SEQ Grade III n Acute toxicity (RTOG) Skin 11 Mucositis 31 Pharynx 9 Salivary glands 10 Late toxicity (LENT scores) Skin 2 Subcutis 5 Mucosa 4 Salivary glands 7 Pharynx 5 Larynx 3 Mandibula 1 (%) (16) (44) (13) (14) (3) (7) (6) (10) (7) (4) (1) n 0 1 1 0 0 0 0 0 0 0 0 (%) (1) (1) BMC Cancer 2006, 6:30 http://www.biomedcentral.com/1471-2407/6/30 Table 2: Acute and late toxicity after radiotherapy and chemotherapy according to RTOG/ECOG and LENT scores (highest level given) Grade IV Grade IV CON Grade III n 5 28 9 4 2 7 3 3 4 2 0 (%) (10) (54) (17) (8) (4) (14) (6) (6) (8) (4) N 0 2 1 0 0 0 0 0 1 0 1 p2) 0.02 n.s. n.s. n.s. n.s. (%) (4) (2) (2) (2) p n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. Nodes (%) 98 (51/52) 58 37 94 4 p2) 0.00 n.s. n.s. n.s. n.s. Page 5 of 9 (page number not for citation purposes) Only in 1/52 of the patients (2%) was radiochemotherapy abandoned, so 51/52, i.e. 98%, of the patients were fur- ther evaluable. radiotherapy (if performed) was significantly longer in the SEQ compared with the CON group (79.9 vs. 43.4 days, p = 0.00). On average, we applied an average radiation dose of 65.3 Gy to the primary tumor in the SEQ group and 71.6 Gy in the CON group. The corresponding mean radiation doses at the involved lymph nodes were 58.1 Gy and 69.5 Gy, respectively. These doses were significantly different in the two groups (p = 0.00). In 23/61 (36%) of the patients in the SEQ group, radio- therapy was interrupted for longer than 1 week, while 14/ 61 (23%) had a break for longer than 3 weeks. In contrast, only 7/51 (14%) of the patients in the CON group had a break of at least 1 week, and 3/51 (6%) for more than 2 weeks (p = 0.00). In consequence, the average duration of Table 3: Comparison of responses in dependency on the schedule Toxicity (table 2) Three treatment-related deaths occurred in the SEQ-group (due to hematotoxicity), whereas no such serious compli- cation was found in patients assigned to the CON group. Acute local toxicity was generally moderate in both groups, except for severe mucositis, which affected 54% of patients receiving hyperfractionated radiotherapy in the CON-group compared with 44% in SEQ group (n.s.). Regarding late toxicity, lymph edema, mouth dryness and dysphagia were the most frequently observed grade III and IV side effects in both groups, as summarized in table 2. The frequency of grade I or II acute toxicity was higher, SEQ (n = 70) After 2 cycles chemotherapy After chemotherapy and radiotherapy Primary (%) Nodes (%) Primary (%) Nodes (%) Primary (%) CON (n = 52) After chemotherapy and radiotherapy Evaluable Complete response 1) (CR) Partial remission 1) (PR) CR and PR NC, Progressive disease 93 (65/70) 11 51 63 30 93 (65/70) 7 51 59 33 89 (62/70) 41 26 67 21 86 (60/70) 33 33 66 20 98 (51/52) 46 44 90 8 1) WHO 2) compared with response in the SEQ-group after chemotherapy and radiotherapy