Unselected Series Of Patients Research Articles

Prognostic significance of vascular endothelial growth factor‐C expression and lymphatic vessel density in supraglottic squamous cell carcinoma

Regional lymph node metastases are very common findings of supraglottic cancer. The mechanism of lymphatic metastasis is as yet unknown because there have been no specific markers that could definitely distinguish lymphatic vessels from blood vessels. The aim of this study is to identify the prognostic significance of vascular endothelial growth factor-C (VEGF-C) expression and lymphatic vessel density (LVD) in supraglottic cancer. The prognostic value of the VEGF-C and LVD was retrospectively evaluated in an unselected series of patients treated with curative intent for supraglottic cancer. We investigated lymphatic vessels in 43 subjects who had previously been diagnosed with supraglottic cancer. Immunohistochemical staining was performed with VEGF-C, D2-40, and CD31 monoclonal antibodies on the paraffin-embedded tissues obtained from these patients. The association among the semiquantitative score of VEGF-C stained cancer cells, the density of immunohistochemically stained microvessels, and the prognostic factors of supraglottic cancers were investigated to evaluate the prognostic significance. VEGF-C and LVD showed a statistically significant difference according to the presence of lymph node metastasis and regional recurrence (P < .05). VEGF-C was only associated with disease-free survival and regional recurrence in multivariate analysis (P < .05). VEGF-C and LVD might be useful as predictors of the risk of lymph node metastasis and regional recurrence.

Prevalence of parathyroid cysts by neck ultrasound scan in unselected patients

Parathyroid cysts (PC) are a rare entity, representing only 0.5-1% of all parathyroid lesions and <1% of neck masses. Since its first description, in the second half of the 19th century, fewer than 300 cases have been reported. By reviewing the literature, it appears that the data available arose from surgical series, and the precise incidence of PC as detected by ultrasound (US) has not been described. The aim of this study was to review 5 yr of routine neck US, mainly performed for thyroid diseases, in order to estimate the prevalence of PC in a large series of patients. We reviewed our database of neck US investigations performed from 2003 to 2007: all data regarding patient's clinical history, US images, and fine needle aspiration cytology were retrospectively collected. Among 6621 patients submitted to neck US investigation, a PC (mean diameter 36.4+/-14.2 mm; range 25-61 mm) was diagnosed in 5 cases. Serum PTH levels were high in all the patients (221+/-140.7 pg/ml; range 111-456 pg/ml), whereas serum calcium levels only in 3 subjects (10.8+/-1.4 mg/dl; range 9.2-12.9 mg/ml). This is the first study evaluating the prevalence of PC in a large series of unselected patients by US. Our results demonstrate a much lower incidence (0.075%) of incidentally detected PC than previously reported.

Geriatric Literature Review: Revisited

Geriatric Literature Review: Revisited

Triple-negative breast cancers are increased in black women regardless of age or body mass index

IntroductionWe investigated clinical and pathologic features of breast cancers (BC) in an unselected series of patients diagnosed in a tertiary care hospital serving a diverse population. We focused on triple-negative (Tneg) tumours (oestrogen receptor (ER), progesterone receptor (PR) and HER2 negative), which are associated with poor prognosis.MethodsWe identified female patients with invasive BC diagnosed between 1998 and 2006, with data available on tumor grade, stage, ER, PR and HER2 status, and patient age, body mass index (BMI) and self-identified racial/ethnic group. We determined associations between patient and tumour characteristics using contingency tables and multivariate logistic regression.Results415 cases were identified. Patients were racially and ethnically diverse (born in 44 countries, 36% white, 43% black, 10% Hispanic and 11% other). 47% were obese (BMI > 30 kg/m2). 72% of tumours were ER+ and/or PR+, 20% were Tneg and 13% were HER2+. The odds of having a Tneg tumour were 3-fold higher (95% CI 1.6, 5.5; p = 0.0001) in black compared with white women. Tneg tumours were equally common in black women diagnosed before and after age 50 (31% vs 29%; p = NS), and who were obese and non-obese (29% vs 31%; p = NS). Considering all patients, as BMI increased, the proportion of Tneg tumours decreased (p = 0.08).ConclusionsBlack women of diverse background have 3-fold more Tneg tumours than non-black women, regardless of age and BMI. Other factors must determine tumour subtype. The higher prevalence of Tneg tumours in black women in all age and weight categories likely contributes to black women's unfavorable breast cancer prognosis.

