gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

MiX – first results of the ongoing prospective, multi-centre, phase II study

Meeting Abstract

  • corresponding author presenting/speaker Michael Patrick Lux - Frauenklinik, Universitätsklinikum Erlangen, Erlangen, Deutschland
  • Johann Weiß - Praxis für Hämatologie/ Internistische Onkologie, Weiden
  • Harald Sommer - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe – Innenstadt, Klinikum der Universität München
  • Anton Scharl - Klinikum St. Marien Amberg, Amberg
  • Kai Beckmann - Frauenklinik, Universitätsklinikum Erlangen, Erlangen
  • Hilde Kreis - Frauenklinik, Universitätsklinikum Erlangen, Erlangen
  • Matthias W. Beckmann - Frauenklinik, Universitätsklinikum Erlangen, Erlangen
  • Peter A. Fasching - Frauenklinik, Universitätsklinikum Erlangen, Erlangen

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO044

The electronic version of this article is the complete one and can be found online at:

Published: March 20, 2006

© 2006 Lux et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Introduction: The treatment of patiens with metastatic breast cancer (MBC) previously treated with anthracycline represents a significant challenge. Several studies have shown that oral capecitabine is an effective and well-tolerated agent. Mitomycin C has notable therapeutic activity and presents additive effects. Primary endpoints of this ongoing prospective, multi-centre, phase II study are to evaluate the safety and efficacy of the combination. TTP and QoL are secondary endpoints.

Material and methods: Patients receive six cycles of mitomycin C 8mg/m2, d1, and capecitabine 2,000mg/m2, d1-14, q21d. 46 patients are planned for treatment, 17 patients are already enrolled. Evaluation (RECIST) has to be done after the fourth and sixth cycle. Safety is evaluated in all patients. Data for 16 patients were analysed, one patient has not be monitored up to date.

Results: 43.8% of the patients received neoadjuvant chemotherapy (CT), 62.5% adjuvant CT and 60.0% adjuvant endocrine therapy (ET) [together with palliative setting 2.31 CT and 1.75 ET in average]. All patients have been pre-treated with anthracyclines and 62.5% with taxanes. 68.8% had multiple sites of metastases [31.3% lung, 43.8% liver, 68.8% bone, 18.8% pleural carcinosis, 50.0% cutis].

6.3% received just 1 cycle, 6.3% 2, 12.5% 3, 31.3% 4 and 43.8% 6 cycles [reasons <6 cycles: progression (n=3), cancer related reduced general condition (n=3), side-effects (n=2), wish of patient (n=1)].

11.3% of the cycles received dose reduction and 12.7% interval prolongation. Following grade 3- and 4-toxicities (NCI CTC) were observed in the 71 cycles: dyspnea [3 x grade 3 and 2 x grade 4; all occurred in patients with pulmonal metastases or pleural effusions], nausea (1 x grade 3), thrombopenia (2 x grade 3), fatigue (1 x grade 3), mucositis (1 x grade 3) and hand-foot-syndrome (4 x grade 3). Most common grade 1- and 2-toxicities were nausea, dyspnea, paraesthesia, thrombopenia, neutropenia, anaemia, mucositis, hand-foot-syndrome, fatigue and elevated liver enzymes.

Best response rates were: 18.8% progressive disease, 37.5% stable disease, 31.3% partial remission and 12.5% complete remission.

Conclusion: The treatment with mitomycin C and capecitabine presents a favourable safety profile, which is well tolerated and active in this setting. The safety commission recommends the continuation after revision of the preliminary data. Further results of the MIX study, expected summer 2006, can be awaited with interest.