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A. Molasiotis
Moderator of
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ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)
- Event: WCLC 2015
- Type: Oral Session
- Track: Palliative and Supportive Care
- Presentations: 8
- Moderators:A. Molasiotis, P. Van Houtte
- Coordinates: 9/08/2015, 16:45 - 18:15, 708+710+712
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- Abstract
- Presentation
Background:
Cachexia is a debilitating condition often observed in patients with advanced non-small cell lung cancer (NSCLC). A decrease in body weight (BW), in particular loss of lean body mass (LBM), is a primary characteristic, and is associated with worsening functional status, quality of life, and survival. Despite the high prevalence and substantial clinical impact of cachexia in patients with advanced cancer, limited therapeutic options exist. Anamorelin is a novel, orally active, selective ghrelin receptor agonist that mimics the appetite-enhancing and anabolic effects of ghrelin. ROMANA 1 and 2 are two randomized, double-blind, Phase III trials evaluating the efficacy and safety of anamorelin in patients with advanced NSCLC and cachexia.
Methods:
In ROMANA 1 (NCT01387269; N=484) and ROMANA 2 (NCT01387282; N=495), patients with unresectable stage III/IV NSCLC and cachexia (≥5% weight loss during prior 6 months or body mass index <20kg/m[2]) were randomized (2:1) to anamorelin 100 mg daily or placebo, for 12 weeks. Co-primary endpoints were change in LBM and handgrip strength (HGS) over 12 weeks. Secondary endpoints included change in BW and in the anorexia/cachexia domain of the Functional Assessment of Anorexia/Cachexia Therapy questionnaire over 12 weeks, and pooled 1-year overall survival (OS) from both studies. Exploratory endpoints included summarizing the incidence of patients who maintained/gained LBM from baseline during 12 weeks by treatment group. Post-hoc analysis compared OS data in patients who had decrease in LBM during 12 weeks versus those who maintained/gained LBM. Safety and tolerability of anamorelin were also evaluated.
Results:
Over 12 weeks, anamorelin significantly increased median LBM versus placebo in ROMANA 1 (1.10 vs –0.44 kg; p<0.001) and ROMANA 2 (0.75 vs –0.96 kg; p<0.001); in both studies there was no difference in HGS changes between treatment arms. A significantly greater proportion of patients in the anamorelin arm versus the placebo arm maintained/gained LBM in both ROMANA 1 (58.1% vs 36.9%; p<0.001) and ROMANA 2 (51.5% vs 26.5%; p<0.001). Post-hoc analysis showed that OS was improved for patients who maintained/gained LBM versus patients who lost LBM (HR, 0.53 [95% CI, 0.42, 0.68]; p<0.001). Anamorelin-treated patients also significantly gained BW (2.20 vs 0.14 kg; p<0.001, and 0.95 vs –0.57 kg; p<0.001), and had significantly improved anorexia-cachexia symptoms and concerns (4.12 vs 1.92; <0.001, and 3.48 vs 1.34; p=0.002), compared with placebo-treated patients, in ROMANA 1 and 2, respectively. The most frequent drug-related adverse event (AE) in the anamorelin arm in both ROMANA 1 and 2 was hyperglycemia (5.3% and 4.2%); there were few drug-related grade ≥3 AEs in the anamorelin arm versus the placebo arm (0.9% vs 1.2% and 2.7% vs 2.5%).
Conclusion:
Anamorelin significantly increased LBM and BW, and improved anorexia-cachexia symptoms and concerns, compared with placebo, in patients with advanced NSCLC and cachexia. Change from baseline in HGS was similar in both treatment arms. A significantly greater proportion of patients maintained/gained LBM in the anamorelin arm versus the placebo arm. When LBM was stable or increased, OS was significantly improved. Anamorelin treatment over 12 weeks was also well tolerated.
