AspECT Trial - ASCO Chicago 2018
2 August 2018
Clinical Trials Our staff
In June, Claire Brooks attended the American Society of Clinical Oncology (ASCO) conference in Chicago where the AspECT trial results were presented. She writes here about both the conference and the challenging process of getting the results published in time!
The AspECT Trial ran in OCTO for 14 years, the final data lock took place on 31 August 2017 and the primary results were discussed at closed meetings in December 2017. The decision was taken to draft a paper for submission to the New England Journal of Medicine (NEJM), and to submit an abstract to ASCO in parallel.
The ASCO submission was accepted as a verbal presentation at the end of April and the primary paper was submitted to NEJM. The effort required in drafting the manuscript and fulfilling the administrative tasks should not be underestimated! Turnaround times were tight. A trial the scale of AspECT had 53 authors and forms for disclosures of interest from all of them had to be obtained. They all had to see and comment on the draft paper and their titles, qualifications and affiliations had to be checked.
There was then a flurry of activity as the NEJM immediately rejected the paper, as it appeared that the trial had not been registered on a publicly searchable database before the recruitment of the first participant. Fortunately, a copy of an email from the first sponsor institution (Leicester) from back in 2005 confirming the ISCRTN registration application and acknowledgement was located.
Further hurdles followed including, managing the ASCO presentation (scheduled for 4 June) and inevitable media interest; the rejection of the paper by NEJM; and preparation of a resubmission to the Lancet, which finally went in on 30 May. All the Principal Investigators needed to be informed that the results would be in the public domain on 4 June so that they could both know what the results were and be prepared to receive questions from the patients who were on the trial.
ASCO was incredible: 40,000 delegates in a conference centre with 4 buildings, 2.6 million sq. ft. of exhibition halls, 600,000 square feet of meeting room space - the theatre where AspECT was to be presented had capacity for 4,249 seats. There was so much going on; the programme for just one of the days was more than 300 pages long.
On the morning of the presentation, I searched the news for anything about aspirin and PPI. Cancer Research UK had sent out their press release and other media articles were coming up every minute. Once in the lecture theatre, it was a proud moment for me to hear the results of a trial I had been involved with for 11 years being announced at such a prestigious event.
Other highlights from ASCO for me were presentations about helping patients understand molecular testing; Ricky Sharma (chief investigator on the FOXFIRE trial) talking about treatment options for oligometastatic colorectal cancer, including the desire to do a trial of SBRT versus proton beam therapy; navigating the challenges of stratified medicine trials; FOLFIRINOX versus gemcitabine for patients with metastatic pancreatic cancer; and preoperative chemotherapy versus immediate surgery for borderline resectable pancreatic cancer. Unsurprisingly the buzzword was immunotherapy, with lots of results presentations of trials using checkpoint inhibitors.
Since my return I have been working to address the reviewers comments from the Lancet (48 hour turnaround this time as it was being reviewed fast-track) As I write this we do not yet know if the paper will be accepted by the Lancet but we are keeping our fingers crossed!