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662 Background: Upper abdominal / lower back pain characterizes celiac plexus involvement from pancreatic and other cancers which may impair HRQOL; its satisfactory treatment is an unmet clinical need. We hypothesized that ablative radiation delivered to the celiac plexus would decrease pain and improve HRQOL. Methods: An international single arm Phase II study included patients with an average pain level ≥ 5/11 on the brief pain inventory (BPI), ECOG 0-2, and anatomical involvement of the celiac axis. The intervention was a single fraction of 25Gy delivered to the celiac plexus. The primary endpoint was ‘complete or partial (≥2 points) pain response’ based upon the BPI ‘average pain’ 11-point scale. Changes in Health-related QOL at 3 & 6 weeks compared to baseline were secondary endpoints as measured by FACT-Hep, > 8 point change being the minimal clinically important difference (MCID). Evaluable patients included eligible irradiated subjects, who had stable pain levels pre-treatment, and were alive 3 weeks’ post-treatment. The sample size was 90 evaluable patients, giving 90% power to show response rate ≥ 40%. Opioid usage was assessed using intravenous morphine equivalent dose. Sensitivity HRQOL analyses imputed worsened outcomes (-9 for total FACT-Hep) for missing data. Results: Between 2018 and 2022, 149 patients were enrolled, 90/125 who received treatment were evaluable. Median age was 65.5 years (range 28-88), 65% were female, 92% had pancreatic cancer, and 86% had metastatic disease. Median Zubrod PS was 1, median number of systemic treatment lines was 1 (range 0-5), and median baseline opioid use 31 mg/d. At 3 weeks, 48 (53.3%, 95% CI 42.5-63.9) had at least a partial pain, the BPI ‘average pain’ score decreased by a mean of 2.5 points at 3 weeks (86/90 reported) and 3.2 points at 6 weeks (67/90 reported), both p < 0.001. Opioid usage decreased by 0.6 mg/d at 3 weeks (NS) and 16.9 mg/d at 6 weeks (p = 0.005). The FACT-Hep total score increased by 7.8 points at 3 weeks (54/90 reported, NS diff. from 8) and 16.6 points at 6 weeks (45/90 reported, sig. > 8, p = 0.01), showing an improvement in patients’ HRQOL. Changes in FACT-Hep were especially noted in the Physical Well Being subscale. The Trial Outcome Index (sum of physical, functional & disease-specific concerns) increased markedly at 3 weeks (6.6 points, p = 0.005) after treatment and even more after 6 weeks (14.5 points, p < 0.). Sensitivity analyses demonstrated improvements in HRQOL at 3 and 6 weeks (1.1, 3.8), but these were less than MCID. Conclusions: Celiac plexus SBRT decreases pain and opioid use amongst patients with pancreatic cancer and other tumors invading the celiac axis. The treatment appears to improve HRQOL. Supported by Gateway for Cancer Research and the Israel Cancer Association. Clinical trial information: NCT03323489 .

The purpose of this study is to develop a European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) questionnaire that captures the full range of physical, mental, and social health-related quality of life (HRQOL) issues relevant to disease-free cancer survivors. In this phase III study, we pretested the provisional core questionnaire (QLQ-SURV111) and aimed to identify essential and optional scales.We pretested the QLQ-SURV111 in 492 cancer survivors from 17 countries with one of 11 cancer diagnoses. We applied the EORTC QLG decision rules and employed factor analysis and item response theory (IRT) analysis to assess and, where necessary, modify the hypothesized questionnaire scales. We calculated correlations between the survivorship scales and the QLQ-C30 summary score and carried out a Delphi survey among healthcare professionals, patient representatives, and cancer researchers to distinguish between essential and optional scales.Fifty-four percent of the sample was male, mean age was 60 years, and, on average, time since completion of treatment was 3.8 years. Eleven items were excluded, resulting in the QLQ-SURV100, with 12 functional and 9 symptom scales, a symptom checklist, 4 single items, and 10 conditional items. The essential survivorship scales consist of 73 items.The QLQ-SURV100 has been developed to assess comprehensively the HRQOL of disease-free cancer survivors. It includes essential and optional scales and will be validated further in an international phase IV study.The availability of this questionnaire will facilitate a standardized and robust assessment of the HRQOL of disease-free cancer survivors.

