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T. McCulloch



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    P3.08 - Poster Session 3 - Radiotherapy (ID 199)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P3.08-023 - Acute Esophagitis and concomittant Chemoradiotherapy with Navelbine. Results from NARLAL, a Phase II randomized Trial. (ID 2686)

      09:30 - 09:30  |  Author(s): T. McCulloch

      • Abstract

      Background
      Radiotherapy (RT) for non-small cell lung cancer (NSCLC) is associated with important side effects with acute esophagitis (AE) as one of the main acute toxicities. RT dose and concomitant chemo-radiotherapy as well as volume of oesophagus treated are known risk factors for development of AE.

      Methods
      This is a multicentre national protocol on RT for locally advanced NSCLC. From 2009-2013 117 patients were randomized between 60 Gy/ 30 F (arm A) and 66 Gy/ 33 F (Arm B), 5 FW. Navelbine[®] 50 mg 3 days a week was given concomitant with RT. Before randomization patients were treated with 2 cycles of carboplatin and Navelbine[®] as induction chemotherapy. During RT, patients were registered for side effects once a week. After RT follow up schedule was every 3[th] month from RT start. Side effects were registered according to NCI CTCAE version 3.

      Results
      A total of 117 patients were randomized in this protocol. Baseline characteristics are summarized in table 1. Since last patient was randomized August 2013, all CRF are not available for the moment. There are complete esophagitis data on 103 patients. Grade 0-1 AE were seen in 66 patients (37 in arm A vs. 29 in Arm B), grade 2 in 27 patients (11 vs. 16), 10 patients experienced grade 3 (3 vs. 7), and none grade 4 AE. In a logistic regression analysis with N2/3, age ≥64 years, histology, gender and dose as covariates; treatment arm B was the only significant covariate (p=0.02) for developing grade 2 esophagitis. Dose volumetric data will be ready for WCLC.Figure 1

      Table 1 Number %
      Performance status 0 59 50
      1 57 49
      missing 1 1
      Gender Male 68 58
      Female 49 42
      Histology Squamos cell carcinoma 41 35
      Adenocarcinoma 54 46

      Conclusion
      From this study we conclude, that the risk of developing grade 2 esophagitis is related to dose 66 Gy but the severity is manageable. Acknowledgements Supported by CIRRO- The Lundbeck Foundation Center for Interventional Research in Radiation Oncology.