Clinicopathologic Analysis and Prognostic Factors for Survival in Patients with Operable Ampullary Carcinoma: A Multi-Institutional Retrospective Experience.

Background and Objectives: In ampullary cancer, 5-year survival rates are 30-50%, even with optimal resection and perioperative systemic therapies. We sought to determine the important clinicopathological features and adjuvant treatments in terms of the prognosis of patients with operable-stage ampullary carcinomas. Materials and Methods: We included 197 patients who underwent pancreaticoduodenectomy to treat ampullary carcinomas between December 2003 and May 2019. Demographics, clinical features, treatments, and outcomes/survival were analyzed. Results: The median disease-free survival (mDFS) and median overall survival (mOS) were 40.9 vs. 63.4 months, respectively. The mDFS was significantly lower in patients with lymphovascular invasion (p < 0.001) and lymph node involvement (p = 0.027). Potential predictors of decreased OS on univariate analysis included age ≥ 50 years (p = 0.045), poor performance status (p = 0.048), weight loss (p = 0.045), T3-T4 tumors (p = 0.018), surgical margin positivity (p = 0.01), lymph node involvement (p = 0.001), lymphovascular invasion (p < 0.001), perineural invasion (p = 0.007), and poor histological grade (p = 0.042). For the multivariate analysis, only nodal status (hazard ratio [HR]1.98; 95% confidence interval [CI], 1.08-3.65; p = 0.027) and surgical margin status (HR 2.61; 95% CI, 1.09-6.24; p = 0.03) were associated with OS. Conclusions: Nodal status and a positive surgical margin were independent predictors of a poor mOS for patients with ampullary carcinomas. Additional studies are required to explore the role of adjuvant therapy in patients with ampullary carcinomas.

Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study.

BACKGROUND: Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown. METHODS: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL. RESULTS: Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms. CONCLUSIONS: Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer. TRIAL REGISTRATION: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).

Comparison of Gemcitabine monotherapy with Gemcitabine and Cisplatin combination in metastatic pancreatic cancer: a retrospective analysis.

PURPOSE: Gemcitabine is among the standard first-line agents for the treatment of metastatic pancreatic cancer. However, as the median survival with gemcitabine monotherapy is 6 months, different combinations are being studied for better, prolonged survival. In this multicenter study, we aimed to compare the results of gemcitabine monotherapy with those of gemcitabine and cisplatin combination therapy as first-line treatments for metastatic pancreatic cancer. METHODS: Data of 664 patients diagnosed with metastatic pancreatic cancer between January 2007 and December 2016 from seven oncology centers in Turkey were retrospectively evaluated, and 319 patients with gemcitabine alone (n=138) or gemcitabine and cisplatin combination (n=181) as first-line treatment were included. RESULTS: The median patient age was 62 years (range 42-79), being 60 years (42-75) in the gemcitabine/cisplatin arm and 67 years (52-79) in gemcitabine alone arm. no complete response was observed in either arm, whereas partial response rates were 30.1% in gemcitabine/cisplatin arm and 15.3% in gemcitabine alone arm (p=0.001). median overall survival was 8 months (95% CI:7.7-10.2) and was significantly longer in the gemcitabine/cisplatin arm than in the gemcitabine alone arm (10 vs. 6 months, p=0.004). CONCLUSION: The cemcitabine and cisplatin combination therapy as first-line treatment of metastatic pancreatic cancer yields significantly prolonged survival over gemcitabine monotherapy. In patients with favorable performance conditions, the combination therapy should be preferred.

Effect of port-care frequency on venous port catheter-related complications in cancer patients.

