A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics.

PURPOSE: The objective of this study was to evaluate whether extended-release hydromorphone (osmotic-controlled release oral delivery system [OROS] hydromorphone) treatment provided pain relief in cancer patients whose pain was inadequately controlled by other analgesics. METHODS: In this prospective, open-label, multicenter trial, patients who have sustained cancer pain with other analgesics were enrolled. After the baseline evaluation (visit 1), OROS hydromorphone was administered. Two evaluations (visits 2 and 3) were made: 29 ± 7 and 57 ± 7 days later, respectively. The primary end point was the pain intensity difference (PID) at visit 3 relative to visit 1 (expressed as percent PID). RESULTS: In total, 879 patients were screened and 432 completed all three visits. Of the 874 full analysis set patients, 343 (39.2 %) improved by more than 30 % PID. Of the 432 per-protocol patients, 282 (65.3 %) improved by more than 30 % PID. At visits 2 and 3, the degree of sleep disturbance, the number of awakenings, and the degree of sleep satisfaction were significantly better than at visit 1 (all P < 0.0001 for both visit 1-visit 2 and visit 1-visit 3). However, this pain relief was not associated with improved quality of life (P = 0.326 and P = 0.055 for visit 1-visit 2 and visit 1-visit 3, respectively). CONCLUSIONS: This study suggested that active pain management using the strong opioid OROS hydromorphone was beneficial in the management of cancer pain that was not controlled by other analgesics.

Downregulation of cell-free miR-198 as a diagnostic biomarker for lung adenocarcinoma-associated malignant pleural effusion.

Circulating cell-free microRNAs (miRNAs) are potential cancer biomarkers. The aim of this study was to identify miRNAs that are differentially expressed between benign pleural effusion (BPE) and lung adenocarcinoma-associated malignant pleural effusion (LA-MPE). The expression level of cell-free miRNA was investigated in 107 patients with pleural effusion. Microarrays were used to screen 160 miRNAs in a discovery set comprising 20 effusion samples (ten BPEs and ten LA-MPEs). Real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) was used to validate the profiling results obtained for the discovery set and those obtained for a validation set comprising 42 BPEs and 45 LA-MPEs. The area under the receiver operating characteristic curve (AUC) was used to evaluate the diagnostic performance of the identified miRNAs and other common tumor markers, such as carcinoembryonic antigen (CEA) and cytokeratin fragment (CYFRA) 21-1. Microarray profiling showed that miR-198 was significantly downregulated in LA-MPE compared with BPE (p = 0.002). The miRNA microarray analysis results were confirmed by qRT-PCR (p < 0.001) using the validation set. The AUCs for miR-198, CEA and CYFRA 21-1 in the validation set were 0.887, 0.898 and 0.836, respectively. The diagnostic performance of miR-198 was comparable with that of CEA, but better than that of CYFRA 21-1. The AUC for all three markers combined was 0.926 (95% confidence interval, 0.843-0.973) with a sensitivity of 89.2% and a specificity of 85.0%. The present study suggests that cell-free miR-198 from patients with pleural effusion might have diagnostic potential for differentiating LA-MPE from BPE.

Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck.

BACKGROUND: The purpose of this study was to evaluate the efficacy and tolerability of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). METHODS: A total of 35 patients with previously untreated, locally advanced HNSCC were enrolled. Seven patients (20%) were diagnosed with stage III HNSCC and 28 patients (80%) were diagnosed with stage IV. Induction treatment included 30 mg/m(2) docetaxel on day 1 and 8, 60 mg/m(2) cisplatin on day 1, and 70 mg/m(2) S-1 on days 1 to 14. The regimen was repeated every 21 days. After three courses of induction chemotherapy, patients received concurrent chemoradiotherapy. RESULTS: Among the 35 patients, 30 (85.7%) completed induction chemotherapy. The response to induction chemotherapy was as follows: nine patients (25.7%) achieved a complete response (CR) and the overall response rate (ORR) was 85.7%. Grades 3-4 toxicity during induction therapy included neutropenia (28.5%), neutropenic fever (8.5%), and diarrhea (17.1%). After completion of concurrent chemoradiotherapy, the CR rate was 62.8% and the partial response (PR) was 22.8%. Estimates of progression-free and overall survival at 2 years were 73.2% and 79.3%, respectively. CONCLUSIONS: Weekly TPS is a promising regimen that is well-tolerated, causes minimal myelosuppression and is effective as an outpatient regimen for locally advanced HNSCC. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01645748.

