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. PATIENTS AND 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. CONCLUSION: 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.
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. PATIENTS AND 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. CONCLUSION: 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: Arun Rajan; Corey A Carter; Arlene Berman; Liang Cao; Ronan J Kelly; Anish Thomas; Sean Khozin; Ariel Lopez Chavez; Isabella Bergagnini; Barbara Scepura; Eva Szabo; Min-Jung Lee; Jane B Trepel; Sarah K Browne; Lindsey B Rosen; Yunkai Yu; Seth M Steinberg; Helen X Chen; Gregory J Riely; Giuseppe Giaccone Journal: Lancet Oncol Date: 2014-01-15 Impact factor: 41.316
Authors: J Syrios; N Diamantis; E Fergadis; L Katsaros; M Logothetis; Iota Iakovidou; E Lianos; A Grivas; A E Athanasiou Journal: Med Oncol Date: 2014-06-07 Impact factor: 3.064
Authors: Giovannella Palmieri; Carlo Buonerba; Piera Federico; Luigi Formisano; Lucia Nappi; Giuseppe Di Lorenzo; Mirella Marino; Vincenzo Damiano Journal: World J Clin Oncol Date: 2012-07-10
Authors: Fabrizio Minervini; Laura Boschetti; Michael Gregor; Mariano Provencio; Virginia Calvo; Peter B Kestenholz; Savvas Lampridis; Davide Patrini; Pietro Bertoglio; L Filipe Azenha; Consolato M Sergi; Gregor J Kocher Journal: Gland Surg Date: 2021-11