Author of

• 10984

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  P1.22 - Poster Session 1 - Epidemiology, Etiology (ID 166)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Prevention & Epidemiology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10995

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    P1.22-011 - Assessment of the accuracy and reliability of health related behavioural data obtained from patient-reported surveys (PRS) compared with electronic patient records (EPR) in lung cancer patient population (ID 2948)

    09:30 - 09:30  |  Author(s): L. Eng
    • Abstract

    Background
    Cigarette smoking, alcohol consumption and presence of co morbidities are important factors that affect health status and mortality in patients diagnosed with lung cancer. While the gold standard for presence or absence of co-morbidities is EPR, the gold standard for obtaining accurate data pertaining to health-related behaviours is by PRS. The purpose of this study is to ascertain, whether in the absence of patient self-reported data, health related behavioural data pertaining to cigarette smoking and alcohol consumption abstracted from EPR provides an accurate and reliable surrogate.

    Methods
    731 lung cancer patients completed a PRS pertaining to information on their lifetime tobacco use, alcohol consumption and whether or not they had been diagnosed with certain co-morbid conditions. Relevant smoking, alcohol consumption and co-morbidity data was collected independently from EPR. Kappa coefficient analysis was used to assess the agreement.

    Results
    Results can be seen in Table 1. Ever/never status for smoking showed almost perfect agreement (k=0.95) between PRS and EPR and surpassed all other health behavioural measures and all co-morbidity agreement values. The calculation of pack-years from EPR and PRS showed substantial agreement (k=0.77); However, categorizing the smoking status into current/ former / never, resulted in only moderate agreement (k=0.47). Alcohol ever/ never status agreement was moderate (0.44) with high sensitivity (0.90) but low specificity (0.50). The lung related co-morbidities like emphysema (k=0.41) and chronic bronchitis (k=0.28) showed fair agreement but with substantial missing data through EPR.

    Table 1
    Health Behaviour	N	Missing Data in EPR	Agreement (k)	95% CI (P value)	Se	Sp
    Smoking (E/N)	709	0	0.95	(0.79, 0.89)	0.995	0.94
    Smoking (Pkyrs)*	606	81(11%)	0.77	P<0.0001
    Smoking (C/F/N)**	705	4(0.5%)	0.47	(0.41, 0.51)
    Alcohol (E/N)	575	150(20.5%)	0.44	(0.36, 0.52)	0.9	0.5
    Comorbidity
    Emphysema	589	126(17.2%)	0.41	(0.33, 0.49)	0.41	0.95
    Chronic Bronchitis	601	94(12.8%)	0.28	(0.19, 0.37)	0.39	0.88
    *Spearman correlation coefficient
    **Weighted kappa

    Conclusion
    In the absence of PRS data, EPR provides a reliable surrogate for ever/ never smoking status and moderately reliable for lifetime smoking exposure in this lung cancer population. However current/ former/ never smoking status and ever/ never alcohol status cannot be reliably ascertained from medical records. Missing EPR data related to smoking pack years, alcohol consumption and lung co-morbidities is concerning and suggests more systematic or synoptic reporting by physicians would improve opportunities for research

• 12648

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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
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12651

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    P3.11-003 - The use of epidermal growth factor receptor tyrosine kinase inhibitors in treatment of advanced EGFR wild-type non-small cell lung cancer: a meta-analysis study (ID 657)

    09:30 - 09:30  |  Author(s): L. Eng
    • Abstract

    Background
    The epidermal growth factor receptor (EGFR) oral tyrosine kinase inhibitors (TKIs), gefitinib and erlotinib, improve progression-free survival (PFS) compared to chemotherapy in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR mutation. Previous trials of TKIs in unselected patients suggest that they may have some activity in EGFR wild-type (WT) patients, but the magnitude of benefit is unclear. We conducted a meta-analysis to determine the outcomes of EGFR WT patients with advanced NSCLC treated with gefitinib or erlotinib.

    Methods
    MEDLINE was searched for phase 2 and 3 clinical trials of gefitinib or erlotinib in advanced NSCLC published between January 2000 and May 2012. Trials using TKI as treatment arm (i.e. compared against placebo or chemotherapy), control arm or maintenance therapy were included. In addition, studies must have tested for EGFR mutation by polymerase chain reaction and analyzed EGFR WT patients. Random effects meta-analysis using the DerSimonian and Laird method was performed to pool survival estimates (hazard ratios (HR), risk ratios) and objective response rate (ORR). Placebo- and chemotherapy-controlled phase 3 trials were evaluated separately in a subgroup analysis.

    Results
    Six randomized controlled trials (RCTs) with a total of 1,180 EGFR WT patients (709 on TKI, 471 on control with placebo or chemotherapy) were available for meta-analysis. Pooled overall survival (OS) from 5 RCTs was not significantly different for patients in the TKI arm compared to control arm (HR 1.00; 95% CI 0.86-1.16). Subgroup analysis according to type of control showed that TKI offered no OS benefit compared to either placebo (HR 0.92, 95% CI 0.63-1.35) or chemotherapy (HR 1.02, 95% CI 0.86-1.22) (interaction p=0.63). Likewise, pooled PFS was similar between TKI and control in 4 RCTs (HR 1.35; 95% CI 0.79-2.31). However, the use of TKI significantly increased PFS compared to placebo (HR 0.78, 95% CI 0.63-0.97), but not compared to chemotherapy (HR 1.64, 95% CI 0.96-2.79) (interaction p=0.01). The rate of patients in the control arm who subsequently received TKI upon progression ranged from 3% to 52%. ORR estimated from 51 studies (1,872 EGFR WT patients) was 8.4% (95% CI 6.0-10.8), and was similar for gefitinib and erlotinib. Sensitivity analysis removing studies with estimated effect sizes did not affect these findings.

    Conclusion
    In this meta-analysis, gefitinib and erlotinib significantly increase PFS compared to best supportive care for advanced NSCLC with EGFR WT status. The lack of OS gain may be explained by significant crossover in these trials. TKIs may have a potential role in the management of EGFR WT patients who are not candidates for chemotherapy. There is a lack of studies on TKIs in EGFR WT patients, and more data with new generation TKIs are needed in this population.