FFCD 9901 - Studie |
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allgemeines |
neoadjuvant chemoradiotherapy (NCRT) in stage I or II EC.
2000 to 2009,
195 patients in
30 centers were
randomly assigned to
surgery alone (group S; n 97) or
NCRT followed by surgery (group CRT; n 98).
CRT protocol was 45 Gy in 25 fractions over 5 weeks with
two courses of concomitant chemotherapy composed of ?uorouracil 800 mg/m 2 and cisplatin 75
mg/m 2 .
follow-up of 93.6 months.
OS Results Pretreatment disease was stage I in 19.0%, IIA in 53.3%, and IIB in 27.7% of patients.
For group CRT compared with group S,
R0 resection rate was 93.8% versus 92.1% (P .749), with
3-year overall survival rate of 47.5% versus 53.0% (hazard ratio [HR], 0.99;
95% CI, 0.69 to 1.40; P .94) and
postoperative mortality rate of 11.1%
versus 3.4% (P .049), respectively. Because interim analysis of the
primary end point revealed an improbability of demonstrating the superiority
of either treatment arm (HR, 1.09; 95% CI, 0.75 to 1.59; P .66), the trial
was stopped for anticipated futility. Conclusion Compared with surgery
alone, NCRT with cisplatin plus ?uorouracil does not improve R0 resection
rate or survival but enhances postoperative mortality in patients with stage
I or II EC.
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Fragestellung | Ist das Behandungsergebnis distaler Ösophaguskarzinome nach praeoperativer Radiochemotherapie besser als nach alleiniger Radikaloperation? | ||||||||||||||||||||||||||||||||||||||||||||||
Ergebnis | Distale Ösophaguskarzinome haben nach praeoperativer Radiochemotherapie ein signifikant höheres Gesamtüberleben als nach alleiniger Radikaloperation. Plattenepithelkarzinome profitieren mehr als Adenokarzinome. | ||||||||||||||||||||||||||||||||||||||||||||||
Ergebnisse |
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Studie | multizentrische, randomisierte Phase III - Studie. | ||||||||||||||||||||||||||||||||||||||||||||||
Arme | praeoperative Radiochemotherapie | Radikaloperation ohne Vorbehandlung | |||||||||||||||||||||||||||||||||||||||||||||
Patienten | 368 Patienten mitpotentiel kurables Ösophagus -
Karzinom, Adenokarzinom oder Plattenepithelkarzinom.175 Patienten pro Arm
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Ergebniss | Gesamtüberleben Aus (3) nach Daten von (2). | ||||||||||||||||||||||||||||||||||||||||||||||
Therapie | 5W, ambulante, simultane Radio-Chemotherapie. | Paclitaxel (50 mg/m2), Carboplatin (Area-Under-Curve = 2) i.v. d1, d8, d15, d22, d29. | 41.4 Gy/ 23 Fraktionen ED 1.8 Gy, 5x/W | ||||||||||||||||||||||||||||||||||||||||||||
Quellen |
1.) Christophe Mariette C, et al.: Surgery Alone Versus Chemoradiotherapy Followed by Surgery for Stage I and II Esophageal Cancer: Final Analysis of Randomized Controlled Phase III Trial FFCD 9901. J Clin Oncol 2014;32:2416-2422 |
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Impressum Zuletzt geändert am 28.09.2014 15:08