title: Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs).
abstract: BACKGROUND
  No previous prospective trials have been reported with capecitabine and gemcitabine (CAP-GEM) in patients with metastatic thymic epithelial tumors (TETs). We conducted a multicenter study to determine the activity and tolerability of this regimen in pretreated TETs.
  
  
  METHODS
  A total of 15 patients were enrolled in the first stage of phase II study. All patients received CAP-GEM every 3 weeks. The primary end point was objective response rate (RR); secondary end points were toxicity, progression-free survival (PFS) and overall survival.
  
  
  RESULTS
  Complete responses (CR) and partial responses were observed in three (20%) and three (20%) patients for a 40% RR, respectively. Grade 1-2 neutropenia, anemia and thrombocytopenia were the most common side-effects, noted in seven (46.7%), five (33.3%) and five (33.3%) patients, respectively. The most common grade 3 toxicity was neutropenia in three patients (20%). Median PFS was 11 months (95% confidence interval 4-17). The 1- and 2-year survival rates were 80% and 67%, respectively.
  
  
  CONCLUSIONS
  We have decided to publish the preliminary results because this regimen was more active than that expected. Although our results are preliminary, CAP-GEM shows activity and safety in pretreated TETs. Furthermore, multicenter trials, also in first-line setting, are necessary to confirm our results.
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli. Electronic address: giovpalm@unina.it.
authors.forename: G
authors.initials: G
authors.lastname: Palmieri
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli.
authors.forename: G
authors.initials: G
authors.lastname: Merola
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli.
authors.forename: P
authors.initials: P
authors.lastname: Federico
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli.
authors.forename: L
authors.initials: L
authors.lastname: Petillo
authors.affiliation: Department of Pathology, Regina Elena National Cancer Institute, Rome.
authors.forename: M
authors.initials: M
authors.lastname: Marino
authors.affiliation: Medical Oncology Division, Ospedale S. Eugenio, Rome.
authors.forename: M
authors.initials: M
authors.lastname: Lalle
authors.affiliation: Medical Oncology Division A, Regina Elena National Cancer Institute, Rome.
authors.forename: M
authors.initials: M
authors.lastname: Milella
authors.affiliation: Medical Oncology Division A, Regina Elena National Cancer Institute, Rome.
authors.forename: A
authors.initials: A
authors.lastname: Ceribelli
authors.affiliation: Medical Oncology Division, Ospedale Frattamaggiore, Napoli.
authors.forename: L
authors.initials: L
authors.lastname: Montella
authors.affiliation: Medical Oncology Division, Casa di Cura 'Villa Maria', Mirabella Eclano, Avellino.
authors.forename: C
authors.initials: C
authors.lastname: Merola
authors.affiliation: Medical Oncology Division, Ospedale Frattamaggiore, Napoli.
authors.forename: S
authors.initials: S
authors.lastname: Del Prete
authors.affiliation: Medical Oncology Unit, Villa Scassi Hospital, Genova, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Bergaglio
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli.
authors.forename: S
authors.initials: S
authors.lastname: De Placido
authors.affiliation: Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli.
authors.forename: G
authors.initials: G
authors.lastname: Di Lorenzo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010865:Pilot Projects; D016879:Salvage Therapy; D016019:Survival Analysis; D013953:Thymus Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine