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Aim: To evaluate the immunogenicity and safety of the CoronaVac vaccine in patients with cancer receiving active systemic therapy. Methods: This multicenter, prospective, observational study was conducted with 47 patients receiving active systemic therapy for cancer. CoronaVac was administered as two doses (3 μg/day) on days 0 and 28. Antibody level higher than 1 IU/ml was defined as ‘immunogenicity.’ Results: The immunogenicity rate was 63.8% (30/47) in the entire patient group, 59.5% (25/42) in those receiving at least one cytotoxic drug and 100% (five of five) in those receiving monoclonal antibody or immunotherapy alone. Age was an independent predictive factor for immunogenicity (odds ratio: 0.830; p = 0.043). Conclusion: More than half of cancer patients receiving active systemic therapy developed immunogenicity., Tweetable abstract Immunogenicity developed with CoronaVac in 25 (59.5%) of 42 patients who received at least one cytotoxic drug and in all patients (n = 5) who received monoclonal antibody or immunotherapy alone.

Purpose: Taxane-containing combinations are recommended for the first-line therapy of advanced gastric cancer. It is not known which chemotherapy regimen is the best with trastuzumab for HER2-positive patients. The aim of this study was to compare taxane-containing intensified chemotherapy versus standard chemotherapy in combination with trastuzumab in the first-line treatment of HER2-positive advanced gastric adenocarcinoma. Methods: This study is a retrospective multicenter study of the Turkish Oncology Group. A total of 130 HER2-positive patients with inoperable locally advanced, recurrent, or metastatic gastric adenocarcinoma being given chemotherapy plus trastuzumab as the first-line treatment were included from 16 different oncology centers. Trastuzumab combination with intensified chemotherapy including taxane or standard chemotherapy was compared in terms of progression-free survival (PFS), overall survival (OS), and toxicity. Results: There were 108 patients in the standard and 22 patients in the intensified chemotherapy group. PFS of the standard and intensified group were 5.6 months (95% confidence interval [CI] 4.8–6.4) and 5.3 months (95% CI 2.6–8), respectively ( p = 0.70). OS of the standard and intensified group were 11.1 months (95% CI 8.3–13.9) and 15.2 months (95% CI 12.7–17.7), respectively ( p = 0.03). Repeated analysis excluding patients given any previous therapy revealed similar results. The intensified group had more fever and febrile neutropenia. Conclusion: Trastuzumab combination with intensified chemotherapy provides better OS in first-line treatment of HER2-positive advanced gastric cancer. Further large-scale studies should be performed in HER2-positive patients.

Purpose: In the ToGA trial for HER2-positive advanced gastric cancer, cisplatin plus fluoropyrimidine was given for 6 cycles; trastuzumab was given until disease progression. However, there is a lack of real-life data about trastuzumab maintenance after 6 cycle chemotherapy. This study aims to present real-life data of trastuzumab ± capecitabine maintenance after 6 cycles of platinum, fluoropyrimidine, and trastuzumab in non-progressive patients. Methods: This is a retrospective multicenter study of the Turkish Oncology Group. A total of 35 HER2-positive, inoperable locally advanced, recurrent, or metastatic gastric adenocarcinoma patients being non-progressive at the end of 6 cycle chemotherapy and being given trastuzumab ± capecitabine as maintenance treatment were included from sixteen oncology centers. Baseline characteristics, objective tumor responses, progression free and overall survival data, and toxicities were determined. Results: About 68% of the patients were given CF, and 32% were given FOLFOX with trastuzumab as the first-line treatment. The best response in 6 cycle chemotherapy was complete 8 (22%), partial 24 (68%), and stable disease 3 (8%). All patients had trastuzumab maintenance (median cycle 13; range 7–51), and 49% of the patients had capecitabine with trastuzumab (median capecitabine cycle 6; range 2–30). The median PFS of the patients was 12.0 months (95% CI 10.3–13.7), and median OS was 17.4 months (95% CI 15.2–19.5). There were 2 patients with grade 1 cardiotoxicity. Conclusion: Trastuzumab maintenance ± capecitabine after 6 cycles of trastuzumab plus combined chemotherapy treatment revealed efficacy and safety in non-progressive HER2-positive advanced gastric cancer. © 2021, Springer Science+Business Media, LLC, part of Springer Nature.

