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Background. There are concerns about growing barriers to cancer research. We explored the characteristics of and barriers to global clinical cancer research. Methods. The American Society of Clinical Oncology International Affairs Committee invited 300 selected oncologists with research experience from 25 countries to complete a Web-based survey. Fisher's exact test was used to compare answers between participants from high-income countries (HICs) and low- and middle-income countries (LMICs). Barriers to clinical cancer research were ranked from 1 (most important) to 8 (least important). Mann-Whitney's nonparametric test was used to compare the ranks describing the importance of investigated obstacles. Results. Eighty oncologists responded, 41 from HICs and 39 from LMICs. Most responders were medical oncologists (62%) at academic hospitals (90%). Researchers from HICs were more involved with academic and industry-driven research than were researchers from LMICs. Significantly higher proportions of those who considered their ability to conduct academic research and industry-driven research over the past 5 years more difficult were from HICs (73% vs. 27% and 70% vs. 30%, respectively). Concerning academic clinical cancer research, a lack of funding was ranked the most important (score: 3.16) barrier, without significant differences observed between HICs and LMICs. Lack of time or competing priorities and procedures from competent authorities were the second most important barriers to conducting academic clinical research in HICs and LMICs, respectively. Conclusion. Lack of funding, lack of time and competing priorities, and procedures from competent authorities might be the main global barriers to academic clinical cancer research.

BACKGROUND AND OBJECTIVES Many patients with relapsed metastatic breast cancer are pre-treated with taxanes and anthracyclines, which are usually given in the neoadjuvant/adjuvant setting or as first-line treatment for metastatic disease. The primary objective of this study was to determine the overall response rate for combination treatment with gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who had relapsed after receiving one adjuvant/neoadjuvant or first-line metastatic chemotherapy regimen containing an anthracycline with/without a taxane. Secondary endpoints included duration of response, time to progression, one-year survival probability, and toxicity. DESIGN AND SETTING A single-arm, open-label, phase 2 study conducted at 17 investigative sites in Egypt. PATIENTS AND METHODS Treatment consisted of gemcitabine (1250 mg/m 2 ) on Days 1 and 8 and cisplatin (70 mg/m 2 ) on Day 1 of each 21-day cycle. Treatment continued until disease progression or a maximum of 6 cycles. RESULTS Of 144 patients all were evaluable for safety and 132 patients were evaluable for efficacy. The overall response rate was 33.3% and 45.5% of the patients with stable disease as their best response. The median time to progression was 5.1 months and the one-year survival probability was 73%. The most common grade 3/4 adverse events were nausea/vomiting (20.1%), neutropenia (19.4%), anemia (13.9%), asthenia (11.1%), diarrhea (9.7%), stomatitis (7.6%), leucopenia (7.6%), and thrombocytopenia (6.2%). Twelve (8.3%) patients had serious adverse events. CONCLUSIONS The results of this study indicate that gemcitabine and cisplatin were active and generally well tolerated in pretreated patients with locally advanced or metastatic breast cancer.

Background: This prospective observational study estimated the effect of prognostic factors, particularly continued smoking during therapy, on survival in advanced non-small cell lung cancer (NSCLC) patients receiving gemcitabine-platinum. Further, prognostic factors were used to build a survival model to improve prognosis prediction in naturalistic clinical settings. Methods: Eligibility criteria included: Stage IIIB/IV NSCLC, no prior chemotherapy, and Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. A Cox regression model was constructed and validated by randomizing patients into two datasets (Construction [C]:Validation [V]; 3:1 ratio). Country, disease stage, hypercalcemia, “N” factor, weight reduction, performance status, and superior vena cava obstruction were pre-defined variables forced into the model. Continued smoking was tested with adjustment for these variables. Results: One thousand two hundred and fourteen patients (C=891 and V=323) were enrolled. The final predictive model, established in the Construction dataset, identified four significant (p≤0.05) and independent predictors of survival, which were disease stage, performance status, gemcitabine-platinum regimen, and T-stage. Smoking during therapy was not significantly associated with survival (Hazard Ratio [95% CI]: 0.955 [0.572, 1.596], p=0.8618; versus never smokers). Conclusions: Although continued smoking during therapy was not significantly associated with shorter survival, the model developed in this study forms an evidence-based approach to assessing prognosis in advanced stage NSCLC.

Primary cardiac lymphoma (PCL) is a rare and usually fatal malignancy, seldom reported in children. This report describes the case of a 10-year-old boy who presented with multiple intracardiac masses which, when biopsied, proved to be small non-cleaved cell (Burkitt's) lymphoma. The first two cycles of chemotherapy according to the LMB 96 protocol were given under close cardiological supervision, with good response. The treatment was then continued with full-dose chemotherapy, without any cardiological complication. The patient who was treated by chemotherapy alone remains in complete remission 36 months after the end of treatment and can presently be considered as cured, without late cardiac effect.

