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Second-line chemotherapy with Capecitabine (Xeloda) and Docetaxel (Taxotere) in previously treated, unresectable adenocarcinoma of pancreas: the final results of a phase II trial

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Abstract

Purpose

To investigate the efficacy and toxicity of the docetaxel and capecitabine combination in patients with previously treated, unresectable adenocarcinoma of the pancreas.

Patients and Methods

Patients with pancreatic adenocarcinoma, pre-treated with gemcitabine-based chemotherapy, were treated with capecitabine (800 mg/m2 orally, twice a day for 14 days) and docetaxel (75 mg/m2 i.v, on day1), every 3 weeks. The primary end-point was overall response rate (RR).

Results

Thirty-one patients were enrolled in the study; 93.6% of them had a performance status (PS) of 0–1 and 96.8% had stage IV disease. Patients received a median of 4 cycles/patient, and the main reason for treatment discontinuation was disease progression. Partial response was observed in three (9.7%) patients, stable disease in seven (22.6%) (disease control rate: 32.3%, 95% CI: 15.80–48.71%) and disease progression in 21 (67.6%). The median progression-free survival (PFS) was 2.4 months (95% CI: 1.6–3.13) and the median overall survival (OS) was 6.3 months (95% CI: 3.38–9.23); the estimated 1-year survival rate was 14.7%. Grade III/IV neutropenia occurred in 10 (32.2%) patients and febrile neutropenia in one patient. Other severe non-hematologic toxicities were mild and manageable. After 2 chemotherapy cycles, pain control occurred in 20% of patients and stabilization of body weight in 40%.

Conclusion

The combination of docetaxel/capecitabine may confer good disease control associated with improvement of quality of life as second-line chemotherapy in patients with metastatic pancreatic cancer.

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Acknowledgments

This work was partly supported by a research grant from the Cretan Association for Biomedical Research (CABR).

Conflict of interest statement

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Authors and Affiliations

  1. Hellenic Oncology Research Group (HORG), 55 Lombardou str., 11470, Athens, Greece

    Ourania Katopodis, Aris Polyzos, Nikolaos Kentepozidis, Stylianos Giassas, Maria Rovithi, Vasiliki Bozionelou, Kostas Kalbakis, Lambros Vamvakas, Dimitris Mavroudis & Vassilis Georgoulias

  2. Department of Medical Oncology, University General Hospital of Heraklion, PO BOX 1352, 711 10, Heraklion, Crete, Greece

    Vassilis Georgoulias

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  1. Ourania Katopodis
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  2. Aris Polyzos
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Correspondence to Vassilis Georgoulias.

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Katopodis, O., Polyzos, A., Kentepozidis, N. et al. Second-line chemotherapy with Capecitabine (Xeloda) and Docetaxel (Taxotere) in previously treated, unresectable adenocarcinoma of pancreas: the final results of a phase II trial. Cancer Chemother Pharmacol 67, 361–368 (2011). https://doi.org/10.1007/s00280-010-1329-6

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