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

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

来源：European Journal of Cancer, 2013, 49(17): 3609-3615.

DOI：10.1016/j.ejca.2013.06.041

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

Background: New strategies to prolong disease control warrant investigation in patients with metastatic pancreatic adenocarcinoma. This open-label, randomised, multicentre 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%, alpha .10; beta .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.

• 出版日期2013-11