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R. Kumar



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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-023 - ALK-Positive NSCLC: A TMH Experience (ID 10491)

      09:30 - 09:30  |  Author(s): R. Kumar

      • Abstract

      Background:
      ALK gene rearranged NSCLC are a rare subset of lung cancers. However, treatment with crizotinib leads to an improvement in outcomes. In this study, we have audited the outcomes of ALK-rearranged NSCLC at our institute.

      Method:
      This was a subset analysis of a prospective observational study. It was approved by the institutional ethics committee and was carried out in accordance with good clinical practice guidelines and declaration of Helsinki. For this analysis all Alk rearranged NSCLC patients, diagnosed at our center between November 2011- April 2017 were selected. The treatment received and the outcomes were noted. Progression-free survival and Overall survival were estimated using Kaplan-Meier method.

      Result:
      We had diagnosed 257 patients during this period. The median age was 50 years ( 23-77 years). There were 102 females (39.7%) and 155 males (60.3%). Only 49 patients were smokers (19.1%). The ECOG PS was 0-1 in 197 patients (76.7%), 2 in 28 patients (10.9%) and 3-4 in 32 patients (12.4%). The median number of sites of metastasis was 2 (0-7). Brain metastasis was seen in 36 patients (14.0%). The upfront treatment received was crizotinib in 168 patients (65.3%), pemetrexed -platinum doublet in 57 patients (22.2%), taxane-platinum in 4 patients (1.6%), gemcitabine-platinum in 4 patients (1.6%), others in 14 patients (5.4%). The crizotinib received was started upfront in 88 patients and after a few cycles chemotherapy in 80 patients. In these 80 patients, 53 patients were started as soon as the ALK rearrangement report was available while 27 patients were started after a few cycles once finances were available. The median PFS for crizotinib was 16.1 months versus 11.4 months in pemetrexed platinum (p-0.159) The median PFS in the patients receiving upfront crizotinib was 17.1 months versus 14.7 months in patients receiving crizotinib after the switch (p-0.399). The median overall OS was 39.9 months and it was similar between the two strategies of crizotinib(p-0.964). There were 57 patients (22.1%) who never received crizotinib. The median OS in patients who never received crizotinib was 11.0 months versus it was not reached in patients receiving crizotinib in any line (p-0.000). The 3 year OS in patients receiving crizotinib in any line was 67.0%.

      Conclusion:
      Crizotinib substantial improves outcomes in ALK-rearranged patients whether given upfront or post start of few cycles of chemotherapy.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.01-076 - QTWiST Analysis to Compare the Benefit of Gefitinib Versus Pemetrexed Platinum for Patients with EGFR Mutated NSCLC (ID 10431)

      09:30 - 09:30  |  Author(s): R. Kumar

      • Abstract

      Background:
      In an open-label, Phase 3 randomized study (Clinical trial registry of India: CTRI/2015/08/006113), Gefitinib was found to be superior to Pemetrexed-Platinum in terms of progression-free survival in patients with EGFR mutated NSCLC. In this analysis, we aimed to assess the benefit of gefitinib over Pemetrexed platinum using quality-adjusted time without symptom or toxicity analysis method.

      Method:
      In this phase III, randomized study EGFR activating mutated patients were randomized in 1:1 fashion to either receive pemetrexed-carboplatin followed by maintenance pemetrexed or gefitinib till progression. Patients post progression received the treatment received in other arm if they were fit. These patients were followed up until death. Toxicity during the whole course of treatment was documented in accordance with CTCAE version 4.02 criteria. For QTWiST analysis, the overall survival and progression-free survival were documented. The overall survival was partitioned in 3 health states. These were TOX, TWiST, and REL. TOX state comprised of time in months spent by the patient in grade 2 or above toxicity post randomization but before the first progression. TWiST state comprised of time in months spent by the patient post randomization but before the first progression without grade 2 or above toxicity. REL state was defined as the time in months spent post the first progression until death. RStudio will be used for analysis. The data will be censored for this analysis on 30th June 2017. The restricted mean of all three health states would be calculated using non-parametric 500 boot straps. The time spent in each state will be weighted by a corresponding health-state utility coefficient for QTWiST calculation. A threshold utility analysis will be performed using utility values between 0-1. Where 0 represents a health state similar to death and 1 represents a perfect health state.

      Result:
      The restricted mean health state duration in months for each state with its 95% CI for each arm, the difference between the 2 arms for each health state with its 95%CI and corresponding p-value will be provided. The results of threshold utility analysis with the corresponding QTWiST difference between the 2 arms with p-value would be presented.

      Conclusion:
      LBA: Not applicable