Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study.

BACKGROUND: In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. PATIENTS AND METHODS: The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. RESULTS: The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. CONCLUSIONS: In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile.

Effect of Intraperitoneal Thymoquinone on Postoperative Peritoneal Adhesions.

BACKGROUND: To determine the effect of thymoquinone on adhesion formation in a rat caecotomy/suture model. MATERIAL AND METHODS: Thirty wistar rats were randomized into three groups: The control group received saline and the thymoquinone group received 10 mg/kg thymoquinone after cecal caecotomy/suture model. In the sham group the abdominal wall was closed without any abrasion to the cecum. On day 15, adhesions were classified, and histopathological samples were taken. RESULTS: There were no incisional hernias or wound dehiscences. In comparing adhesion scores, a significant difference was found between the thymoquinone and the control groups (p < 0.05). The grade of inflammation for the thymoquinone and the sham groups were significantly lower than that of the control group (p < 0.01 and p < 0.001, respectively). Hydroxyproline levels were significantly lower in the sham and thymoquinone groups compared to the control group (p < 0.05). CONCLUSIONS: Based on the results of this study in a rat peritoneal adhesion model, intraperitoneal administered thymoquinone has a strong anti-adhesive effect.

Sigmoid colon torsion: mortality and relevant risk factors.

INTRODUCTION: Sigmoid volvulus is an important acute intestinal obstruction, leading to high mortality and requiring urgent operation. The purpose of this study is to analyze risk factors for mortality in patients that were operated on due to sigmoid volvulus at our Department. MATERIALS AND METHODS: The retrospective study included 158 patients, who were operated on due to sigmoid volvulus between January 1994-December 2010, in terms of age, gender, complaints at admission, physical signs, period of symptoms before admission, associated diseases, laboratory and radiological parameters, hospital stay, morbidity, and mortality. RESULTS: The study consisted of 135 men (85.4%) and 23 women (14.6%), with a mean age of 62.54 years. Cardiovascular disease and respiratory disease were present in 34 (21.5%) and 42 (26.6%) patients, respectively. Urgent operation was undertaken in 125, while 33 received elective surgery. Abdominal distension and pain was evident in all the patients. Generalized tenderness was detected in 58.2%, while 70.9% had hyperactive bowel sound with tympanism. Plain radiograph revealed an impression of "omega ans" in all patients, while free air was detected in 11.4% of them. Risk factors for mortality included age (p = 0.008), delayed admission (p = 0.001), cardiovascular and respiratory diseases (p = 0.001), fluid-electrolyte imbalance (p =0.001), presence of necrosis (p = 0.001), and major contamination (p = 0.001). Wound infection and intraabdominal abscess were more common in patients that developed mortality (p = 0.001 and p = 0.002). CONCLUSIONS: Complications like wound infection and intraabdominal abscess are more frequent in the patients with the risk of mortality. Delayed admission results in higher risk of mortality. Mortality rates can be reduced by early admission, preoperative intensive resuscitation, suitable antibiotics, and emergent and viable surgery.  

The effects of pomegranate on bacterial translocation in rats with obstructive jaundice.

BACKGROUND: Obstructive jaundice may promote bacterial overgrowth and altered intestinal barrier function, with resultant increased bacterial translocation. AIMS: This study aimed to evaluate potential effects of pomegranate on bacterial translocation after bile duct ligation in rats. MATERIALS AND METHODS: Wistar albino rats were randomized into four groups. Group 1 underwent sham operation; Group 2 underwent sham operation and simultaneous treatment with pomegranate; Group 3 underwent common bile duct ligation, and Group 4 underwent common bile duct ligation and simultaneous treatment with pomegranate. After 8 days, the samples of systemic blood, liver, spleen and mesenteric lymph nodes (MLNs) were obtained under sterile conditions for microbiological culture. The segments of the ileum were removed for histopathological examination. RESULTS: Bacterial translocation significantly decreased in Group 4 compared to Group 3 (p = 0.007). The bacterial counts (Colony forming unit: CFU/g) of Group 3 were significantly higher than those of Groups 1, 2 and 4 (p < 0.05). The mean ileal villus heights in the Groups 1, 2, 3 and 4 were 480.5±20.5 µm, 494.7±17.3 µm, 356.3±25.7 µm and 420.7±23.7 µm, respectively. The mean villus height in Group 4 was higher than that of Group 3 (p = 0.010). CONCLUSIONS: Pomegranate has significant protective effects on intestinal mucosa barrier in obstructive jaundice and reduces bacterial translocation.  

The effects of curcumin on the liver and remote organs after hepatic ischemia reperfusion injury formed with Pringle manoeuvre in rats.

BACKGROUND: We aimed to investigate the effects of curcumin on ischemia/ reperfusion (IR) injury of the liver and distant organs resulting from liver blood flow arrest. MATERIALS AND METHODS: Totally 40 rats, divided into four groups, each included 10 rats were used. Group I as only laparatomy, Group II laparatomy and curcumin application, Group III hepatic IR; and Group IV as hepatic IR and curcumin application group. Ischemia was generated by hepatoduedonal ligament clamping for 30 minutes and then reperfusion is started. Curcumin capsules were opened and appropriate dose had been created within weighing scales. After calculations, the powder was diluted with saline. Fifteen minutes before the ischemia, curcumin was applied via oral gavage. Blood samples were taken from the animals for biochemical analysis at 60th minutes of the experiment in the first and second groups; 30 minutes after beginning reperfusion in the third and forth groups. Simultaneously, liver, lung and kidney tissues were sampled for biochemical and histopathological examinations. RESULTS: Plasma malondialdehyde levels were found to be higher (p < 0.001), but total antioxidant activity values were not different in IR group compared with IR + curcumin group (p > 0.05). Biochemical and histopathological evaluation of tissue samples revealed that there were no differences in total antioxidant activity, total oxidant activity and histopathologic scores in IR + curcumin group compared with values of IR group (p > 0.05). CONCLUSIONS: Curcumin did not reduce the effects of hepatic ischemia reperfusion injury on the liver and distant organs including kidneys and lungs significantly.

The protective effect of ellagic acid on lung damage caused by experimental obstructive jaundice model.

AIM: This study aimed to investigate protective effects of ellagic acid on lungs in an experimental obstructive jaundice model. METHODS: Four groups were established, each consisting of ten randomly selected rats: Group 1: sham, Group 2: ellagic acid, Group 3: obstructive jaundice, and Group 4: obstructive jaundice + ellagic acid. Ellagic acid was administered orally at a dose of 60 mg/kg/day to group 2 and 4. The animals were sacrificed eight days later. The total oxidative status and the total antioxidant capacity in their lung tissue were determined, and malondialdehyde levels in their blood were measured. Histopathological changes in the lungs were examined. RESULTS: In the obstructive jaundice group treated with ellagic acid, there was a decrease in malondialdehyde levels and a reduction in the total oxidative status and the oxidative stress index, whereas the total antioxidant capacity increased (p < 0.001). The histopathological examination showed that neutrophil leukocyte infiltration and edema formation decreased and destruction of lung parenchyma disappeared following the treatment with the ellagic acid (p < 0.05). CONCLUSION: This study shows that ellagic acid has a protective effect against oxidative damage in lung tissue in obstructive jaundice.

Clinically palpable breast abnormalities with normal imaging: is clinically guided biopsy still required?

AIM: To determine the need for a fine-needle or core biopsy in patients with clinically palpable breast abnormalities who have negative mammographic and sonographic findings. METHOD AND MATERIALS: Over a 12-year period, 251 patients with a palpable abnormality at presentation and who had a negative ultrasound and mammogram underwent clinically guided biopsy (CGB) by breast surgeons. This was 2.7% (251/9313) of all breast biopsies performed from January 1999 to December 2010. Physical findings were qualitatively categorized into five groups as clinically "normal", "benign", "probably benign", "suspicious", and "malignant" at the time of initial assessment. The number of biopsies for each category and biopsy results were analysed retrospectively. RESULTS: Three (1.2%) of the 251 CGBs were reported as malignant; two (0.8%) of which were invasive. Forty-six (18.3%) of the 251 cases were regarded as clinically suspicious or malignant while the remaining 215 examinations were categorized as benign or probably benign. All three malignancies were in the clinically suspicious or malignant group. CONCLUSION: A negative ultrasound and mammogram in patients with a palpable abnormality does not exclude breast cancer; however, the likelihood is very low (1.2%). In this study, 81.7% of biopsies (205/251) could have been avoided if CGB was reserved for the clinically suspicious or malignant group only without missing any malignancies.

