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A phase II study of capecitabine in the treatment of ovarian cancer resistant or refractory to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) trial

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Abstract

Purpose

Capecitabine is an oral chemotherapeutic agent, already used in breast and colon cancer. Previous data showed encouraging results in the treatment of recurrent ovarian cancer. The aim of this study was to describe activity and toxicity of capecitabine in patients with platinum resistant or refractory ovarian cancer.

Methods

Patients were eligible if they had cytologically or histologically proven epithelial ovarian cancer, refractory or resistant to prior platinum-containing chemotherapy. Capecitabine was administered at the dose of 1,250 mg/m2 twice daily on days 1–14 of a 21-day cycle for a maximum of six cycles. The primary end point of the study was activity in terms of objective response rate in according to RECIST criteria. A two-stage minimax design for phase II studies was used: at least four objective responses had to be reached among 32 evaluable patients to define the treatment active.

Results

Between March 2006 and October 2007, 36 patients were enrolled. All patients had ovarian cancer and 83.3% had previously received two or three lines of chemotherapy. Thirty-two patients were evaluable for response and included in the activity analysis. The objective response rate was 3.1% [95% exact confidence interval (CI): 0.08–16.22%], lower than the threshold required to define the treatment as active. The median progression free survival was 68 days (95% CI: 65–120). Haematological toxicity was not frequent. Nausea and fatigue were common, but never severe, and they were observed in 13 (37.1%) and 12 (34.2%) patients, respectively. Diarrhoea occurred in 11 patients (31.5%) and it was of grade 3 in 8.6% of cases. Grade 1–2 stomatitis was observed in seven patients (20%). Cardiovascular toxicity was reported in two cases, including a death for pulmonary embolism.

Conclusions

Capecitabine is not active in platinum resistant non mucinous ovarian cancer, producing a response rate lower than that required by study design. Further trials are not warranted in these patients.

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Acknowledgments

Partially supported by AIRC. The Authors thank Alfonso Savio for informatic assistance. Roche supported the study giving capecitabine at no cost and a research grant, without any right of property of data nor any influence on protocol planning, study conduction, analysis and interpretation.

Conflict of interest statement

No conflict of interest declared by the authors.

Author information

Authors and Affiliations

  1. Oncologia Medica, Ginecologia, Medicina di Laboratorio, Anatomia Patologica, Istituto Nazionale Tumori, Naples, Italy

    Carmela Pisano, Stefano Greggi, Gerardo Beneduce, Simona Losito & Sandro Pignata

  2. Unità Sperimentazioni Cliniche, Istituto Nazionale Tumori, Naples, Italy

    Alessandro Morabito & Massimo Di Maio

  3. Oncologia Medica, Centro di Riferimento Oncologico, Aviano, Italy

    Roberto Sorio & Simona Scalone

  4. Oncologia Medica, Ospedale Ospedale S. Giovanni Calabita, Fatebenefratelli, Rome, Italy

    Enrico Breda & Vittorina Zagonel

  5. Oncologia Medica, Università Federico II, Naples, Italy

    Rossella Lauria & Valeria Forestieri

  6. Oncologia Medica, Università di Palermo, Casa di Cura La Maddalena, Palermo, Italy

    Vittorio Gebbia

  7. Oncologia Medica, Ospedale Ramazzini, Carpi, Italy

    Laura Scaltriti

  8. Cattedra di Biostatistica, Seconda Università di Napoli, Naples, Italy

    Ciro Gallo

  9. Dipartimento Uro-Ginecologico, Instituto Nazionale Tumori di Napoli, UOC Oncologia Medica, via M Semmola, 80131, Naples, Italy

    Sandro Pignata

Authors
  1. Carmela Pisano
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  2. Alessandro Morabito
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  3. Roberto Sorio
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  4. Enrico Breda
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  5. Rossella Lauria
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  6. Vittorio Gebbia
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  7. Laura Scaltriti
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  8. Simona Scalone
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  9. Vittorina Zagonel
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  10. Stefano Greggi
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  11. Gerardo Beneduce
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  12. Simona Losito
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  13. Ciro Gallo
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  14. Massimo Di Maio
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  15. Valeria Forestieri
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  16. Sandro Pignata
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Corresponding author

Correspondence to Sandro Pignata.

Appendix

Appendix

Participating Institutions and other coauthors

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Pisano, C., Morabito, A., Sorio, R. et al. A phase II study of capecitabine in the treatment of ovarian cancer resistant or refractory to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) trial. Cancer Chemother Pharmacol 64, 1021–1027 (2009). https://doi.org/10.1007/s00280-009-0958-0

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  • DOI: https://doi.org/10.1007/s00280-009-0958-0

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