Peripheral neuropathy in monoclonal gammopathy of undetermined significance: prevalence and immunopathogenetic studies.

In an unselected series of patients with monoclonal gammopathy of undetermined significance (MGUS) we found neuropathy in 2 of 34 patients with IgG (6%), 2 of 14 with IgA (14%), and 8 of 26 with IgM MGUS (31%). The neuropathy was subclinical in 6 patients (1 IgG, 1 IgA, and 4 IgM). Patients with IgG or IgA MGUS had a prominent motor impairment with electrophysiologic and morphologic findings suggestive of predominant axonal degeneration. No deposit of the M-protein in sural nerve and no reactivity of the M-protein with nerve was detected in these patients. Patients with IgM MGUS had a prominent sensory impairment with evidence of predominant demyelination. In 6 of these patients the M-protein reacted with the myelin-associated glycoprotein (MAG). The higher prevalence of neuropathy in patients with IgM MGUS may be related to the frequent reactivity of IgM M-proteins with MAG.

The GNAS1 T393C Polymorphism Predicts Survival in Patients With Advanced Squamous Cell Carcinoma of the Larynx

In previous studies, we have demonstrated that the T-allele of a specific single nucleotide polymorphism (SNP) in the Galphas gene (T393C) correlates with increased Galphas expression and hence apoptosis. The T-allele was associated with a favorable outcome in a variety of human cancers, for example, carcinoma of the urinary bladder, kidney, colorectal, oro- and hypopharynx. The prognostic value of the T393C SNP was retrospectively evaluated in an unselected series of patients treated with curative intent for laryngeal squamous cell carcinomas including all tumor stages with different therapeutic regimens. DNA analysis was performed using DNA from paraffin-embedded tissue samples from 157 patients (142 men, 15 women) with a median follow-up of 68 (3-143) months. The various genotypes were correlated with the overall survival. Survival was significantly dependent on the T393C genotype in advanced American Joint Committee on Cancer (AJCC) stages (III-IV) with an apparent gene-dose effect (P = .0437). Five-year survival rates were 76% for TT, 49% for TC, and 43.5% for CC. In multivariate analysis including age at diagnosis, AJCC stage, grade, gender, and T393C genotypes, patients with CC genotype displayed a higher risk for death with a hazard ratio of 2.59 (95% confidence interval: 1.01-6.64, P = .047) compared with the reference group consisting of T393 homozygous individuals. The T393C SNP is a prognostic marker that could help to identify high risk patients suffering from head and neck cancer.

Axillary recurrence in sentinel lymph node-negative breast cancer patients

BackgroundSentinel lymph node biopsy (SLNB) was developed to axillary lymph node dissection (ALND) in the treatment of breast cancer. SLNB is predictive of axillary node status. Major concern is the occurrence of a false-negative SLN. Purpose of this study is to determine the rate of axillary recurrence in our series of unselected patients. Patients and methodsAll patients with a negative SLNB from November 1999 to December 2006 have been treated and followed at our unit. Information on patients' characteristics, treatment and follow-up has been collected. ResultsEight-hundred and four patients with negative SLNB did not receive ALND. After a median follow-up of 38.8 months, 21 patients had distant metastases, four had axillary relapse, nine had an in-breast recurrence and two had both. All patients with axillary recurrence received axillary dissection and systemic adjuvant therapy. They are all presently alive and free from disease. ConclusionData from this series, the largest from a general hospital, showed that isolated axillary node recurrence after negative SLNB is rare (<1%) and comparable with those reported from referral cancer institutions. We confirm that SLNB for the treatment of early breast cancer patients of a community-based hospital is safe and reliable.

No Association of the NF-κB1 −94INS/Delattg Promoter Polymorphism with Relapse-Free and Overall Survival in Patients with Squamous Cell Carcinomas of the Head and Neck Region

