Evaluating specialty referral, research involvement, and PROs in a CNS-involved metastatic breast cancer care coordination program.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 47-47
Author(s):  
Nicole Margo Grogan ◽  
Donna Pierce-Gjeldum ◽  
Leigh Klaus Swartz ◽  
Kait Verbal ◽  
Sofia Merajver ◽  
...  

47 Background: Central nervous system (CNS) metastases are associated with decreased survival and quality of life for patients with metastatic breast cancer (MBC). Multi-disciplinary care can optimize outcomes. This project aims to improve access to coordinated care for patients with MBC and CNS metastases while assessing patient-reported outcomes (PROs) in the context of the multidisciplinary care experience. Methods: Patients with MBC and CNS metastases are referred and offered to enroll in our care coordination program. A team of specialists (breast medical oncology, breast cancer genetics, radiation oncology, neurosurgery, neuro-oncology, physical medicine and rehabilitation (PM&R), neuropsychology, and palliative care) supports a dedicated program coordinator who provides navigation, education, specialty referral, and clinical trial screening. A unique intake form developed for the program creates personalized, coordinated, and expedited referrals. PROs and caregiver assessments are collected on a voluntary basis using the following validated questionnaires: PROMIS Cancer Function Brief 3D Profile, MD Anderson Symptom Inventory Brain Tumor (MDASI), and Short Form Zarit Burden Interview (ZBI-12), a screening tool for caregiver burden. Results: Since May 2020, 43 patients were referred and a total of 40 patients (93%) were enrolled – 2 (5%) declined due to perceived burden of participation and 1 (2%) died before enrollment. The majority of patients were White (n = 34, 85%). Median time to program intake was 1 day (range: 0-8 days). Of the 43 patients referred, 17 (40%) consented to research studies in the metastatic setting. 11 were for an interventional trial (65%), while 9 consents were for non-interventional studies (53%). In addition to the initially referred specialty, 56 referrals were made across 7 sub-specialties; 37 patients (66%) were subsequently seen by a sub-specialist, most commonly radiation oncology (n = 9), PM&R (n = 9), neuro-oncology (n = 8), and neuropsychology (n = 8). Of the nine patients seen by PM&R, 5 completed the PROMIS Profile (55%). Similar completion rates were seen for the MDASI (13 of 23 surveys given, 56.5%) and ZBI-12 (13 of 26 surveys given, 50%) questionnaires. Conclusions: Implementation of a care coordination program for patients with MBC and CNS metastases allows for improved access to care across sub-specialties and supports participation in clinical research for a group of cancer patients historically underrepresented in research studies. Though completion of questionnaires is optional in this program, the rate of completion raises the question of whether this patient population faces unique challenges that make it difficult to complete questionnaires that are often required in research studies. Funding source: National Comprehensive Cancer Network Oncology Research Program from financial support from Pfizer.

2021 ◽  
Vol 3 (Supplement_3) ◽  
pp. iii17-iii17
Author(s):  
Nicole Grogan ◽  
Donna Pierce-Gjeldum ◽  
Leigh Swartz ◽  
Kait Verbal ◽  
Sofia Merajver ◽  
...  

Abstract Central nervous system (CNS) metastases are associated with decreased survival and quality of life for patients with metastatic breast cancer (MBC). Multi-disciplinary care can optimize outcomes. This project aims to improve access to coordinated care for patients with MBC and CNS metastases. Patients with MBC and CNS metastases are referred and offered to enroll in our care coordination program. A team consisting of specialists (breast medical oncology, breast cancer genetics, radiation oncology, neurosurgery, neuro-oncology, physical medicine and rehabilitation (PM&R), neuropsychology, and palliative care) supports a dedicated program coordinator who provides navigation, education, specialty referral, and clinical trial screening. A unique intake form developed for the program creates personalized, coordinated, and expedited referrals. Patient-reported outcomes and caregiver burden assessments are collected. Since May 2020, 43 patients were referred and a total of 40 patients (93%) were enrolled – 2 (5%) declined due to perceived burden of participation and 1 (2%) died before enrollment. 85% of patients were Caucasian (n = 34) and 15% were non-Caucasian (n=6). Median time to program intake was 1 day (range: 0–8 days). Of the 43 patients referred, 17 (40%) consented to research studies in the metastatic setting. 11 were for an interventional trial (65%), while 9 consents were for non-interventional studies (53%). In addition to the initially referred specialty, 56 referrals were made across 7 sub-specialties; 37 patients (66%) were subsequently seen by a sub-specialist, most commonly radiation oncology (n = 9), neuro-oncology (n=8), PM&R (n=8), and neuropsychology (n=8). Implementation of a care coordination program for patients with MBC and CNS metastases is feasible. Further, it allows for improved access to care across sub-specialties and supports participation in clinical research for a group of cancer patients historically underrepresented in research studies. Funding: National Comprehensive Cancer Network Oncology Research Program from financial support provided by Pfizer.


