Zusammenfassung
Adjuvante Chemotherapie für Patienten mit Weichteilsarkom Grad 2 und 3 muss nach wie vor als experimentell erachtet werden. Neunundfünfzig Patienten wurden primär weit oder knapp im gesunden exzidiert und wurden anschließend in den Radiotherapiearm oder in den Therapiearm mit Radiotherapie und Chemotherapie randomisiert eingeschlossen. Die Chemotherapie, bestehend aus sechs Zyklen Ifosfamid, DTIC und Doxorubicin, wurde alle 14 Tage verabreicht. Zusätzlich erfolgte eine unterstützende Therapie mit G-CSF an den Tagen 5–13. Achtundzwanzig Patienten erhielten Radiotherapie (Kontrollgruppe) und 31 Patienten wurden mit zusätzlicher Chemotherapie behandelt. Nach einer medianen Observationszeit von 97 Monaten (Range: 13–158 Monate), wurden 58 Patienten verlaufskontrolliert. Es wurden Langzeit rezidivfreies Überleben (RFS), lokalrezidivfreies Überleben (TLF), fernmetastasenfreies Überleben (TDF) und Gesamtüberleben (OS) evaluiert. Fünfzehn Patienten (56 %) in der Kontrollgruppe vs. 19 Patienten (61 %) in der Chemotherapiegruppe waren rezidivfrei. Innerhalb der Kontrollgruppe erlitten 12 Patienten (44 %) ein Tumorrezidiv vs. 12 Patienten (39 %) in der Chemotherapiegruppe. Es zeigte sich kein signifikanter Unterschied für RFS (P = 0,87), TLF (P = 0,58), TDF (P = 0,60) und OS (P = 0,99) zwischen den zwei Gruppen. Adjuvante Chemotherapie ergab keinen signifikanten Benefit betreffend RFS, TLF, TDF, und OS für Patienten mit Weichteilsarkom.
Summary
Adjuvant chemotherapy for grade 2 and 3 soft tissue sarcoma (STS) patients still has to be considered experimental. Fifty-nine patients underwent primary surgery by wide or marginal excision and were subsequently randomized to receive radiotherapy alone or in combination with six courses of chemotherapy consisting of ifosfamide, DTIC, and doxorubicin administered in 14-day intervals supported by G-CSF on days 5–13. Twenty-eight patients received radiotherapy (control group) and 31 patients were treated with additional chemotherapy. After a median observation period of 97 months (range: 13–158 months), 58 patients were followed up to assess long-term relapse-free survival (RFS), time to local failure (TLF), time to distant failure (TDF), and overall survival (OS). Fifteen patients (56%) in the control group vs. 19 patients (61%) in the chemotherapy group were free of disease. Within the control group, tumor relapses occurred in 12 patients (44%) vs. 12 patients (39%) in the chemotherapy group. RFS (P = 0.87), TLF (P = 0.58), TDF (P = 0.60) as well as OS (P = 0.99) did not differ significantly between the two groups. Adjuvant chemotherapy was not translated into a significant benefit concerning RFS, TLF, TDF, and OS for STS patients.
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Fakhrai, N., Ebm, C., Kostler, W. et al. Intensified adjuvant IFADIC chemotherapy in combination with radiotherapy versus radiotherapy alone for soft tissue sarcoma: long-term follow-up of a prospective randomized feasibility trial. Wien Klin Wochenschr 122, 614–619 (2010). https://doi.org/10.1007/s00508-010-1472-4
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DOI: https://doi.org/10.1007/s00508-010-1472-4