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  • WCLC 2018

    19th World Conference on Lung Cancer

    Access to all presentations that occur during the 19th World Conference on Lung Cancer in Toronto, ON

    Presentation Date(s):
    • Sept 23 - 26, 2018
    • Total Presentations: 2384

    To review abstracts of the presentations below, narrow down your search by using the Filter options below, and then select the session listing of your choice. Click the "+" for a presentation to expand & view the corresponding Abstract details.

    Presentations will be available 24 hours after their live presentation time

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

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 112
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
    • +

      P1.01-28 - Impact of Afatinib Dosing on Safety and Efficacy Real-World in Patients with EGFR Mutation-Positive Advanced NSCLC (ID 13276)

      16:45 - 18:00  |  Presenting Author(s): Balazs Halmos  |  Author(s): Eng-Huat Tan, Ross Soo, Jacques Cadranel, Min Ki Lee, Pascal Foucher, Te-Chun Hsia, Maximilian Johannes Hochmair, Frank Griesinger, Toyoaki Hida, Edward S Kim, Barbara Melosky, Angela Märten, Enric Carcereny

      • Abstract
      • Slides

      Background

      Tolerability-guided dose adjustment of afatinib reduced incidence and severity of adverse drug reactions (ADRs) without affecting efficacy in the LUX-Lung (LL) studies in patients with EGFR mutation-positive (EGFRm+) NSCLC. We evaluated the impact of modifying the recommended starting dose of afatinib (40mg) on efficacy and safety in a real-world setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This non-interventional, observational, multi-country/site study used medical records of TKI-naïve patients with EGFRm+ (Del19/L858R) NSCLC treated with first-line afatinib. Primary outcomes were % patients with ADRs by severity, time on treatment (TT), and time to progression (TTP), relative to LL3. Secondary outcomes were % of patients with/reasons for modified starting dose.

      4c3880bb027f159e801041b1021e88e8 Result

      228 patients from 13 countries were included. Baseline characteristics were generally similar to LL3, but with more Del19 patients (78% vs 49%) and fewer Asian patients (44% vs 72%); 12% had ECOG PS 2–3. 31% of patients received an afatinib starting dose of <40 mg; 20% of patients starting with <40 mg increased their dose during the study. 67% of 40 mg starters underwent dose reductions, with 86% of those occurring in the first 6 months. Dose reductions were more frequent in females, Eastern Asian patients, and those with lower body weight. The main reason for dose modification was ADRs. In <40 mg starters, overall ADR incidence was similar to that in ≥40 mg starters, with fewer G3 (17% vs 25%) and no G4 ADRs. There were no new safety signals, and fewer ≥G3 ADRs and serious adverse events (SAEs) than in LL3 (28% vs 49% and 5% vs 14%, respectively). >60% of patients received medications to treat diarrhea and manage skin AEs. Median TT and TTP were 18.7 months and 20.8 months, respectively, and were not impacted by reduced starting dose or dose modification (19.4/17.7/19.5 and 25.9/20.0/29.0 months for patients who started on ≤30 mg/reduced to <40 mg/remained on ≥40 mg, respectively). The efficacy of afatinib was demonstrated across all patient subgroups analysed (ECOG PS 0/1 vs 2/3, age <75 yrs vs 75 yrs, EGFR mutational status); TT and TTP were significantly longer in patients with ECOG PS0/1 versus PS2/3.

      8eea62084ca7e541d918e823422bd82e Conclusion

      As in pivotal trials, dose adjustments with afatinib in real-world practice reduced the frequency and intensity of ADRs without impacting efficacy. RealGido demonstrated long TT/TTP regardless of afatinib dose adjustment or reduced starting dose, and an acceptable safety profile. The results highlight the benefit of tailoring afatinib dose based on individual patient characteristics and ADRs to optimize outcomes.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    MA10 - Considerations in Immunotherapy / Real World (ID 911)

    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 12
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 105
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      MA10.08 - Choice of Taxane and Outcomes in the KEYNOTE-407 Study of Pembrolizumab Plus Chemotherapy for Metastatic Squamous NSCLC (ID 14698)

      11:25 - 11:30  |  Presenting Author(s): Balazs Halmos  |  Author(s): Alexander V Luft, Margarita Majem, Rina Hui, Romain Corre, Mahmut Gümüş, Konstantin Laktionov, Barbara Hermes, İrfan Çiçin, Andrew G Robinson, Terufumi Kato, Ying Cheng, Dariusz Kowalski, Xiaodong Li, Gregory M Lubiniecki, Bilal Piperdi, Luis Paz-Ares

      • Abstract
      • Presentation
      • Slides

      Background

      In the randomized, double-blind, phase 3 KEYNOTE-407 study (NCT02775435), pembrolizumab plus chemotherapy with carboplatin and paclitaxel or nab-paclitaxel significantly prolonged OS (HR 0.64, 95% CI 0.49-0.85, P=0.0008) and PFS (HR 0.56, 95% CI 0.45-0.70, P<0.0001) compared with placebo plus chemotherapy in patients with previously untreated, metastatic squamous NSCLC. The benefit of pembrolizumab plus chemotherapy was observed irrespective of PD-L1 TPS. Pembrolizumab plus chemotherapy also had a manageable safety profile. We performed an exploratory analysis of outcomes by investigator’s choice of paclitaxel or nab-paclitaxel, which was a randomization stratification factor.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      559 eligible patients were randomized 1:1 to pembrolizumab 200 mg or placebo Q3W for up to 35 cycles plus 4 cycles of carboplatin AUC 6 mg/mL/min Q3W and investigator’s choice of paclitaxel 200 mg/m2 Q3W or nab-paclitaxel 100 mg/m2 QW. Primary end points were OS and PFS; ORR and safety were secondary.

