Search

Background: In a randomized phase II/III trial (JCOG1008), weekly cisplatin (40 mg/m 2 ) was non-inferior to 3-weekly cisplatin (100 mg/m 2 ) for postoperative high-risk head and neck cancer. We investigated how acute kidney injury (AKI), a major dose-limiting toxicity effect of cisplatin, affects overall survival (OS)., Methods: We analyzed 251 patients from JCOG1008 receiving chemoradiotherapy. AKI was defined based on AKI Network criteria (serum creatinine increase of ≥0.3 mg/dL or ≥1.5-fold [≥ stage I]) within 30 days after completing chemoradiotherapy. OS in the two arms was compared according to AKI development using the log-rank test., Results: The total incidence of AKI was lower in the weekly arm than in the 3-weekly arm (38/122 [31.1%] vs. 56/129 [43.4%]). Additionally, stage II/III AKI occurred less frequently in the weekly arm than in the 3-weekly arm (8/122 [6.6%] vs. 19/129 [14.7%]). Cisplatin doses were similar in the weekly arm for patients with and without AKI (median, 238.6 mg/m 2 vs. 239.2 mg/m 2 ; p = 0.94), but lower in the 3-weekly arm for those who developed AKI (median, 276.3 mg/m 2 vs. 297.4 mg/m 2 ; p = 0.007). In the weekly arm, there was no difference in OS between patients with and without AKI (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.53 to 2.10). However, in the 3-weekly arm, patients with AKI had poorer OS than those without AKI (HR, 1.83; 95% CI, 1.04 to 3.21)., Conclusions: In this supplementary analysis of JCOG1008 data, AKI impacted the OS of patients with head and neck cancer undergoing postoperative chemoradiotherapy in the 3-weekly arm but not in the weekly arm. Our results further endorse the utilization of weekly cisplatin at 40 mg/m 2 in this setting., (© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.)

Objectives: Acute kidney injury (AKI) represents a major toxicity associated with cisplatin. We developed a risk prediction model for cisplatin-induced AKI in patients with postoperative high-risk head and neck cancer who received chemoradiotherapy during a randomized phase II/III trial, JCOG1008., Materials and Methods: Two hundred and fifty-one patients received radiotherapy with weekly cisplatin at 40 mg/m 2 (weekly arm) or 3-weekly cisplatin at 100 mg/m 2 (3-weekly arm). AKI was defined using the AKI Network classification/staging system as increased serum creatinine of ≥0.3 mg/dL or a ≥1.5-fold increase from baseline 30 days after completing chemoradiotherapy. The Akaike information criterion was used to explore the optimal model by combining explanatory variables at registration., Results: Among the 251 patients (210 men and 41 women (median age; 62 years)), 94 (37.5 %) developed cisplatin-induced AKI. The optimal cisplatin-induced AKI risk prediction model comprised four factors, including a primary site of hypopharynx/larynx (vs. oral cavity/oropharynx), 3-weekly arm (vs. weekly arm), serum albumin of ≤3.5 g/dL (vs. >3.5 g/dL) and creatinine clearance (CCr) of <90 mL/min (vs. ≥90 mL/min). The incidence of cisplatin-induced AKI rose with cumulative count of the four factors. When the cumulative count was ≥2, the positive predictive value for cisplatin-induced AKI was 50.3 %., Conclusions: We developed a risk prediction model for cisplatin-induced AKI in patients with head and neck cancer who received postoperative chemoradiotherapy using primary site, cisplatin administration method, serum albumin, and CCr. Patients with risk factors unrelated to the cisplatin administration method should adopt a weekly cisplatin regimen., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Yoshinori Imamura Speakers' Bureau - Daiichi Sankyo/UCB Japan; MSD Naomi Kiyota Honoraria - AstraZeneca; Bayer; Bristol-Myers Squibb Japan; Eisai; Lilly Japan; Merck Serono; MSD; Ono Pharmaceutical Consulting or Advisory Role - Adlai Nortye; Ono Pharmaceutical; Shift Zero Research Funding - Adlai Nortye (Inst); Bayer (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squibb (Inst); Lilly (Inst); Ono Pharmaceutical (Inst); Rakuten Medical (Inst) Makoto Tahara Honoraria - Bayer; Bristol-Myers Squibb; Eisai; Lilly; Merck