This abstract was withdrawn by the authors. Citation Format: Bjelic-Radisic V, Bottomley A, Cardoso F, Cameron D, Brain E, Kuljanic K, de Costa RA, Conroy T, Deville V, Inwald E, Serpentini S, Pinto M, Bleiker E, Arrares J, Duhoux F, Weiss J, Morag O, Lindviksmoen Astrup G, Tomaszweksi K, Velikova G, Pogoda K, Nagele E, Bliem B, Sinai P, Sprangers M, Aaronson N, Greimel E. Withdrawn [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-12-01.

IntroductionPancreatic cancer is characterised by severe mid-back and epigastric pain caused by tumour invasion of the coeliac nerve plexus. This pain is often poorly managed with standard treatments. This clinical trial investigates a novel approach in which high-dose radiation (radiosurgery) is targeted to the retroperitoneal coeliac plexus nerve bundle. Preliminary results from a single institution pilot trial are promising: pain relief is substantial and side effects minimal. The goals of this study are to validate these findings in an international multisetting, and investigate the impact on quality of life and functional status among patients with terminal cancer.Methods and analysisA single-arm prospective phase II clinical trial. Eligible patients are required to have severe coeliac pain of at least five on the 11-point BPI average pain scale and Eastern Cooperative Oncology Group performance status of two or better. Non-pancreatic cancers invading the coeliac plexus are also eligible. The intervention involves irradiating the coeliac plexus using a single fraction of 25 Gy. The primary endpoint is the complete or partial pain response at 3 weeks. Secondary endpoints include pain at 6 weeks, analgesic use, hope, qualitative of life, caregiver burden and functional outcomes, all measured using validated instruments. The protocol is expected to open at a number of cancer centres across the globe, and a quality assurance programme is included. The protocol requires that 90 evaluable patients" be accrued, based upon the assumption that a third of patients are non-evaluable (e.g. due to death prior to 3-weeks post-treatment assessment, or spontaneous improvement of pain pre-treatment), it is estimated that a total of 120 patients will need to be accrued. Supported by Gateway for Cancer Research and the Israel Cancer Association.Ethics and disseminationEthic approval for this study has been obtained at eight academic medical centres located across the Middle East, North America and Europe. Results will be disseminated through conference presentations and peer-reviewed publications.Trial registration numberNCT03323489.

Background: Lung cancer causes impairment of health-related quality of life (QoL), but little is known about gender aspects in QoL and symptom burden of lung cancer patients. The aim of this study was to investigate gender differences in QoL as assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the updated lung cancer module. Methods: In a prospective, international, cross-cultural, multicenter study that was undertaken to update the lung cancer-specific module EORTC QLQ-LC13, patients filled in the core questionnaire EORTC QLQ-C30 and the updated lung cancer module. Gender differences were calculated for all QoL scores using ANCOVAs that controlled for known and suspected confounders. Comparisons with historic data were drawn. Results: A total of 200 patients (82 female and 118 male, median age 65 years) were recruited. With the exception of coughing (estimated marginal means: women 33.86 and men 43.52, P=0.022) and diarrhea (estimated marginal means: women 26.01 and men 17.93, P=0.038) there were no significant QoL gender differences. Fatigue was the most pronounced symptom in both, men and women, outpacing typical respiratory symptoms. Quite generally, our sample of lung cancer patients showed considerably worse QoL in all scores when compared to EORTC reference data (lung cancer and combined cancer diagnoses, mean differences up to 13.70 and 21.54 score points, respectively) and to a German norm reference sample (up to 35.37 score points). Conclusions: This study adds to the literature in showing that the typical QoL gender difference effect (women doing worse than men) may not be generalizable across all patient samples.

