The increased number of cancer survivors and the recognition of physical and psychosocial challenges, present from cancer diagnosis through active treatment and beyond, led to the discipline of ...cancer survivorship.
Herein, we reflected on the different components of survivorship care, existing models and priorities, in order to facilitate the promotion of high-quality European survivorship care and research.
We identified five main components of survivorship care: (i) physical effects of cancer and chronic medical conditions; (ii) psychological effects of cancer; (iii) social, work and financial effects of cancer; (iv) surveillance for recurrences and second cancers; and (v) cancer prevention and overall health and well-being promotion. Survivorship care can be delivered by structured care models including but not limited to shared models integrating primary care and oncology services. The choice of the care model to be implemented has to be adapted to local realities. High-quality care should be expedited by the generation of: (i) focused and shared European recommendations, (ii) creation of tools to facilitate implementation of coordinated care and (iii) survivorship educational programs for health care teams and patients. The research agenda should be defined with the participation of health care providers, researchers, policy makers, patients and caregivers. The following patient-centered survivorship research areas were highlighted: (i) generation of a big data platform to collect long-term real-world data in survivors and healthy controls to (a) understand the resources, needs and preferences of patients with cancer, and (b) understand biological determinants of survivorship issues, and (ii) develop innovative effective interventions focused on the main components of survivorship care.
The European Society for Medical Oncology (ESMO) can actively contribute in the efforts of the oncology community toward (a) promoting the development of high-quality survivorship care programs, (b) providing educational material and (c) aiding groundbreaking research by reflecting on priorities and by supporting research networking.
•Patients’ challenges from cancer diagnosis to treatment and beyond led to the discipline of cancer survivorship.•Despite the progress made in cancer survivorship, the need for high-quality care, education and research remains.•We attempted to define the principles for promotion of high-quality survivorship, suggesting areas for ESMO’s contribution.
Breast cancer is the most common cancer in women younger than age 50 years. Cancer treatments in younger women may cause premature menopause, infertility, and negative psychosocial effects. In this ...systematic review, we examined three key domains of functioning that are particularly relevant for younger breast cancer survivors: health-related quality of life (QOL), menopausal symptoms and fertility concerns, and behavioral health outcomes.
We conducted a literature review using PubMed and secondary sources and examined 840 articles published between January 1990 and July 2010. Inclusion criteria for articles were 1) published in English after 1989; 2) exclusively analyzed female breast cancer survivors aged 50 years or younger or premenopausal at diagnosis, with baseline characteristics and/or quantitative or descriptive analyses for this age group; 3) investigated QOL (health-related QOL including physical functioning and mental health, depression, and anxiety), menopause- or fertility-related concerns, and weight gain or physical activity-related behavioral health outcomes. Data were extracted using a standardized table collecting the purpose, design, population, and results of each study. Extracted data were reviewed for accuracy by two investigators and presented as descriptive tables.
A total of 28 articles met the inclusion criteria (15 cross-sectional studies, eight longitudinal studies, and five randomized trials). Regarding data review, no discordance between investigators was noted. Standardized measures of QOL and depressive symptoms identified worse outcomes as being more frequent or severe in breast cancer survivors aged 50 years or younger when compared with the general age-matched population of women without cancer and to older women (aged >50 years) with breast cancer. Concerns about premature menopause, menopausal symptoms, and infertility were common in younger women (aged ≤ 50 years) and had a role in the level of distress after treatment. Weight gain and physical inactivity were common health outcomes in younger women.
Younger women with breast cancer were found to experience distinct psychosocial and menopause-related concerns, weight gain, and physical inactivity. A need for more longitudinal research, including efforts at intervention to manage these symptoms and adverse health outcomes, remains.
•This ESMO Guideline provides key recommendations on the role of PROMs during the care of patients with cancer.•It covers the use of PROMs in patients with cancer from the start of active treatment ...during follow-up and at the end of life.•Recommendations are based on available scientific evidence and the authors’ collective expert consensus.•Authorship includes a multidisciplinary group of experts from Europe, North America, Asia and Australia.
Abstract The 1st international Consensus Conference for Advanced Breast Cancer (ABC 1) took place on November 2011, in Lisbon. Consensus guidelines for the management of this disease were developed. ...This manuscript summarizes these international consensus guidelines.
In early breast cancer (BC), there has been a trend to escalate endocrine therapy (ET) and to de-escalate chemotherapy (CT). However, the impact of ET versus CT on the quality of life (QoL) of early ...BC patients is unknown. Here, we characterize the independent contribution of ET and CT on patient-reported outcomes (PROs) at 2 years after diagnosis.
We prospectively collected PROs in 4262 eligible patients using the European Organization for Research and Treatment of Cancer QLQ-C30/BR23 questionnaires inside CANTO trial (NCT01993498). The primary outcome was the C30 summary score (C30-SumSc) at 2 years after diagnosis.
