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E. Bachrach Makovsky
Moderator of
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ORAL 12 - Quality of Life and Trials (ID 96)
- Event: WCLC 2015
- Type: Oral Session
- Track: Advocacy
- Presentations: 8
- Moderators:E. Bachrach Makovsky, C. Malnati
- Coordinates: 9/07/2015, 10:45 - 12:15, 708+710+712
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ORAL12.01 - Priority of Daily Life v's Medical Care Challenges for Lung Cancer Patients and Carers (ID 2632)
10:45 - 12:15 | Author(s): A. McNamara, W. Boerckel, A. Van Eijk
- Abstract
- Presentation
Background:
People living with lung cancer (LC), LC survivors and carers are impacted by LC in different ways. The Global Lung Cancer Coalition (GLCC) recognises lung cancer patients’ and carers’ isolation and the challenges they face (GLCC, 2015). However for those affected by LC, limited data exists on the priority of their challenges, their ability to cope with these challenges and if enough relevant information and support is available. Identifiable variances between patient and carer experience and how challenges differ based on gender, age and nationality are also unknown. In 2013, The GLCC and Boehringer Ingelheim collaborated to create a global survey to identify these priorities and variances.
Methods:
A unique web-based survey was designed to isolate the single greatest challenge faced by individuals affected by LC. 200 specific and globally relevant challenges were identified by LC experts from the GLCC, grouped into categories and illustrated, with a small text descriptor. At survey entry, respondents identified their greatest challenge relevant to either daily life or medical care. Via an associated illustration, respondents chose subsequent sub-categories of challenges until one specific challenge was identified as the most significant. Respondents answered 3 questions in relation to that challenge regarding 1) availability of information 2) ability to cope 3) level of support required. Screening was conducted for age, gender, treatment and nationality. Respondents were asked to identify if they were living with LC, a LC survivor or a carer. The survey was available in 11 languages and promoted through the GLCC, LC clinicians, charities and associated support groups.
Results:
2871 individuals visited the survey site. 725 (25%) completed the survey. 64% of LC patients chose a daily life challenge as their most significant, compared to a medical care challenge (36%); 55% of carers also chose a daily life challenge, compared to a medical care challenge (45%). Of all participants who chose daily life, 19.8% identified emotional and/or social needs as the most significant sub-topic, 14.8% identified survivorship/ caring for myself; 13.8% body image and 7.6% stigma. Of all participants who chose medical care, 20.5% identified diagnosis as the most significant sub-topic; 18.9% identified treatment planning & options; 14.9% receiving treatment and 10.2% end of life issues. 56.2% of individuals who chose one of the top 16 challenges (n=589, 81% of all participants) requested more information about the challenge identified.
Conclusion:
Psychosocial issues related to daily life and a lack of relevant information posed some of the greatest challenges to LC patients. LC patients were more likely to identify daily life issues such as dealing with emotional needs, self-care, body image or changing relationships as their greatest challenge rather than medical care issues such as diagnosis, treatment planning or screening. Lung cancer patients have the right to have the enormous burden of lung cancer acknowledged by professional carers, policy makers and the general public (GLCC, 2015). Daily life challenges should be identified and alleviated as part of routine LC care to ensure LC patients and carers receive the necessary spectrum of support and information.
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ORAL12.02 - The PACE Continuous Innovation Indicators<sup>TM</sup>: A New Tool to Objectively Measure Progress and Identify Unmet Needs in Lung Cancer Treatments (ID 582)
10:45 - 12:15 | Author(s): S. Paddock, L. Brum, K. Sorrow, S. Thomas, S. Spence, C. Maulbecker-Armstrong, C. Goodman, M. Peake, G. McVie, J. Ferguson, D. Grainger, R.M. Li
- Abstract
- Presentation
Background:
Over the past decades, researchers have evaluated numerous treatment options for lung cancer with varying degrees of success. The stepwise nature of innovation in this process has made it difficult to assess progress across different therapeutic areas. Stakeholders therefore frequently disagree about the extent of past achievements, the current greatest unmet needs, and priorities for future efforts. In an effort to bridge this gap, Lilly Oncology’s Patient Access to Cancer care Excellence (PACE) initiative developed the Continuous Innovation Indicators[TM ](CII): a robust tool to generate consistent measures of progress in cancer treatments with flexibility to accommodate different cancer subtypes and treatment modalities.