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ORAL29.02 - ONO-7643/Anamorelin for the Treatment of Cancer Cachexia in Advanced NSCLC Patients: Results From the Phase 2 Study in Japan (ID 1375)
16:56 - 17:07 | Author(s): N. Katakami, T. Yokoyama, S. Atagi, K. Yoshimori, H. Kagamu, Y. Takeda, K. Takase, H. Saito, K. Eguchi
- Abstract
- Presentation
Background:
Cancer cachexia is characterized by decreased body weight (BW), mainly lean body mass (LBM) and negatively impacts quality of life (QOL) and prognosis. ONO-7643/anamorelin (ANAM) is a novel selective ghrelin receptor agonist with appetite-enhancing and anabolic activity.
Methods:
ONO-7643-03 was a double-blind, exploratory Phase 2 trial assessing ANAM efficacy and safety in Japanese non-small cell lung cancer (NSCLC) patients with unresectable stage III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and cachexia (main criteria: ≥5% weight loss within prior 6 months). Patients were randomized to ANAM at 100 or 50 mg, or placebo, given daily orally for 12 weeks. Co-primary endpoints were change from baseline over 12 weeks in LBM (measured by DXA) and handgrip strength (HGS). Secondary endpoints included change in BW, ECOG PS, Karnofsky performance scale (KPS) and QOL assessment (QOL-ACD).
Results:
Demographics were balanced (N=180); median age=66 yr, male (68.9%), ECOG PS=1 (77.5%) and stage IV (76.1%). Treatment effects: the change in LBM over 12 weeks was 0.55 kg in the placebo arm and 1.15 kg in the ANAM 100 mg arm, and the change in LBM at both Weeks 8 and 12 showed significant differences between ANAM 100 mg and placebo (p<0.05). However, the change in HGS was similar between arms at both time points. The change in BW to Weeks 12 was -0.93 kg in the placebo arm vs +0.54 kg in the 50 mg arm and +1.77 kg in the 100 mg arm, and was significantly different between the 100 or 50 mg arms and the placebo arm at all time points (p<0.05). The cumulative rate of deterioration of ECOG PS was lowest in the 100 mg arm, and ANAM 100mg significantly improved KPS and QOL-ACD compared to placebo at Weeks 4 and 12 (p<0.05). Regarding safety, ANAM treatment for 12 weeks was well tolerated. While median survival time (MST) was not significantly different between active treatment arms and placebo, MST of patients with BW loss was significantly shorter than those without (215 vs 327 days; p=0.0055).
Conclusion:
This phase 2 study demonstrated that ANAM has promising potential in improving body composition, performance status and QOL in patients with cancer cachexia.
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ORAL29.03 - Efficacy of the Antiemetic Combination Agent, NEPA, in Patients with Lung Cancer Receiving Platinum Chemotherapy (ID 1275)
17:07 - 17:18 | Author(s): P.J. Hesketh, M. Palmas, E.M. Carreras
- Abstract
- Presentation
Background:
Lung cancer is the most common cancer worldwide with first-line chemotherapy treatments consisting predominantly of emetogenic platinum agents. Chemotherapy-induced nausea and vomiting (CINV) can be prevented in most patients with appropriate combination antiemetic regimens. The antiemetic standard-of-care for patients receiving cisplatin consists of a combination of a NK~1~ receptor antagonist (NK~1~RA), a 5-HT~3~ RA, and dexamethasone (DEX). Adherence to antiemetic guidelines is unacceptably low with patients frequently not receiving recommended antiemetic combinations. NEPA has been developed as the first oral antiemetic combination; it delivers guideline-consistent prophylaxis with its combination of a highly selective NK~1~ RA (netupitant [NETU] 300 mg) and the pharmacologically/clinically distinct 5-HT~3~ RA, palonosetron (PALO 0.50 mg). NEPA has demonstrated superior prevention of CINV compared with oral PALO. The intent of this retrospective analysis was to evaluate the efficacy of NEPA in a subset of lung cancer patients from two of the pivotal trials.
