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A. Jaiswal



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    MINI 33 - Radiotherapy and Complications (ID 164)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      MINI33.08 - Feasibility & Efficacy of Hypofractionated Radiotherapy in LA-NSCLC: A Phase II Study (ID 452)

      18:30 - 20:00  |  Author(s): A. Jaiswal

      • Abstract
      • Presentation
      • Slides

      Background:
      Accelerated repopulation of tumour cells causes inferior local control in locally advanced NSCLC (non-small cell lung cancer). Hypofractionated radiation schedule with a shorter overall treatment time may address this issue. The current study was aimed at evaluating the feasibility and efficacy of using hypofractionated radiotherapy with concurrent chemotherapy after neoadjuvant chemotherapy in locally advanced NSCLC.

      Methods:
      Thirty patients of locally advanced NSCLC were enrolled in this randomized controlled study and were allocated to one of the two treatment arms between October 2011 and July 2013. Arm A (n=15) received neoadjuvant chemotherapy (NACT) (paclitaxel 200mg/m2 and carboplatin AUC 5) followed by external radiotherapy (EBRT) (60Gy/30fractions/6weeks). Arm B (n=15) received the same NACT followed by EBRT (48Gy/20fractions/4weeks) with concomitant chemotherapy (cisplatin 30mg/m2 weekly). Quality of life analysis was done using EORTC (European organization for Research and Treatment in Cancer) QLQ C30 and LC13. Toxicity scoring was done using CTCAE (Common Terminology Criteria for Adverse Events) version 3.0. The treatment response between two arms was computed using Fisher’s exact test. The difference in QOL parameters were compared by Wilcoxon signed rank test and Mann-Whitney U test for paired and unpaired samples. Survival time was estimated by Kaplan–Meier survival analysis. Survival pattern was compared using the log-rank test. Factors which had p value <0.25 in univariate analysis were subjected to multivariate analysis using Cox regression analysis. Statistical analysis was carried out using Stata software version 12.0.

      Results:
      The overall response rate at the time of first follow-up for arm A was 54.55% as compared to 85.71 %( p=0.08) in arm B. At median follow-up duration of 12 months the ORR was numerically superior in arm B though not statistically significant 33% vs 47%).The median PFS in arm A and B were 9.2 and 17.23 months respectively [hazard ratio 2.92 (95% C.I: 1.02-9.11); p=0.05]. No significant difference was discernible in OS between two arms on multivariate analysis. Social functioning showed a trend towards improvement while alopecia showed a trend towards worsening in arm B. The most common grade 3/4 hematological and non-hematological toxicity were neutropenia peripheral neuropathy and dysphagia (arm A: 3; arm B: 1).

      Conclusion:
      Hypofractionated radiotherapy with concomitant chemotherapy after NACT is feasible for locally advanced NSCLC. Such management approach can expedite treatment with an acceptable morbidity, patient compliance and quality of life and thus reduces the waiting time, machine load, socio-economic burden in patients which is significant in a developing nation.

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    P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P3.03-024 - Efficacy of 18 F-FDG PET/CT as Response Predictor in Locally Advanced Non-Small Cell Lung Cancer (ID 442)

      09:30 - 17:00  |  Author(s): A. Jaiswal

      • Abstract
      • Slides

      Background:
      The study was aimed to assess the role of [18]F-FDG PET/CT in response assessment of patients with locally advanced non-small cell lung cancer (NSCLC) and in evaluating the predictive value of metabolic response for progression-free survival (PFS) and overall survival (OS).

      Methods:
      Thirty patients of locally advanced NSCLC were enrolled in this randomized controlled study and were allocated to one of the two treatment arms. Patients in Arm A (n=15) received neoadjuvant chemotherapy (NACT) and external beam radiotherapy (EBRT) while arm B (n=15) received NACT and EBRT with concomitant chemotherapy. [18]F-FDG PET/CT was carried out at baseline and after 6-weeks of completion of intended treatment. Pre and post-treatment maximum standardized uptake value (SUVmax) was noted. A reduction of SUVmax> 50% (∆SUVmax) were considered to be metabolic responders (MR) and ≤ 50% as non-responders (MNR). The difference in SUVmax parameters were compared by Wilcoxon signed rank test and Mann-Whitney U test for paired and unpaired samples. The significance of difference in the number of MR and MNR between two arms was computed using Fisher’s exact test. Survival time was estimated by Kaplan–Meier survival analysis. Survival pattern was compared using the log-rank test. Factors which had p value <0.25 in univariate analysis were subjected to multivariate analysis using Cox regression analysis. Statistical analysis was carried out using Stata software version 12.0.

      Results:
      Twenty one patients completed the intended treatment. The median pre and post-treatment SUVmax were 14, 6.4 for arm A and 15.3, 3.5 for arm B. There was no statistically significant difference between pre and post treatment SUVmax among the two treatment arms. Significant decrease in SUVmax was observed in both arms (median ∆SUVmax of 50% and 74% in arm A and B; p=0.618). Twelve patients achieved metabolic response. Metabolic response rate in arm A and B was 50% and 64% respectively (p=0.783). At median follow-up of 18.98 months the median PFS and OS of the MR were 22.31, 24.73 months and of MNR were 7.83, 8.26 months The Cox proportional hazard ratio for PFS and OS in MNR group was 2.33 (95% confidence interval i.e. C.I: 0.78-6.91) and 2.12 (95% C.I: 0.65-6.97). No significant difference in OS and PFS was observed between MR and MNR subpopulation of two arms (table-1).

      Group Median PFS (in months) P value (Log rank test) Median OS (in months) P value (Log rank test)
      Total cohort: 17.02 (95% C.I:7.44-22.31) - 24.73 -
      MR: MNR: 22.31 7.83 0.09 24.73 8.26 0.12
      Arm A Arm B 18.7 9.12 0.59 24.73 15.4 0.27
      MR of Arm A MR of arm B 10.5 22.3 0.34 15.4 Not achieved 0.27
      MNR of arm A MNR of Arm B 7.44 7.83 0.71 7.47 8.26 0.71


      Conclusion:
      PET/CT distinguishes responders to treatment based on metabolic activity in patients with locally advanced NSCLC, but did not provide any prognostic significance.

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