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1747 Oral cancer therapy: Nurses and patients perceptions about education
Abstracts 1746 POSTER Oral anticancer agents: Necessity of personalized monitoring of patients S. Falkowski1 , P. Raffy1 , A. Lagarde2 , V. Le Brun-ly1 , L. Venat-bouvet1 , F. Thuillier1 , N. Tubiana-mathieu1 . 1 University Hospital, Medical Oncology, Limoges, France; 2 University Hospital, Pharmacology Department, Limoges, France Background: Alongside the development of oral anticancer agents (OAA), cancer care has been shifted from hospital to home, requiring new organization concepts in oncology departments. The daily use of OAA is a heavy responsibility for many patients because they also have to care side effects and adherence. Various studies have reported on high variability in medication adherence for cancer patients on OAA regimens, adherence rates ranging from less than 20% to 100%. To support patients in following their OAA treatment, we believe that a specific/dedicated monitoring is mandatory. Methods: The specific monitoring that we develop is a multidisciplinary approach involving physicians, nurses and pharmacists. Different tools were developed including relevant documentation; a nurse-initiated telephone call; individual pharmaceutical counseling; and collective therapeutic educational sessions. Over a one-year period, a form summarizing drug use/effect/toxicity was provided to each patient initiating an OAA treatment. A nurse called the patient after 8 days of treatment to complete a survey regarding OAA adherence and side effects. Upon patient request (if any), individual pharmaceutical counseling was proposed after one month of treatment. Additionally dedicated collective therapeutic educational sessions were organized on nutrition, high blood pressure and physical activity. Results: Here we report on an initiation stage of OAA treatment for a cohort of 176 patients. For OAA with complex handlings, 91 patients have answered to a specific questionnaire of one OAA during the nurse-initiated telephone call. For 66 of them, side effects were reported and the patients often presented more than one side effect. Toxicities were grade 1, grade 2 and grade 3 for 48, 28 and 6 patients, respectively. Nurses have provided counseling for 43 patients. No lack of adherence was observed up to Day-8. Fourteen patients have requested individual pharmaceutical counseling. Only 7 patients have participated to three collective therapeutic educational sessions. Conclusion: OAA treatment requires specific and intensive monitoring. A multidisciplinary team is the corner stone to reach quality and safety. Telephonic monitoring appears particularly relevant in terms of efficacy and timing. Nevertheless, to propose optimal and universal monitoring programs still require some developments. No conflict of interest.
Poster Session (Saturday, 26 September − Monday, 28 September) Oncology Nursing − Transitions in Care 1747 POSTER Oral cancer therapy: Nurses and patients perceptions about education D. Valcarenghi1 , C. Pedrazzani1 , M. Bianchi2 . 1 Istituto Oncologico della Svizzera Italiana, Ufficio Sviluppo e Ricerca Infermieristica, Bellinzona, Switzerland; 2 Scuola Universitaria Professionale della Svizzera Italiana, DEASS, Manno, Switzerland Background: The paradigm shift in increasingly providing cancer therapies via an oral route involves new responsibilities for patients and caregivers and new roles for healthcare providers. Patient education is essential in promoting patient safety, adherence and clinical outcomes and nurses play a critical role in this field. This study explores how nurses provide education to patients, receiving oral cancer treatment, and how patients perceive education given by nurses to detect opportunities of clinical practice improvement. Material and Methods: This is a descriptive quantitative and qualitative study. Data have been collected with a semi-structured questionnaire, referring to MOATT® , given to all consenting patients receiving oral cancer treatment from at least one week, in four outpatients departments in Southern Switzerland. Sixteen in-depth interviews with patients and four focus groups with nurses have been done. A statistical analysis has been done for quantitative data while for qualitative ones NVivo 10 software has been used. The study has been approved by the local Ethical Committee. Results: One hundred-forty-two questionnaires have been analysed. Most participants are women (64.8%), have an intermediate instruction level (58.5%) and are assuming oral treatment for 1−6 months (39.4%) or more than an year (38%). The mean age is 65.2 years (±12.3). Most patients