Objective: To compare the efficacy, safety, and outcome of thoracoscopic talc poudrage (TTP) versus povidone—iodine pleurodesis (PIP) through a thoracostomy tube as a palliative treatment of pleural effusion due to metastatic breast carcinoma (MBC). Methods: A total of 42 MBC patients were prospectivelyenrolled in a randomized controlled trial. Twenty-two patientsreceived TTP (groupA), whereas 20 patients(group B) underwentpleurodesisbyinstillingpovidone—iodinethrougha thoracostomytube,asabedsideprocedure.Results:Themeanagewas48.2 9.9 (range: 29—64) years and 50.2 7 (range: 32—62) years for groups A and B, respectively (p = ns). At presentation, all patients had moderate to severe dyspnea, NewYork Heart Association(NYHA) > II and MedicalResearch Council(MRC)dyspnea scale3—5. Morbidityin both groupswas low. Post-procedure analgesic requirements due to severe pleuritic chest pain were higher in group A (18% vs 0%, p = 0.2). Four patients in group A (18%) and one in group B (5%) were febrile (>38 8C) within 48 h of the procedure. Both groups achieved good symptom control, with improvement in MRC dyspnea scale (1—3). There were no in-hospital deaths. Post-procedure hospital stay was lower in group B (p = 0.009). The mean progression-free interval was 6.6 (range 3—15) months. At follow-up (mean: 22.6 (range: 8—48) months), recurrence of significant pleural effusion requiring intervention was noted in two and three patients in group A and group B, respectively (p = ns). Conclusion: Povidone—iodine can be consideredasa goodalternativeto TTPto ensure effectivepleurodesisfor patientswith malignantpleural effusiondue to MBC. Thedrug is available, cost effective and safe, can be given through a thoracostomy tube and can be repeated if necessary. # 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Backgroud: To evaluate the doses of prophylactic cranial irradiation (1800cGy/1200cGy) as regards central nervous system (CNS) relapse, late cognitive abilities and learning disabilities. Subjects and Methods: 42 patients treated for acute lymphoblastic leukemia (ALL) and categorized to be at high risk of relapse were assessed. None of the patients had CNS disease at diagnosis. 28 patients received 1800 cGy prophylactic cranial irradiation and 14 received 1200 cGy. All patients received intrathecal methotrexate as well as high dose methotrexate. Visual and auditory P300 studies were carried out after a mean of 4.6 years follow-up. Visual and auditory evoked potentials were done to assess visual and auditory functions at lower brain levels. Selected subscales of Wechsler Intelligence scale for children namely; similarities, vocabulary, picture completion, design, total performance, total verbal and total IQ and arithmetic abilities were applied to both subgroups. Results: There was no difference in CNS relapse between the two groups (p=0.845). The 1800cGy group showed a significant delay of the visual P300 latency and reduction of the amplitude and delay of auditory P300 latency (p

1098 Background: MBC (metastatic breast cancer) is among the leading causes of cancer deaths in women worldwide and in Egypt. Gemcitabine has shown synergy with vinorelbine in preclinical models, and has a toxicity profile that is different from vinorelbine. Methods: This was an open-label, single-arm, non-randomised phase II study in patients with locally advanced or MBC who have been previously treated with one anthracycline with/without taxane, based regimen in the adjuvant/neoadjuvant setting. The primary objective of this study was to assess the efficacy of this combination by determining overall response rate. Secondary endpoints were the assessment of the toxicity of gemcitabine in combination with vinorelbine, as well as the time to disease progression, one-year survival. Results: Of the 74 patients enrolled, 72 patients were evaluable for primary treatment outcome (tumor response rates). Overall response rate was 42%. Four patients (6%) had complete response and 26 patients (36%) had partial response. Nineteen patients (26%) had stable disease. Among the 30 patients who had a response to treatment during the study period, the median time to disease progression was 37 weeks (range 1 -60). Median duration of response was 43 weeks (95% CI 31- unestimated). The probability of surviving one year from the Kaplan-Meier estimate for 12 months is 77% (95% CI 64%-86%). Mean percentage of dose intensity of gemcitabine and vinorelbine received was 86% (SD 13%). Mean number of cycles received was 4.4 (SD 1.8). Grade III-IV neutropenia was reported to be 10%, thrombocytopenia was 1.4%, and febrile neutropenia (with documented infection) was 1.4%. As for the clinical toxicities, the most common grade III-IV toxicities were nausea (24%) and diarrhea and stomatitis (11%). Serious clinical adverse events; 5 (7%) hospitalizations for adverse events mainly due to anemia, febrile neutropenia, septic shock and hepatic failure. There were 2 platelet transfusions and 14 RBC transfusions. Conclusions: With a disease control rate of 68%, gemcitabine/vinorelbine demonstrated to have a promising efficacy and at the same time good tolerability in metastatic breast cancer patients. [Table: see text]

7588 Background: Previous studies have assessed prognostic factors for advanced NSCLC. This international observational study quantifies the effect of a set of clinically relevant prognostic marker...