Gemcitabine and cisplatin combination chemotherapy in triple negative metastatic breast cancer previously treated with a taxane/anthracycline chemotherapy; multicenter experience.

This study was aimed to establish clinical efficacy and tolerability of gemcitabine and cisplatin combination in patients with metastatic triple negative breast cancer progressing after anthracycline and taxane based chemotherapies.Thirty-three patients who were given cisplatin and gemcitabine for triple negative and metastatic breast cancer were evaluated retrospectively. A total of 141 cycles were administered with a median 4 cycles per patient. Median follow-up time was 14 months (range, 2-36 months). Objective response rate was 27.3%. Total clinical benefit of the combination was 48.4%. The estimated median progression free survival and median overall survival were 5 months and 14 months, respectively. The most common Grade 3 and 4 toxicity were neutropenia and thrombocytopenia observed in 10 (27.7%) and 9 (24.9%) patients, respectively. The combination of the gemcitabine and cisplatin after taxane/anthracycline is well tolerated and seems to be effective with acceptable toxicity profile.

Gemcitabine alone versus combination of gemcitabine and cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: a retrospective analysis of multicenter study.

The majority of patients with pancreatic cancer is of advanced disease. Several randomized Phase II and III trials suggest that the combination of gemcitabine and cisplatin (GemCis) response rates were higher than Gemcitabine (Gem) alone, however the trials were not enough powered to indicate a statistically significant prolongation of survival in patients with advanced pancreatic adenocarcinoma. The aim of this retrospective multicenter study is to evaluated the efficiency of Gem alone versus GemCis in patients with locally advanced and/or metastatic pancreatic adenocarcinoma .A total of 406 patients, from fourteen centers were evaluated retrospectively. All patients received Gem or GemCis as first-line treatment between September 2005 to March 2011. Primary end of this study were to evaluate the toxicity, clinical response rate, progression-free survival (PFS) and overall survival (OS) between the arms. There were 156 patients (M: 98, F: 58) in Gem arm and 250 patients (M: 175, F: 75) in the combination arm. Gemcitabin arm patients older than the combination arm ( median 63 vs 57.5, p=0.001). In patients with the combination arm had a higher dose reduction (25.2% vs 11.3%, p=0.001) and dose delay (34% vs 16.8%, p=0.001). Among patients with the combination and Gemcitabin arm gender, diabetes mellitus, performance status, cholestasis, grade, stage did not have a statistically difference (p>0.05). Clinical response rate to the combination arm was higher than the Gem arm (69.0% vs 49.7%, p=0.001). PFS was more favorable in the GemCis arm than Gem alone, but the difference did not attain statistical significance (8.9 vs 6.0, p=0.08). OS was not significantly superior in the GemCis arm (12.0 vs 10.2, p>0.05). Grade III-IV hematologic and nonhematologic toxicity were higher in the combination arm. PFS was more favorable in the GemCis arm than Gem alone, but the difference did not attain statistical significance. OS was not significantly superior in the GemCis arm.

The effects of ellagic acid on the liver and remote organs' oxidative stress and structure after hepatic ischemia reperfusion injury caused by pringle maneuver in rats.

INTRODUCTION: We aimed to investigate the possible protective effects of ellagic acid (EA) on the liver and remote organs against the hepatic ischemia-reperfusion injury. METHODS: Forty Wistar-Albino rats were divided into four groups each containing 10 rats. Group I with laparotomy only, Group II with laparatomy and ellagic acid application, Group III with hepatic ischemia-reperfusion and Group IV with hepatic ischemia-reperfusion and ellagic acid application. Hepatic ischemia was induced by pringle's manoeuvre for 30 minutes followed by 30 minutes reperfusion period. After induction of ischemia, EA was applied via oral gavage at a dose of 85 mg/kg. Blood samples were taken from the animals for biochemical analysis at 60th minute of the experiment in all groups. Simultaneously, liver, lung and kidney tissues were sampled for biochemical analyses and histopathological examinations. RESULTS: The administration of EA reduced serum malonyldialdehid levels (p<0.05) and liver's oxidative stress index compared with the non-use EA groups (p0.05). The use of EA did not exert significant protective effects against the effects of liver ischemia-reperfusion injury on the kidney and lung. CONCLUSION: In our experiments ellagic acid reduced the liver oxidative stress induced by ischemia-reperfusion injury. However, no significant histological improvement was found with EA. There were no significant protective effects on the remote organ injuries induced by ischemia-reperfusion (Tab. 3, Fig. 7, Ref. 37).