S263 have been informed by both physicians and nurses (81%), alone (33%) or with caregivers (29.6%). Nurses provide information in a private room (40.9%), during the physician visit (23.5%), but also with other patients (18.3%). Language comprehensibility is high in the total population (72%) but lower in elder patients (65.3%) compared to patients <70 years (85%) (p = 0.04) while understanding evaluation is regularly done in 34.8% of all cases. Patients are mainly informed about modality of drug assumption, although less those in hormonal treatment (p = 0.012), and side effects identification and management. As a whole, patients give a good evaluation of education provided by nurses (VNRS: 8.59/10). The interviews data underline and enhance quantitative data with several issues such as the need of safety and the importance of having a reference nurse and of consistency between inter-professional communication. Nurses in focus groups point out issues such as the importance of formal and informal patient assessment to adjust education approach, expertise, training and organizational conditions. Conclusions: Patients in oral treatment are, in a whole, satisfied with education received and perceive there is concordance and integration between physicians and nurses information. Nurses should improve some aspects in setting organization, patient assessment and individualization of education approach. Organizational conditions may also be very important to enhance the nurses role in education. No conflict of interest.
Proffered Paper Session (Saturday, 26 September) Breast Cancer − Advanced Disease 1800 ORAL Final results for overall survival (OS), the primary endpoint of the CECOG TURANDOT prospective randomised trial evaluating bevacizumab–paclitaxel (BEV–PAC) vs BEV–capecitabine (CAP) for HER2-negative locally recurrent/metastatic breast cancer (LR/mBC) C.C. Zielinski1 , I. Lang2 , M. Inbar3 , Z. Kahan4 , R. Greil5 , S. Beslija6 , S.M. Stemmer7 , Z. Zvirbule8 , G.G. Steger1 , B. Melichar9 , T. Pienkowski10 , D. Sirbu11 , L. Petruzelka12 , A. Eniu13 , B. Nisenbaum14 , M. Dank15 , R. Anghel16 , D. Messinger17 , T. Brodowicz1 . 1 Medical University of Vienna, Department of Medicine I and Comprehensive Cancer Center, Vienna, Austria; 2 National Institute of Oncology, Medical Oncology Department, Budapest, Hungary; 3 Tel Aviv Sourasky Medical Center, Medical Oncology Department, Tel Aviv, Israel; 4 University of Szeged, Department of Oncotherapy, Szeged, Hungary; 5 Paracelsus Medical University, Medical Oncology Department, Salzburg, Austria; 6 Institute of Oncology, Medical Oncology Department, Sarajevo, Bosnia-Herzegovina; 7 Rabin Medical Center, Medical Oncology Department, Petah Tikva, Israel; 8 Riga Eastern Clinical University Hospital, Medical Oncology Department, Riga, Latvia; 9 Palacky University, Medical Oncology Department, Olomouc, Czech Republic; 10 Postgraduate Medical Center, Medical Oncology Department, Warsaw, Poland; 11 Oncomed Oncology Practice, Medical Oncology Department, Timisoara, Romania; 12 Charles University Prague, Department of Oncology, First Faculty of Medicine, Prague, Czech Republic; 13 Cancer Institute I Chiricuta, Department of Breast Cancer, Cluj-Napoca, Romania; 14 Meir Medical Center, Medical Oncology Department, Kfar Saba, Israel; 15 Semmelweis University 1st Department of Internal Medicine, Oncology Division, Budapest, Hungary; 16 Institutul Oncologic Bucuresti, Medical Oncology Department, Bucharest, Romania; 17 IST GmbH, Biometrics, Mannheim, Germany Background: The open-label randomised phase III TURANDOT trial aimed to demonstrate non-inferior OS with first-line BEV–CAP vs BEV–PAC for LR/mBC. The interim analysis did not confirm non-inferior OS (stratified hazard ratio [HR] 1.04; 97.5% repeated confidence interval [CI]: −∞ to 1.69) [Lang Lancet Oncol 2013]. Here we report the final OS analysis. Methods: Patients (pts) with HER2-negative LR/mBC who had received no prior chemotherapy for LR/mBC were randomised to either BEV−PAC (BEV 10 mg/kg d1 & 15 + PAC 90 mg/m2 d1, 8 & 15 q4w) or BEV−CAP (BEV 15 mg/kg d1 + CAP 1000 mg/m2 bid d1−14 q3w) until disease progression or unacceptable toxicity. Stratification factors were oestrogen/progesterone receptor (ER/PgR) status, country and menopausal status. The primary objective was to demonstrate non-inferior OS with BEV−CAP vs BEV−PAC in the per-protocol (PP) population by rejecting the null hypothesis of inferiority (HR 1.33) using a stratified Cox proportional hazard model. Sensitivity analyses included unstratified Cox model, intent-to-treat (ITT) and subgroup analyses. Results: At the primary final OS analysis in the PP population after deaths in 183 of 266 pts (69%) in the BEV−PAC arm and 201 of 265 (76%) in the BEV−CAP arm (median OS: 30.2 vs 26.1 months, respectively), the
Poster Session (Saturday, 26 September − Monday, 28 September) Oncology Nursing − Transitions in Care 1747 POSTER Oral cancer therapy: Nurses and patients perceptions about education D. Valcarenghi1 , C. Pedrazzani1 , M. Bianchi2 . 1 Istituto Oncologico della Svizzera Italiana, Ufficio Sviluppo e Ricerca Infermieristica, Bellinzona, Switzerland; 2 Scuola Universitaria Professionale della Svizzera Italiana, DEASS, Manno, Switzerland Background: The paradigm shift in increasingly providing cancer therapies via an oral route involves new responsibilities for patients and caregivers and new roles for healthcare providers. Patient education is essential in promoting patient safety, adherence and clinical outcomes and nurses play a critical role in this field. This study explores how nurses provide education to patients, receiving oral cancer treatment, and how patients perceive education given by nurses to detect opportunities of clinical practice improvement. Material and Methods: This is a descriptive quantitative and qualitative study. Data have been collected with a semi-structured questionnaire, referring to MOATT® , given to all consenting patients receiving oral cancer treatment from at least one week, in four outpatients departments in Southern Switzerland. Sixteen in-depth interviews with patients and four focus groups with nurses have been done. A statistical analysis has been done for quantitative data while for qualitative ones NVivo 10 software has been used. The study has been approved by the local Ethical Committee. Results: One hundred-forty-two questionnaires have been analysed. Most participants are women (64.8%), have an intermediate instruction level (58.5%) and are assuming oral treatment for 1−6 months (39.4%) or more than an year (38%). The mean age is 65.2 years (±12.3). Most patients
S263 have been informed by both physicians and nurses (81%), alone (33%) or with caregivers (29.6%). Nurses provide information in a private room (40.9%), during the physician visit (23.5%), but also with other patients (18.3%). Language comprehensibility is high in the total population (72%) but lower in elder patients (65.3%) compared to patients <70 years (85%) (p = 0.04) while understanding evaluation is regularly done in 34.8% of all cases. Patients are mainly informed about modality of drug assumption, although less those in hormonal treatment (p = 0.012), and side effects identification and management. As a whole, patients give a good evaluation of education provided by nurses (VNRS: 8.59/10). The interviews data underline and enhance quantitative data with several issues such as the need of safety and the importance of having a reference nurse and of consistency between inter-professional communication. Nurses in focus groups point out issues such as the importance of formal and informal patient assessment to adjust education approach, expertise, training and organizational conditions. Conclusions: Patients in oral treatment are, in a whole, satisfied with education received and perceive there is concordance and integration between physicians and nurses information. Nurses should improve some aspects in setting organization, patient assessment and individualization of education approach. Organizational conditions may also be very important to enhance the nurses role in education. No conflict of interest.
Proffered Paper Session (Saturday, 26 September) Breast Cancer − Advanced Disease 1800 ORAL Final results for overall survival (OS), the primary endpoint of the CECOG TURANDOT prospective randomised trial evaluating bevacizumab–paclitaxel (BEV–PAC) vs BEV–capecitabine (CAP) for HER2-negative locally recurrent/metastatic breast cancer (LR/mBC) C.C. Zielinski1 , I. Lang2 , M. Inbar3 , Z. Kahan4 , R. Greil5 , S. Beslija6 , S.M. Stemmer7 , Z. Zvirbule8 , G.G. Steger1 , B. Melichar9 , T. Pienkowski10 , D. Sirbu11 , L. Petruzelka12 , A. Eniu13 , B. Nisenbaum14 , M. Dank15 , R. Anghel16 , D. Messinger17 , T. Brodowicz1 . 1 Medical University of Vienna, Department of Medicine I and Comprehensive Cancer Center, Vienna, Austria; 2 National Institute of Oncology, Medical Oncology Department, Budapest, Hungary; 3 Tel Aviv Sourasky Medical Center, Medical Oncology Department, Tel Aviv, Israel; 4 University of Szeged, Department of Oncotherapy, Szeged, Hungary; 5 Paracelsus Medical University, Medical Oncology Department, Salzburg, Austria; 6 Institute of Oncology, Medical Oncology Department, Sarajevo, Bosnia-Herzegovina; 7 Rabin Medical Center, Medical Oncology Department, Petah Tikva, Israel; 8 Riga Eastern Clinical University Hospital, Medical Oncology Department, Riga, Latvia; 9 Palacky University, Medical Oncology Department, Olomouc, Czech Republic; 10 Postgraduate Medical Center, Medical Oncology Department, Warsaw, Poland; 11 Oncomed Oncology Practice, Medical Oncology Department, Timisoara, Romania; 12 Charles University Prague, Department of Oncology, First Faculty of Medicine, Prague, Czech Republic; 13 Cancer Institute I Chiricuta, Department of Breast Cancer, Cluj-Napoca, Romania; 14 Meir Medical Center, Medical Oncology Department, Kfar Saba, Israel; 15 Semmelweis University 1st Department of Internal Medicine, Oncology Division, Budapest, Hungary; 16 Institutul Oncologic Bucuresti, Medical Oncology Department, Bucharest, Romania; 17 IST GmbH, Biometrics, Mannheim, Germany Background: The open-label randomised phase III TURANDOT trial aimed to demonstrate non-inferior OS with first-line BEV–CAP vs BEV–PAC for LR/mBC. The interim analysis did not confirm non-inferior OS (stratified hazard ratio [HR] 1.04; 97.5% repeated confidence interval [CI]: −∞ to 1.69) [Lang Lancet Oncol 2013]. Here we report the final OS analysis. Methods: Patients (pts) with HER2-negative LR/mBC who had received no prior chemotherapy for LR/mBC were randomised to either BEV−PAC (BEV 10 mg/kg d1 & 15 + PAC 90 mg/m2 d1, 8 & 15 q4w) or BEV−CAP (BEV 15 mg/kg d1 + CAP 1000 mg/m2 bid d1−14 q3w) until disease progression or unacceptable toxicity. Stratification factors were oestrogen/progesterone receptor (ER/PgR) status, country and menopausal status. The primary objective was to demonstrate non-inferior OS with BEV−CAP vs BEV−PAC in the per-protocol (PP) population by rejecting the null hypothesis of inferiority (HR 1.33) using a stratified Cox proportional hazard model. Sensitivity analyses included unstratified Cox model, intent-to-treat (ITT) and subgroup analyses. Results: At the primary final OS analysis in the PP population after deaths in 183 of 266 pts (69%) in the BEV−PAC arm and 201 of 265 (76%) in the BEV−CAP arm (median OS: 30.2 vs 26.1 months, respectively), the