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A. Ramaswamy



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    P2.03 - Chemotherapy/Targeted Therapy (ID 704)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Chemotherapy/Targeted Therapy
    • Presentations: 1
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      P2.03-027 - Comparative Longitudinal Toxicity Analysis of EGFR Mutated NSCLC Treated with Either Pemetrexed Carboplatin or Gefitinib (ID 8967)

      09:30 - 09:30  |  Author(s): A. Ramaswamy

      • Abstract
      • Slides

      Background:
      Toxicity analysis in randomized studies is classically reported as maximum grade toxicity occurring during the course of treatment. Unfortunately, the duration of toxicity is neglected. Patients receiving targeted therapy like gefitinib frequently have low grade continuous toxicities. Longitudinal toxicity analysis may be a more appropriate method of quantifying and comparing toxicity.

      Method:
      EGFR mutated NSCLC patients treated with gefitinib or pemetrexed-carboplatin as a part of randomized study were selected for this analysis. Patients were evaluated on the 7th day after the start of therapy and then on days 15, 21, 42, 63, 84,105 and then subsequently every 2 months till progression. Toxicities in accordance with CTCAE version 4.02 occurring during each visit were documented at each visit. Three toxicities were selected for this analysis and these were diarrhea, skin rash and fatigue. R software was used for analysis. Maximum grade toxicity and longitudinal time -toxicity analysis was performed. Toxicities were compared between the 2 arms using both methods.

      Result:
      Among the 290 patients, half each were randomized to gefitinib and pemetrexed-carboplatin arm respectively. Any grade diarrhea was seen in 22 % of patients receiving gefitinib as opposed to 12% receiving pemetrexed-platinum (p-0.12%). Similar higher proportion of toxicity was seen in gefitinib arm for skin rash (33% versus 13%, p-0.00).The proportion of fatigue in gefitinib and pemetrexed -platinum arm were similar (6% versus 9%, p-0.59). The longitudinal time-toxicity analysis revealed that both rash and diarrhea were higher and more sustained in gefitinib arm. The difference area under the curve for rash and diarrhea were 10 units (p-0.192) and 21.89 units (p-0.09) respectively. The fatigue was similar in both arms (p-0.779)

      Conclusion:
      Longitudinal time -toxicity analysis provides information which is clinically relevant and might impact patients quality of life and hence should be performed in patients receiving targeted therapies.

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