CP: 66.7%, p?=?0.042 by Fisher exact test), but the pStage3?+?4 rate did not differ between the groups (SP: 94.7% vs. those groups. The 5-year overall survival rate was significantly higher in patients who received postsurgical treatment with cetuximab (CP) compared to that in the other two groups ((CP vs. NP, p?=?0.028; CP vs. SP, p?=?0.042). Furthermore, we performed multivariate analysis to evaluate the effects of the main components of the treatment. D-Pinitol Among CDDP, radiotherapy, and cetuximab, only cetuximab significantly contributed to improved survival by univariate analysis (crude HR:0.228, 95%CI:0.05C0.968, p?=?0.045). cetuximab also showed the same D-Pinitol tendency in multivariate analysis, although p value did not reach significant level (Adjusted HR: 0.233, 95%CI: 0.053C1.028, p?=?0.054). The results suggest that the postsurgical treatment with cetuximab as a preemptive postsurgical therapy after complete surgical resection of a visible tumor is considerably effective for OSCC patients with major risk, in other words, invisible dormant metastasis. values of ?0.05 were considered to be significant. IBM SPSS ver. 24.0 (IBM SPSS, Inc., Tokyo, Japan) was used for all statistical analyses. Results Characteristics and treatment of OSCC patients with major risk The characteristics and treatment of the 88 OSCC patients are shown in Table ?Table1.1. The patients included 60 males (68.2%) and the median age was 65?years. Primary site, T stage, N stage, and cancer stage in all patients are shown. The most frequent primary site was tongue (47 patients, 53.4%), followed by lower gingiva (18 patients, 20.5%). In pathologically, patients with pT4a (47 patients, 53.4%) at the pT stage, pN2b (20 patients, 22.7%) and pN3b (25 patients, 28.4%) at the pN stage, and pStage 4a (37 patients, 42.0%) and 4b (25 patients, 28.4%) were frequently observed, because we selected the patients with major risk in this study. Extranodal expansion (3 patients, 3.4%), positive or close margins (10 patients, 11.4%), pN2 or pN3 (13 patients, 14.8%), YK-4C or YK-4D (37 patients, 42.0%) was picked up as major risk factors. Table 1 Characteristics of patients with CD86 OSCC with major risk factors (n?=?88) thead th align=”left” rowspan=”1″ colspan=”1″ Item /th th align=”left” colspan=”2″ rowspan=”1″ Value /th /thead Sex, male, n (%)60(68.2)Age, mean (SD) y63.7(13.6)Age, median y65Age group, n (%)? ?65 y40(45.5)??65 to ?75 y30(34.1)??75 y18(20.5)Primary site, n(%)?Tongue47(53.4)?Lower gingiva18(20.5)?Upper gingiva8(9.1)?Buccal mucosa8(9.1)?Dental ground4(4.5)?Lip1(1.1)?Palate2(2.3)Pathological T stage, n(%)?T13(3.4)?T219(21.6)?T319(21.6)?T4a47(53.4)Pathological N stage, n(%)?N0 (includes instances with community resection D-Pinitol only)32(36.4)?N19(10.2)?N2b20(22.7)?N2c2(2.3)?N3b25(28.4)Pathological Stage, n(%)?Stage 13(3.4)?Stage 210(11.4)?Stage 313(14.8)?Stage 4a37(42.0)?Stage 4b25(28.4)Major risk factor, n (%) overlapping distribution?Extranodal extension3(3.4)?Positive or close margins10(11.4)?pN2 or pN313(14.8)?YK-4C or YK-4D37(42.0)Treatment, n (%)Surgery only (NP group)29(33.0)Surgery?+?standard postsurgical treatment (SP group)38(43.2)?Chemotherapy with Cisplatin8?Radiation11?Chemoradiation with Cisplatin19Surgery?+?Cetuximab-combined postsurgical treatment (CP group)21(23.9)?Chemotherapy with Cetuximab?+?Paclitaxel12?Chemoradiation with Cetuximab6?Chemoradiation with Cetuximab, and chemotherapy with Cetuximab?+?Paclitaxel3 Open in a separate window NP: No Postsurgical treatment SP: Standard Postsurgical treatment CP: Cetuximab-combined Postsurgical treatment The NP group (no postsurgical treatment) included 29 patients (33.0%). The SP group (standard postsurgical treatment based on the NCCN recommendations) included 38 individuals (43.2%) who received radiotherapy alone, cisplatin alone, or concurrent chemoradiotherapy with cisplatin. The CP group (postsurgical treatment including cetuximab) included 21 individuals (23.9%) who received cetuximab?+?Paclitaxel (PTX), combination bioradiotherapy (BRT) of radiotherapy and cetuximab, or cetuximab /PTX therapy after BRT. Characteristics and prognoses in the individuals with different postsurgical treatment The characteristics and prognoses in the NP, SP and CP organizations are demonstrated in Table ?Table2.2. There was no difference in the sex percentage or pT classification among the organizations, but there were significant variations in the pN and pStage classifications. The pN positive-rates (NP: 27.6%, SP: 89.5%, CP: 66.7%) varied, having a significantly lower rate in the NP group (p?=?0.001). The pStage3/4 classification rate also assorted (NP: 69.0%, SP: 94.7%, CP: 90.5%), having a significantly lower rate in the NP group (p?=?0.010). The pace of recurrence or metastasis within 5?years after surgery was lowest in the CP group (NP: 27.6%, SP: 36.8%, CP: 14.3%), but with no significant difference among the organizations (p?=?0.183). The 5-yr mortality rate after surgery was least expensive in the CP group (NP: 34.5%, SP: 34.2%, CP: 9.5%), but the difference among the three organizations was not significant (p?=?0.089). However, in Kaplan-Meier analyses, the OS rate was found to be significantly higher in the CP group (CP vs. NP, p?=?0.028; CP vs. SP, p?=?0.042) (Fig.?1). There was similar tendency of the difference in the DF rates, although p ideals did not reach the significant level in Kaplan-Meier analysis (CP vs. NP, p?=?0.149; CP vs. SP, p?=?0.071) (Fig.?2). Table 2 Characteristics and prognoses in individuals.
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