Author of

• 11946

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  P2.24 - Poster Session 2 - Supportive Care (ID 157)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Supportive Care
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11951

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    P2.24-005 - Oral EGFR TKIs as first line treatment for NSCLC: experience from a tertiary care centre in North India (ID 701)

    09:30 - 09:30  |  Author(s): A.N. Aggarwal
    • Abstract

    Background
    Therapeutic armamentarium for advanced NSCLC includes oral EGFR-TKIs. There is paucity of data from India on experience with oral EGFR-TKIs in newly diagnosed NSCLC. The current study sought to assess demographic profile and treatment outcomes for NSCLC patients receiving first line treatment with oral EGFR-TKIs at a tertiary care institute in North India.

    Methods
    Retrospective analysis of data on newly diagnosed NSCLC patients initiated on treatment with oral EGFR-TKIs over a 4 year period (January 2008 to December 2011). Demographic characteristics, histology, disease stage and smoking status were noted. Radiological response to treatment was assessed using RECIST. Toxicity was graded as per Common Toxicity Criteria (CTC v3.0). Numerical and categorical data were compared between groups using Mann Whitney U test and chi-square test respectively. Survival probabilities and median survivals were calculated by Kaplan-Meier method and group differences analyzed using the log-rank test.

    Results
    Of the 76 patients who comprised the study population, the percentage of males and current/ex-smokers was 67.1% (n=51) and 51.3% (n=39) respectively. Histological distribution was as follows: Adenocarcinoma 59.2% (n=45), Squamous cell 23.7% (n=18), NSCLC-NOS 11.8% (n=9) and Large cell carcinoma 5.3% (n=4). Majority of patients were in stages IV 64.5% (n=49) and IIIB 26.3% (n=20) while only 9.2% (n=7) were in stages I-IIIA. Malignant pleural effusion was present in 20 (26.3%) patients. Baseline Karnofsky performance status (KPS) was 80-100 in 25.5%, 60-70 in 42.6% and ≤50 in 31.9%. Gefitinib (n=70, 92.1%) was the most frequently used EGFR-TKI. Most common indications for use of oral EGFR-TKI were poor PS/physiological status in 65.8% (n=50) and unwillingness for chemotherapy in 27.6% (n=21). Overall, 47 patients had atleast one follow up visit after one month and were eligible for assessment for response and toxicity. There were no complete responses while partial response (PR), stable disease (SD) and progressive disease (PD) were documented in 36.2%, 29.8% and 34.0% respectively of assessable patients. The most common side effects were skin rash and diarrhoea that developed in 17.0% and 10.6% of patients respectively. These were mild (grade 1/2) in all except one patient each with grade 3. Objective PR was observed in all (100%) patients with skin rash as compared to 23.1% among those without skin rash (p<0.001). Among patients without skin rash, the median OS was 178 days (IQR 53-320 days) while among those with skin rash the median OS had not been reached (figure 1).Figure 1 Gender, histology and smoking status did not differ amongst patients with and without skin rash. However, skin rash occurred in 25.0% and 5.4% of patients with and without malignant pleural effusion (MPE) respectively (p=0.26). On multivariate logistic regression analysis, only MPE was associated with occurrence of rash [odds ratio=0.19 (95% CI=0.04-0.95); p=0.04].

    Conclusion
    Oral EGFR-TKIs are a useful treatment option for clinically selected patients with advanced NSCLC who have either poor PS or are unwilling for chemotherapy. Occurrence of skin rash has an independent association with objective treatment response and with better OS. Presence of MPE is associated with occurrence of skin rash.