PURPOSE: Subcutaneous central venous port catheters (SCVPC) are of great importance in the treatment of patients with malignancies since they provide secure vascular access. Our aim was to assess the impact of long-term catheter care frequency on the frequency of port-related complications. PATIENTS AND METHODS: Two hundred and seven patients who had not been on active chemotherapy through their SCVPC for at least 3 months were enrolled into the study. Those who received catheter care every 3 months or more frequently were assigned to the frequent care group, and the others to the infrequent care group. The patients were examined for port-related complications and thrombosis including port occlusion. Routinely in our clinic, catheter care was done by using 300 IU of heparin. RESULTS: According to the frequency of SCVPC care, 49 (23.7 %) patients were in the frequent care group and 158 (76.3 %) were in the infrequent care group. Median follow-up of all patients was 671 days (range 133-1712). Median frequency of port care in the frequent care group was 90 days (range 30-90), but 441.5 days in the infrequent care group (range 91-1630). None of the patients experienced port-related severe complications during the follow-up time. None of them presented with port occlusion. When the groups were analysed for thrombus (symptomatic and asymptomatic), there was no statistically significant difference (6.4 vs 13.8 %, p = 0.17). Those patients who had received more than first-line chemotherapy were found to have more thrombi than the patients who were treated with only one type of chemotherapy protocol (28.6 vs 10.2 %, p = 0.01), and the patients who had metastatic disease at the last control were found out to have thrombi more frequently than the non-metastatic patients (24.3 vs 9.3 %) (p = 0.01). CONCLUSIONS: In the present study, there was no difference in port-related severe complications between frequent and infrequent care groups during follow-up. However, the rate of thrombosis was slightly higher in the infrequent port care group.

Prognostic factors in gastrointestinal stromal tumors: multicenter experience of 333 cases from Turkey.

BACKGROUND/AIMS: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal neoplasm of the gastrointestinal tract. In an attempt to survey the approximate incidence, clinicopathological characteristics, and immunophenotypic features of GISTs in Turkey, we conducted a clinicopathological and immunohistochemical analysis of GISTs. METHODOLOGY: Three hundred and thirty-three patients with GIST from nine institutions in Turkey were retrospectively evaluated. RESULTS: Between January 2001 and March 2011, a total of 333 patients with GISTs were included; of these, 204 (61.2%) were male and 129 (38.8%) were female. The median age was 55 years (range; 22-102 years). At the median follow-up of 26 months (range; 4-166 months), the 1-, 3- and 5-year OS rates of the 333 patients were 96.9%, 85.8% and 78.5%, respectively. The 5-year DFS rate was 40%. The 5-year OS rate and median OS time for the patients with R0 resection were significantly higher than for patients with metastatic diseases (79.7 vs. 75.7% and not reached vs. 115 months, respectively, p=0.04). CONCLUSION: Although our results should be confirmed by prospective studies, we believe that they contribute to the literature because the study included both resectable and metastatic or unresectable GIST patients and multicenter findings from Turkey.

Co-existence of gastrointestinal stromal tumors with other primary neoplasms.

BACKGROUND/AIMS: Gastrointestinal stromal tumors (GISTs) are the most common primary mesenchymal neoplasms of the tubular gastrointestinal tract (GI). Here, we present a series of 32 patients diagnosed with a primary neoplasm in addition to GIST, from six different institutions in Turkey. METHODOLOGY: In total, 200 patients with GIST were evaluated; 32 patients with both GISTs and other primary malignancies were identified. RESULTS: This study included 20 men and 12 women median age 66.5 years (range 43-78). GIST was incidentally found intra-operatively in 12 of the cases. All patients underwent surgery. Detection of the GIST was synchronous in 19 cases, metachronous in 7 cases and preceded the GIST diagnosis in 6 cases. The median time before follow-up evaluation ranged from 4 to 80 months. CONCLUSIONS: To our knowledge, no cases of GISTs co-existing with leiomyosarcoma of the spermatic cord and larynx tumors have been reported previously. The prevalence of malignancies in this subpopulation of GIST patients is significantly higher than the prevalence of malignancies in the healthy Turkish population. The high occurrence rate of additional primary malignancies in GIST patients has focused the attention of clinical oncologists on this problem, and may imply a common genetic mechanism for their etiology.

Clinicopathologic features of the nine patients with primary diffuse large B cell lymphoma of the breast.

BACKGROUND: Non-Hodgkin lymphomas of the breast are uncommon cancers that occur as either primary extranodal diseases or secondary localizations of a systemic disease. The term "primary breast lymphoma" (PBL) is used to define malignant lymphomas primarily occurring in the breast in the absence of previously detected lymphoma localizations. In this report, we analyzed nine patients with primary diffuse large B cell lymphoma (DLBCL) of breast. PATIENTS AND METHODS: Patients with newly diagnosed PBLs treated between 1997 and 2009 in five institutions were retrospectively evaluated. RESULTS: The median age of the patients with PBL was 49 years (range 30-82 years), and four patients had left-sided and five had right-sided disease. All of the nine patients were classified as DLBCL. Five patients with DLBCL received chemotherapy followed by involved-field or elective-field radiotherapy and four received chemotherapy alone. Complete remission (CR) following primary treatment for all patients with PBL except for two cases was obtained. In two patients, recurrence occurred. At the median follow-up of 24.2 months, the 5-year OS rate was 76.2%. Univariate analysis indicated that age, ECOG PS, clinical stage, international prognostic index score, lactate dehydrogenase levels and the presence of B symptoms were not important prognostic factors in our study. CONCLUSIONS: Our series contained a small sample size, but it is interesting because it included only DLBCL cases. However, definitive conclusions about treatment and follow-up options of patients cannot be made in such a small series of patients. There are very few reports of patients with PBL treated with R-CHOP rather than CHOP alone. The followup is probably still too short and sample size very few to know how R-CHOP compares with CHOP-treated patients in other series, but this is definitely worth looking at in more detail when reasonable median follow-up has been achieved and sample size are sufficient.

Prognostic and Predictive Value of NAR Score in Gastric Cancer.

INTRODUCTION: Neoadjuvant treatment is a widely accepted approach for locally advanced rectum cancer. Efforts to explore a surrogate endpoint for clinical trials revealed a new prognostic scoring system which is named as neoadjuvant rectal score (NAR) in patients who received neoadjuvant treatment for rectal cancer. MATERIAL AND METHODS: 88 patients who met inclusion criteria were included in the study. The optimal cutoff value of the NAR score was 17.6 with 71% sensitivity and 63% specificity. Patients with NAR score > 17.6 (n: 48, 54%) were defined as the high-risk group and those with NAR score ≤ 17.6 (n: 40, 56%) as the low-risk group. RESULT: Survival analysis according to the NAR score group (low-risk vs high-risk) revealed that there was a statistically significant difference between groups regarding OS and DFS. The median OS for high-risk patients was 27.3 months (95% CI, 15.0-39.6); it was 76.6 months (47.3-106.0) for low-risk patients (p < 0.0001). The median DFS was 15.1 months (11.8-18.4) for high-risk patients; it was 44.3 months (95% CI, 4.1-84.6) in the low-risk group (p = 0.002). DISCUSSION: As a result, we interpreted our findings as supporting data about the utility of NAR score not only as a surrogate endpoint for the clinical trial of rectal cancer but also as a prognostic marker in patients with gastric cancer who received neoadjuvant treatment.

Prediction of Peritoneal Recurrence in Patients with Gastric Cancer: a Multicenter Study.

