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C.A. Silva

Moderator of

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    OA21 - Palliative and Supportive Care for Lung Cancer Patients (ID 405)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Palliative Care/Ethics
    • Presentations: 8
    • Now Available
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      Q&A (ID 7167)

      12:20 - 12:30 PM

      • Abstract

      Abstract not provided

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      OA21.01 - Pooled Analysis of the Incidence and Risk of Treatment-Related Pneumonitis with Anti-PD-1/PD-L1 Therapies in Cancer Patients (Now Available) (ID 6070)

      11:00 - 11:10 AM  |  Author(s): S. Hong, W. Fang, Y. Huang, L. Zhang

      • Abstract
      • Presentation
      • Slides

      Background:
      Blockade of programmed death 1 (PD-1), or its ligand, PD-L1, could restore T-cell immunity. Anti-PD-1/ or anti-PD-L1 antibodies have demonstrated promising efficacy in the treatment of cancer patients. The toxicity spectrum of PD-1/PD-L1 blockers is distinct from chemotherapy or other target agents. Pneumonitis is one of the major side effects of these drugs, and reported incidences vary substantially between clinical trials. We tried to investigate the overall incidence and risk of treatment-related pneumonitis with anti-PD-1/PD-L1 therapies in cancer patients.

      Methods:
      A systematic search of literature up to January 2016 was performed in EDLINE, EMBASE, and Cochrane databases to identify relevant clinical trials. Paired reviewers independently selected articles for inclusion and extracted data. Incidence and relative risk (RR) of hypertension were calculated using a random-effects or fixed effects model, depending on the heterogeneity of the included studies.

      Results:
      A total of 23 clinical trials with 5333 patients were included. The overall incidence of all- and high-grade pneumonitis in cancer patients receiving anti-PD-1/PD-L1 therapies were 3.5% (95% CI, 2.9% to 4.3%) and 1.3% (95% CI, 1.1% to 1.9%), respectively. Anti-PD-1/PD-L1 antibodies were associated with a significantly increased risk of all-grade pneumonitis in patients with cancer with an RR of 5.47 (95% CI, 2.17 to 13.81; p<0.001) compared with controls. The risk of high-grade pneumonitis was also increased with the use of anti-PD-1/PD-L1 antibodies, though not statistically significant (RR 3.86; 95% CI 0.98 to 15.22; p=0.054).

      Conclusion:
      Patients with cancer receiving anti-PD-1/PD-L1 therapies have a significant risk of developing pneumonitis. Early and appropriate management is strongly recommended to avoid unnecessary dose reductions and transitory or definitive treatment discontinuations due to pneumonitis.

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      OA21.02 - ALK-Rearranged Non-Small Cell Lung Cancer is Associated with a High Rate of Venous Thromboembolism (Now Available) (ID 4290)

      11:10 - 11:20 AM  |  Author(s): A. Zer, M. Moskovitz, D.M. Hwang, A. Hershko-Klement, L. Fridel, G.J. Korpanty, E. Dudnik, N. Peled, T. Shochat, N. Leighl, G. Liu, R. Feld, R. Burkes, M. Wollner, M.S. Tsao, F. Shepherd

      • Abstract
      • Presentation
      • Slides

      Background:
      Patients with lung cancer are at increased risk for venous thromboembolism (VTE), particularly those receiving chemotherapy. It is estimated that 8-15% of patients with advanced non-small cell lung cancer (NSCLC) experience a VTE in the course of their disease. The incidence in patients with specific molecular subtypes of NSCLC is unknown. We undertook this review to determine the incidence of VTE in patients with ALK-rearranged NSCLC.

      Methods:
      We identified all patients with ALK-rearranged NSCLC, diagnosed and/or treated at the Princess Margaret Cancer Centre (PM CC) in Canada between July 2012 and January 2015. Retrospective data were extracted from electronic medical records. We then included a validation cohort comprising all consecutive patients with ALK-rearranged NSCLC treated in two tertiary centers in Israel.

      Results:
      Within the PM CC cohort, of 55 patients with ALK-rearranged NSCLC, at a median follow-up of 22 months, 23 (42%) experienced VTE. Patients with VTE were more likely to be Caucasian (p=0.006). The occurrence of VTE was associated with a trend towards worse prognosis (overall survival HR=2.88, p=0.059). Within the validation cohort (N=43), VTE rate was 28% at a median follow-up of 13 months. Combining the cohorts (N=98) the VTE rate was 36%. Patients with VTE were younger (age 52 vs 58, p=0.04) and had a worse ECOG performance status (p=0.04). VTE was associated with shorter OS (HR=5.71, p=0.01)Figure 1.



      Conclusion:
      We found the rate of VTE in our ALK-rearranged cohort is 3-5-fold higher than previously reported for the general NSCLC population. This warrants confirmation in larger cohorts.