Methods:
Patients in two randomized, double-blind trials received a single dose of NEPA on Day 1 prior to cisplatin- or carboplatin-based chemotherapy. Three dose groups (NETU 100/200/300 mg + PALO 0.50 mg) showing similar efficacy were pooled in Study 1, while all patients in Study 2 received NETU 300mg/PALO 0.50 mg. All patients also received oral DEX on Day 1 (carboplatin) or Days 1-4 (cisplatin). Study 1 was single cycle, while Study 2 included evaluation over multiple chemotherapy cycles. The focus of this analysis was on the efficacy of NEPA only, as a PALO comparator group was included in only one of these studies. Endpoints were complete response (CR: no emesis, no rescue) and no significant nausea (max <25 mm on 100 mm visual analog scale) during the acute (0-24h), delayed (25-120h), and overall (0-120h) phases.
Results:
231 patients (78% males, 22% females) with lung cancer received NEPA; 152 patients received cisplatin and 79 received carboplatin as initial chemotherapy. CR rates in Cycle 1 exceeded 90% in Study 1 and 80% in Study 2 (Table). As expected, overall nausea rates were somewhat lower than CR rates (87% Study 1, 80% Study 2). Overall CR rates were maintained over subsequent cycles in Study 2 (87%, 95% and 94% in Cycles 2-4, respectively). Figure 1
Conclusion:
As a combination antiemetic agent targeting two critical pathways associated with emesis, NEPA offers a convenient and highly effective option for prevention of CINV in lung cancer patients receiving platinum-based emetogenic chemotherapy.
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ORAL29.04 - The Impact of Perioperative Immunonutrition on Tissue Healing and Infection Related Morbidity in Patients Undergoing Lung Resection for NSCLC (ID 1462)
17:18 - 17:29 | Author(s): G. Olgaç, T. Cosgun, M. Vayvada, S. Bayram, G. Yanikkaya Demirel, F.T. Akdeniz, Ö. Albayrak, G. Terzioglu, C.A. Kutlu
- Abstract
- Presentation
Background:
Despite several improvements in surgical techniques and postoperative management, tissue healing and infection related complications comprise substantial amount of morbidity associated with major lung resections. Perioperative use of immunomodulating diets in order to decrease the risk of acquired infections and wound complications remains controversial. This study aims to investigate the impact of perioperative immunonutrition over a standard regimen in decreasing tissue healing and infection related morbidity and if any, its relation to immune cell function in patients undergoing major lung resection for NSCLC.
Methods:
Seventy-eight patients undergoing a major lung resection for NSCLC were randomized into two groups to receive either study formula enriched with L-arginine, nucleotides and ω-3 polyunsaturated long-chain fatty acids (Group S; n=39) or isocaloric and isonitrogenous standard formula (Group C; n=39) starting at least 4 days prior to scheduled operation and discontinued on the 8th postoperative days at the earliest. At least half of the required daily calorie intake of each patient was supplied with their assigned nutrition formula. Primary outcome of the study was incidence of tissue healing and infection related morbidity, including prolonged air leak, bronchopleural fistula, wound infection, empyema, pneumonia and sepsis leading to prolonged hospital stay and/or both ICU and hospital readmissions. Leukocyte (WBC) and Lymphocyte counts, CRP, and ratio of CD4/CD8 were also obtained as secondary outcomes at 4 different time points (t1=Randomization; t2= 1st postoperative day; t3= Prior to discharge or 7th postoperative day; t4= 1st outpatient visit following discharge).
