BACKGROUND:Oncology involves complex care and multidisciplinary management of patients; however, misinformation and ineffective communication remain problematic.OBJECTIVE:The educational objective of our study was to develop a new teaching method to improve cancer treatment and management by emphasizing the link between hospitals (inpatients) and their surrounding communities (outpatients).METHODS:A team of 22 professionals from public and private institutions developed a small private online course (SPOC). Each offering of the course lasted 6 weeks and covered 6 topics: individual health care plans, cancer surgery, ionizing radiation, cancer medicines, clinical research, and oncological supportive care. For participants in the course, we targeted people working in the cancer field. The SPOC used an active teaching method with collaborative and multidisciplinary learning. A final examination was offered in each session. We evaluated participants' satisfaction rate through a questionnaire and the success of the SPOC by participants' completion, success, and commitment rates.RESULTS:Of the total participants (N=1574), 446 completed the evaluation form. Most participants were aged 31 to 45 years. Participants included 56 nurses, 131 pharmacists, 80 from the medical field (including 26 physicians), 53 from patients' associations, 28 health teachers, and 13 students (medical and paramedical). Among the participants, 24.7% (90/446) had an independent medical practice, 38.5% (140/446) worked in a public institution, and 36.8% (134/446) worked in a private institution. After completing the SPOC sessions, 85.9% (384/446) thought they had learned new information, 90.8% (405/446) felt their expectations were met, and 90.4% (403/446) considered that the information had a positive impact on their professional practice. The completion rate was 35.51% (559/1574), the success rate was 71.47% (1025/1574), and the commitment rate was 64.67% (1018/1574). Concerning the cost effectiveness of SPOC compared with a traditional classroom of 25 students, online education became more effective when there were more than 950 participants.CONCLUSIONS:SPOCs improved the management of oncology patients. This new digital learning technique is an attractive concept to integrate into teaching practice. It offered optimal propagation of information and met the students' expectations.

This report describes the results of an observational, retrospective cohort study, evaluating the use of iron sucrose (IS) and red blood cell (RBC) transfusions in patients with cancer in routine clinical practice in France. A parallel investigated cohort treated with ferric carboxymaltose (FCM) has been reported earlier.

Purpose This study collected data on the use of ferric carboxymaltose (FCM) in a cancer patient population in France to evaluate the feasibility and the conditions of use of FCM in routine clinical practice beyond the limiting criteria of clinical trials. Methods This observational, prospective study of patients with a solid tumour or a haematological malignancy who have received treatment with FCM after 01 July 2011 evaluated data about the circumstances of iron administration, concomitant medication and laboratory tests in the period from 3 months prior to the first FCM administration (baseline) until 3 months post-baseline. Results Data from 367 FCM-treated patients were analysed. FCM was mainly given as a single dose at baseline (69.2 %) and without additional erythropoiesis-stimulating agent (ESA, 64.3 %). The median total iron dose was 1000 mg per patient. Median haemoglobin (Hb) levels of FCM-treated patients improved from 10.3 g/dL (interquartile range 9.5, 11.1 g/dL) at baseline to 11.8 g/dL (11.1, 13.0 g/dL) until the end of the 3-month observational period. Patients treated with FCM alone or additional ESA achieved similar median Hb increase (1.3 [0.4, 2.1] g/dL and 1.4 [0.4, 2.5] g/dL, respectively). Patients with baseline Hb up to 11.0 g/dL and serum ferritin up to 500 ng/mL and beyond achieved stable median Hb levels ≥11.0 g/dL without signs of iron overload. No severe or serious adverse reaction and no hypersensitivity reactions were reported. Conclusions The results of this observational study confirm the effectiveness and tolerability of FCM when given in clinical routine practice alone or in combination with an ESA.