Background The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer. Methods This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's a value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691. Findings Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: chi(2)=370.233, root mean square error of approximation=0.075, and comparative-fit index=0.901. Cronbach's alpha for internal consistencies of all multi-item scales were above the threshold of 0.70. Intra-class coefficients for test retest reliabilities ranged between 0.82 and 0.97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values

BACKGROUND Although studied in a few randomized controlled trials, the efficacy of medical cannabis (MC) for chronic pain remains controversial. Using an alternative approach, this multicentre, questionnaire-based prospective cohort was aimed to assess the long-term effects of MC on chronic pain of various aetiologies and to identify predictors for MC treatment success. METHODS Patients with chronic pain, licensed to use MC in Israel, reported weekly average pain intensity (primary outcome) and related symptoms before and at 1, 3, 6, 9 and 12 months following MC treatment initiation. A general linear model was used to assess outcomes and identify predictors for treatment success (≥30% reduction in pain intensity). RESULTS A total of 1,045 patients completed the baseline questionnaires and initiated MC treatment, and 551 completed the 12-month follow-up. At 1 year, average pain intensity declined from baseline by 20% [-1.97 points (95%CI = -2.13 to -1.81; p

Background: The European Organization for Research and Treatment of Cancer (EORTC) QLQ- BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I–III update of the QLQ-BR23 questionnaire. Patients and methods: The update of the EORTC QLQ- BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. Results: The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. Conclusion: Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module. © 2019 European Society for Medical Oncology

Innate immunity serves an important role in the healthy population, providing surveillance and protection against infections. Chemotherapy suppresses the body's immune system, including neutrophil and natural killer (NK) cell numbers and activity. This leads to an increased risk of infection which often requires the reduction or even discontinuation of the chemotherapeutic regimens. The botanical formula LCS102 was designed to stimulate the body's immune system. The effect of the formula on innate immunity was examined in human blood samples, as were its effect on the anti-cancer activity of chemotherapeutic agents on human cancer cells. Blood samples drawn from 20 volunteers (19 healthy subjects; 1 patient with breast cancer undergoing chemotherapy) and were exposed to LCS102. The effects on neutrophil and NK cell activity were tested using FACS. The anti-cancer effects of LCS102 were tested on T24, A549, MCF7, PANC-1 and U2OS human cancer cell lines, as were the effects of the formula on doxorubicin, Taxol, etoposide and cisplatin-treated cells using a sulforodamine B viability assay. LCS102 was shown to significantly increase the percentage of activated neutrophils and NK cells in the blood samples tested. The formula did not inhibit the cytotoxic effects of the chemotherapeutic agents, and in certain cases increased their anti-cancer activity. Further research is required to improve our understanding of the clinical value of LCS102; however, it may serve as an adjuvant during chemotherapy, to reduce the effects of chemotherapy on innate immunity.

Introduction: To evaluate quality of life of lung cancer patients, the European Organisation for research and treatment of cancer (EORTC) updated the former module LC13, which includes symptoms with targed therapy und surgery and is used together with the QLQ-C30. Recently the influence of gender especially in lung cancer is investigated. Aims and objectives: Hence we analyzed gender differences with the help of the questionnaire QLQ-C30 and LC 29. Methods: This is a prospective, non-interventional, multicentre study, which took place in nine different countries (Germany, Great Britain, Italy, Israel, Norway, Poland, Spain, Taiwan, Cyprus). To determinate gender differences we used covarianz analyses, in which gender was a fixed factor. Following covariates were included Tumor type, therapy approach (palliative vs curative), education, surgery vs radiochemotherapy, targed therapy vs radiochemotherapy, NSCLC stage IV vs all other stages, comorbidity (yes vs no) Results: 200 patients participated in this study (women n=82 and men n=118). Median age was 65 years. Most women were non smoker (n=17, 65.4%) in comparison to men (n=9, 34.5%). Women as well as men had a median Karnofsky Performance Status of 80%. The important clinical variables are shown in the table. Conclusions: In summery the data show that there is no significant gender difference in quality of life of lung cancer patients except the symptom “coughing”. Estimated marginal means

Backround The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. Methods We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. Results We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. Conclusions Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment. Electronic supplementary material The online version of this article (10.1186/s12955-018-0920-0) contains supplementary material, which is available to authorized users.

