BMC Cancer 2006, 6:30 http://www.biomedcentral.com/1471-2407/6/30 Table 1: Comparison of patients' characteristics differentiated to the type of schedule SEQ (sequential, n = 70) CON (concomitant, n = 52) Parameter Age, years Mean (Range) Performance status (WHO) 0,1 2,3 Unknown T-stage (UICC) T2 T3 T4 N-stage N2c N3 RTOG stage groupings III (T3-4 N0, T1-2 N2) IV (T1-2 N3, T3 N1-2, T4 N1) V (T4 N2-3) UICC stage groupings IV (a + b) Tumor location Oral cavity Oropharynx Hypopharynx, Larynx Mean tumor size (cm) number 53 (37–77) 35 27 8 4 18 48 23 8 5 23 41 69 7 38 25 4.8 (%) (50) (39) (11) (6) (26) (68) (33) (11) (7) (33) (59) (99) (10) (54) (36) number 52.8 (39–66) 30 19 2 3 9 40 15 7 1 16 35 52 10 30 12 4.6 (%) (58) (37) (4) (6) (17) (77) (29) (14) (2) (31) (67) (100) (19) (58) (23) p 0.80 0.79 0.67 0.54 0.13 0.58 0.19 0.46 end of treatment) in any tumor lesion, or histopathologi- cal validation of recurrent disease after a CR. Results Seventy patients in the SEQ group and 52 patients in the CON group were included in an intent-to-treat analysis. The median observation times for the surviving patients were 53 months for the SEQ group and 41 for the CON group, respectively (for all patients, 19.8 and 14.7 months in the two groups). Patients' characteristics We found a comparable distribution of prognostic factors in both groups with regard to age, gender and perform- ance status (WHO). Tumors of the oropharynx predomi- nated, with frequencies of 54% and 58% in the SEQ and CON group, respectively (p = 0.66). The percentage of tumors located in the hypopharynx was found to be slightly higher in the SEQ group (29% vs. 17% of patients, p = 0.13). All other tumor characteristics were statistically equally distributed according to table 1. Most patients had advanced stages, with T4-categories in 68% vs. 77% (p = 0.28), and N2c-N3 in 44% vs. 43%, of patients in the SEQ vs. CON groups, respectively. The resulting clinical stages were as high as IV and V (RTOG) for the majority of the patients, i.e. 33% and 59% (together 92%) for the SEQ group and 31% and 67% (together 98%, p = 0.37) for the CON group. Treatment parameters In the SEQ group, 5/70 patients (7%) received only one chemotherapy course owing to rapid tumor progression and/or poor performance status. Two courses were applied to 22/70 patients (31%), and three cycles were given to only 43/70 (62%). Of these, 65/70 (95%) could be evaluated for response after induction chemotherapy, and 62/70 (89%) after the whole treatment course. Patients who could not be evaluated for response included three treatment-related deaths during the first two cycles. At the second checkpoint (after radiotherapy), 4/70 patients were non-evaluable and received no radio- therapy. In the CON group, the first course of chemotherapy was given to all patients with at least 80% of the prescribed 5- FU dose level. Two of the patients received only one appli- cation of mitomycin C in week 1 because the whole treat- ment had resulted in considerable toxicity by week 6. Page 4 of 9 (page number not for citation purposes)