To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.

This was an open-label, multicenter, single-arm clinical study to evaluate the safety and efficacy of everolimus in Chinese adult patients with locally advanced, unresectable or metastatic, well differentiated progressive pancreatic neuroendocrine tumors. The inclusion and exclusion criteria, as well as the dosing and dose modification criteria are designed according to the approved Chinese Package Insert. The planned sample size of the study was approximately 60 subjects.

Subjects who were eligible received the treatment with everolimus provided by sponsor to treat pNET and followed the visit schedule in the protocol to collect safety and efficacy data until progression of disease, unacceptable toxicity, death, protocol deviation or other reason that may lead to discontinuation before the end of study. All subjects were followed-up for survival status every 6 months by the investigator until death, lost to follow-up, withdrawal of consent for survival or end of study.

The "End of study" is defined as either at least 75% of subjects have completed survival follow up or all subjects discontinued study treatment or the last subject finished 5-year survival follow up, whichever comes first. Final analysis was conducted at the end of the study.

Inclusion Criteria:

• Patients must have histological confirmed G1 or G2 pancreatic neuroendocrine tumors(pNETs) (WHO 2010)
• Patients must have radiological documentation of progression of disease per RECIST 1.1 within 12 months prior to enrollment.
• Measurable disease per RECIST 1.1 criteria using triphasic computed tomography (CT) scan or multiphase MRI for radiologic assessment.
• everolimus treatment which is recommended by the treating physician

Exclusion Criteria:

• Hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
• Patient who is unwilling to receive Afinitor treatment due to any reason.
• Pregnant or nursing (lactating) women,
• Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
• Use of an investigational drug within the 30 days prior to enrollment

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).

Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.