Author(s):  
Larissa Elisabeth Hillebrand ◽  
Ulrike Söling ◽  
Norbert Marschner

Background: Breast cancer is still the most common malignancy in women worldwide. Once metastasized, breast cancer treatment primarily aims at reducing symptom burden, thereby trying to maintain and improve a patient´s quality of life (QoL), delaying disease progression, and prolonging survival. Curing the disease is not possible in the palliative setting. To better understand metastatic breast cancer patients, their symptoms and wishes, which are important for treatment-decision making and outcome, patient-reported outcomes (PROs) are of great importance, giving an impression of what really matters to and concerns a patient. Summary: Many advances have been made to implicate PROs in clinical trials, non-interventional studies, registries, and clinical routine care of metastatic breast cancer. For example, large phase III trials like PALOMA-3 (NCT01942135), MONALEESA-7 (NCT02278120), HER2CLIMB (NCT02614794), and KEYNOTE-119 (NCT02555657) trials implemented PROs in their trial design to assess the QoL of their trial patients. Also, non-interventional studies on metastatic breast cancer, like e.g., the NABUCCO study (IOM-02240), and prospective non-interventional, multicenter registries e.g., the tumor registry breast cancer (NCT01351584) or the breast cancer registry platform OPAL (NCT03417115), have implemented PROs to assess QoL during the anti-cancer treatment periods of the patients. Key Message: Using PROs in metastatic breast cancer can support shared treatment-decision making and management of symptoms, eventually leading to an improvement in QoL. Progressively, regulatory authorities take PROs into consideration for the approval of new drugs. Hence, the implication of PROs in cancer treatment, and especially in MBC, is of significant value.


2020 ◽  
Vol 10 (4) ◽  
pp. 227
Author(s):  
Maria Ida Amabile ◽  
Federico Frusone ◽  
Alessandro De Luca ◽  
Domenico Tripodi ◽  
Giovanni Imbimbo ◽  
...  

Although they cannot be considered curative, the new therapeutic integrated advances in metastatic breast cancer (MBC) have substantially improved patient outcomes. Traditionally, surgery was confined to palliation of symptomatic or ulcerating lumps. Data suggest, in some cases, a possible additive role for more aggressive locoregional surgical therapy in combination with systemic treatments in the metastatic setting, although a low level of evidence has been shown in terms of improvement in overall survival in MBC patients treated with surgery and medical treatment compared to medical treatment alone. In this light, tumor heterogeneity remains a challenge. To effectively reshape the therapeutic approach to MBC, careful consideration of who is a good candidate for locoregional resection is paramount. The patient’s global health condition, impacting on cancer progression and morbidity and their associated molecular targets, have to be considered in treatment decision-making. In particular, more recently, research has been focused on the role of metabolic derangements, including the presence of metabolic syndrome, which represent well-known conditions related to breast cancer recurrence and distant metastasis and are, therefore, involved in the prognosis. In the present article, we focus on locoregional surgical strategies in MBC and whether concomitant metabolic derangements may have a role in prognosis.


2019 ◽  
pp. 1-3
Author(s):  
Sarah S. Mougalian ◽  
Jenerius A. Aminawung ◽  
Carolyn J. Presley ◽  
Maureen E. Canavan ◽  
Margaret L. Holland ◽  
...  

2017 ◽  
Vol 3 (4) ◽  
pp. 289-303 ◽  
Author(s):  
Hiroji Iwata ◽  
Seock-Ah Im ◽  
Norikazu Masuda ◽  
Young-Hyuck Im ◽  
Kenichi Inoue ◽  
...  

Purpose To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy–resistant metastatic breast cancer. Patients and Methods The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment. Results This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; P = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant. Conclusion This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.