Serono; MSD; Ono Pharmaceutical Consulting or Advisory Role - Astellas Pharma; Bayer; Boehringer Ingelheim; Bristol-Myers Squibb; Eisai; Genmab; Janssen; Lilly; MSD; Nanobiotix; Nektar; Ono Pharmaceutical; Pfizer; Rakuten Medical Research Funding - AstraZeneca (Inst); Bayer (Inst); Bristol-Myers Squibb (Inst); GlaxoSmithKline (Inst); Lilly (Inst); Merck Serono (Inst); Merck Sharp & Dohme (Inst); Novartis (Inst); Ono Pharmaceutical (Inst); Pfizer (Inst); Rakuten Medical (Inst) Takeshi Kodaira Speakers' Bureau - Accuray; AstraZeneca; Bristol-Myers Squibb; Chugai Pharma; Hitachi; Janssen; Merck Serono; Ono Pharmaceutical; Reason Why Co. Ryuichi Hayashi Consulting or Advisory Role - Rakuten Medical Japan Research Funding - Japan Agency for Medical Research and Development Hiroshi Nishino No Relationships to Disclose Yukinori Asada No Relationships to Disclose Hiroki Mitani No Relationships to Disclose Shigemichi Iwae Consulting or Advisory Role - Merck (Inst) Speakers' Bureau - Bristol-Myers Squibb Japan; Merck; MSD; Ono Pharmaceutical Research Funding - Ascent Development Services (Inst); GlaxoSmithKline (Inst); Merck (Inst); MSD (Inst); Ono Pharmaceutical (Inst) Nobuhiro Hanai Honoraria - Bristol-Meyers Squibb; Covidien; Eisai; Merck; MSD K.K; Ono Pharmaceutical; Rakuten Medical Research Funding - MSD K.K Hiroki Hara Honoraria - Asahi Kasei; Bayer; Bristol-Myers Squibb; Chugai Pharma; Daiichi Sankyo/UCB Japan; Lilly; Merck Serono; MSD; Ono Pharmaceutical; Taiho Pharmaceutical; Takeda; Yakult Honsha Consulting or Advisory Role - Boehringer Ingelheim; Bristol-Myers Squibb Japan; Chugai Pharma; MSD; Ono Pharmaceutical Research Funding - ALX Oncology (Inst); Amgen (Inst); Astellas Pharma (Inst); AstraZeneca (Inst); Bayer (Inst); BeiGene (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squibb Japan (Inst); Chugai Pharma (Inst); Daiichi Sankyo (Inst); Dainippon Sumitomo Pharma (Inst); Eisai (Inst); Janssen Oncology (Inst); Merck Serono (Inst); MSD (Inst); Ono Pharmaceutical (Inst); Taiho Pharmaceutical (Inst) Akihiro Homma Speakers' Bureau - Bayer Yakuhin; Bristol-Myers Squibb; Demant; Eisai; Kyorin; Lilly Japan; Meiji Seika Kaisha; Merck; Mitsubishi Tanabe Pharma; MSD K.K; Ono Pharmaceutical; Rakuten Medical Japan; Sanofi; Taiho Pharmaceutical Research Funding - Eisai; Iwasaki Denshi; Kyorin; Mitsubishi Tanabe Pharma; Ono Pharmaceutical; Otsuka; Taiho Pharmaceutical; Torii Pharmaceutical Others had no relationships to disclose., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Concurrent chemoradiotherapy with 3-weekly cisplatin 100 mg/m 2 has been the standard of care for locoregionally advanced head and neck cancer (LA-HNC) with level I evidence. While the outcomes in terms of efficacy have been well established, the toxicity profile, compliance, and real-world applicability has been an area of ongoing concern for this regimen, leading the oncologists to explore weekly cisplatin chemoradiotherapy regimen to potentially address the issue. A review of literature was conducted in Pubmed, Scopus, and Medline to compare and evaluate the present role of weekly cisplatin chemotherapy along with radiotherapy versus 3-weekly cisplatin chemotherapy along with radiotherapy in both adjuvant and definitive settings for locoregionally advanced head and neck cancers. Nasopharyngeal subsites were excluded from the literature review and 50 relevant articles were included in the analysis. Recently published evidences of noninferiority of weekly over 3-weekly cisplatin chemoradiotherapy regimen in definitive as well as adjuvant settings in locoregionally advanced head and neck cancers is highlighted and interpreted. Results supporting and against the above in different publications is elaborated in this article. Trials designed to demonstrate noninferiority of the weekly cisplatin chemoradiotherapy regimen over 3-weekly regimen, especially in definitive setting may conclude the debate in future. A lacunae in the existing literature is noted in the form of lack of superiority trials on the above topic, which may impact future conclusions., (© 2023 Wiley Periodicals LLC.)

