gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

Bolus MIT Tomycin C in Combination with Protracted Infusional 5-Flurouracil/Folinic Acid in Pretreated Patients with Advanced Gastric Adenocarcinoma: Results of an Extended Phase II Study

Meeting Abstract

  • corresponding author presenting/speaker Joerg Thomas Hartmann - Universitätsklinikum Tübingen, Deutschland
  • Detlef Quietzsch - Klinikum, Chemnitz
  • Salah-Eddin Al-Batran - Krankenhaus Nordwest, Frankfurt
  • Jan Pintoffl - Universitätsklinikum Tübingen
  • Oliver Nehls - Universitätsklinikum Tübingen
  • Gabriele Käfer - Krankenhaus, Sigmaringen
  • Christof Burkart - Universitätsklinikum Tübingen
  • Lothar Kanz - Universitätsklinikum Tübingen

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO211

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

Published: March 20, 2006

© 2006 Hartmann 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.



Background: Single agent Mitomycin C (MMC) reaches remission rates of approximately 10-20% in patients with advanced gastrointestinal cancer in first- and second-line therapy.MMC has shown its antitumor efficacy in patients refractory to 5-fluorouracil (FU)/folinic acid, and partial remissions have been found particularly in gastric cancer.The combination of MMC with continuous infusional FU/ folinic acid has an increased antitumor activity in patients with pretreated gastrointestinal carcinoma with objective remission rates of up to 46% in patients with gastric cancer. We therefore aimed to assess the toxicity and activity of bolus MMC in combination with a 24h-continuous infusion of 5-fluorouracil/folinic acid in patients with gastric cancer that received at least one prior chemotherapy.

Methods: 38 patients (male=79,8%,female=15,8%) with gastric cancer, 5 patients after failure of first-line and 32 after failure of at least two prior chemotherapies were treated with fixed doses of MMC at 10mg/m2 applied on days 1 and 22 given to 5-FU (2600mg/m2) as a 24h infusion and folinic acid at 500mg/m2 weekly for 6 weeks. Patients were recruited in 4 different centers across germany. Three patients could not be evaluated due to missing data.

Results: Of the evaluated patients, 11 (28,9%) showed a partial response. Progressive disease was also seen in 28,9% of the patients while 7,9% were not evaluable due the pattern of growth of their disease or due to missing date or death before first evaluation.Disease stabilisation was achieved in 10 patients (26,3%).The median time to progression (TTP was 4,9 months (range 0,37m to 12,4m; CI95 3,68m to 6,13m), the median overall survival (OS) was 6,9 months (range 0,3m to 23,17 m; CI95 6,0m to 7,8m). The most severe hematological toxicity,ie. grade III and IV (WHO Criteria) was leukopenia which was seen in 9 patients in this trial.Severe neutropenic infection (WHO Grade III) occurred in one patient (2,6%).30 patients (78,9%) showed nonhemolytic anemia of different severities, five (13%) in grades III or IV.Thrombocytopenia occurred in 53% of the patients (n=20), 5 patients (13%) presented with thrombocytopenia grade III or IV. The most frequent non-hematological grade III/IV toxicities were mucositis (n=17) and diarrhea (n=10), which occurred in 7,9% of the patients (n=3) at grade III each.

Conclusion: As the tested regimen was generally safe and well tolerated by the patients, MMC plus infusional 5FU/folinic acid may be a potential second-line regimen with a good antitumor activity for patients with advanced gastric cancer.