- Email: [email protected]
Erectile dysfunction in patients with metastatic renal cell carcinoma
abstracts
Annals of Oncology Conclusions: Letrozole co-administration during COS resulted to be as effective as standard COS but with significantly decreased peak estradiol levels, suggesting its increased safety especially for hormone-sensitive cancer patients. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy
Background: Data on the long-term effects of prenatal exposure to maternal cancer and its treatment on child development are scarce. Methods: In a multicentre cohort study, the neurologic and cardiac outcomes of 6year-old children born to women diagnosed with cancer during pregnancy (study group) were compared to the outcome of children born after an uncomplicated pregnancy (control group) (ClinicalTrials.gov, NCT00330447). Neurodevelopment was assessed by clinical evaluation and neuropsychological testing (including intelligence, attention and memory tests) and by general health and behaviour questionnaires. Cardiac evaluation included electro- and echocardiography. Results: In total, 132 study children and 132 controls (mean age 6.2 years) were included. In the study group, 97 children (73.5%) were prenatally exposed to chemotherapy (alone or in combination with other treatments), 14 (10.6%) to radiotherapy (alone or in combination), 1 (0.8%) to trastuzumab, 12 (9.1%) to surgery alone and 16 (12.1%) to no treatment. Although within normal ranges, the mean Verbal IQ score was significantly lower in the study versus control group (98.9 vs 103.0, p ¼ 0.001, q < 0.001). Also, children in the study group had a significantly lower score for visuospatial long-term memory compared to the control group (3.9 vs 4.5, p ¼ 0.005, q ¼ 0.043). No significant differences were found in Full Scale IQ, Performance IQ, Processing Speed, memory span, verbal and visuospatial short-term memory, attention and behaviour problems or in cardiac dimensions and left ventricular function. Conclusions: Children prenatally exposed to maternal cancer and its treatment may be at risk for lower Verbal IQ and visuospatial long-term memory scores, but other cognitive functions and cardiac outcomes were normal at the age of 6 years. Clinical trial identification: NCT00330447. Legal entity responsible for the study: University Hospitals Leuven, Belgium. Funding: European Union’s Horizon 2020 research and innovation programme under grant agreement No. 647047, Research Foundation-Flanders (F.W.O)., Stichting tegen Kanker, Belgian Cancer Plan, Koningin Wilhemina Fonds (K.W.F.), Kom Op Tegen Kanker, Stichting Mitialto and Charles University grant Progres Q-34. Disclosure: All authors have declared no conflicts of interest.
Update of the registry of young women with cancer by the International Network of Cancer, Infertility and Pregnancy
C. Maggen1, K. Van Calsteren2, E. Cardonick3, R.G. Shmakov4, M. Gziri5, A.C. Garcia6, R. Fruscio7, C.A.R. Lok8, M. Halaska9, I.A. Boere10, P. Zola11, P. Ottevanger12, C.J.M. de Groot13, G. Scarfone14, M. Fumagalli15, R.C. Painter16, J. de Haan13, F. Amant8 1 Obstetrics and Gynecology, University Hospitals Leuven and Department of Oncology, KU Leuven, Leuven, Belgium, 2Obstetrics and Gynecology, University Hospitals Leuven and Department of Development and Regeneration, KU Leuven, Leuven, Belgium, 3 Obstetrics and Gynecology, Cooper University Hospital, Philadelphia, PA, USA, 4 Academician V.I.Kulakov of the Ministry of Healthcare of Russian Federation, National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russian Federation, 5Obstetrics, Cliniques Universitaires St Luc, Brussels, Belgium, 6Oncology, Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), Mexico City, Mexico, 7 Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy, 8Department of Gynecologic Oncology, Antoni Van Leeuwenhoek Hospital – The Netherlands Cancer Institute, Amsterdam, Netherlands, 9Obstetrics and Gynecology, Third Medical Faculty Charles University and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic, 10Medical Oncology Department, Erasmus University Medical Center, Rotterdam, Netherlands, 11Department of Surgical Sciences, University of Turin, Turin, Italy, 12Internal Medicine, Radboud UMC Nijmegen, Nijmegen, Netherlands, 13 Obstetrics and Gynecology, Amsterdam UMC, VU University Medical Center, Amsterdam, Netherlands, 14Obstetrics and Gynecology, Department of Ob-Gyn University of Milan, Milan, Italy, 15Neonatal Intensive Care Unit and Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, 16Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, Netherlands Background: The International Network of Cancer, Infertility and Pregnancy was launched in order to register women of reproductive age with a cancer diagnosis. Over the years, the project has expanded with currently 2653 cases registered by 114 centres and an annual registration rate of 150 patients. The expected rising numbers of cancer diagnosis during pregnancy as a result of an increased age at first childbirth and the possibility of early cancer detection by the non-invasive prenatal testing calls for an ongoing evaluation of clinical practice. Moreover, women might become pregnant while exposed to adjuvant or maintenance therapies that are increasingly being used. Methods: The INCIP database consists of a secured on-line registration tool. Oncological, obstetric and neonatal data are registered by members. Annual scientific meetings give updates on the ongoing research projects. Results: Most patients