PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment

N/AUnknownNCT04331912

University of Warmia and Mazury100 enrolled

Overview

This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. Systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib and everolimus), chemotherapy and peptide radioisotope therapy (Peptide Receptor Radionuclide Therapy). The data of patients with advanced NEN with histopathological or/and clinical or/and biochemical confirmation is collected from medical records. Neuroendocrine cancer from digestive system, respiratory system and another rarely occurring cancer including cancer connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx will be included. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. Analyzed factors: age, sex, ethnicity, specific symptoms at the time of diagnosis, carcinoid heart disease, level of 5HIAA in DZM, level of CgA, liver test, size of tumor, cell differentiation of tumor based on Ki-67 index, liver metastases. The research will be conducted for above 3 years since July 2019 till December 2022 on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment. The second goal is to create clinical practice recommendation based on potential prognostic factors of OS and PFS due to type of therapy in different NEN subgroups.

Study Type

OBSERVATIONAL

Enrollment

100

Eligibility

Sex: ALLMin age: 18 YearsMax age: 87 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥18 years old, male or female, * Patients with histopathological confirmation of advanced neuroendocrine cancer (NEN), * Patients with NETG1, NETG2 based on Ki-67, * Patients with diagnosed NEN, who did not receive prior treatment and were qualified to systemic treatment, * Patients with advanced NEN who previously received first-line systemic therapy or second-line systemic therapy, * Patients with advanced, inoperable NEN cancer before the treatment, during the treatment and after the treatment regardless of lines of systemic therapy, * Patients with diagnosed NEN and performance status (PS) ≤3 according to ECOG/WHO classification, who received systemic therapy. Exclusion Criteria: * Patients without histopathological confirmation of neuroendocrine carcinoma (NEN), * Patients with diagnosed another type of cancer or benign tumor confirmed in histopathological examination, * Patients treated prior with intention to treat (ITT), * Patients with residual disease in further clinical follow-up without active systemic treatment, * Patients with advanced, progressive and poor performance status, who were disqualified from further systemic treatment, * Patients, who finished treatment during first month or their further disease process was unknown.

Outcomes

Primary Outcomes

PFS - Progression Free Survival

the time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy). Patients without progression at the time of analysis will be censored.

Time frame: 7 years

OS - Overall Survival

is defined as the time from the start of systemic treatment date to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Time frame: 7 years

Secondary Outcomes

Log-rank test

assessment of differences in survival of patients between subgroups

Time frame: 7 years

Cox proportional-hazards model

uni- and multivariate analyses used for investigating the association between the survival time of patients and prognostic factors

Time frame: 7 years

PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment

Overview

Conditions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts