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Background: Hairy cell leukemia (HCL) is characterized by the underlying genetic lesion of BRAFV600E and responsiveness to BRAF inhibitors. We assessed the safety and activity of the BRAF inhibitor vemurafenib combined with obinutuzumab in patients with previously untreated HCL. Methods: We conducted a single-arm, multicenter clinical study of vemurafenib plus obinutuzumab. Vemurafenib 960 mg twice daily was administered for four cycles, and obinutuzumab was administered in cycles 2 to 4. The primary end point was complete remission (CR). Secondary end points included assessment of safety, minimal residual disease (MRD), and BRAF allele burden according to digital droplet polymerase chain reaction (ddPCR). Results: Thirty patients were enrolled in the study, and 27 patients completed all four cycles of treatments and achieved CR (90%; 95% confidence interval [CI], 73 to 98). Three patients discontinued the study early because of adverse events and were not evaluable for response. Of the 27 patients who achieved CR, 26 patients (96%; 95% CI, 81 to 99) achieved MRD negativity. BRAFV600E allele was undetectable by ddPCR in all 21 evaluable patients. At a median follow-up of 34.9 months (95% CI, 29.6 to 36.9), no patient experienced disease relapse. The most common vemurafenib-related adverse events were rash and arthralgia. Febrile neutropenia occurred in two patients, and blood or platelet transfusions were required in two patients. Conclusions: Combined time-limited vemurafenib and obinutuzumab achieved CR in more than 90% of patients with previously untreated HCL. In this small study, acquired vemurafenib resistance or dose-limiting toxicity was not observed. Patients were not observed long enough to reveal secondary malignancies. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT03410875.) [ABSTRACT FROM AUTHOR]

Background: A growing number of lifestyle interventions are being developed to promote weight loss and adoption of a healthful lifestyles among breast cancer survivors; yet Black and Latina women remain underrepresented. Purpose: We performed a scoping review of the available peer-reviewed literature to describe and compare the content, design, methods, and primary outcomes of current diet and/or physical activity (PA) interventions after a breast cancer diagnosis among Black and Latina women. Methods: We queried PubMed, EMBASE, CINAHL, MEDLINE, and Clinicaltrials.gov up to October 1, 2022, to identify all randomized controlled trials of diet and/or PA after diagnosis of breast cancer with a majority (>50%) of Black or Latina participants. Results: Twenty-two randomized controlled trials were included in this review (five efficacy, twelve pilot, five on-going). Nine trials were among Latinas (two diet, four PA, and three diet/PA), six among Blacks (one PA and five diet/PA) and seven included both populations (five PA and two diet/PA), all of which examined different endpoints. Two of the five efficacy studies achieved their a priori outcome (one diet trial improved short term dietary intake; one PA trial achieved clinically significant improvements in metabolic syndrome score), both in Latinas. Eight pilot trials intervened on both diet and PA and three of them found favorable behavioral changes. Three (two for Latinas and one for Blacks) out of the nine diet and PA trials and three (all for Latinas) efficacy trials incorporated a culturally focused approach (i.e., traditional foods, music, Spanish content, bicultural health coaches, spirituality). Overall, four trials, including one efficacy trial, had one-year follow-up data, with three finding sustained behavior change. Electronic/mobile components were incorporated in five trials and one involved informal care givers. Most of the trials were geographically limited to the Northeast USA (n=8, NY, NC, DC, NJ) and Texas (n=4). Conclusions: Most of the trials we identified were pilot or feasibility studies and of short duration, demonstrating the need for large randomized controlled efficacy lifestyle interventions among Black and Latina breast cancer survivors. Culturally tailored programing was limited but is an important component to incorporate in future trials in these populations. [ABSTRACT FROM AUTHOR]