202 Background: The medical doctor's (MD) perspective of supportive care in cancer (SCC) in France was previously assessed on a national survey. However, the opinion of patients (P) has never been evaluated nor compared to MD’s perception.Wepromoted and compared P and MD awareness via national surveys to monitor implementation and information delivered to patients on SCC. Methods: The French Speaking Association for SCC (AFSOS) conducted two observational studies, analyzed with a Chi2 test: S1: a 30 points questionnaire sent to 2,263 physicians caring for cancer P (oncologists, radiotherapists, haematologists, gastroenterologists); and S2: a 40 points questionnaire performed by physicians to P, using a face-to-face method. Results: 711 MDs returned S1 and S2 was conducted with 1,562 P. In S1, MDs declared relying on SCC organization (81%) but 19% of P declared they were offered to benefit from an organization called SCC (54% at diagnosis, 35% after complication). The name SCC was known by 34% of P, most frequently described as complementary care to specific treatments (55%). Palliative Care word had been previously heard by 80% P, mostly considered as care to improve quality of life during cancer treatment for 59%. In S2, professional resources identified outside the hospital were: general practitioners (84%), nurses (58%), pharmacists (52%). According to P, the top 3 supportive care consultations proposed were psychology (61%), nutrition (55%) and announcement organization (55%), while MDs mentioned palliative care (98%), psychological care (98%), social care (98%), S2 showed that supportive treatment was prescribed to 63% of P, mostly by their oncologist (74%), and 64% of those P received information on side-effects. Epoetin was prescribed to 25% and analgesics to 73%, with discussion on adverse events respectively for 38% and 53%. MDs declared delivering information on adverse events to 49% of P receiving epoetin and to 74% of P running for analgesic treatment. Conclusions: Oncologist is the cornerstone of SCC organization. Information as well as treatment must be developed to further enhance SCC and patient quality of care.

Aim: The Medical Doctor's (MD) perspective of supportive care in cancer (SCC) in France was previously assessed on a national survey. However, the opinion of patients (P) has never been evaluated nor compared to MD's perception. We promoted and compared P and MD awareness via national surveys to monitor implementation and information delivered to patients on SCC.

e20654 Background: Iron deficiency with anemia is a frequent complication in cancer.Ferric carboxymaltose (FCM) is approved for the correction of iron deficiency in France since the beginning of 2011. This observational multicenter study has recruited 2 cohorts of patients to describe FCM use in daily practice for patients with hematological malignancies or solid tumors. Methods: Cohort 1 (retrospective): 450 patients treated in 2010 with any intravenous (IV) iron or red blood cell transfusion (BT); Cohort 2 (prospective): 450 patients treated with FCM after July 1, 2011. Patient characteristics are collected for 3 months pre and post intervention. Recruitment of the 810 patients has been completed. Results: Outcomes of the first 100 patients are described below. The majority of patients receiving FCM had metastatic solid tumors and received just under 1000 mg iron. Hematological malignancies were only included in BT cohort. Results are detailed below. Number of patients at baseline with serum ferritin (SF) level and TSAT are 10 and 7 respectively in cohort 1 and 28 and 26 respectively in cohort 2, therefore the reason for initiating FCM appeared to be based predominately on Hb level. Functional iron deficiency was present in 85% where TSAT and ferritin were measured. No related serious adverse events were reported for the IV iron preparations. Conclusions: FCM was well tolerated and seemed effective in treating iron deficiency anemia. Administration was usually delivered at home with fewer infusions required for FCM compared to iron sucrose. These interim results need to be confirmed in the final analysis. [Table: see text]

The concentration of the progesterone receptor (PR), both cytosol and nuclear, has been measured in the endometrium of 31 normal menstruating women during the 2 phases of their menstrual cycle and compared with the plasma 17 beta-estradiol and progesterone concentrations. There was no relationship between PR concentrations and the plasma steroid levels when the 2 phases of the cycle were considered; however, a statistically significant correlation (r = 0.70; P less than 0.005) was observed between PR concentration and plasma 17 beta-estradiol when only the follicular phase was considered. PR was then measured in the endometrium of 14 postmenopausal patients treated with ethinylestradiol at increasing doses with or without association of chlormadinone acetate. Ethinylestradiol was shown to increase PR concentration (P less than 0.05), and chlormadinone acetate was found to prevent this increase. These data suggest that in humans, as in other mammalian species, the endometrial PR concentration is under estrogen and progestin control.The respective roles of estrogens and progestins on endometrial progesterone receptors (PRs) were evaluated in 16 proliferative-phase and 15 secretory-phase biopsy samples from normally menstruating women. Plasma estradiol-17-beta and progesterone were measured in both cytosol and nuclear extracts. In addition PRs were measured in biopsied tissue taken from 14 postmenopausal women who had been treated with increasing doses of ethinylestradiol (with or without chlormadinone acetate) who presented with breast cancer. Among the normally menstruating women, there were no relationships between PR concentrations and plasma steroid levels when both phases of the cycle were considered; however, a correlation of significance (P .005) was apparent between PR concentration and plasma 17-beta-estradiol when only the follicular stage was considered. In the postmenopausal women who were under treatment, ethinylestradiol administration seemed to increase PR concentration (P ,05), whereas concomitant treatment with chlorimadinone acetate blocked this increase. Therefore, mammals seem to have endometrial PR levels controlled by both estrogens and progestins.