Methods:
Trained analysts review references from the primary literature and record statistical measures of relevant outcomes in a standardized format called “Pieces of Evidence.” A Value Matrix classifies each Piece of Evidence by its therapeutic goal, creating a map of available treatments across different stages of disease. A transparent algorithm then tallies these records and generates Evidence Scores (E-Scores), a novel measure of progress over time. Analyses can be weighted by therapeutic goals or restricted to specific disease subtypes or classes of treatment. The Indicators currently contain data on non-small cell lung cancer (NSCLC) and 11 other solid tumors.
Results:
The first data release of the CII demonstrates steady progress in the development of chemotherapeutic agents against NSCLC, particularly since 1990 (Panel A). Analysis of the data by histological subtype reveals relatively greater progress against non-squamous compared to squamous NSCLC (Panel B). Data from the CII further indicate the relative contributions to progress against NSCLC from different classes of treatment (Panel C). Aligning progress curves with drug approval dates allows us to better understand how the value of new treatments evolves over time (Panel C). Importantly, the CII highlight a critical unmet need in NSCLC (Panel D): there are no curative therapies for regional or metastatic disease supported by current evidence.Figure 1
Conclusion:
Through the use of treatments in multiple classes and combinations, steady progress has been made against NSCLC. Still, pressing unmet needs remain. By offering a standardized and comprehensive approach, the Continuous Innovation Indicators[TM] can help researchers, policymakers, and advocates objectively understand past progress and current needs of NSCLC in a broader context. A link to the public interface is available on the PACE Continuous Innovation website at: https://pacenetworkusa.com/continuousinnovation.php.
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ORAL12.03 - The Predictors and Effects of Explicit and Implicit Attitudes Against Lung Cancer (LC) (ID 1459)
10:45 - 12:15 | Author(s): T. Ma, J. Schiller, J. Tian, H. Dickson, C. Smith, Y. Xie
- Abstract
- Presentation
Background:
LC may be associated with negative societal perceptions compared to other cancers. This study measured the explicit, conscious attitudes (EAs), implicit, unconscious attitudes (IAs) and implicit stereotypes of LC relative to breast cancer (BC), explored the demographic factors associated with the explicit and implicit biases in LC, and whether these biases affect the LC drug treatment rates.
Methods:
EAs were derived from participants (Ps) [cancer patients (n = 493), caregivers (n = 1332), healthcare providers (HCPs, n = 623), and the general public (n = 1356)] ratings about how patients with LC and BC “do feel” (descriptive attitudes) or “ought to feel” (normative attitudes) about their disease. IAs and implicit stereotypes were measured with the Implicit Association Test (IAT). Analysis of covariance (ANCOVA) was used to assess the demographic factors associated with bias toward LC. Linear regressions were performed to analyze the association between the biases against LC and LC treatment rates across different states in the United States.
Results:
Females (p < 0.001), higher income (p = 0.015), and people reporting themselves with more knowledge about cancer disease (p < 0.001), caregivers (p = 0.008), and whites (p < 0.001) expressed stronger negative descriptive attitudes toward LC. Males (p = 0.007), and higher income (p = 0.010) expressed less-positive normative attitudes toward LC. Females (p < 0.001), higher education (p = 0.003), non-cancer patient participants (p = 0.019), and whites (p = 0.031) had stronger negative IAs about LC. State-level analysis showed that the lower drug treatment rates for LC patients are significantly associated with older patients population (p = 0.011) and higher percentage of government as payer (p = 0.023). State-level analysis shows no significant association between IAT scores and LC treatment rates.
Conclusion:
Explicit and implicit bias against LC compared to BC was associated with gender, education, income levels and cancer knowledge, but not treatment rates.
