Publications

Authors:

Palmieri, G; Merola, G; Federico, P; Petillo, L; Marino, M; Lalle, M; Milella, M; Ceribelli, A; Montella, L; Merola, C; Del Prete, S; Bergaglio, M; De Placido, S; Di Lorenzo, G

Title:

Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)

Year:

2010

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

A Stampa

Referee:

No

Name of journal:

ANNALS OF ONCOLOGY

ISSN of journal:

1569-8041

N° Volume:

21

Number or Folder:

6

Page numbers:

1168-1172

Keyword:

Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Deoxycytidine; Female; Fluorouracil; Humans; Male; Middle Aged; Neoplasm Metastasis; Neoplasms, Glandular and Epithelial; Pilot Projects; Salvage Therapy; Survival Analysis; Thymus Neoplasms

Short description of contents:

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.

Product ID:

127099

Handle IRIS:

11562/1066318

Last Modified:

March 28, 2023

Bibliographic citation:

Palmieri, G; Merola, G; Federico, P; Petillo, L; Marino, M; Lalle, M; Milella, M; Ceribelli, A; Montella, L; Merola, C; Del Prete, S; Bergaglio, M; De Placido, S; Di Lorenzo, G, Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs) «ANNALS OF ONCOLOGY» , vol. 21 , n. 6 , 2010 , pp. 1168-1172

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