were registered in Belgium, the Netherlands, Italy and USA and one third of participating centres are non-European. Currently 2059 patients with a cancer diagnosis or treatment during pregnancy are registered, 395 women that received fertility preservation and 199 patients with a postnatal cancer diagnosis (Figure 1). Breast cancer, lymphoma and cervical cancer are the most frequent registered cancer types and the majority of patients (67%) received antenatal cancer treatment (Figure 2). Most women delivered a live born baby (88%), however 47% delivered preterm and 80% of preterm deliveries were medically induced. One-fifth of neonates (21%) were small for gestational age. Congenital malformations were reported in 3% of live births. Conclusions: Cancer occurring in women endangers obstetrical and neonatal outcome and potentially future fertility. The INCIP registry is open for further collection of data since for such a relatively rare situation, only a large-scale project will provide better insights on maternal and foetal risks assessment, which is essential for optimal patient counselling and care. Clinical trial identification: NCT00330447. Legal entity responsible for the study: The authors. Funding: European Union’s Horizon 2020 research and innovation program under grant agreement No 647047. Disclosure: All authors have declared no conflicts of interest.
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Erectile dysfunction in patients with metastatic renal cell carcinoma
I. Tsimafeyeu1, R. Zukov2, L. Demidov3, P. Borisov4, V. Kuznetsov5, V. Leonenko5, A. Bondarenko6, K. Zakurdaeva7, Y. Tishova8 1 Moscow Office, Kidney Cancer Research Bureau, Moscow, Russian Federation, 2Dept. of Oncourology, A.I. Kryzhanovsky Krasnoyarsk Cancer Center, Krasnoyarsk, Russian Federation, 3Dept. of Biotherapy, N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation, 4Outpatient Department, City Clinical Oncology Center, St. Petersburg, Russian Federation, 5Tuchkovo Branch, Stolichnaya Diagnostica Clinic, Tuchkovo, Russian Federation, 6Dept. of Internal Medicine, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation, 7 Oncology Department, RakFond, Moscow, Russian Federation, 8Dept. of Endocrinology, RUDN University, Moscow, Russian Federation Background: Metastatic renal cell carcinoma (mRCC) can cause sexual dysfunction as an adverse effect in male patients. Erectile dysfunction (ED) can also result from adverse effects of targeted therapy of mRCC, such as fatigue, pain, anorexia, asthenia or hypothyroidism. The objective of the study was to evaluate the rate of ED in a male population with mRCC.
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T. Vandenbroucke1, M. Verheecke1, M. van Gerwen2, K. Van Calsteren3, M. Halaska4, M. Fumagalli5, R. Fruscio6, M. Veening7, L. Lagae8, P. Ottevanger9, J-U. Voigt10, J. de Haan11, M. Gziri12, A. Gandhi13, C. Maggen1, L. Mertens14, G. Naulaers15, L. Claes13, F. Amant16 1 Obstetrics and Gynecology, University Hospitals Leuven and Department of Oncology, KU Leuven, Leuven, Belgium, 2Center for Gynecologic Oncology, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, 3 Obstetrics and Gynecology, University Hospitals Leuven and Department of Development and Regeneration, KU Leuven, Leuven, Belgium, 4Obstetrics and Gynecology, Third Medical Faculty Charles University and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic, 5Neonatal Intensive Care Unit and Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, 6Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy, 7Pediatric Oncology, Princess Maxima Center for Pediatric Oncology, Utrecht, Netherlands, 8Pediatrics, University Hospitals Leuven, Leuven, Belgium, 9Internal Medicine, Radboud UMC Nijmegen, Nijmegen, Netherlands, 10Cardiology, University Hospitals Leuven, Leuven, Belgium, 11Obstetrics and Gynecology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, Netherlands, 12Obstetrics, Cliniques Universitaires St Luc, Brussels, Belgium, 13Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium, 14Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada, 15Neonatology, University Hospitals Leuven, Leuven, Belgium, 16 Department of Gynecologic Oncology, Antoni Van Leeuwenhoek Hospital – The Netherlands Cancer Institute, Amsterdam, Netherlands
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abstracts
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Exercise level, interest and preferences in cancer patients
A. Avancini1, V.M. Pala2, V. Krogh2, S. Sieri2, L. Mariani2, D. Tregnago3, G. Sartori4, I. Trestini3, E. Bria5, M. Milella4, M. Lanza6, S. Pilotto4 1 Biomedical Sciences, Department of Medicine, University of Verona Hospital Trust, Verona, Italy, 2Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, 3Medical Oncology, University of Verona Hospital Trust, Verona, Italy, 4Department of Oncology, University of Verona Hospital Trust, Verona, Italy, 5 Fondazione Policlinico Agostino Gemelli IRCCS, Universit a Cattolica del Sacro Cuore, Rome, Italy, 6Biomedicine and Movement Sciences, University of Verona Hospital Trust, Verona, Italy Background: After a cancer diagnosis, exercise (EX) has shown to reduce risk of recurrence/mortality, help in managing cancer treatment side effects and maintain functional abilities. Nevertheless, most of cancer patients are insufficiently active. The purpose of this research is to investigate the EX level, interest and preference in oncological patients. Methods: A self-administered questionnaire was used to collect demographic, health and EX information. EX level was assessed by leisure score index (LSI), using the validated Godin’s Leisure Time Exercise Questionnaire, while the EX preferences questions were drawn from previous studies. Patients from Medical Oncology Unit of Verona Hospital were asked to anonymously complete the questionnaire. Descriptive statistic was used to calculate frequencies and percentages of responses to survey questions. Results: With a 57% of response rate, a total of 405 survey were completed and analyzed. Breast (26%) and upper gastrointestinal (42%) were the most frequent diagnosis. Only 10% of patients resulted to be sufficiently active (LSI24). A large majority (80%) indicated that they are willing to participate in an EX program designed for cancer patients. Patients reported that they prefer receive EX information by an oncologist (57%) followed by physiotherapist (29%), with a face to face approach (71%). The preferred composition of EX group was with “other cancer patients” (27%). The patients chose outdoors (27%) and a fitness center for adapted physical activity (21%) as favorite places to perform EX. Training in group was preferred (39%), followed by an individual program to perform at home (27%) and an individual program with a personal trainer (25%). The majority preferred a supervised Ex program (57%). The favorite EX frequencies were two times/week (37%) and three times/week (30%), whereas “mild” intensity was chosen by 44% of patients followed by “moderate” (36%). Conclusions: Despite the demonstrated benefits of EX in oncological patients, we found 90% of them insufficiently active, but 80% willing to start an EX program. According to these data, we designed a prospective clinical trial including dedicated EX programs based on patient’s preferences, currently recruiting. Legal entity responsible for the study: University of Verona. Funding: Has not received any funding. Disclosure: E. Bria: Honoraria (self): MSD, AstraZeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis, and Roche; Research grant / Funding (self): AIRC. S. Pilotto: Honoraria (self): AstraZeneca, BMS, Roche, MSD, Boeringher Ingelheim; Research grant / Funding (self): AIRC; Travel / Accommodation / Expenses: BMS, Roche, AstraZeneca, Boehringer Ingelheim. All other authors have declared no conflicts of interest.
v744 | Supportive Care
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Filling the gaps in informed consent for advanced cancer patients considering phase I oncology trials: An in-depth qualitative study of key stakeholders at a large United Kingdom phase I unit
A. Pal1, S. Stapleton2, J. Lopez1 Drug Development Unit, The Royal Marsden Foundation Trust and The Institute of Cancer Research, London, UK, 2Drug Development Unit, The Royal Marsden Foundation Trust, London, UK
1
Background: Extensive research has demonstrated that patients considering early phase oncology trials do not appreciate the design or purpose of these trials and also harbour unrealistic expectations of the personal benefit they can expect from the trial. There have been few interventional studies examining the informed consent process in this setting and they have shown limited effectiveness. We aimed to use a qualitative methodology to understand the perspectives of key stakeholders and identify the areas of need and the potential opportunities for an intervention to improve our informed consent processes. Methods: We used an experience-based co-design framework which consisted of a semi-structured interview script of ten key questions. Two trained interviewers performed interviews of three consultant medical oncologists, nine clinical fellows, two study managers, two clinical nurse specialists, two focus groups with four patients each and two regulatory officers. We also interviewed four members of our investigator-initiated sponsor team to obtain an understanding of the sponsor perspective. All audio interviews were transcribed, and thematic analysis was performed on the narrative text to extract core themes. Results: Consistent themes raised by participants included 1. The core elements that participants need to comprehend prior to consenting are that trials are experiments and not treatment, the low prospect of benefit, potential toxicity and the significant time commitment. 2. Participant information sheets (PIS) are too long, too complex and the information is not provided in a patient centred manner. Sponsors were in strong support of shorter and more accessible PIS. 3. Digital media would be acceptable and useful but to be mindful of subgroups of patients who are not as comfortable with digital media. Conclusions: There is widespread understanding that improvement is required in the length, design and style of participant information sheets for phase 1 oncology trials. Furthermore, digital media would be acceptable to all stakeholders but its development will require ongoing stakeholder engagement to ensure user acceptability. Legal entity responsible for the study: Drug Development Unit - Royal Marsden Hospital, Sutton. Funding: Cancer Research UK (CRUK), Experimental Cancer Medicine Centres (ECMC), National Institute of Health Research (NIHR) Royal Marsden Biomedical Research Centre. Disclosure: J. Lopez: Advisory / Consultancy: Genmab; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Basilea; Travel / Accommodation / Expenses: Basilea; Travel / Accommodation / Expenses: Roche/Genentech. All other authors have declared no conflicts of interest.