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ORAL12.04 - Discussant for ORAL12.01, ORAL12.02, ORAL12.03 (ID 3402)
10:45 - 12:15 | Author(s): M. Weitz
- Abstract
- Presentation
Abstract not provided
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ORAL12.05 - Impact of Time to Drug Approval on Potential Years of Life Lost: The Compelling Need for Improved Trial and Regulatory Efficiency (ID 1547)
10:45 - 12:15 | Author(s): D.J. Stewart, A.A. Stewart, P. Wheatley-Price, G. Batist, H. Kantarjian, J. Schiller, M. Clemons, J. Bradford, L. Gibbons, R. Kurzrock
- Abstract
- Presentation
Background:
Survival of incurable cancer patients is improving gradually. Several hundred new therapies are under development. However, internationally, regulatory complexity slows progress by increasing drug development costs (hence, fewer drugs can be assessed with available resources) and by producing numerous speed bumps that delay approval of useful drugs and that increase resources required to document that other agents are ineffective.
Methods:
We assessed cancer therapies undergoing phase III trials between 2001 and 2015. To be included, trials had to document statistically significant improvement in overall survival. We excluded adjuvant trials and trials in uncommon malignancies. To determine the number of life-years potentially lost per year required for drug approval, we multiplied the improvement in median survival in years by the estimated number of patients (North American and worldwide) dying annually from the relevant malignancy.
Results:
In the Table, we present the life-years lost per year required for approval for 21 therapies in 10 malignancies. When the combined impact of all tumor sites and drugs are considered together, there were 29 life-years lost in North America per hour of delay in therapy approval (1 for every 2 minutes of delay) and 260 life-years lost worldwide per hour of delay (1 for every 14 seconds of delay). These numbers do not take into account impact of drugs non-evaluable due to cross-over or missing survival data, drugs that were prematurely abandoned, drugs still undergoing investigation, or approaches for non-malignant lethal diseases. Figure 1
Conclusion:
Clearly, the survival gains associated with the foregoing drugs are only modest. Despite this, there would be a large negative impact associated with approval delays even if factors such as co-morbidities, performance status, ability to pay, etc, limit the number of patients treated to a fraction of the total dying from a specific malignancy. There are numerous opportunities to improve efficiency of cancer drug approval without sacrificing safety or data integrity. This requires urgent attention.
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ORAL12.06 - Trial Eligibility of NSCLC Patients Receiving Proton Therapy: Are Cooperative Group Trials Being Designed for the Right Patients? (ID 2759)
10:45 - 12:15 | Author(s): M. Dunn, B. Hoppe, C.B. Simone
- Abstract
- Presentation
Background:
Participation in oncology clinical trials has historically been low compared to the number of individuals diagnosed with cancer each year. It has been reported that between 3% and 5% of adults with cancer participate in clinical trials. However, research into this statistic usually focuses on the reasons why patients choose not to participate, rather than whether or not clinical trials are designed adequately to capture a proper patient sample truly representative of the population being studied. This study explored a sample of lung cancer patients who received treatment with proton therapy and compared the group to the eligibility requirements of two lung cancer trials. We hypothesized that most patients treated with proton therapy would not be eligible to participate in the currently accruing cooperative group studies.
Methods:
The Proton Collaborative Group’s (PCG) prospective registry was mined for information on all lung cancer patients who received proton therapy between the years of 2010 and 2015. These patients were then evaluated to determine if they would have been eligible to participate in either of the two active cooperative group clinical trials for proton therapy currently enrolling patients with inoperable stage II-IIIB non-small cell lung cancer (NSCLC): PCG LUN005 (phase I/II trial of hypofractionated proton therapy) and RTOG 1308 (phase III trial randomizing to protons versus photons).
