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Rudolf M Huber
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MA 04 - Advocacy: Listen to the Patients (ID 655)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Patient Advocacy
- Presentations: 11
- Moderators:Rudolf M Huber, C.L. Dégi
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 313 + 314
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MA 04.01 - Prospective Comparative Evaluation of Patient and Caregiver Perspectives on a Multidisciplinary Model of Lung Cancer Care (ID 10279)
11:00 - 11:05 | Presenting Author(s): Matthew P Smeltzer | Author(s): K.D. Ward, F.E. Rugless, N.R. Faris, M.A. Ray, B. Jackson, C. Foust, A. Patel, M. Meadows, N. Boateng, K. Roark, F. Crossley, G. Oliver, L. McHugh, W. Hastings, O. Osborne, J. Osborne, T. Ill, M. Ill, R.S. Signore, R. Fox, E.T. Robbins, Raymond U. Osarogiagbon
- Abstract
- Presentation
Background:
Coordinated multidisciplinary (MD) lung cancer care, with all key specialists concurrently providing early input to develop a consensus care plan in collaboration with patients and their caregivers, may improve patient-centered outcomes over the usual serial care (SC) model, but needs rigorous evaluation.
Method:
Prospective, longitudinal study comparing newly-diagnosed lung cancer patients receiving MD vs. SC within the same US healthcare system. The MD intervention was implemented from lung cancer care initiation until definitive treatment decision. After that, both cohorts of patients received their actual cancer treatments within the same environments. At baseline and 6 months, patients completed treatment-related satisfaction measures from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and the Functional Assessment of Cancer Therapy- Lung (FACT-L) quality of life instrument. All measures were coded so that larger scores are better. Time-specific comparisons were made with the Wilcoxon-Mann-Whitney test and changes from baseline to 6 months were compared between MD vs. SC patients in mixed linear models.
Result:
The 463 patients who participated (156 MD, 307 SC) were similar in sex and health insurance. MD cohort was slightly older (69 v 66 years), with more racial minorities (37% v 29%). Patients receiving MD care reported greater satisfaction with the treatment plan (p=0.0266) and overall quality of care (p<0.0010) at 6 months. Additionally, satisfaction with the treatment plan showed greater improvement over time for MD vs. SC (p-value for trend=0.0046). SC patients showed more improvement in satisfaction with overall care than MD patients, but did not reach the level of satisfaction of MD patients at 6 months (p-value for trend=0.0018). Caregivers of MD patients perceived receiving better quality of care compared to other lung cancer patients than caregivers of SC patients (p=0.0049). Caregiver satisfaction did not differ between MD and SC in the communication measures or overall quality, and did not have significant differences in the trend over time. Patient reported Health-Related Quality of Life (HRQOL) improved from baseline to 6 months for the lung cancer-specific scale compared with no change with SC (p-value for trend= 0.0334). Other HRQOL scales were similar between groups
Conclusion:
Compared with SC patients, MD patients experienced improved lung cancer-specific HRQOL and greater satisfaction with both treatment plan and quality of care received. MD patients’ caregivers were more likely than SC patients’ caregivers to think their care was better than that of other patients.
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MA 04.02 - Assessing the Psychosocial Needs of Newly Diagnosed NSCLC Patients: Identifying the Population Most At-Risk (ID 8345)
11:05 - 11:10 | Presenting Author(s): Bonnie Leung | Author(s): H. Naik, J. Laskin, J. Wu, R. Mackenzie, A. Bates, C. Ho
- Abstract
- Presentation
Background:
The Psychosocial Screen for Cancer (PSSCAN-R) questionnaire and the Canadian Problem Checklist (CPC) are validated screening tools used to identify the psychosocial needs of patients with cancer. The questionnaire identifies at-risk patients requiring timely psychosocial intervention and the CPC comprises of patient-reported support needs in 6 psychosocial domains. The study goal was to review reported needs of patients with NSCLC to facilitate the development of programs and resources specific to those identified as at-risk for psychosocial distress.
