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Michael Shackcloth
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P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.16-02 - Randomising Patients into Trials of Thoracic Cancer Surgery: An Analysis of Patient and Cancer Team Behaviour in Practice (Now Available) (ID 984)
10:15 - 18:15 | Presenting Author(s): Michael Shackcloth
- Abstract
Background
Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) is a multicentre trial funded by Cancer Research UK. In Stage 1 participants were invited to consent for further evaluation within the PulMiCC protocol and if eligible were offered randomisation (Stage 2) to lung metastasectomy or continued active monitoring. Noting a decreasing rate of randomisation during 2016, the Data Monitoring Committee recommended that the reasons should be investigated.
Method
The three most actively recruiting centres were approached and asked to provide reasons for patients in Stage 1 not being randomised and to provide data according to the fields in the first column of the table. We sought to discover who made the decision to not randomise and to establish what clinical management was then followed. If participants were deemed ineligible we asked for the reason.
Result
Of 155 patient participants consented into Stage 1 of the trial, and after full information and counselling during the period of assessment, 41 elected to make their own decision. The split to have or not have metastasectomy was 22:19. When the clinicians made the decision 77/78 (99%) patients had metastasectomy. Full data are given in the table. Ten patients had other pathology, nine lung cancer and one carcinoid. The protocol placed no constraint on the number of metastases but one unit set its own limits at 2-4 deeming patients outside as not eligible for randomisation but as suitable for metastasectomy.
ConclusionReasons for not randomising a sample of 155 registered patients Patients elected to make their own decision 41 Chose metastasectomy 22 (54%) Chose to not have metasasectomy 19 (46%) Clinical team overrode the trial protocol 78 Metastasectomy 77(99%) Non-operative management 1 (1%) Primary lung neoplasia 10 Deemed ineligible 18 Local interpretation of the trial protocol 9 Undecided at time of data collection 8 Total sample 155
At trial closure, of 512 patients in Stage 1, 82% were not randomised resulting in an inconclusive result despite the efforts of many doctors and scientists and the participation of a large number of patients. In the sample of 155 drawn from the three most active centres, 78 patients deemed eligible had the decision made for them by the clinical team and of the 18 deemed ineligible, half of the reasons were not aligned with the written protocol. That means at least 56% of the patients were lost to randomisation by clinicians' decisions.The 41 patients who elected to make their own decision, to have or not have metastasectomy, did so in numbers which better reflected equipoise. The difficulty faced by clinicians in declaring uncertainty is well recognised. In PulMiCC this resulted in exclusion of many patients who had given their informed consent. Learning from this and similar experiences, later UK trials of thoracic oncology (MARS-2, VIOLETS) have recruited well after specific training in the QuinteT method for randomisation into surgical trials.
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.06 - In Hospital Clinical Efficacy, Safety and Oncologic Outcomes from VIOLET: A UK Multi-Centre RCT of VATS Versus Open Lobectomy for Lung Cancer (Now Available) (ID 1257)
08:00 - 10:15 | Author(s): Michael Shackcloth
- Abstract
- Presentation
Background
VATS is currently the most popular form of access for lung cancer resection in the UK. However, there is limited comparative information from high quality randomised controlled trials and no information on early oncologic outcomes for quality assurance for a minimal access approach. VIOLET is the largest randomised trial conducted to date to compare clinical efficacy, safety and oncologic outcomes of VATS versus open surgery for lung cancer.
Method
VIOLET is a parallel group randomised trial conducted across 9 UK thoracic surgery centres. Participants with known or suspected primary lung cancer were randomised in a 1:1 ratio to VATS (one to four ports) or open lobectomy. Randomisation was stratified by surgeon. Patients within clinical stage cT1-3, N0-1 and M0 using TNM 8 with disease suitable for VATS or open surgery were eligible to join the trial. We report on early outcomes in the period from randomisation to hospital discharge after surgery.
Result
From Jul 2015 to Feb 2019, 2,109 patients were screened to randomise 503 participants to VATS (n=247) or open (n=256) lobectomy. The mean age (SD) was 69 (8.8) years and 249 (49.5%) were male. Baseline clinical T category was cT1 333 (67.3%), cT2 125 (25.2%), cT3 37 (7.5%) with cN0 466 (94%) and cN1 30 (6%). Lobectomy was undertaken in 221 (89.5%) patients randomised to VATS and 232 (90.6%) patients randomised to open surgery. The in-hospital mortality rate was 1.4% (7/502) and the conversion rate from VATS to open was 5.7% (14/246) with the main reasons listed as pleural adhesions (n=4) and bleeding (n=4).
There were no differences in R0 resection; which was 98.8% (218/223) in the VATS group and 97.4% (228/234) in the open group; P=0.839 or in nodal upstaging from cN0/1 to pN2 disease which was observed in 6.2% (15/244) of the VATS group and 4.8% (12/252) of the open group; P=0.503.
The median (visual analogue) pain score was 4 (interquartile range, IQR 2 to 5) in both groups on day one with 3 (1 to 5) in the VATS group and 4 (2 to 5) in the open group on day two.
A significant reduction of overall in-hospital complications was observed in patients receiving VATS at 32.8% (81/247) compared to open 44.3% (113/255) surgery; P=0.008 without any difference in serious adverse events between the two groups, which was 8.1% (20/247) for VATS and 7.8% (20/255) for open surgery; P=0.897.
Patients randomised to VATS had a shorter median (IQR) length of stay of 4 (3 to 7) versus 5 (3 to 8) days compared to patients randomised to open surgery, P=0.008.
Conclusion
In early stage lung cancer, VATS lobectomy is associated with significantly lower in-hospital complications and shorter length of stay compared to open lobectomy. This was achieved without any compromise to early oncologic outcomes (pathologic complete resection and upstaging of mediastinal lymph nodes) nor any difference in serious adverse events in the early post-operative period.
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