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      OA21.03 - Unmet Needs in Physical and Emotional Side Effects during Lung Cancer Treatment and Survivorship (Now Available) (ID 4380)

      11:20 - 11:30 AM  |  Author(s): J. Bankhead, J.C. King, M. Rigney

      • Abstract
      • Presentation
      • Slides

      Background:
      Previous research has shown that supportive care needs in lung cancer patients are high and that this population may have significantly more unmet care needs than other cancer patients. Our goals for this study were to determine the most prevalent and problematic side-effects of lung cancer and lung cancer treatment in our community and to understand where both patients and caregivers felt there were unmet needs.

      Methods:
      A Community Needs Assessment survey was distributed to lung cancer patients and caregivers electronically between 11/9/2015 and 2/8/2016. 820 people responded, including 471 patients/survivors and 349 caregivers, 181 of whom identified as the primary caregiver. The overall completion rate was 72.6%, similar for both groups. Respondents identified all side effects they or their loved one experienced during and after treatment, as well as 5+ years after diagnosis. They also indicated which of these side-effects were most problematic during those time periods. Respondents were also for demographic information and for open-ended responses about their unmet needs during care and follow-up.

      Results:
      Respondents indicated a high rate of side effects, with over 95% reporting at least one. Importantly, both patients and caregivers reported that physical side effects were significantly more problematic during treatment but that emotional side effects were more problematic after treatment and in the long-term. Patients rated anxiety, fatigue, and shortness of breath as the most problematic short and long-term post-treatment side effects, with 18-29% of patients indicating these items at a particular time period. During treatment, gastrointestinal issues including constipation (18%), diarrhea (17%), and nausea (14%) were also identified as highly problematic side effects by the patients. Caregivers reported similar effects but also rated pain as problematic across all time periods (15-24%) and identified loss of appetite (28%) and weight loss (25%) during treatment. When questioned about unmet needs during treatment and survivorship, respondents frequently commented that their treatment team focused on treatment and survival and not on managing side effects.

      Conclusion:
      Side effect management is a clear unmet need for lung cancer patients and to help support their caregivers. Our data show high levels of emotional and physical side effects and a perceived lack of support for proper management. Notably, emotional side effects are prevalent after treatment for lung cancer into long-term survivorship and are frequently cited as the most problematic issue for those no longer in active treatment.

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      OA21.04 - Discussant for OA21.01, OA21.02, OA21.03 (Now Available) (ID 6950)

      11:30 - 11:45 AM  |  Author(s): N. Singh

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      OA21.05 - Wet M1a Non-Small Cell Lung Cancer: Is It Possible to Predict Recurrence of Pleural Effusion? (Now Available) (ID 5512)

      11:45 - 11:55 AM  |  Author(s): F.C. Abrao, I. Abreu, M.C. Oliveira, G.G. Viana, R.N. Younes

      • Abstract
      • Presentation
      • Slides

      Background:
      Pleural and oncological treatment options for malignant pleural effusion (MPE) are increasing and hence, more accurate prognosis at presentation may help to identify patients with the higher risk of pleural recurrence, in order to individualize more intensive treatment strategies. The aim of this study was to identify predictors of malignant pleural effusion recurrence in patients with M1a non-small cell lung cancer (NSCLC)

      Methods:
      All patients with NSCLC and MPE submitted to pleural palliative procedures including simple pleural drainage, videothoracoscopic pleural drainage, pleurodesis and indwelling pleural catheter were enrolled in a prospective study between 2014 and 2015, and divided into two groups. Group I included patients who had pleural recurrence, and Group II with no pleural recurrence after the palliative procedures. Prognostic factors for pleural recurrence were identified by univariate analysis, using Fisher's exact test for the analysis of categorical variables and Student’s t test for quantitative variables. Subsequently the significant variables were entered into a multivariate logistic regression analysis (with p< 0.05 considered significant). The cutoff points for any significant continuous variables were determined by receiver operating characteristics (ROC) analysis.

      Results:
      A total of 82 patients were included in the analysis. Median follow-up time for surviving patients was 81 days (range 1 to 1070 days). There were 15 patients (18.3%) in Group I and 67 patients (81.7%) in Group II. Univariate analysis of factors affecting postoperative recurrence were: adenosine deaminase concentration in pleural fluid < 16 mg/dl (p=0.04), albumin concentration in pleural fluid < 2.4 mg/dl (p= 0.03), administration of second-line palliative chemotherapy (p= 0.018) and type of procedure (simple pleural drainage vs. videothoracoscopic pleural drainage, pleurodesis and indwelling pleural catheter) (p= 0.023). At the multivariate analysis, only the type of procedure (simple pleural drainage)( p= 0.031) was identified as independent predictor of recurrence.

      Conclusion:
      In our cohort of NSCLC patients with MPE submitted to pleural palliative procedures, simple pleural drainage was the only significantly factor associated with recurrence of MPE. The identification of this factor may assist the choice of the optimal palliative technique, at the first episode of MPE in NSCLC patients. Definitive procedure as pleurodesis is recommended, the indwelling pleural catheter or videothoracoscopic drainage are options for patients whom lung are trapped.

