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C.S. Cleeland
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MA 18 - Global Tobacco Control and Epidemiology II (ID 676)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
- Presentations: 1
- Moderators:H. Kawai, Christian Klaus Manegold
- Coordinates: 10/17/2017, 15:45 - 17:30, Room 511 + 512
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MA 18.08 - Assessment of Baseline Symptom Burden in Treatment-Naïve Patients with Lung Cancer (ID 10246)
16:30 - 16:35 | Author(s): C.S. Cleeland
- Abstract
- Presentation
Background:
While most cancer therapies are associated with toxicities, a major component of cancer treatment is to reduce cancer-related symptoms and impairment of function. Assessing how well this goal is achieved is dependent on accurate assessments of baseline symptoms prior to initiation of therapy. The objectives of this study were to describe the symptom burden of treatment-naïve lung cancer patients and to examine demographic and disease factors that correlate with symptom severity.
Method:
Symptom data from 460 treatment-naïve patients with lung cancer were obtained using the validated MD Anderson Symptom Inventory via a 0-10 numeric rating scale. Descriptive statistics were used to summarize patient demographic and clinical characteristics. Differences in symptom severity, symptom interference and quality of life by disease stage and histology were examined using either t-test or ANOVA. Multiple linear regression analysis was performed using age, gender, tumor stage and histology to determine significant predictors of pain and shortness of breath.
Result:
The most severe symptoms were fatigue, disturbed sleep, distress, pain, shortness of breath, sadness and drowsiness. About 62% of patients had at least one moderate to severe (rated 5 or greater) symptom, while 48% had at least one severe (rated 7 or greater) symptom. Disturbed sleep, distress, shortness of breath, sadness, and drowsiness were reported to be severe by at least 16% of the patients. As expected, patients with advanced stage had significantly more severe symptoms. Patients with small-cell carcinoma reported the most severe pain and shortness of breath. Multiple linear regression analysis showed that stage was a significant predictor of pain severity while controlling for histology, age and gender. Patients with advanced stage had a pain level that was 1.2 higher than patients with early stage disease (95% CI= 0.5 – 1.8, p<0.001. For shortness of breath, both histology and stage were significant predictors of severe levels while controlling for age and gender. Patients with advanced stage had a shortness of breath level that was 0.9 higher than patients with early stage disease (95% CI= 0.4 – 1.6, p<0.001). Patients with small cell carcinoma had a shortness of breath level that was 1.5 higher than those with adenocarcinoma (95% CI= 0.35 – 2.6, p<0.01).
Conclusion:
In conclusion, as much as 62% of treatment-naïve patients with lung cancer reported at least one moderate-to-severe symptoms prior to initiation of cancer therapy. This high burden suggests that symptoms should be assessed routinely and tracked in parallel with cancer treatment.
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OA 01 - The New Aspect of Radiation Therapy (ID 652)
- Event: WCLC 2017
- Type: Oral
- Track: Radiotherapy
- Presentations: 1
- Moderators:M. Hiraoka, S.H. Kim
- Coordinates: 10/16/2017, 11:00 - 12:30, F201 + F202 (Annex Hall)
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OA 01.07 - Tracking Major Symptom Burden from Chemotherapy Concurrent with 3D vs. IMRT vs. Proton Beam Radiotherapy for NSCLC (ID 9443)
12:05 - 12:15 | Author(s): C.S. Cleeland
- Abstract
- Presentation
Background:
During standard concurrent chemoradiotherapy (CRT), patients with NSCLC often report severe symptoms that should be routinely assessed and managed. According to the United States FDA specified standards, patient-reported outcome (PRO) instruments used in clinical trials should have good measurement properties of reliability, validity, and the ability to detect change. This quantitative study used a validated PRO symptom-assessment tool, the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), to compare a cluster of CRT-related symptoms in NSCLC patients receiving CRT, and to investigate the sensitivity of a composite score of these symptoms.
Method:
We enrolled patients with locally advanced NSCLC (n=118) who underwent intensity-modulated radiation therapy (IMRT, n=33), 3-dimensional conformal radiation therapy (3DCRT, n=22), or proton-beam therapy (PBT, n=63). Patients completed the MDASI-LC weekly for up to 12 weeks. Two criteria used for item selection to form a subscale for CRT-related symptoms: MDASI-LC items rated 4-10 in >25% of observations, and that increased significantly during therapy (by mixed-effect models). A CRT-symptom score (MDASI-LC-CRT) was generated by averaging scores from those symptoms. The MDASI-LC-CRT’s responsiveness to treatment was examined by within-person change over time and effect size (ES) statistics.
