The following research abstracts in lung cancer were accepted by the Academy of Oncology Nurse & Patient Navigators for the 2018 Annual Conference. We congratulate the authors on their work and the impact they have had on the field of navigation.
Testing Telephone-Based Patient Navigation for Lung Cancer Screening in an Integrated Safety Net System
Simon Craddock Lee, PhD, MPH1,2; Heidi A. Hamann, PhD3; Magalis Z. Tijerina, BA1; Cynthia Ortiz, MPH1; Claudia Chavez, MBA1; Noel Santini, MD4; David E. Gerber, MD1,2
1University of Texas Southwestern Medical Center, Dallas, TX; 2Harold C. Simmons Comprehensive Cancer Center, Dallas, TX; 3University of Arizona Cancer Center, Tucson, AZ; 4Parkland Health and Hospital System, Dallas, TX
Background: While adherence to annual screening exceeded 90% in the National Lung Screening Trial, the trial population was disproportionately white, educated, and received care in the tightly controlled environment of a clinical trial. Rates of adherence in real-world settings are likely to be far lower. Low-dose computed tomography (LDCT)-based lung cancer screening represents a complex clinical undertaking that, for some patients, could require multiple referrals, appointments, and time-intensive procedures.1
We are conducting a pragmatic randomized controlled trial (N = 340) to determine the impact of telephone-based patient navigation on completion of the lung cancer screening process in a county-integrated health system.2 Algorithm-driven navigation involves instrumental (task-oriented or logistic) support to assist study participants with appointment scheduling, reminders, expenses, transportation, and other access to care and adherence issues.3 Patient navigators also provide emotional support, address patient-provider communication, manage cancer-related distress, and focus on quality of life.
Protocol approved by the UT Southwestern Medical Center Institutional Review Board (STU#122015-046), and by the Parkland Office of Research.
Objectives: To characterize navigation encounters by type and navigator-identified barriers and facilitators among those patients randomized to intervention (study accrual June 2017-June 2018) on standard-of-care referral to LDCT screening.
Methods: Research navigators, bilingual in English and Spanish, worked individually with study participants by telephone to educate, motivate, and empower participants to traverse the county health system. Navigators were trained using an abbreviated curriculum (~20 hours) adapted from GWU Cancer Institute.4 Navigators received supplemental training on motivational techniques and behavioral aspects of lung cancer screening, especially smoking cessation and modalities, as well as on patient resources specific to the county health system. Navigators make systematic contact with patients: initial intake; reminder (2-3 days prior to appointment); follow-up (3-7 days after scheduled appointment); and outreach (triggered by subsequent screening or diagnostic orders). We used both quantitative (EHR-derived trial database) and qualitative (navigator case tracking drawn from the database) methods.
Results: Of 318 patients enrolled at 12 months, 152 had been randomized to navigation. Intake calls averaged 4.9 minutes, with shorter reminder and follow-up calls (3.9; 2.3 minutes). Calls for subsequent procedures averaged 7.4 minutes. For all call types, Spanish language calls were ~30% longer. We found patient-reported barriers varied by screening process step. For example, reported lack of or failure to recall physician discussion of screening was common at intake. Patient motivation to complete screening appointment varied highly; many patients emphasized competing demands, including prevalent diagnoses, and limited transportation options. Although most current smokers were initially unresponsive or resistant to discussion of smoking cessation, uptake of referral to services and resources appeared to increase with navigation contact.
Conclusions: In an era of significant cost constraints, this randomized controlled trial of telephone-based patient navigation will provide key information on whether these services will strengthen lung cancer screening adherence and patient-reported outcomes. Indeed, sustainability of population adoption of CT screening for early detection of lung cancer may well hinge on the capacity of health systems to enable patients to complete all steps of this complex process.
References
- Gerber DE, Gillam AO, Hamann HA. Lung cancer screening in the “real world” and the role of nurse navigators. Journal of Oncology Navigation & Survivorship. 2013;4(2):21-23.
- Gerber DE, Hamann HA, Santini NO, et al. Patient navigation for lung cancer screening in an urban safety-net system: protocol for a pragmatic randomized clinical trial. Contemp Clin Trials. 2017;60:78-85.
- Lin CJ, Schwaderer KA, Morgenlander KH, et al. Factors associated with patient navigators’ time spent on reducing barriers to cancer treatment. J Natl Med Assoc. 2008;100:1290-1297.
- The GW Cancer Institute. Guide for Patient Navigators. A supplement to the Oncology Patient Navigator Training: The Fundamentals. https://smhs.gwu.edu/gwci/sites/gwci/files/Guide%20for%20Patient%20Naviga tors%20Final%20Jan%202016.pdf.