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Breast cancer patients’ quality of life: Real-world data
T. Kosmidis, B. Athanasakou, P.A. Kosmidis Research Department, Care Across Ltd, London, UK Background: CareAcross is a digital platform dedicated to support, inform and engage with cancer patients. It also collects medical and other data, and generates real world evidence. Methods: In an effort to collect and analyze information from breast cancer patients regarding side effects in relation to their treatments and supplements intake, we contacted 5373 patients in the UK, Germany, France, Spain and Italy. 547 had triple negative breast cancer (TNBC) and the remaining 4826 had other breast cancer subtypes (non-TNBC). All data was collected anonymously, with strong privacy and security controls. Results: Different regimens were given as adjuvant or as systemic treatments. AC treatment was given to 10% of TNBC vs 5% of non-TNBC patients; FEC-T to 18% vs 11%, FEC to 9% vs 7%, taxanes to 39% vs 22% and platinum-based chemotherapy to 14% vs 2%, respectively. Among non-TNBC patients, 12% received Trastuzumab and 52% received hormonal treatment. Some of the patients were asked regarding side effects as well as vitamins and supplements intake. Among them, 136 TNBC patients reported an average of 3.0 side effects (95% CI 2.6-3.5), 22% more than those reported by 1015 non-TNBC patients (2.5 side effects; 95% CI 2.4-2.6); p ¼ 0.03. Similarly, an average of 3.6 vitamins and supplements was reported by 111 TNBC patients (95% CI 2.9-4.3), 15% more compared to 854 non-TNBC patients (3.1 supplements; 95% CI 2.9-3.3); p ¼ 0.22. An analysis of the patients reporting at least 1 side-effect showed 120 TNBC patients with an average of 3.5 side effects (95% CI 3.0-3.9), 17% more than 862 nonTNBC patients (3.0 side effects, 95% CI 2.8-3.1); p ¼ 0.05. Regarding consumption of at least 1 vitamin/supplement, the average intake across 85 TNBC patients was 4.7 (9.5% CI 3.9-5.5), 23% more than 697 non-TNBC patients (3.8 vitamins/supplements, 95% CI 3.5-4.0); p ¼ 0.04. Conclusions: The real world evidence obtained through an international analysis shows that TNBC patients receive more toxic treatments due to the aggressive disease, as expected. TNBC patients experience significantly more side effects compared to
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Methods: One hundred thirty-two male patients with clear cell mRCC were enrolled. All patients were evaluated for erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) before and after the first cycle/month of the first-line targeted therapy with sunitinib, pazopanib, bevacizumabþIFN, sorafenib, or temsirolimus. Results: Median age was 59 years (range 43–67 years). 89 (67%) patients had at least one cardiovascular risk factor. At baseline, IIEF-5 mean score was 19 (SD, 2.6). Patients with 2 and more IMDC risk factors (39%) had a lower IIEF-5 mean score (14; SD, 3.3). 99 (75%) patients reported a negative change in their sexual life since the start of the targeted therapy. 35 (27%) patients had no sexual activity. After the first treatment cycle/month IIEF-5 mean score reduced to 8 (SD, 1.9), which was statistically significant (P < 0.001). The IIEF-5 scores were not associated with a type of anticancer treatment (P > 0.05). Conclusions: Prospective evaluation in a large cohort of patients with mRCC revealed mild ED (19/25) in the treatment-naive male population and severe ED (8/25) after the first cycle/month of the first-line targeted therapy. Significant decrease in erectile function should be considered as a potential adverse event in male patients undergoing treatment of mRCC with targeted agents. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology
Annals of Oncology Conclusions: Letrozole co-administration during COS resulted to be as effective as standard COS but with significantly decreased peak estradiol levels, suggesting its increased safety especially for hormone-sensitive cancer patients. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy
Background: Data on the long-term effects of prenatal exposure to maternal cancer and its treatment on child development are scarce. Methods: In a multicentre cohort study, the neurologic and cardiac outcomes of 6year-old children born to women diagnosed with cancer during pregnancy (study group) were compared to the outcome of children born after an uncomplicated pregnancy (control group) (ClinicalTrials.gov, NCT00330447). Neurodevelopment was assessed by clinical evaluation and neuropsychological testing (including intelligence, attention and memory tests) and by general health and behaviour questionnaires. Cardiac evaluation included electro- and echocardiography. Results: In total, 132 study children and 132 controls (mean age 6.2 years) were included. In the study group, 97 children (73.5%) were prenatally exposed to chemotherapy (alone or in combination with other treatments), 14 (10.6%) to radiotherapy (alone or in combination), 1 (0.8%) to trastuzumab, 12 (9.1%) to surgery alone and 16 (12.1%) to no