The transcription factor, nuclear factor-kappaB (NF-kappaB) is known to play a major role in immune response, inflammation and, via apoptosis and proliferation, also in oncogenesis. Transcription of NFKB1, which encodes the subunit p50/p105 of NF-kappaB, seems to be influenced by an insertion/deletion polymorphism in its promoter region. Accordingly, the goal of this study is to investigate whether this polymorphism can serve as a putative prognostic marker in patients with Squamous Cell Carcinomas of the Head and Neck region (HNSCC). The prognostic value of the -94ins/delATTG NFKB1 promoter polymorphism was analyzed in an unselected series of patients treated with curative intent for HNSCC, including all tumor stages with different therapeutical regimens. Genotyping was performed by means of pyrosequencing, using DNA from paraffin-embedded tissue samples from 364 patients with a median follow-up of 61 (2-143) months. The various genotypes were correlated with relapse-free and overall survival, as well as risk, compared to healthy volunteers. The NFKB1 polymorphism was not related to risk of HNSCC. Kaplan-Meier curves revealed no significant association between the -94ins/delATTG alleles and survival or disease progression of patients with HNSCC. In conclusion, the results suggest that the investigated NFKB1 promoter polymorphism has no prognostic impact on risk or clinical course in HNSCC.

A new prognosticator for post‐transplant lymphoproliferative disorders after renal transplantation

A new prognosticator for post‐transplant lymphoproliferative disorders after renal transplantation

Central nervous system metastases in a cohort of metastatic breast cancer patients treated with trastuzumab

Several analyses suggest an increase of brain metastases in HER2 over-expressing breast cancers treated with trastuzumab as compared to historical series of unselected patients. We analyzed the incidence of central nervous system (CNS) metastases in 78 patients with HER2 over-expressing breast cancer treated with trastuzumab between July 2000 and June 2006 at the Oncology Department of University Federico II in Naples. We also characterized and compared patients with and without CNS involvement. The median follow-up was 35.3 months (95%CI 26.3-44); median overall survival was 56 months (95%CIs 46-nr); 5 patients showed CNS involvement before trastuzumab therapy while 31 developed CNS metastases during trastuzumab treatment. The median overall survival after CNS metastases was 25.4 months (95%CIs 15.2-nr); patients with CNS lesions showed worse overall survival than patients without CNS lesions (39.1 vs. 75 months, p = 0.005). CNS metastases are common events in patients with metastatic HER2 over-expressing breast cancer treated with trastuzumab; the impact on survival is detrimental even if survival after CNS metastases is longer than historical reports. Appropriate investigation of the role of CNS imaging screening and the prophylactic treatment strategies for CNS represents a priority research in this setting.

Overall and Relapse-Free Survival in Oropharyngeal and Hypopharyngeal Squamous Cell Carcinoma Are Associated with Genotypes of T393C Polymorphism of the GNAS1 Gene

In previous studies, we have shown that the T allele of a specific single-nucleotide polymorphism (SNP) in the Galphas gene (T393C) correlates with increased Galphas expression and hence apoptosis. The T allele was associated with a favorable outcome in a variety of human cancers, e.g., carcinoma of the urinary bladder, kidney, and colorectum. The prognostic value of the T393C SNP was evaluated in an unselected series of patients treated with curative intent for oropharyngeal and hypopharyngeal squamous cell carcinomas, including all tumor stages with different therapeutic regimens. Genotype analysis was done using DNA from paraffin-embedded tissue samples from 202 patients (162 men, 40 women) with a median follow-up of 38 months (1-133 months). The various genotypes were correlated with relapse-free and overall survival. GNAS1 393C homozygous patients displayed a higher risk for disease progression than T393 homozygous patients (hazard ratio CC versus TT, 1.9; 95% confidence interval, 1.1-3.2; P = 0.019). The same genotype effect was observed for overall survival with CC genotypes at higher risk for death compared with TT genotypes (hazard ratio, 1.7; 95% confidence interval, 1.1-2.9; P = 0.015). Multivariate analysis showed that, besides American Joint Committee on Cancer stage, tumor localization, and gender, the T393C polymorphism was an independent prognostic factor for disease progression and death. The T393C SNP could be considered as a genetic marker to predict the clinical course of patients suffering from oropharyngeal and hypopharyngeal cancer.

Short-term outcomes following total minimally invasive oesophagectomy

Minimally invasive oesophagectomy (MIO; thoracoscopy, laparoscopy, cervical anastomosis) is a complex procedure and few substantial series have been published. This study documented the morbidity, mortality and challenges of adopting MIO in a specialist unit in the UK. A prospective group of 77 patients was listed consecutively with the intention of performing MIO. Three other patients underwent open oesophagectomy during the study period. MIO was attempted in 77 patients, completed successfully in 70, abandoned in six patients (8 per cent) with unsuspected metastatic disease, and converted to a thoracoscopic anastomosis in one patient. There was one in-hospital death (1 per cent). Complications occurred in 33 patients (47 per cent), including nine gastric conduit-related complications (13 per cent). Median lymph node harvest was 21 (range 7-48) nodes. Mean overall and disease-free survival times were 35 and 33 months respectively. Median disease-free survival for patients with stage III disease was 26 months. MIO can be performed with acceptable mortality and morbidity rates in an unselected series of patients. There was more morbidity related to gastric tube ischaemia than was expected.