Objectives: This study aimed to evaluate the efficacy of chemoradiotherapy (CRT) for patients with advanced cancer of the external auditory canal (EAC) by analyzing the outcome of the patients., Methods: This is a multi-institutional retrospective survey, and we reviewed the medical records of the subjects. A total of 181 patients with tumor (T)3 or T4 tumor in 17 institutions were enrolled. Further analysis was performed for 74 patients who underwent CRT under curative intent., Results: Overall 5-year survival rates of the patients who underwent CRT (n = 74) were 54.6%. Those of the patients who underwent CRT with modified TPF (docetaxel, cisplatin [CDDP], and 5-fluorouracil) regimen (n = 50) and CRT with CDDP regimens (n = 24) were 64.4% and 36.7%, respectively. Significant differences were observed between these two groups., Conclusion: Given the tendency that head and neck surgeons prefer CRT for advanced larger cancer of the EAC, CRT for advanced EAC cancer using the modified TPF regimen showed good clinical outcomes., Level of Evidence: 4 Laryngoscope, 131:E870-E874, 2021., (© 2020 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives: To explore the risk factors of laryngo-esophageal dysfunction-free survival and nutritional support dependence over 12 months in patients with unresectable locally advanced head and neck carcinomas who received chemoradiotherapy in a phase II trial of JCOG0706 (UMIN000001272)., Methods: Forty-five patients received radiation therapy for a total of 70 Gy/35fr concurrently with S-1 and cisplatin. Risk factors of laryngo-esophageal dysfunction-free survival and nutritional support dependence over 12 months were analyzed using Cox regression models and logistic regression models, respectively, with consideration to patient laboratory data just before chemoradiotherapy. Radiation fields were reviewed to analyze the relationship between the extent of the irradiated field and functional outcome., Results: With a median follow-up period of 3.5 years, 3-year laryngo-esophageal dysfunction-free survival was 48.9%. For laryngo-esophageal dysfunction-free survival, hazards ratio of 2.35 in patients with nutritional support at registration (vs. without nutritional support; 95% confidence interval 0.96-5.76). For nutritional support dependence over 12 months, odds ratio was 6.77 in patients with hemoglobin less than the median of 13.4 g/dl (vs. higher than or equal to the median; 95% confidence interval 1.24-36.85) and was 6.00 in patients with albumin less than the median of 3.9 g/dl (vs. higher than or equal to the median; 95% confidence interval 1.11-32.54). Primary sites in disease-free patients with nutritional support dependence over 12 months were the oropharynx (N = 2) or hypopharynx (N = 1), and all pharyngeal constrictor muscles were included in irradiated fields with a curative dose., Conclusions: This supplementary analysis showed that pretreatment severe dysphagia requiring nutritional support, anemia and hypoalbuminemia might have a negative prognostic impact on long-term functional outcomes after curative chemoradiotherapy in head and neck cancer., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Concomitant chemoradiotherapy (CCRT) produces severe mucositis and swallowing dysfunction, often resulting in malnutrition. Intensive nutrition support (INS) in addition to percutaneous endoscopic gastrostomy (PEG) is reported to decrease adverse effects during CCRT., Patients and Methods: Fifty-eight patients with oropharyngeal cancer treated by CDDP-based CCRT were retrospectively analyzed. Twenty-nine patients treated with INS in addition to PEG were classified as INS group, and other 29 patients treated with PEG but without INS were classified as control group., Results: INS in addition to PEG significantly increased calorie intake in the second half of CCRT and reduced adverse events including mucositis (p = 0.0019), leukopenia (p = 0.04), and renal function (p = 0.006). Moreover, 21 out of 29 patients had successfully administration of 200 mg/m2 or more of CDDP, while only 10 out of 29 patients had enough amount of CDDP in control group., Conclusions: These results suggest that INS in addition to prophylactic PEG not only decreases adverse effects but also may potentially improve oncological outcome of the patients with oropharyngeal cancer treated by CCRT.

