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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4066 - “The German- Registry” of Incidental gallbladder cancer and the GAIN- phase III trial– transformation from a registry to treatment platform due to a trial in trial concept

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Tumour Site

Hepatobiliary Cancers

Presenters

Thorsten Götze

Citation

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

Authors

T.O. Götze1, V. Paolucci2, S. Al-Batran1

Author affiliations

  • 1 Institute Of Clinical Cancer Research, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 2 Surgical Deptartment, Ketteler- Krankenhaus, 63071 - Offenbach/DE
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Resources

Abstract 4066

Background

The biggest biliary platform in Europe - the German- Registry (GR) shows significant survival benefit for radical resection (RR) in gallbladder carcinoma. But nevertheless results for T2-3 are still disappointing even after RR.

Methods

For data analysis the GR was used. Currently more than 1100 cases of incidental gallbladder carcinoma (IGBC) are registered. Based on the GR a new multicenter a neoadjuvant trail (GAIN) with the support of the DFG (grant) /AIO/CALGP/ACO has been started in 20 centers in Germany and in addition a trial in trial concept, including GAIN and the GR is planned. GAIN is a randomized multicenter phase III study for T2-3 IGBC`s + resectable and borderline resectable biliary tract cancers (BTC), evaluating the role of neoadjuvant CTX with Gem/Cis in a multimodal setting in front of and after surgery vs. upfront surgery alone. If screened pts. is not eligible for curative treatment, pts. will be directly included in another 1st. line trial (trial- in- trial concept) under the direction of the GR. All IGBC`s in addition will be directly registered in the GR.

Results

In the GR (n > 1100pts) in T1b- T3 cases there is a significant survival benefit for patients with IRR. Wedge resection of the liver showed good data in T1b and T2. For T3 more radical techniques showed better results. Less than 50% of T2–3 tumors in the GR have had RR.

Conclusions

There is a significant benefit after RR in T1b- T3 IGBC but the results in T2-3 are disappointing like in the whole entity of BTC. Data of current (PRODIGE 12, BILCAP) adjuvant trials are inconsistent. Therefore the multimodal concept based on a biliary network is needed. The GAIN trial is supported by the DFG and is also supported by the German AIO and the German CALGP/ACO. Due to the trial in trial concepts patients screened for GAIN but are candidates for 1st line will be directly included in another 1st line trial without time delay so the project directly closes a healthcare gap. The data of the GR were already able to change the current treatment standards for GBCA in Germany, reflected by the current S3- Guidelines. So GR will now transform to treatment platform and potentially create a new way how to treat biliary pts.

Clinical trial identification

EudraCT: 2017-004444-38; DFG Projektnumber 316590476.

Legal entity responsible for the study

Krankenhaus Nordwest gGmbH Frankfurt.

Funding

DFG (Deutsche Forschungsgemeinschaft/ German Research Foundation) DFG- Projektnumber 316590476.

Editorial Acknowledgement

Disclosure

T.O. Götze: COI: MSD, Lilly, BMS, Celgene; Shire, Bayer. All other authors have declared no conflicts of interest.

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