Locally recurrent penile apocrine carcinoma initially diagnosed as metastatic adenocarcinoma of colon.

Apocrine carcinoma is a rare malignant adnexal neoplasm. The differential diagnosis between apocrine carcinoma and cutaneous metastasis is often difficult. Here, we report a case of locally recurrent penile apocrine carcinoma initially diagnosed as metastatic adenocarcinoma of the colon. A 75-year-old man with a history of surgical resection due to sigmoid colon cancer and penile metastasis two years prior to this study presented with a nodule at the left penile base. He underwent a wide local resection of the penile mass under a suggested preoperative diagnosis of extra-mammary Paget's disease (EMPD) associated with previous sigmoid colon cancer. However, the previously and currently resected penile masses were identified as primary apocrine carcinoma upon hematoxylin and eosin (H&E) staining and immunohistochemical staining. Although the incidence is extremely rare, both clinicians and pathologists should be alert to the possibility of synchronous double primary apocrine carcinoma in cancer patients with malignant cutaneous lesions.

ABCB1, FCGR2A, and FCGR3A polymorphisms in patients with HER2-positive metastatic breast cancer who were treated with first-line taxane plus trastuzumab chemotherapy.

OBJECTIVE: The aim of this study was to elucidate clinical implications of ABCB1, FCGR2A, and FCGR3A polymorphisms in patients with HER2-positive metastatic breast cancer (MBC) after taxane plus trastuzumab (TH) chemotherapy. METHODS: Using genomic DNA samples extracted from mononuclear cells of consecutive patients with HER2-positive MBC who received first-line TH, we analyzed five polymorphisms (ABCB1 1236C>T, ABCB1 2677G>T/A, ABCB1 3435C>T, FCGR2A 131H/R, and FCGR3A 158V/F) and then correlated them with the response rate, progression-free survival (PFS), overall survival (OS), and adverse events of patients. RESULTS: A total of 57 women were analyzed. The median age was 46 years (range 27-72). ABCB1 2677T carriers had a longer PFS (p = 0.037) along with a tendency toward a longer OS (p = 0.057). ABCB1 3435CC genotype carriers had a shorter PFS (p = 0.039) along with a tendency toward a shorter OS (p = 0.093). In combined analysis, PFS was significantly longer in ABCB1 1236CC and/or 2677TT carriers compared to the others (p = 0.006). FCGR2A 131H/R and FCGR3A 158V/F polymorphisms were not significantly associated with response rate, PFS, and OS. CONCLUSIONS: Our data support that ABCB1 polymorphisms may predict PFS after first-line TH chemotherapy in patients with HER2-positive MBC. In contrast, FCGR2A 131H/R and FCGR3A 158V/F polymorphisms could not predict treatment outcomes.

Pneumatosis intestinalis and portal venous gas secondary to Gefitinib therapy for lung adenocarcinoma.

BACKGROUND: Pneumatosis intestinalis (PI), defined as the presence of gas in the bowel wall, and portal venous gas (PVG) are relatively rare radiological findings. Although several chemotherapeutic agents and anti-vascular endothelial growth factor agents are reported to be associated with PI and PVG, an association with anti-epidermal growth factor receptor (EGFR) agents has not been described previously. CASE PRESENTATION: The present report describes a case of PI and PVG secondary to treatment with an EGFR tyrosine kinase inhibitor. A 66-year-old woman who had been diagnosed with metastatic lung adenocarcinoma presented with nausea, vomiting and abdominal distension after commencing gefitinib. A computed tomography (CT) scan of the abdomen revealed PI extending from the ascending colon to the rectum, hepatic PVG, and infarction of the liver. Gefitinib therapy was discontinued immediately and the patient was managed conservatively. A follow-up CT scan 2 weeks later revealed that the PI and hepatic PVG had completely resolved. CONCLUSION: This is the first report of PI and PVG caused by EGFR tyrosine kinase inhibitor. Although these complications are extremely rare, clinicians should be aware of the risk of PI and PVG in patients undergoing targeted molecular therapy.

A pilot study of adrenal suppression after dexamethasone therapy as an antiemetic in cancer patients.