e19640 Background: Second Cancer Act was defined in France in December 2009 including enhancement of supportive care in Cancer (SCC). How are supportive care organized in France? Are patients informed about supportive treatment side effects? Methods: The AFSOS (French Speaking Association for Supportive Care in Cancer) conducted this observational study to evaluate practices, organizations and informations given to patients (pts) about SCC. Among 1621 french medical doctors (MD) caring cancer pts who were sent an adhoc questionnaire, 20% (330 MD including 44% medical oncologists) answered. Results: Three different organizations were described: Single MD, transversal team and specific structure specialized in global care (specifically developed in comprehensive cancer centers-CCC). Psycho-oncology, palliative care, nutrition and pain care were the four main items considered as supportive care. During their disease, 68% of pts are receiving SCC, presented by their MD (88%) or nurse devoted to announcement of disease and SCC information (57%). Supportive care is more dispensed during palliative period (90%) than at diagnosis (44%). Patients information is rather supplied during palliative care (85%) than at diagnosis (52%) using a specific questionnaire for outpatient (20%) or specific supportive care session (17%). 71% of cancer department have a cross team to provide supportive care, with specific SCC team particularly in CCC (62%; p=0.01)). 37% have inpatient specific units. Only 40% have a specific organization in home care connection, more in CCC than in public or private centers (respectively 69%, 45%, 20%; p=0.01). 73% use specific financial valorization of CSC activity. Adverse events information is dispensed to 54% of the pts for erythropoiesis stimulating agents (ASE), 74% for biphosphonates and 94% for opioids treatments, rather by medical oncologist than other specialists (p=0.01). Conclusions: Specific organization developed especially in comprehensive cancer centers seems to facilitate SCC organization and information to pts. In the mean time, recommendations include this information, involvement in supportive care team and methods have to be enhanced. Further results compared with patient point of views are expected.

BACKGROUND:Supportive care in cancer (SCC) was further enhanced in the Second National Cancer Act decreed in December 2009. The aim of our study was to assess current SCC efficacy. PATIENTS AND METHODS:The French speaking association for supportive care in cancer (AFSOS) conducted an observational study to evaluate practices, organisations and information given to patients. A specific 32 point questionnaire was sent to 1621 French physicians (MDs) caring for cancer patients. RESULTS:Three different organisations were evaluated: the individual MDs, the transversal team and its particular structure specialised in global patient care specifically developed at comprehensive cancer centres - CCC. During their disease, 68% of patients received SCC, which was more available during the palliative period (90%) than at the diagnosis (44%). Our results found that 71% of cancer departments had a specific interdisciplinary cross-team to provide SCC, particularly in CCC (62%; p=0.01) while 37% had specific inpatient units. A specific organisation dedicated to home care was greater in CCC than in public or private centres (69%, 45%, 20% respectively; p=0.01). Adverse event information was performed more by an oncologist than other specialists (p=0.01). CONCLUSION:Our results suggest that the specific SCC organisation could be a useful management tool to improve supportive care for cancer patients.

OBJECTIVE:To evaluate the economic impact of intravenous iron (in the form of intravenous iron preparation of ferric carboxymaltose) in three different clinical settings of iron deficiency anemia: chemotherapy-induced anemia in breast cancer, chemotherapy-induced anemia in digestive cancer, and perioperative anemia in knee and hip surgery.METHODS:The economic model compared the usual therapeutic strategies of anemia without intravenous iron and strategies including intravenous iron, in each of the three clinical settings selected. Costs related to anemia treatment by erythropoiesis-stimulating agents (ESA), blood transfusion, and intravenous iron were estimated and compared inside each setting. Cost savings were calculated from the French healthcare payer perspective. Data included in the economic model were obtained from scientific literature, public health agencies, and medical experts.RESULTS:The most prominent annual cost savings were observed in chemotherapy-induced anemia in breast cancer (€997 and €360 per patient for metastatic and non-metastatic breast cancers, respectively; global cost saving, €33.6 million). This large impact of intravenous iron on costs was mainly explained by both a lower number of women treated and lower ESA dosing. Mean annual cost saving in digestive cancers and knee and hip surgery were estimated to €168 and €216 per patient and global cost savings of €7.5 and €12.1 million, respectively. Overall, annual cost savings in these three settings were estimated to €53 million including €39 million for ESA cost savings. Sensitivity analysis showed that strategies including intravenous iron remained cost-effective even with wide variations in the assumptions, particularly for cost savings on ESA.LIMITATIONS:Economic model based on literature data and expert opinions.CONCLUSIONS:The present economic model suggests that use of intravenous iron, according to recommendations of international guidelines, is cost saving, particularly in chemotherapy-induced anemia in breast cancers.