Results:
A total of 244 consecutive patients with lung cancer were available in the registry for evaluation. Patients were ineligible for LUN005 and RTOG 1308 due to exclusionary stage (n=77), histology (n=37), performance status (n=66), prior surgery for lung cancer (n=53), and/or prior radiation therapy (RT) for lung cancer (n=53). Of the remaining 55 patients, 27 were enrolled in the PCG registry prior to LUN005 or RTOG 1308 opening for accrual. This left 28 patients. Those patients were ineligible for the following reasons: prior chemotherapy (n=3), prior RT within the treatment field (n=3), prior cancer (n=6), weight loss (n=2), outdated procedures (n=2), oxygen dependence (n=1), disease progression prior to RT start (n=2), or not felt to be an upfront candidate for concurrent chemotherapy and RT (n=2). This left 7 patients who were ultimately eligible for enrollment, one of which refused trial participation and one of which the reason for not participating was unknown. Reasons for lack of enrollment of the 5 remaining patients on LUN005 were due to administrative issues (ex: protocol enrollment on hold pending interim review), whereas RTOG 1308 was unavailable for those patients at their treating center.
Conclusion:
The vast majority of patients treated with proton therapy for lung cancer on PCG’s prospective registry were not eligible for participation cooperative group trials. Given the high ineligibility rate among patients found in this study, pragmatic trials with more inclusive eligibility criteria are needed to better mirror the general population of patients with newly diagnosed, locally advanced NSCLC. More inclusive trials may allow for increased rates of trial participation and further advances and improvements in survival.
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ORAL12.07 - Twitter: Is There an Opportunity to Improve Participation in Lung Cancer Clinical Trials? (ID 2467)
10:45 - 12:15 | Author(s): M. Sedrak, R.B. Cohen, R.M. Merchant, M.M. Schapira
- Abstract
- Presentation
Background:
Twitter is a social media platform that may improve clinical trial awareness and enrollment. Little is known about current communication on Twitter regarding clinical trials.
Methods:
We searched the keyword “lung cancer” in Twitter messages from January 5 - 21, 2015. Duplicate and non-English tweets were excluded. Randomly selected tweets were independently evaluated for content and user type by two coders (kappa=0.71). An exploratory analysis was conducted on tweets regarding lung cancer clinical trials. Differences in user type by content were evaluated by Pearson’s chi square test.
Results:
We found 26,059 tweets with the keyword “lung cancer” from 10,039 unique users with 72,239,356 followers, including 15,346 unique tweets. We randomly selected 1,516 (10%) as the study cohort. Table 1 summarizes tweet categories and Table 2 shows tweet content by user type. Most of the dialogues focused on support and prevention. 221 (15%) of tweets were about clinical trials. 92 (42%) were from individuals, such as patients, health advocates, health providers and non-health users (p-value < 0.001). Of clinical trial tweets, 183 (83%) concerned therapeutic trials, 28 (13%) non-therapeutic, and 10 (4.5%) basic research. 144 (65%) of the therapeutic clinical trial tweets concerned immunotherapy. Most of the 183 therapeutic clinical trial tweets, 158 (86%), had embedded-links directing users to news articles. Only 1 tweet linked to a recruitment website with patient enrollment information.Table 1. Lung cancer tweets by content type
Tweet categories Frequency, N (%) Support 358 (24) Prevention 357 (24) Miscellaneous (non-health related) 256 (17) Clinical Trials 221 (15) Treatment 86 (6) Diagnosis 78 (5) General Information 69 (4) Screening 53 (3) Symptoms 38 (2) Table 2. Lung cancer tweets by user type
Tweet categories Individual Organization News Media Support 258 28 42 Prevention 210 50 74 Miscellaneous 221 6 11 Clinical Trials 92 48 71 Treatment 48 13 17 Diagnosis 35 15 26 General Information 23 33 8 Screening 19 23 9 Symptoms 26 1 7
Conclusion:
A significant proportion (15%) of lung cancer tweets concern clinical trials and are from individuals. Most of these tweets focus on immunotherapy. Our data suggest that Twitter represents a contemporary medium that could connect patients and other interested individuals with information about clinical trials, including links on screening and enrollment. The ubiquity of current social media use and our findings suggest that tailored messages about clinical trials on Twitter could have utility, improve awareness, trial referral and perhaps enrollment.
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ORAL12.08 - Discussant for ORAL12.05, ORAL12.06, ORAL12.07 (ID 3533)
10:45 - 12:15 | Author(s): D. Sturges
- Abstract
- Presentation
Abstract not provided
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