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      OA21.06 - Turning Best Supportive Care into Active Care. A Service Development for Patients with Advanced Lung Cancer in NHS Fife, Scotland  (Now Available) (ID 4036)

      11:55 - 12:05 PM  |  Author(s): J.C.S. Bowden, C. Macpherson, S. Boyce, M. Lyell, S. Fenning, S. Scragg

      • Abstract
      • Presentation
      • Slides

      Background:
      In South East Scotland, 40% of patients with newly-diagnosed lung cancer are unfit for anti-cancer treatment and are for ‘best supportive care’ (BSC). Many more become for BSC following palliative anti-cancer treatment or disease relapse. But there is no consensus about what constitutes BSC and who should deliver it. Patients and families are left unclear about realistic goals of care, and about what support and follow-up they can expect. Given the typically short prognosis (2012 data from NHS Fife reveals a median survival of 73 days), rapidly changing needs and high risk of hospital admission, the lack of consistency in BSC can be a serious barrier to high quality end of life care. Therefore, Fife Specialist Palliative Care have developed and piloted a model of 'proactive best supportive care' for patients with incurable lung cancer and those close to them.

      Methods:
      The new model of best supportive care was based around the following framework: *Robust identification of all patients for BSC *Comprehensive palliative care assessment and care planning *Care coordination and follow-up Every assessment began with sensitive discussion about the lung cancer diagnosis and BSC. Detailed assessments of physical, psychological, practical and spiritual needs followed and immediate care plans were agreed. Where appropriate, anticipatory care planning was started. Structured letters were available online to all health professionals within two days. Patients were followed-up and supported for as long as they lived.

      Results:
      246 patients were supported by the new model of care during its first 15 months. Patients were assessed wherever they were. Most were assessed and followed-up at home or in the acute hospital, with a minority fit to attend clinic. Unnecessary outpatient appointments were cancelled. Patients and families appreciated the potential to maintain independence afforded by knowing where to access support when needed. The process of care coordination was not directly visible to them, but the quality of care it provided was deeply appreciated. Under the new model of care, patients spent significantly less time in the acute hospital before they died, with both length of stay and total bed days reduced by almost a third (comparisons with local data from 2012).

      Conclusion:
      A new model of proactive BSC in lung cancer has been successfully developed and piloted in NHS Fife. Patients and those close to them are now consistently supported from the point of diagnosis, with the impact of improved quality of care and more appropriate use of healthcare resources.

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      OA21.07 - Discussant for OA21.05, OA21.06 (Now Available) (ID 7101)

      12:05 - 12:20 PM  |  Author(s): E. Masel

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    YI01a - Clinical Trials & Scientific Mentoring (ID 414)

    • Event: WCLC 2016
    • Type: Young Investigator Session
    • Track: WCLC 2016
    • Presentations: 1
    • Now Available
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      YI01a.01 - How to Implement an Idea/Hypothesis into a Clinical Trial (Now Available) (ID 6735)

      08:00 - 08:20 AM  |  Author(s): C.A. Silva

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Last decades have shown an impressive advance in terms of biological knowledge in cancer. Traditional way to bring new ideas/hypotesis into clinical trials was overcoming by this fact. New agents directed against specific molecular targets have important impact in terms of response rate (RR), response duration (RD), progression free survival and eventually overall survival (OS) as well as quality of life (QoL). If you have an interesting idea/hypotesis, today you have to take on account several points that can exclude it. Select population becomes a very important issue. How to do this? Selecting a target, a tumor, both, other conditions? Following the tradition of research phases, Phase I refers to measure safety and pharmacokinetics assesing maximum tolerated dose (MTD) but a number of new agents have a non reachable MTD because they have a low toxicity. On the other hand, phase II refers to the assesing of efficacy in a certain tumor as well as safety, but, in the case of new agents you may select a tumor (as ussual), a specific target no matter wath tumor carry it (basket), or other conditions. In this phase measurement of response is important as a precedent of next phase trials and the challenge is the method you will use to do it. New inmunotherapeutic agents probably need a different way to do this. Also, to have predictive biomarkers for most of these agent will help to select the potential population that will achieve the more benefit and avoid futile toxicity and a waste of time and resources. We have to remember that biological effects not always means clinical benefit. Breaking barriers, for phase III comparator selection, primary and secondary end points as well as inclusion and exclusion criteria become a very important point and are different in the traditional way and in a proposed new way. OS is the gold standard end point but there are many more very important like PFS, RR, DoR, QoL. Again, measurement methods are very important and may be different related with biological mechanism and length of response for different agents than chemotherapy. As phase III trials select (include and exclude) patients troughout very strict criteria and there are some late toxicities that can be as important as the acute and subacute toxicities, phase IV trials are very important because they represent better the daily patient we see at office practice and is a powerfull pharmacovigilance mechanism. Sanctuaries have to be consider as far as the prevalent tumors have a very frequent involvement of Central Nervous System and these patient are mostly excluded from clinical trials at the beggining. Ethics is a fundamental point as far as the most important objective is the patient safety and treatment accesibility. If we went troughout these restriction points and our idea/hypotesis has survive, we can follow the development of trials around wasting less time and resources.

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