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K.N. Franks
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-029 - SABRTOOTH-A Feasibility Study of SABR Compared to Surgery in Patients with Peripheral Stage I NSCLC Considered to Be at Higher Risk from Surgery (ID 4432)
14:30 - 14:30 | Author(s): K.N. Franks
- Abstract
Background:
Stereotactic Ablative Radiotherapy (SABR) is a well established treatment for medically inoperable peripheral stage I NSCLC. Previous non-randomised evidence supports SABR as an alternative to surgery, but high quality randomised control trial (RCT) evidence is lacking due to low recruitment. The UK SABRtooth study aims to see if a large RCT is feasible.
Methods:
The trial management group includes pulmonologists, thoracic surgeons, nurses, patient representatives, oncologists and statisticians. Patients considered at higher-risk of operative mortality and morbidity with a peripheral stage I (<5cm) NSCLC are eligible. Defining “higher-risk” patients considers multiple criteria, but the final decision is left to the individual tumour boards. Equipoise in presenting the two interventions to patients was considered key. Bias is minimised by ensuring the initial approach is by the pulmonologist with subsequent counseling by the research nurse and randomisation occurring before consultation with a surgeon or oncologist . Patients who decline the trial or do not proceed with their allocated treatment are invited to take part in qualitative interviews. The trial is open in 4 thoracic oncology centres and their referral units. The aim is to recruit on average 3 patients/month to demonstrate that a phase III RCT would be feasible.
Results:
Following a launch meeting in April 2015 the trial opened in July (all centres opened October 2015). To help train research staff with introducing the trial to patients, mock patient consultations were recorded. Recruitment was initially slow. Specific research nurse meetings have taken place (December 2015 and June 2016) to understand the barriers to recruitment, centre-specific issues and provide additional education to improve nurses’ confidence in recruiting patients. Regular updates are provided with monthly emails and In February 2016, the Chief Investigator and Trial Manager visited each site to promote the trial and help with any local barriers to recruitment. In response to feedback, changes to the protocol to aid patient recruitment, additional promotional and patient information provided and a video for patients were produced. The study has also been presented at various oncology/thoracic meetings. As a result recruitment has increased with 15 patients successfully randomised into the trial.
Conclusion:
Whether SABR is an alternative to surgery is a key question in stage I NSCLC. However, SABRtooth is a challenging study but with a novel trial design and continual adaptive feedback we hope to be able to meet recruitment targets and demonstrate that a definitive phase III RCT is feasible.
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P1.05-030 - Lung SABR for Early Stage Lung Cancer: Outcomes and Toxicity of 803 Patients Treated at the Leeds Cancer Centre (ID 5874)
14:30 - 14:30 | Author(s): K.N. Franks
- Abstract
Background:
SABR is an established treatment for early peripheral stage non-small cell lung cancer (NSCLC) in medically inoperable patients We present the outcomes 803 patients, a large prospective series of patients, with a minimum 12 months follow-up after undergoing SABR treatment in Leeds, UK, between May 2009 and May 2015.
Methods:
Patients with a pathological or clinical diagnosis of peripheral stage I lung cancer, and deemed medically inoperable, were treated with SABR at the Leeds Cancer Centre, using a dose fractionation of 54Gy/3#, 55Gy/5#, or 60Gy/8# depending on proximity of organs at risk. Patient follow-up was assessed using an electronic patient record and radiology reports. Survival analysis was performed using Kaplein-Meier estimation and log rank test was used to compare survival distibutions including performance status, histology, tumour T stage, tumour location, post-SABR fibrosis, and toxicity.
Results:
803 patients were treated with SABR and had at least 12 months follow-up. Mean age at treatment was 73.9 years (39 to 94 years). Median follow-up was 23.3 Months, from time of last treatment fraction to last medical contact or death. Median overall survival estimate was 33.3 Months (95% C.I. 29.54-27.1 Months) 1 year OS – 80.1% (SE 1.4%), 3 year OS – 46.4% (SE 2%), 5 year OS – 29.5% (SE 2.6%) Local control (LC) 1 year LC – 99.2% (SE 0.3%), 2 year LC – 97.2% (SE 0.7%), 3 year LC – 95.1% (SE 0.9%) Both performance status and tumour size were associated with a worse overall survival, Log rank p<0.001 (PS), p=0.035 (T stage). Toxicity Only 4 patients had documented grade 3 toxicity. 3 pneumonitis requiring admission, and 1 patient developed a bronchopulmonary fistula 2 years post-treatment. 44 Patients had a rib fracture recorded, of these 16 patients were symptomatic, and were treated with analgesia or neuropathic adjuncts. 156 patients had documented radiological pneumonitis (gd 1), with 331 developing fibrotic change in the treatment area. Of interest the presence of radiological pneumonitis and fibrotic changes was associated with an improved overall survival, Log rank P=0.009 (Rad pneum), P<0.001 (Fibrosis).
Conclusion:
SABR for early stage lung cancer is a safe and effective treatment even in medically inoperable patients, with excellent local control. In our cohort, we found radiological pneumonitis and fibrosis was associated with an improved overall survival, which may be indicative of the patient response to SABR, and will need further evaluation. Performance status and tumour size were associated with a poorer overall survival.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-035 - Exploring Recruitment Factors in a Feasibility Trial of SABR versus Surgery (ID 4714)
14:30 - 14:30 | Author(s): K.N. Franks
- Abstract
Background:
The SABRTooth trial aims to assess the feasibility of recruiting patients with stage I non-small cell lung cancer (NSCLC) to a study comparing surgery to stereotactic ablative radiotherapy (SABR). Both trial treatments were available outside of the trial. An embedded qualitative study aimed to explore reasons for non-participation or refusal to take up the randomised treatment arm in the SABRTooth trial to help identify factors that affect recruitment.
Methods:
Using in-depth qualitative interviews we aimed to interview sixteen patients not taking part in the trial across five sites using a pre-defined topic guide. The data were thematically analysed using a compare and contrast approach, identifying similarities and differences.
Results:
Fifteen patients have been approached so far for interview, ten opted out, five were interviewed. Although, from a limited sample there were three key themes affecting patients decision making that are similar to those reported in the literature. These were 1) treatment preferences 2) influence of personal contacts 3) influence of professionals. We interviewed patients about their experience of being offered the trial and reasons for their treatment preference. Patients described existing treatment preferences that were amenable to change in some cases. Their choice of treatment was subject to change throughout the process of being of being offered the trial and treatment options and was shaped by previous experience and knowledge. Treatment decisions were influenced by people in their close personal networks. Those that chose SABR had previous knowledge or experience of this treatment. Professionals could influence decisions by using specific phrases such as "surgery is your golden ticket" or comparing the effectiveness of treatments using percentages e.g. "surgery is 100% and SABR is 99.9%". Patients said they were happy with the way the trial was presented to them. However, they asked for time to come to terms with their diagnosis and then to be offered the trial alongside treatment options as early as possible to allow informed decision making.
Conclusion:
Information from interviews to date suggests that patients with NSCLC may prefer to be informed about clinical trial options at an early stage in their care pathway. This not only enables them to take account of all the information but also encourages equipoise when considering different treatment options. Treatment preferences should be explored to assess the basis for making a decision about taking part in the trial or choosing a particular treatment and to identify potential factors that could influence these decisions.