PURPOSE: Dexamethasone has a high therapeutic index when used to prevent chemotherapy-induced nausea and vomiting. However, the chronic use of glucocorticoids has been associated with suppression of the hypothalamic-pituitary-adrenal axis. Therefore, the authors designed this pilot study to assess the incidence of adrenal insufficiency after dexamethasone therapy as an antiemetic in cancer patients receiving chemotherapy. METHODS: The rapid adrenocorticotropic hormone (ACTH) stimulation test was performed in 103 cancer patients, who had been treated with high-dose dexamethasone as an antiemetic for more than 3 months. When response to the rapid ACTH stimulation test was abnormal, the patient received corticosteroid replacement by prednisolone 7.5 mg daily for 1-2 weeks and after prednisolone replacement, changes in symptoms associated with adrenal insufficiency were investigated using a visual analog scale. RESULTS: Forty-five of the 103 patients (43.7%) showed a suppressed adrenal response to the rapid ACTH stimulation test, and the incidence of adrenal suppression was found to be significantly affected by megestrol acetate use (P = 0.035). Thirty-three patients with a suppressed adrenal function achieved an improvement in quality of life after prednisolone replacement, as determined using a self-report questionnaire (22.9 ± 14.7 to 14.8 ± 11.0, P < 0.001). CONCLUSIONS: We suggest that suppression of adrenal response is common after antiemetic dexamethasone therapy in cancer patients receiving chemotherapy.

Gallbladder Metastasis of Non-small Cell Lung Cancer Presenting as Acute Cholecystitis.

Although non-small cell lung cancer (NSCLC) can metastasize to almost any organ, metastasis to the gallbladder with significant clinical manifestation is relatively rare. Here, we report a case of gallbladder metastasis of NSCLC presenting as acute cholecystitis. A 79-year-old man presented with pain in the right upper quadrant and fever. A computed tomography (CT) scan of the chest and abdomen showed a cavitary mass in the right lower lobe of the lung and irregular wall thickening of the gallbladder. Open cholecystectomy and needle biopsy of the lung mass were performed. Histological examination of the gallbladder revealed a moderately-differentiated squamous cell carcinoma displaying the same morphology as the lung mass assessed by needle biopsy. Subsequent immunohistochemical examination of the gallbladder and lung tissue showed that the tumor cells were positive for P63 but negative for cytokeratin 7, cytokeratin 20 and thyroid transcription factor-1. A second primary tumor of the gallbladder was excluded by immunohistochemical methods, and the final pathological diagnosis was gallbladder metastasis of NSCLC. Although the incidence is extremely rare, acute cholecystitis can occur in association with lung cancer metastasis to the gallbladder.

Positive response to trastuzumab in a case of HER2-overexpressing metastatic gastric cancer that presented as severe thrombocytopenia.

BACKGROUND: Trastuzumab, a humanized monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2), has been shown to be active against metastatic gastric cancers that overexpress HER2. CASE REPORT: A 47-year-old man presented with a headache and visual disturbance. He was subsequently found to have an intracranial hemorrhage. Laboratory testing showed severe thrombocytopenia, and a bone marrow biopsy revealed aggregates of malignant tumor cells. Endoscopic biopsy of an ulcerative lesion of the gastric antrum confirmed signet ring cell carcinoma based on the results of H&E staining. Immunohistochemistry of the tumor cells revealed HER2 overexpression with an intensity of 3+, and silver in situ hybridization showed HER2 gene amplification. The patient was treated with trastuzumab because of the presence of severe thrombocytopenia. After 2 months of trastuzumab therapy, gastric wall thickening and ascites were diminished and thrombocytopenia was markedly improved. Trastuzumab was continued for an additional 3 months. CONCLUSION: This is the first report of a positive response to trastuzumab in a patient with HER2-overexpressing metastatic gastric cancer that was accompanied by bone marrow involvement and severe thrombocytopenia. This finding is of considerable relevance for difficult cases of metastatic gastric cancer that preclude the administration of aggressive antineoplastic regimens.

Extranodal interdigitating dendritic cell sarcoma presenting in the pleura: a case report.