Background: Early reports suggested increased mortality from COVID‐19 in patients with cancer but lacked rigorous comparisons to patients without cancer. We investigated whether a current cancer diagnosis or cancer history is an independent risk factor for death in hospitalized patients with COVID‐19. Patients and Methods: We identified patients with a history of cancer admitted to two large hospitals between March 13, 2020, and May 10, 2020, with laboratory‐confirmed COVID‐19 and matched them 1:2 to patients without a history of cancer. Results: Men made up 56.2% of the population, with a median age of 69 years (range, 30–96). The median time since cancer diagnosis was 35.6 months (range, 0.39–435); 80% had a solid tumor, and 20% had a hematologic malignancy. Among patients with cancer, 27.8% died or entered hospice versus 25.6% among patients without cancer. In multivariable analyses, the odds of death/hospice were similar (odds ratio [OR], 1.09; 95% confidence interval [CI], 0.65–1.82). The odds of intubation (OR, 0.46; 95% CI, 0.28–0.78), shock (OR, 0.54; 95% CI, 0.32–0.91), and intensive care unit admission (OR, 0.51; 95% CI, 0.32–0.81) were lower for patients with a history of cancer versus controls. Patients with active cancer or who had received cancer‐directed therapy in the past 6 months had similar odds of death/hospice compared with cancer survivors (univariable OR, 1.31; 95% CI, 0.66–2.60; multivariable OR, 1.47; 95% CI, 0.69–3.16). Conclusion: Patients with a history of cancer hospitalized for COVID‐19 had similar mortality to matched hospitalized patients with COVID‐19 without cancer, and a lower risk of complications. In this population, patients with active cancer or recent cancer treatment had a similar risk for adverse outcomes compared with survivors of cancer. Implications for Practice: This study investigated whether a current cancer diagnosis or cancer history is an independent risk factor for death or hospice admission in hospitalized patients with COVID‐19. Active cancer, systemic cancer therapy, and a cancer history are not independent risk factors for death from COVID‐19 among hospitalized patients, and hospitalized patients without cancer are more likely to have severe COVID‐19. These findings provide reassurance to survivors of cancer and patients with cancer as to their relative risk of severe COVID‐19, may encourage oncologists to provide standard anticancer therapy in patients at risk of COVID‐19, and guide triage in future waves of infection. This article focuses on whether a current cancer diagnosis or cancer history is an independent risk factor for death or hospice admission in hospitalized patients with COVID‐19. [ABSTRACT FROM AUTHOR]

Caring for older patients with breast cancer presents unique clinical considerations because of preexisting and competing comorbidity, the potential for treatment-related toxicity, and the consequent impact on functional status. In the context of the COVID-19 pandemic, treatment decision making for older patients is especially challenging and encourages us to refocus our treatment priorities. While we work to avoid treatment delays and maintain therapeutic benefit, we also need to minimize the risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposures, myelosuppression, general chemotherapy toxicity, and functional decline. Herein, we propose multidisciplinary care considerations for the aging patient with breast cancer, with the goal to promote a team-based, multidisciplinary treatment approach during the COVID-19 pandemic and beyond. These considerations remain relevant as we navigate the "new normal" for the approximately 30% of breast cancer patients aged 70 years and older who are diagnosed in the United States annually and for the thousands of older patients living with recurrent and/or metastatic disease. [ABSTRACT FROM AUTHOR]

Background Newly diagnosed multiple myeloma patients have many available treatment options. While lenalidomide, bortezomib, and dexamethasone (RVD) is the preferred initial treatment for many patients, several other agents may provide similar efficacy with less toxicity and improved ease of administration. Methods We evaluated the safety and efficacy of the all-oral regimen of ixazomib, cyclophosphamide, and dexamethasone with the use of metronomic cyclophosphamide dosing in the treatment of patients with newly diagnosed multiple myeloma. Results The study was stopped prior to planned enrollment due to slow recruitment, with 12 patients available for final analysis. The overall response rate was 58.3% with 2 patients achieving a very good partial response (16.7%) and 5 patients achieving a partial response (41.7%). Median progression-free survival was 16 months, and median overall survival was 43 months. There were no episodes of grade 3 or greater peripheral neuropathy. Grade 3 or greater dermatologic toxicity was experienced in 50% of patients. Conclusion Although limited enrollment prevented full efficacy evaluation, our data do not support further study of metronomic cyclophosphamide in combination with ixazomib and dexamethasone in the treatment of newly diagnosed multiple myeloma. The activity of this regimen in the relapsed/refractory setting requires further study (ClinicalTrials.gov Identifier: NCT02412228). [ABSTRACT FROM AUTHOR]

