Meeting
2020 ASCO Virtual Scientific Program
Australasian Gastrointestinal Trials Group (AGITG) CONTROL NET Study: Phase II study evaluating the activity of 177Lu-Octreotate peptide receptor radionuclide therapy (LuTate PRRT) and capecitabine, temozolomide CAPTEM)—First results for pancreas and updated midgut neuroendocrine tumors (pNETS, mNETS).
Authors
Nick Pavlakis
Northern Cancer Institute, St Leonards, Sydney, Australia
Nick Pavlakis , David Turner Ransom , David Wyld , Katrin Marie Sjoquist , Rebecca Asher , Val Gebski , Kate Wilson , Andrew Ddembe Kiberu , Matthew E. Burge , William Macdonald , Paul Roach , David A. Pattison , Patrick Butler , Timothy Jay Price , Michael Michael , Benjamin James Lawrence , Dale L. Bailey , Simone Leyden , John Raymond Zalcberg , J. Harvey Turner
Organizations
Northern Cancer Institute, St Leonards, Sydney, Australia, St John of God Clinic, Subiaco, Australia, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, NHMRC CTC Centre, University of Sydney, Camperdown, Sydney, Australia, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, Sydney, Australia, Royal Perth Hospital, Perth, WA, Australia, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia, Fiona Stanely Hospital, Perth, Australia, Royal North Shore Hospital, St Leonards, Australia, Royal Brisbane and Women’s Hospital, Brisbane, Australia, St George Hospital, Sydney, Australia, Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia, Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia, Yale Univ, Easton, CT, PharmaScint, Sydney, Australia, Unicorn Foundation, Victoria, Australia, Peter MacCallum Cancer Centre, Melbourne, Australia
Research Funding
Other
Unicorn Foundation, Tour de Cure Australia
Background: CAPTEM is an accepted regimen for patients (pts) with advanced pNETs. Single agent 177Lu-Octreotate PRRT is now a standard of care for progressive WHO Grade (G) 1/2 mNETs. High activity was seen with LuTate/CAPTEM in a single arm Phase I/II trial. This study was undertaken to determine the relative activity of adding CAPTEM to LuTate PRRT in pts with mNETs and pNETs. Methods: Non-comparative randomised open label parallel group phase II trial with 2:1 randomisation to PRRT/CAPTEM (experimental arm) vs. PRRT (mNETs control) and CAPTEM (pNETS control). PRRT/CAPTEM: 7.8GBq LuTate day(D) 10, 8 weekly (wkly) x 4, with b.i.d. oral CAP 750mg/m2 D1-14 & TEM 75mg/m2D10-14, 8 wkly x 4; PRRT: 8 wkly x 4; CAPTEM 8 wkly x 4. Primary endpoint: Progression free survival (PFS). mNETS- at 15 months (mo) assuming 15mo PFS 66.4% in control arm, aiming for PFS ³ 80%; pNETS- at 12mo assuming 12mo PFS 60% in control arm, aiming for PFS ³ 75%. Secondary endpoints: Objective tumour response rate (complete or partial) (OTRR), clinical benefit rate (OTRR, stable disease) (CBR), toxicity, quality of life. Results: 75 pts enrolled (Dec 2015 – Nov 2018): mNETs 33 PRRT/CAPTEM and 14 PRRT; pNETS 19 PRRT/CAPTEM and 9 CAPTEM. mNETS: Median follow-up 35mo; 15mo PFS was 90% (95% CI: 73-97%) v 92% (95% CI: 57-99%); OTRR 31% vs 15%; and CBR 97% vs 92% for PRRT/CAPTEM v PRRT respectively. Treatment related adverse events (AEs): 24/32 PRRT/CAPTEM pts had at least one G3 event (75%) vs 5/13 (38%, PRRT); and 4/32 pts at least one G4 event (13%) v 1/13 (8%) respectively, mostly haematologic (haem). Only one patient failed to complete therapy (PRRT/CAPTEM). pNETS: Median follow-up 34mo; 12mo PFS was 76% (95% CI: 48-90%) v 67% (95% CI: 28-88%); OTRR 68% vs 33%; and CBR 100% vs 100% for PRRT/CAPTEM v CAPTEM respectively. Treatment related AEs: 5/18 PRRT/CAPTEM pts had at least one G3 event (28%) vs 3/9 (33%) CAPTEM; 3/18 pts at least one G4 event (17%) v 1/9 (11%) respectively. Conclusions: CAPTEM/PRRT is active, meeting its target landmark PFS for CAPTEM/PRRT (12mo pNETs; 15mo mNETs) with numerically greater OTRR in both pNETs and mNETs, but with more haem toxicity in mNETs. As activity was high in both control arms longer follow up is required to determine if the relative activity of PRRT/CAPTEM is sufficient to warrant Phase III evaluation. Clinical trial information: ACTRN12615000909527.
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Abstract Details
Session Type
Poster Session
Session Title
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Track
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Sub Track
Neuroendocrine/Carcinoid
Clinical Trial Registration Number
ACTRN12615000909527
Citation
J Clin Oncol 38: 2020 (suppl; abstr 4608)
DOI
10.1200/JCO.2020.38.15_suppl.4608
Abstract #
4608
Poster Bd #
216
Abstract Disclosures
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