Method:
All patients with NSCLC referred to BC Cancer Agency centres from 2011-2015, who completed a prospective PSSCAN-R and CPC questionnaire at the time of their first visit, were included in the study. Demographics and baseline disease characteristics were collected retrospectively. Univariate analysis using the Chi-squared test and Fisher’s exact test were used to compare patient groups based on gender, age and stage of disease.
Result:
4313 patients completed the PSSCAN-R and CPC questionnaire. The median age was 70 (21-99), with 50% female and 51% of patients with stage IV disease. 29% of patients live alone with 13% having lost their spouse/partner. However, 93% of patients report regular contact with friends/relatives and 85% have someone who can provide assistance with daily tasks (shopping, cooking, transportation). Female patients, patients aged 65 or younger, and those with advanced disease were more likely to report significantly higher levels of anxiety and depression, and reported higher number of needs on the CPC. Figure 1
Conclusion:
Newly diagnosed patients with NSCLC report clinically higher levels of anxiety and depression and have greater number of concerns in multiple psychosocial domains. Resources should be developed for lung cancer patients based on their care needs with careful consideration of patients' age, gender and disease stage to optimally support their psychosocial needs during treatment and follow up.
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MA 04.04 - Discussant - MA 04.01, MA 04.02, MA 04.03 (ID 10862)
11:10 - 11:25 | Presenting Author(s): Kathy Weber
- Abstract
- Presentation
Abstract not provided
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MA 04.05 - The Impact of the Meso Foundation on Advocacy Efforts for Funding Mesothelioma Research (ID 7462)
11:25 - 11:30 | Presenting Author(s): M. Kotizan | Author(s): Gleneara Elizabeth Bates, J. Mostel, Mary Hesdorffer
- Abstract
- Presentation
Background:
The Mesothelioma Applied Research Foundation is the nonprofit collaboration of patients and families, physicians, advocates, and researchers dedicated to eradicating the life-ending and vicious effects of mesothelioma. The Meso Foundation’s Advocacy Program objective is to obtain federal funding for mesothelioma research.
Method:
An analysis was performed of the Meso Foundation’s advocacy efforts and grant funding from years 2000- 2015.
Result:
The Meso Foundation has funded 103 projects from 8 countries for a total awarded amount of 9.8 million dollars. From 2000- 2015, the Meso Foundation grant program has funded research that has produced over 240 publications in peer reviewed journals. As a direct result of Foundation advocacy, the Department of Defense has awarded a total of $12.4 million to mesothelioma research since 2008. The Meso Foundation’s grant program has funded the basic science research that helped lay the groundwork for several mesothelioma clinical trials. A few of the more notable trials include the measles virus and the WTI Vaccine. Several of the proposals funded by Meso Foundation grants have extended to global levels through presentations at international conferences including but not limited to International Association for the Study of Lung Cancer (IASLC), American Society of Clinical Oncology (ASCO), and American Association for Cancer Research (AACR).
Conclusion:
Through actively engaging members of congress, the Meso Foundation has successfully advocated for increased funding for mesothelioma research. The Meso Foundation is committed to leveraging the knowledge we gain from our own research, as well as discoveries made by our collaborations with academic institutions and industry partners to work toward the development of innovative treatments and care platforms for mesothelioma patients and their families.
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MA 04.06 - Developing a Lung Cancer Clinical Quality Registry Framework to Collect Longitudinal Patient-Reported Outcomes (ID 8197)
11:30 - 11:35 | Presenting Author(s): Mary Duffy | Author(s): N. Moloczij, K. Gough, David L Ball, Ben J Solomon, L. Mileshkin, M. Krishnasamy
- Abstract
- Presentation
Background:
When captured by psychometrically-sound patient-reported outcomes measures (PROMs), patients’ appraisals of their symptoms, quality of life and functional status can provide powerful data to better inform clinicians about the impact of health conditions and the consequences of medical care. Reviewing and reporting on integrated PROMs alongside clinical data may translate to health service improvements and efficiencies. There are, however, many challenges including the need to find sustainable and cost-efficient methods for the routine collection of PROMs across the whole patient journey. This two-phase study set out to develop a lung cancer clinical quality registry framework to collect longitudinal patient-reported outcome measures. Phase 1 focused on the development of the data collection framework and phase 2 sees a 12-month implementation and mixed-method evaluation of the feasibility of implementing the framework. We will report on development of the framework and provide preliminary results on the implementation phase.
Method:
The development phase utilised a formative evaluation method to decide on essential aspects of the PROMs framework. Specifically, a Delphi process was employed to seek consensus on PROMs to administer and the schedule of assessments, with a specific focus on clinical relevance and feasibility of administration. The first Delphi round consisted of individual interviews with lung cancer clinical experts to generate a list of domains to be included in the PROMs. In the second round, aggregated results were presented to the panel and domains of interest were considered alongside PROMs meeting minimum measurement standards. Then, four patients previously treated for lung cancer were invited to provide feedback on the content of PROMs and data collection methods.
Result:
From Delphi findings, it was determined that the EORTC QLQ-C30 and the lung cancer-specific module (QLQ LC13) would be administered at baseline and two, six and 12 months after baseline, and a brief social isolation measure (PROMIS) would be administered at baseline only. A clearly defined subset of patients about to commence chemo-radiation treatment for lung cancer was chosen for the implementation phase and commenced on October 31 2016. To date, 74% (14/19) of eligible patients have been recruited thus far. Preliminary data indicate high adherence to baseline assessments (100%). Adherence is much lower at two months (50%), with non-adherence frequently due to side effects or ill health (38%).
Conclusion:
Identifying and deciding which PROMs to collect, the overall purpose of PROMs collection, data completeness and utility requires careful consideration and evaluation to determine framework sustainability.
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MA 04.07 - Understanding Patient Barriers to Utilization of Low Dose CT Lung Cancer Screening (ID 9624)
11:35 - 11:40 | Presenting Author(s): Cherie Parungo Erkmen | Author(s): F. Dako
- Abstract
- Presentation
Background:
Despite evidence that lung cancer disproportionately affects minority populations, there is a paucity of data describing the impact of lung cancer screening. Results of NLST may not be generalizable to all populations given that 91% of the participants were Caucasians. Further study of lung cancer screening in a diversity of racial and ethnic groups is a necessary step in the implementation of lung cancer screening. Before underrepresented populations can be screened, community perceptions about lung cancer screening must be explored and barriers to screening must be identified. The purpose of our study was to identify potentially correctable barriers to obtaining LDCT for lung cancer screening in a diverse, but predominantly African American population.
Method:
We developed a questionnaire consisting of 22 items. Five questions assessed patient demographics including socioeconomic status and insurance coverage. Two questions assessed patient access and utilization of health care. Three questions assessed smoking history and prevalence in interpersonal relationships. One questions assessed patient concern about lung cancer. Two questions measured patient knowledge about lung cancer. One question addressed patient willingness to go to a doctor’s appointment to learn more about lung cancer screening. One question elicited whether LDCT had been mentioned by a healthcare provider. Six questions assessed awareness and knowledge about LDCT lung cancer screening. One question addressed reasons for non-adherence to appointments.
Result:
The questionnare was complete by 100 patients. Almost all of our patients reported having health insurance and a primary care doctor (96%). 50% of patients are current or former smokers. 83% are current or former smokers or have friends and/or family members who are heavy/long time smokers. 90% of patients knew that smoking is the most common cause of lung cancer. 56% of patients know that lung cancer can be treated successfully at least sometimes. 81% of patients reported to be at least somewhat concerned that they or someone they know can die of lung cancer. 87% of patients are willing to go to a doctor’s appointment to learn more about lung cancer screening. 100 % of patients reported to have not heard about LDCT from their doctors. The average score was 2/6 (33%) on items accessing knowledge about lung cancer screening. Cost was the most frequently reported reason (52%) for nonadherence to appointments.
Conclusion:
Our study was able to identify potentially correctable barriers to utilization of low dose CT lung cancer screening such a lack of primary care support and perceived cost.