Background The European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 was the first module to be used in conjunction with the core questionnaire, the QLQ-C30. Since the publication of the LC13 in 1994, major advances have occurred in the treatment of lung cancer. Given this, an update of the EORTC QLQ-LC13 was undertaken. Methods The study followed phases I to III of the EORTC Module Development Guidelines. Phase I generated relevant quality-of-life issues using a mix of sources including the involvement of 108 lung cancer patients. Phase II transformed issues into questionnaire items. In an international multicenter study (phase III), patients completed both the EORTC QLQ-C30 and the 48-item provisional lung cancer module generated in phases I and II. Patients rated each of the items regarding relevance, comprehensibility, and acceptance. Patient ratings were assessed against a set of prespecified statistical criteria. Descriptive statistics and basic psychometric analyses were carried out. Results The phase III study enrolled 200 patients with histologically confirmed lung cancer from 12 centers in nine countries (Cyprus, Germany, Italy, Israel, Spain, Norway, Poland, Taiwan, and the UK). Mean age was 64 years (39 − 91), 59% of the patients were male, 82% had non-small-cell lung cancer, and 56% were treated with palliative intent. Twenty-nine of the 48 questions met the criteria for inclusion. Conclusions The resulting module with 29 questions, thus currently named EORTC QLQ-LC29, retained 12 of the 13 original items, supplemented with 17 items that primarily assess treatment side-effects of traditional and newer therapies.

Background: Many patients with upper-abdominal malignancies suffer from severe low back / epigastric pain caused by infiltration of the celiac plexus. The celiac plexus is a network of nociceptive nerves, located along the aorta. Contemporary approaches (opioids, celiac plexus chemical neurolysis, systemic chemotherapy) are often inadequate. The celiac plexus has not previously been targeted using radiation. We hypothesized that ablative radiation targeted to the celiac plexus would alleviate pain and improve quality of life (QOL). Methods: We conducted a single arm prospective clinical trial. Eligible patients had celiac-pain > 4/10 on Numerical Rating Scale (NRS) and completed treatment per protocol with at least one post-treatment visit. The celiac plexus was irradiated from D12 to L2. Radiation was given as either five fractions of 9 Gy or a single-fraction 25 Gy. The primary endpoint was NRS pain 3 weeks post-treatment. Secondary endpoints were toxicity, pain at 6w, analgesic use, and pain interference with daily activities as evaluated by ‘Brief pain assessment short-form’. Analgesic use was not restricted. Here we report results from those who received single fraction treatment. Results: 19 patients were evaluable. The median age of the study population was 67 yr with a median ECOG of 2, 89% had pancreatic cancer. Patients were a median 8 months from diagnosis, and had received a median of one systemic treatment. Toxicity was limited to grade 1-2. Average pain decreased from 5.9/10 at baseline, to 3.1/10 at 3w, and to 1.8/10 (both p < 0.0001) at 6w post-treatment. Number of rescue analgesic doses decreased from 3.6 (baseline) to 1.9 at 3w and 1.7 at 6w (both p Conclusions: Single fraction celiac plexus radiosurgery alleviates pain, and improves quality of life among patients with advanced upper-GI cancer. An international phase II trial is accruing. Pain interference measuresdomainweek 0 (baseline)week 3p (w0 vs v3)week 6p (w0 vs v6)General Activity7.93.4 Citation Format: Yaacov R. Lawrence, Liat Hammer, Ofir Morag, Maoz Ben-Ailan, Dror Alezra, Ofer Margalit, Naama Halpern, Ben Boursi, Einat Shacham Shmueli, Galia Jacobson, Uri Amit, Tamar Katzman, Kinneret Shefer, Ilana Weiss, Inessa Yanovsky, Adam P. Dicker, Talia Golan, Zvi Symon, David Hausner. Celiac plexus radiosurgery a new palliative modality for upper gastrointestinal malignancies - final quality of life results from a proof-of-concept clinical trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT147.

