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A.S.M. Harle
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O11 - Symptom Management (ID 137)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Supportive Care
- Presentations: 2
- Moderators:B. Ivimey, I.N. Olver
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside Gallery A, Level 1
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O11.02 - The "CLiC" Cough in Lung Cancer Study: The Characterisation of Cough in Lung Cancer (ID 2986)
16:25 - 16:30 | Author(s): A.S.M. Harle
- Abstract
- Presentation
Background
The “CLiC” Study seeks to characterise cough and identify its predictors using subjective and objective cough assessment tools, including the recently validated Manchester Cough in Lung Cancer Scale (MCLCS). Results will enable the identification of robust endpoints and therapeutic targets for novel antitussive interventional trials.Methods
Patients with lung cancer (LC) and complaining of cough were recruited irrespective of stage and treatment, from two cancer centres. Demographic and clinical data were collected. Patients completed the MCLCS, Cough Severity Diary (CSD), cough severity Visual Analogue Scale (VAS) and the Brief Reflux Inventory (BRI, a validated 5-item questionnaire assessing gastro-oesophageal reflux disease (GORD)). The oncology specific European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 with the module (LC13), (including item 31: "In the past week, how often did you cough?") was also completed. Cough was graded according to Common Toxicity Criteria for Adverse Events (CTCAEv4.0). A sample size of 178 patients was required for analysis of 160 (based on Peduzzi J Clin Epidem 1996) for 10 participants per correlate per outcome in binary logistic regression, assuming a 10% attrition rate, the prevalence of severe cough to be 50% and 8 cough predictors.Results
We recruited 179 patients (Oct'11-Nov'12). The median age was 65 yrs (range 25-83 years), with 53% patients male. The majority (79%) had non small cell lung cancer (NSCLC) and advanced stage disease (>IIIA 60%). In total, 36% were receiving cancer therapy at entry. Overall, 60% felt their cough warranted treatment. Having ensured validity of the cough assessment tools, the mean cough severity score (VAS) (n=171) was 43.4mm (SD 29.6). The mean cough-specific QoL score (MCLCS) was 25.3 (SD 8.8, with a range 1-50, high scores representing worse QoL).Table showing association between cough predictors and cough severity (VAS) and cough specific QoL (MCLCS) scores on univariate analysis[*] Cough Severity (VAS) Cough Specific QoL (MCLCS) Comment Age (≤70yrs vs >70yrs) p=0.365# p=0.834# Gender p=0.048# p=0.171# women worse cough severity Smoking Status (current, ex, never) p=0.191## p=0.356## Performance Status (WHO PS 0-3) p<0.0001## p<0.0001## poorer PS worse cough severity poorer PS worse cough related QoL Histology (NSCLC vs SCLC) p=0.348# p=0.274# Stage (early vs advanced) p=0.358# p=0.301# Tumour Location (central vs peripheral) p=0.486# p=0.040# central tumours poorer cough related QoL COPD (Chronic Obstructive Pulmonary Disease) (self-reported) p=0.578# p=0.128# LRTI (Lower Respiratory Tract Infection) (self-reported) p=0.022# p=0.044# LRTI worse cough severity LRTI worse cough related QoL Asthma (self-reported) p=0.021# p=0.054# asthma worse cough severity GORD (BRI questionnaire) p<0.0001# p<0.0001# GORD worse cough severity GORD worse cough related QoL Nausea (EORTC QLQ C30) p=0.004## p=0.017## Increased nausea worse cough severity. Increased nausea worse cough related QoL Oral Steroids p=0.434# p=0.017# On steroids worse cough related QoL Over the Counter Antitussives p=0.011# p=0.067# On antitussives worse cough severity Opiates p=0.497# p=0.018# On opiates worse cough related QoL *Not all analysed cough predictors shown # Mann-Whitney-U Test ## Kruskal-Wallis Test Conclusion
This is the largest single study to use validated cough-specific assessment tools in LC to characterise and assess potential influences on cough. LC patients have a severe cough, with comparable VAS scores to those of patients presenting to specialist chronic cough clinics. New antitussive therapies are needed. Key predictors of cough severity and reduced cough-specific QoL are performance status (PS), nausea and GORD. Preclinical research suggests that the neurokinin-1 pathway may mediate the vagal cough reflex pathway. Our results further support this hypothesis and imply that the neurokinin-1 pathway may be a relevant therapeutic target. The association with GORD may be explained by the shared vagal innervation of the airway and upper gastrointestinal tract.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.