treatment. Although within normal ranges, the mean Verbal IQ score was significantly lower in the study versus control group (98.9 vs 103.0, p ¼ 0.001, q < 0.001). Also, children in the study group had a significantly lower score for visuospatial long-term memory compared to the control group (3.9 vs 4.5, p ¼ 0.005, q ¼ 0.043). No significant differences were found in Full Scale IQ, Performance IQ, Processing Speed, memory span, verbal and visuospatial short-term memory, attention and behaviour problems or in cardiac dimensions and left ventricular function. Conclusions: Children prenatally exposed to maternal cancer and its treatment may be at risk for lower Verbal IQ and visuospatial long-term memory scores, but other cognitive functions and cardiac outcomes were normal at the age of 6 years. Clinical trial identification: NCT00330447. Legal entity responsible for the study: University Hospitals Leuven, Belgium. Funding: European Union’s Horizon 2020 research and innovation programme under grant agreement No. 647047, Research Foundation-Flanders (F.W.O)., Stichting tegen Kanker, Belgian Cancer Plan, Koningin Wilhemina Fonds (K.W.F.), Kom Op Tegen Kanker, Stichting Mitialto and Charles University grant Progres Q-34. Disclosure: All authors have declared no conflicts of interest.
Update of the registry of young women with cancer by the International Network of Cancer, Infertility and Pregnancy
C. Maggen1, K. Van Calsteren2, E. Cardonick3, R.G. Shmakov4, M. Gziri5, A.C. Garcia6, R. Fruscio7, C.A.R. Lok8, M. Halaska9, I.A. Boere10, P. Zola11, P. Ottevanger12, C.J.M. de Groot13, G. Scarfone14, M. Fumagalli15, R.C. Painter16, J. de Haan13, F. Amant8 1 Obstetrics and Gynecology, University Hospitals Leuven and Department of Oncology, KU Leuven, Leuven, Belgium, 2Obstetrics and Gynecology, University Hospitals Leuven and Department of Development and Regeneration, KU Leuven, Leuven, Belgium, 3 Obstetrics and Gynecology, Cooper University Hospital, Philadelphia, PA, USA, 4 Academician V.I.Kulakov of the Ministry of Healthcare of Russian Federation, National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russian Federation, 5Obstetrics, Cliniques Universitaires St Luc, Brussels, Belgium, 6Oncology, Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), Mexico City, Mexico, 7 Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy, 8Department of Gynecologic Oncology, Antoni Van Leeuwenhoek Hospital – The Netherlands Cancer Institute, Amsterdam, Netherlands, 9Obstetrics and Gynecology, Third Medical Faculty Charles University and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic, 10Medical Oncology Department, Erasmus University Medical Center, Rotterdam, Netherlands, 11Department of Surgical Sciences, University of Turin, Turin, Italy, 12Internal Medicine, Radboud UMC Nijmegen, Nijmegen, Netherlands, 13 Obstetrics and Gynecology, Amsterdam UMC, VU University Medical Center, Amsterdam, Netherlands, 14Obstetrics and Gynecology, Department of Ob-Gyn University of Milan, Milan, Italy, 15Neonatal Intensive Care Unit and Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, 16Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, Netherlands Background: The International Network of Cancer, Infertility and Pregnancy was launched in order to register women of reproductive age with a cancer diagnosis. Over the years, the project has expanded with currently 2653 cases registered by 114 centres and an annual registration rate of 150 patients. The expected rising numbers of cancer diagnosis during pregnancy as a result of an increased age at first childbirth and the possibility of early cancer detection by the non-invasive prenatal testing calls for an ongoing evaluation of clinical practice. Moreover, women might become pregnant while exposed to adjuvant or maintenance therapies that are increasingly being used. Methods: The INCIP database consists of a secured on-line registration tool. Oncological, obstetric and neonatal data are registered by members. Annual scientific meetings give updates on the ongoing research projects. Results: Most patients were registered in Belgium, the Netherlands, Italy and USA and one third of participating centres are non-European. Currently 2059 patients with a cancer diagnosis or treatment during pregnancy are registered, 395 women that received fertility preservation and 199 patients with a postnatal cancer diagnosis (Figure 1). Breast cancer, lymphoma and cervical cancer are the most frequent registered cancer types and the majority of patients (67%) received antenatal cancer treatment (Figure 2). Most women delivered a live born baby (88%), however 47% delivered preterm and 80% of preterm deliveries were medically induced. One-fifth of neonates (21%) were small for gestational age. Congenital malformations were reported in 3% of live births. Conclusions: Cancer occurring in women endangers obstetrical and neonatal outcome and potentially future fertility. The INCIP registry is open for further collection of data since for such a relatively rare situation, only a large-scale project will provide better insights on maternal and foetal risks assessment, which is essential for optimal patient counselling and care. Clinical trial identification: NCT00330447. Legal entity responsible for the study: The authors. Funding: European Union’s Horizon 2020 research and innovation program under grant agreement No 647047. Disclosure: All authors have declared no conflicts of interest.