Result:
Six symptoms—pain, fatigue, drowsiness, lack of appetite, sore throat, coughing—were identified as the most-severe CRT-related symptoms during and after therapy. Before CRT, MDASI-LC-CRT scores did not differ by treatment (3DCRT 2.2±1.8, IMRT 1.6±1.5, PBT 1.8±1.7, p=0.329). At the end of CRT, MDASI-LC-CRT was highest for 3DCRT (4.85±2.40), followed by IMRT (3.18±1.85) and PBT (2.29±1.65). A large ES (1.24) was found for 3DCRT vs. PBT; medium ES were found for 3DCRT vs. IMRT (0.78) and IMRT vs. PBT (0.51). The ES for pre-CRT vs. post-CRT difference (1.8±1.7 vs. 3.0±2.1) was medium (0.63) for all patients, large for 3DCRT (1.25) and IMRT (0.93), and small for PBT (0.28). The MDASI-LC-CRT score increased significantly over treatment (estimated weekly increase=0.21, p<0.0001), peaking at week 7 (95%CL=6.2-7.8, p<.0001) and then decreasing to week 12 (est=0.18, p=0.001). Significantly larger weekly increase was reported by 3DCRT and IMRT patients, compared with PBT patients (all p<0.0001).
Conclusion:
The MDASI-LC-CRT is a sensitive indicator of dynamic change in major symptom burden during CRT. This subscale could be routinely used for symptom monitoring while patients are going through CRT and appropriate supportive measures could be instituted early. PBT was the best tolerated of the radiation modalities when given concurrently with chemotherapy with the least worsening of symptoms over the CRT period.
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P1.10 - Nursing/Palliative Care/Ethics (ID 696)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Nursing/Palliative Care/Ethics
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.10-005 - Generation of Symptom Burden Patient-Reported Outcomes for Patients with Lung Cancer (ID 8675)
09:30 - 09:30 | Author(s): C.S. Cleeland
- Abstract
Background:
Systematic collection of patient experience of disease and treatment through validated patient-reported outcome measures (PROs) is recommended for research and practice. Symptom burden, the combined impact of disease- and therapy-related symptoms on daily functioning, is important to patients and appropriate for PRO measurement. PRO development should include literature reviews, patient input, and expert opinion for content domain specification and item generation. Our purpose is to describe initial development of symptom burden PROs for malignant pleural mesothelioma (MPM) and small-cell lung cancer (SCLC).
Method:
The MD Anderson Symptom Inventory (MDASI) Core is a 13-symptom-item (pain, fatigue, nausea, sleep disturbance, distress, shortness of breath, trouble remembering, appetite loss, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling) and 6-functional-item (general activity, mood, work, relations with others, walking, enjoyment of life) PRO measuring cancer symptom burden. Additional symptoms for specific diseases and treatments can be added. We performed systematic literature reviews for symptoms of MPM and SCLC. We conducted open-ended interviews with 20 patients with MPM and 25 patients with SCLC about their disease and treatment experiences. Descriptive exploratory analysis identified symptoms. Expert panels of physicians, other healthcare providers, patients, and family caregivers rated the relevance of symptoms from patient interviews. Symptoms consistently found in literature, mentioned in ≥ 20% of interviews, or with mean relevance ratings of “relevant/very relevant” were added to the MDASI Core to form the MDASI-MPM and MDASI-SCLC.
Result:
For MPM: Literature review found 5 major symptoms, patient interviews identified 24 symptoms, and experts rated 13 symptoms “relevant/very relevant.” Five symptoms were added to the MDASI Core to make the MDASI-MPM. For SCLC: Literature review found 8 major symptoms, patient interviews identified 37 symptoms, and experts rated 20 symptoms “relevant” or “very relevant.” Nine symptoms were added to the MDASI Core to make the MDASI-SCLC. Lung cancer-specific symptoms common to the two groups are: coughing, muscle weakness, malaise, and trouble with balance or falling. The additional MPM symptom was chest tightness. Additional SCLC symptoms were dizziness, constipation, difficulty concentrating, headache, and foot swelling.
Conclusion:
Patient report of the experience of MPM or SCLC frequently includes symptoms and how those symptoms interfere with daily activities. The MDASI-MPM and MDASI-SCLC are undergoing psychometric testing and may be modified based on the results. They will be the only validated measures of the symptom burden of MPM and SCLC.
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-036 - Symptom Trajectories During Chemotherapy Predict Overall Survival in Patients with Advanced Non-Small Cell Lung Cancer (ID 9393)
09:00 - 09:00 | Author(s): C.S. Cleeland
- Abstract
Background:
Patient–reported symptoms have shown prognostic value for patients with advanced non-small-cell lung cancer (NSCLC). The value of persistently high levels of critical symptoms during chemotherapy for predicting survival is seldom addressed. We examined symptom trajectories during first 15 weeks of chemotherapy and their relations to 3-year overall survival (OS) in patients with advanced NSCLC.
