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Victor Lee



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-98 - A Phase IIIb Trial of Afatinib in EGFRm+ NSCLC: Analyses of Outcomes in Patients with Brain Metastases or Dose Reductions (ID 12906)

      16:45 - 18:00  |  Author(s): Victor Lee

      • Abstract

      Background

      We previously reported interim results of a large (n=479) open-label, single-arm Phase IIIb study of afatinib in EGFR TKI-naïve patients with EGFRm+ NSCLC, in a setting similar to ‘real-world’ practice (Wu et al, WCLC, 2017). In this broad population of Asian patients, the tolerability profile of afatinib was predictable and manageable. Adverse events (AEs) were consistent with the LUX-Lung 3, 6 and 7 trials; 3.8% of patients discontinued due to drug-related AEs. Progression-free survival (PFS) and time to symptomatic progression (TTSP) was encouraging, in patients with both common and uncommon EGFR mutations. TTSP data suggested effective treatment beyond progression. Here, we assess the impact of baseline brain metastases and use of dose reductions on efficacy outcomes.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with locally advanced/metastatic EGFRm+ NSCLC were recruited in China, Hong Kong, India, Singapore and Taiwan. Afatinib 40mg/day was given until disease progression (investigator-assessed) or lack of tolerability. Treatment-related AEs could be managed by protocol-specified tolerability-guided dose adjustment.

      4c3880bb027f159e801041b1021e88e8 Result

      At data cut-off (13 Feb 2017), patient characteristics were as follows: median age, 59.0 years; female, 52.4%; EGFR mutations: Del19+/-L858R+/-uncommon, 86.0%; uncommon only, 14.0%; ECOG PS0, 19.8%; PS1, 78.1%. Prior chemotherapy lines: 0, 59.7%; 1, 30.1%; ≥2, 10.2%.

      Overall, dose reductions from 40mg/day to 30mg/day occurred in 119 patients (25%). Incidences of the most frequently reported AEs before and after dose reduction were (any grade): diarrhea, 96/51%; rash/acne, 69/58%; stomatitis, 65/42%; (≥grade 3) diarrhea, 27/4%; rash/acne, 24/11%; stomatitis, 11/5%. A total of 96 patients had a dose reduction during the first six months; median PFS in this subgroup was 14.1 months (95% CI: 10.0–19.3) versus 11.33 (10.7–13.6) months in those who remained on the starting dose (n=383); HR=1.37 (1.01–1.85), p=0.041. Median TTSP was 17.7 (13.5–23.7) and 14.7 (12.7–17.0) months, respectively; HR=1.26 (0.92–1.72), p=0.15.

      Among 92 patients (19.2%) with brain metastases at baseline, median PFS was 10.9 (8.3–14.3) months, versus 12.4 (10.8–13.9) months in those without metastases (n=387); HR=1.23 (0.91–1.65), p=0.18. Median TTSP was 14.8 (12.7–20.7) and 15.4 (12.9–18.0) months, respectively; HR=1.0 (0.71–1.40), p=1.0.

      8eea62084ca7e541d918e823422bd82e Conclusion

      These findings demonstrate that tolerability-guided dose adjustment of afatinib is an effective measure to reduce treatment-related AEs, while maintaining therapeutic efficacy. TTSP was similar between patients with and without brain metastasis. This is additional evidence for the efficacy of afatinib in patients with brain metastases.

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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-53 - Local Treatment for Oligoprogression/Oligometastases After Failure to Crizotinib for ALK-Rearranged Stage IV Lung Cancer (ID 12044)

      16:45 - 18:00  |  Author(s): Victor Lee

      • Abstract
      • Slides

      Background

      Crizotinib is approved as 1st line treatment for ALK-rearranged stage IV non-small-cell lung cancer (NSCLC). We investigated if local treatment for oligoprogression/metastases (<=5 lesions) while maintaining crizotinib could prolong progression-free survival (PFS) for ALK-rearranged stage IV NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a retrospective review on crizotinib for ALK-rearranged stage IV NSCLC in the real-world setting in 4 public oncology hospitals. All patients who received crizotinib outside clinical trials were reviewed. Patients who developed oligoprogression/metastases following progressive disease to crizotinib were assessed for local treatment (surgery, palliative or radical radiotherapy or combination of surgery and radiotherapy) for these sites while continuing crizotinib until further progressive disease beyond the definition of oligoprogression/metastases. The primary study endpoint is PFS after local treatment for olioprogression/metastases. Secondary endpoints are overall survival and toxicity profiles.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 165 patients were recruited, of which 115 (69.7%) and 50 (30.3%) received it as 1st line treatment and at later lines respectively. Of the 161 (97.6%) patients eligible for tumour response assessment, the objective response rate was 64.5%. After a median follow up of 18.5 months (range 0.6-70.1 months), the median PFS and OS of the whole population were 10.8 and 18.5 months. There was no statistical difference in PFS and OS among those who received crizotinib as 1st line and later lines. Twenty-nine (17.6%) patients developed oligoprogression/oligometastasis following crizotinib. Eighteen (62.1%) received local treatment (surgery – 2 , stereotactic radiosurgery/radiotherapy – 7, intensity-modulated radiation therapy/tomotherapy – 3, palliative radiotherapy – 7), of whom 3 patients received 2 courses of local treatment to different oligoprogressive/oligometastatic sites at oncologists’ discretion while continuing crizotinib until their next date of progressive disease. Median PFS was significantly longer in those who received local treatment (20.9 months [95% CI 11.8-30.1 months] vs. 11.4 months [95% CI 5.1-17.7 months]; p=0.004) than those who did not for their oligoprogression/oligometastases. Median OS was not different between those who received local treatment and those who did not for their oligoprogression/oligometastases (p=0.742). Seventy-one (43.0%) patients received other ALK inhibitors following progression to crizotinib (1 line – 50, 2 lines – 19, 3 lines – 1, and 4 lines – 1). Four (2.4%) patients are still receiving crizotinib without progression. Crizotinib was well-tolerated with only 7.9% grade 3/4 adverse events. No grade >=2 events were reported for local treatment.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Local treatment for oligoprogressive/metastatic diseases could significantly prolong PFS in the real-world setting, which procrastinates the later use of other systemic therapies.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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