Breast cancer patients’ quality of life: Real-world data

Breast cancer patients’ quality of life: Real-world data

abstracts 1833P Exercise level, interest and preferences in cancer patients A. Avancini1, V.M. Pala2, V. Krogh2, S. Sieri2, L. Mariani2, D. Tregnag...

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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


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


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.


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


Annals of Oncology non-TNBC patients. They also consume more vitamins and supplements; the difference across patients reporting at least one vitamin/supplement was larger and statistically significant. Legal entity responsible for the study: Care Across Ltd. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

patients (0% vs 0.1%; p ¼ 0.36) probably because of a lack of follow-up after chemotherapy. Optimal follow-up for HBVr based on the decisional algorithm appears to be better in group 1 than group 2 (50% vs 25%; p ¼ 0.13). For patients on anti-CD20 therapy in group 1, HBV screening was done for 92% of patients which is a higher rate compare to previously reported data. In group 3, 89 patients had ALT elevation (>100U/L and x3 baseline value) during chemotherapy but only 17 patients (19%) were tested for the possibility of HBVr.

Table: 1837P 1836P

High-sensitivity troponin as a cardiotoxicity biomarker in breast cancer treatment

Background: Cardiotoxicity is one of the effects described with anthracyclines (AC) or antiHER2 therapies. Monitoring is usually performed with an echocardiogram and the main effect is the left ventricular ejection fraction reduction. On the other hand, cardiotoxicity biomarkers, such as high-sensitivity troponin (TropHS), can be evaluated at shorter intervals and have been described as an early diagnosis indicator of myocardial injury. Methods: Retrospective analysis of 83 breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with AC, with or without antiHER2 therapy, from January 2017 to July 2018. All patients were evaluated with cardiotoxicity biomarkers, electrocardiogram and transthoracic echocardiogram prior to treatment, and 3, 6, 9 and 12 months thereafter. After assessment of the cardiovascular risk, cardioprotective therapy has been initiated in patients with TropHS elevation. Cardiotoxicity was defined by a decline in LVEF> 10% of baseline or LVEF <50%. Results: The median age was 49 years (26-76) and 14.5% of the patients had history of cardiovascular disease (namely arterial hypertension). Almost 29% (n ¼ 24) were treated with association of antiHER2 therapy and the median chemotherapy treatment time was 3.8 months (1-6). About 84% (n ¼ 70) were submitted to adjuvant radiotherapy. Eight percent had a very high (7) Cardiotoxicity Risk Score, being most of them of the group with TropHS elevation. Almost 57% (n ¼ 47) of the patients presented TropHS elevation and we observed a major elevation at 3 months treatment, with a median of 21.25 (1.90-209.0). Approximately 5% (n ¼ 4) of the patients had cardiotoxicity, all of them treated with combination of antiHER2 therapy, and this was more frequent in patients with TropHS elevation (p ¼ 0.215). Among 15 patients who presented TropHs elevation and started cardioprotective therapy, only three developed cardiotoxicity. The median follow-up was 12 months (3-23). Conclusions: Recently, the role of TropHS, as a biomarker in the early identification of cardiotoxicity, has been affirmed. The consequent use of cardioprotective agents has emerged as an effective approach in the prevention of cardiac dysfunction. For the moment, more studies are needed to validate this biomarker in clinical practice. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.


Impact of routine screening and preemptive treatment on hepatitis B virus reactivation (HBVr) in patients receiving chemotherapy

C. Marty1, D. Martel2, V. Martel-Laferrie`re3, S. Doucet4, P. Ce´ballos5, J-P. Adam2 Faculty of Pharmacy, Aix-Marseille Universite´, Marseille, France, 2Pharmacy, Centre Hospitalier de l’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 3Microbiology and Infectious Diseases, Centre Hospitalier de l’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 4Medical Oncology/Hematology, Centre Hospitalier de l’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 5Clinical Hematology, Centre Hospitalier Universitaire Saint-Eloi, Montpellier, France


Background: Guidelines diverge about the need for systematic HBV screening for all patients starting chemotherapy. At the Centre hospitalier de l’Universite´ de Montre´al (CHUM), systematic HBV screening is requested on pre-printed chemotherapy order (PPCO) at high risk of HBVr with follow-up by a pharmacist. For all other PPCO, doctors can request HBV screening and follow-up. A decision algorithm is available for all clinicians. The aim of this study is to assess whether patients undergoing routine HBV screening could reduce the incidence of HBVr. Methods: This is a retrospective observational study including patients who received an IV chemotherapy for cancer between July 2017 and June 2018 at the CHUM. We compared the incidence and complications of HBVr in patients with HBV screening as requested on PPCO (group 1) or on demand from the medical team (group 2) to patients who were not screened (group 3). Results: On a total of 1374 patients, 179 of 206 (13%) patients were screened as requested on PPCO (group 1) and 421 (30%) by the medical team (group 2). Patient characteristics, duration of treatment and follow-up for all groups are listed in the table. No difference was seen on the incidence of HBVr between screened and unscreened

