title: Somatostatin analogs and prednisone in advanced refractory thymic tumors.
abstract: BACKGROUND
  Therapeutic options to cure advanced, recurrent, and metastatic thymic tumors are limited. Evidence of a high uptake of indium-labeled octreotide ((111)In-DTPA-D-Phe(1)-octreotide) in thymic tumors and the curative application of somatostatin analogs and prednisone in one patient with thymoma and pure red cell aplasia led the authors to start a Phase II study.
  
  
  METHODS
  Sixteen patients with advanced thymic tumors, unresponsive to conventional chemotherapeutic regimens, were enrolled in the study. The schedule includes administration of somatostatin analog octreotide (1.5 mg/day subcutaneously) associated with prednisone (0.6 mg/kg/day orally for 3 months, 0.2 mg/kg/day orally during follow-up). In 8 cases, octreotide was replaced by the long-acting analog lanreotide (30 mg/every 14 days intramuscolarly). Treatment was prolonged until progression of disease was documented. Overall response rate, survival, progression free survival, and toxicity were evaluated.
  
  
  RESULTS
  The overall response rate among 16 evaluable patients was 37%. One patient (6%) had a complete response, 5 (31%) had a partial response, 6 obtained a stabilization of disease, and 4 progressed during the treatment. After a median follow-up of 43 months, the median survival was 15 months, and median time to progression was 14 months. Treatment was generally well tolerated with acceptable toxicity: cholelithiasis (1 patient), Grade 2 cushingoid appearance (3 patients), Grade 1 diarrhea (5 patients), Grade 2 hyperglycemia (3 patients).
  
  
  CONCLUSIONS
  Treatment with somatostatin analogs and prednisone has shown efficacy in patients with recurrent and metastatic malignant thymic tumors refractory to standard therapeutic options. The results obtained are very satisfactory given the lack of effective alternative treatments. Such therapy is not burdened by the same toxicity of chemotherapy; thus, it can be administered to heavily pretreated patients. Somatostatin analogs and prednisone are well tolerated, and the long-acting analog lanreotide, which requires fewer injections, improves patients' compliance.
authors.affiliation: Department of Molecular and Clinical Endocrinology and Oncology, University of Naples Federico II, Naples, Italy. giovpalm@unina.it
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Liliana
authors.initials: L
authors.lastname: Montella
authors.forename: Angelo
authors.initials: A
authors.lastname: Martignetti
authors.forename: Pietro
authors.initials: P
authors.lastname: Muto
authors.forename: Dolores
authors.initials: D
authors.lastname: Di Vizio
authors.forename: Annarosaria
authors.initials: A
authors.lastname: De Chiara
authors.forename: Secondo
authors.initials: S
authors.lastname: Lastoria
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D010349:Patient Compliance; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology*; D016019:Survival Analysis; D013953:Thymus Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin; D015282:Octreotide; D011241:Prednisone