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Mitomycin C and capecitabine in pretreated patients with metastatic gastric cancer: a multicenter phase II study

  • Manuel Barreto Miranda
  • Jörg Thomas Hartmann
  • Salah-Eddin Al-Batran
  • Melanie Kripp
  • Deniz Gencer
  • Andreas Hochhaus
  • Ralf-Dieter Hofheinz
  • Kirsten MerxEmail author
Original Article – Clinical Oncology

Abstract

Purpose

We conducted a multicenter phase II study to assess the toxicity and efficacy of a combination of mitomycin C (MMC) and capecitabine in pretreated patients with metastatic or locally advanced gastric cancer.

Methods

Thirty-nine patients (77 % male) between 33 and 78 years (median 66) with pretreated locally advanced or metastatic esophagogastric adenocarcinoma and eastern cooperative oncology group performance status of ≤2, measurable lesions, and adequate organ functions were recruited into the study. Eight patients (21 %) had received more than one prior chemotherapy regimen. Treatment consisted of three-weekly MMC 10 mg/m2 day 1 and capecitabine 2,000 mg/m2 (day 1–14; repeated day 22).

Results

A median of three cycles of therapy was administered. Grade 3 toxicity occurred in 20 patients (54 %). Main grade 3 adverse events were thrombocytopenia (11 %, n = 4), fatigue (8 %, n = 3), and neuropathy (8 %, n = 3). Two events of grade 4 toxicity were reported (5 %) (dyspnea and elevation of alkaline phosphatase due to bone metastases). Partial remission was noticed in 10.3 % (n = 4), stable disease in 33.3 % (n = 13) adding to a tumor control rate of 43.6 %. The median progression-free and overall survival were 2.8 and 5.6 months, respectively.

Conclusion

The combination of MMC and capecitabine exhibited a favorable tolerability profile in pretreated patients with gastric cancer. The disease control rate compares adequately with that of other phase II and phase III trials for second-line therapy in gastric cancer. This regimen may be considered as an alternative second-line treatment, especially for patients not suitable for or pretreated with taxanes and/or irinotecan.

Keywords

Gastric cancer Second-line chemotherapy Capecitabine Mitomycin C 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Manuel Barreto Miranda
    • 1
  • Jörg Thomas Hartmann
    • 2
  • Salah-Eddin Al-Batran
    • 3
  • Melanie Kripp
    • 1
  • Deniz Gencer
    • 1
  • Andreas Hochhaus
    • 4
  • Ralf-Dieter Hofheinz
    • 1
  • Kirsten Merx
    • 1
    • 5
    Email author
  1. 1.III. Medizinische Klinik, Hämatologie und OnkologieUniversitätsmedizin MannheimMannheimGermany
  2. 2.Abteilung Hämatologie/OnkologieFranziskus HospitalBielefeldGermany
  3. 3.Krankenhaus NordwestUniversity Cancer Center (UCT)Frankfurt am MainGermany
  4. 4.Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin IIUniversitätsklinikum JenaJenaGermany
  5. 5.Department of Hematology and OncologyUniversity Hospital MannheimMannheimGermany

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