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C. Yu



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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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      MO12.09 - BIM deletion polymorphism in Asian and treatment outcome to chemotherapy in advanced non-small cell lung cancer (ID 2530)

      11:20 - 11:25  |  Author(s): C. Yu

      • Abstract
      • Presentation
      • Slides

      Background
      BIM deletion polymorphism was reported to be associated with poor outcome to epidermal growth factor receptor (EGFR) inhibitor in advanced non-small cell lung cancer (NSCLC) harboring mutant EGFR gene. Little is known whether BIM deletion polymorphism influences treatment outcome to chemotherapy in NSCLC.

      Methods
      We prospectively collect blood samples and clinical data from two independent cohorts of advanced NSCLC patients. The first cohort is composed of 52 patients who received first-line chemotherapies, and the second cohort is composed of 69 patients who received chemotherapy after front-line gefitinib. BIM deletion polymorphism was determined from blood using polymerase chain reaction. EGFR gene was studied in 94 tumors and were classified as wild type, common EGFR mutation (deletion 19 or L858R), or other mutations.

      Results
      The median progression-free survival (PFS) to the first cohort and second cohort were 4.6 and 5.7 months, respectively (p=0.94). The PFS for tumors carrying wild-type, common mutant, and other mutant EGFR genes were 5.8, 4.4, and 7.2 months, respectively (p=0.31). The BIM deletion polymorphism was detected in 19 samples (15.7%). The PFS of patients with normal BIM (solid line of the figure) and BIM deletion polymorphism (dashed line of the figure) were 5.6 and 3.5 months (p=0.03). BIM deletion was related to shorter PFS in tumors carrying mutant EGFR gene (p=0.006) but not those carrying wild-type or other mutant EGFR genes. A multivariate analysis suggested BIM deletion was an independent predictor for shorter PFS to chemotherapy (harzard ratio=2.71, p=0.003).

      variate hazard ratio p-value
      BIM deletion 2.71 0.003
      Male gender 1.57 0.04
      stage IV disease 1.93 0.18
      EGFR mutation 1.0 0.96
      Old age 1.01 0.21
      Figure 1

      Conclusion
      BIM deletion polymorphism is associated with shorter PFS to chemotherapy in advanced NSCLC.

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    O01 - Prognostic and Predictive Biomarkers I (ID 94)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O01.06 - Dynamic change in plasma EGFR mutation DNA in response to first line therapy for advanced stage non-small cell lung cancer (NSCLC) (ID 2496)

      11:25 - 11:35  |  Author(s): C. Yu

      • Abstract
      • Presentation
      • Slides

      Background
      Diagnostic utility study of EGFR mutation analysis of tumor and plasma from FASTACT 2 confirmed that the plasma EGFR mutation DNA (pEGFRmut) is a sensitive and specific biomarker. (Wu et al, Lancet Oncology 2013; T. Mok, ASCO 2013). Primary objective of this study is to investigate the dynamic change in pEGFRmut during course of treatment. Secondary objective is to study the diagnostic utility of pEGFRmut in patients with distant organ metastasis whom we assumed to have higher level of plasma DNA.

      Methods
      Retrospective EGFR mutation testing of FFPET and plasma from FASTACT 2 were performed with two allele-specific assays, cobas® 4800 EGFR_FFPET test and cobas® EGFR_blood test (in Development). Both tests are designed to detect one or more of the 42 known EGFR mut. One FFPET section was used for tissue test and 2-ml plasma was used for blood test. We studied the plasma samples collected at baseline, post cycle 3 (C3) and at tumor progression according to RECIST criteria (PD).

      Results
      Complete analysis of plasma samples at baseline, C3 and PD was available in 305 of 451 pts(67.6%). Incidence of pEGFRmut positive at baseline, C3 and PD was 35% (106/305),15% (47/305)and 27% (81/305), respectively. 98 of 106 pEGFRmut patients harbor the Exon 19 deletion or L858R at baseline. (C arm 51; CE arm 47). At C3, 21 (41%) pts lose pEGFRmut positivity in C arm comparing to 39 (83%) in CE arm. At PD, 8 of the 21pts in C arm and 18 of the 39 in CE arm regained pEGFRmut positivity. Table 1 summarized the median pEGFRmut copies/PCR. There was a considerable decline at C3 in both C and CE arm. However, pEGFRmut copies/PCR rebounded to high level at PD in C arm only and remained low in CE arm. Correlation of dynamic change in pEGFRmut copies/PCR with clinical tumor response and PFS will be presented at the meeting. We have also identified 93 (out of 224 matched tissue and plasma samples) patients with known distant organ metastasis. Sensitivity of pEGFRmut in this patient subgroup is 91% (41/45), specificity at 98% (47/48) and overall concordance at 95% (88/93). Table 1

      Median pEGFRmut copies/PCR Baseline C3 PD
      C (Exon 19) 27.6 2.3 35.8
      CE (Exon 19) 43.2 0 2.7
      C(Exon 21) 40.9 2.6 63.9
      CE (Exon 21) 87.1 0 3.5

      Conclusion
      This is the first study demonstrating the quantitative dynamic change in pEGFRmut in pts who received C or CE for advanced NSCLC. At RECIST progression, pEGFRmut remained low in patients who received erlotinib but not in patients who received chemotherapy only. pEGFRmut is a potential biomarker for monitoring tumor response.