Currently, no targeted therapies are available for metastatic triplenegative breast cancer (mTNBC). We evaluated the safety, efficacy, and biomarkers of response to cabozantinib, a multikinase inhibitor, in patients with mTNBC. We conducted a single arm phase II and biomarker study that enrolled patients with measurable mTNBC. Patients received cabozantinib (60 mg daily) on a 3-week cycle and were restaged after 6 weeks and then every 9 weeks. The primary endpoint was objective response rate. Predefined secondary endpoints included progression-free survival (PFS), toxicity, and tissue and blood circulating cell and protein biomarkers. Of 35 patients who initiated protocol therapy, 3 (9% [95% confidence interval (CI): 2, 26]) achieved a partial response (PR). Nine patients achieved stable disease (SD) for at least 15 weeks, and thus the clinical benefit rate (PR+SD) was 34% [95% CI: 19, 52]. Median PFS was 2.0 months [95% CI: 1.3, 3.3]. The most common toxicities were fatigue, diarrhea, mucositis, and palmar-plantar erythrodysesthesia. There were no grade 4 toxicities, but 12 patients (34%) required dose reduction. Two patients had TNBCs with MET amplification. During cabozantinib therapy, there were significant and durable increases in plasma placental growth factor, vascular endothelial growth factor (VEGF), VEGF-D, stromal cell-derived factor 1a, and carbonic anhydrase IX, and circulating CD3 + cells and CD8 + T lymphocytes, and decreases in plasma soluble VEGF receptor 2 and CD14+ monocytes (all p < .05). Higher baseline concentrations of soluble MET (sMET) associated with longer PFS ( p = .03). In conclusion, cabozantinib showed encouraging safety and efficacy signals but did not meet the primary endpoint in pretreated mTNBC. Exploratory analyses of circulating biomarkers showed that cabozantinib induces systemic changes consistent with activation of the immune system and antiangiogenic activity, and that sMET should be further evaluated a potential biomarker of response. The Oncologist 2017;22:25-32 Implications for Practice: Triple-negative breast cancer (TNBC)-a disease with a dearth of effective therapies-often overexpress MET, which is associated with poor clinical outcomes. However, clinical studies of agents targeting MET and VEGF pathways-alone or in combination-have shown disappointing results. This study of cabozantinib (a dual VEGFR2/MET) in metastatic TNBC, while not meeting its prespecified endpoint, showed that treatment is associated with circulating biomarker changes, and is active in a subset of patients. Furthermore, this study demonstrates that cabozantinib therapy induces a systemic increase in cytotoxic lymphocyte populations and a decrease in immunosuppressive myeloid populations. This supports the testing of combinations of cabozantinib with immunotherapy in future studies in breast cancer patients. [ABSTRACT FROM AUTHOR]

Preoperative bevacizumab and chemotherapy may benefit a subset of breast cancer (BC) patients. To explore potential mechanisms of this benefit, we conducted a phase II study of neoadjuvant bevacizumab (single dose) followed by combined bevacizumab and adriamycin/cyclophosphamide/paclitaxel chemotherapy in HER2- negative BC. The regimen was well-tolerated and showed a higher rate of pathologic complete response (pCR) in triple-negative (TN)BC (11/21 patients or 52%, [95% confidence interval (CI): 30,74]) than in hormone receptor-positive (HR)BC [5/78 patients or 6% (95%CI: 2,14)]. Within the HRBCs, basal-like subtype was significantly associated with pCR (P = 0.007; Fisher exact test). We assessed interstitial fluid pressure (IFP) and tissue biopsies before and after bevacizumab monotherapy and circulating plasma biomarkers at baseline and before and after combination therapy. Bevacizumab alone lowered IFP, but to a smaller extent than previously observed in other tumor types. Pathologic response to therapy correlated with sVEGFR1 postbevacizumab alone in TNBC (Spearman correlation 0.610, P = 0.0033) and pretreatment microvascular density (MVD) in all patients (Spearman correlation 0.465, P = 0.0005). Moreover, increased pericyte- covered MVD, amarker of extent of vascular normalization, after bevacizumab monotherapy was associated with improved pathologic response to treatment, especially in patients with a high pretreatment MVD. These data suggest that bevacizumab prunes vessels while normalizing those remaining, and thus is beneficial only when sufficient numbers of vessels are initially present. This study implicates pretreatment MVD as a potential predictive biomarker of response to bevacizumab in BC and suggests that new therapies are needed to normalize vessels without pruning. [ABSTRACT FROM AUTHOR]

