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M. Harris



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    O14 - Radiotherapy - Toxicity and Clinical Trials (ID 105)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      O14.06 - Investigation of a Patient Reported Outcome (PRO) tool to assess radiotherapy-related toxicity in patients with lung cancer (ID 1614)

      10:30 - 12:00  |  Author(s): M. Harris

      • Abstract
      • Presentation
      • Slides

      Background
      Discrepancies between clinician and patient reported symptoms validate the investigation of a PRO tool in clinical trials and routine practice. There is a paucity of data regarding the feasibility and relevance of PRO tools to assess radiotherapy toxicity in patients with lung cancer.

      Methods
      From January to June 2013, lung cancer patients undergoing thoracic radiotherapy or chemo-radiotherapy completed a PRO toxicity tool (adapted Radiogenomics Biorepository and Databank lung questionnaire) consisting of 9 patient-adapted Common Terminology Criteria for Adverse Events (CTCAE) items and World Health Organisation (WHO) performance status (PS) at baseline, at the end of radiotherapy and at 4-10 weeks follow-up (FU). At the same time points, patients completed the European Organisation for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire along with its lung cancer specific module (EORTC QLQ-C30/LC13) and the Hospital Anxiety and Depression Scale (HADS). Clinicians completed the same CTCAE items for each time point. Agreement between patients’ and clinicians’ toxicity reports was assessed using weighted kappa coefficients. The patients’ QoL and HADS scores were correlated with the patients’ and clinicians’ reported toxicity using Spearman rank correlation coefficients.

      Results
      Of the 116 patients consented, 70 (85 paired responses) completed all 3 questionnaires for at least one time point excluding baseline. Median age was 71.5 years (39-89 years), 54.3% of the patients were male and 85.7% had a diagnosis of non-small cell lung cancer. Agreement between patients’ and clinicians’ reported toxicity ranged from poor to substantial (Figure 1). Perfect agreement was ≥50% for all assessed items with the exception of PS for both the end of radiotherapy and FU. The majority of discrepancies (≥74%) differed by 1 grade of toxicity. At the end of radiotherapy patients reported greater severity than clinicians for all items but not for PS; however this was less pronounced at FU. QoL scores were generally more strongly correlated with the patients’ compared to clinicians’ matching toxicity grades at the exception of dyspnoea. The correlation of HADS scores with patients’ CTCAE anxiety and depression grades ranged from moderate-to-low to moderate. There was no correlation with clinicians’ grading for depression and no-to-moderate correlation for anxiety. The adapted Radiogenomics Biorepository and Databank lung questionnaire demonstrated a high Cronbach’s α value (0.848) indicating good reliability. Figure 1

      Conclusion
      The use of a PRO tool in radiotherapy for lung cancer is feasible, reliable and acceptable to patients and complements the clinicians’ assessment. Further research is required to evaluate its validity.

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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-034 - Treatment Beyond Progression in Patients with Non-Small Cell Lung Cancer Harbouring EGFR Mutations - The Manchester Lung Cancer Group Experience (ID 2431)

      09:30 - 16:30  |  Author(s): M. Harris

      • Abstract

      Background
      The presence of EGFR activating mutations in NSCLC and sensitivity of these tumours to EGFR tyrosine kinase inhibitors (TKI) was first described in 2005. For NSCLC patients harbouring an activating EGFR mutation the treatment of choice is an EGFR TKI which is better tolerated and easier to administer than chemotherapy. However, questions remain about duration of therapy and optimal management on radiological progression.

      Methods
      A retrospective case note review was undertaken with the aim of establishing current practice in prescription and discontinuation of EGFR-TKIs, subsequent therapies and clinical outcomes. We identified consecutive patients from the database of the genetic testing laboratory (from Q4 2009 when routine testing commenced to a cut-off point of February 2013). 171 case- notes were reviewed for demographic and clinical data including survival.

      Results
      Of 171 cases 116 (69%) had received treatment with an EGFR TKI (Gefitinib 79%, Erlotinib 19%, both 2%). The reasons for not receiving treatment included: patient received radical therapy, patient died before oncology assessment and patient preference. 63% of patients were female, 26% never smokers, 44% ex-smokers, 6% current smokers and smoking history was not documented in 23%. 76% of patients had Stage IV disease and performance status was 0-1 in 47%, 2 in 22%, 3 in 7%, 4 in 2% and not documented in 23%. The average length of treatment on EGFR TKI was 10.5 months (range 0.5-40) and 36 (31%) patients were still on treatment at the time of analysis. Disease progression on the EGFR-TKI (PD) had occurred in 82 (71%) of patients and 28 (34%) of these continued EGFR TKI treatment beyond PD. The average length of time on treatment beyond PD was 5.6 months (range 1-16) and TKI treatment was ongoing in 9 of the 28 patients. 25 of the 73 patients (34%) with PD who had stopped EGFR TKI went onto receive a second line systemic treatment: pemetrexed and platinum 60%, gemcitabine and carboplatin 20%, single agent pemetrexed 8%, vinorelbine 8%, gemcitabine 4%. Third line therapy was received by 40% of those who had received 2[nd] line treatment.

      Conclusion
      Patients with EGFR activating mutations often derive a significant clinical benefit and marked reduction in tumour burden with oral EGFR TKI therapy, which results in a reluctance, from both patients and clinicians, to stop therapy at the time of radiological progression if the patient is still experiencing symptomatic improvement. Our results show that treatment beyond disease progression is common (34%) in ‘real –life’ clinical practice with some patients continuing to derive benefit for more than a year beyond the time of disease progression. .