Method:
Stage IIIB-IV NSCLC patients scheduled to receive either intravenous chemotherapy or the oral tyrosine kinase inhibitor erlotinib were enrolled in a multicenter longitudinal study. Patients rated 15 symptoms on the MD Anderson Symptom Inventory-Lung (MDASI-LC) before chemotherapy and weekly thereafter for 15 weeks, on 0-10 severity scales. Group-based trajectory analysis was used to categorize patients into groups according to the level and trajectory of symptom severity (either high or low) that patients experienced over time. The 3-year OS was compared between high/low groups via Kaplan-Meier analysis. Hazard ratios (HRs) and 95% confidence intervals (95%CIs) were estimated by Cox regression modeling, with adjustment for demographic and clinical factors.
Result:
We analyzed data from 140 patients (90 died by end of study). High-severity trajectories of three symptoms (fatigue, shortness of breath (SOB), lack of appetite (LOA)) significantly predicted 3-year OS. Patients in the high-fatigue group (n=60) began with moderate fatigue (4.1±3.4) that increased significantly during weeks 1-4 of therapy (5.7±4.5 at week 4; estimated weekly change=0.33, p=0.0004) and remained at this level to week 15. Compared with patients in the low-fatigue group (mean=2.0±1.8, no significant change over time), high-fatigue patients had shorter OS (median=290 vs. 623 days, HR=2.3, 95%CI=1.4-3.8, p=0.001). The high-SOB group (n=62) maintained a moderate level of SOB (4.6±3.5) over 15 weeks and had lower 3-year OS rate than did patients in the low-SOB group (median=256 vs. 566 days; HR=2.7, 95%CI=1.6-4.4, p<0.0001). Compared with patients in the low-LOA group (n=66, mean=0.8±1.8, no change over time), high-LOA patients (n=74, mean=3.2±3.1, no change over time) had shorter OS (median=261 vs. 566 days, p=0.019). The prognostic value of LOA was insignificant after adjusting for other factors.
Conclusion:
Our results suggest that, through longitudinal patient-reported symptom profiling during chemotherapy, persistently high symptom burden can independently predict overall survival in patients with advanced NSCLC. Patients with persistently high symptoms should be targeted for alerts to providers about the need for symptom control during chemotherapy in routine care for advanced NSCLC. Such information could also be used as reference parameters for clinical trial/research design.
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P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.04-014 - Computing the Impact of Immunotherapy on NSCLC Landscape: The Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) (ID 9505)
09:30 - 09:30 | Author(s): C.S. Cleeland
- Abstract
Background:
Anti-PD-1 and anti-PD-L1 antibodies including pembrolizumab, nivolumab and atezolizumab have entered clinical practice in the management of metastatic NSCLC as monotherapy and immunotherapy-based combinations. We have established a real-world Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) to understand how the emergence of immunotherapy impacts choice of treatment, clinical outcomes, and patient reported outcomes (PROs) in the different histo-molecular subtypes of metastatic NSCLC. The objectives of ANCHoR are to determine the treatment choice and treatment sequence by PD-L1 status in the various histo-molecular categories of NSCLC and to understand the impact of such treatment choice on response rates, progression-free survival (PFS), and overall survival (OS). Additionally we will measure the impact the treatment choices have on the PROs by utilizing the validated instruments, EuroQol-5D version 5L (EQ-5D-5L) and MD Anderson Symptom Inventory module specific to lung cancer (MDASI-LC).
Method:
The study will enroll patients with metastatic NSCLC diagnoses who are treated at MD Anderson Cancer Center (MDA) between January 1, 2017 and December 31, 2020. The study period will end on June 30, 2021 to allow a minimum of six months of follow-up. Trained abstractors will collect demographic, diagnostic, clinical, molecular (biomarker and PD-L1), treatment (regimens utilized in sequence and reason for discontinuation), response and survival (including PFS and OS), health care resource utilization and PRO (EQ-5D-5L and MDASI-LC) information that will be integrated in a comprehensive database. Information from the MDA electronic medical record will be extracted and populated in the GEnomic Marker-guided therapy INItiative (GEMINI) database and the PRO database which are linked. EQ-5D-5L followed by MDASI-LC will be completed directly by the patients and these will be automatically populated in the web-based PRO database at treatment initiation, at the time of response assessments and when switching lines of therapy.
Result:
Interim analysis will be conducted every six months to measure the impact of immunotherapy over time. Study results will be presented using descriptive statistics for continuous variables (mean, standard deviation, median, and interquartile range), categorical variables (frequency and proportions), and time-to-event variables (Kaplan-Meier). Regression models will be used for estimating the relationship between dependent variable and one or more predictors. Cox proportional hazards model will be used to estimate hazard ratios for time-to-event outcomes.
Conclusion:
The ANCHoR study is the first comprehensive registry of its kind that will enable the quantification of the changing impact of immunotherapy on the real-world NSCLC treatment landscape.
