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FFCD 9901 - Studie

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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.

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
Ergebnis praeoperative Radio- Chemotherapie primäre RadikaloperatiomStatistik
Anzahl 178 188
OS 49,4M 24M p = 0,003
pathologisch CR 29% -
postoperative Mortalität 4% 4%
DFS nicht erreicht 24,2M
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
Arm: praeoperative
Radio- Chemotherapie
primäre
Radikaloperatiom
Anzahl 178 188
Alter 60 60
männlich 75% 81%
proximaler Ösophagus 4 4
mittlerer Ösophagus 25 24
distaler Ösophagus 104 107
ösophago-gastraler Übergang 39 49
Adeno - Karzinom 134 141
Plattenepithel - Karzinom 41 43
cT1 1 1
cT2 26, 15% 35, 19%
cT3 150, 84% 147, 78%
cT4 0 1
cN1 65% 64%
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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