Prevalence of malnutrition in paediatric hospital patients

Childhood malnutrition has severe adverse effects on growth and development, but only limited information is available on the prevalence of malnutrition in paediatric hospital patients. We determined the prevalence of malnutrition in a series of unselected patients consecutively admitted as inpatients to a large tertiary care children's hospital in Germany. Data for weight and height upon admission were recorded in 475 unselected children aged 7.9+/-5 years (mean+/-SD). Weight for height 81-90 of median values were considered to indicate mild malnutrition, 70-80% moderate malnutrition and <70% severe malnutrition according to cut-off points defined by Waterlow. Some 24.1% of the patients were malnourished, with 17.7% of all patients who were mildly, 4.4% who were moderately and 1.7% who were severely malnourished. The largest proportion of malnourished patients was found among patients with multiple diagnoses (42.8% malnourished), mental retardation (40.0%), infectious diseases (34.5%) and cystic fibrosis (33.3%). The very high prevalence of malnutrition among children admitted to a children's hospital is considered intolerable, given the adverse consequences for short- and long-term health and well-being. Strategies for systematic screening and treatment of malnutrition in paediatric patients need to be refined and implemented.

Preoperative bi-fractionated accelerated radiation therapy for combined treatment of locally advanced rectal cancer in a consectutive series of unselected patients

Backgroundalthough preoperative RT (Radiation Therapy) is becoming the preferred approach for combined treatment of locally advanced rectal adenocarcinoma, no regimen can be now considered as a standard. Since the toxicity of preoperative RT isn't yet completely known, and the advantages of preoperative RT could be counterbalanced by increased postoperative morbidity and mortality, a monocentre series of preoperative bifractionated accelerated RT was retrospectively reviewed to clarify toxicity and outcomes after a prolonged follow up.Methodspatients were screened following these eligibility criteria: histology-proven adenocarcinoma of the rectum; distal tumour extent at 12 cm or less from the anal verge; clinical stage T3–4/anyN, or anyT/N1–2; ECOG Performance Status 0–2. A total dose of 41.6 Gy (26 twice daily fractions of 1.6 Gy) was delivered. Surgery was carried out 17 ± 2 days after RT completion, adopting the total mesorectal excision technique.Results24 men and 23 women were enrolled; median age was 55 years (r.: 39–77). Twenty-eight patients were stage II and 19 stage III. 9 patients suffered from a recurrent tumour. 2 patients experienced a severe grade 4 gastrointestinal toxicity (a colo-vaginal fistula and an intestinal obstruction, both successfully treated). Operative mortality was nil; postoperative early complications occurred in 13 cases; mean length of hospital stay was 15 days. After a mean follow up of 44 months (r.: 18–84) 8 patients had deceased for recurrent disease, 15 were alive with a disease progression (2 pelvic recurrences and 13 pure distant deposits) and 24 were alive, without disease. The 5-year actuarial overall survival was 74.2%, the disease-free survival 62.9% and the regional control rate 84.7%. Long-term complications included 1 case of radiation enteritis requiring surgery, 2 cases of anastomotic stricture and 3 cases of bladder incontinence.Conclusionbifractionated accelerated RT administered in the preoperative setting to patients bearing locally advanced rectal cancer is reliable and safe, as its immediate and late toxicity (mainly infectious) is acceptably low and long-term survivals are achievable. These findings support the increasing use of preoperative RT for treatment of this malignancy in experienced centres. Ongoing multicentric trials are expected to address still unsolved issues, including the benefit of CT adjunct to preoperative RT.