Interdigitating dendritic cell sarcoma (IDCS) is an extremely rare neoplasm arising from the antigen-presenting cells of the immune system. This disease usually involves the lymph nodes, and rarely, extranodal sites may be affected. The authors report a case of extranodal IDCS presenting in the pleura. A 32-yr-old man presented with progressive chest pain. Imaging studies showed diffuse pleural thickening with pleural effusion. Morphological and immunohistochemical analysis of an incisional biopsy of the pleura were consistent with a diagnosis of IDCS; tumor cells were positive for S100 and CD45, but negative for CD1a, CD21, CD35, B cell and T cell markers. The patient was administered chemotherapy, but died of progressive disease. Although its incidence is extremely rare, this case suggests that extranodal IDCS should be considered in the differential diagnosis of undifferentiated neoplasms and that immunohistochemical staining be performed using appropriate markers.

Analysis of chemotherapy-induced amenorrhea rates by three different anthracycline and taxane containing regimens for early breast cancer.

PURPOSE: Chemotherapy-induced amenorrhea (CIA) by newer taxane-containing regimens was evaluated in early breast cancer (EBC) patients. METHODS: A prospective cohort of 122 premenopausal EBC patients participated in a phase III trial of preoperative docetaxel/capecitabine (TX) versus doxorubicin/cyclophosphamide (AC); 34 patients received adjuvant AC followed by paclitaxel (T) and 129 patients received 5-fluorouracil/doxorubicin/cyclophosphamide (FAC). RESULTS: The CIA rate was 90.2% with TX/AC, 73.5% with AC followed by T, and 72.1% with FAC at 1 year (P = 0.002), and 66.7%, 73.3%, and 58.9%, respectively, at 3 years (P = 0.268). At one year, age (P < 0.001) and taxane use (P = 0.002), and after two years, age and tamoxifen use were significant factors for CIA in multivariate analysis. Serum estradiol and follicle-stimulating hormone levels were significantly correlated with menstrual status, age, and tamoxifen use. CONCLUSION: Taxanes resulted in higher CIA rates in the first year, but age and tamoxifen use were significant factors for persistent CIA.

Weight changes after adjuvant treatment in Korean women with early breast cancer.

BACKGROUND: Weight gain is a common problem in breast cancer patients and is reported to be associated with poorer survival. However, most data are limited to Western women. We evaluated weight changes after adjuvant treatment in Korean women with early breast cancer. METHODS: The authors reviewed the records of 260 patients with stage I-III breast cancer treated between June 2003 and February 2006. Body weight, body mass index (BMI) and menopausal status at baseline and after 3, 6, 12 and 24 months of adjuvant treatment were reviewed. RESULTS: Mean patient age was 47.0 years and 61.1% of women were premenopausal. Among them, 195 patients (75.8%) received chemotherapy and 186 (71.5%) received hormonal therapy. Mean baseline weight was 57.5 +/- 9.8 kg and mean BMI was 23.5 +/- 1.6 kg/m(2) (22.8 +/- 3.0 vs. 24.7 +/- 3.2 kg/m(2) for pre- vs. post-menopausal women, P = 0.286). Mean weight changes were; 0.30 kg at 3 months (P = 0.019); 0.16 kg at 6 months (P = 0.367); -0.34 kg at 1 year (P = 0.082); -0.40 kg at 2 years (P = 0.097). Twenty-three patients (10.4%) gained more than 5% of baseline body weight at 1 year, but no clinical variable was found to be associated with these weight gains. CONCLUSION: This study shows that Korean women with early breast cancer do not gain weight after adjuvant treatment. Further studies are needed to determine differences between Asian and Western women in terms of weight changes and prognosis in early breast cancer.

Epidermal growth factor receptor expression discrepancies in metastatic colorectal cancer patients treated with cetuximab plus irinotecan-based chemotherapy refractory to irinotecan and oxaliplatin.

PURPOSE: This study was designed to evaluate the efficacy and safety of cetuximab plus irinotecan-based therapy in metastatic colorectal cancer refractory to irinotecan and oxaliplatin. In addition, discrepancies in the expression of epidermal growth factor receptor were examined by immunohistochemistry using two different antibodies. METHODS: The records of patients with metastatic colorectal cancer who were heavily pretreated with irinotecan and oxaliplatin and subsequently received cetuximab plus irinotecan-based therapy were reviewed. Differences in the expression of epidermal growth factor receptor detected by the PharmDx antibody and the clone H11 antibody in these patients were compared. RESULTS: Between February 2005 and August 2007, 52 patients were treated; median age was 53.5 years. The confirmed overall response rate was 30.8 percent, and the disease control rate was 67.3 percent. Median time to progression was 3.1 months, and median overall survival was 8.1 months. Of the 27 patients evaluable for epidermal growth factor receptor status, epidermal growth factor receptor expression was positive in 12 patients (44.4 percent) using the clone H11 antibody test and in 26 patients (96.3 percent) with the PharmDx kit. CONCLUSION: Cetuximab plus irinotecan-based therapy showed promising antitumor activity even in patients with metastatic colorectal cancer refractory to irinotecan and oxaliplatin. In addition, discrepancies in the expression of the epidermal growth factor receptor detected by the clone H11 antibody and the PharmDx kit were observed.