The prevalence and significance of autoantibodies in patients with non-Hodgkin's lymphoma: are they correlated with clinicopathological features?

PURPOSE: It is well known that an association exists between the pathogenesis of lymphomas and autoimmune diseases. Autoantibodies are detected at higher frequency in lymphoproliferative diseases, but neither the precise role of the immune system nor the cause of this is comprehensively understood. In this study we evaluated the presence and significance of some autoantibodies for patients with non- Hodgkin's lymphoma (NHL). METHODS: 150 patients with NHL who had either newly diagnosed disease, or active disease being under chemotherapy or were disease-free during follow-up, were analyzed. The frequency of autoantibodies and the relationship between autoantibodies and several clinicopathological factors were evaluated. RESULTS: The majority of the patients (50%) had diffuse large B-cell lymphoma (DLBCL). Thirty-two patients (21.4%) were newly diagnosed, 81 (54%) had active disease and were receiving chemotherapy and 37 (24.6%) were disease-free and followed-up. Fifty-one patients (34%) had stage IV disease. Antinuclear antibodies (ANA) were found in 7 (4.7%) patients, perinuclear anti-neutrophil cytoplasmic antibody (p-ANCA) in 10 (6.7%), anti dsDNA in 1 (0.7%), anti ssDNA in 16 (10.7%), anti Jo-1 in 3 (2%), anti-scleroderma antibody (anti Scl-70) in 4 (2.7%), and rheumatoid factor (RF) in 85 (56.7%) patients. No c7horbar;ANCA positivity was found. The mean levels of anti Jo-1 (p=0.028), anti ssDNA (p=0.014), c-ANCA (p=0.015), ANA (p=0.026) and RF (p=0.046) were significantly higher in cases with DLBCL compared to patients with non-DLBCL. In addition, in patients with newly diagnosed NHL the mean levels of anti Scl- 70 (p=0.023), anti Jo-1 (p7equals;0.017), and RF (p=0.046) were significantly higher than the other patient groups. No significant correlation was detected between the presence of autoantibodies and other clinicopathological factors. CONCLUSION: Our results show that the frequency of autoantibodies is high in NHL patients, especially in DLBCL and newly diagnosed cases. Autoantibodies may be helpful for the diagnosis of autoimmune diseases, but regular and long follow-up is needed in NHL patients with high levels of autoantibodies.

Elective bladder preservation with multimodality treatment for bladder cancer.

PURPOSE: To observe the outcome of maximal transurethral resection of bladder tumor (TURBT) followed by induction chemotherapy and concurrent chemoradiotherapy in medically inoperable patients with bladder cancer. METHODS: This study included 30 patients with stage T 2-4 bladder cancer. The patients were first treated with TURBT, and then received 2 cycles of induction chemotherapy with gemcitabine and cisplatin, followed by concurrent chemoradiotherapy with gemcitabine. RESULTS: Median follow up was 28.9 months. Radiologically, complete and partial response rates were 60 and 36.7%, while cystoscopically they were 40 and 30%, respectively. Local progression (4 cases) and distant metastasis (11 cases) were noted. Median overall survival and progressionfree survival were 32 and 21 months, respectively. One -and 2-year overall survival and progression-free survival rates were 97.60% and 83.49%, respectively. CONCLUSION: The multimodal treatment performed in this study was well tolerated and achieved a high rate of bladder preservation in selected patients with bladder cancer.

Prognostic factors in patients with advanced pancreatic cancer treated with gemcitabine alone or gemcitabine plus cisplatin: retrospective analysis of a multicenter study.

