Australian medical technology company Ferronova has announced preliminary findings from the MAGMAP multi-centre trial involving 62 gastric and oesophageal patients evaluating the safety and feasibility of a new nanoparticle-based platform to assist clinicians in identifying lymph nodes draining a primary cancer (sentinel nodes). The findings were presented today by principal investigator Dr Markus Trochsler at the 22^nd ISDE World Congress for Esophageal Diseases held in Kyoto, Japan.

The lead study site was Royal Adelaide Hospital with participating hospitals and research organisations including the Peter MacCallum Cancer Centre, Austin Hospital, the Olivia Newton John Cancer Research Institute, Flinders Medical Centre, The Queen Elizabeth Hospital, and the South Australian Health and Medical Research Institute Clinical & Research Imaging Centre.

Key findings

• FerroTrace® was administered to 62 patients with no toxicity related adverse events. 
• In 24 patients considered potentially suitable for a de-escalated surgical approach, 18 had pre-operative chemotherapy (75%). Sentinel nodes were identified in 23 of these patients (identification rate of 96%), no false negatives were observed among the seven node-positive patients evaluated (FNR=0%), and the patient level negative predictive value of sentinel node pathology was 100% (n=16).
• In 26 patients with gastric-oesophageal junction or distal oesophageal cancers 10 were node positive.  The FerroTrace sentinel node drainage direction corresponded to the positive node direction in all 10 patients.  Of 19 patients with Siewert Type I or II cancers, seven had drainage confirmed to the gastric lymphatic basin, highlighting the potential for lymphatic mapping to inform less extensive surgery in selected patients.
• Overall, 68% of patients had at least one identified sentinel lymph node outside the tissue removed using standard of care surgery.

Dr Trochsler said using radioisotopes and dyes for identification of lymph nodes draining a primary tumour is already a standard of care in breast cancer and melanoma and is highly effective. However, efforts to translate this technology to gastric and oesophageal cancer patients, who typically undergo chemotherapy or radiotherapy before surgery, have been unsuccessful to date.

"To our knowledge, this study was the first where a marker was injected prior to pre-surgical chemotherapy or radiotherapy and shown to persist and be detectable at the time of surgery.  The preliminary results are extremely promising.

"The absence of false-negatives and the high negative predictive value observed in this preliminary cohort of patients with earlier-stage disease are encouraging and suggest the potential to minimise surgery in selected patients. Future research will build on these findings by investigating a larger patient cohort. We hope this ongoing work will identify new opportunities to individually tailor treatment approaches."

Mr Geoff Parnell, GI cancer survivor, patient advocate, and Chair of GI Cancer Trials (Australia), said new developments to improve the patient experience were vital.

"Those with lived experience know the journey of a patient with oesophageal or stomach cancer isn't pretty," Mr Parnell said.

"I was lucky to have found the cancer very early and purely by accident, but the surgery and long recovery was tough.

"This new study sponsored by Ferronova will help us investigate approaches that improve quality of life for patients without compromising long-term survival, while ideally also improving overall outcomes. This is particularly important because the outlook for patients with gastric and oesophageal cancers remains relatively poor."

Ferronova's CEO Mr Stewart Bartlett and the clinical team will be at the Kyoto conference until Friday 18^th September at booth number 7.