      4c3880bb027f159e801041b1021e88e8 Result

      Paclitaxel was the chosen taxane in 60% of patients. The addition of pembrolizumab to chemotherapy improved OS, PFS, and ORR regardless of choice of carboplatin and paclitaxel or carboplatin and nab-paclitaxel (Table). Incidence of grade 3-5 AEs in the pembrolizumab plus chemotherapy arm vs placebo plus chemotherapy arm was 63.9% vs 59.3% in paclitaxel recipients and 78.9% vs 81.4% in nab-paclitaxel recipients. AEs led to discontinuation of all treatment in 13.6% vs 8.4% of paclitaxel recipients and 12.8% vs 3.5% of nab-paclitaxel recipients and led to discontinuation of any treatment in 19.5% vs 13.2% and 29.4% vs 9.7%, respectively. Immune-mediated AEs occurred in 29.6% vs 9.6% of paclitaxel recipients and 27.5% vs 7.1% of nab-paclitaxel recipients.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Adding pembrolizumab to chemotherapy with carboplatin and a taxane improved efficacy and was generally tolerable compared with chemotherapy alone as first-line therapy in patients with metastatic squamous NSCLC regardless of whether paclitaxel or nab-paclitaxel was the chosen taxane.

      Carboplatin plus Paclitaxel Carboplatin plus Nab-Paclitaxel

      Pembrolizumab + Chemotherapy

      N = 169

      Placebo + Chemotherapy

      N = 167

      Pembrolizumab + Chemotherapy

      N = 109

      Placebo + Chemotherapy

      N = 114

      OS, median

      (95% CI), mo

      14.0 (12.6-16.6) 10.3 (8.2-14.8) NR (NE-NE) 12.6 (9.6-NE)
      HR (95% CI)a 0.67 (0.48-0.93) 0.59 (0.36-0.98)

      PFS, median

      (95% CI), mo

      6.4 (6.0-8.3) 4.4 (4.2-5.1) 6.5 (6.2-8.5) 5.9 (4.4-6.9)
      HR (95% CI)a 0.52 (0.40-0.68) 0.65 (0.45-0.94)
      ORR, % (95% CI) 57.4 (49.6-65.0) 37.7 (30.4-45.5) 58.7 (48.9-68.1) 39.5 (30.4-49.1)
      aBased on a Cox regression model with treatment as a covariate.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 132
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
    • +

      P2.01-39 - Can Benefit or Futility in Treating Advanced Nsclc Be Determined Early Using the LCSS 3-Item Global Index (3-IGI) PRO? (ID 12299)

      16:45 - 18:00  |  Presenting Author(s): Richard J Gralla  |  Author(s): Patricia J. Hollen, Richard Hall, Ryan Gentzler, Haiying Cheng, Balazs Halmos, Jeffrey Crawford, Jane Cerise, Martin Lesser

      • Abstract
      • Slides

      Background

      Background: Early assessment of the effect of treatment for advanced NSCLC can prevent unnecessary exposure to toxic and costly therapy while aiding in decision making to continue or change treatment. In a prior analysis in patients with mesothelioma (Symanowski JCO 2014), a 20% decline from baseline after 2 cycles of chemotherapy in the 3-Item Global Index of the LCSS identified patients unlikely to benefit. The 3-IGI (which evaluates: 1) global distress, 2) patient rated activities, and 3) quality of life, all in single VAS scales) takes less than 2 minutes to assess.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Methods: 164 patients with NSCLC receiving chemotherapy or checkpoint inhibitors were prospectively evaluated with the LCSS at baseline and every 3 weeks using electronic media. Patients were also randomized 1:1 so that their physicians knew the results of the LCSS immediately in half of the patients.

      4c3880bb027f159e801041b1021e88e8 Result

      Results: Patients: Stage IV 92%; first line 73%; female 43%; median PS 1; mean age 63. The LCSS was completed after 2 cycles of treatment and prior to planning for the next cycle (generally 6 weeks after baseline; representing 91% of the 148 patients living). Patients with a 20% decline in the 3-IGI compared with baseline had a median survival of 7.6 months, contrasted to 15.8 months for those without this degree of 3-IGI decline (p = 0.01); 1 year survivals = 26% versus 62%. Even with the marked PRO decline after 2 treatment cycles, patients in the 20% decline group received a median of 2.3 more cycles of the same chemotherapy (median cost = $10,712 per patient). In the 50% of patients for which their physicians knew the ongoing LCSS results, fewer chemotherapy and imaging studies were performed, but the differences were not significant (p = 0.8).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusions: Assessing change from baseline with the 3-IGI of the LCSS identifies after only 2 cycles of treatment those patients who have poor response and survival outcomes if continued on the same therapy. This PRO assessment is rapid, easy, and inexpensive. Physicians need to consider the impact of decline on decision options given that even when physicians were aware of the worsening PRO they often did not act on the findings. Patient responses to this validated PRO questionnaire provide valuable information that is not otherwise attainable. Responding to 3-IGI changes can result in better decisions concerning continuing or changing treatment, lessening toxicity, and savings in cost of unhelpful treatment.

      Supported by: NIH/NCI R01 CA157409

      6f8b794f3246b0c1e1780bb4d4d5dc53

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