PURPOSE: The majority of patients with pancreatic cancer present with advanced disease. Systemic chemotherapy for patients with pancreatic cancer has limited impact on overall survival (OS). Patients eligible for chemotherapy should be selected carefully. The aim of this study was to analyse prognostic factors for OS in advanced pancreatic cancer patients treated with first-line palliative chemotherapy with gemcitabine alone or gemcitabine plus cisplatin. METHODS: We retrospectively reviewed 343 locally advanced or metastatic pancreatic cancer patients who were treated with gemcitabine or gemcitabine plus cisplatin as first-line chemotherapy between December 2000 and June 2011. Fifteen potential prognostic variables were chosen for analysis. Univariate and multivariate analyses were conducted to identify prognostic factors associated with OS. Univariate and multivariate statistical methods were used to determine prognostic factors. RESULTS: Among the 15 variables of univariate analysis, 6 were identified to have prognostic significance: stage (p<0.001), cholestasis (p=0.02), weight loss, prior pancreatectomy, serum CEA level (p<0.001) and serum CA19-9 level (p>0.001). In addition, age, chemotherapy and liver metastasis were of borderline significance (p=0.06). Multivariate analysis (Cox proportional hazard model) included the 6 significant prognostic factors of univariate analysis and showed that stage was independent prognostic factor for OS, as were weight loss, and serum CEA level. CONCLUSION: Stage, weight loss, and serum CEA level were identified as important prognostic factors for OS in advanced pancreatic cancer patients. These findings may also facilitate pretreatment prediction of OS and can be used for selecting patients for treatment.

Is docetaxel-free interval a predictive factor for castration-resistant prostate cancer?

OBJECTIVE: Prostate cancer (PCa) is the second most common solid tumor in men and the fifth leading cause of cancer-related death. In advanced stage, palliative treatments are used instead of curative therapies. Therefore, finding predictive indicators seems crucial. Patients with castration-resistant prostate cancer (CRPC) that received Dx chemotherapy have been retrospectively reviewed. The aim of this study was to investigate whether docetaxel (Dx)-free interval could have a predictive value for PCa and influence other sequential therapies. MATERIAL AND METHODS: This clinical trial study was performed on 104 patients at Medeniyet University Oncology Clinic in 2018-2020. All CRPC patients had metastases, received Dx as first-line treatment and underwent androgen receptor axis targeted (ARAT) therapy after disease progression. We analyzed patients' progression time after Dx therapy and the effects on sequential treatment. RESULTS: After Dx therapy, all patients received ARAT (abiraterone (ABI) n: 49 (47.1%) and enzalutamide (ENZ) n: 54 (51.9%)) as a second-line treatment, except for one patient who received cabazitaxel. There was a statistically significant relationship between the Dx-free interval and duration of response to ARAT (p<0.001). The response time of ARAT treatment was <10.5 months in all patients whose Dx-free interval period was <9 months. CONCLUSIONS: Our findings support the theory that Dx-free interval can be a predictive factor for CRPC. CRPC disease can be classified as Dx-sensitive disease or Dx-resistance disease, based on the Dx-free interval. Decision on subsequent treatments could be made considering this information.

Surgical management of pyogenic liver abscess.

BACKGROUND AND AIM: Although Pyogenic Liver Abscess (PLA) has lower mortality rate in recent years due to the broad spectrum antibiotic usage, developed imaging techniques and improved intensive care services, it is still a potentially fatal disease. The objective of this study is to examine the treatment methods and our case load with the current literature. MATERIALS AND METHODS: Of 55 patients with PLA, between January 2000 and December 2009, records of 28 who received surgical drainage treatment have retrospectively been analysed. RESULTS: Nineteen (67.9%) of the patients were male, while 9 (32.1%) were female. Average age was 41.07 (15-76). Seven (25%) had associated disease. The most common symptoms were fever and abdominal pain. Twenty three (82.1%) patients had single and 5 (17.9%) had multiple cavitary lesion. Nineteen (67.9%) patients had abscess on the right and 7 (25%) had on the left one, while 2 (7.1%) had on both lobes. All were treated surgically, because of 11 (39.3%) inappropriate localization for percutaneous treatment, 6 (21.5%) insufficient percutaneous drainage, 6 (21.5%) intraabdominal free rupture and 5 (17.7%) multiple cavitary lesion. We observed 5 pulmonary complications, 5 wound infections and 2 perihepatic collections. The average hospital stay was 11.2 days. We observed only two deaths (7.1%). CONCLUSIONS: Surgical treatment is the sole option for the patients with PLA who; (a) can't be treated by percutaneous drainage or had an unsuccessful one, (b) have multiple abscess cavity, (c) are thought to have perforated abscess, (d) have additional abdominal pathology requiring laparatomy.