Background: In Muslim majority countries (MMC) opioid use for pain management is extremely low. The underlying factors contributing to this are not well defined. Aim: The aim of this study was to survey the attitudes of cancer patients towards morphine use for pain management in a MMC and identify the factors that influence patient decisions to accept or refuse morphine as treatment for cancer pain. Settings/participants: Patients were questioned whether they had pain or not, the severity and the medications for pain management. Questions included what type of medication they thought morphine was, whether or not they would be willing to take morphine if recommended for pain management and the basis for their decision if they were against morphine use. Results: Four hundred and eighty-eight patients participated in the study. Some 50% of the patients who refused morphine use and 36.8% of the patients who would prefer another drug, if possible, identified fear of addiction as the basis for their decision. Reservation of morphine for later in their disease was the case for 22.4% of the patients who refused morphine use. Only 13.7 % of the patients refusing morphine and 9.7% of the patients who preferred another drug, if possible, cited religious reasons as the basis for this decision. Conclusions: Identifying the underlying factors contributing to low opioid use for pain management in MMC is important. Once the underlying factors were identified, all efforts should be taken to overcome them as they are barriers to improving patient pain management.

Diskapi Education & Research Hospital, Department of Medical Oncology, Ankara, Turkey *Author for correspondence: Tel.: +90 312 596 2854; Fax: +90 312 318 6690; m_f_karatas@hotmail.com

Summary. Background Small cell lung cancer (SCLC) is a chemotherapy-responsive tumor type but most patients ultimately experience disease progression. SCLC is associated with alterations in the coagulation system. The present randomized clinical trial (RCT) was designed to determine whether addition of low-molecular-weight heparin (LMWH) to combination chemotherapy (CT) would improve SCLC outcome compared with CT alone. Methods Combination CT consisted of cyclophosphamide, epirubicine and vincristine (CEV) given at 3-weekly intervals for six cycles. Eighty-four patients were randomized to receive either CT alone (n ¼ 42) or CT plus LMWH (n ¼ 42). LMWH consisted of dalteparin given at a dose of 5000 U once daily during the 18 weeks of CT. Results Overall tumor response rates were 42.5% with CT alone and 69.2% with CT plus LMWH (P ¼ 0.07). Median progression-free survival was 6.0 months with CT alone and 10.0 months with CT plus LMWH (P ¼ 0.01). Median overall survival was 8.0 months with CT alone and 13.0 months with CT plus LMWH (P ¼ 0.01). Similar improvement in survival with LMWH treatment occurred in patients with both limited and extensive disease stages. The risk of death in the CT + LMWH group relative to that in the CT group was 0.56 (95% confidence interval 0.30, 0.86) (P ¼ 0.012 by log rank test). Toxicity from the experimental treatment was minimal and there were no treatment-related deaths. Conclusions These results support the concept that anticoagulants, and particularly LMWH, may improve clinical outcomes in SCLC. Further clinical trials of this relatively non-toxic treatment approach are indicated.

PubMedID: 24338610 Background: Optimal duration of adjuvant trastuzumab in early breast cancer is an unresolved issue. In this observational study, we compared the outcome of 9 weeks and 1 year adjuvant trastuzumab in early breast cancer patients in Turkey. Methods: Records of 680 patients with HER2-positive early breast cancer who received adjuvant trastuzumab plus chemotherapy were obtained and patients were followed up to compare the disease-free survival (DFS) outcome of 9 weeks versus 1 year trastuzumab. Results: Nine weeks and 1 year trastuzumab was given to 202 (29.7 %) and 478 (70.3 %) patients, respectively. There was a significantly lower rate of patients with negative lymph nodes in the 9-week trastuzumab group. At median 3 years of follow-up from the date of starting trastuzumab, the DFS rates were 88.6 and 85.6 %, respectively (p = 0.670). When adjusted for all the prognostic factors that were significant on univariate analysis, again there was no significant difference in DFS between the groups (HR 0.675; 95 % CI 0.370–1.231; p = 0.200). Cardiac toxicity defined as a ?15 % decrease in LVEF was significantly higher in the 1-year trastuzumab group (1.88 % versus none for 1-year and 9-week trastuzumab groups, respectively; p = 0.050). Conclusion: The results of this observational study suggest that DFS outcome of 9 weeks of adjuvant trastuzumab may be comparable to 1 year adjuvant trastuzumab: this needs confirmation by randomized trials. © 2013, The Japanese Breast Cancer Society.