The Importance of Nurse Navigation in Lung Cancer Screening
Stephanie Hoopes, RN, BSN, OCN, HNB-BC; Gina Franco, MSN, ANP-C; Jo Weathers, RN, BSN, OCN, CBNC; Pam Cloys, MSN, ANP-C; LeAnn Perkins, MSN, APRN; Mark O’Rourke, MD; Patricia Leighton, MSN Ed, OCN, ONN-CG
Center for Integrative Oncology and Survivorship
Background: Lung cancer is the leading cause of cancerrelated death for men and women in the United States.1 An early detection of lung cancer was shown to directly correlate to lower mortality by the National Lung Screening Trial (NLST) results. The NLST showed a 20% decrease in mortality in those patients who had a low-dose CT (LDCT) scan of their chest compared with those who only had a chest x-ray. In 2015, Greenville Health System (GHS) created a multidisciplinary Lung Cancer Screening (LCS) program with the Center for Integrative Oncology and Survivorship (CIOS) as 1 of 2 portals of entry to provide a shared decision-making screening visit the Centers for Medicare & Medicare Services required. The nurse navigator is an invaluable part of the interdisciplinary team for the patients within the LCS program.
Objective: Nurse navigation was implemented within the LCS program at CIOS to increase initial screening, navigate patients through the process, provide the necessary education to patients and staff, and record and report data.
Methods: The multidisciplinary approach to LCS at GHS includes staff radiology, pulmonology, thoracic surgery, and CIOS. Primary care and specialists refer eligible patients to LCS, and their screening visit is provided by either CIOS or pulmonology. Patients then receive their LDCT at accredited radiology centers within the system. CIOS is a Screening Center of Excellence from the Lung Cancer Alliance. The data received from the LCS visits at CIOS are entered into REDCaps database to follow compliance. The nurse navigator at CIOS is a constant throughout the multidisciplinary process.
Results: LCS is one of many responsibilities of the nurse navigator at CIOS and takes approximately 25% of their time. The coordination of care the navigator provides at CIOS allows appropriate patients to be screened, educated, receive timely results, and get appropriate referrals to other disciplines as needed.
Conclusions: The LCS program has grown and thrived at CIOS with the support of the nurse navigator. Numerous disciplines within the health system, including primary care, financial counseling, and radiology, depend on the navigator for questions and support. The patient also can depend on the navigator for education within the shared decision-making visit about screening, risks and benefits, and smoking cessation and beyond with result phone calls, information on incidental findings, and referrals to appropriate specialists. The navigator, alongside the nurse practitioner, works with the multidisciplinary team to ensure continuity of care within the 2 departments providing screening visits. Discussions on how to expand the program and have navigation for LCS in outlying areas of the health system are already underway. Although some barriers exist, the LCS program is an innovative approach to preventive health measures, including consistent monitoring, adherence, and promotion of screening. It allows for patient tracking, early detection, and standardization of follow-up care for patients within the department and other specialties.
Reference
- American Cancer Society. Lung Cancer Prevention and Early Detection. www.cancer.org/cancer/lung-cancer/prevention-and-early-detec tion.html. 2018.
Expanding Multidisciplinary Lung Conference in Rural/Regional North Carolina
Kimberly Cobb, RN, BSN1; Hope Gibson, RN2
1Chest Center of the Carolinas, FirstHealth of the Carolinas; 2Scotland Cancer Treatment Center, Scotland Healthcare System
Background: Multidisciplinary care conferences for lung cancer patients have been linked to both increased quality of care and timeliness of care.1 The Chest Center Conference was established at FirstHealth Moore Regional Hospital in 2004 to encourage multidisciplinary discussion and to expedite treatment planning for patients with lung and esophageal cancer. Lung cancer patients who are treated at Scotland Cancer Treatment Center (SCTC) are frequently referred to Moore Regional Hospital pulmonology or thoracic surgery services for diagnosis and/or treatment. To improve the communication between hospitals, expanding the Chest Center Conference to SCTC via teleconferencing was proposed.
Objective: Ensure seamless comprehensive lung cancer care and an optimal patient experience by improving communication between providers at 2 community cancer centers.
Methods: To incorporate SCTC physicians/staff into Chest Center Conference discussions, our IT Department was contacted to establish videoconferencing via Webex. A projector was added that would focus on the screen, allowing the participants to view the imaging and pathology images in real time. A conference call was established at the beginning of each conference to allow for easy flow of conversations during the conference.
Our Health Information Management Department was consulted to ensure that HIPAA requirements were met. Anonymized conference summary sheets were faxed to Scotland Cancer Center prior to the start of the conference, and patients were referred to only by initials during discussion. Imaging was viewed without identifiers. The project was piloted in July 2016.