16041 Background: Many strategies have been proposed to enhance the ability of PSA in differentiation of Prostate Cancer from BPH. The present study aimed at evaluating the measurement of serum lev...

1125 Background: The efficacy of vinorelbine with capecitabine was shown to be more than just additive in vitro. Moreover, vinorelbine-capecitabine combination demonstrated promising antitumor acti...

18048 Background: The aim of this prospective, multi-country, observational study (B9E-AA-B004) is to estimate the effect of prognostic factors, including continued smoking during therapy, on treatment outcomes in patients (pts) with advanced NSCLC receiving first- line chemotherapy with a gemcitabine (gem)-platinum combination as part of their routine care. Methods: Major eligibility criteria included: tissue diagnosis of advanced stage IIIB/IV NSCLC not amenable to curative surgery/radiotherapy; no prior chemotherapy; ECOG performance status (PS) 0 or 1; and written informed consent. A predictive model was constructed and validated by splitting the data at random by centre into two datasets in a ratio of 3:1 Construction:Validation. The primary and secondary endpoints are the effect of prognostic factors on survival and selected adverse events (AEs), respectively. The association of smoking with outcomes was tested in the Construction dataset. Results: This interim analysis to assess the effect of prognostic factors on AEs occurred when all pts had completed treatment. 1214 pts were enrolled: 75.1% male; mean age 60.5 yr, range 23–86 yr; 57.1% Stage IV; 66.2% PS 1; 69.4% received gem-cis, 30.5% gem-carb; 25.7% had never smoked, 70.8% had ever smoked and 11.2% continued smoking during therapy. 22.0% of pts had =1 AE. After variable selection in the Construction database (891 pts) the following factors were associated with an AE possibly related to therapy: disease stage (IV vs III, odds ratio (OR) =1.48, p=0.034), weight loss >10% (OR=0.60, p=0.017), age ( [Table: see text]

8548 BACKGROUND Bifocal tumours represent 7–12 % of primary cerebral germ cell tumours and are mostly germinomas. The treatment of non metastatic germinomas includes either craniospinal irradiation (CSI) or chemotherapy with focal RT. BIG still represent a challenge. Should they be treated as localized or metastatic disease? This study aims to evaluate the outcome of treatment of BIG treated by chemotherapy followed by localized radiation to tumour bed in non metastatic disease METHODS The data of 118 patients included from 1990–1999 in the SFOP-TGM-TC 90–92 protocol for intracranial germ cell tumours were reviewed. The treatment of patients with germinomas (80 patients) included 2 cycles of alternating carboplatine/Etoposide and Ifosfamide /Etoposide followed by focal RT (40 Gy) delivered to initial target in localised diseases or CSI in metastatic patients. RESULTS 12/118 germ cell tumours had bifocal disease: 2/38 in the secreting group, 10/80 in the non secreting germinoma group. Two of these 10 were ...

BACKGROUND AND OBJECTIVES There is an unmet need for new combination treatments, especially for aggressive, visceral, and high tumor burden metastatic breast cancer. Gemcitabine (GEM) has shown synergy with vinorelbine (VRL) in preclinical models, and has a toxicity profile that is different from VRL, another recently approved cytotoxic drug that seems to be effective in the treatment of breast cancer. METHODS We studied the efficacy and side effects of the GEM-VRL combination as first-line chemotherapy in patients in an open-label, single arm, phase II study in patients with locally advanced or metastatic breast cancer who had been previously treated with an anthracycline-based regimen in the adjuvant/neoadjuvant setting. RESULTS Of the 74 patients enrolled, 72 patients were evaluable for the primary treatment outcome (tumor response rates). Four patients (6%) had a complete response and 26 patients (36%) had a partial response. Nineteen patients (26%) had stable disease. The median time to disease progression was 37 weeks (range, 1-60 weeks). Median duration of response was 43 weeks (range, 8.6 to 55 weeks) and one-year survival was 77% (95% confidence interval, 64% to 86%). Grade 3-4 neutropenia without fever was reported in 10% of patients, thrombocytopenia in 1%, and febrile neutropenia in 11%. The most common clinical grade 3-4 toxicities were nausea (24%) and diarrhea and stomatitis (11% each). Hospitalizations for adverse events mainly due to anemia, febrile neutropenia, septic shock and hepatic failure occured in 7%. CONCLUSION With an overall response rate of 42%, the GEM-VRL combination had promising efficacy and good tolerability in metastatic breast cancer patients.