Volume 30 | Supplement 5 | October 2019

Screening before chemotherapy Nb of pts who had finished chemotherapy treatment at the time of analysis Median duration (months) of chemotherapy (IQR) HBsAg þ Anti-HBc þ HBV-DNA þ Incomplete screening Antiviral prophylaxis required Antiviral prophylaxis initiated Follow-up required Follow-up Optimal follow-up Number of patients who had a follow-up after chemotherapy HBV reactivation

Group 1 n ¼ 206 (%)

Group 2 n ¼ 421 (%)

Group 3 n ¼ 747 (%)

179 (86.9)

421 (100)

0 (0)

174 (84.5)

402 (95.5)

699 (93.6)

10.5 (6.4-14.4)

4 (1.4-9.1)

3.6 (1.6-5.6)

0 (0) 17 (8.3) 1 (0.5) 5 (2.8) 8 (3.9) 7 (3.4)

2 (0.5) 36 (8.6) 2 (0.5) 31 (7.4) 3 (0.7) 3 (0.7)


18 (8.7) 10 (4.9) 9 (4.4) 3 (1.5)

36 (8.6) 13 (3.1) 9 (2.1) 5 (1.2)


0 (0)

0 (0)

1 (0.1)


Conclusions: Systematic HBV detection requested on PPCO is an effective way to increase HBV screening and prevent HBVr in patients receiving chemotherapy. However, this method does not guarantee optimal follow-up and requires improvements. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: D. Martel: Honoraria (self): Abbvie Canada; Honoraria (self): Gilead Sciences Canada; Honoraria (self): Merck Canada. V. Martel-Laferrie`re: Research grant / Funding (self), Clinical Research Scholars - Junior 1: Fonds de la recherche en sante´ du Que´bec. S. Doucet: Honoraria (self), Advisory / Consultancy: AbbVie Canada; Honoraria (self), Advisory / Consultancy: Gilead Sciences Canada; Honoraria (self): Merck Canada; Advisory / Consultancy: Roche; Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self): Seattle Genetics. J. Adam: Honoraria (self): Amgen Canada; Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: AbbVie; Advisory / Consultancy: Lundbeck. All other authors have declared no conflicts of interest.


The uptake, patient satisfaction and efficacy of scalp cooling among patients receiving chemotherapy in an Irish oncology day ward

W. Maher, K. Murphy, D. O Connor, C.G. Murphy Medical Oncology, Bon Secours Hospital, Cork, Ireland Background: Chemotherapy-induced alopecia (CIA) is a common and distressing side effect of chemotherapy treatment. Significant progress has been made during the past 2 decades in treating many of the side effects associated with cancer chemotherapy including emesis, hematopoietic cytopenias, xerostomia, infection, pain, and thrombosis. Similar progress has not been made in the prevention of CIA, apart from scalp cooling. We set out to examine the uptake, patient satisfaction and efficacy (as perceived by medical staff and patients) of scalp cooling treatment among patients receiving chemotherapy. Methods: We reviewed a prospectively maintained database of patients who were offered scalp cooling treatment in our oncology dayward between 01/10/2014 and 22/ 06/2018. We analysed patient uptake and efficacy as perceived and recorded by medical staff (“medical efficacy”). A questionnaire was sent to patients who had accepted scalp cooling treatment and were alive at follow-up, to assess patient perceived efficacy and patient satisfaction. Patient perceived efficacy was compared to medical efficacy using the Fisher’s exact test.

doi:10.1093/annonc/mdz265 | v745

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J. Sim~ oes1, N.T. Tavares2, C. Borges2, R. Pinto3, M. Silva3, M. Paiva3, C. Sousa3, I. Sousa1, D. Almeida1, I. Augusto1, C. Caeiro4, S.R. Meireles2 1 Medical Oncology, Hospital de S. Jo~ ao, Porto, Portugal, 2Medical Oncology, HSJ Hospital de S~ao Jo~ao, EPE, Porto, Portugal, 3Cardiology, Hospital de S. Jo~ao, Porto, ario de S~ ao Jo~ ao, EPE, Porto, Portugal, 4Medical Oncology, Centro Hospitalar Universit Portugal