Tumor-induced pancreatic damage or insulin resistance may be responsible for diabetes in pancreatic cancer (PC) patients, but the exact cause of association remains controversial. In this study, we aimed to investigate the prevalence of diabetes in patients with PC in central Anatolia, Turkey, and to evaluate whether diabetes is caused by PC. A total of 40 patients with primary PC were enrolled in the study. 13 (32.5%) of the patients had diabetes before PC diagnosis. Oral glucose tolerance test was performed in the remaining 27 patients. The period between the diagnosis of diabetes and detection of PC was less than 1 year in seven (17.5%) patients who had previous diabetes. Recent-onset diabetes and impaired glucose tolerance were detected in 13 (32.5%) and two (5%) of the PC patients, respectively. The prevalence of recent-onset and shortly-before-diagnosed diabetes has been found very high (50%) in our patients with PC. Interestingly, we determined higher levels of insulin and C-peptide in PC patients having abnormal glucose tolerance than patients having normal glucose tolerance. In conclusion, as it has been reported in other population, we determined high prevalence of diabetes in PC patients in central Anatolia. High insulin and C-peptide level indicate that different mechanisms such as insulin resistance may be responsible for abnormal glucose tolerance in PC patients other than the tumor caused insulin deficiency. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.

Aim: To evaluate efficacy and tolerability of topotecan treatment for recurrent small cell lung carcinoma. Patients and Methods: A total of 62 patients were evaluated retrospectively. Statistical analysis was performed using GraphPad Instat (version 3.05). Results: DFifty five of patients (89%) were male and 7 (11%) were female. Median age was 56.7 +/- 9.3 (34-75). Forty eight of patients (80%) were extensive stage (ES) at the time of diagnosis. Fifty of the patients (80.6 Medical Oncology Clinic) were given median 5.36 cycles of cisplatin-etoposide (2-8 cycles). Time to recurrence was 15.6 +/- 6.13 weeks in patients with limited stage (LS) and 6.3 +/- 3.82 weeks in extensive stage (ES) (p

Aims and Background We aimed to evaluate the prevalence of and factors related to the use of complementary/alternative medicine among cancer patients undergoing or following conventional treatment at the Erciyes University Oncology Hospital in Central Anatolia. Study Design and Patients Face-to-face interview and a questionnaire were carried out with cancer patients attending the outpatient clinic of Medical Oncology. Questionnaire items included patients’ demographic data, treatment, use of complementary/alternative medicine and possible related factors. Multivariate analysis was performed to compare the factors related to use of complementary/alternative medicine. Results A total of 268 consecutive cancer patients were enrolled in the study. Overall, 43% of the patients were using or had used complementary/alternative medicine. Totally, 90% of the patients using complementary/alternative medicine utilized herbs, and most of the herbs used were stinging nettle. Nearly half of the patients using complementary/alternative medicine (46.1%) were aiming to fight the disease. Among users, nearly half of them regarded the method used as effective and 54 (50.5%) suggested the use of complementary/alternative medicine to other patients. Only 23.1% of the patients discussed the use of complementary/alternative medicine with their physician. In logistic regression analysis, younger age, higher educational status, advanced stage of the disease, longer duration of the disease and current treatment status were significantly associated with the use of complementary/alternative medicine. In our regression model, the predictivity rate of these variables was 72.2% for use of complementary/alternative medicine according to the backward Wald test. Conclusions Use of complementary/alternative medicine among cancer patients in our center is modestly high, and the most common method is herbal therapy. Communication between the patient and the physician shouldbe improvedon this subject.

Rectal carcinoids comprise 12.6% of all carcinoid tumors and represent the third largest group of the gut carcinoids. A 64-year-old woman was diagnosed as high-grade neuroendocrine carcinoma. She had liver, bone, and bone marrow metastasis. Carcinoid syndrome was diagnosed due to diarrhea, nausea, vomiting, tachycardia, and high level of 24-hour urinary 5-hydroxyindoleacetic acid (160 mg/24 hours). No response was obtained by octreotide treatment. Rectal carcinoid tumors usually show favorable prognosis; however, poorly differentiated tumors might have unusually aggressive behavior and resistance to treatment. Bone marrow involvement might be a poor prognostic factor in carcinoid tumor as has been the case in many other tumors.