Results: A comparison of patients presented at Chest Center Conference in 2015 (514 patients) and 2017 (519 patients) did not show that video conferencing with SCTC affected patient volume. However, anecdotally, patient care was often expedited through the interdisciplinary approach.
Mr JG underwent 2 nondiagnostic bone biopsies. His films were reviewed by pulmonology, radiology, and pathology at multidisciplinary conference, and diagnostic thoracentesis with cell block for diagnosis and possible placement of pleural catheter for management of recurrent pleural effusion was recommended, alleviating an additional specialist consultation.
Mr BS was diagnosed with squamous cell lung cancer. A review at Chest Center Conference allowed for in-depth pulmonary evaluation to include lung perfusion scan, cardiopulmonary exercise testing, and cardiothoracic surgical evaluation. The patient was not a surgical candidate, but an expeditious evaluation allowed the patient to be treated earlier with combined-modality chemoradiation.
Conclusions: Ensuring that patients receive quality comprehensive lung cancer care is essential. Patients in rural and regional areas do not have easy access to larger, university-based cancer centers due to a myriad of factors. By expanding multidisciplinary lung cancer conferences to another institution in the same regional area, additional patients will receive the clinical benefit of a multidisciplinary approach.
Reference
- Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. The effects of a multidisciplinary care conference on the quality and cost of care for lung cancer patients. Ann Thorac Surg. 2015;100:1834-1838.
CheckMate 227: Nivolumab + Ipilimumab vs Platinum-Doublet Chemotherapy as First-Line Treatment for Advanced Non–Small Cell Lung Cancer (NSCLC) with High Tumor Mutational Burden (TMB)
David E. Gerber1; Martin Reck2; Matthew D. Hellmann3; Luis Paz-Ares4; Hossein Borghaei5; Julie Brahmer6; Kenneth J. O’Byrne7; Prabhu Bhagavatheeswaran8; Faith Nathan8; Suresh S. Ramalingam9
1UT Southwestern Medical Center, Dallas, TX, USA; 2Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany; 3Memorial Sloan Kettering Cancer Center, New York, NY, USA; 4Hospital Universitario Doce de Octubre, Madrid, Spain; 5Fox Chase Cancer Center, Philadelphia, PA, USA; 6Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA; 7Princess Alexandra Hospital, Brisbane, Queensland, Australia; 8Bristol-Myers Squibb, Princeton, NJ, USA; 9Winship Cancer Institute, Emory University, Atlanta, GA, USA
Background: CheckMate 227 (NCT02477826) is a large phase 3 study of first-line nivolumab or nivolumab-based regimens vs chemotherapy in advanced NSCLC.
Objectives: Here we report results from Part 1, including a preplanned coprimary end point evaluating progression-free survival (PFS) of nivolumab + ipilimumab vs chemotherapy in patients with high TMB (≥10 mut/Mb), safety of nivolumab + low-dose ipilimumab, and patient-reported outcomes (PROs).
Methods: Patients (N = 1739) with chemotherapy-naive, stage IV/recurrent NSCLC without known sensitizing EGFR/ALK alterations were randomized 1:1:1 to nivolumab (3 mg/kg every 2 weeks [Q2W]) + ipilimumab (1 mg/kg Q6W), nivolumab monotherapy (240 mg Q2W), or chemotherapy for patients with ≥1% tumor programmed death-ligand 1 (PD-L1) expression and to nivolumab + ipilimumab, nivolumab (360 mg Q3W) + chemotherapy, or chemotherapy for patients with <1% tumor PD-L1 expression. Coprimary end points were overall survival for nivolumab + ipilimumab vs chemotherapy in patients with PD-L1–selected tumors and PFS (blinded independent central review) for nivolumab + ipilimumab vs chemotherapy in patients with high TMB ≥10 mut/Mb. TMB was determined from tumor tissue using the FoundationOne CDx assay. Safety analyses included time to onset and time to resolution of select treatment-related adverse events (select TRAEs; those with a potential immunologic cause) and corticosteroid use. PROs were assessed using the Lung Cancer Symptom Scale and EQ-5D instruments.
Results: Minimum follow-up was 11.2 months. PFS was significantly longer with nivolumab + ipilimumab vs chemotherapy in patients with high TMB ≥10 mut/Mb (HR = 0.58 [97.5% CI, 0.41-0.81]; P = .0002); results were consistent across subgroups, including PD-L1 expression and tumor histology. Rates of TRAEs leading to discontinuation were 17% with nivolumab + ipilimumab and 9% with chemotherapy. Grade 3/4 TRAEs were reported in 31% and 36% of patients treated with nivolumab + ipilimumab and chemotherapy, respectively. Grade 3/4 select TRAEs by category with nivolumab + ipilimumab included hepatic (8%), endocrine (4%), and skin (4%), and were consistent with previous reports. Median time to onset of select TRAEs ranged from 2 to 15 weeks, and the majority resolved (median time to resolution, ≤10 weeks). PRO results will be reported in the final presentation.