PURPOSE: The peritoneum is the common recurrence site of gastric cancer (GC) presenting with worse survival. Although some predictive clinicopathological factors have been identified, there is no comprehensive assessment of peritoneal recurrence risk prediction for patients treated with adjuvant chemotherapy (CR) or chemoradiotherapy (CRT) after surgery. We aimed to predict peritoneal recurrence and develop a new scoring model in GC. METHODS: This retrospective study included 274 GC patients who presented with recurrence after curative gastrectomy followed by adjuvant chemotherapy (CT) or chemoradiotherapy (CRT). Risk factors for peritoneal recurrence were analyzed using the following parameters: age, gender, tumor location and characteristics, and differences between treatment modalities. All parameters were assessed by binary logistic regression analysis to compare the patients with and without peritoneal recurrence. Then, a new risk scoring model was developed. RESULTS: Peritoneal recurrence was observed in 115 (44.1%) patients. Peritoneal recurrence was higher in female gender (odds ratio (OR), 1.93; 1.07-3.49, P = 0.030, 1 point), T4a-b stage (OR, 2.47; 1.14-5.36, P = 0.022, 1 point), poor/undifferentiated (OR, 2.04; 1.31-4.06, P = 0.004, 1 point), and signet cell carcinoma (OR, 2.04; 1.04-4.02, P = 0.038, 1 point) after adjusted for resection and dissection types. The risk scoring model was developed using the related parameters: Peritoneal recurrence rates were 24.6%, 42.6%, and 71.4% for group 1 (0 point), group 2 (1-2 points), and group 3 (3-4 points), respectively. CONCLUSION: Female gender, T4 tumor stage, undifferentiated histopathology, and signet cell type had a tendency to peritoneal recurrence after adjusted for treatment modalities. Patients with 3 or 4 risk factors had an 8.8-fold increased risk for the development of peritoneal recurrence.

Cisplatin plus docetaxel combination in the first-line treatment of metastatic non-small cell lung cancer.

AIMS: To evaluate activity and toxicity of cisplatin plus docetaxel combination in the first-line treatment of chemotherapy-naive patients with metastatic non-small cell lung cancer. PATIENTS AND METHODS: Between October 2004 and July 2008, 186 patients with metastatic non-small cell lung cancer treated with first-line cisplatin plus docetaxel were retrospectively evaluated in 7 centers. The chemotherapy schedule consisted of cisplatin, 75 mg/m(2) iv infusion, and docetaxel, 75 mg/m(2) iv infusion on day 1, every 3 weeks. RESULTS: Median age was 56 years (range, 28-75). Eighteen patients (9.7%) were females and 168 (90.3%) were males, with a median ECOG performance status of 1 (range, 0-2). A total of 833 cycles of chemotherapy was administered (median, 4 cycles; range, 1-6). Two patients (1.1%) achieved clinical complete response, 77 patients (41.4%) partial response, and 66 patients (35.5%) stable disease. Median time to disease progression was 6 months (95% CI, 5.54-6.46). Median overall survival was 14.6 months (95% CI, 11.47-17.73). One- and 2-year overall survival was 55.2% and 19.7%, respectively. The most common grade 3-4 hematological toxicities were neutropenia (n = 32, 17.2%) and anemia (n = 4, 2.2%). CONCLUSIONS: The cisplatin plus docetaxel combination was effective and safe in the first-line treatment of patients with metastatic non-small cell lung cancer.

It appears to be safe to start chemotherapy on the day of implantation through subcutaneous venous port catheters in inpatient setting.

GOALS: It is generally recommended to wait for at least 24 h before starting chemotherapy after implanting venous port catheters (VPC). Our aim was to evaluate whether it is safe to start chemotherapy on the day of implantation. PATIENTS AND METHODS: One hundred eighty patients who had to be given chemotherapy on the day of VPC implantation at our institution from June 2005 to April 2007 were included. MAIN RESULTS: Of patients, 122 were male (67.8%) and median age was 55 years. Majority (133, 72.8%) had colon and gastric adenocancer. Median time to chemotherapy onset from VPC implantation was 102 min (minimum-maximum, 12-402). One hundred sixty-four (91.1%) received prolonged chemotherapy infusions beyond 48 h. No life-threatening acute complications like pneumothorax and hemothorax developed. In one patient extravasation (empty saline extravasation secondary to wrong insertion of the needle), in 17 (9.4%) pain, and in 41 (22.8%) minor bleeding as echymosis were seen. Thrombosis developed in 11 (6.1%). Reasons for VPC removal were thrombosis (2), sepsis (2), cellulitis (1), skin dehiscence (1), and patient will (1). CONCLUSION: Chemotherapy administration immediately after VPC implantation appears safe without increased acute and chronic complications in inpatient setting.