We have performed a prospective evaluation of the efficacy, safety and convenience of the transdermal therapeutic system - fentanyl (TTS-F) in Turkish cancer patients when it was newly available in Turkey. Ninety-nine patients with historically confirmed malignancy and pain entered the study; the mean age was 55.1 (16-58) years. The study duration was 28 days. Transdermal therapeutic system - fentanyl was used in opioid-naive or pre-treated patients. Most patients reported a decrease in pain severity. Use of rescue medication decreased from day 4 to day 28. The majority of patients rated patch convenience of use as excellent. A total of 22.2% of patients experienced adverse events that were either probably related or very likely to be related to the study drug. The majority of the adverse events mentioned were related to the digestive system. Eighteen serious adverse events were reported by 13 patients. Six events were doubtfully related, and 12 events were not related to the study drug. Four patients died during the trial. None of these deaths was attributed to the study drug. In conclusion, the trial showed that TTS-F is easily managed, effective and will help to enable the appropriate opioid administration to patients who are suffering from cancer pain in Turkey.

The aim of this study was to determine the incidence and role of c-erbB-2 overexpression as a predictive/prognostic marker in small-cell lung carcinoma (SCLC). We performed a retrospective study on subjects with a biopsy-proven diagnosis of SCLC. A chart review for demographic and clinical data was performed on patients with SCLC diagnosed between 1998 and 2004. c-erbB-2 overexpression was evaluated using immunohistochemistry performed on archival paraffin-embedded specimens. Sixty-seven patients with SCLC were identified (6 females, 61 males; median age- 56.5 yr, range-34-75) all of whom had adequate tissue specimens available for c-erB-2 testing. Of the 67 specimens, 12 (17.9%) showed c-erbB-2 overexpression. Seventy-five of the cases were positive for c-erbB-2, had extensive disease. The median overall survival of patients with SCLC whose tumors were positive and negative for c-erbB-2 were 8 +/- 0.9 months (95%CI 6.3-9.7) and 11 +/- 1.5 months (95%CI 8.0-14.0), respectively. c-erbB-2 overexpression detected using immunohistochemistry is observed in 17.9% of patients with SCLC and has statistically significant prognostic value. Our findings suggest that c-erbB-2 may be a potential target for site-specific immunotherapy in SCLC. Considering one technique examined, further molecular investigation is needed to confirm these preliminary findings.

In this phase II study, we aimed to detect efficacy and toxicity of the combination of CPT-11 and cisplatin administered to patients with metastatic gastric carcinoma. On d 1, CPT-11, 100 mg/m2, was administered by intravenous infusion for 90 min, followed by a 2 h infusion of cisplatin, at 70 mg/m2 every 3 wk. Forty-one patients were enrolled into the study. Twenty-eight patients were chemotherapy naive. The total number of chemotherapy cycles administered was 165, and the median number of cycles received was 4 (range, 1-8 cycles). The median follow-up time was 12 mo (range, 4-34 mo). There were 4 complete responses (9.7%) and 14 partial responses (34.2%), which result in a response rate of 43.9% (18 of 41 patients). The median time to progression was 8.0 +/- 0.8 mo with 56% and 13% of patients progression free at 6 and 12 mo, respectively. The median overall survival was 9.0 +/- 1.1 mo, with 68 % and 32% of patients alive at 6 and 12 mo, respectively. Grade 3-4 nausea and vomiting was observed in five patients (12%) and grade 3-4 neutropenia in five patients (12%). Grade 3 infection was observed in only one patient (2%). Grade 2 transient liver dysfunction related to chemotherapy was observed in one patient (2%). Chemotherapy was stopped due to nephrotoxicity in one patient (2%). There was no treatment-related death. In conclusion, administration of CPT-11 and cisplatin in this particular dose every 3 wk is effective and well-tolerated treatment regimen.

Background Solitary plasmacytoma localised to bone or soft tissue without myeloma. Aim Clinical features and survival was analysed in patients from Central Anatolia. Methods Twenty-three solitary plasmacytoma (18 male, 5 female) were evaluated retrospectively. Median age was 58 years (46-72). The major localisation was vertebral column. Results All patients but one (larynx) had surgical resection and 21 patients received radiotherapy postoperatively. Multiple myeloma developed in eight patients (35%) and local relapse was detected in one patient. Eight patients died, causes of death were multiple myeloma progression in six patients, local relapse of intracranial plasmacytoma in one patient and cranial trauma in one patient who was in complete remission. Three and 5 years progression free survival were 45.6% and 22.8% respectively and overall survivals were 54.4% and 27.2% respectively. Conclusion Solitary plasmacytoma cases should be followed carefully regarding local relapse and progression to myeloma.