Objectives: Altered fractionation radiotherapy and concomitant chemoradiotherapy represent commonly used intensification strategies in the management of locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). This meta-analysis compares compliance, safety, and efficacy between two single-agent cisplatin schedules given concurrently with altered fractionation radiotherapy., Methods: We systematically searched for prospective trials of patients with LA-SCCHN who received post-operative or definitive altered fractionation concurrent chemoradiotherapy. High-dose cisplatin once every three to four weeks (100 mg/m 2 , 2 doses) was compared with a weekly low-dose protocol (≤50 mg/m 2 , ≥4 doses). The primary outcome was overall survival. The secondary endpoints comprised treatment adherence, acute and late toxicities, and objective response rate., Results: Twelve studies with 1373 patients treated with definitive chemoradiotherapy were included. Compared to the weekly low-dose cisplatin regimen, the three- to four-weekly high-dose cisplatin regimen improved overall survival (p=.0185), was more compliant with respect to receiving all planned cycles of cisplatin (71% versus 95%, p=.0353), and demonstrated less complications in terms of severe (grade 3-4) acute mucositis and/or stomatitis (75% versus 40%, p=.0202) and constipation (8% versus 1%, p=.0066), toxic deaths (4%, versus 1%, p=.0168), 30-day mortality (8% versus 3%, p=.0154), and severe late subcutaneous fibrosis (21% versus 2%, p<.0001). Overall and complete response rates were similar between both chemotherapy schedules., Conclusion: In chemoradiotherapy incorporating altered fractionation, two cycles of high-dose cisplatin with a three to four week interval are superior to weekly low-dose schedules. Further studies should identify those who might derive the greatest benefit from this intensified approach., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: Three-weekly high-dose cisplatin (100 mg/m 2 ) is considered the standard systemic regimen given concurrently with postoperative or definitive radiotherapy in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, due to unsatisfactory patient tolerance, various weekly low-dose schedules have been increasingly used in clinical practice. The aim of this meta-analysis was to compare the efficacy, safety, and compliance between these two approaches., Materials and Methods: We systematically searched literature for prospective trials of patients with LA-SCCHN who received postoperative or definitive conventionally fractionated concurrent chemoradiation. Radiation doses were usually 60-66 gray (Gy) in the postoperative setting and 66-70 Gy in the definitive setting. Standard, three-weekly high-dose cisplatin (100 mg/m 2 , 3 doses) was compared with the weekly low-dose protocol (≤50 mg/m 2 , ≥6 doses). The primary endpoint was overall survival. Secondary outcomes comprised response rate, acute and late adverse events, and treatment compliance., Results: Fifty-two studies with 4,209 patients were included in two separate meta-analyses according to the two clinical settings. There was no difference in treatment efficacy as measured by overall survival or response rate between the chemoradiation settings with low-dose weekly and high-dose three-weekly cisplatin regimens. In the definitive treatment setting, the weekly regimen was more compliant and significantly less toxic with respect to severe (grade 3-4) myelosuppression (leukopenia p  = .0083; neutropenia p  = .0024), severe nausea and/or vomiting ( p  < .0001), and severe nephrotoxicity ( p  = .0099). Although in the postoperative setting the two approaches were more equal in compliance and with clearly less differences in the cisplatin-induced toxicities, the weekly approach induced more grade 3-4 dysphagia ( p  = .0026) and weight loss ( p  < .0001)., Conclusion: In LA-SCCHN, current evidence is insufficient to demonstrate a meaningful survival difference between the two dosing regimens. Prior to its adoption into routine clinical practice, the low-dose weekly approach needs to be prospectively compared with the standard three-weekly high-dose schedule., Implications for Practice: Given concurrently with conventional radiotherapy in locally advanced head and neck cancer, high-dose three-weekly cisplatin has often been replaced with weekly low-dose infusions to increase compliance and decrease toxicity. The present meta-analysis suggests that both approaches might be equal in efficacy, both in the definitive and postoperative settings, but differ in toxicity. However, some toxicity data can be influenced by unbalanced representation, and the conclusions are not based on adequately sized prospective randomized studies. Therefore, low-dose weekly cisplatin should not be used outside clinical trials but first prospectively studied in adequately sized phase III trials versus the high-dose three-weekly approach., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2017.)

