title: Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours.
abstract: OBJECTIVE
  Treatment with the radiolabelled somatostatin analogue (177)Lu-octreotate results in tumour remission in 47% of patients with gastroenteropancreatic neuroendocrine tumours. Adding capecitabine to (177)Lu-octreotate, as a radio-sensitiser, may enhance these anti-tumour effects. We now present the short-term toxicity profile of this novel combination.
  
  
  METHODS
  Seven patients were treated with 7.4 GBq (177)Lu-octreotate and capecitabine (1650 mg/m(2) per day) for 2 weeks with an intended number of four cycles. Toxicity, and especially haematological and renal parameters, were monitored on a weekly basis for the first two cycles and 4 and 6 weeks after subsequent cycles.
  
  
  RESULTS
  None of the patients had hand-foot syndrome. One patient had grade 1 stomatitis occurring after one of four cycles. Grade 3 or 4 leukopenia or neutropenia did not occur. One patient had grade 3 anaemia, but none had grade 4 anaemia. One patient had grade 2 thrombocytopenia after the fourth cycle, and one had grade 3 thrombocytopenia. Grade 4 thrombocytopenia did not occur. No significant changes in serum creatinine levels were observed. None of the patients had symptoms of cardiac ischaemia.
  
  
  CONCLUSIONS
  Treatment with the combination of (177)Lu-octreotate and capecitabine was feasible and safe considering acute and subacute side effects. We therefore started a randomised, controlled clinical trial to compare this combination with (177)Lu-octreotate as single agent with regard to anti-tumour effects and side effects.
authors.affiliation: Department of Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands. m.vanessen@erasmusmc.nl
authors.forename: Martijn
authors.initials: M
authors.lastname: van Essen
authors.forename: Eric P
authors.initials: EP
authors.lastname: Krenning
authors.forename: Boen L
authors.initials: BL
authors.lastname: Kam
authors.forename: Wouter W
authors.initials: WW
authors.lastname: de Herder
authors.forename: Maarten O
authors.initials: MO
authors.lastname: van Aken
authors.forename: Dik J
authors.initials: DJ
authors.lastname: Kwekkeboom
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003404:Creatinine / Q000097:blood; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D007275:Injections, Intravenous; D007958:Leukocyte Count; D008297:Male; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D015282:Octreotide / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D010976:Platelet Count; D011868:Radioisotopes / Q000008:administration & dosage / Q000627:therapeutic use*; D017481:Receptors, Somatostatin / Q000187:drug effects / Q000502:physiology
chemical_list: D000964:Antimetabolites, Antineoplastic; D009942:Organometallic Compounds; D011868:Radioisotopes; D017481:Receptors, Somatostatin; D003841:Deoxycytidine; D000069287:Capecitabine; C447941:lutetium Lu 177 dotatate; D003404:Creatinine; D015282:Octreotide; D005472:Fluorouracil