Objective: To describe the management of anaemia in 2009-2010 in France in patients with haematological malignancies (HM) or solid tumours (ST).Methods: Retrospective observational study in 57 centres, enrolling adult patients with HM or ST treated for an episode of anaemia (duration of the episode >= 3 months occurring in the last 12 months).Results: 220 patients with ST (breast, 18%; lung, 18%) and 56 with HM (lymphoma, 60%) were included (median age, 68 years; female, 53%). Mean haemoglobin level at anaemia diagnosis was 9.3 +/- 1.4 g/dL (<8 g/dL for 16%) and 9.8 +/- 1.1 g/dL (<8 g/dL for 6%) in HM and ST patients, respectively. At least one parameter of iron deficiency (ferritin, transferrin saturation) was assessed in 26% of HM and 19% of ST patients. Treatment of anaemia included erythropoiesis-stimulating agents (ESA) for 98% of HM and 89% of ST patients. Iron was prescribed to 14% (oral, 12%; intravenous, 2%) of HM patients and to 42% (oral, 17%; intravenous, 25%) of ST patients. The rates of blood transfusions were high: 70% in HM and 46% in ST patients; transfusions alone or administrated with ESA were more frequent in patients with Hb <8 g/dL.Conclusion: Although recent guidelines recommend evaluating iron deficiency and correcting anaemia by using intravenous iron, our study in cancer patients evidenced that ESA and blood transfusions are still frequently used as the treatment of anaemia in cancer patients. Iron deficiency is insufficiently assessed (only one patient among five) and as a consequence iron deficiency is most likely insufficiently treated. (C) 2011 Elsevier Ltd. All rights reserved.

Objectives: This study investigated the effect of capecitabine-oxaliplatin (XELOX) on functional independence in patients aged >= 70 years with histologically proven metastatic colorectal cancer (mCRC).Materials and methods: Patients received capecitabine 750 mg/m(2) bid d1-14+oxaliplatin 90 mg/m(2) d1, every 3 weeks; doses were increased to 1000 and 120 mg/m(2,) respectively, in the absence of significant toxicity. The primary endpoint was stabilization/improvement of Katz Activities of Daily Living (ADL) scale.Results: Sixty patients were enrolled. ADL was stabilized/improved in 36/40 patients (90%) after 3 cycle, and in 25/27 patients (93%) after 6 cycles. Capecitabine and oxaliplatin doses were increased in 31% of patients. The objective response rate was 37% (1 complete and 21 68%, grade 3/4 in 2%), and grade 3/4 anemia (7%).Conclusion: This study demonstrates the feasibility of XELOX in elderly mCRC patients, with no impairment of independence among patients who remained on therapy. (C) 2010 Elsevier Ltd. All rights reserved.

In this randomized, double-blind, placebo-controlled study comparing gemcitabine+tipifarnib (G+t) or gemcitabine+placebo (G+p) in patients with pancreatic cancer, the primary endpoint of time to deterioration (TTD) was based primarily on patient-reported outcomes. Deterioration was defined as death or worsening of disease-related symptoms, based on patient-reported outcomes of pain intensity and analgesic use in a daily diary, plus investigator-rated weekly performance status. Secondary endpoints included survival and safety. Two hundred and forty-four patients were treated for a total of 4780 weeks, during which the diary was completed daily. Overall, the completion of the diary was found to be feasible: patients completed approximately 95% of scheduled diary entries. Baseline characteristics were well balanced between the two treatment arms. The primary endpoint of TTD was not significantly different between the G+t arm (69 days) and the G+p arm (91 days, P=0.40). Survival was not significantly different between the G+t arm (202 days) and the G+p arm (221 days, P=0.66). The combination of G+t had an acceptable toxicity profile, with primarily neutropenia and thrombocytopenia. Methodologically, measurement of patient-reported outcomes is feasible and useful in assessing the effect of anti-cancer therapy in pancreatic cancer if comprehensive initial and ongoing training is provided to all people involved, including not only the patients but also the study personnel.