Purpose: To clarify, in a multicenter, single-arm, phase 2 study (UMIN Clinical Trials Registry no. UMIN000001439), the clinical profile of chemoradiotherapy (CRT) for cervical esophageal cancer., Patients and Methods: Patients with operable cervical esophageal cancer, excluding candidates for endoscopic resection, were enrolled. Protocol treatment consisted of CRT and adjuvant chemotherapy (CT). First, patients received concurrent CRT with 5-fluorouracil (5-FU) plus cisplatin (CDDP). Chemotherapy consisted of 5-FU at 700 mg/m 2 intravenous on days 1 to 4 and CDDP at 70 mg/m 2 intravenous on day 1, repeated every 4 weeks for 2 cycles. Radiation therapy consisted of 60 Gy in 30 fractions. After completion of CRT, 2 additional cycles of CT with 5-FU (800 mg/m 2 , days 1-5) and CDDP (80 mg/m 2 , day 1) were repeated at a 4-week interval. The primary endpoint was 3-year overall survival., Results: Thirty patients were enrolled across 8 institutions in Japan, consisting of 26 men and 4 women with a median age of 64.5 years (range, 50-75 years). No grade 4 hematologic toxicity was seen in the CRT phase, and 1 grade 4 thrombocytopenia was seen in the CT phase. Grade 3 nonhematologic acute toxicities in the CRT phase were nausea (10%), mucositis (13.3%), and dysphagia (13.3%). No treatment-related death in either phase occurred. Overall complete response rate was 73%, and 3-year overall and laryngectomy-free survival were 66.5% and 52.5%, respectively. Regarding T4 disease, 3-year overall and laryngectomy-free survival were 58.3% and 38.5%, respectively., Conclusions: This study, the first prospective study for cervical esophageal cancer, showed that CRT has sufficient efficacy and safety for use as an alternative to surgery for these patients., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Standard care for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Neoadjuvant chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) has demonstrated promising activity, with a pathological complete response (CR) of 17 % for resectable stage II/III ESCC. Here, we conducted a multicenter study to assess the efficacy and safety of induction chemotherapy with DCF followed by CRT in patients with unresectable locally advanced ESCC., Methods: Eligibility criteria included clinical T4 and/or M1 lymph node ESCC, PS 0-1 and age 20-70 years. Treatment consisted of docetaxel 70 mg/m(2) and cisplatin 70 mg/m(2) on day 1, and fluorouracil 750 mg/m(2) on days 1-5, repeated every 3 weeks for three cycles, followed by cisplatin 70 mg/m(2) on days 64 and 92, and fluorouracil 700 mg/m(2) on days 64-67 and 92-95, concurrently with radiotherapy (60 Gy in 30 fractions, 5 days/week). Primary endpoint of the phase II part was CR rate., Results: Thirty-three patients were enrolled. The completion rate of protocol treatment was 88 %. Thirteen patients (39.4 %) achieved a CR. With a median follow-up period of 41 months (range 24-49 months), median progression-free survival was 12.2 months, and median survival was 26.0 months, with a survival rate of 40.4 % at 3 years. The most common grade 3 or 4 toxicities were neutropenia, leukopenia, anorexia and dysphagia. No treatment-related death was observed., Conclusion: Induction chemotherapy with DCF followed by CRT is tolerable and shows promising efficacy for unresectable locally advanced ESCC.