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Erectile dysfunction in patients with metastatic renal cell carcinoma
I. Tsimafeyeu1, R. Zukov2, L. Demidov3, P. Borisov4, V. Kuznetsov5, V. Leonenko5, A. Bondarenko6, K. Zakurdaeva7, Y. Tishova8 1 Moscow Office, Kidney Cancer Research Bureau, Moscow, Russian Federation, 2Dept. of Oncourology, A.I. Kryzhanovsky Krasnoyarsk Cancer Center, Krasnoyarsk, Russian Federation, 3Dept. of Biotherapy, N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation, 4Outpatient Department, City Clinical Oncology Center, St. Petersburg, Russian Federation, 5Tuchkovo Branch, Stolichnaya Diagnostica Clinic, Tuchkovo, Russian Federation, 6Dept. of Internal Medicine, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation, 7 Oncology Department, RakFond, Moscow, Russian Federation, 8Dept. of Endocrinology, RUDN University, Moscow, Russian Federation Background: Metastatic renal cell carcinoma (mRCC) can cause sexual dysfunction as an adverse effect in male patients. Erectile dysfunction (ED) can also result from adverse effects of targeted therapy of mRCC, such as fatigue, pain, anorexia, asthenia or hypothyroidism. The objective of the study was to evaluate the rate of ED in a male population with mRCC.
Volume 30 | Supplement 5 | October 2019
doi:10.1093/annonc/mdz265 | v743
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T. Vandenbroucke1, M. Verheecke1, M. van Gerwen2, K. Van Calsteren3, M. Halaska4, M. Fumagalli5, R. Fruscio6, M. Veening7, L. Lagae8, P. Ottevanger9, J-U. Voigt10, J. de Haan11, M. Gziri12, A. Gandhi13, C. Maggen1, L. Mertens14, G. Naulaers15, L. Claes13, F. Amant16 1 Obstetrics and Gynecology, University Hospitals Leuven and Department of Oncology, KU Leuven, Leuven, Belgium, 2Center for Gynecologic Oncology, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, 3 Obstetrics and Gynecology, University Hospitals Leuven and Department of Development and Regeneration, KU Leuven, Leuven, Belgium, 4Obstetrics and Gynecology, Third Medical Faculty Charles University and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic, 5Neonatal Intensive Care Unit and Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, 6Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy, 7Pediatric Oncology, Princess Maxima Center for Pediatric Oncology, Utrecht, Netherlands, 8Pediatrics, University Hospitals Leuven, Leuven, Belgium, 9Internal Medicine, Radboud UMC Nijmegen, Nijmegen, Netherlands, 10Cardiology, University Hospitals Leuven, Leuven, Belgium, 11Obstetrics and Gynecology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, Netherlands, 12Obstetrics, Cliniques Universitaires St Luc, Brussels, Belgium, 13Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium, 14Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada, 15Neonatology, University Hospitals Leuven, Leuven, Belgium, 16 Department of Gynecologic Oncology, Antoni Van Leeuwenhoek Hospital – The Netherlands Cancer Institute, Amsterdam, Netherlands
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abstracts
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Exercise level, interest and preferences in cancer patients
A. Avancini1, V.M. Pala2, V. Krogh2, S. Sieri2, L. Mariani2, D. Tregnago3, G. Sartori4, I. Trestini3, E. Bria5, M. Milella4, M. Lanza6, S. Pilotto4 1 Biomedical Sciences, Department of Medicine, University of Verona Hospital Trust, Verona, Italy, 2Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, 3Medical Oncology, University of Verona Hospital Trust, Verona, Italy, 4Department of Oncology, University of Verona Hospital Trust, Verona, Italy, 5 Fondazione Policlinico Agostino Gemelli IRCCS, Universit a Cattolica del Sacro Cuore, Rome, Italy, 6Biomedicine and Movement Sciences, University of Verona Hospital Trust, Verona, Italy Background: After a cancer diagnosis, exercise (EX) has shown to reduce risk of recurrence/mortality, help in managing cancer treatment side effects and maintain functional abilities. Nevertheless, most of cancer patients are insufficiently active. The purpose of this research is to investigate the EX level, interest and preference in oncological patients. Methods: A self-administered questionnaire was used to collect demographic, health and EX information. EX level was assessed by leisure score index (LSI), using the validated Godin’s Leisure Time Exercise Questionnaire, while the EX preferences questions were drawn from previous studies. Patients from Medical Oncology Unit of Verona Hospital were asked to anonymously complete the questionnaire. Descriptive statistic was used to calculate frequencies and percentages of responses to survey questions. Results: With a 57% of response rate, a total of 405 survey were completed and analyzed. Breast (26%) and upper gastrointestinal (42%) were the most frequent diagnosis. Only 10% of patients resulted to be sufficiently active (LSI24). A large majority (80%) indicated that they are willing to participate in an EX program designed for cancer patients. Patients reported that they prefer receive EX information by an oncologist (57%) followed by physiotherapist (29%), with a face to face approach (71%). The preferred composition of EX group was with “other cancer patients” (27%). The patients chose outdoors (27%) and a fitness center for adapted physical activity (21%) as favorite places to perform EX. Training in group was preferred (39%), followed by an individual program to perform at home (27%) and an individual program with a personal trainer (25%). The majority preferred a supervised Ex program (57%). The favorite EX frequencies were two times/week (37%) and three times/week (30%), whereas “mild” intensity was chosen by 44% of patients followed by “moderate” (36%). Conclusions: Despite the demonstrated benefits of EX in oncological patients, we found 90% of them insufficiently active, but 80% willing to start an EX program. According to these data, we designed a prospective clinical trial including dedicated EX programs based on patient’s preferences, currently recruiting. Legal entity responsible for the study: University of Verona. Funding: Has not received any funding. Disclosure: E. Bria: Honoraria (self): MSD, AstraZeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis, and Roche; Research grant / Funding (self): AIRC. S. Pilotto: Honoraria (self): AstraZeneca, BMS, Roche, MSD, Boeringher Ingelheim; Research grant / Funding (self): AIRC; Travel / Accommodation / Expenses: BMS, Roche, AstraZeneca, Boehringer Ingelheim. All other authors have declared no conflicts of interest.
v744 | Supportive Care
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Filling the gaps in informed consent for advanced cancer patients considering phase I oncology trials: An in-depth qualitative study of key stakeholders at a large United Kingdom phase I unit
A. Pal1, S. Stapleton2, J. Lopez1 Drug Development Unit, The Royal Marsden Foundation Trust and The Institute of Cancer Research, London, UK, 2Drug Development Unit, The Royal Marsden Foundation Trust, London, UK
1
Background: Extensive research has demonstrated that patients considering early phase oncology trials do not appreciate the design or purpose of these trials and also harbour unrealistic expectations of the personal benefit they can expect from the trial. There have been few interventional studies examining the informed consent process in this setting and they have shown limited effectiveness. We aimed to use a qualitative methodology to understand the perspectives of key stakeholders and identify the areas of need and the potential opportunities for an intervention to improve our informed consent processes. Methods: We used an experience-based co-design framework which consisted of a semi-structured interview script of ten key questions. Two trained interviewers performed interviews of three consultant medical oncologists, nine clinical fellows, two study managers, two clinical nurse specialists, two focus groups with four patients each and two regulatory officers. We also interviewed four members of our investigator-initiated sponsor team to obtain an understanding of the sponsor perspective. All audio interviews were transcribed, and thematic analysis was performed on the narrative text to extract core themes. Results: Consistent themes raised by participants included 1. The core elements that participants need to comprehend prior to consenting are that trials are experiments and not treatment, the low prospect of benefit, potential toxicity and the significant time commitment. 2. Participant information sheets (PIS) are too long, too complex and the information is not provided in a patient centred manner. Sponsors were in strong support of shorter and more accessible PIS. 3. Digital media would be acceptable and useful but to be mindful of subgroups of patients who are not as comfortable with digital media. Conclusions: There is widespread understanding that improvement is required in the length, design and style of participant information sheets for phase 1 oncology trials. Furthermore, digital media would be acceptable to all stakeholders but its development will require ongoing stakeholder engagement to ensure user acceptability. Legal entity responsible for the study: Drug Development Unit - Royal Marsden Hospital, Sutton. Funding: Cancer Research UK (CRUK), Experimental Cancer Medicine Centres (ECMC), National Institute of Health Research (NIHR) Royal Marsden Biomedical Research Centre. Disclosure: J. Lopez: Advisory / Consultancy: Genmab; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Basilea; Travel / Accommodation / Expenses: Basilea; Travel / Accommodation / Expenses: Roche/Genentech. All other authors have declared no conflicts of interest.