Background. Plasmablastic lymphoma (PBL) is a variant of diffuse large B-cell lymphoma commonly seen in the oral cavity of HIV-infected individuals. PBL has a poor prognosis, but prognostic factors in patients who have received chemotherapy have not been adequately evaluated. Methods. An extensive literature search rendered 248 cases of PBL, from which 157 were HIV+. Seventy cases with HIV-associated PBL that received chemotherapy were identified. Whenever possible, authors of the original reports were contacted to complete clinicopathological data. Univariate analyses were performed calculating Kaplan-Meier estimates and compared using the log-rank test. Results. The mean age was 39 years, with a male predominance. The mean CD4+ count was 165 cells/mm3. Advanced clinical stage was seen in 51% and extraoral involvement was seen in 43% of the cases. The expression levels of CD20 and Epstein-Barr virus- encoded RNA were 13% and 86%, respectively. The overall survival duration was 14 months. In a univariate analysis, early clinical stage and a complete response to chemotherapy were associated with longer survival. There was no apparent difference in survival with regimens more intensive than cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Conclusions. Patients with HIV-associated PBL have a poor prognosis. Prognosis is strongly associated with achieving a complete clinical response to CHOP or CHOP-like chemotherapy. The role of more intensive regimens is currently unclear. Further research is needed to improve responses using novel therapeutic agents and strategies. [ABSTRACT FROM AUTHOR]

Objectives: The Survivor's Health and Reaction study used a quality-of-life model adapted for cancer survivors by Dow and colleagues to identify factors related to global health-related quality of life (HRQL) and to document the prevalence of problems and health-oriented behaviors in a follow-up study of breast cancer patients who participated in CALGB 8541. Methods: A total of 245 survivors (78% of those invited) who were 9.4–16.5 years post-diagnosis completed surveys that inquired about current HRQL, economic, spiritual, physical and psychosocial concerns, and health-oriented behaviors (e.g. smoking, exercise, and supplement use). A regression model was developed to examine factors related to global HRQL across all domains. Results: The regression model revealed that decreased energy levels (odds ratio (OR)=1.05, 95% confidence interval (CI): 1.03, 1.07), having heart disease (OR=5.01, 95% CI: 1.39, 18.1), having two or more co-morbidities (OR=2.39, 95% CI: 1.10, 5.19), and lower social support (OR=1.03, 95% CI: 1.02, 1.05) were associated with lower global HRQL. Factors related to psychological, spiritual, and economic domains were not predictive of global HRQL. Regarding lifestyle changes, some women reported engaging in health-oriented behaviors since their cancer diagnosis, such as improving eating habits (54%), increasing exercise (32%), and reducing/quitting smoking (20%). The most prevalent problems reported by women at follow-up were menopausal symptoms (64%), such as hot flashes and vaginal dryness, osteoporosis (25%), and lymphedema (23%). Conclusion: Suggestions are provided to target interventions, such as provider-based strategies, in order to improve HRQL in long-term breast cancer survivors. Copyright © 2008 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Variations in hospice use are not well understood.Objective: Assess whether care before death, including the types of physicians seen, number of outpatient visits, and hospitalizations, was associated with hospice use and the timing of enrollment.Design/setting: Observational study of a population-based sample of advanced breast cancer patients included in the Surveillance, Epidemiology, and End Results--Medicare database.Patients: There were 4,455 women aged > or =65 diagnosed with stage III/IV breast cancer during 1992-1999 who died before the end of 2001.Measurements: Hospice use and, among enrollees, enrollment within 2 weeks of death. Independent variables of interest included hospitalizations, outpatient visits, and physicians seen before death.Results: Adjusted hospice use rates were higher for hospitalized patients (45% if hospitalized for 1-7 days, 46% if 8-20 days, 35% if > or =21 days) than those not hospitalized (31%, P < 0.001). Adjusted rates were also higher among patients seeing a cancer specialist and primary care provider (PCP; 41%) and those seeing a cancer specialist and no PCP (38%) than among those seeing a PCP and no cancer specialist (30%) or neither type of physician (22%; P < 0.001). Hospice use also increased with increasing frequency of outpatient visits (P < 0.001). Hospitalizations, physicians seen, and visits were not associated with referral within 2 weeks of death (all P > or = 0.10).Discussion: Care before death is associated with hospice use among older women with advanced breast cancer. Additional research is needed to understand better how differences in patient characteristics and disease status influence cancer care before death and the role of various types of physicians in hospice referrals. [ABSTRACT FROM AUTHOR]

