title: Assessment of the safety and efficiency of sunitinib malate in metastatic neuroendocrine tumours of the pancreas (NEN G1/G2) depending on the number and type of earlier therapeutic lines - initial report.
abstract: BACKGROUND
  The objective of this paper was to assess the safety and efficacy of sunitinib malate in patients with well-differentiated metastatic pancreatic neuroendocrine neoplasms (PNENs) who relapsed on standard therapy.
  
  
  METHODS
  Overall, eight patients with well-differentiated pancreatic neuroendocrine tumours/neoplasm (NET/NEN G1/G2, Ki-67 < 20%), who had relapsed on a standard therapy approach, were treated. All had non-resectable, progressive disease. All received therapy using a standard dose of sunitinib malate. Adverse events were evaluated using NCI-CTC AE v. 3.0.
  
  
  RESULTS
  Of the eight patients, seven had non-secretor and single secretor tumour (gastrinoma). Partial remission (PR) was noted in three patients (one after a single therapeutic line, two after two lines), five patients had stabilisation (SD) - including three individuals after three lines, one patient after two lines and another after a single line. Haematological adverse events: leukopenia (25%) - occurred in one patient after three lines and in one patient after two lines; anaemia (25%) - in one patient after three lines and in one patient after one therapeutic line. Mucocutaneous lesions were noted in 37.5% of patients after 2-3 lines of treatment. All of them experienced fatigue syndrome irrespective of the number of therapies. The majority of the patients simultaneously received somatostatin analogues, which did not exacerbate the toxicity profile. The median progression-free survival time (PFS) was 11 months.
  
  
  CONCLUSIONS
  Sunitinib may be considered as a fairly well-tolerated and effective therapeutic option in progressive non-resectable PNEN patients in the second and subsequent lines of treatment, irrespective of the types of treatment previously applied.
authors.affiliation: Division of Radiotherapy and Oncology, Department of Clinical Oncology, Silesian Medical University, Katowice, Poland. e.wachula@wp.pl.
authors.forename: Ewa
authors.initials: E
authors.lastname: Wachuła
authors.forename: Jarosław B
authors.initials: JB
authors.lastname: Ćwikła
authors.forename: Wojciech
authors.initials: W
authors.lastname: Rogowski
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Boratyn-Nowicka
authors.forename: Sylwia
authors.initials: S
authors.lastname: Szabłowska-Siwik
authors.forename: Michał
authors.initials: M
authors.lastname: Piątek
authors.forename: Anna
authors.initials: A
authors.lastname: Zemczak
authors.forename: Barbara
authors.initials: B
authors.lastname: Michalik
authors.forename: Barbara
authors.initials: B
authors.lastname: Jarząb
authors.forename: Sergiusz
authors.initials: S
authors.lastname: Nawrocki
authors.forename: Beata
authors.initials: B
authors.lastname: Kos-Kudła
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007970:Leukopenia / Q000139:chemically induced; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000473:pathology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib