Utility of Platelet Count for Predicting Cirrhosis in Alcoholic Liver Disease: Model for Identifying Cirrhosis in a US Population.

BACKGROUND: Thrombocytopenia has been shown to be the single most useful laboratory investigation for identifying subclinical cirrhosis of varying etiologies. However, alcohol per se can result in thrombocytopenia, and hence it is unclear whether platelet count can identify cirrhosis in patients who are alcoholic. OBJECTIVES: To characterize the utility of clinical predictors, especially platelet count, for identifying the presence of cirrhosis in alcoholics. To develop a simple, objective model for identifying cirrhosis in alcoholics. DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 2,471 consecutive hospitalized patients with abnormal liver enzyme levels were screened, from which 272 patients with a history of recent and ongoing alcohol intake, negative diagnostic studies for alternative etiologies of chronic liver disease, and recent liver imaging with ultrasound or CT scan were included. MAIN MEASURES: Results of liver imaging and admission laboratory studies including liver enzymes, coagulation studies, and blood counts. KEY RESULTS: One hundred twenty-nine patients (47%) had cirrhosis based on imaging; 143 patients (53%) had no cirrhosis. A pre-sobriety platelet count (during ongoing alcohol intake) of less than 70*10(3) cells/mm(3) was effective for ruling in cirrhosis (positive likelihood ratio [LR] 6.8, 95% CI: 3.4, 14); platelet count greater than 200*10(3) was useful for ruling out cirrhosis in alcoholics (negative LR 0.18, 95% CI: 0.10, 0.35). Multivariate logistic regression analysis identified international normalized ratio (INR) (p < 0.01) and pre-sobriety platelet count (p < 0.01) as independent predictors of cirrhosis. A Model for identifying Cirrhosis in Alcoholic Liver Disease (MCALD) was developed using the INR and pre-sobriety platelet count; it had an area under the receiver operating characteristic curve of 0.89 and Hosmer-Lemeshow goodness of fit chi(2) (p value) of 8.9 (0.35) for predicting cirrhosis in alcoholics. A MCALD score > 5.5 corresponded to an increased likelihood of cirrhosis (LR: 6.5, 95% CI: 4.3, 11.0) and a MCALD score < 5.5 corresponded to decreased likelihood of cirrhosis in alcoholics (LR: 0.25, 95% CI: 0.19, 0.36). Sobriety platelet count (after alcohol abstinence) at a cutoff of 160*10(3) had positive LR of 7.9 (95% CI: 4.4, 14) and negative LR of 0.42 (95% CI: 0.34, 0.52) for predicting cirrhosis in alcoholics. CONCLUSIONS: A simple model of platelet count and INR has good diagnostic accuracy for identifying cirrhosis in alcoholics.

Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery.

This work aimed at evaluating patients' swallowing functions by a newly validated swallow-specific questionnaire, the Sydney Swallow Questionnaire (SSQ), in a cohort of oral and oropharyngeal cancer patients. Mean/median SSQ scores were calculated and compared with study variables using the Mann-Whitney U test and Kruskal-Wallis test. The mean composite SSQ scores (SD) for the base of tongue, oral tongue, and tonsillar cancer patients were 663.8 (382.8), 456.2 (407.6), and 283.0 (243.1), respectively (p = 0.005); for advanced vs. early T stage disease they were 918.1 (319.5) vs. 344.8 (292.1) (p ≤ 0.001); for patients <60 years vs. ≥60 years they were 549.3 (415.1) vs. 314.0 (247.3) (p = 0.02); and for patients with reconstruction vs. without reconstruction they were 676.5 (410.5) vs. 331.9 (286.5) (p = 0.002). SSQ is a useful tool for evaluation of swallowing in head and neck cancer patients. Site of cancer, T stage, patient's age, and reconstruction directly affect post-treatment swallow outcome.

An exploratory study of the influence of clinico-demographic variables on swallowing and swallowing-related quality of life in a cohort of oral and oropharyngeal cancer patients treated with primary surgery.

There are insufficient data on swallowing and the consequences of its dysfunction in patients with cancers of the oral cavity (OC) and oropharynx (OP) that are treated with primary surgery. The study attempts to explore the effect of important clinico-demographic variables on post-treatment swallowing and related quality of life (QOL) in post-surgical OC and OP cancer patients. Sixty-two consecutive OC and OP cancer patients completed the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Mean scores were computed. Comparison of scores based on mean ranks were performed using Mann-Whitney U test or Kruskal-Wallis test. Level of significance was set at P ≤ 0.02. Adjustments were made for multiple comparisons. Significantly worse mean (SD) QOL scores were observed in late T-stage (T3/T4) versus early T-stage (T1/T2) patients for global domain, physical domain, functional domain and emotional domains [44.4 (21.9) vs. 78.7 (22.7) (P < 0.001); 50.0 (9.4) vs. 75.9 (16.3), (P < 0.0001); 57.8 (20.6) vs. 84.1 (16.7), (P < 0.001) and 55.2 (18.0) vs. 78.5 (16.3), (P < 0.001)], respectively. Patients undergoing reconstruction versus without reconstruction had worse QOL scores; 58.8 (26.9) versus 79.5 (22.8), (P < 0.01); 61.2 (15.1) versus 76.4 (17.5), (P = 0.002); 65.4 (20.5) versus 86.3 (15.9), (P < 0.0001) and 63.3 (18.8) versus 79.8 (16.3), (P < 0.01), respectively, for global, physical, functional and emotional domains. Advanced T-stage, reconstruction, younger age and base of tongue tumours have a negative impact on post-treatment swallow function and related QOL in these patients.

Evaluation of factors affecting post-treatment quality of life in oral and oropharyngeal cancer patients primarily treated with curative surgery: an exploratory study.

The aim was to explore the impact of important clinico-demographic factors on the post-treatment quality of life (QOL) in surgically treated oral and oropharyngeal cancer patients. 63 consecutive follow-up oral and oropharyngeal cancer patients treated primarily with surgery were recruited. 55 patients sent the completed questionnaires and finally included in this study. QOL and important sub-domains of the QOL were assessed. Mean QOL scores (SD) were computed, level of significance was set at P < 0.05. The mean composite QOL score and standard deviation (SD) for oral and oropharyngeal cancer patients were 76.6 (15.2) and 73.4 (13.9), respectively. Patients with higher T-stage (T3 and T4) and higher overall-stage (III and IV) had lower mean QOL scores as against early T (T1 and T2) and overall early-stage (I and II); mean scores (SD) 64.3 (13.6) and 72.3 (13.8), and 76.6 (13.6) and 81.7 (14.1), respectively. Younger patients had lower mean scores (SD) than older patients; mean QOL scores (SD) 69.7 (14.0) and 79.6 (SD), respectively. Patients with reconstruction had lower mean QOL scores as compared to those without reconstruction; mean scores (SD) 67.6 (16.0) and 77.4 (12.5), respectively. In conclusion, tumor-stage, overall-stage, age of patients, and reconstruction had a significant direct effect on the post-treatment QOL of oral and oropharyngeal cancer patients.

Secondary free tissue transfer in head and neck reconstruction.

BACKGROUND: The incidence of head and neck cancer (H&N) continues to increase together with the need for reconstructive surgery. Head and Neck microsurgeons are likely to encounter challenging secondary free flap surgery on the background of failed primary flaps, radiotherapy treatment or recurrence. The aim of this study was to review our experience of treating such cases in a tertiary referral centre in the United Kingdom. METHODS: We performed a retrospective analysis of all patients undergoing sequential free flap surgery for head and neck defects in our unit during 2010-2017. Parameters recorded included indication for surgery, type and sequence of reconstruction, recipient vessel use and post-operative complications. RESULTS: We identified 17 patients who underwent 39 free tissue transfers for the reconstruction of head and neck defects (five transfers were performed at other units). The radial forearm and anterolateral thigh flaps were most commonly used. Almost a quarter of patients underwent three or more free flap reconstructive procedures. In over a third, the same vein and artery were used for subsequent anastomoses, and we used five vein grafts over 68 anastomoses. There were no flap failures recorded. CONCLUSIONS: Secondary free flaps in the head and neck are required for a variety of aetiologies and can have success rates similar to those for primary free tissue transfers with minimal morbidity and mortality. Free tissue transfer is the best reconstructive option in H&N patients and should still be considered the first choice option in salvage cases until the patient's donor sites have been depleted.

Role of planned postchemoradiotherapy selective neck dissection in the multimodality management of head and neck cancer.

OBJECTIVE/HYPOTHESIS: To assess the oncologic efficacy and functional outcome of selective postchemoradiotherapy neck dissection for stage IV head and neck squamous cell carcinoma. METHODS: Retrospective review of patients with N2-3 cervical metastases at presentation who underwent planned neck dissection after complete biopsy-proven clearance of primary site mucosal disease with chemoradiotherapy between 2000 and 2006. RESULTS: There were 31 males and 10 females. The average age at presentation was 57 +/- 9 years. The oropharynx was the most common primary site (n = 23; 56%). Forty-nine hemineck dissections were performed, including six bilateral and two revision procedures. Sixteen (39%) patients had residual viable postchemoradiotherapy neck disease. Patient weight did not deteriorate after neck dissection (P > .4). Two patients had persistently worsened postoperative swallowing. Ten patients required shoulder physiotherapy, of whom eight were treated with conservative measures. Five-year hemineck disease control and disease-specific survival rates were 92% and 64%, respectively. Presence of viable postchemoradiotherapy neck disease was the only independent predictor of regional control (P < .001; hazard ratio 0.00; 0.00-0.40) and disease-specific survival (P < .02; hazard ratio 0.23; 0.04-0.55). Surgery was twice more likely to confer therapeutic benefit than to cause a significant, albeit in most cases, transitory, complication. CONCLUSIONS: Neck dissection is a safe and effective procedure and a necessary component of the multimodality management of all head and neck cancer patients with N2-3 disease. It should be performed soon after satisfactory demonstration of primary site disease clearance. Universal deployment of radical surgery appears unnecessary and should, when possible, be abandoned in favor of more selective procedures to lessen morbidity.

Incidence and significance of myocardial injury after surgical treatment of head and neck cancer.

OBJECTIVE/HYPOTHESIS: To review the incidence of, and risk factors for myocardial injury after head and neck surgery to help optimize patient care and develop perioperative cardioprotective strategies. STUDY DESIGN: Observational cohort study. METHODS: Records of 65 patients surgically treated for upper aerodigestive tract squamous cell carcinoma between 2005 and 2006 were reviewed. Information about cardiovascular history, tumor characteristics, details of surgery, and postoperative complications were recorded. Patients had troponin assays on the third postoperative day. Logistic regression was used to identify risk factors for postoperative myocardial injury. RESULTS: The average age at presentation was 62+/-12 years. There were 46 (71%) males and 19 (29%) females. Troponin-positive and -negative groups were matched for age, sex, cardiovascular risks, comorbidity, site, tumor-node-metastasis status, and duration of the operations. Sixteen (25%) patients had postoperative myocardial injury including five clinical myocardial infarctions. Factors identified as independent predictors of postoperative myocardial injury were blood pressure level (odds ratio [OR] 1.17; 95% confidence interval [CI] 1.04-1.31; P<.02), intraoperative heart rate variability (OR 1.33; 95% CI 1.04-1.71; P<.02), and the degree of postoperative inflammatory response (OR 1.07; 95% CI 1.02-1.13; P<.001). CONCLUSIONS: Postoperative myocardial injury is a known independent predictor of cardiovascular prognosis. Its incidence in head and neck patients could potentially be reduced through stringent blood pressure management, tight intraoperative heart rate control, and dampening of the postoperative inflammatory response. Troponin testing is a valuable screening tool, and patients who have elevated levels postoperatively should be closely monitored and referred to a cardiologist for optimization of cardiovascular care.

Teaching cardiac examination skills. A controlled trial of two methods.

OBJECTIVE: To determine if structured teaching of bedside cardiac examination skills improves medical residents' examination technique and their identification of key clinical findings. DESIGN: Firm-based single-blinded controlled trial. SETTING: Inpatient service at a university-affiliated public teaching hospital. PARTICIPANTS: Eighty Internal Medicine residents. METHODS: The study assessed 2 intervention groups that received 3-hour bedside teaching sessions during their 4-week rotation using either: (1) a traditional teaching method, "demonstration and practice" (DP) (n=26) or (2) an innovative method, "collaborative discovery" (CD) (n=24). The control group received their usual ward teaching sessions (n=25). The main outcome measures were scores on examination technique and correct identification of key clinical findings on an objective structured clinical examination (OSCE). RESULTS: All 3 groups had similar scores for both their examination technique and identification of key findings in the preintervention OSCE. After teaching, both intervention groups significantly improved their technical examination skills compared with the control group. The increase was 10% (95% confidence interval [CI] 4% to 17%) for CD versus control and 12% (95% CI 6% to 19%) for DP versus control (both P<.005) equivalent to an additional 3 to 4 examination skills being correctly performed. Improvement in key findings was limited to a 5% (95% CI 2% to 9%) increase for the CD teaching method, CD versus control P=.046, equivalent to the identification of an additional 2 key clinical findings. CONCLUSIONS: Both programs of bedside teaching increase the technical examination skills of residents but improvements in the identification of key clinical findings were modest and only demonstrated with a new method of teaching.