Weekly paclitaxel and trastuzumab as a first-line therapy in patients with HER2-overexpressing metastatic breast cancer: magnitude of HER2/neu amplification as a predictive factor for efficacy.

We evaluated the efficacy and safety of weekly paclitaxel plus trastuzumab as first-line chemotherapy in women with HER2-overexpressing metastatic breast cancer (MBC), and we investigated the prognostic factors including magnitude of HER2/neu amplification in this population. We analyzed 54 patients with HER2-overexpressing MBC that were treated with weekly paclitaxel plus trastuzumab as first-line chemotherapy from February 2004 to December 2006. At a median follow-up of 28 months, median time to progression (TTP) was 16.6 months (95% CI, 9.4 to 23.7 months) and median overall survival was 25.6 months (95% CI, 21.8 to 27.3 months). Therapy was generally well tolerated, although three patients (5.5%) experienced reversible, symptomatic heart failure. Of the 27 patients evaluable for the HER2 FISH, patients with a HER2/CEP17 ratio of < or =4.0 had significantly shorter TTP than those with a HER2/CEP17 ratio of >4.0 (10.8 vs. 23.2 months, P=0.034). A HER2/CEP17 ratio of >4.0 was identified as significant predictive factor of TTP by multivariate analysis (P=0.032). The combination of weekly paclitaxel plus trastuzumab as first-line chemotherapy is an effective regimen in patients with HER2-FISH-positive MBC. Furthermore, the magnitude of HER2 amplification is an independent predictive factor of TTP.

Diagnostic benefits of the combined use of liquid-based cytology, cell block, and carcinoembryonic antigen immunocytochemistry in malignant pleural effusion.

BACKGROUND: Malignant pleural effusion (MPE) is a common complication of cancer cell metastasis to the pleura. Discrimination between MPE and benign pleural effusion is necessary to design treatment strategies. Cytology is important for the diagnosis of MPE. Carcinoembryonic antigen (CEA) is an epithelial biomarker with a strong staining pattern in adenocarcinomas. Here, the diagnostic performances of liquid-based cytology (LBC), cell block (CB) preparation, and CEA immunostaining for the detection of malignancy in effusion cytology were compared in a large case series. METHODS: In a single institution, 1,014 cytology samples from 862 patients were retrospectively collected and reviewed between January 2013 and November 2015. Ethanol-fixed, paraffin embedded CB of pleural effusions was analyzed by CEA immunostaining. Diagnostic values were compared among LBC, CB, CEA immunostaining, and the combination of two methods. RESULTS: The sensitivity and specificity of the CB preparation were 94.3% and 98.7%, respectively, compared with 81.3% and 99.4% for LBC preparations, respectively. Combination of LBC and CB increased sensitivity by 98.3%. Although the accuracy of CEA staining itself was moderate (sensitivity, 89.8%), the combined use of CB and CEA tumor marker increased the detection rate of malignancy (sensitivity, 100%; specificity, 100%), compared with that of cytology (LBC or CB) alone. CONCLUSIONS: The sensitivity and specificity for the diagnosis of MPE could be improved by integrating the CB and CEA staining into LBC in routine clinical practice to improve diagnostic accuracy.

Long-term survival after gastrectomy and metastasectomy for gastric cancer with synchronous bone metastasis.