Background: The purpose of this study was to analyze outcomes for the treatment of locally advanced temporal bone cancer by means of concomitant chemoradiotherapy (CCRT) with a combination of cisplatin (CDDP), 5-fluorouracil (5-FU), and docetaxel (TPF)., Methods: Between 2006 and 2011, 34 patients with squamous cell carcinoma of the temporal bone were treated at Kobe University Hospital. Medical records were retrospectively reviewed to obtain information concerning patient characteristics, extent of disease, treatment, adverse events, and oncologic results., Results: Ten patients were treated with CCRT using TPF regimen. The 5-year overall survival rate and disease-free survival rate were both 60%. Of special interest is that even for patients with unresectable T4 disease, the 5-year overall survival rate was 56%., Conclusion: The results of our study indicate that CCRT with TPF for locally advanced temporal bone cancer is an effective and promising regimen. © 2015 Wiley Periodicals, Inc. Head Neck 38: E949-E953, 2016., (© 2015 Wiley Periodicals, Inc.)

We conducted a phase II study to evaluate the efficacy and safety of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck. Chemotherapy consisted of S-1 twice daily on days 1-14 at 60 mg/m(2) /day and cisplatin at 20 mg/m(2) /day on days 8-11, repeated twice at a 5-week interval. Single daily radiation of 70 Gy in 35 fractions was given concurrently starting on day 1. For patients achieving an objective response after chemoradiotherapy, two additional cycles of chemotherapy were administered. Of the 45 enrolled patients, the percentage of clinical complete remission, the primary endpoint, was 64.4% (8 complete response, 21 good partial response) on central review. After a median follow-up of 3.52 years, 3-year local progression-free survival was 62.2%, with 3-year progression-free survival of 60.0%, 3-year overall survival of 64.4%, and 3-year time to treatment failure of 48.9%. Grade 3 or 4 toxicity included pharyngeal mucositis (46.7%), oral mucositis (44.4%), dysphagia (46.7%), anorexia (42.2%), radiation dermatitis (26.7%), neutropenia (26.7%), and febrile neutropenia (4.4%). No treatment-related deaths were observed. This combination showed promising efficacy with acceptable toxicities., (© 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.)

Objective: The current standard of care for post-operative high-risk squamous cell carcinoma of the head and neck is concurrent chemoradiotherapy with a 3-weekly cycle of cisplatin (3W-CDDP/RT). In previous pivotal trials, the complete delivery rate of three cycles of cisplatin and radiation therapy was only ~60%. Here, we evaluated the feasibility and safety of 3W-CDDP/RT in a Japanese population., Methods: The study enrolled post-operative high-risk squamous cell carcinoma of the head and neck patients. High-risk factors were a microscopically incomplete resection, extracapsular extension and two or more lymph node metastases. Subjects received three cycles of cisplatin at a dose of 100 mg/m(2) concomitant with radiation therapy (66 Gy/33 Fr)., Results: From August 2006 to May 2009, 25 eligible subjects were accrued, including 13 males, with a median age of 59 years, Eastern Cooperative Oncology Group performance status 0/1 (18/7), Stage III/IVA/IVB/recurrent (1/18/1/5) and oral cavity/oropharynx/hypopharynx/larynx (17/4/3/1). Protocol completion rate was 80%. The lower limit of the one-sided 90% confidence interval was 66%, which met the predefined statistical criteria. Grade 3/4 acute and late toxicities were almost identical to those in previous pivotal trials. No treatment-related deaths were observed. With a median follow-up of 39 months, 14 have had progression and 10 have died. Estimated 3-year locoregional control rate, relapse-free survival and overall survival were 74, 43 and 60%, respectively. On univariate analysis, oral cavity cancer and a cumulative cisplatin dose below 240 mg/m(2) appeared to be poor prognostic factors., Conclusions: This is the first Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for post-operative high-risk squamous cell carcinoma of the head and neck in a Japanese population. This treatment was feasible and the safety profile was identical to those in pivotal Phase III trials.