Maxillary haemangioma.

Maxillary haemangioma is a rare entity. It presents with a painless, slow-growing swelling and if it involves the paranasal sinuses it may present with severe epistaxis, mimicking a malignancy. A case of haemangioma arising in the bony maxilla and causing a cosmetic problem is presented here.

Acoustic parameters of speech: Lack of correlation with perceptual and questionnaire-based speech evaluation in patients with oral and oropharyngeal cancer treated with primary surgery.

BACKGROUND: Acoustic evaluation of speech is the least explored method of speech evaluation in patients with oral cavity and oropharyngeal cancer. The purpose of this study was to explore acoustic parameters of speech and their correlation with questionnaire evaluation and perceptual evaluation in patients with oral cavity and oropharyngeal cancer. METHODS: One hundred seventeen subjects (65 consecutive patients with oral cavity and oropharyngeal cancer and 52 controls) participated in this study. Formant frequencies (by Linear Predictive Coding), Speech Handicap Index, and London Speech Evaluation scale were used for acoustic evaluation, questionnaire evaluation, and perceptual evaluation, respectively. RESULTS: Men showed significant elevation in second formant (F2) values for patients with oral cavity cancer and those who underwent surgery alone. Female patients with early T classification cancers and those who underwent surgery and chemoradiation showed significant reduction in the mean F2 values. Importantly, however, acoustic evaluation parameters did not correlate with either perceptual evaluation or questionnaire evaluation parameters, although there was moderate correlation between questionnaire evaluation and perceptual evaluation speech parameters. CONCLUSION: Acoustic evaluation modalities have no clear role in the management of patients with oral cavity and oropharyngeal cancer.

Composite Hemangioendothelioma of the Submandibular Region.

Composite hemangioendothelioma (HE) is a rare vascular neoplasm of intermediate malignant potential that predominantly occurs within the dermis or subcutis of the extremities, and occurs in a wide age range. It is locally aggressive with a high rate of local recurrence, and more rarely regional lymph node or distant metastasis. Histologically, it is composed of a complex admixture of benign, intermediate and malignant vascular components. Although composite HE may contain angiosarcoma-like areas, its prognosis is better than that of pure angiosarcoma. We describe a case of composite HE presenting as a submandibular mass in a 43 year-old male, which included areas of prominent 'high grade' epithelioid angiosarcoma. This adds to the range of anatomic sites of these neoplasms, highlights the importance of recognition of the head and neck as a potential site, and emphasizes the importance of accurate diagnosis for correct management (including of long term follow up) and prognostication.

Cricothyroid approximation and thyroid chondroplasty: a patient survey.

OBJECTIVE: Cricothyroid approximation is performed in male-to-female transsexuals to raise the pitch of the voice often accompanied by a thyroid chondroplasty, an aesthetic reduction of the thyroid cartilage. The survey was conducted to ascertain patient satisfaction with the procedures. STUDY DESIGN AND SETTING: Fifty-four patients had the procedures performed in our department over an 8-year period; 45 patients were sent postal questionnaires to evaluate patient satisfaction with the appearance of the laryngeal prominence, pitch of the voice, and which they found more beneficial, the surgery or speech therapy. RESULTS: A response rate of 93% was obtained; 86% of patients thought their laryngeal profile had improved, 79% thought their voice had improved, and 55% thought that surgery and 21% thought that speech therapy had helped more in improving the voice. Overall, 79% were satisfied with the results of the surgery. CONCLUSIONS: Cricothyroid approximation and thyroid chondroplasty have a high patient satisfaction rate.

Development and validation of first-ever speech-specific perceptual speech evaluation tool for patients with head and neck cancer: the London speech evaluation (LSE) scale.