Prognostic importance of the albumin to globulin ratio in metastatic gastric cancer patients.

AIM: The aim of this study was to evaluate the prognostic importance of the albumin to globulin ratio (AGR) in terms of overall survival (OS) and progression free survival (PFS) in metastatic gastric cancer patients. METHODS: The patients diagnosed with metastatic gastric cancer between 2009 and April 2016 at the hospital have been studied retrospectively. The clinicopathological characteristics, laboratory, and treatment parameters have been assessed. AGR value has been calculated using the following formula (AGR = serum albumin/total protein - serum albumin). RESULTS: In total, 251 patients were included in the study population. The median value of AGR was 1.206 (range = 0.460-3.130), and the cut-off value was set as 1.20. Based on the cut-off value, 126 patients were categorized in the low AGR group, while the remaining 125 patients were categorized in the high AGR group. ECOG (Eastern Cooperative Oncology Group) performance scores, CEA levels, CA19-9 levels, hemoglobin levels, lactate dehydrogenase levels, and liver metastasis ratios varied significantly between the low and high AGR groups (p < .05). The Kaplan-Meier curve has shown that, compared to the low AGR group, the high AGR group has better OS (12.2 vs 9.3 months, p = .002) and better PFS (8.0 vs 5.7 months, p < .001) rates. The univariate and multivariate analyses also proved that low AGR is an independent bad risk factor in metastatic gastric cancer patients, both in terms of OS (p = .019, Hazard Ratio (HR) = 1.380, 95% Confidence Interval (CI) = 1.055-1.805) and PFS (p = .002, HR = 1.514, 95% CI = 1.164-1.968). CONCLUSION: In metastatic gastric cancer patients, AGR is an independent prognostic factor for OS and PFS. Thus, in this patient group, the low cost albumin and globulin which can be measured with routine clinical practice may be used as an appropriate prognostic tool.

A rare case: Branch retinal vein occlusion associated with the use of tamoxifen.

Tamoxifen-induced ocular complications including cataracts, keratopathies, retinopathy, impaired visual acuity, ocular irritation, optical neuritis, and retinal vein occlusion are uncommonly reported in the literature. Herein, we report on a premenopausal patient with right-side breast carcinoma who received adjuvant tamoxifen therapy (20 mg/day) for 1.5 years and developed sudden visual loss. Fundal examination revealed an obstruction in the branch of the retinal vein. The diagnosis was confirmed by fluorescein angiography and optical coherence tomography. Thus, tamoxifen was switched to an aromatase inhibitor. Tamoxifen-induced ocular complications should be kept in mind when visual symptoms are seen in patients undergoing tamoxifen therapy. In such cases, a complete ocular examination should be performed.

Prognostic factors and clinicopathological characteristics of carcinoma of ampulla Vateri.

The aim of this study was to describe the clinicopathological characteristics and prognostic factors of carcinoma of ampulla Vateri. The medical records of 32 patients (24 men, 8 women) were evaluated. Median age was 59 years (range, 36-80 years). The performance status at the time of admission of (European Cooperative Oncology Group) 18 patients (56.3%) were ECOG-1; 8 patients (25.0%) were ECOG-2. Fifteen patients had early stage, 15 patients had locally advanced stage. Twenty-eight of 32 patients underwent curative surgery. Eleven, nine, and four patients had high-, moderate-, and low-grade histology, respectively. Fourteen patients received adjuvant treatment. Ten out of 14 patients were treated with chemotherapy. ECOG performance status (P = 0.06), stage (P = 0.05), perineural invasion (P = 0.01), tumor grade (P = 0.01), and treatment with chemotherapy, chemoradiotherapy, or only radiotherapy (P = 0.001) had a statistically significant impact on overall survival, whereas only tumor histopathology (P < 0.001) was shown to have a statistically significant effect on disease-free survival. Carcinoma of ampulla Vateri is a rare gastrointestinal tumor. Prospective trials with larger number of patients are needed to determine the prognostic factors to help select patients for adjuvant treatment.