From eligible patients, 37.2% were premenopausal and 62.8% postmenopausal; 81.9% received ET and 52.8% CT. In the overall cohort, QoL worsened by 2 years after diagnosis in multiple functions and symptoms; exceptions included emotional function and future perspective, which improved over time. ET (Pint = 0.004), but not CT (Pint = 0.924), had a persistent negative impact on the C30-SumSc. In addition, ET negatively impacted role and social function, pain, insomnia, systemic therapy side-effects, breast symptoms and further limited emotional function and future perspective recovery. Although CT had no impact on the C30-SumSc at 2-years it was associated with deteriorated physical and cognitive function, dyspnea, financial difficulties, body image and breast symptoms. We found a differential effect of treatment by menopausal status; in premenopausal patients, CT, despite only a non-significant trend for deteriorated C30-SumSc (Pint = 0.100), was more frequently associated with QoL domains deterioration than ET, whereas in postmenopausal patients, ET was more frequently associated with QoL deterioration, namely using the C30-SumSc (Pint = 0.004).
QoL deterioration persisted at 2 years after diagnosis with different trajectories by treatment received. ET, but not CT, had a major detrimental impact on C30-SumSc, especially in postmenopausal women. These findings highlight the need to properly select patients for adjuvant ET escalation.
Background: Women with breast cancer are the largest group of female survivors of cancer. There is limited information about the long-term quality of life (QOL) in disease-free breast cancer ...survivors. Methods: Letters of invitation were mailed to 1336 breast cancer survivors who had participated in an earlier survey and now were between 5 and 10 years after their initial diagnosis. The 914 respondents interested in participating were then sent a survey booklet that assessed a broad range of QOL and survivorship concerns. All P values were two-sided. Results: A total of 817 women completed the follow-up survey (61% response rate), and the 763 disease-free survivors in that group, who had been diagnosed an average of 6.3 years earlier, are the focus of this article. Physical well-being and emotional well-being were excellent; the minimal changes between the baseline and follow-up assessments reflected expected age-related changes. Energy level and social functioning were unchanged. Hot flashes, night sweats, vaginal discharge, and breast sensitivity were less frequent. Symptoms of vaginal dryness and urinary incontinence were increased. Sexual activity with a partner declined statistically significantly between the two assessments (from 65% to 55%, P = .001). Survivors with no past systemic adjuvant therapy had a better QOL than those who had received systemic adjuvant therapy (chemotherapy, tamoxifen, or both together) (physical functioning, P = .003; physical role function, P = .02; bodily pain, P = .01; social functioning, P = .02; and general health, P = .03). In a multivariate analysis, past chemotherapy was a statistically significant predictor of a poorer current QOL (P = .003). Conclusions: Long-term, disease-free breast cancer survivors reported high levels of functioning and QOL many years after primary treatment. However, past systemic adjuvant treatment was associated with poorer functioning on several dimensions of QOL. This information may be useful to patients and physicians who are engaging in discussion of the risks and benefits of systemic adjuvant therapy.
During the last decade, survival rates for breast cancer have increased as a result of earlier detection and increased use of adjuvant therapy. Limited data exist on the psychosocial aspects of the ...transitional period between the end of primary treatment and survivorship. We investigated the baseline psychosocial status of women enrolled in a randomized trial testing two psychosocial interventions for women at the end of primary treatment.
Participants, identified within 1 month after surgery (registration), provided demographic information and limited measures of quality of life. They were followed until they finished primary treatment (enrollment), at which time they completed a mailed baseline survey that included standardized measures of quality of life (including standardized scales of physical and emotional functioning), mood, symptoms, and sexual functioning. A total of 558 patients (mean age = 56.9 years) were enrolled in the study between July 1, 1999, and June 30, 2002. Health outcomes were examined according to treatment received: mastectomy with and without chemotherapy, and lumpectomy with and without chemotherapy. All statistical tests were two-sided.
Among all treatment groups, patients who had a mastectomy had the poorest physical functioning at registration (P<.001) and at enrollment (P=.05). At enrollment, mood and emotional functioning were similar among all patients, with no differences by type of treatment received. At enrollment, symptoms, including muscle stiffness, breast sensitivity, aches and pains, tendency to take naps, and difficulty concentrating, were common among patients in all groups and were statistically significantly associated with poor physical functioning and emotional well-being. Sexual functioning was worse for women who received chemotherapy than for those who did not, regardless of type of surgery (P<.001).
At the end of primary treatment for breast cancer, women in all treatment groups report good emotional functioning but report decreased physical functioning, particularly among women who have a mastectomy or receive chemotherapy. Clinical interventions to address common symptoms associated with treatment should be considered to improve physical and emotional functioning at the end of primary treatment for breast cancer.
Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in ...patients with
or
germline mutation-associated early breast cancer.
We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with
or
germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival.
A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval CI, 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P = 0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest.
Among patients with high-risk, HER2-negative early breast cancer and germline
or
pathogenic or likely pathogenic variants, adjuvant olaparib after completion of local treatment and neoadjuvant or adjuvant chemotherapy was associated with significantly longer survival free of invasive or distant disease than was placebo. Olaparib had limited effects on global patient-reported quality of life. (Funded by the National Cancer Institute and AstraZeneca; OlympiA ClinicalTrials.gov number, NCT02032823.).
Summary
Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a ...regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included intra/perioperative complications, hospital readmissions, procedure‐related interventions, reoperations, and device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non‐emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first 1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device and the implantation technique. The overall event rates were low based on data from 82 institutions. The MSAD is a safe therapeutic option for patients with chronic, uncomplicated gastroesophageal reflux disease.
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