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P. Taylor
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O11 - Symptom Management (ID 137)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Supportive Care
- Presentations: 1
- Moderators:B. Ivimey, I.N. Olver
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside Gallery A, Level 1
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O11.06 - The effects of inspiratory muscle training in the management of breathlessness in patients with lung cancer: a pilot feasibility randomized trial (ID 3179)
17:00 - 17:10 | Author(s): P. Taylor
- Abstract
- Presentation
Background
Breathlessness in patients with lung cancer is common symptom affecting 50-70% of patients, rising to 90% for those with advanced lung cancer. Managing breathlessness is complex, treatment options are limited and treatments are sometimes unsuccessful. Inspiratory muscle training (IMT) is a non-pharmacological method that has shown positive results in Chronic Obstructive Pulmonary Disease and mixed results in other respiratory illnesses. As this treatment method has never been tested in patients with lung cancer, the aim of the current study was to assess how feasible this treatment is in the lung cancer population and explore changes in outcome variables, before launching a larger randomized trial.Methods
Pilot feasibility randomized trial in patients with lung cancer having stable disease. The experimental group received training using a pressure threshold device (commercially available from Phillips Respironics). Patients were instructed to do 5 sessions weekly for 12 weeks for a total of 30mins per day, divided over 2 sessions. Patients in the control group received standard care and received the treatment at the end of their trial participation. Outcome measures were completed at baseline and monthly for 3 months, and included: physiological parameters (FEV1,FVC); perceived severity of breathlessness in six 10-point VAS assessing average breathlessness over past 24 hours, worst breathlessness over past 24hrs, breathlessness now, distress from breathlessness, ability to cope with breathlessness and satisfaction with breathlessness management; modified Borg scale; quality of life using the short form-Chronic Respiratory Disease Questionnaire (with subscales on dyspnea, fatigue; emotional function and mastery of breathlessness); Hospital Anxiety & Depression Scale, and safety.Results
46 patients (M=37, F=9) at a mean age of 69.5 years old and a mean of 16 months post-diagnosis who were not currently receiving chemotherapy/radiotherapy were recruited from 3 centres in the UK and Cyprus. Seventy-percent had NSCLC and advanced disease. There were no changes in FEV1 and FVC levels between groups. There were time by intervention interaction effects in average breathlessness and worst breathlessness in past 24hrs (p<0.01) with the intervention arm showing stable breathlessness and the control group deteriorating, but no between-group differences. Statistical and clinically important differences were seen with regards to ability to cope with breathlessness (p=0.02), satisfaction with breathlessness management (p=0.024), fatigue (p=0.007), emotional function (p=0.006), breathlessness mastery (p=0.031), anxiety (p=0.027) and depression (p=0.048). The m-Borg difference between the 2 groups at 3 months was 0.80, which is borderline clinically significant but not statistically significant. Changes were more evident in the 3-month assessment. IMT was safe with only a small number of patients complaining of muscle fatigue and dizziness.Conclusion
This trial shows the IMT is feasible and safe in patients with lung cancer with significant benefits particularly in their ability to cope with breathlessness and emotional distress. The details of this trial allow us to refine the treatment protocol and findings guarantee a fully-powered larger trial (N should be around 196 with m-Borg as primary outcome).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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O21 - SCLC II (ID 119)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:M. Ahn, P. Lara
- Coordinates: 10/29/2013, 16:15 - 17:45, Parkside Ballroom B, Level 1
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O21.01 - A multicenter phase III randomized double-blind placebo controlled trial of pravastatin added to first-line standard chemotherapy in patients with small cell lung cancer (SCLC) (ID 1568)
16:15 - 16:25 | Author(s): P. Taylor
- Abstract
- Presentation
Background
Most SCLC patients initially respond to chemotherapy but then relapse and die so new therapies are urgently required. Pre-clinical data shows statins induce growth arrest and apoptosis in SCLC and several other tumour cell types and are additive with chemotherapy. This may in part be due to impaired Ras superfamily function as statins deplete mevalonate, reducing geranylgeranylation and farnesylation of these proteins. We therefore undertook this large pragmatic phase III trial in SCLC patients to determine if overall survival (OS) was affected by the addition of pravastatin to standard treatment. Methods
Patients with limited (LD) or extensive (ED) stage SCLC were randomised to pravastatin 40mg OD or placebo for up to 2 years and given standard chemotherapy according to local practice but recommended as either cisplatin 60mg/m2 iv or carboplatin AUC 5 or 6 and etoposide 120 mg/m2iv d1 to 3 or 100 mg BD po d2 & 3; max 6 cycles plus radiotherapy as usually given. Patients were excluded if they had used statins within 12 months prior to randomisation. Stratification was: LD vs ED and ECOG 0,1 vs 2,3. Endpoints were: primary - OS; secondary - progression free survival (PFS), local PFS (local control), response rates (RR) and toxicity.Results
Between 2007 and 2012, 846 patients were randomised, 422 (49.9.%) received pravastatin and 424 (50.1%) placebo in 93 participating sites in the UK. The median age was 64 years (range 54-69); ECOG performance status: 0: 23%; 1: 54%; 2: 17% and 3: 6%; weight 72.6 kg; LD, 357 (42.2%); ED, 479 (56.6%); 211 (24.9%) had ipsilateral effusion and 201 (23.8%) had ipsilateral SCF lymph nodes; Relative Dose intensity of cisplatin/carboplatin and etoposide was 91.6% (range 80.8 to 99.7), and 94.7% (range 85.7 to 100); 83.4% vs 86.3% completed >4 cycles of chemotherapy on the pravastatin and placebo arms respectively. Most patients completed 6 cycles of chemotherapy: 263 (62.3%) vs 265 (62.5%) in the pravastatin vs. placebo groups. Unblinded results showing the effect of pravastatin on OS, PFS, local PFS and toxicity will be presented.Conclusion
This trial will report on whether pravastatin 40 mg OD added to standard therapy alters the outcome for SCLC patients.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.