5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as a third-line chemotherapy treatment in metastatic gastric cancer, after failure of fluoropyrimidine, platinum, anthracycline, and taxane.

Studies on the effects of third-line chemotherapy (CT) in advanced gastric cancer (GC) patients are still scarce. The aim of this study was to evaluate the efficacy and safety of the modified 5-fluorouracil, leucovorin, and irinotecan (mFOLFIRI) regimen as a third-line CT in metastatic GC patients, after failure of fluoropyrimidine, platinum, anthracycline, and taxane. After failure of first- and second-line therapies, 42 patients received third-line FOLFIRI (180 mg/m² irinotecan and 400 mg/m² leucovorin administered concomitantly as a 90-minute intravenous (IV) infusion on day 1, followed by a 400 mg/m² 5-fluorouracil IV bolus then 2600 mg/m² continuous infusion over 46 hours), between January 2009 and December 2015. FOLFIRI was administered for a median of 6 cycles (range 4-12 cycles). Eight patients achieved partial response, while 13 patients showed stable disease, resulting in the overall response rate (ORR) of 19% and disease control rate (DCR) of 50%. The most frequent grade 3-4 hematological and non-hematological toxicities were neutropenia (14.2%) and diarrhea (7.1%). The median progression-free survival (PFS) and overall survival (OS) from the start of third-line CT were 3.8 months (95% confidence interval [CI], 3.0-4.5) and 6.8 months (95% CI, 5.6-7.9), respectively. According to the multivariate analysis, two factors were independently predictive of the poor OS: >2 regions of metastasis (relative risk [RR], 2.6; 95% CI, 1.3-5.4) and a high level of carcinoembryonic antigen [CEA] (RR, 3.4; 95% CI, 1.6-7.4). In conclusion, FOLFIRI was well tolerated as third-line CT and showed promising PFS and OS in advanced GC patients, after failure of fluoropyrimidine, platinum, anthracycline, and taxane.

Advanced signet-ring cell carcinoma of the stomach: Clinicopathological characteristics of patients and efficacy of the modified docetaxel, cisplatin, and fluorouracil regimen.

BACKGROUND: The aim of this retrospective study was to investigate the clinicopathological characteristics of patients with signet-ring cell carcinoma (SRCC) of the stomach, and the efficacy of the modified docetaxel, cisplatin, and fluorouracil (mDCF) chemotherapy regimen. PATIENTS AND METHODS: Sixty-five patients diagnosed with metastatic or recurrent SRCC and treated with at least one course of mDCF regimen as the first-line treatment at our hospital July 2007 and January 2015, were included in this study. The mDCF protocol comprised docetaxel at 60 mg/m2/day (day 1), cisplatin at 60 mg/m2/day (day 1), and 5-fluorouracil at 600 mg/m2/day (days 1-5) for every 3 weeks. RESULTS: The median age was 53 years (range, 25-69 years). The most frequent sites of metastasis were the peritoneum (50.8%) and liver (21.5%). The median number of chemotherapy courses was six. In assessing 61 patients for response evaluation, one patient (1.6%) achieved a complete response, and 36 (59.0%) achieved a partial response. Fifteen patients (24.6%) had stable disease and nine (14.8%) had progressive disease. Grades 3-4 hematological toxicity revealed anemia in three (4.6%) patients, thrombocytopenia in two (3.1%), and neutropenia in five (7.7%). Grades 3-4 nonhematological side effects revealed nausea and vomiting in four (6.1%) patients and mucositis in one (1.5%). The overall survival (OS) and progression-free survival (PFS) were 10.4 months (95% confidence interval [95% CI], 8.9-12.0) and 6.1 months (95% CI, 5.1-7.0), respectively. Multivariate analysis showed that Eastern Cooperative Oncology Group (ECOG) performance score of 2 and a high pretreatment carcinoembryonic antigen level were statistically significant. CONCLUSIONS: mDCF is an effective regimen in patients with SRCC of the stomach who have ECOG performance score of 0-1 when the PFS, OS, and tumor response rate are considered. Further prospective studies including more patients should be conducted on this subject.