BACKGROUND: The aim of this study was to develop and validate the first ever speech-specific perceptual speech-evaluation tool for patients with head and neck cancer. METHODS: Five speech parameters (intelligibility, articulation, speech rate, nasality, and asthenia) and overall grade were included and evaluated. Speech samples of 117 subjects were recorded on electroglottograph equipment using a standard protocol and were independently judged and rated by 3 experienced speech and language therapists and re-rated 12 weeks apart. RESULTS: Among patients the Cronbach's alpha (α) coefficients for internal consistency for connected speech were 0.89, whereas for single words the α coefficients ranged between 0.80 and 0.84. The Spearman's correlation coefficients for intra-rater reliability for connected speech and words varied between 0.30 and 0.90 and 0.49 and 0.76, respectively, whereas for inter-rater reliability the coefficients ranged between 0.53 and 0.99 and 0.56 and 0.99, respectively. For construct validity, the Spearman's correlation coefficient ranged between 0.41 and 0.55. CONCLUSIONS: The London Speech Evaluation (LSE) scale demonstrated a high reliability and validity in our cohort of patients with head and neck cancer. surgery.

Evaluation of speech outcomes using English version of the Speech Handicap Index in a cohort of head and neck cancer patients.

The aim of this study was to explore post-treatment speech impairments using English version of Speech Handicap Index (SHI) (first speech-specific questionnaire) in a cohort of oral cavity (OC) and oropharyngeal (OP) cancer patients. Sixty-three consecutive OC and OP cancer patients in follow-up participated in this study. Descriptive analyses have been presented as percentages, while Mann-Whitney U-test and Kruskall-Wallis test have been used for the quantitative variables. Statistical Package for Social Science-15 statistical software (SPSS Inc., Chicago, IL) was used for the statistical analyses. Over a third (36.1%) of patients reported their speech as either average or bad. Speech intelligibility and articulation were the main speech concerns for 58.8% and 52.9% OC and 31.6% and 34.2% OP cancer patients, respectively. While feeling of incompetent and being less outgoing were the speech-related psychosocial concerns for 64.7% and 23.5% OC and 15.8% and 18.4% OP cancer patients, respectively. Worse speech outcomes were noted for oral tongue and base of tongue cancers vs. tonsillar cancers, mean (SD) values were 56.7 (31.3) and 52.0 (38.4) vs. 10.9 (14.8) (P<0.001) and late vs. early T stage cancers 65.0 (29.9) vs. 29.3 (32.7) (P<0.005). The English version of the SHI is a reliable, valid and useful tool for the evaluation of speech in HNC patients. Over one-third of OC and OP cancer patients reported speech problems in their day-do-day life. Advanced T-stage tumors affecting the oral tongue or base of tongue are particularly associated with poor speech outcomes.

Anatomic distribution of cervical lymph node spread in parotid carcinoma.

BACKGROUND: The pattern of distribution of cervical nodal involvement from primary parotid carcinomas has not been extensively described. METHODS: All cases of parotid carcinoma over a 10-year period treated at our institution were reviewed. Data from the patients with cervical metastases were analyzed. These findings were pooled with previously published data on topography of cervical lymph nodes from parotid carcinomas. RESULTS: Of 80 cases, 15 had cervical metastases (N+) in our series. When pooled with the data from all other reports, a total of 66 N+ cases were available for analysis. Twenty-eight percent of cases had involvement of level I, 59% had level II, 52% had level III, 38% had level IV, and 41% had level V. There were frequent skip metastases to level V but all were ipsilateral. CONCLUSION: The diffuse distribution of cervical nodal metastases does not support a high echelon neck dissection or radiotherapy fields limited to the upper chain in the management of cervical nodal disease.

First report on the reliability and validity of speech handicap index in native English-speaking patients with head and neck cancer.

BACKGROUND: Posttreatment speech problems are seen in nearly half of patients with head and neck cancer. Although there are many voice-specific scales, surprisingly there is no speech-specific questionnaire for English-speaking patients with head and neck cancer. The aim of this study was to validate the Speech Handicap Index (SHI) as the first speech-specific questionnaire in the English language. METHOD: In all, 55 consecutive patients in follow-up for oral and oropharyngeal cancer completed the SHI and University of Washington Quality of Life Questionnaire (UWQOL V.04). Thirty-two patients completed both questionnaires again 4 weeks later to address test-retest reliability. RESULTS: Internal consistency, test-retest reliability, construct validity, and group validity of the SHI were found to be highly significant (p < .01) using Cronbach's alpha, Spearman's correlation coefficient (r), and Mann-Whitney U tests. CONCLUSIONS: The SHI is a precise, highly reliable, and valid speech assessment tool for patients with head and neck cancer. Further dedicated studies using the SHI in patients with head and neck cancer would be useful.