This article presents a cast study of the management of breast cancer in a 62-year old woman. This postmenopausal women had a second breast cancer raising issues relating to diagnosis and disease management. The use of magnetic resonance imaging in the detection of breast cancer and current guidelines for HER2 testing are mentioned. A discussion of treatment centered upon whether the cancer represented a new primary tumor or a metastasis. Adjuvant systemic and endocrine therapies, chemotherapy and the use of trastuzamab are discussed.

Background: The study's objective was to test whether there were signfiicant differences in adjustment between younger and older breast and endometrial cancer survivors. Methods: Two hundred and fifty-two breast and endometrial cancer survivors participated in this study, ranging in age from either 18 to 55 years old or 65 years old or older. Survivors were interviewed by telephone at study entry and 12 months, using a battery of measures to assess their adjustment, physical functioning, and treatment-related physical problems. Results: With an average of 3.7 years since treatment completion, almost all survivors reported good adjustment to having had cancer. While most differences in psychosocial adjustment between groups were small, younger survivors reported significantly worse adaptation than older survivors, as measured by the Hospital Anxiety and Depression Scale (HADS, p<0.0001), Appearance-Orientation Scale (AOS, body image; p=0.02), Fear of Recurrence (p<0.0001), Distress about Long-term Treatment-Related Cancer Problems (p=0.01), and Number of Sexual Problems Attributed to Cancer (p<0.0001). Conclusion: Survivors reported few cancer-related problems with only a small subset reporting problems in adjustment. Although differences were small, younger cancer survivors reported significantly worse adaptation than older survivors. Much of the adaptation to having had cancer may have already occurred in long-term survivors. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article presents a study which described the vinorelbine/trastuzumab and taxane/trastuzumab treatments for HER2-positive, metastatic breast cancer. The study included eligible patients which had HER2-overexpressing, metastatic breast cancer and had received no prior chemotherapy for advanced disease. The study found that response rates were 51% and 40% for the vinorelbine/trastuzumab arm and the taxane/trastuzumab arm, respectively.

The article presents a medical report concerning estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. The article suggests the much progress has been made in the treatment of early stage breast cancer, and that in patients with hormone-sensitive tumors, tamoxifen reduces the risk of recurrence and death by more than 30%. Additionally, treatment with aromatase inhibitors further reduces the risk of recurrence in post-menopausal women with estrogen-receptor positive tumors.

High-dose chemotherapy with autologous stem cell support for the treatment of breast cancer can have a profound effect on patients' quality of life (QOL).  This article reviews findings from studies assessing QOL before, during, and after high-dose chemotherapy.  The impact of high-dose therapy on overall QOL and specific aspects of QOL including physical functioning, symptoms, psychosocial/emotional and cognitive functioning, sexual functioning, and role functioning is considered.  High-dose chemotherapy with stem cell transplant results in largely transient impairment of overall QOL and physical functioning, with subsequent improvement to baseline or better over time. Despite these encouraging global QOL findings, many patients continue to suffer considerable symptoms and concerns attributable to their transplant long after completion of the therapy.  Additional research in this area is needed to optimize QOL for patients receiving high-dose chemotherapy. [ABSTRACT FROM AUTHOR]

A correction is presented to the article "Phase II and Biomarker Study of Cabozantinib in Metastatic Triple-Negative Breast Cancer Patients" which appeared in the October 27, 2016 issue.