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MA 04.08 - Discussant - MA 04.05, MA 04.06, MA 04.07 (ID 10863)
11:40 - 11:55 | Presenting Author(s): Andrea Katalin Borondy Kitts
- Abstract
- Presentation
Abstract not provided
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MA 04.09 - A Study on the Damage of Passive Smoking to Japanese Lung Cancer Patients (ID 8789)
11:55 - 12:00 | Presenting Author(s): Kazuo Hasegawa | Author(s): T. Yamaoka, Satoko Kono, H. Nakahara
- Abstract
- Presentation
Background:
Japan’s measures to prevent passive smoking are considered to be among the world’s worst. Creating smoke-free environments is an urgent task for Japan as it prepares to host the 2020 Tokyo Olympics and Paralympics Games. In spring of 2017, discussions on a draft bill to strengthen measures against passive smoking were stalled due to opposition from within the ruling party. One lawmaker remarked that “(Cancer patients) don’t have to work”, indicating that patients can choose their occupation and avoid secondhand smoke as they wish. Against this backdrop, the Japan Lung Cancer Alliance conducted a survey on damage by secondhand smoke to cancer patients. Based on the survey’ result, this study aims to shed light on the problems experienced by lung cancer patients including the impact of secondhand smoke on their employment.
Method:
For 5 days from 28 May to 1 June 2017, a survey by questionnaires was conducted on lung cancer patients. The announcement of the survey was made by ten patient advocacy groups.
Result:
There were 231 responses, among which valid responses were 215. 91 percent of the respondents considered passive smoking “unpleasant” due to fears or anxieties for recurrence of lung cancer and/or hatred. It was found that among those respondents who were employed at the time of the survey, about 31 percent had been exposed to secondhand smoke at their workplace, and 4.2 percent had quitted their job. Not only at the work place, 6.2 percent of the respondents were exposed to the secondhand smoke at home, event after they were diagnosed as lung cancer.
Conclusion:
It is understood that working cancer patients worry about recurrence of cancer and/or hatred. Moreover, the experiences of those lung cancer patients who had left their job because of passive smoking reveal a lack of the freedom to choose their occupation. The urgent countermeasure is also required to prevent the passive smoking at home. Japan’s delay in adopting measures against passive smoking appears be related to an insufficient level of understanding in the society about difficulties faced by cancer patients. It is hoped that this study will draw attention to the damage by passive smoking to lung cancer patients and foster international support for the advocacy of legislation enacting stricter measures.
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MA 04.10 - An Assessment of the Willingness to Provide Serial Bio-Specimens: Experience from an Irish Tertiary Cancer Centre (ID 10076)
12:00 - 12:05 | Presenting Author(s): Anne-Marie Baird | Author(s): N.M. Keegan, Martin P Barr, S. Fishleder, A.F. Idris, E. Harrold, P. O'Kelly, E. Duff, S. Lim, M. O'Donnell, D.J. Gallagher, C. Grant, J. Kennedy, D.M. O'Donnell, S. Sukor, C.P. O'Brien, Stephen P Finn, S. Cuffe
- Abstract
- Presentation
Background:
The rising imperative to improve our understanding of cancer heterogeneity and individualised drug response has led to a high demand for biopsy material. With improvements in technologies, there is now a move away from more traditional tissue based sampling to liquid based biopsies. ‘Liquid biopsies’ provide a non-invasive means for molecularly profiling patients with cancer, thus benefiting patients and clinicians in terms of treatment choice and shared decision-making. We assessed the willingness of patients to undergo repeated tissue and/or ‘liquid’ based sampling.
Method:
Detailed questionnaires, assessing patients’ perceptions of, and willingness to undergo serial biopsies were distributed to ambulatory patients at a tertiary cancer referral centre (St. James’s Hospital, Dublin). Multivariate analysis was performed using ordinal logistic regression analysis.
