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Gortec 99-02 |
ausführlicher Titel
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Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma |
| Fragestellung |
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| Ergebnis |
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| Random |
konventionelle Radio - Chemotherapie |
70 Gy in 7 W |
3 Zyklen Carboplatin-5-FU, d1-d4 |
| akzelerierte Radio - Chemotherapie |
40 Gy in 4 W, dann 30 Gy hyperfraktioniert mit
2x 1,5Gy |
2 Zyklen Carboplatin-5-FU, d1-d5 |
| akzelerierte, hyperfraktionierte Radiotherapie |
64,8 Gy, 1,8 Gy 2x/d, in 3,5 W |
- |
| Tumoren |
Oropharynx, Mundhöhle, Hypopharynx, Larynx,
Hals-CUP |
| Patienten |
840 Patienten mit Plattenepithelkarzinom des HNO-Bereichs im
Stadium III und IVa. Performance status 0-2. 2000 - 2007 |
Art der Studie |
Phase III |
Ergebnis |
Ergebnis |
konv.
Radio-
Chemotherapie |
akzellerierte
Radio-
Chemotherapie |
akzelerierte,
hyperfraktionierte
Radiotherapie |
Statistik |
Patienten |
287 |
280 |
281 |
3a - PFS |
37,6% |
34,1% |
32,2% |
LRC |
41,7% |
45,4% |
49,9% |
| Mukositis 3-5° |
69% |
76% |
84% |
| Sondenernährung |
60% |
64% |
70% |
LRC: Lokoregionale Kontrolle
|
| Quelle |
chemoradiotherapy improved PFS compared with very accelerated radiotherapy (0·82, 0·67-0·99; p=0·041). 3-year PFS was 37·6% (95% CI 32·1-43·4) after conventional chemoradiotherapy, 34·1% (28·7-39·8) after accelerated radiotherapy-chemotherapy, and 32·2% (27·0-37·9) after very accelerated radiotherapy. More patients in the very accelerated radiotherapy group had RTOG grade 3-4 acute mucosal toxicity (226 [84%] of 268 patients) compared with accelerated radiotherapy-chemotherapy (205 [76%] of 271 patients) or conventional chemoradiotherapy (180 [69%] of 262; p=0·0001). 158 (60%) of 265 patients in the conventional chemoradiotherapy group, 176 (64%) of 276 patients in the accelerated radiotherapy-chemotherapy group, and 190 (70%) of 272 patients in the very accelerated radiotherapy group were intubated with feeding tubes during treatment (p=0·045).
INTERPRETATION:
Chemotherapy has a substantial treatment effect given concomitantly with radiotherapy and acceleration of radiotherapy cannot compensate for the absence of chemotherapy. We noted the most favourable outcomes for conventional chemoradiotherapy, suggesting that acceleration of radiotherapy is probably not beneficial in concomitant chemoradiotherapy schedules.
|
| Quelle |
1.) Bourhis J, et al.:
Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02):
an open-label phase 3 randomised trial.
Lancet Oncol 13(2012):145-53
Institut Gustave Roussy, Villejuif, France.
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