Abstract

Introduction: The CRUK SMP2 programme was set-up to evaluate
the feasibility of performing large scale molecular analysis within the
NHS on the (often small) diagnostic biopsies obtained in NSCLC. The
results are used to allocate patients to an appropriate molecular therapy
within the “umbrella” MATRIX trial. Newcastle opened SMP2 on
01/10/2014. Here we report our first year’s experience.
Methods: NSCLC patients with PS 0–2 were consented onto the CRUK
SMP2. Matched residual diagnostic tissue and blood were sent to All
Wales Genetics Laboratory, Cardiff. Samples with >70ng DNA were
assessed for 28 oncogenes using Next Genuine Sequencing on the Illumina
SMP2 panel.
Results: 116 patients were consented from 6/10/14–1/10/15 referred
from 12 oncologists. The data on patient/sample flow is shown in Fig
1. Median survival was 161 days from consent. The 1st sample was
sent to Cardiff on 28/1/15 as the Illumina panel was undergoing fi-
nal validation. 50 samples have been sent; 11 had insufficient DNA;
these samples had lower cell number (but with no impact of necrosis/tumour
proportion); The most commonly altered gene was K-Ras
(13 of 22 adenocarcinomas). Only 2 patients with results from >25
of the 28 genes had no tier 1 or 2 ie potentially treatable molecular
abnormalities. The median time from consent to result was 109 days
(range 45–250) with delays occurring throughout the pathway.
Conclusion: Patients and oncologists are keen to be involved in
molecular profiling; but patients need to be consented early to allow
results to guide therapy. Prioritisation of samples is key. Not all
samples are suitable for analysis due to small cell number or low tumour
proportion. Molecular analysis may require extra resource in
pathology, if it is to become standard of care. The first 4 patients to
start treatment on MATRIX were enrolled from 27/8/15 in Newcastle.
Disclosure: All authors have declared no conflicts of interest.