Background: Over the past decade, high dose chemotherapy with autologous bone marrow (HDC-ABMT) support has been used increasingly in the treatment of patients with breast cancer. In evaluating the results of HDC-ABMT in patients with breast cancer, an assessment of quality of life can add to the traditional endpoints (toxicity, and disease-free and overall survival) that are routinely assessed in clinical trials. Purpose: This study evaluated the quality of life (QOL) of breast cancer patients who had survived I or more years following high dose chemotherapy with autologous bone marrow transplant (HDC-ABMT) support. Methods: Eighty-two patients who had undergone HDC-ABMT were surveyed by written questionnaire and follow-up telephone interview at least 1 year following HDC-ABMT. Patients were asked to complete the Functional Living Index-Cancer (FLIC), the Symptom Distress Scale (SDS), and a survey of sexual function developed as part of the study. Results: The mean FLIC score among all patients was 130 ± 19.1 (possible range 22–154). FLIC scores were significantly lower in patients with evidence of recurrent disease than in patients who were free of disease. The most commonly reported symptoms after HDC-ABMT were insomnia, fatigue, and pain. Sexual interest and sexual activity were reported to be lower after participation in HDC-ABMT than prior to the procedure. The majority of patients who were employed outside the home prior to HDC-ABMT returned to work with a median time away from work of 48 weeks. Conclusions: Patients with breast cancer who survive 1 or more years following HDC-ABMT rate their QOL at a relatively high level and frequently return to work. Less than one-third of patients who were interviewed reported moderate to severe symptoms. Problems with sexual functioning were common. Implications: Future research is needed on long-term outcomes after HDC-ABMT and on specific areas of concern, such as sexual functioning. [ABSTRACT FROM AUTHOR]

Background: We aimed to examine the safety and efficacy of bevacizumab and carboplatin in patients with breast cancer brain metastases.Methods: We enrolled patients with breast cancer and > 1 measurable new or progressive brain metastasis. Patients received bevacizumab 15 mg/kg intravenously (IV) on cycle 1 day 1 and carboplatin IV AUC = 5 on cycle 1 day 8. Patients with HER2-positive disease also received trastuzumab. In subsequent cycles, all drugs were administered on day 1 of each cycle. Contrast-enhanced brain MRI was performed at baseline, 24-96 h after the first bevacizumab dose (day + 1), and every 2 cycles. The primary endpoint was objective response rate in the central nervous system (CNS ORR) by composite criteria. Associations between germline VEGF single nucleotide polymorphisms (rs699947, rs2019063, rs1570360, rs833061) and progression-free survival (PFS) and overall survival (OS) were explored, as were associations between early (day + 1) MRI changes and outcomes.Results: Thirty-eight patients were enrolled (29 HER2-positive, 9 HER2-negative); all were evaluable for response. The CNS ORR was 63% (95% CI, 46-78). Median PFS was 5.62 months and median OS was 14.10 months. As compared with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, patients with ECOG PS 1-2 had significantly worse PFS and OS (all P < 0.01). No significant associations between VEGF genotypes or early MRI changes and clinical outcomes were observed.Conclusions: The combination of bevacizumab and carboplatin results in a high rate of durable objective response in patients with brain metastases from breast cancer. This regimen warrants further investigation.Trial Registration: NCT01004172 . Registered 28 October 2009. [ABSTRACT FROM AUTHOR]

The article comments on the controversy surrounding the recommendations for breast-cancer screening released by the U.S. Preventive Services Task Force (USPSTF). The recommendations include the elimination of mammography as a standard screening for women age 40 to 49 years old and that mammography should be conducted biennially in women from 50 to 74 years old. The authors offer their interpretation of the recommendations to enlighten some confusions regarding the effectiveness of mammography.

