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Poster Discussion session -Gastrointestinal, non-colorectal

3339 - Progression-free survival and recurrence results for AGITG DOCTOR. Pre-op cisplatin, 5FU & DOCetaxel +/-radioTherapy after poOR early response to cisplatin & 5FU for resectable oesophageal adenocarcinoma.

Date

19 Oct 2018

Session

Poster Discussion session -Gastrointestinal, non-colorectal

Presenters

Andrew Barbour

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

A.P. Barbour1, E.T. Walpole2, G.T. Mai3, L. Barnes4, D.I. Watson5, S.P. Ackland6, V. Wills7, J. Martin8, M. Burge9, C.S. Karapetis10, J. Shannon11, L.M. Nott12, V. Gebski13, M. Oostendorp14, K. Wilson14, J. Thomas15, G. Lampe16, J.R. Zalcberg17, J. Simes18, M. Smithers1

Author affiliations

  • 1 Department Of Surgery, Princess Alexandra Hospital, 4102 - Woolloongabba/AU
  • 2 Department Of Medical Oncology, Princess Alexandra Hospital, 4102 - Woolloongabba/AU
  • 3 Department Of Radiation oncology, Princess Alexandra Hospital, 4102 - Woolloongabba/AU
  • 4 Biostatistics, NHMRC Clinical Trials Centre, 2050 - Sydney/AU
  • 5 Department Of Surgery, Flinders Medical Centre, 5042 - Adelaide/AU
  • 6 Department Of Medical Oncology, Calvary Mater Hospital Newcastle, 2298 - Newcastle/AU
  • 7 Department Of Surgery, John Hunter Hospital, 2035 - New Lambton Heights/AU
  • 8 Department Of Radiation oncology, Calvary Mater Hospital Newcastle, 2298 - Newcastle/AU
  • 9 Department Of Medical Oncology, Royal Brisbane and Women's Hospital, 4006 - Brisbane/AU
  • 10 Department Of Medical Oncology, Flinders Centre for Innovation in Cancer, 5042 - Bedford Park/AU
  • 11 Department Of Medical Oncology, Nepean Cancer Care Centre, 2747 - Kingswood/AU
  • 12 Department Of Medical Oncology, Royal Hobart Hospital, 7005 - Tasmania/AU
  • 13 Biostistics, NHMRC Clinical Trials Centre, 2050 - Sydney/AU
  • 14 Oncology, NHMRC Clinical Trials Centre, 2050 - Sydney/AU
  • 15 Clinical Trials Research, Mater Misericodiae Research Institute, 4102 - South Brisbane/AU
  • 16 Department Of Anatomical Pathology, Princess Alexandra Hospital, 4102 - Woolloongabba/AU
  • 17 Department Of Medical Oncology, Alfred Hospital, 3004 - Melbourne/AU
  • 18 Clinical Trials Research, The NHMRC Clinical Trials Centre, 2050 - Camperdown/AU
More

Resources

Abstract 3339

Background

Resectable oesophageal and gastro-oesophageal junction adenocarcinoma patients (pts) without early metabolic response (EMR) to chemotherapy as defined by 18-FDG-PET (PET) show poor survival and major histological response rates (RR) <5%. This multicentre trial previously reported changing neoadjuvant therapy improved major histological RR for early metabolic non-responders (MNR). Grade 3/4 toxicities were seen in 27% of pts on 5-FU + cisplatin (CF); 42% on docetaxel + CF (DCF) and 71% on DCF + concurrent 45Gy radiotherapy (DCFRT). Updated results now report progression-free survival (PFS) and local recurrence.

Methods

Pts had a day 15 PET scan after induction CF. Early metabolic responders (SUVmax decreasing by ≥ 35% from baseline to day 15 PET) received a 2nd CF cycle then oesophagectomy. Early metabolic non-responders were centrally randomised 1:1 to 2 cycles of DCF or DCFRT then oesophagectomy. Primary endpoint was major histological RR (<10% residual tumour). Seconday endpoints were PFS and local recurrence.

Results

From 2009 -2016, 124 pts were recruited. 45 were deemed early metabolic responders. 77 were deemed early metabolic non-responders and 31 allocated DCF and 35 to DCFRT. 11 were not randomised (progression, toxicity, refusal). 2 were not evaluable. Major histological response rates: 7% EMR (CF); 20% DCF; 63% DCFRT. Local recurrence: 5/45 (11%) EMR (CF); 10/31 (32%) MNR allocated DCF; 4/35 (11%) MNR allocated DCFRT. PFS at 36m: 46% (95% CI 31-60%) for EMR; 31% (95% CI 16-48%) for MNR allocated DCF; 46% (95% CI 29- 61%) MNR allocated to DCFRT.

Conclusions

Early metabolic response to CF alone is associated with favourable PFS and low local recurrence rate despite a low major histological RR. The addition of docetaxel in MNR group may augment histological RR but PFS & local recurrence outcomes remained inferior. Further addition of RT to DCF produced the highest histological RR and PFS/local recurrence outcomes matching EMR group. Early PET can enable tailoring of therapy to ‘close the gap’ in outcomes between early metabolic response and early metabolic non-response patients.

Clinical trial identification

Australian New Zealand Clinical Trials Registry: 12609000665235.

Legal entity responsible for the study

The Australasian Gastro-Intestinal Trials Group (AGITG).

Funding

The National Health and Medical Research Council, Australia.

Editorial Acknowledgement

No editorial assistance was accessed for this abstract.

Disclosure

All authors have declared no conflicts of interest.

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