Left‐Sided microsatellite unstable colorectal cancers show less frequent methylation of hMLH1 and CpG island methylator phenotype than right‐sided ones

We compared the methylation status of several loci between right-sided and left-sided colorectal cancers (CRCs). To the best of our knowledge, this is the first to report that left-sided CRCs show significantly less frequent methylation at several loci and CpG island methylator phenotype (CIMP) than right-sided ones. MSI CRC occurs in 10-20% of unselected series of patients with CRC. Somatic hMLH1 promoter methylation is reported to cause MSI in sporadic cases. Many researchers report that MSI CRCs are more frequently located in the right-side colon than MSS CRCs. Though the number is very small, some MSI CRCs are located in the left-side colorectum. We focused on the existence of left-sided MSI CRCs and investigated whether they arise through hMLH1 methylation as they do in right-sided ones. Thirty-eight sporadic MSI CRCs were included in the study. The methylation status of the promoter of hMLH1, p16, MINT1, 2 and 31 were examined and the proportions of methylated samples for each locus were compared. The left-sided group showed significantly less frequent methylation in hMLH1, p16, MINT1, 2 and 31. The frequency of CIMP+ samples in the left-sided group was significantly lower than the right-sided group. Left-sided MSI CRCs show significantly less frequent methylation of hMLH1. They also showed significantly less frequent occurrence of CIMP+ than right-sided ones. It is possible that left-sided MSI CRCs differ from the right-sided ones in the way of acquiring MSI.

Clinicopathological correlations of Bcl‐xL and Bax expression in differentiated thyroid carcinoma

The Bcl-2 family proteins are essential mediators in the apoptotic process. Our aim was to investigate whether anti-apoptotic Bcl-xL and pro-apoptotic Bax were over-expressed in a large series of differentiated thyroid carcinomas (DTC) and to study their association with tumour presentation at diagnosis and prognosis. We examined the immunohistochemical expression of Bcl-xL and Bax in benign nodular thyroid disease (BNTD) and DTC and their association with clinicopathological parameters. Thyroid tissue samples were collected from an unselected series of patients undergoing surgical resection for DTC (n = 74) or BNTD (n = 15). Among DTC cases, expression of Bcl-xL was found to be high in 43.2% and low or absent in 56.8%. Expression of Bax was high in 75.7% and low or absent in 24.3%. Non-neoplastic thyroid tissue was largely unstained for both proteins. Among BNTD cases, expression of Bcl-xL was high in 13.3% and low or absent in 86.6%. Expression of Bax was high in 14.3% and low or absent in 86.6%. A significant association was found between Bcl-xL expression and the presence of high-risk histological subtype (P < 0.05), and regional lymph node (P < 0.01) and distant metastases (P < 0.01). The association between high Bcl-xL expression levels and a longer time of persistent disease after radioiodine ablation was also significant (P < 0.01). Bcl-xL expression was confirmed as an independent prognostic factor for persistent disease in DTC (relative risk, 2.5; 95% confidence interval, 1.1-5.9; P < 0.05). Immunohistochemical expression of Bcl-xL might be a valuable tool in the prediction of tumour aggressiveness in DTC.

Early Arterial Study in the Prediction of Mortality After Acute Ischemic Stroke

The purpose of this study was to evaluate the value of the initial arterial study as a predictor of 90-day mortality in patients with acute ischemic stroke. A total of 1220 unselected patients assessed during the first 24 hours after stroke onset were prospectively studied. Initial stroke severity was evaluated by the National Institutes of Health Stroke Scale and dichotomized in mild (National Institutes of Health Stroke Scale < or =7) and severe (National Institutes of Health Stroke Scale >7). Severe arterial stenosis (> or =70%) or arterial occlusion in the symptomatic territory was determined by a Doppler study and also by additional explorations (carotid duplex, MR or CT angiography) in the first 24 hours after admission. The following variables were also analyzed: age, gender, previous functional status, smoking, hypertension, hyperlipidemia, diabetes mellitus, peripheral arterial disease, ischemic heart disease, heart failure, atrial fibrillation, previous stroke, and prior use of antithrombotic or statins. Ninety-day mortality was the end point of the study. Ninety-day mortality was 15.7%. A total of 25.5% of all deaths were in patients with mild stroke. In addition to well-known factors related to mortality (age, stroke severity, ischemic heart disease, heart failure, and previous disability), severe arterial stenosis/occlusion was the factor with the highest relationship with 90-day mortality (adjusted OR: stenosis 2.13, occlusion 4.42, both 3.36). Arterial stenosis/occlusion was a higher predictor of 90-day mortality in patients with mild (adjusted OR: 5.38) than severe stroke (adjusted OR: 3.05). Severe arterial stenosis/occlusion in the early arterial study was highly related with 90-day mortality in an unselected series of patients with stroke. These data achieve special relevance in patients with initial mild stroke.