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O11.03 - The "CLiC" Cough in Lung Cancer Study: The Validation of Objective and Subjective Cough Assessment Tools in Lung Cancer Patients (ID 3006)
16:30 - 16:35 | Author(s): A.S.M. Harle
- Abstract
Background
Cough is a common lung cancer (LC) symptom, yet effective therapies are lacking. The development and testing of novel therapies relies upon appropriate tools for the assessment of cough. CLiC is the first study to evaluate two new tools 1) objective ambulatory cough monitoring (ACM) from acoustic recordings (VitaloJAK™) and 2) the Manchester Cough in Lung Cancer Scale (MCLCS) quality of life (QoL) questionnaire. These provide complementary assessments of cough frequency and its impact upon the patient.Methods
Patients with LC and complaining of cough were recruited, irrespective of stage or treatment, from two cancer centres. Demographic and clinical data were collected. All patients completed the MCLCS, Cough Severity Diary (CSD) and cough severity Visual Analogue Scale (VAS). The European Organization for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ) C30 with the module (LC13), (including item 31: "In the past week, how often did you cough?") was also completed. The Common Toxicity Criteria for Adverse Events (CTCAEv4.0) was used to grade cough. A subgroup underwent ACM and MCLCS on Days 0&60.Results
We recruited 179 patients (Oct'11-Nov'12): median age 65yrs (range 25-83 years), 53% male. Majority (79%) had non small cell lung cancer, 60% advanced stage (>IIIA), 36% were on cancer therapy.Table showing correlations between subjective cough assessment tools EORTC QLQ C30 cough item 31 CTCAE Cough Grading MCLCS Manchester Cough LC Scale CSD Cough Severity Diary VAS Cough Severity 0.54**§ n=171 0.50**§ n=170 0.67**§ n=163 0.70**¥ n=84 EORTC QLQC-30 cough item Q31 0.45**§ n=173 0.57**§ n=165 0.52**§ n=85) CTCAE Cough Grading 0.56**§ n=164 0.59**§ n=85 MCLCS Manchester Cough LC Scale 0.76**¥ n=82 ** p<0.0001 ¥high correlation §moderate correlation
Intra-class correlations demonstrated good repeatability over time between Days 0&60 for cough frequency (24hour: r=0.77, p<0.0001, awake: r=0.79, p<0.0001, sleep: r=0.66, p=0.004) and MCLCS: r=067,p<0.001 .The median cough scores/hour were 14.1(24hour: range 0.7-156), 18.5 (awake: range 1-233) and 6.0 (asleep: range 0-110).Table showing correlations between objective ACM and subjective cough tools VAS Cough Severity MCLCS Manchester Cough LC Scale Log Cough/hr Asleep Log Cough/hr Awake Log Cough/hr 24-hour VAS Cough Severity 0.73** n=37 0.33* n=37 0.61** n=37 0.57** n=37 MCLCS Manchester Cough LC Scale 0.24 n=35 0.51* n=35 0.44* n=35 Log Cough/hr Asleep 0.52** n=35 0.62** n=35 Log Cough/hr Awake 0.97** n=37 ** p<0.0001 * p<0.05 Conclusion
We have demonstrated moderate to strong correlations between established measures of cough and two novel assessment tools, suggesting the validity of MCLCS and ACM. Their good repeatability suggests they have excellent potential for the assessment of novel treatments in future intervention studies for LC-related cough. In contrast, standard oncology tools are blunt and poorly discriminate cough.
