BMC Cancer 2006, 6:30 http://www.biomedcentral.com/1471-2407/6/30 Table 4: Comparison of treatment results between the two groups Overall survival (5 ys.) Median overall survival Disease-free survival (5 ys.) Progression free survival (5 ys.) years) Median time to (local) progression 1) WHO 2) compared with response in the SEQ-group after chemotherapy and radiotherapy SEQ 14.7 % 14.6 months 19.8 % 17.6 % 10.7 months CON 23.7 % 20.1 months 31.4 % 41.0% 15.0 months p 0.11 0.08 0.03 as expected, in the CON group. Occurrences of grade I or II late toxicity proved to be equally distributed. Response The complete primary tumor remission (CR) rates were 41% in the SEQ vs. 46% in the CON group, and the par- tial remission (PR) rates were 26% vs. 44%, respectively. Response in the lymph nodes was also less frequent in the SEQ than the CON group (86% vs. 98%). A survey of the response rates in primary tumors and involved lymph nodes is given in table 3. The overall differences (CR + PR + PD/NC) in response (CON vs. SEQ) were significant for both the primary tumors (p = 0.02) and the lymph nodes (p = 0.00), but the single endpoints (CR or PR or PD/NC) did not show significant between-group differences. Cal- culations were performed on the total number of eligible patients, but it is notable that the proportion of non-eval- uable patients was considerably higher in the SEQ group (8/70 versus 1/52) and included four patients receiving no radiotherapy at all (three were treatment-related deaths). This difference in treatment failure and disrup- tion is a further criterion in favour of the CON group, but it is not encompassed by the response analysis. pdFKreiagotpeutlocarntcei-onM2gletimeres-utorv-liovaclalcpurovegsrewssitiohnlo,icnorelgaitoionnaltcootnhterotly,pi.ee.of Kaplan-Meier survival curves with locoregional control, i.e. detecting time-to-local progression, in relation to the type of protocol. Local control and survival Calculations were performed on the eligible patients and the results are summarised in table 4. The 5-year local con- trol rate (local-progression-free survival) was significantly lower in the SEQ-group than in the CON-group according to fig. 2 (17.6% vs 41%, p = 0.03 with 51 patients vs. 26 patients relapsing locally). Among the patients achieving complete remission, 29% had recurrences of the primary and 24% in the lymph nodes in the CON group after 5 years, compared with 55% and 48% in the SEQ group. The most common site of recurrence in the SEQ-group was locoregional (90% of progressive patients), whereas distant metastases (DM) alone or combined with local failure (LF) occurred very rarely (4% or 6%, DM ± LF). In contrast, only 73% had LF alone in the CON-group, whereas 17% of the patients suffered from initial DM (± LF). Overall, fewer patients in the SEQ-group than in the CON-group presented with DM (± LF) (actuarially 18% or 26% after 5 years, 6 patients vs. 10 patients). Secondary cancers occurred in both groups with similar frequencies (7% and 8%). The actuarial disease-specific survival curves (fig. 3, table 4) were not statistically different (5 years: 19.8% and 31.4%, with tumor-related deaths of 52 patients and 30 patients), but showed a trend in favour of the CON-group (p = 0.08). The overall survival curves showed the same tendency, with 3-year survival rates of 30% vs. 21% and 5- year survival rates of 24% vs. 15% in favour of the CON- group (p = 0.11, 56 vs. 36 patients dying from all causes) (fig. 4). Predictors of outcome The prognostic factors that had proved significant in uni- variate analysis were subjected to multivariate analysis, which showed that T-categories (≤ T3 vs. T4, p < 0.001) and N-categories (≤ N2a vs. N2b, N3, p < 0.01) were sig- nificantly correlated with locoregional control. The type of treatment protocol had a borderline significant rela- tionship (p = 0.06) with local treatment outcome. Per- formance status, RTOG stage and radiation dose proved not to be significantly correlated in the multivariate anal- ysis. Page 6 of 9 (page number not for citation purposes)