Results:
Demographic and preoperative clinical characteristics were comparable between the groups. All patients achieved targeted nutritional support during the study period. Incidence of tissue healing and infection related morbidity was significantly higher in Group C than in Group S [20 (51%) vs. 9 (23%); p=0.02)]. Cumulative rate of both ICU and hospital readmissions were also higher in Group C than in Group S [12 (31%) vs. 4 (10%), respectively; p=0.049], although this difference was not reflected to the median length of hospital stay [5 (4-7) vs. 5.5 (4-9) days, respectively; p=0.12]. Compared to randomization, WBC was significantly higher in Group C than in Group S throughout the postoperative period (8.0x10[3] vs. 8.1x10[3], 14.0x10[3] vs. 12.1x10[3], 12.2x10[3] vs. 10.4x10[3] and 11.8x10[3] vs. 9.8x10[3] for t1, t2, t3 and t4, respectively; p=0.01). Lymphocyte counts as percentages of total WBC declined considerably during the postoperative period in both groups; however this drop was significantly more evident in Group C than in Group S (22.7% vs. 23.5%, 10.2% vs. 16.7%, 14.8% vs. 18.9% and 16.8% vs. 18.7% for t1, t2, t3 and t4, respectively; p=0.01). Confirming the favorable effect on immunity, CD4/CD8 ratio was significantly higher in Group S during postoperative period, reaching its maximum value at t3 (1.6 vs. 1.5, 1.8 vs. 1.3, 2.2 vs. 1.5 and 2.0 vs. 1.4 for t1, t2, t3 and t4, respectively; p=0.02).
Conclusion:
This study suggests that supplementary immunonutrition enriched with L-arginine, nucleotides and ω-3 polyunsaturated long-chain fatty acids may help reducing the incidence of tissue healing and infection related complications in patients undergoing lung resection for NSCLC.
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ORAL29.05 - Discussant for ORAL29.01, ORAL29.02, ORAL29.03, ORAL29.04 (ID 3543)
17:29 - 17:39 | Author(s): R.J. Gralla
- Abstract
- Presentation
Abstract not provided
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ORAL29.06 - Skeletal Muscle and Lean Body Mass Loss Are Associated with Poorer Prognosis in Patients with NSCLC Treated with Afatinib (ID 3053)
17:39 - 17:50 | Author(s): M. De La Torre-Vallejo, J. Turcott, J. Luvián, O. Arrieta Rodriguez
- Abstract
- Presentation
Background:
Irreversible tyrosine kinase inhibitors of the epidermal growth factor receptor (EGFR) such as afatinib have shown clinical benefits and prolonged survival in patients with NSCLC. Weight loss and sarcopenia are common in NSCLC patients and have been recognized as important prognostic factors of toxicity and survival. The aim of this study was to assess the impact of muscle and
Methods:
Patients diagnosed with NSCLC, who progressed to prior chemotherapy, received 40 mg of afatinib. Skeletal muscle (SM) was quantified by computed tomography scan analysis using pre-established Hounsfield (HU) unit threshold and lean body mass (LBM) was calculated with the following formula: LBM (kg)=(0.30 × (skeletal muscle area at L3 using CT (cm[2]))+6.06). These variables were estimated at baseline (T0) and after four months of treatment with afatinib (T1).
Results:
Eighty-four patients were assessed at baseline. 70.2% were female, mean age was 59.3±1.6 years, 94% had adenocarcinoma, 53.6% received afatinib as 2nd line of treatment, and 91.7% had a good performance status (ECOG 0-1). Patients included were both EGFR+ (23.8%) and EGFR- (76%). Body composition evaluation was obtained at T0 and T1 in 46 patients, median differences (∆) between T0 and T1 for SM, LBM and weight were -1.4(-56.8, +27.9 cm[2]), -0.42(-17,-8 kg) and -0.1(-12,+6), respectively, and were not statistically significant. Median OS and PFS were 23.8(17.9-29.7) months and 8.9(5.5-12.4) months, respectively (including EGFR+ and EGFR-). Weight loss was not statistically associated with poorer OS or PFS. However, SM and LBM loss greater that the median had a negative impact on PFS and OS. Figure 1(Figure1).
Conclusion:
SM and LBM changes throughout treatment with EGFR TKIs should be evaluated. Nutritional interventions should be focused on the maintenance of SM and LBM. Further clinical trials should focus on interventions improving these body composition variables since they are associated with better OS and PFS in patients with NSCLC treated with afatinib.
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- Abstract
- Presentation
Background:
The systemic immunonutritional status has been postulated as related to the long-term prognosis in various cancer types. However, no studies have assessed the prognostic role of prognostic nutritional index (PNI) on the survival of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations and receiving tyrosine kinase inhibitors (TKIs).
Methods:
Advanced NSCLC patients with sensitive EGFR mutations (19 deletion or L858R in exon 21) were retrospectively screened. The PNI was calculated as 10 x serum albumin value (g/dl) + 0.005 x peripheral lymphocyte count (per mm3). Univariate and multivariate analysis were performed to assess the prognostic value of relevant parameters.
Results:
144 cases were included for analysis after eligibility review. The optimal cut-off value of PNI for OS stratification was determined as 48.78 according to a R software-engineered, web-based system. Low PNI was significantly associated with elevated CRP level (p<0.0001) and non-response to TKIs (p=0.002). High PNI (high vs low, 35.10 vs 25.67 months; HR, 0.44; 95 % CI, 0.25–0.77; p = 0.004) correlated to superior OS. Survival analysis identified PNI as an independent prognostic factor(p=0.012). Subgroup analysis revealed that PNI was generally a significant prognostic factor in different clinical situations.
Conclusion:
Low PNI correlates with worse survival in patients with advanced NSCLC harboring EGFR sensitive mutations and treated with EGFR-TKIs. The assessment of PNI could assist the identification of patients following EGFR-TKIs treatment with poor prognosis and has implications for the routine monitoring and treatment.
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ORAL29.08 - Discussant for ORAL29.06, ORAL29.07 (ID 3568)
18:01 - 18:11 | Author(s): R. Catane
- Abstract
- Presentation
Abstract not provided
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MTE 07 - Pharmacologic and Non-Pharmacologic Management of Dyspnea (Ticketed Session) (ID 59)
- Event: WCLC 2015
- Type: Meet the Expert (Ticketed Session)
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 07:00 - 08:00, 108+110+112
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MTE07.01 - Pharmacologic and Non-Pharmacologic Management of Dyspnea (ID 1987)
07:00 - 08:00 | Author(s): A. Molasiotis
- Abstract
- Presentation
Abstract:
Dyspnea (or the subjective experience of breathlessness) has a prevalence of about 50% in people with any cancer (not just lung cancer), and moderate to severe dyspnea is present in 28% of terminally ill cancer patients. Up to 60% of patients with lung cancer can experience dyspnea. Typically dyspnea experience will be of moderate level intensity, distressing and interfere with activities of daily living. Managing dyspnea is often challenging and should include an assessment to identify first and treat reversible causes. The following table shows such causes and possible treatment (Cancer Care Ontario, 2010).
Pharmacological options, beyond treating the underlying cause, include systemic opioids (but not nebulized opioids), and occasionally benzodiazepines for managing dyspnea-related anxiety. Systematic reviews and meta-analyses (ie. Ben-Aharon et al, 2012) have shown the following: Systemic opioids (Oral and parenteral routes) Effective Nebulised opioids Not effective (nebulized hydromorphone very effective in 1 small trial) Supplemental Oxygen (non-hypoxic patients) Not recommended Supplemental Oxygen (hypoxic patients) Recommended Nebulised furosemide Insufficient evidence but probably ineffective Nebulised lidocaine Not recommended Benzodiazepines Not recommended for managing dyspnea, but can be used to treat related anxiety Systemic corticosteroids No comparative data available Phenothiazines No comparative data available. To consider if other interventions have failed in severe dyspnea Morphine combined with midazolam More effective than either option alone. Contradictory evidence The session will provide more data supporting the above statements. Non-pharmacological interventions may include diaphragmatic breathing exercises, positioning, education or supportive counseling. The session will also focus on recent findings from a new intervention to manage the symptom cluster of respiratory distress (breathlessness-cough-fatigue) and the results of a new study testing the effects of resistance inspiratory muscle training (Yorke et al, in press; Molassiotis et al, 2015). In relation to the newly developed complex psycho-educational and self-management interventions in 101 patients with lung cancer, results suggest improvements in managing dyspnea over the 3 months of the follow-up. In the last study to be presented, using resistance inspiratory muscle training (IMT) through a breathing device in 46 patients with lung cancer, results suggest a clinically meaningful improvement for those patients using the device for 3 months. The session will look at the symptom clusters around breathlessness and also cough management as this is impacting dyspnea too. Finally, the research gaps in the field will be highlighted. References: Cancer Care Ontario (2010). Symptom Management Guide-to-Practice: Dyspnea. file:///C:/Users/hkpuadmin/Downloads/Dyspnea%20(Full)%20(2).pdf Ben-Aharon I, Gafter-Gvili A, Leibovici L, Stemmer SM. (2012). Interventions for alleviating cancer-related dyspnea: a systematic review and meta-analysis. Acta Oncol.; 51(8):996-1008. Yorke J, Lloyd-Williams M, Smith J, Blackhall F, Harle A, Warden J, Ellis J, Pilling M, Haines J, Luker K, Molassiotis A. (in press). Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial. Support Care Cancer. Molassiotis A, Charalambous A, Taylor P, Stamataki Z, Summers Y. (2015). The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Support Care Cancer.; 23(6):1637-1645.Treatable causes of dyspnea Treatment Options RESPIRATORY SYSTEM Chronic obstructive pulmonary disease (COPD) Large airway obstruction Pleural effusion Pneumonia Pulmonary emboli CARDIOVASCULAR SYSTEM Angina pectoris Atrial fibrillation Congestive Heart Failure Pericardial effusion Superior vena cava obstruction OTHER SYSTEMS Anemia Severe Ascites Inhaled bronchodilators; inhaled or systemic corticosteroids Radiotherapy; systemic corticosteroids; stenting; heliox; nebulized epinephrine Drain; if recurrent - sclerosing agents; indwelling catheter Antibiotics Anti-coagulation; inferior vena cava filter Optimize conventional medications Medications for ventricular rate control Optimize conventional medications Drain; if recurrent - sclerosing agents; pericardial window; indwelling catheter Corticosteroids; radiotherapy; stenting Red blood cell transfusion Drain; if recurrent- indwelling catheter
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P1.11 - Poster Session/ Palliative and Supportive Care (ID 229)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.11-001 - Short Form Chronic Respiratory Questionnaire Validation in a Lung Cancer Population (ID 28)
09:30 - 09:30 | Author(s): A. Molasiotis
- Abstract
Background:
The Chronic Respiratory Questionnaire short form (SF-CRQ) is frequently used in patients with obstructive pulmonary disease and it has demonstrated excellent psychometric properties. The CRQ (both in its original or short form) has not been previously used in the assessment of lung cancer patients’ HRQL. Therefore this study, being part of a larger therapeutic trial, aims to evaluate the psychometric properties of the SF-CRQ in patients diagnosed with thoracic malignancies.
Methods:
Forty-six patients were assessed at two time points (with a four-week interval) using the SF-CRQ, the modified Borg Scale, five numerical rating scales related to perceived severity of breathlessness, and the Hospital Anxiety & Depression Scale. Internal consistency reliability was investigated by Cronbach’s α reliability coefficient, test-retest reliability by Spearman-Brown reliability coefficient (p) and convergent validity by Pearson’s correlation coefficient between the SF-CRQ, and the conceptual similar scales mentioned above and content validity was also explored. A principal component factor analysis was performed.
Results:
The internal consistency was high, indicated by an α=0.88 (baseline) and 0.91 (after one month). The SF-CRQ had good stability with test-retest reliability ranging from r=0.64 to r=0.78, p<0.001. Factor analysis suggests a single construct in this population showing that the items of the SF-CRQ scale are strongly correlated and represent the conceptual meaning of the underlying construct, which is the quality of life of lung cancer patients as related to breathlessness.
Conclusion:
The data analyses supported the convergent, content, and construct validity of the SF-CRQ indicating this is a valid and reliable instrument for the assessment of quality of life related to breathlessness in lung cancer patients. This study is the first study that provides initial data of the psychometric properties of the SF-CRQ in lung cancer patients, and further validation with larger sample sizes and across different settings and dyspnea severity is needed.
