Virtual Library
Start Your Search
Fergus Macbeth
Author of
-
+
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
-
+
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 | Author(s): Fergus Macbeth
- 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.