A retrospective analysis of women's chances to become pregnant after completion of chemotherapy: a single center experience.

PURPOSE: With the improvement in anticancer therapies, the survival of women with malignancies has increased and infertility may affect the quality of life of premenopausal women, who experience temporary or permanent amenorrhea due to chemotherapy. The aim of this study was to review the rate of pregnancies among women with malignancy previously treated with chemotherapy. METHODS: We retrospectively recorded 317 women younger than 40 years of age who were treated with chemotherapy (and a number of them with additional radiotherapy/RT) due to several malignancies between 2007-2010. The patients who got pregnant after stopping chemotherapy and during followup were analyzed. RESULTS: Among women with breast cancer (n=116), malignant lymphoma (n=85), ovarian cancer (n=26) and colon cancer (n=90), 20 got pregnant after a median 22.9 months (range 10.7-96.5) from the end of chemotherapy. Childbearing was uneventful and newborns were healthy. CONCLUSION: Women who had previously received chemotherapy for malignancy can get pregnant and deliver healthy newborns.

Mitomycin-C in combination with fluoropyrimidines in the treatment of metastatic colorectal cancer after oxaliplatin and irinotecan failure.

PURPOSE: To retrospectively evaluate the efficacy and tolerability of mitomycin-C (MMC) in combination with fluoropyrimidines as salvage 3rd -or 4th-line therapy in metastatic colorectal cancer (MCRC) patients. METHODS: All patients in this study had previously failed oxaliplatin and irinotecan-based chemotherapy. Patients were treated with MMC (6 mg/m(2) intravenously/i.v.) on day 1 in combination with either oral UFT (500 mg/m(2)) and oral leucovorin (LV) (30 mg) on days 1-14 every 3 weeks (group A) or infusional 5-fluorouracil (5-FU) by deGramont regimen with i.v. LV (200 mg/m(2)) on days 1 and 2, every 2 weeks (group B). RESULTS: Thirty-nine MCRC patients were analyzed. Twenty-two of them were in group A and 17 in group B. Thirty-three were evaluable for clinical efficacy. The clinical benefit in the intent-to-treat (ITT) population was 30.8%. Median progression free survival (PFS) was 6 months (95% confidence interval/ CI 4-8) and median overall survival (OS) 9 months (95% CI 6.5-11.5). Median PFS was 3 months (95% CI 2.4-3.6) in group A and 7 months (95% CI 5.1-8.9) in group B (p=0.009). Median OS was 7 months (95% CI 4.3-9.7) in group A and 12 months (95% CI 5.4-18.6) in group B (p=0.422). The combination of MMC and fluoropyrimidines was generally well tolerated. The most common severe toxicities were nausea and vomiting, neutropenia, hepatotoxicity and diarrhea. CONCLUSION: MMC in combination with fluoropyrimidines is safe and active in heavily-pretreated MCRC patients. This combination remains a viable option in these patients. However, better therapies are urgently needed.

Is there any correlation among adiponectin levels in serum, tumor tissue and normal tissue of the same patients wih breast cancer?

PURPOSE: Adiponectin is secreted from adipose tissue and is characterized by hyperinsulinemia which is related with obesity. Although serum adiponectin levels in patients with breast cancer have been studied previously, adiponectin levels in the serum, tumor and normal tissue of the same patients have not been simultaneously investigated. The aim of this study was thus to evaluate the relationship among serum, tumor and normal tissue adiponectin levels in patients with breast cancer. METHODS: Fifty-three patients with breast cancer who were operated at the Dr. Lutfi Kirdar Kartal Education and Research Hospital, Department of Surgery, between February 2008 and June 2008, were analyzed. Their serum adiponectin levels, tumor tissue and normal breast tissue adiponectin levels were compared. The correlation between postoperative histopathological parameters, insulin resistance parameters and adiponectin levels was also examined. RESULTS: The mean adiponectin levels in tumor tissue, normal breast tissue and serum were 56 ± 9.6 ng/ml, 56 ± 10 ng/ml and 43.5 ± 3.1 ng/ml, respectively. The serum adiponectin levels were inversely correlated with tumor tissue adiponectin levels (p=0.001, r=-0.43). When tumor tissue adiponectin levels were increased, serum adiponectin levels were decreased. O n the other hand, there was a positive correlation between normal breast tissue adiponectin levels and tumor tissue adiponectin levels (p=0.0001, r= 0.850). The tumor tissue adiponectin level was inversely correlated with tumor stage (p=0.037 , r= -0.29). Moreover, in early-stage and low grade tumors, both tumor tissue and normal tissue adiponectin levels were high compared with those of advanced stage or high grade tumors (p=0.027, r= -0.32 and p=0.004, r= -0.408, respectively). In the subgroup analyses, no significant relationship was found between insulin resistance parameters and adiponectin levels (p>0.05). CONCLUSION: Our results indicate that serum adiponectin levels were inversely correlated with tumor tissue adiponectin levels, but no relationship between normal breast tissue and tumor tissue adiponectin levels was demonstrated. Adiponectin levels in breast tumor tissue increase while serum adiponectin levels decrease. Adiponectin might play an important role in the prevention of tumor progression by decreasing tissue neovascularization.

Efficacy, safety and prognostic features of resected colon carcinoma treated in "real world" practice: a retrospective cohort-study.

PURPOSE: Treatment outcomes and prognostic features of a specific cancer generally come from prospective randomized studies. It seems reasonable to ask the question whether the results of prospective randomized studies entirely reflect the results of the population treated in "real world" practice. Therefore we performed a retrospective cohort analysis in order to find out the efficacy of adjuvant chemotherapy as well as the prognostic factors of our patient population treated in daily practice, and compared these findings with those defined in the prospective studies. METHODS: Data of patients with high risk stage II and all stage III colon cancers treated with adjuvant chemotherapy were retrospectively analyzed. RESULTS: A total of 190 patients were retrospectively analyzed. The rates of T2, T3, and T4 tumors were 4.2, 77.9, and 17.9%, respectively. Over 35% of the patients had stage II disease. Of the 5- fluorouracil (5-FU)-based chemotherapy group (n=141), 15% had a dose reduction because of toxicity and 73% were given the total planned dose and cycles, whereas these rates were 18.5 and 66% for oxaliplatin+5-FU treated group, respectively (p=0.66 and 0.44, respectively). The 3-year disease-free survival (DFS) and 5-year cancer-specific overall survival (OS) for all patients were 69.4 and 73%, respectively. In multivariate analysis, cancer-specific OS showed significant correlation with T stage (p=0.015) and with perineural invasion (p=0.024). Also patients ≥ 65 years old had significantly lower OS (p= 0.003) CONCLUSION: This study is the fi rst to report the efficacy of adjuvant treatment in a curatively resected Turkish colon carcinoma population treated in "real world" practice. Our study showed that the treatment results and the prognostic parameters of Turkish colon carcinoma patients treated in "real world" practice are not different from those of selected patients treated in randomized prospective studies.

Is there a cut-off value for standardized uptake values in positron emission tomography for predicting response to treatment and survival in patients with advanced non-small cell lung cancer? Single center experience.

PURPOSE: Positron emission tomography (PET) is an important imaging technique for the diagnosis and staging of patients with non-small cell lung cancer (NSCLC). In this study, we evaluated the standardized uptake values (SUV) of PET in NSCLC patients to determine whether there was a cut-off value for predicting response to treatment and survival. METHODS: We retrospectively analyzed 149 patients with locally advanced NSCLC. All the patients were staged by PET-computerized tomography (CT) after diagnosis. 18fluoro-2-deoxyribose (FDG) was used as the PET tracer. Univariate and multivariate analyses were performed to detect whether any prognostic factors were related to response to treatment. RESULTS: The median patient age was 60 years and the median follow-up time 10.3 months. One-year progression-free survival (PFS) and overall survival (OS) rates were 31% and 58.7%, respectively. The median OS was 15.4 months. Stage, sex and response to treatment were important factors for OS and PFS. We defined a cut-off value for SUVmax (the highest standardized uptake value for all cross sectional areas) as 10.8 by using ROC analysis. Multivariate analysis identified response to treatment as the most significant (p<0.05) prognostic factor for OS. Logistic regression analysis showed that SUVmax and weight loss were important for response to treatment. CONCLUSION: Multivariate analysis indicated that whilst response to treatment was an important factor for predicting survival, the SUVmax was also significant for determining response to therapy and a cut-off value for SUVmax was defined as 10.8.