Περίληψη:
The primary objective of the present randomized phase III trial was to
compare the 3-yr survival rate of patients treated with standard
fractionated radiotherapy (RT) alone or with the same RT concomitantly
with cisplatin (DDP) or carboplatin (Cb). From January 1995 until July
1999, 124 patients with histologically proven locally advanced
non-nasopharyngeal head and neck cancer (HNC) were randomized to receive
either RT monotherapy (70 Gy, Group A) or the same RT concomitantly with
DDP (100 mg/m(2) on d 2, 22, 42, Group B) or Cb (7 AUC on d 2, 22, 42,
Group Q. There were no significant differences in complete response
rates between patients treated with RT alone or combined
chemoradiotherapy. However, median time to progression (TTP) and overall
survival (OS) were significantly longer in patients treated with
concomitant chemoradiotherapy. Thus, median TTP was 6.3, 45.2, and 17.7
mo in groups A, B, and C respectively (p = 0.0002). Similarly, median OS
was 12.2, 48.6, and 24.5 mo, respectively (p = 0.0003). At 3 yr
follow-up, 17.5% of patients in group A were alive compared to 52% in
group B and 42% in group C (p < 0.001). Patients treated with
concomitant chemoradiotherapy experienced more frequently severe
hematological toxicity. Also, severe nausea/vomiting was more pronounced
in group B, as expected. The present study clearly demonstrated that
concomitant chemoradiotherapy with platinum analogs significantly
prolongs 3-yr survival and median OS in patients with locally advanced
HNC compared to conventional RT alone.
Συγγραφείς:
Fountzilas, G
Ciuleanu, E
Dafni, U
Plataniotis, G and
Kalogera-Fountzila, A
Samantas, E
Athanassiou, E
Tzitzikas,
J
Ciuleanu, T
Nikolaou, A
Pantelakos, P
Zaraboukas, T
and Zamboglou, N
Daniilidis, J
Ghilezan, N