Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours

Eur J Nucl Med Mol Imaging. 2008 Apr;35(4):743-8. doi: 10.1007/s00259-007-0688-7. Epub 2008 Jan 11.

Abstract

Purpose: 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.

MeSH terms

  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use
  • Capecitabine
  • Combined Modality Therapy
  • Creatinine / blood
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives*
  • Fluorouracil / therapeutic use
  • Gastrointestinal Neoplasms / drug therapy
  • Gastrointestinal Neoplasms / pathology
  • Gastrointestinal Neoplasms / radiotherapy
  • Humans
  • Injections, Intravenous
  • Leukocyte Count
  • Male
  • Neoplasm Metastasis
  • Neoplasm Staging
  • Neuroendocrine Tumors / drug therapy*
  • Neuroendocrine Tumors / pathology
  • Neuroendocrine Tumors / radiotherapy*
  • Octreotide / administration & dosage*
  • Octreotide / analogs & derivatives*
  • Octreotide / therapeutic use
  • Organometallic Compounds / administration & dosage
  • Organometallic Compounds / therapeutic use*
  • Pancreatic Neoplasms / drug therapy
  • Pancreatic Neoplasms / pathology
  • Pancreatic Neoplasms / radiotherapy
  • Platelet Count
  • Radioisotopes / administration & dosage
  • Radioisotopes / therapeutic use*
  • Receptors, Somatostatin / drug effects
  • Receptors, Somatostatin / physiology

Substances

  • Antimetabolites, Antineoplastic
  • Organometallic Compounds
  • Radioisotopes
  • Receptors, Somatostatin
  • Deoxycytidine
  • Capecitabine
  • lutetium Lu 177 dotatate
  • Creatinine
  • Octreotide
  • Fluorouracil