Afinitor for carcinoid – pro

Everolimus has been approved by the US Food and Drug Administration (FDA) as the first oral, daily therapy (5 mg and 10 mg tablets) to treat advanced kidney cancer after failure of treatment with sunitinib or sorafenib. New data demonstrate that treatment with Afinitor® (everolimus) in combination with Sandostatin® LAR® (octreotide acetate suspension for injection) and Afinitor monotherapy may have the potential to stabilize tumour growth in patients with advanced pancreatic neuroendocrine tumours (NET).

Data from the study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), were first presented last year at the 12th World Congress on Gastrointestinal Cancer in Barcelona. Regulatory submissions for everolimus to treat this patient population are underway worldwide. Results from the trial showed that everolimus more than doubled median PFS from 4.6 to 11.0 months when compared with placebo and reduced the risk of cancer progression by 65% (hazard ratio [HR] =0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001) in patients with advanced pancreatic NET. After 18 months, 34% of patients treated with everolimus (95% CI, 26 to 43) were alive and progression-free versus 9% of those treated with placebo (95% CI, 4 to 16), showing a more prolonged benefit for patients treated with everolimus.

On February 9, 2011, The US Food and Drug Administration (FDA) has granted everolimus priority review designation for the application of advanced NET of gastrointestinal (GI), lung or pancreatic origin based on results of RADIANT-3 and another Phase III trial, RADIANT-2.

The indication also says that the safety and effectiveness of AFINITOR® in the treatment of patients with carcinoid tumors have not been established. however, several recent studies suggest that it is effective also in the carcinoid syndrome(Pavel, Rindi, Ring etal). NCCN lists it for carcinoid.

Yao, James C., Lombard-Bohas, Catherine, Baudin, Eric, Kvols, Larry K., Rougier, Philippe, Ruszniewski, Philippe, Hoosen, Sakina, St. Peter, Jessica, Haas, Tomas, Lebwohl, David, Van Cutsem, Eric, Kulke, Matthew H., Hobday, Timothy J., O’Dorisio, Thomas M., Shah, Manisha H., Cadiot, Guillaume, Luppi, Gabriele, Posey, James A., Wiedenmann, Bertram Daily Oral Everolimus Activity in Patients With Metastatic Pancreatic Neuroendocrine Tumors After Failure of Cytotoxic Chemotherapy: A Phase II Trial
J Clin Oncol 2010 28: 69-76

Yao JC. et al “A randomized, double-blind, placebo-controlled, multicenter phase III trial of everolimus in patients with advanced pancreatic neuroendocrine tumors (PNET)(RADIANT-3)” ESMO 2010; Abstract LBA 9.

Pavel M, et al “A randomized, double-blind, placebo-controlled, multicenter phase III trial of everollimus + octreotide versus placebo + octreotide LAR in patients with advanced neuroendocrine tumors (NET)(RADIANT-2)” ESMO 2010; Abstract LBA 8.

Pavel M, et al “Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumors associated with carcinoid syndrome: a randomized, placebo-controlled, phase 3 study” Lancet 2011140-6736(11)61742-x.

Rindi G, Caplin M “mTOR inhibitor therapy for patients with carcinoid” Lancet 2011; DOI: 10.1016/S0140-6736(11)61789-3.

Ping Gu, Treatment of Liver Metastases in Patients with Neuroendocrine Tumors of Gastroesophageal and Pancreatic Origin International Journal of HepatologyVolume 2012 (2012)


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