1. Identify the name and role of the family caregivers involved in the oncology patient's care during the ambulatory care visit 2. Assemble a list of community-based and hospital-based resources that offer support for family caregivers to any family caregiver in need As cancer care has shifted from inpatient to ambulatory settings, family members assume additional caregiving responsibility without the same close attention of an inpatient care team. Family caregivers' needs in the ambulatory setting are often underaddressed, and little is known about what specific support is lacking. To identify the recommendations of family caregivers from diverse racial and ethnic backgrounds for improving their experience of providing care to ambulatory patients with newly diagnosed advanced cancer in community- and academic-based ambulatory settings. We conducted semistructured interviews in caregivers of adults with newly diagnosed advanced solid tumors and hematologic malignancies receiving outpatient oncology care (n = 20). Interviews were recorded, transcribed, and analyzed via open, line-by-line, and inductive coding until thematic saturation was reached. Three primary recommendations emerged from these family caregivers. First, they expressed a desire to feel acknowledged by both the clinical care team and people in their community. Therefore, family caregivers recommended that health systems establish routine check-ins to assess and support them throughout the illness trajectory. Second, they asked that clinicians facilitate their positive adaptation to poor prognosis, including how they might face and accept the reality of prognosis and be involved in care decisions. Finally, family caregivers recommended that clinicians share resources and information on who, when, and how to access support in advance of their need for these services. Family caregivers offered key recommendations to enhance caregiver wellbeing when caring for patients with advanced cancer in the ambulatory care setting. Institutions should consider routine check-ins to assess caregiver wellbeing and interventions to help caregivers adapt to prognosis and access information about support services. Family caregiver roles are rapidly evolving due to shifts in cancer care toward ambulatory settings. Increased efforts are needed to promote wellbeing in this unique caregiver population. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated the administration of adjuvant treatment of exemestane with ovarian suppression to patients with premenopausal breast cancer. Topics explored include the evaluation of patient eligibility to the study, the oral endocrine therapy provided following chemotherapy, and the statistical analysis of research data gathered. Brief details about the breast cancer recurrence and patient outcomes recorded are also presented.

Growing evidence supports that cancer patients are interested in being offered the results of clinical trials for which they participate. However there is no standardization or requirements for clinicians or researchers to offer such information to patients. Better understanding oncology nurses' perspectives on this issue is important to the development and integration of formalized systems to share clinical trial results with patients. To examine the attitudes and practices of oncology nurses with regard to informing clinical trial participants study results. This study was guided by key principles of research ethics: respect for persons, benefi cence, and justice. A geographically dispersed sample of 125 oncology nurses who are members of the cancer cooperative group, Cancer and Leukemia Group B, completed and returned a mailed 31-item questionnaire designed and piloted for this study. Descriptive statistics were conducted. 62% of the nurses sampled do not offer results to patients and only 10.4% offer over half of the time. 73% agreed that most patients want to know study results and 83% agreed that patients should be offered this information. Benefi ts of routinely offering results to patients include: courtesy to patients, improve patient understanding of trials, improve patient satisfaction with care, and increase accrual to trials. Concerns about offering results to patients include: patients might not understand, entail too much money and time, patients can't act on this knowledge, negative emotional effects on clinicians and patients. 78% indicated willingness to offer results to patients, with 30% indicating they were less willing to do it for phase I/II compared with phase III studies. 9% would be less likely to enroll patients on trials if providing results was obligated, while 33% believe a policy obligating is a bad idea. Oncology nurses play an essential role in educating and counseling patients regarding clinical trials participation. Nurses need to be aware of their own attitudes and consider the implications if policies are put into place. If mandated, resources will be needed to account for the additional time required to appropriately provide this information to patients. [ABSTRACT FROM AUTHOR]

The article presents a medical protocol in examining the specimens of breast cancer patients offered by the College of American Pathologists in the U.S. It notes that the protocol is applicable to all invasive carcinomas of the breast which include ductal carcinoma in situ (DCIS) with microinvasion. Moreover, it also provides instructions, explanatory notes, and images that further explain the protocol.

