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Annals of Oncology Advance Access published online on October 30, 2009
Annals of Oncology, doi:10.1093/annonc/mdp483
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

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

G. Palmieri1,*, G. Merola1, P. Federico1, L. Petillo1, M. Marino2, M. Lalle3, M. Milella4, A. Ceribelli4, L. Montella5, C. Merola6, S. Del Prete5, M. Bergaglio7, S. De Placido1 and G. Di Lorenzo1

1 Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Napoli
2 Department of Pathology, Regina Elena National Cancer Institute, Rome
3 Medical Oncology Division, Ospedale S. Eugenio, Rome
4 Medical Oncology Division A, Regina Elena National Cancer Institute, Rome
5 Medical Oncology Division, Ospedale Frattamaggiore, Napoli
6 Medical Oncology Division, Casa di Cura ‘Villa Maria’, Mirabella Eclano, Avellino
7 Medical Oncology Unit, Villa Scassi Hospital, Genova, Italy

* Correspondence to: Dr G. Palmieri, Molecular and Clinical Endocrinology and Oncology Department, University Federico II, Via Pansini 5, 80128 Napoli, Italy. Tel: +39-081-7463660; Fax: +39-081-2203147; E-mail: giovpalm{at}unina.it

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.

capecitabine, gemcitabine, pretreated patients, thymic epithelial tumor

Received for publication May 15, 2009. Revision received September 1, 2009. Accepted for publication September 4, 2009.


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