A Modified Epirubicin and Oxaliplatin Plus Capecitabine (EOX) Regimen as a Second- Line Therapy in Patients with Advanced Gastric Cancer

Objective: We aimed to evaluate the effectiveness of an mEOX (modified epirubicin, oxaliplatin plus capecitabine) regimen as second line therapy after failure of mDCF (modified docetaxel, cisplatin plus fluorouracil). Methods: Gastic cancer patients for whom first-line therapy was unsuccessful and who subsequently received mEOX (epirubicin 50 mg/ m2 on day 1, oxaliplatin 85 mg/m² day 1 and capecitabine twice-daily dose of 625 mg/ m2, p.o. for 2 weeks) every 3 weeks until disease progression or unacceptable toxicity, were retrospectively analyzed. Results: The study population comprised 129 cases with a median age of 55 years (range= 27-78), the majority being male (76 %). Most (75.2%) had ≥ 2 sites of metastasis. The median number of chemotherapy courses was five (range= 2­9). Forty-nine achieved a partial response and 33 showed stable disease, resulting in a ORR (overall response rate) of 38% and a DCR (disease control rate) of 63.6%. The most frequent features of grade 3-4 hematological and non-hematological toxicity were neutropenia (8.5%) and nausea/vomiting (5.4%). None of the patients suffered death due to toxicity. The median PFS was 4.7 months (95% CI, 4.1­5.3) and the OS was 7.4 months (95% CI, 6.3­8.5). On multivariate analysis, age ≥ 60 years and ECOG performance status (0-1) were independent prognostic factors affecting PFS and OS. Conslusions: In advanced gastric cancer patients, who progress after first line chemotherapy and have an ECOG performance status of 0-1, mEOX is a well tolerated triple regimen associated with a promising OS and PFS.

Is serum survivin expression a predictive biomarker in locally advanced gastric cancer patients treated with neoadjuvant chemotherapy?

BACKGROUND: The potential prognostic value of survivin is variably reported depending on the gastric cancer. OBJECTIVE: Evaluation of the prognostic and predictive significance of serum survivin and its relation with survival and treatment response rates in patients with locally advanced gastric cancer (LAGC). METHODS: Serum samples were prospectively collected from 50 patients with newly diagnosed LAGC. Serum samples of 32 healthy subjects were also collected as control groups for survivin levels. Serum survivin levels were evaluated at baseline and after three cycles of neoadjuvant chemotherapy in LAGC patients. RESULTS: Median survivin level was 147 IU/L (range = 4.4-4936) at baseline and was 27 IU/L (range = 4.2-4737) after neoadjuvant chemotherapy. The difference between survivin levels of the control group (26 IU/L, range = 3.8-1430) and pre-treatment patient group was statistically significant (p< 0.001). Clinical response to mDCF regimen was classified as progressive (progressive disease) and non-progressive groups (partial response + stable disease). Baseline survivin levels were similar between patients in progressive and non-progressive groups (p= 0.55). Survivin levels were significantly reduced after chemotherapy in non-progressive group (p< 0.001). In contrast, serum survivin levels increased in a stepwise fashion from baseline to post-chemotherapy in patients with progressive disease (p= 0.06). Patients were divided into low and high survivin groups according to baseline median survivin levels. Median DFS was 12.4 and 14.6 months for low and high groups, respectively (p= 0.18). Moreover, median OS was 14.4 and 24.9 months for low and high group, respectively (p= 0.14). CONCLUSION: It can be suggested that serum survivin can be used as a predictor of response to chemotherapy- but not survival- in LAGC patients receiving neoadjuvant mDCF chemotherapy. However, large multicenter prospective studies are required to confirm these results.