Recanalization after thrombolysis in stroke patients

To estimate rates, predictors, and prognostic importance of recanalization in an unselected series of patients with stroke treated with IV thrombolysis. We performed a CT angiography or transcranial Doppler (TCD) follow-up examination 24 hours after IV thrombolysis in 64 patients with documented occlusion of the intracranial internal carotid or middle cerebral artery (MCA). Complete recanalization was defined by a rating of 3 on the Thrombolysis in Myocardial Infarction or 4/5 on the Thrombolysis in Brain Ischemia grading scales. Information about risk factors, clinical features, and outcome was prospectively collected by standardized procedures. Complete recanalization was achieved in 36 of the 64 patients (56.3%). There was a nonsignificant trend of recanalization rates to decline with a more proximal site of occlusion: 68.4% (M2 segment of MCA), 53.1% (M1 segment), and 46.2% (carotid T) (p for trend = 0.28). Frequencies of vessel reopening were markedly reduced in subjects with diabetes (9.1% vs 66.0% in nondiabetics, p < 0.001) and less so in subjects with additional extracranial carotid occlusion (p = 0.03). Finally, complete recanalization predicted a favorable stroke outcome at day 90 independently of the information provided by age, NIH Stroke Scale, and onset-to-needle time. We found a high rate of vessel recanalization after IV thrombolysis occlusion. However, recanalization was infrequent in patients with diabetes and extracranial carotid occlusion. Information on recanalization was a powerful, early predictor for clinical outcome.

Right Ventricular Outflow Tract Pacing: Radiographic and Electrocardiographic Correlates of Lead Position

To characterize the pacing site in an unselected series of patients undergoing right ventricular outflow tract (RVOT) lead placement and investigate the role of the electrocardiogram (ECG) in predicting implantation. Right ventricular apical pacing is associated with long-term adverse effects on left ventricular function, fuelling interest in alternative pacing sites, especially the RVOT. Previous studies have been conflicting, possibly due to poor definition of pacing site within the RVOT. In 150 patients undergoing pacemaker implantation, implanters were asked to place the lead in the RVOT. Radiographs were performed in the antero-posterior (AP) and 40 degrees right and left anterior-oblique projections post procedure. Fifty-six had left lateral radiographs. Lead position was categorized using AP/RAO (right anterior oblique) to confirm RVOT placement and left anterior oblique to distinguish free wall from septum. A 12-lead ECG was performed during ventricular pacing. Leads were below the RVOT in 18. Of the remaining 132, the majority (94%) were in the inferior/low RVOT. Eighty-one out of 132 were septal and 51 free wall. Septal sites were associated with shorter QRS duration (134 ms vs 143 ms, P < 0.02). Free wall sites displayed more frequent notching of the inferior leads (P < 0.01). A negative deflection in lead I provided a positive predictive value of 90% for septal sites. In those with lateral radiographs, a posteriorly projected lead was 100% specific for septal placement. This study demonstrates the heterogeneity of lead placement within the RVOT. Septal and free wall sites display characteristic ECG patterns which may be used to aid placement. The left lateral radiograph is useful in confirming a true septal location.

Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma

Trabectedin is a marine-derived cytoxic alkaloid which has shown promising antitumour activity in a variety of human malignancies including sarcoma. Fifty-four patients with advanced sarcoma (age 43 yrs, range 18–70), all pretreated with prior chemotherapy, were enrolled on a named individual basis for treatment with trabectedin. Diagnosis was adult soft tissue sarcoma (STS) in 46 patients, Ewing’s family tumour (EFT) in 4, and osteosarcoma (OS) in 4. The initial 23 patients (total number of courses administered: 68) did not receive premedication prior to trabectedin, while the other 31 patients (total number of courses administered: 134) received premedication with dexamethasone 4 mg po bid 24 hours before therapy. Incidence of toxicity (grade 3–4), expressed as percentage of courses, was as follows: in patients without dexamethasone, elevation of transaminases 34%, neutropenia 24% and thrombocytopenia 25%; in patients with prior dexamethasone, elevation of transaminases 2%, neutropenia 2% and no thrombocytopenia. The median received dose intensity of trabectedin was superimposable in the two groups (404 μg and 400 μg per week, respectively), as well as progression-free survival (19% at 6 months). Among STS patients, 9% had objective responses. In this unselected patient series, premedication with dexamethasone strongly reduced drug-induced hepatotoxicity and myelosuppression.