Objective: A variety of pharmacologic therapies are available or in development for the prevention of breast cancer recurrence. Assessing the value of these treatments is compromised by a paucity of data on the impact of recurrence on economic costs and survival. The purpose of this study was to shed light on these issues. Methods: We conducted a retrospective analysis of linked SEER-Medicare data. All patients in the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) registry who were diagnosed with nonmetastatic breast cancer during 1991–1993 were identified, and their subsequent Medicare claims were scanned for evidence of further breast cancer events (local or distant recurrence, contralateral breast cancer). Medicare claims were then scanned from the time of the event through 2002 to assess patterns of survival and costs. Results: We identified 10,798 patients in SEER who were diagnosed with nonmetastatic breast cancer during 1991–1993, including 1833 who subsequently had another breast cancer event (local recurrence, 958; distant recurrence, 622; contralateral breast cancer, 253). Median survival was 37 months and 8 months among patients with local and distant recurrence, respectively; 53% of patients with contralateral breast cancer remained alive after all the data were censored at 97 months. Expected 10-year costs (2004 US$, discounted 3%) attributable to distant recurrence, local recurrence, and contralateral breast cancer were $11,450 (SE 2056), $19,596 (SE 1754), and $19,183 (SE 4131), respectively. Conclusion: Breast cancer recurrence and contralateral breast cancer lead to substantial increases in costs, amounting to approximately $11,000–19,000 over 10 years depending on type. The impact of these events on survival also varies considerably by type. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To understand the psychosocial outcomes related to decision-making processes of individuals eligible for participation in clinical trials. Methods: Individuals eligible to participate in selected clinical trials were contacted to complete two surveys; one shortly after participants were identified, and the second 6 weeks after the first survey was completed (N =50). Measures included subjective informed consent; satisfaction with decision-making; decisional regret; and timing of consent (early versus late signers). ANOVA and correlation coefficients were used to test the relationships between variables. Results: Early signers reported themselves to be less informed about the details of their particular clinical trials than later signers (M =81.9 versus 91.2; F =5.5; p =.02). There was a non-significant trend for early signers to be less satisfied with their decisions than late signers. Satisfaction with decision-making and subjective informed consent were both strongly associated with later decisional regret (r =−.32 and −.30, respectively). However, there was no relationship between timing of consent and decisional regret. Conclusion: Participants who enroll in clinical trials quickly may not believe they fully understand the implications of trial participation. In general, participants who do not believe they fully understand the implications of trial participation, or who are less satisfied with their decision to enroll in the trial may ultimately feel regret about their decision to participate. Practice implications: More effort is needed to ensure that clinical trial participants fully understand the risks and benefits of participation and are satisfied with their decision to enroll in a trial prior to signing consent forms. [Copyright &y& Elsevier]

Purpose: To determine the long-term prognosis of patients who develop a local recurrence (LR) after conservative surgery (CS) and radiation therapy (RT) for early-stage invasive breast cancer. Methods and materials: Between 1970 and 1987, 2102 patients with clinical Stage I-II breast cancer were treated with CS+RT. LR was defined as any recurrence within the ipsilateral breast with or without simultaneous regional nodal or distant metastasis. Patients were at risk for a LR until the first of distant metastases, second nonbreast malignancy, or death (DF/S/D). The final study population comprised 341 patients with LR. The median time to LR was 72 months. The median follow-up time after LR was 85 months. A proportional hazards model of time from LR to DF/S/D was done to investigate the influence of factors at initial diagnosis and at LR on subsequent outcome. Results: The actuarial freedom from DF/S/D 5 years after LR was 65% and the survival was 81%. Variables significantly associated with time to DF/S/D were: LR histology (invasive vs. ductal carcinoma in situ, hazard ratio [HR] = 4.1, p < 0.0001); local therapy for LR (none vs. mastectomy or unknown, HR = 3.2, p < 0.0001; and CS ± RT vs. mastectomy or unknown, HR = 2.0, p = 0.02); time to LR (≤2 years vs. >5 years, HR = 2.6, p < 0.0001; and 2–5 years vs. >5 years, HR = 1.8, p = 0.006); and age at initial diagnosis (≥60 vs. <60, HR = 1.6, p = 0.01). Conclusions: Many patients with LR after CS+RT have prolonged distant disease-free survival, particularly those able to be treated with mastectomy. Patients with a noninvasive LR, longer interval to LR, or age <60 had a longer time to distant failure, second malignancy, or death than other patients. [Copyright &y& Elsevier]

In general, patients are not given information about the results of trials in which they have participated. We aimed to assess the process and effect of providing clinical trial participants with results of a negative study. We offered results to 135 participants in a phase II trial of breast excision alone for women with ductal carcinoma in situ, which was stopped early because of an early high rate of local recurrence. 85 (90%) of 94 respondents chose to receive results; these women were more educated (57 [67%] of 85 college graduates) than those who chose not to (two [22%] of nine, p=0.006). Most participants reported positive feelings about being offered results and about clinical trials in general. These preliminary findings from sharing clinical trial results are encouraging. [ABSTRACT FROM AUTHOR]