Result:
The questionnaire response rate was 97% (247/255). Respondents were primarily female (73%), aged between 51-70 yrs (51%), with breast (39%), colorectal (16%), oesophagogastric (13%), and lung cancer (12%). Of those that responded, repeat biopsy of an easily accessible lesion was acceptable to 203 (82%) patients if recommended by an oncologist. However this reduced to 102 (41%) patients, if the purpose was solely for clinical trial. Acceptability decreased to 168 (68%) and 81 (33%) patients respectively for more invasive biopsies. Additionally, 79 (32%) patients were willing to undergo additional biopsy for research purposes only, with 54 (21%) patients uncertain of its utility in research. Lower performance status (OR=0.44, p=0.04) and the belief that biopsy was unimportant for research (OR=0.74, p=0.04) negatively impacted on willingness to undergo biopsy, while a prior invasive biopsy increased acceptance (OR=1.02, p=0.02). In terms of blood sampling, 82% of patients would consent to repeated blood sampling over the course of their treatment, with >5 samples considered acceptable by 51.5% of patients. Patients with lung cancer had 3.38 greater odds (OR=3.38, p=0.047) of consenting to a repeated blood sample for purely research purposes (compared to any other type of cancer); however their willingness to undergo repeat biopsy was similar to that of other patients (OR=1.99, p=0.129). Data analysis is currently on-going.
Conclusion:
Patients with cancer are willing to participate in serial sampling of blood and urine but are less likely to consent to repeated tissue biopsies. Patients with lung cancer were particularly amenable to repeated blood sampling compared to patients with other cancer types. This is significant given the recent data supporting the use of ‘liquid’ biopsy for real-time monitoring of resistance mutations and treatment response dynamics in patients with lung cancer.
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MA 04.11 - A Comprehensive Vision to Reduce Lung Cancer Stigma: Changing Cultural Perspectives on Lung Cancer (ID 9507)
12:05 - 12:10 | Presenting Author(s): Angela Meredith Criswell | Author(s): Maureen Rigney, J.L. Studts
- Abstract
- Presentation
Background:
Lung cancer stigma has wide-reaching effects and impacts treatment, quality of life, survival, societal attitudes, research funding, and advocacy efforts. Those affected by lung cancer commonly feel hopeless, isolated, reluctant to share their diagnosis in addition to feelings of guilt, shame, anxiety and depression. Stigma responses can hinder information seeking information related to treatment options and psychosocial support and, tragically, can cause delays in diagnosis and even refusal of treatment. Major pan-cancer organizations, those dedicated to all lung diseases as well as lung cancer-specific organizations conduct awareness raising campaigns designed to confront lung cancer stigma, all working in some measure to create a more compassionate and empathic environment for those at-risk and diagnosed. These efforts have not been coordinated and to date, no known comprehensive vision to address lung cancer stigma in its entirety has been developed.
Method:
HIV/AIDS and mental health advocates have devoted extensive efforts to developing coordinated stigma reduction plans. While not always applicable, their approaches can inform our efforts in lung cancer. To develop a comprehensive framework to address lung cancer stigma, a synthesis of relevant strategies used in other disease-states, a review of lung cancer stigma literature and exploration of the efforts of organizations and individuals from around the world was conducted.
Result:
Awareness-raising, myth-busting and public health advocacy are featured prominently in other stigma-reduction plans. Lung cancer, like HIV/AIDS and other smoking-related cancers, must also address nihilism from medical professionals and work to ensure non-judgmental discussions and compassionate treatment environments that explore appropriate treatment options become the norm. Founded on seven key areas of opportunity, the plan includes multiple areas of impact that need to be addressed. Included are suggested remediation methods and real-world examples from all over the globe to illustrate creative ways lung cancer stigma reduction can be approached. This comprehensive, multi-level, multi-pronged vision allows individuals, systems and organizations to find points of convergence and work collaboratively on addressing the stigma so closely associated with lung cancer.
Conclusion:
Through a comprehensive approach, lung cancer stigma can be reduced and ultimately eliminated. To initiate a global conversation and better unite the lung cancer community, we offer this unifying strategy to address lung cancer stigma. Through the menu of stigma-reduction strategies, we hope to spark conversation, collaboration, and convergence. Dedicated medical professionals, survivors, loved ones, advocacy organizations and others can use the vision to apply appropriate strategies in their regions/countries and work collaboratively toward this all-important goal.
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MA 04.12 - Discussant - MA 04.09, MA 04.10, MA 04.11 (ID 10864)
12:10 - 12:25 | Presenting Author(s): Sita Andarini
- Abstract
- Presentation
Abstract not provided
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Author of
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OA 05 - Next Generation TKI (ID 657)
- Event: WCLC 2017
- Type: Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:James Chih-Hsin Yang, Fiona Blackhall
- Coordinates: 10/16/2017, 15:45 - 17:30, Room 301 + 302
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OA 05.05 - Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Updated Efficacy and Safety Results From ALTA, a Randomized Phase 2 Trial (ID 8027)
16:30 - 16:40 | Author(s): Rudolf M Huber
- Abstract
- Presentation
Background:
Brigatinib, a next-generation ALK inhibitor, recently received accelerated approval in the United States for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. We report updated data from the randomized phase 2 trial (ALTA; NCT02094573), which was designed to investigate the efficacy and safety of 2 brigatinib regimens in patients with crizotinib-refractory, advanced ALK+ NSCLC.
Method:
Patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib and randomized 1:1 to receive brigatinib at 90 mg qd (arm A) or 180 mg qd with a 7-day lead-in at 90 mg (arm B). Investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1 was the primary endpoint.
Result:
Among 222 patients (n=112/n=110, arm A/B), median age was 51/57 years; 71%/67% had brain metastases. As of February 21, 2017, 17 full months since the last patient enrolled, median follow-up was 16.8/18.6 months and 32%/41% of patients continued to receive brigatinib in A/B. The table shows brigatinib efficacy. Per independent review committee, confirmed ORR was 51%/55% and median PFS was 9.2/16.7 months in A/B. Among patients with measurable baseline brain metastases (n=26/n=18, A/B), confirmed intracranial ORR was 50%/67% as of January 24, 2017; median intracranial DoR was not reached/16.6 months. The most common treatment-emergent adverse events (TEAEs) were: nausea (38%/47%, A/B), diarrhea (28%/44%), cough (28%/40%), headache (30%/35%), and vomiting (36%/30%); the most common grade ≥3 TEAEs were: increased creatine phosphokinase (5%/13%), hypertension (6%/8%), pneumonia (4%/5%), and increased lipase (5%/4%). Dose reduction (9%/30%, A/B) or discontinuation (4%/11%) due to TEAEs was reported.
Conclusion:
In ALTA, brigatinib continues to show substantial efficacy and acceptable safety at both dose levels, with numerically longer PFS and higher intracranial ORR at the recommended dosing regimen of 180 mg qd (with lead-in) vs 90 mg qd.Investigator Assessment Independent Review[a] Arm A (n=112) Arm B (n=110) Arm A (n=112) Arm B (n=110) Confirmed ORR, % 46 (35–57[b]) 55 (44–66[b]) 51 (41–61[c]) 55 (45–64[c]) Median DoR in responders,[d] months 12.0 (9.2–17.7[c]) 13.8 (10.2–17.5[c]) 13.8 (7.4–NR[c]) 14.8 (12.6–NR[c]) Median PFS,[d] months [% of events] 9.2 (7.4–11.1[c]) [65] 15.6 (11.1–19.4[c]) [50] 9.2 (7.4–12.8[c]) [54] 16.7 (11.6–NR[c]) [41] Median OS,[d] months [% of events] NR (20.2–NR[c]) [38] 27.6 (27.6–NR[c]) [29] — — 1-year OS probability,[d ]% 70 (61–78[c]) 80 (71–87[c]) — — DoR, duration of response NR, not reached OS, overall survival PFS, progression-free survival [a]Last scan date: February 28, 2017 [b]97.5% CI for primary endpoint [c]95% CI [d]Kaplan-Meier estimate
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-001 - Depth of Target Lesion Response to Brigatinib and Its Association With Outcomes in Patients With ALK+ NSCLC in the ALTA Trial (ID 8035)
09:30 - 09:30 | Author(s): Rudolf M Huber
- Abstract
Background:
Depth of target lesion response to crizotinib has been associated with overall survival (OS) (J Clin Oncol 2016;34:abstract 2590). ALTA (NCT02094573) is an ongoing randomized phase 2 trial of brigatinib, an ALK inhibitor, in crizotinib-refractory advanced ALK+ NSCLC patients. As the ALTA primary endpoint of confirmed objective response rate (cORR), a binary outcome, might not fully capture clinical benefit, we examined the association of maximum decrease in target lesions with progression-free survival (PFS) and OS.
Method:
Patients were randomized to receive brigatinib at 90 mg qd (arm A; n=112) or 180 mg qd with a 7-day lead-in at 90 mg (arm B; n=110). Arms were pooled in this analysis. Patients with any target lesion shrinkage were sorted into 4 groups based on greatest decrease from baseline per RECIST v1.1; outcomes in these groups were compared with outcomes in patients with no shrinkage.
Result:
As of February 21, 2017, cORR in arm A/B (ITT population) was 46%/55% per investigators. 201/222 patients had ≥1 evaluable response assessment with 18.4-month median follow-up. Median age of these patients was 53 years; 57% were female. Patients with target lesion shrinkage (vs none) had numerically longer PFS (hazard ratios [95% CIs]: 0.61 [0.30–1.22], 1%–25% shrinkage; 0.47 [0.24–0.91], 26%–50%; 0.54 [0.28–1.05], 51%–75%; 0.30 [0.15–0.63], 76%–100%) and numerically higher estimated 1-year OS (Table). In a multivariable analysis, 76%–100% shrinkage (vs none) was independently associated with longer PFS/OS (hazard ratios [95% CIs]: 0.37 [0.18–0.76]/0.35 [0.14–0.89]); arm B (vs A) was independently associated with longer PFS.
Conclusion:
In this exploratory post hoc analysis, brigatinib-treated patients with target lesion shrinkage, including those without confirmed partial response, had improved PFS/OS vs patients without shrinkage. Patients with the deepest response (76%–100% shrinkage) appeared to have the longest PFS and higher estimated 1-year OS.Best Target Lesion Shrinkage n (%)[a] Median PFS,[b,c] Months (95% CI) Median OS,[b ]Months (95% CI) 1-year OS,[b ]% (95% CI) None 18 (9) 3.7 (1.9–11.0) 8.3 (4.7–NR) 48 (22–99) 1%–25% 40 (20) 9.3 (4.0–21.2) NR (14.5–NR) 75 (58–99) 26%–50% 60 (30) 12.8 (9.2–15.7) NR (NR–NR) 82 (70–99) 51%–75% 44 (22) 11.1 (7.4–18.2) 27.6 (20.2–NR) 77 (62–99) 76%–100% 39 (19) 19.5 (12.6–NR) NR (22.3–NR) 92 (78–99) NR, not reached [a]Evaluable patients [b]Kaplan-Meier estimate [c]Per investigator
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P1.01-004 - Hypertension With Brigatinib: Experience in ALTA, a Randomized Phase 2 Trial in Crizotinib-Refractory ALK+ NSCLC (ID 8346)
09:30 - 09:30 | Author(s): Rudolf M Huber
- Abstract
Background:
The next-generation ALK inhibitor brigatinib received accelerated approval in the United States in April 2017 for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. Hypertension has been identified as an adverse event of interest with brigatinib treatment based on prior clinical data; here, we report incidence, management, and outcomes of hypertension in ALTA (NCT02094573).
Method:
In ALTA, 222 patients were randomized 1:1 to receive brigatinib at 90 mg qd (arm A; n=112 randomized, n=109 treated) or 180 mg qd with a 7-day lead-in at 90 mg (arm B; n=110 randomized and treated). A medical history of hypertension was allowed, but patients with significant, uncontrolled, or active cardiovascular disease were excluded. Blood pressure (BP) was measured at screening, on days 1, 8, and 15 of the first 28-day cycle, and then every 4 weeks (starting on day 1 of cycle 2).
Result:
Median age was 50/57 years in treated patients in A/B; 22%/25% of treated patients in A/B had a history of hypertension at baseline. As of February 21, 2017, hypertension was reported as a treatment-emergent adverse event (TEAE; any grade) in 17%/27% of patients (A/B) and as a grade 3 TEAE in 6%/8%; no grade 4 hypertension was reported. Few patients had dose interruptions (1%/2%, A/B) or reductions (1%/1%) due to hypertension; no patients discontinued brigatinib due to hypertension. Among patients with hypertension, median time to onset of first hypertension TEAE was 5.8 months/2.1 months in A/B. Among patients with baseline systolic BP <120 mmHg (n=50/n=48, A/B), 20%/42% had a maximum shift to 140–159 mmHg postbaseline (6%/10%, <120 mmHg to ≥160 mmHg); among patients with baseline diastolic BP <80 mmHg (n=68/n=72, A/B), 29%/35% had a maximum shift to 90–99 mmHg postbaseline (10%/8%, <80 mmHg to ≥100 mmHg). Among patients with hypertension TEAEs (n=19/n=30, A/B), 84%/80% started a new antihypertensive medication during the study. Among patients with hypertension TEAEs and no medical history of hypertension (n=11/n=20, A/B), 73%/70% started a new antihypertensive medication during the study. Cardiovascular events in patients with hypertension TEAEs included: angina pectoris in 1 patient without a medical history of hypertension and, in patients with a medical history of hypertension, hypertensive retinopathy (n=1), intermittent claudication (n=1), and peripheral artery stenosis (n=1).
Conclusion:
Hypertension was observed frequently with brigatinib, and appeared dose-related, but was managed with antihypertensive therapy and rarely led to dose modification or discontinuation.
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P1.07 - Immunology and Immunotherapy (ID 693)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.07-019 - Immune Cell Infiltrates in Non-Small Cell Lung Cancer and Interleukin-22 Expression (ID 9238)
09:30 - 09:30 | Presenting Author(s): Rudolf M Huber
- Abstract
Background:
In non-small cell lung cancer (NSCLC) the TNM staging remains standard for prognostic assessment and therapy decisions. Nevertheless, stage-specific outcomes vary significantly, indicating a need for additional prognosticators.Lymphocytic infiltrates are found in 6-11% of NSCLC patients and associated with a significant increase in disease-free and overall survival (OS). We now want to assess T cells and PD-L1[+] cells in tissue microarrays (TMAs) cored at the invasive margin (IM) and tumor center (CT) via multispectral imaging. We asked the question of their link to interleukin-22 (IL-22). Furthermore, we want to elucidate the role of IL-22 in prognosis, therapy response and recurrence.
Method:
TMAs were generated from formalin-fixed paraffin embedded tissue of 89 curatively resected patients with stage IA-IIIA NSCLC. TMAs included each 3 cores from CT and IM, selected from areas with the most dense lymphocytic infiltrates. Immunolabelling followed mIHC technique for PD-L1, CD8, CD3, FoxP3, CD163 and Cytokeratin. IL-22 expression was analyzed by immunohistochemistry (double-staining: IL-22, CD3).
Result:
We could show that the ratio of CD8[+] cells in CT compared to IM is significantly higher in stage I than stage II/III NSCLC. A similar pattern was seen for CD3[+], but not for ratios of PD-L1[+], FoxP3[+] or CD163[+]. Based on the CT/IM ratios of CD8[+] and PD-L1[+] we established an 'Invasive Score' ranging from 0–2. A Score of 0 (low CD8, low PD-L1) had a median OS of 45 months. A score of 1 (high CD8 or PD-L1) had a median OS of 53 months. A score of 2 (high CD8 and PD-L1) had a 62% survival rate at 72-months: Combining the rate of CD8 T cell infiltrates with PD-L1 positivity in the tumor is a stronger predictor for survival than one based only on CD8 CT/IM ratio. We will now combine these results with the IL-22 expression and present the respective progression free and OS data.
Conclusion:
Multispectral assessment of CD8 and PD-L1 performed on “hot-spots” NSCLC does show a clear correlation with clinical outcome: A tumor-controlling immune response appears to be associated with the permeability of the tumor to CD8 cells. This is consistent with other reports that immune infiltrates are associated with improved outcome. Current studies are seeking to verify these findings in a larger cohort of patients with NSCLC. *Authors Stump and Reu contributed equally to this study. Supported by the Harder Family, Lynn and Jack Loacker, Robert W. Franz, Wes and Nancy Lematta, the Murdock Trust and Providence Medical Foundation.
