. Tumor response was assessed every 4 weeks.

      Results
      103 patients were enrolled at 11 dose levels, including dose escalations and dose expansions. The most common drug-related adverse events were rash (51.5%, 53/103) and diarrhea (19.4%, 20/103), which were generally mild (grade 1/2) and revisable on symptomatic treatment. Two of six patients at 1875 mg/day experienced dose-limiting toxicity (grade 3 rash), and no further dose escalation occurred. Tumor responses were observed from 300 mg/day to 1875 mg/day. Out of 100 patients evaluable for tumor responses, the overall objective response rates and disease control rates were 27% and 76%, respectively, and the overall progression-free survival (PFS) was 5.0 months. Dose expansions were carried out in 300 mg/day, 375 mg/day and 450mg/day cohorts, and the median PFS for each cohort were 5.0 months, 5.6 months, and 4.0 months, respectively. Table 1: Safety profile of icotinib at various dose levels.

      Dose (mg/tid) N Rash (N) Diarrhea (N) Overall adverse events (%) Overall adverse reaction (%)
      Grade I/II Grade III/IV Grade I/II Grade III/IV
      75 7 5 - 1 - 85.7 (6/7) 85.7 (6/7)
      100 27 6 1 7 - 70.4(19/27) 55.6(15/27)
      125 24 13 1 4 - 75.0(18/24) 70.8(17/24)
      150 13 6 - 1 - 69.2 (9/13) 69.2 (9/13)
      200 3 1 - 1 - 100 (3/3) 100 (3/3)
      250 8 4 - 1 - 75.0 (6/8) 62.5 (5/8)
      300 3 2 - - - 100 (3/3) 100 (3/3)
      350 3 1 - 1 - 100 (3/3) 100 (3/3)
      400 3 3 - - - 100 (3/3) 100 (3/3)
      500 6 5 1 1 - 100 (6/6) 100 (6/6)
      625 6 3 2 2 - 100 (6/6) 100 (6/6)
      Total 103 49 5 20 - 79.6(82/103) 73.8(76/103)
      Table 2: Tumor response of icotinib at various dose levels.
      Dose (mg/tid) N CR/PR SD PD ORR (%) DCR (%)
      75 6 0/0 6 0 -- --
      100 25 2/5 14 4 28 (7/25) 84 (21/25)
      125 24 -/7 13 4 29.2 (7/24) 83.3 (20/24)
      150 13 1/5 4 3 46.2 (6/13) 76.9 (10/13)
      200 3 0/0 2 1 -- --
      250 8 0/1 4 3 12.5 (1/8) 62.5 (5/8)
      300 3 0/0 2 1 -- --
      350 3 0/1 0 2 -- --
      400 3 0/2 0 1 -- --
      500 6 0/1 1 4 -- --
      625 6 0/1 1 4 -- --
      Total 100 3/24 49 26 27(27/100) 76(76/100)

      Conclusion
      Icotinib was well tolerated with manageable and revisable AEs at all dose levels. The MTD of icotinib was 1875 mg/day, and the tolerable and effective dose range was from 300 mg/day to 1875 mg/day. This study demonstrated that icotinib provided favorable safety profile and antitumor activity in advanced NSCLC patients.