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R. Hui
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MINI 28 - Psychological Impact of Lung Cancer and its Treatment (ID 150)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:A. Oton
- Coordinates: 9/09/2015, 16:45 - 18:15, 102+104+106
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MINI28.01 - The Impact of Physical Activity on Fatigue and Quality of Life in Lung Cancer Patients: A Randomized Controlled Trial (RCT) (ID 3173)
16:45 - 16:50 | Author(s): R. Hui
- Abstract
- Presentation
Background:
Physical activity (PA) has been shown to improve fatigue and quality of life (QOL) in a range of cancer populations. Little research has been done in the advanced lung cancer setting. This RCT evaluated a 2-month PA intervention in patients with unresectable lung cancer.
Methods:
Participants were stratified (disease stage, performance status [PS] 0-1 vs 2, centre) and randomized (1:1) to usual care (UC) (general nutrition and PA education materials) or UC plus 2-month program of supervised weekly PA and behaviour change sessions and home-based PA. Assessments were completed at baseline, 2, 4 and 6 months. The primary endpoint was fatigue (FACT-F subscale) at 2-months. Secondary endpoints included: QOL, functional abilities, physical fitness, activity (accelerometers), mood, dyspnea, survival and blood results. Intention-to-treat analysis using linear mixed models was done.
Results:
111 patients were randomized: male 55%, median age 62 (35-80); 95% NSCLC, 5% SCLC; 95% Stage IV. At baseline 77% were on active treatment. Baseline characteristics, including PA levels, comorbidities and Glasgow Prognostic Score (GPS) were well balanced between groups. Attrition was 22, 36 and 50% at 2, 4 and 6 months respectively; no difference between groups. Adherence to intervention sessions: behavioral 77%, PA 69%. There were no significant differences in fatigue, QOL, symptoms, mood, distress, sleep, dyspnea, activities of daily living, GPS between the groups at 2, 4 or 6 months. Patients over report PA levels compared to accelerometer data. Using accelerometer data, PA only increased in the PA group from 0 – 2 months, but the difference in PA between groups was not significant. Median survival (months): PA 13.7 vs UC 12.6 (p= 0.76): 38 participants remain alive.PA n=55 UC n=56 p-value FACT-F Fatigue: 0 2 4 6 38.4 37.5 39.6 36.6 36.3 36.3 35.4 34.5 0.61 0.10 0.44 EORTC Global QOL 0 2 4 6 63.8 63.2 64.2 60.8 58.9 64.3 60.2 54.2 0.81 0.45 0.26 Performance Status 0 2 4 6 0.8 0.8 0.8 0.7 0.9 1.0 1.0 1.2 0.30 0.16 0.01
Conclusion:
Adherence to the 8-week intervention was good but did not increase PA levels compared to education materials alone. No difference was seen in fatigue, QOL, symptom control or functional status.
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-001 - Pembrolizumab for Advanced NSCLC: Patterns of Response and Progression (ID 1005)
09:30 - 09:30 | Author(s): R. Hui
- Abstract
Background:
Anti-PD1 therapy has activity in patients with NSCLC, as assessed by RECIST or immune-related response criteria (irRC) on selected index lesions. Baseline tumour size was reported as an independent predictor of response to pembrolizumab in melanoma, but little is known about NSCLC. Tumour burden varies depending on number and size of lesions. We investigate the relationship of treatment response and baseline disease burden using comprehensive lesion-specific analysis on imaging at a single centre from a large multicentre Phase I study.
Methods:
Clinicopathologic characteristics of patients with advanced NSCLC enrolled from May 2012 to April 2014 at Westmead Hospital on the phase I pembrolizumab (MK-3475) KEYNOTE-001 were collected, including age, ethnicity, smoking status, histopathology (squamous or non-squamous), stage and prior treatments. Patients were treated with pembrolizumab until disease progression determined by irRC on index lesions or intolerable toxicity. Bi-dimensional measurements of individual lesions on computed tomography scans at baseline, week 9 and thereafter were performed. Every metastasis ≥5mm (up to 30 lesions per organ, excluding bone) and every lymph node ≥15mm in the short axis were assessed. Overall response was determined by change in sum of the product of longest perpendicular diameters (SPD) and categorised as complete response (CR, 100% reduction SPD), partial response (PR, ≥50% reduction SPD), progressive disease (PD, ≥25% increase in SPD) or stable disease (SD, neither CR/PR/PD) using comprehensive lesion-specific analysis.
Results:
Of 25 evaluable patients with at least one post-baseline imaging, 12 were treatment-naïve, 21 were PD-L1 positive (>1% staining of cells) determined by prototype assay using 22C3 antibody and 4 were unknown. A total of 226 lesions were evaluated, 196 at baseline and 22 new lesions by first scan. Objective response (OR, ≥50% reduction SPD) was achieved in 9/25 patients (36%) by first scan, with 1 out of the 9 patients subsequently achieving CR. The patients with treatment response by first scan had a lower median number of lesions at baseline, 4.0 (range 2-8) vs 8.5 (range 4-30) and a lower median SPD per patient at baseline, 2516 vs 4178.5 Clinical benefit (CR/PR/SD) occurred in 15/25 patients (60%) with median treatment duration of 18.4 months (range 2.8 – 33.5 months). At the time of analysis on 11 April 2015, 10/25 patients were still receiving ongoing treatment. Clinical benefit was seen in 14/17 Caucasians and 1/8 non-Caucasians; 14/16 current or former smokers and 1/9 non-smokers. However, all Asians but one were non-smokers and this ex-smoker was the only Asian patient who achieved SD as best response. No differences were found in histopathology, stage, number of prior treatments or age.
Conclusion:
Fewer lesions or lower tumour burden at baseline as determined by comprehensive lesion-specific analysis may predict treatment response to anti-PD1 in advanced NSCLC. More responses were also observed in Caucasians and current or former smokers. Due to small sample size, these results need to be interpreted with caution and warrant further investigation.