309 Background: Pancreatic cancer is characterized by severe epigastric/lower back pain caused by infiltration of the celiac plexus. The celiac plexus is a network of nociceptive nerves, located along the abdominal aorta. Contemporary approaches (opioids, celiac plexus chemical neurolysis, systemic chemotherapy) are often inadequate. We hypothesized that ablative radiation targeted to the celiac plexus would alleviate pain. Here we report results for pancreatic cancer patients treated with a single fraction of radiation. Methods: We conducted a single-institution single-arm prospective clinical trial. Eligible cancer patients had celiac-pain > 4/10 on Numerical Rating Scale (NRS) and completed treatment per protocol with at least one post-treatment visit. The celiac plexus was irradiated from D12 to L2. Radiation was given as a single-fraction 25 Gy. The primary endpoint was NRS pain 3 weeks post-treatment. Secondary endpoints were toxicity, pain at 6w, analgesic use, and pain interference with daily activities as evaluated by the ‘The Brief Pain Inventory’. Analgesia was not restricted. Total daily dose of opioids was measured in morphine milligram equivalents (MME). Results: Seventeen patients were evaluable, 65% female, median age 68 yr (range 51-79), three had undergone pancreatic resection, nine had liver metastases, median ECOG = 1. Sixteen patients reported 3-week outcomes, and 10 reported 6-week outcomes. At time of treatment subjects were a median of 8.2 months from diagnosis, and had received a median of one systemic treatment (range 0-3). Toxicity was limited to grade 1. Median baseline pain was 6/10 (IQR 5-7), was reduced to 2.3/10 (IQR 0.9-3.6) (p < 0.0005) at 3 w, and to 2.5/10 (IQR 0-3.1) at 6 w post-treatment, for both p < 0.001. Median opioid consumption numerically decreased (baseline 52.9 MME, 3 w 43.9 MME, 6 w 37.5 MME, NS). ‘BPI pain interference’ improved significantly: median baseline score 7.1 dropped to 1.1 at 3 weeks and 0 at 6 weeks (p < 0.01 for both time points). Conclusions: Celiac plexus radiosurgery alleviates pain, and improves quality of life among patients with pancreatic cancer. A follow-up international trial is accruing. Clinical trial information: NCT02356406.

With recent advances in mapping the genetic mutations involved in breast cancer and the availability of genetic testing, it has become necessary to explore the psychological consequences of women who have tested positive for the gene mutations involved in breast cancer (BReast CAncer gene one and two, BRCA1/2). Findings regarding psychological consequences of positive results in genetic testing for breast cancer are ambiguous and insufficient. The aim of the current study was to explore the relationship between experience of the death of a relative due to breast cancer, perception of the illness, distress, and well-being among BRCA1/2 mutation women carriers. Forty asymptomatic carriers who attended BRCA1/2 clinics in Israel completed self-administered questionnaires assessing socio-demographic variables, illness perception, and well-being. It was found that experiencing the death of a relative as a result of breast cancer was significantly correlated with illness perception. Carriers who experienced the death of a relative perceived breast cancer as having a stronger identity (i.e. as having severe symptoms), dire consequences, and as being uncontrollable in comparison to carriers who had not experienced the death of a relative. Nevertheless, psychological distress and well-being were not found to be significantly correlated to either an experience of death of a relative as a result of breast cancer or to illness perception. Implications and limitations are discussed in light of these findings. Among these is the need to consider the illness perception of healthy BRCA carriers women.

The worldwide incidence of diabetes mellitus is rapidly increasing. There is recent interest in the influence of glucose metabolism on oncogenesis. We investigated the role of diabetes mellitus and the metabolic syndrome (MS) on prostate cancer development. This study consisted of 11 541 men with coronary heart disease screened to participate in a secondary cardiac prevention trial. MS was defined according to modified NCEP/ATP III criteria. Multivariable regression analysis accounting for competing risks was performed using a modified Cox proportional hazard model in order to assess the association between diabetes, the MS and the subsequent development of prostate cancer. At baseline, subjects were classified into one of the four groups: (1) 6119 (53%) with neither diabetic mellitus nor MS, (2) 3376 (29%) with the MS but without diabetes, (3) 560 (5%) with diabetes mellitus but without MS and (4) 1486 (13%) with both conditions. Median follow-up was 12.7 years (range 0–15.7 years). During follow-up, 459 new cases of prostate cancer were recorded. The age-adjusted hazard ratio (HR) for prostate cancer was reduced in diabetic patients compared with those without diabetes, 0.54 and 95% confidence interval of 0.40–0.73. No significant association was noted between the presence of MS and prostate cancer development. On multivariate analysis, diabetes mellitus continued to protect against the development of prostate cancer, this was more pronounced in the absence of MS (HR=0.43, P=0.01 for diabetes in the absence of MS; HR=0.64, P=0.08 in the presence of MS). The results of this study indicate an inverse association between type 2 diabetes mellitus and prostate cancer risk.