2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Mark D. Danese ◽  
Karla Lindquist ◽  
Justin Doan ◽  
Deepa Lalla ◽  
Melissa Brammer ◽  
...  

Background. Trastuzumab improves survival in HER2-positive women with metastatic breast cancer (MBC). The consequences of longer survival include a higher likelihood of additional metastases, including those in the central nervous system (CNS). The effect of CNS metastases on both trastuzumab discontinuation and survival in older patients has not been described.Patients and Methods. We used the Surveillance Epidemiology and End Results (SEER) Medicare data to identify a cohort of 562 women age 66 or older with MBC who were diagnosed between January 1, 2000 and December 31, 2005, free of CNS metastases, and initiated trastuzumab after MBC diagnosis. Time to discontinuation and time to death were analyzed using proportional hazards models.Results. Newly diagnosed CNS metastases were associated with both higher risk of trastuzumab discontinuation (relative hazard[RH]=1.78, 95% CI 1.11–2.87) and higher risk of death (RH=2.49, 95% CI 1.84–3.37). The incidence rate of new CNS metastases was comparable among various sites of metastasis (10.7 to 14.7 per 1,000 patient-months), except for bone which was higher (24.1 per 1,000).Conclusion. The diagnosis of CNS metastases was associated with an increase in both the likelihood of discontinuing trastuzumab therapy as well as the risk of death.


2014 ◽  
Vol 8 ◽  
pp. CMO.S14038 ◽  
Author(s):  
Diana Donovan ◽  
Laura Urquhart ◽  
Una Hopkins ◽  
Sandra Knight ◽  
Laura Moore

Nurse practitioners play important roles in breast cancer prevention, early detection, therapeutic efficacy, and surveillance. Assessment of a patient's health status is part of the nine nurse practitioner core competencies updated in 2012 by the National Organization of Nurse Practitioner Faculties. Although adverse events are common in treatment for metastatic breast cancer (MBC), proactive management strategies can limit the number and/or severity of adverse events. Additionally, knowledge of common metastatic sites and clinical signs/symptoms of recurrence provides one of the first-line strategies for successful treatment. We review five case studies of women with MBC who were managed successfully with eribulin mesylate in late lines of therapy after at least two chemotherapeutic regimens for advanced breast cancer that included both an anthracycline and a taxane in either the adjuvant or metastatic setting.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11086-e11086
Author(s):  
Alexey Manikhas ◽  
Ineza O. Sharvashidze ◽  
Tatjana N. Kotkova

e11086 Background: One of effective ways to overcome resistance to trastusumab is to prescribe lapatinib, an inhibitor of ErbB1 and ErbB2 receptors, in combination with capecitabine, a fluopirimidine cytostatic agent. We examined the efficacy and safety of combination of lapatinib plus tegafur, another oral fluopirimidine, in patients with ErbB2-positive metastatic breast cancer (MBC). Methods: 13 patients with HER2+ MBC were enrolled into the study. 11 patients were analyzed, as 2 women had been included into the study too late to be assessed. Median age was 43.5 years. All patients had previously received trastuzumab for MBC, 92% of patients had been treated with taxanes, 77% - with anthracyclines, and 31% received capecitabine. 69% of patients were treated with more than 2 lines of chemotherapy for MBC. The study included 4 patients with CNS metastases. During the study, the patients received lapatinib 1250 mg/day and tegafur 1200 mg/day, days 1-21, with 3-week intervals. Results: 1 patient achieved and still is in partial response which has been lasting for 5 months, while disease stabilization was observed in 9 out of 10 cases. The clinical benefit rate in this trial was 90%. There was 1 case of the disease progression. At the time of analysis median TTP was 10.1 months (95%CI 6-13). The combination of lapatinib and tegafur was effective in 4 out of 5 patients with CNS metastases. There were no adverse events greater than grade I observed on lapatinib plus tegafur therapy. Diarrhea was the most common adverse event, but it did not compromise the patients' quality of life. Conclusions: The lapatinib plus tegafur combination is a promising option for treatment of patients with HER2+ MBC after progression on trastuzumab-containing therapy. This mode was acceptable for patients who had received 2 or more lines of previous therapy. The combination was well tolerated by the patients. Both agents being oral formulations, the treatment mode is quite suitable for outpatient use.


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