Maintenance sunitinib or observation in metastatic pancreatic adenocarcinoma: A phase II randomised trial

Michele Reni, Stefano Cereda, Michele Milella, Anna Novarino, Alessandro Passardi, Andrea Mambrini, Giuseppe Di Lucca, Giuseppe Aprile, Carmen Belli, Marco Danova, Francesca Bergamo, Enrico Franceschi, Clara Fugazza, Domenica Ceraulo, Eugenio Villa

Research output: Contribution to journalArticle

Abstract

Background: New strategies to prolong disease control warrant investigation in patients with metastatic pancreatic adenocarcinoma. This open-label, randomised, multi-centre phase II trial explored the role of maintenance sunitinib after first-line chemotherapy in this setting. Methods: Patients with pathologic diagnosis of metastatic pancreatic adenocarcinoma, performance status >50%, no progression after 6 months of chemotherapy were centrally randomised by an independent contract research organisation, which was also responsible for data collection and monitoring, to observation (arm A) or sunitinib at 37.5 mg daily until progression or a maximum of 6 months (arm B). The primary outcome measure was the probability of being progression-free at 6 months (PFS-6) from randomisation. Assuming P0 = 10%; P1 = 30%, α.10; β.10, the target accrual was 26 patients per arm. Results: 28 per arm were randomised. One arm B patient had kidney cancer and was excluded. Sunitinib was given for a median of 91 days (7-186). Main grade 3-4 toxicity was thrombocytopenia, neutropenia and hand-foot syndrome (12%), diarrhoea 8%. In arm A versus B, PFS-6 was 3.6% (95% confidence interval (CI): 0-10.6%) and 22.2% (95% CI: 6.2-38.2%; P <0.01); 2y overall survival was 7.1% (95% CI: 0-16.8%) and 22.9% (95% CI: 5.8-40.0%; P = 0.11), stable disease 21.4% and 51.9% (P = 0.02). Conclusion: This is the first randomised trial on maintenance therapy in metastatic pancreatic adenocarcinoma. The primary end-point was fulfilled and 2y overall survival was remarkably high, suggesting that maintenance sunitinib is promising and should be further explored in this patient population.

Original languageEnglish
Pages (from-to)3609-3615
Number of pages7
JournalEuropean Journal of Cancer
Volume49
Issue number17
DOIs
Publication statusPublished - Nov 2013

Keywords

  • Anti-angiogenic therapy
  • Maintenance therapy
  • Metastatic disease
  • Pancreas
  • Pancreatic adenocarcinoma
  • Pancreatic cancer
  • Phase II trial
  • Randomised trial
  • Sunitinib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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  • Cite this

    Reni, M., Cereda, S., Milella, M., Novarino, A., Passardi, A., Mambrini, A., Di Lucca, G., Aprile, G., Belli, C., Danova, M., Bergamo, F., Franceschi, E., Fugazza, C., Ceraulo, D., & Villa, E. (2013). Maintenance sunitinib or observation in metastatic pancreatic adenocarcinoma: A phase II randomised trial. European Journal of Cancer, 49(17), 3609-3615. https://doi.org/10.1016/j.ejca.2013.06.041