1835P
Breast cancer patients’ quality of life: Real-world data
T. Kosmidis, B. Athanasakou, P.A. Kosmidis Research Department, Care Across Ltd, London, UK Background: CareAcross is a digital platform dedicated to support, inform and engage with cancer patients. It also collects medical and other data, and generates real world evidence. Methods: In an effort to collect and analyze information from breast cancer patients regarding side effects in relation to their treatments and supplements intake, we contacted 5373 patients in the UK, Germany, France, Spain and Italy. 547 had triple negative breast cancer (TNBC) and the remaining 4826 had other breast cancer subtypes (non-TNBC). All data was collected anonymously, with strong privacy and security controls. Results: Different regimens were given as adjuvant or as systemic treatments. AC treatment was given to 10% of TNBC vs 5% of non-TNBC patients; FEC-T to 18% vs 11%, FEC to 9% vs 7%, taxanes to 39% vs 22% and platinum-based chemotherapy to 14% vs 2%, respectively. Among non-TNBC patients, 12% received Trastuzumab and 52% received hormonal treatment. Some of the patients were asked regarding side effects as well as vitamins and supplements intake. Among them, 136 TNBC patients reported an average of 3.0 side effects (95% CI 2.6-3.5), 22% more than those reported by 1015 non-TNBC patients (2.5 side effects; 95% CI 2.4-2.6); p ¼ 0.03. Similarly, an average of 3.6 vitamins and supplements was reported by 111 TNBC patients (95% CI 2.9-4.3), 15% more compared to 854 non-TNBC patients (3.1 supplements; 95% CI 2.9-3.3); p ¼ 0.22. An analysis of the patients reporting at least 1 side-effect showed 120 TNBC patients with an average of 3.5 side effects (95% CI 3.0-3.9), 17% more than 862 nonTNBC patients (3.0 side effects, 95% CI 2.8-3.1); p ¼ 0.05. Regarding consumption of at least 1 vitamin/supplement, the average intake across 85 TNBC patients was 4.7 (9.5% CI 3.9-5.5), 23% more than 697 non-TNBC patients (3.8 vitamins/supplements, 95% CI 3.5-4.0); p ¼ 0.04. Conclusions: The real world evidence obtained through an international analysis shows that TNBC patients receive more toxic treatments due to the aggressive disease, as expected. TNBC patients experience significantly more side effects compared to
Volume 30 | Supplement 5 | October 2019
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Methods: One hundred thirty-two male patients with clear cell mRCC were enrolled. All patients were evaluated for erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) before and after the first cycle/month of the first-line targeted therapy with sunitinib, pazopanib, bevacizumabþIFN, sorafenib, or temsirolimus. Results: Median age was 59 years (range 43–67 years). 89 (67%) patients had at least one cardiovascular risk factor. At baseline, IIEF-5 mean score was 19 (SD, 2.6). Patients with 2 and more IMDC risk factors (39%) had a lower IIEF-5 mean score (14; SD, 3.3). 99 (75%) patients reported a negative change in their sexual life since the start of the targeted therapy. 35 (27%) patients had no sexual activity. After the first treatment cycle/month IIEF-5 mean score reduced to 8 (SD, 1.9), which was statistically significant (P < 0.001). The IIEF-5 scores were not associated with a type of anticancer treatment (P > 0.05). Conclusions: Prospective evaluation in a large cohort of patients with mRCC revealed mild ED (19/25) in the treatment-naive male population and severe ED (8/25) after the first cycle/month of the first-line targeted therapy. Significant decrease in erectile function should be considered as a potential adverse event in male patients undergoing treatment of mRCC with targeted agents. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology