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Janet Freeman-Daily
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MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Diego Villalón, Christina Sit
- Coordinates: 9/09/2019, 15:45 - 17:15, Amsterdam (2011)
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MA22.03 - The ROS1ders: Partnering to Drive Research and Improve Outcomes in ROS1+ Cancers (Now Available) (ID 2751)
15:45 - 17:15 | Presenting Author(s): Janet Freeman-Daily
- Abstract
- Presentation
Background
ROS1 fusions are found in a dozen types of cancer. However, these fusions are rare, occurring in a small fraction of patients (e.g.,1%-2% of non-small cell lung cancer). The small population hampers gathering sizeable patient cohorts and investment in medical research. The ROS1ders are a group of patients and caregivers dealing with ROS1-positive (ROS1+) cancer who strive to better outcomes for all ROS1+ cancers by supporting patients and caregivers, increasing awareness and education, accelerating research, and improving access to effective diagnosis and treatment.
Method
We created a private ROS1+ Facebook group for sharing personal information and support among patients and caregivers. We created a public Facebook group for outreach. We launched a website at ROS1cancer.com to share sourced information about ROS1 drugs, clinical trials, expert clinicians, and research developments as well as patient blogs and tips for living with our disease. We attended medical conferences and met with cancer advocacy organizations, clinicians, researchers, and industry; we collectively began working on projects to accelerate research into our disease through the Global ROS1 Initiative. We are active in developing and implementing our projects as well as serving as fundraisers and the ROS1+ public face.
Result
The ROS1ders is the largest cohort of ROS1+ patients and caregivers ever collected. We add new members weekly, and have grown to include 400+ members from 28 countries. We network with ROS1+ communities who communicate in languages other than English in Europe, China and Japan. Expert ROS1 clinicians collaborate with us to ensure we provide accurate information about our disease in our Facebook groups and our website. ROS1+ patients have donated fresh tissue and pleural fluid specimens to the ROS1 Cancer Model Project to create cell lines and patient-derived xenograft (PDX) mice; the resulting cell lines have been shared with several institutions in academia and industry. We have contributed data to an epidemiological study. We are collaborating to develop a registry-based study of blood clots in ROS1+ and other lung cancer patients. Some ROS1ders are developing new projects in their home countries.
Conclusion
The ROS1ders are breaking new ground, sharing current information, collecting data and biospecimens from ROS1+ patients, and enabling research and development of treatments for our cancer in ways that were not possible before. The Global ROS1 Initiative is truly a partnership between patients, caregivers, advocacy organizations, clinicians, researchers, and industry.
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P1.14 - Targeted Therapy (ID 182)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.14-29 - Disrupting the Paradigm: Partnering with Oncogene-Focused Patient Groups to Propel Research (ID 1498)
09:45 - 18:00 | Presenting Author(s): Janet Freeman-Daily
- Abstract
Background
Genomic alterations drive more than 60% of adenocarcinoma cases of non-small cell lung cancer (NSCLC). About 20% of cases will have an oncogenic driver (EGFR, ALK, ROS1, BRAF, NTRK, etc.) that can be treated with approved targeted therapy drugs, and more (RET, Exon 20 insertions, etc.) have clinical trial options. Patients and caregivers dealing with these cancers have organized globally into oncogene-focused groups (“Groups”—see Table 1) and are building partnerships that seek to provide support, increase awareness and education, accelerate and fund research, and improve access to effective diagnosis and treatment.
Method
We partnered in a variety of ways to accelerate research. While each Group sets its own research priorities, we’ve found successful collaborative research has the following seven characteristics. It includes patients from the start, in all aspects of the project. It addresses questions meaningful to patients. It develops patient-centered measurements. It accommodates patients’ clinical realities. It leverages social media and patient groups. It shares progress with participants frequently. It makes results rapidly and freely available.
Result
These methods have enabled the Groups to collaborate successfully with clinicians, researchers, advocacy organizations, and industry to generate ideas for next steps in research for their disease, forge new studies and clinical trials for a specific oncogenic driver, create new patient-derived models of oncogene-driven cancers to study acquired resistance, develop registry-based studies to collect real-world data, and guide patients to clinical trials.
Conclusion
Oncogene-focused patient-caregiver groups are creating new paradigms across the research continuum. They have demonstrated that their partnerships with advocacy organizations, clinicians, researchers, and industry, can increase available patient-derived models, patient data, and specimens among geographically distributed, oncogene-driven cancer populations.
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PC01 - Reinventing Clinical Trials (ID 83)
- Event: WCLC 2019
- Type: Pro-Con Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Ivy Elkins, Jose Luis Gonzalez Larriba
- Coordinates: 9/09/2019, 11:00 - 12:30, Seoul (2007)
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PC01.04 - Lung Cancer Patients Should Have Better Access to Clinical Research: Relax the Eligibility Criteria (Now Available) (ID 3558)
11:00 - 12:30 | Presenting Author(s): Janet Freeman-Daily
- Abstract
- Presentation
Abstract
Clinical trials are essential for improving treatment of cancer patients. However, only 2%-3% of adult cancer patients participate in clinical trials, and many trials close because they do not enroll enough patients. Others are slow to accrue patients, which prolongs the time required to obtain results. Those trials that meet accrual goals often have cohorts that don’t reflect the demographics or performance status of the real-world population of patients who have the disease.
Why do trials have trouble enrolling enough patients? Some of the significant barriers to clinical trial participation stem from over-restrictive trial eligibility criteria. Unger et al (2019) found 21.5% of patients did not enroll in a clinical trial because they were not eligible. A Kaiser Permanente study of non-small cell lung cancer patients found 80% of the patients were not eligible for two NSCLC treatment studies.
Trial eligibility must balance opposing factors. It must be narrow enough to ensure the effect of the treatment can be determined, yet broad enough that the population of patients is meaningful. Researchers often use “common” eligibility criteria without giving due consideration to how those criteria may impact trial recruitment and the real-world applicability of their study. A population of younger patients with no health issues other than lung cancer might make it easier to identify the effect of the experimental treatment, but this population gives no real insight into how the treatment affects the typical population of lung cancer patients (which has an average age of 71).
Recommendations to modernize eligibility criteria have been recently published by a joint effort of the American Society for Clinical Oncology and Friends of Cancer Research, as well as the US Food and Drug Administration and the National Cancer Institute. The recommendations include relaxing restrictions on brain metastases, minimum age, HIV/AIDS, organ dysfunction, and prior and concurrent malignancies while ensuring patient safety.
Other aspects of a trial may cause patients to decide not to enroll even if they meet the eligibility requirements. Locations of trial sites might require the patient to travel, yet the patient might not be able to afford time or cost of travel, or their insurance might not cover treatment at any trial site. The trial protocol may prohibit certain previous treatments, or require weeks of washout from previous tyrosine kinase inhibitor (TKI) treatments (which raises the possibility of TKI flare).
Preliminary evidence shows that relaxing trial eligibility requirements could result in a greater number of patients becoming eligible for clinical trials. Harvey et al (2019) conducted a retrospective study of 10,500 CancerLinq records of patients with lung adenocarcinoma. They found 47.7% of patients were excluded from clinical trials by traditional exclusion criteria (no brain metastases, no other malignancies, and creatinine clearance greater than 60 mL/minute), while only 1.5% of patients were excluded by the ASCO-Friends recommended expanded criteria that removed these restrictions.
Relaxing clinical trial eligibility while maintaining safety is in the best interest of the patient. Patients are not for clinical trials. Clinical trials are for the patient.
References:
Gore, L, et al. (2017). "Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group." Journal of Clinical Oncology 35(33): 3781-3787
Harvey RD, et al. (June 2019). “Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.” Presentation at ASCO Annual Meeting 2019, Chicago, IL. https://meetinglibrary.asco.org/record/178360/abstract
Jin, S, et al. (2017). "Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015." Journal of Clinical Oncology 35(33): 3745-3752.
Lichtman, SM, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group." Journal of Clinical Oncology 35(33): 3753-3759.
Lin, NU, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Brain Metastases Working Group." Journal of Clinical Oncology 35(33): 3760-3773.
Sharpless NE, Doroshow JH. “Modernizing Clinical Trials for Patients With Cancer.” JAMA. Published online January 23, 2019. 321(5):447–448. doi:10.1001/jama.2018.18938
Uldrick, TS, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research HIV Working Group." Journal of Clinical Oncology 35(33): 3774-3780.
Unger JM, Hershman DL, Fleury ME, Vaidya R. “Association of Patient Comorbid Conditions With Cancer Clinical Trial Participation.” JAMA Oncol. Published online January 10, 2019 5(3):326–333. Doi:10.1001/jamaoncol.2018.5953
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