Cancer treatment-related toxicities often require dose reductions and delays. Herbal medicine use is prevalent among cancer patients. Though evidence is lacking regarding benefits in treatment outcomes and immunity, a large body of evidence supports the use of herbals for reducing treatment-induced toxicities. We present three cases where herbal medicine provided relief from side effects of anti-cancer treatment, enabling the completion of treatment protocols. In the first case, a 79 year-old female patient with metastatic breast cancer developed flushing and excessive sweating from Tamoxifen treatment. Herbal medicine reduced symptoms significantly, enabling the continuation of treatment with partial disease resolution. In the second case, a 69 year-old male with esophageal cancer terminated treatment on the adjuvant treatment protocol because of severe nausea and vomiting, diarrhea, peripheral neuropathy and fatigue. Herbal medicine reduced symptom severity and chemotherapy was reinstituted. In the third case, a 58 year-old female patient with advanced metastatic colon cancer was referred by her oncologist for treatment with herbal medicine for alleviation of fatigue and weakness, flushing and palpitations, mouth ulcers and dyspnea. Despite significant symptom reduction, with completion of treatment regimens, her disease progressed and she subsequently succumbed to the disease. In summary, the above cases illustrate potential benefits of herbal medicine in the reduction of cancer treatment-related symptoms, enabling patients to complete their anti-cancer treatment regimen. Further research examining the efficacy and safety of herbal compounds is needed, in light of potential toxicity and negative interactions with conventional treatment.

e21540Background: Primary caregivers of cancer patients deal with enormous physical and emotional burden without any training or support. Inevitable consequences include impaired individual well-be...

5158 Background: The lifetime risk of an American man developing prostate cancer (PC) is one in six. Metabolic syndrome (MS) is a cluster of medical disorders (hypertension, dyslipidaemia, hyperglycaemia, obesity) associated with the subsequent development of diabetes mellitus (DM). DM and MS afflict 11% and 22% of US adults respectively. MS and DM are associated with disturbed lipid homeostasis, and hypogonadism. DM and MS predispose to the development of gastrointestinal and endometrial cancer. DM and MS's influence on PC is less clear; some studies have suggested that whereas DM inhibits PC, MS promotes PC development. Methods: The Bezafibrate Infarction Prevention study was a randomized trial of fibrate therapy for the secondary prevention of ischemic heart disease. Between 1990–2 15524 men and women with ischemic heart disease were screened, of whom 3090 entered the trial. 81% were male. Participants were divided into three groups according to baseline parameters: (A) those with neither MS nor DM, (B) those with MS but no DM, (C) those with DM (with or without MS). MS was defined according to ATPIII guidelines. DM was defined by medical history or fasting glucose > 125 mg/dL. Follow-up for PC incidence and all-cause mortality was obtained through the Israeli cancer registry and the Ministry of the Interior respectively. Analysis accounts for differences in age and non-cancer-related-mortality between groups. Ethics approval was obtained. Results: 1350 participants were excluded due to missing data or previous cancer diagnosis, leaving 11,541 men. Mean age at enrollment 61 years (45–74). Median follow-up was 12 years. There were 6119 (53%), 3,376 (29%), and 2,046 (18%) participants in groups A, B and C respectively. Overall there were 459 cases of PC; 298, 123 and 48 in groups A, B and C. The age adjusted PC rates were 4.30, 3.61 and 2.55 per 1,000 patient years in groups A, B and C respectively (A vs C p = 0.003). Data were also analyzed examining PC incidence as a function of ‘number of components of MS present’ after pooling groups A, B and C. Relative risk of developing PC was 1.00, 0.92, 0.90, 0.69, 0.71, and 0.33 for 0, 1, 2, 3, 4, and 5 components respectively. Conclusions: A baseline diagnosis of DM (highly significant) or MS (trend) was associated with a decreased prostate cancer rate over the subsequent 12 years. No significant financial relationships to disclose.