Bone metastasis is a rare event in patients with gastric cancer, but pathologic fracture, paralysis, pain and hematological disorders associated with the bone metastasis may influence the quality of life. We report herein the case of a 53-year-old man who presented with primary remnant gastric cancer with bone metastasis. The patient requested further investigations after detection of a metastatic lesion in the 2nd lumbar vertebra during evaluation for back pain that had persisted for 3 mo. No other metastatic lesions were detected. He underwent total gastrectomy and palliative metastasectomy to aid in reduction of symptoms, and he received combination chemotherapy with tegafur (S-1) and cisplatin. The patient survived for about 60 mo after surgery. Currently, there is no treatment guideline for gastric cancer with bone metastasis, and we believe that gastrectomy plus metastasectomy may be an effective therapeutic option for improving quality of life and survival in patients with resectable primary gastric cancer and bone metastasis.

Comparison of liquid-based cytology (CellPrepPlus) and conventional smears in pancreaticobiliary disease.

BACKGROUND/AIMS: Endoscopic ultrasound-guided fine needle aspiration (EUSFNA) and brushing cytology are used worldwide to diagnose pancreatic and biliary malignant tumors. Liquid-based cytology (LBC) has been developed and it is currently used to overcome the limitations of conventional smears (CS). In this study, the authors aimed to compare the diagnostic value of the CellPrepPlus (CP; Biodyne) LBC method with CS in samples obtained using EUS-FNA and brushing cytology. METHODS: This study prospectively enrolled 75 patients with pancreatic or biliary lesions from June 2012 to October 2013. For cytological analyses, including inadequate specimens, benign and atypical were further classified into benign, and suspicious and malignant were subcategorized as malignant. Sensitivity, specificity, accuracy, and positive predictive values (PPV) and negative predictive values (NPV) were evaluated. RESULTS: In the EUS-FNA based cytological analysis of pancreatic specimens, CP had a sensitivity of 60.7%; specificity, 100%; accuracy, 77.1%; PPV, 100%; and NPV, 64.5%. CS had a sensitivity of 85.7%; specificity, 100%; accuracy, 91.7%; PPV, 100%; and NPV, 83.3%. In the brushing cytology based analysis of biliary specimens, CP had sensitivity of 53.1%; specificity, 100%; accuracy, 54.5%; PPV, 100%; and NPV, 6.3%. CS had a sensitivity of 78.1%; specificity, 100%; accuracy, 78.8%; PPV, 100%; and NPV, 12.5%. CONCLUSION: Our study found that CP had a lower sensitivity because of low cellularity compared with CS. Therefore, CP (LBC) has a lower diagnostic accuracy for pancreatic EUS-FNA based and biliary brush cytology based analyses compared with CS.

Cytoplasmic HuR over-expression is associated with increased cyclooxygenase-2 expression in laryngeal squamous cell carcinomas.

AIMS: Cyclooxygenase-2 (COX-2) is an enzyme that catalyses the synthesis of prostaglandins and is over-expressed in a variety of premalignant and malignant conditions. The human embryonic lethal abnormal vision (ELAV)-like protein, HuR, is an mRNA stability protein that can regulate COX-2 expression. Because the regulation of gene expression through the post-transcriptional modification of the mRNA stability is an important mechanism in the control of cellular growth, this study investigated the expression and cellular localisation of the HuR protein and the relationships between COX-2 and HuR in laryngeal epithelium. METHODS: The expression patterns of HuR and COX-2 in 39 laryngeal squamous cell carcinomas and paired samples of 38 normal and/or 30 dysplastic mucosa adjacent to an infiltrating carcinoma were analysed by immunohistochemistry and compared. RESULTS: An immunohistochemical evaluation of the specimens revealed high nuclear and cytoplasmic immunoreactivity for HuR in 39 (100%) and 26 (66.6%) of 39 lesions with laryngeal squamous cell carcinoma, 27 (90.0%) and one (3.3%) of 30 lesions with epithelial dysplasia, and 19 (50.0%) and 0 (0%) of 38 specimens with normal-appearing laryngeal epithelium, respectively. High levels of COX-2 expression were observed in 66.6% and 6.7% of laryngeal squamous cell carcinoma and epithelial dysplasia, respectively, but no COX-2 expression was detected in the normal epithelium. There was no significant correlation between HuR expression and the other clinicopathological parameters such as age, site, tumour size, or nodal status as well as histological differentiation. There was a statistically significant correlation between COX-2 immunoreactivity and the cytoplasmic HuR expression level in laryngeal squamous cell carcinoma. CONCLUSIONS: Based on the fact that HuR in the cytoplasm indicates mRNA dysregulation of COX-2, our results suggest that their correlation plays an important role in the development and progression of laryngeal carcinoma.