BACKGROUND:Vinorelbine (VRL)-cisplatin (CDDP) is an active doublet for advanced non-small cell lung cancer. CDDP has a narrow therapeutic index and may produce a cumulative nephrotoxicity over the treatment period. This study was to assess the risks of drug-drug interaction (DDI) over 3 consecutive cycles of VRL-CDDP combined treatments.PATIENTS AND METHODS:An open-label, nonrandomised, phase I study was carried out. Patients with normal hepatic/renal functions. D1: CDDP 100 mg/m2--D1, D8: oral VRL 60 mg/m2 q3w. Pharmacokinetics (PK) over the first 3 cycles. PK comparison between cycles and between study vs. literature.RESULTS:Thirteen patients were evaluable for safety and PK. Adverse events were those frequently observed with CDDP or VRL, and consisted of hematological toxicities, nausea, vomiting and constipation. Concerning VRL and CDDP PK, no difference was detected between the 3 administrations nor between the study and reference values.CONCLUSION:The absence of DDI between CDDP and oral VRL was demonstrated over 3 consecutive cycles of therapy.

BACKGROUND:This multicenter adjuvant phase III trial evaluated the addition of irinotecan to LV5FU2 in colon cancer patients at high risk of relapse. PATIENTS AND METHODS:A total of 400 patients with histologically proven primary colon cancer with postoperative N1 detected by occlusion/perforation or N2 were randomised to: A-LV5FU2 [leucovorin 200 mg/m(2), 2-h infusion, 5-fluorouracil (5-FU) 400 mg/m(2) bolus, 600 mg/m(2) 22-h continuous infusion, days 1 and 2] or B-LV5FU2 + IRI (irinotecan 180 mg/m(2) 90-min infusion day 1 + LV5FU2) fortnightly for 12 cycles. Primary end point was disease-free survival (DFS). RESULTS:Median follow-up was 63 months. Significantly more T4 tumours and 15 or more positive lymph nodes were observed in arm B. 5-FU relative dose intensity (RDI) was >0.80 for 94% and 77% in arms A and B, respectively (P < 0.001). Irinotecan RDI was >0.80 for 70% patients. There were more grades 3 and 4 neutropenia in arm B (4% versus 28%, P < 0.001). The 3-year DFS was 60% [95% confidence interval (CI) 53% to 66%] and 51% (95% CI 44% to 58) in arms A and B, respectively. No difference was observed [hazard ratio (HR) = 1.12, 95% CI 0.85-1.47, P = 0.42] even when adjusted for prognostic factors (adjusted HR = 0.98, 95% CI 0.74-1.31, P = 0.92). The 5-year overall survival (OS) was 67% (95% CI 59% to 73%) and 61% (95% CI 53% to 67%) in arms A and B, respectively. CONCLUSION:Adjuvant LV5FU2 + IRI compared with LV5FU2 alone in patients at high risk of relapse showed no improvement in DFS and OS.

A phase III randomised trial of LV5FU2 1 irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802) M. Ychou*, J.-L. Raoul, J.-Y. Douillard, S. Gourgou-Bourgade, R. Bugat, L. Mineur, F. Viret, Y. Becouarn, O. Bouché, E. Gamelin, M. Ducreux, T. Conroy, J.-F. Seitz, L. Bedenne & A. Kramar CRLC Val d’Aurelle, Montpellier; CRLC Eugène Marquis, Rennes, France and European University in Brittany; CRLC René Gauducheau, St Herblain; CRLC Claudius Régaud, Toulouse; Clinique Sainte Catherine, Avignon; CRLC Antoine Lacassagne, Nice; Institut Bergonié, Bordeaux; CH R. Debré, Reims; CRLC Paul Papin, Angers; Institut Gustave Roussy, Villejuif; CRLC Alexis Vautrin, Vandoeuvre-les-Nancy; CH La Timone, Marseille; CHU du Bocage, Dijon, France

Purpose The quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented. Methods Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling. Results A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months ( P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale ( P = 0.024), nausea\vomiting ( P = 0.001) and EQ-5D thermometer ( P = 0.020) in favour of the IF treatment arm. Conclusion There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.