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CONKO-101: Erste Ergebnisse einer offenen Phase II Studie mit Gemcitabin, 5-FU (24h), Folinsäure und Cisplatin bei Patienten mit inoperablem Ösophaguskarzinom
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Veröffentlicht: | 20. März 2006 |
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Introduction: Standard therapy for inoperable esophageal cancer is a combination of cisplatin and 5-FU combined with radiation for locally advanced stages. As gemcitabine shows synergy with cisplatin and 5-FU, we evaluated the combination of cisplatin 30 mg/m2 (90 min), Gemcitabine 1000 mg/m2 (30 min), FS 200 mg/m2 (30 min) and 5-FU 750 mg/m2 24h CI) d1,8 q d22 for patients with inoperable esophageal cancer. For locally advanced stages, patients received sequential radiochemotherapy with 5-FU CI afterwards.
Patients: 89 (75m/14w)pts. were included into this multicentrical phase 2 study. 58 had SCC, 30 AC, 1 undifferentiated carcinoma. Median age was 61(22-86) years, Median KI 90 (60-100) %. 2 pts. had stage IIa, 4 stage IIb, 30 stage III, 16 stage IVa and 37 stage IVb.
Results: 67 pts. are so far evaluable for response and 84 (according to 410 cycles of therapy) for toxicity. 1 Pt. had pathologically confirmed CR (1,5%), 21 had PR (31,3%), 33 SD (49,2%) and 13 PD (18%) as best response. MS was 10,68 months (13,07 for stage II/III and 9,07 for stage IV). Median TTP was 6 months, and PFS was 5,96 months. Observed toxicity was low and predominantly hematologic with Leukopenia WHO Grade ¾ in 10% of cycles, Hb grade ¾ in 5,3% of cycles and Thrombopenia grade ¾ in 2,4% of cycles.
Conclusion: This regimen is well tolerable and can easily be applied on an outpatient basis, but the remission rates and survival data are within the range previously reported for Cisplatin/5-FU alone.