PubMedID: 15726120 Our objective was to determine whether oral etoposide and cisplatin combination (EoP) is superior to paclitaxel in the treatment of advanced breast cancer (ABC) patients pretreated with anthracyclines. From December 1997 to August 2003, 201 patients were randomised, 100 to EoP and 101 to paclitaxel arms. Four patients in each arm were ineligible. The doses of etoposide and cisplatin were 50 mg p.o. twice a day for 7 days and 70 mg m-2 intravenously (i.v.) on day 1, respectively, and it was 175 mg m-2 on day 1 for paclitaxel. Both treatments were repeated every 3 weeks. A median of four cycles of study treatment was given in both arms. The response rate obtained In the EoP arm was significantly higher (36.3 vs 22.2%; P = 0.038). Median response duration was longer for the EoP arm (7 vs 4 months) (P = 0.132). Also, time to progression was significantly in favour of the EoP arm (5.5 vs 3.9 months; P = 0.003). Median overall survival was again significantly longer in the EoP arm (14 vs 9.5 months; P = 0.039). Toxicity profile of both groups was similar. Two patients in each arm were lost due to febrile neutropenia. The observed activity and acceptable toxicity of EoP endorses the employment of this combination in the treatment of ABC following anthracyclines. © 2005 Cancer Research UK.

A 59-year-old woman who had dyspnea and neck swelling for 10 days was admitted to the hospital. Malignant peritoneal mesothelioma was diagnosed previously. According to the clinical findings, and laboratory and pathologic examination, the patient was found to have disseminated venous thrombosis and antiphos pholipid syndrome, which is treatment-resistant autoimmune paraneoplastic syndrome.

High-grade gliomas are the most common primary brain tumors in adults. Twenty-seven patients with histopathologically proven anaplastic astrocytoma and glioblastoma multiforme were enrolled in this study from November 1998 to August 2002. Radiotherapy was administered after surgery and fotemustine (100 mg/m(2)) was sequentially administered every 3 weeks for 6 cycles. Overall, 111 cycles were administered to the 27 patients (median, 5 cycles; range, 1 to 6 cycles). Myelosuppression was mild to moderate. The median overall survival and progression free survival were 11 +/- 3.1 months (95%CI, 4.9-17.1) and 8 +/- 0.5 months (95%CI 7.1-8.9), respectively. One-year and two-year survivals were calculated at 48% and 7%, respectively. Significant prognostic factors (P

The purpose of this study was to evaluate the impact of granulocyte-colony stimulating factor (G-CSF) on the therapy for febrile neutropenia (FN). Our patient population differed significantly from those of previous studies as no patients received antimicrobial or CSF prophylaxis before randomization and all were solid tumor patients. When the diagnosis of FN was established, patients were started on intravenous meropenem 1 g every 8 hours and randomly assigned to receive G-CSF (5 microg/kg body weight per day subcutaneously) or not. Twenty-eight patients with 30 FN episodes received G-CSF and 25 patients with 30 FN episodes did not receive G-CSF according to randomization. The time to resolution of fever, recovery of neutrophil count over 1000/mm3, duration of hospitalization, need for erythrocyte and platelet transfusion and mortality rate were similar in both study groups. Side effects of therapy were mild. These results provide preliminary evidence that G-CSF administration, in addition to effective antibiotic therapy as treatment of febrile neutropenic patients with solid tumor, does not help improve infection-related morbidity and mortality.

Recent studies suggested that the expression of P-Selectin on stored platelets is related to in vitro activation and loss of viability. We examined the effects of dimethylsulfoxide (DMSO) on in vitro function and P-Selectin expression of platelet concentrates. Fresh random-donor platelet units (n = 60) were divided into four equal groups. A DMSO-free group was chosen as a control. DMSO (0.5%, 1.0% and 3.0%) was added to the other three groups. The samples were stored on a horizontal shaker at room temperature. Biochemical, morphological and platelet function tests and P-Selectin expression were monitored during storage. In all groups, P-Selectin expression, lactate and LDH levels, mean platelet volumes and PO2 increased but the aggregation response to agonist, the recovery response to hypotonic shock, platelet count, glucose level, pCO(2), and HCO3 decreased during storage. In DMSO-containing groups, the P-Selectin expression which is a predictor of in vitro activation, was found significantly less often than in the DMSO-free group. (C) 2001 Elsevier Science Ltd. All rights reserved.

Our aim was to determine the efficacy of ifosfamide, mesna, and interferon alpha combination therapy in malignant mesothelioma (MM) patients. Fourty-two patients (39 evaluable) with histologically proven MM were enrolled into this study from January 1999 to October 2002. The drug schedule consisted of a combination of ifosfamide, 3000 mg/m(2) 1-3 d intravenous infusion (iv), the uroprotective agent mesna, 3000 mg/m(2) 1-3 d iv every 3 wk, and interferon alpha2a, 4.5 MU subcutaneously (sc) 3 d/wk for 6 mo as first-line chemotherapy. Overall, 140 cycles were administered to the 39 patients (median, 3.5 cycles; range, I to 6 cycles). Among the 39 patients, 8 partial remissions (PR) (21%) were observed. Thirteen patients (33%) had stable disease for at least 8 wk and 18 (46%) had progressive disease. Overall survival (OAS) and progression free survival (PFS) for all patients were 10.0 +/- 2.9 mo (95%CI 4.3-15.7) and 5.0 +/- 1.9 mo (95%CI 1.38-8.62), respectively. One and two year survival rates were calculated as 39% and 5%, respectively. All of the PR patients had the epithelial type of MM. Their survival time was 21.0 +/- 5.7 mo (95% CI 9.9-32.1) and significantly longer than that of nonresponders (p = 0.0061). The toxicity of the drug combination was mild and well tolerated. There were no treatment-related deaths. Grade 3-4 neutropenia and febrile neutropenia were seen in 10 patients (26%) and 3 patients (8%), respectively. Chemotherapy was stopped in three patients because of renal function deficiency. One of these patients-who had peritoneal MM-required hemodialysis. In conclusion, this combination therapy showed encouraging antitumor activity with modest toxicity.

Granulocytic sarcoma is an extramedullary tumor associated with acute or chronic leukemias or myeloproliferative disorders. Rarely, the tumor may be seen before the diagnosis of leukemia. Symptomatic facial nerve paralysis and spinal cord invasion by granulocytic sarcomas are also relatively uncommon. We present here a 17-year-old-female patient who had facial nerve paralysis and paraplegia due to granulocytic sarcoma as the presenting symptoms of acute myeloid leukemia.

A case history is reported here in which leukocytosis, thrombocytosis and hypercalcemia associated with rapidly relapsing squamous cell carcinoma (SCC) of the renal pelvis were observed. In a 58-year-old man, SCC of the renal pelvis was documented during nephrolithotomy, and right nephrectomy was performed. Local relapse of the tumor occurred rapidly in 2 months' time and hypercalcemia, leukocytosis and thrombocytosis worsened in accordance with tumor volume. Cranial computerized tomography (CT), thorax CT and bone scintigraphy were negative for metastasis. The serum parathyroid hormone level was 28 pg/ml (normal 9-55 pg/ml). To disclose leukocytosis and thrombocytosis, peripheral smear and bone marrow aspiration were performed and no pathologic finding regarding any hematologic disorder was found; the samples were also BCR-ABL negative and Philadelphia chromosome negative. Production of several factors by tumor cells may be responsible for this paraneoplastic syndrome. The association of SCC of the renal pelvis with this triple paraneoplastic syndrome is an extremely rare occurrence. Copyright (C) 2001 S. Karger AG, Basel.

To identify and describe the frequency and severity of hepatotoxicity in patients who received flutamide therapy for prostate cancer, 22 patients were treated with the combination of flutamide and goserilin or orchiectomy. After diagnosis and staging of prostate cancer, baseline results were obtained for a set of five liver function tests (LF Ts). Hepatotoxicity was assessed according to the WHO criteria. After initiation of flutamide therapy, LF Ts were performed at 4, 8 and 12 weeks and every 2 months thereafter. Severe hepatotoxicity appeared in two of 22 (9%) patients. Following the discontinuation of flutamide, one patient died due to acute liver failure. On the other patient an improvement of LF Ts occurred after cessation of flutamide. The observed severe hepatotoxicity in two of 22 (9%) patients occurred more frequent than is predicted in the literature. Patients treated with flutamide, having symptomatic or asymptomatic liver enzyme elevations, should be taken off therapy as soon as possible.