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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

1463 - CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET imaging and biological markers (SENECA study)

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

Presenters

Alberto Bongiovanni

Citation

Annals of Oncology (2018) 29 (suppl_8): viii467-viii478. 10.1093/annonc/mdy293

Authors

A. Bongiovanni1, S. Pusceddu2, S. Leo3, G. Di meglio4, F. Gelsomino5, F. Pucci6, R. Berardi7, S. Ricci8, I. Lolli9, F. Bergamo10, D. Campana11, D. Santini12, S. Tamberi13, D. Pastorelli14, M. Cives15, N. Silvestris16, A. Russo17, A. Buonadonna18, F. FOca19, T. Ibrahim20

Author affiliations

  • 1 Osteoncology And Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. IRCCS, 47014 - Meldola/IT
  • 2 Department Of Medical Oncology, Fondazione IRCCS Istituto Naz, 20133 - Milan/IT
  • 3 Medical Oncology, Ospedale Vito Fazzi, Lecce/IT
  • 4 Medical Oncology, Hospital of Bolzano, 39100 - Bolzano/IT
  • 5 Medical Oncology, University Hospital of Modena, 41100 - Modena/IT
  • 6 Medical Oncology, Department Of Medicine And Surgery, University Hospital of Parma, 43121 - parma/IT
  • 7 Clinical Oncology, Dept. Of Internal Medicine, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 8 Medical Oncology 1 Unit, Azienda Ospedaliero-Universitaria S.Chiara, 56121 - Pisa/IT
  • 9 Medical Oncology Unit, IRCCS Saverio de Bellis, Castellana Grotte/IT
  • 10 Medical Oncology Unit 1, Department Of Clinical And Experimental Oncology, Veneto Institute of Oncology IOV - IRCCS, Padula/IT
  • 11 Medical Oncology, Policlinico Sant'Orsola-Malpighi, 40138 - Bologna/IT
  • 12 Oncology, Campus Bio-Medico di Roma, 128 - Rome/IT
  • 13 Oncology, Ospedale degli Infermi, 48018 - Faenza/IT
  • 14 Oncology Unit, Ospedale Civile, 32032 - Feltre/IT
  • 15 Gi Oncology, University of Bari, 70121 - Bari/IT
  • 16 Oncology, Ospedale Oncologico "Giovanni Paolo II"- IRCCS, bari/IT
  • 17 Oncology Unit, AOU Policlinico "Paolo Giaccone", 90127 - Palermo/IT
  • 18 Oncology, CRO di Aviano, 33081 - Aviano/IT
  • 19 Biostatistic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. IRCCS, 47014 - Meldola/IT
  • 20 Osteoncology And Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 - Meldola/IT
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Resources

Abstract 1463

Background

Patients with metastatic or locally advanced, non-resectable, grade 3 neuroendocrine carcinoma (NEC) of the lung or gastroenteropancreatic system (GEP NEC) are usually treated with first-line platinum-based chemotherapy. There is no standard second-line treatment when progression occurs. Different second-line chemotherapy combinations have been evaluated retrospectively, but with poor results. FOLFIRI was evaluated in a retrospective monocentric study, showing a disease control rate (DCR) of 62%. In another retrospective study, temozolomide-based chemotherapy obtained a DCR of 71%. There is growing evidence that the current grading system for NECs has a number of inconsistencies, highlighting the need for more accurate biomarkers to better understand the natural history of this very aggressive disease.

Trial design

SENECA study is a randomized, non-comparative, multicenter phase II trial designed to evaluate the efficacy and safety of FOLFIRI or capecitabine plus temozolomide (CAPTEM) after failure of first-line treatment in lung and GEP NECs. Primary aim is to assess DCR of the regimens, with safety as a co-primary. Secondary aims are the evaluation of overall survival (OS), progression-free survival (PFS) and quality of life. It is also planned to assess Gallium-PET/CT and tissue and circulating biomarkers as prognostic and predictive factors. Eligibility criteria are age ≥18 years, metastatic or locally advanced, non-resectable, lung or GEP NEC, and documented evidence of progressive disease during or after first-line platinum-based chemotherapy (cisplatin/carboplatin and etoposide; FOLFOX4 or CAPOX). Each patient is randomized to receive FOLFIRI or CAPTEM, considering Ki-67 (21-55 % vs > 55%) and primary tumor site (lung vs. GEP) as stratification factors. The randomized study design allows for two active treatments to be evaluated in a comparable patient population. Analysis will be performed for each regimen separately. 56 patients will be enrolled in each arm of the study (total of 112 patients). Sixteen centers are taking part in the study and recruitment is ongoing. The first patient was randomized on March 6, 2017.

Clinical trial identification

IRST100.22

Legal entity responsible for the study

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, FC, Italy.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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