Reconstruction of pharyngolaryngectomy defects using the jejunal free flap: a 10-year experience from a single reconstructive center.

BACKGROUND: Reconstruction following pharyngolaryngectomy presents a complex reconstructive challenge, and a single-stage, reliable reconstruction allowing prompt discharge from the hospital and return of swallowing and speech function is required. The authors present their 10-year experience of 43 jejunal free flaps for pharyngolaryngectomy reconstruction by a single team and outline their operative algorithm to minimize postoperative morbidity. METHODS: The data for patients who underwent jejunal free flap reconstruction of circumferential pharyngoesophageal defects between March of 2000 and September of 2009 were reviewed retrospectively. All cases were included for analysis. RESULTS: There were 31 male patients and 12 female patients, with 100 percent acute flap survival. The authors' overall benign pharyngocutaneous fistula rate was two of 43 (5 percent), with two of 29 (7 percent) occurring in the group without a prophylactic pectoralis muscle flap and zero of 14 occurring in the group that had a prophylactic pectoralis muscle flap. No fistulas occurred when the anastomosis was performed with the gastrointestinal stapler (zero of 48). The authors' overall benign stricture rate was six of 43 (14 percent). Thirty-six patients received either a primary or secondary tracheoesophageal puncture; of these, 28 of 36 (78 percent) used their tracheoesophageal puncture as their primary mode of communication. CONCLUSION: The authors' recommendations for minimizing fistulas and stricture rate, following free jejunal reconstruction, include the gastrointestinal stapler for bowel anastomosis whenever possible, and the use of a prophylactic pedicled pectoralis major muscle flap for patients exposed to previous radiotherapy.

Phase I/II study of oncolytic HSV GM-CSF in combination with radiotherapy and cisplatin in untreated stage III/IV squamous cell cancer of the head and neck.

PURPOSE: This study sought to define the recommended dose of JS1/34.5-/47-/GM-CSF, an oncolytic herpes simplex type-1 virus (HSV-1) encoding human granulocyte-macrophage colony-stimulating factor (GM-CSF), for future studies in combination with chemoradiotherapy in patients with squamous cell cancer of the head and neck (SCCHN). EXPERIMENTAL DESIGN: Patients with stage III/IVA/IVB SCCHN received chemoradiotherapy (70 Gy/35 fractions with concomitant cisplatin 100 mg/m(2) on days 1, 22, and 43) and dose-escalating (10(6), 10(6), 10(6), 10(6) pfu/mL for cohort 1; 10(6), 10(7), 10(7), 10(7) for cohort 2; 10(6), 10(8), 10(8), 10(8) for cohort 3) JS1/34.5-/47-/GM-CSF by intratumoral injection on days 1, 22, 43, and 64. Patients underwent neck dissection 6 to 10 weeks later. Primary end points were safety and recommended dose/schedule for future study. Secondary end points included antitumor activity (radiologic, pathologic). Relapse rates and survival were also monitored. RESULTS: Seventeen patients were treated without delays to chemoradiotherapy or dose-limiting toxicity. Fourteen patients (82.3%) showed tumor response by Response Evaluation Criteria in Solid Tumors, and pathologic complete remission was confirmed in 93% of patients at neck dissection. HSV was detected in injected and adjacent uninjected tumors at levels higher than the input dose, indicating viral replication. All patients were seropositive at the end of treatment. No patient developed locoregional recurrence, and disease-specific survival was 82.4% at a median follow-up of 29 months (range, 19-40 months). CONCLUSIONS: JS1/34.5-/47-/GM-CSF combined with cisplatin-based chemoradiotherapy is well tolerated in patients with SCCHN. The recommended phase II dose is 10(6), 10(8), 10(8), 10(8). Locoregional control was achieved in all patients, with a 76.5% relapse-free rate so far. Further study of this approach is warranted in locally advanced SCCHN.