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    O11 - Symptom Management (ID 137)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Supportive Care
    • Presentations: 1
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      O11.04 - Patterns of Quality of Life, Their Characteristics and Relationship to Symptoms -- 12 Months Follow-up in Newly Diagnosed Advanced Lung Cancer Patients (ID 3359)

      16:35 - 16:45  |  Author(s): C. Yu

      • Abstract
      • Presentation
      • Slides

      Background
      Patients with newly diagnosed advanced lung cancer may experience severe impacts on their quality of life (QOL). However, relatively few studies have examined the longitudinal patterns of QOL and their relationship to patients’ symptoms during the first 12 months of cancer diagnosis. Thus, the purposes of this study were to (1) examine the overall pattern and the potential sub-patterns (if any) of QOL in these patients during the first 12 months of cancer diagnosis; and (2) identify those important characteristics of each QOL sub-pattern and their relationship to patients’ symptoms.

      Methods
      This is a 12-month prospective longitudinal study. Newly diagnosed advanced lung cancer patients (Stage IIIB & IV) were eligible to be recruited and followed for 12 months on 5 time points (Pre-treatment, 1, 3, 6 and 12 months since treatments). The overall QOL was measured by the overall QOL item in the EORTC QLQ-C30 (0-100 scoring, higher is better). The QOL patterns and factors related to the patterns were analyzed by Latent Class Growth Analysis (LCGA). Potential factors (independent variables) used to predict the overall QOL change and each QOL sub-pattern (dependent variables) included: physical function, selected symptoms, emotion distress, self-efficacy (on coping with cancer) and important demographic and treatment related variables.

      Results
      A total of 200 subjects completed the 5 follow-up assessments. Generally, patients had moderate level of QOL across the 12 months. There were three QOL sub-patterns were identified. In the pattern I (around 50% of subjects), patients reported moderate to relatively good levels of QOL (scoring around 70-80) across the 12 months. In the pattern II (around 45% of subjects), patients reported moderate levels of QOL (scoring around 50-70 QOL). In the pattern III (<10% subjects), patients reported poor level of QOL (scoring around 40 or less). Overall, symptoms including fatigue, pain, lack of appetite and dyspnea were significantly related to the changes of QOL. Other factors also included psychological distress, uncertainty and self-efficacy (level of confidence) in coping well with lung cancer.

      Conclusion
      The results provide a relatively comprehensive picture about the overall QOL and the sub-patterns of QOL for those newly diagnosed advanced lung cancer patients. The results further support the giving timing and tailoring interventions are needed to better improve lung cancer patients’ QOL. (Acknowledgement: National Health Research Institute,NHRI,Taiwan).

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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-047 - Clinical Factors Associated with the Efficacy of Pemetrexed as Continuation Maintenance Chemotherapy in Patients with Advanced Lung Adenocarcinoma (ID 2859)

      09:30 - 09:30  |  Author(s): C. Yu

      • Abstract

      Background
      Pemetrexed maintenance therapy significantly improved survival in patients with advanced nonsquamous non-small cell lung cancer. This study was to investigate the clinical characteristics and to identify the prognostic factors of pemetrexed as continuation maintenance chemotherapy for patients with advanced lung adenocarcinoma.

      Methods
      Patients with advanced lung adenocarcinoma treated with pemetrexed for continuation maintenance therapy after platinum-based doublet frontline treatment without disease progression were enrolled. The medical records were analyzed for basic characteristics, epidermal growth factor receptor (EGFR) mutation analysis, treatment responses, progression-free survival (PFS) and overall survival (OS).

      Results
      From September 2009 to September 2012, the medical records of 121 patients with advanced lung adenocarcinoma treated with pemetrexed and platinum as first line chemotherapy were reviewed. Sixty-nine patients treated with pemetrexed for continuation maintenance therapy after 6 cycles platinum-based doublet frontline treatment were included. Thirty-five patients (50.7%) were male. The mean of age was 66 ± 13 years old. Twenty-one patients (30.4%) were current or former smoker. The median cycles of pemetrexed as maintenance therapy was 6 cycles (range from 1 to 36 cycles). Elderly patients (age ≥ 70 years old v.s. age < 70 years old, median PFS: 9.6 months v.s. 4.0 months, p=0.002) and patients with lower glomerular filtration rate (GFR) (GFR ≥ 60 ml/min vs. GFR < 60 ml/min, median PFS: 4.0 months vs. 7.9 months, p=0.03) had longer PFS in maintenance phase of pemetrexed treatment. Other clinical factors, including EGFR mutation status, use of cisplatin or carboplatin, gender, smoking history, and treatment response to first-line chemotherapy, had no eventful effect on PFS. However, there was no significant association between OS and these clinical factors.

      Conclusion
      Pemetrexed continuation maintenance therapy may be more beneficial for elderly patients and patients who had lower renal function.