Conclusions: First-line nivolumab + ipilimumab significantly prolonged PFS vs chemotherapy in patients with NSCLC and high TMB ≥10 mut/Mb regardless of PD-L1 expression. These results validate the role of TMB as a biomarker for the use of nivolumab + ipilimumab in first-line NSCLC. Safety of nivolumab + low-dose ipilimumab was manageable.
Prior Presentation at Congress: Abstract is an adaptation from data originally presented in part at the 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL, USA, and the American Association for Cancer Research Annual Meeting, April 14-18, 2018; Chicago IL, USA. The adapted abstract has been submitted to: German Society for Hematology and Medical Oncology 2018, International Association for the Study of Lung Cancer Latin America Conference on Lung Cancer 2018, Sociedad Española de Oncología Médica 2018, and American Society of Clinical Oncology Quality Care Symposium 2018.
Health Status in Patients with Small Cell Lung Cancer Treated with Nivolumab Alone or Combined with Ipilimumab: CheckMate 032
Andrea Ardizzoni,1 Anna F. Farago,2 Akin Atmaca,3 Emiliano Calvo,4 Fiona Taylor,5 Bryan Bennett,6 Giovanni Selvaggi,7 Anne Pieters,7 John R. Penrod,7 Yong Yuan,7 D. Ross Camidge8
1S. Orsola-Malpighi University Hospital, Bologna, Italy; 2Massachusetts General Hospital, Boston, MA, USA; 3Institut für Klinisch–Onkologische Forschung (IKF), Frankfurt am Main, Germany; 4START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; 5Adelphi Values, Boston, MA, USA; 6Adelphi Values, Bollington, Cheshire, UK; 7Bristol-Myers Squibb, Princeton, NJ, USA; 8University of Colorado, Denver, CO, USA
Background: CheckMate 032 (NCT01928394) is an open-label, phase 1/2 trial evaluating the efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab in patients with advanced or metastatic solid tumors. In this study, nivolumab alone or in combination with ipilimumab showed durable responses, encouraging survival, and manageable safety in patients with small cell lung cancer (SCLC) that progressed after ≥1 previous platinum-containing regimens.
Objectives: An exploratory objective of the study is to describe changes in patient-reported health status using the EuroQoL-5 Dimensions (EQ-5D) instrument.
Methods: The EQ-5D visual analog scale (VAS; scale: 0-100 [worst-best health]; minimally important difference [MID] = 7) was assessed in the treatment period at baseline (week 1 prior to study drug administration) and then every 2 weeks in the nivolumab (3 mg/kg) arm and at baseline and then every 3 weeks in the nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) arm through week 13, and in both arms at subsequent tumor assessments (every 6 weeks until week 24 and every 12 weeks thereafter). After treatment discontinuation, the EQ-5D was assessed at follow-up visits 1 and 2, and at survival visits. EQ-5D VAS mean and mean within-patient change from baseline were estimated at each assessment. Time to first deterioration (TTD) in health status was also evaluated.
Results: In the nivolumab (n = 245) and nivolumab plus ipilimumab (n = 156) arms, EQ-5D VAS completion rates were 90% and 85%, respectively, at baseline and remained ≥60% at the last assessment (≥5 patients/arm; weeks 97 and 121, respectively). Baseline mean EQ-5D VAS scores for the nivolumab and nivolumab plus ipilimumab arms were 67.1 and 65.2, respectively, and similar to a lung cancer population norm (68). With monotherapy, EQ-5D VAS mean within-patient changes from baseline suggested health status stability while on treatment (estimated changes <MID). With the combination, stability was suggested through week 37 (n = 24 at this time point); 4/6 subsequent assessments (through week 109) suggested improvements from baseline (estimated changes ≥MID). Mean EQ-5D VAS scores increased over time, approximating the general population norm (80.05) in the nivolumab and nivolumab plus ipilimumab arms from weeks 37 and 49 onward, respectively. Additional data, including TTD, will be presented.
Conclusions: Preliminary EQ-5D VAS results from CheckMate 032 showed that on-treatment health status
in patients with recurrent SCLC remained stable with nivolumab and improved (ie, increases in scores exceeded the MID) with nivolumab plus ipilimumab. For patients remaining on treatment for ≥6 months, mean EQ-VAS scores in both arms trended toward the population norm.
