Mode of Detection of Second Events in Routine Surveillance of Early Stage Breast Cancer Patients.

INTRODUCTION: NCCN and ASCO guidelines recommend breast cancer (BC) follow-up to include clinical breast examination (CBE) every 6 months and annual mammography (AM) for 5 years. Given limited data to support CBE, we evaluated the modes of detection (MOD) of BC-events in a contemporary practice. METHODS: We conducted a retrospective review of registry patients with early stage BC (DCIS, Stage I or II) diagnosed between 2010 and 2015 with at least 5 years of follow-up. Second events were defined as malignant (contralateral primary, ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, regional node recurrence or distant relapse) or benign. MOD was categorized as patient complaint, clinical examination or breast imaging. RESULTS: Sixty-three of 351 BC patients experienced second events. 15 had BC malignant events, including 4 distant disease, 5 contralateral primary, and 3 IBTR. 7/8 of IBTR and contralateral primary BC were AM detected. Patient complaints identified 4/4 distant relapses. Clinical exam identified 2/2 chest wall recurrences in post-mastectomy patients. CONCLUSIONS: Only 2.8% (10/351) of early stage BC patients experienced recurrence during 5 years of follow-up. AM was the predominate MOD of both IBTR and new contralateral primary following breast conserving therapy. Patient complaints prompted evaluation for distant disease. Provider CBE was MOD in only 2/351, 0.6% 95% CI (2.1%-0.1%) of patients as chest wall recurrences postmastectomy. Given modern enhancements to imaging and lower recurrence rates, this data encourages the reassessment of guidelines for every 6-month CBE and provides basis to study telehealth in survivorship care.

Insulin resistance and weight gain in women treated for early stage breast cancer.

PURPOSE: Both weight gain and insulin resistance have been associated with poorer prognosis in women receiving adjuvant therapy for early stage breast cancer, however, interactions between weight gain and insulin resistance have not been explored longitudinally throughout the breast cancer treatment continuum. METHODS: One hundred non-diabetic women with early stage breast cancer receiving adjuvant chemotherapy and /or hormonal therapy were enrolled in this prospective, observational study. Metrics of weight, body composition (BMI, waist/hip circumference ratio (WHR)), and cardiometabolic health (fasting insulin, glucose and triglycerides) were obtained prior to adjuvant therapy (baseline) and repeated 6, 12, and 24 months post-diagnosis. Insulin resistance was calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). RESULTS: Complete data were available for 95 participants. Compared to baseline, body weight was significantly higher at the 12-month time-point (75.3 ± 15.7 vs. 76.2 ± 16.7, p = 0.03), however there was no difference in waist circumference (p = 0.96) or WHR (p = 0.52). HOMA-IR tended to increase 6 months after diagnosis (2.36 ± 2.17 vs. 2.70 ± 2.83, p = 0.06), largely driven by adverse responses in patients treated with chemotherapy (mean change + 0.53 (chemotherapy) vs - 0.64 (no chemotherapy), p = 0.005). Despite 12-month weight gain, the 6-month increase in HOMA-IR was fully abrogated 12 months after diagnosis. CONCLUSION: Breast cancer patients experience small but significant weight gain in the year following diagnosis, and those who receive chemotherapy experience significant short-term metabolic impairments suggestive of insulin resistance. While the acute insulin resistance appears to attenuate over time, the long-term ramifications are unclear and may help explain weight gain in this population.

Weight gain following breast cancer diagnosis: Implication and proposed mechanisms.

Weight gain occurs in the majority of women following breast cancer treatment. An overview of studies describing weight gain amongst women treated with early to modern chemotherapy regimens is included. Populations at higher risk include women who are younger, closer to ideal body weight and who have been treated with chemotherapy. Weight gain ranges between 1 to 5 kg, and may be associated with change in body composition with gain in fat mass and loss in lean body mass. Women are unlikely to return to pre-diagnosis weight. Possible mechanisms including inactivity and metabolic changes are explored. Potential interventions are reviewed including exercise, dietary changes and pharmacologic agents. Although breast cancer prognosis does not appear to be significantly impacted, weight gain has negative consequences on quality of life and overall health. Future studies should explore change in body composition, metabolism and insulin resistance. Avoiding weight gain in breast cancer survivors following initial diagnosis and treatment should be encouraged.

Using quality oncology practice initiative metrics for physician incentive compensation.

PURPOSE: To demonstrate the use of American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) measures as part of a financial incentive plan for an academic health center-based hematology-oncology division. METHODS: An 11-member QOPI-certified hematology-oncology division participated in a pilot variable compensation (VC) plan with group-specific targets selected based on prior below-average performance. Twenty percent of overall VC was linked to success in two QOPI categories: completion of treatment summaries within 90 days of end of chemotherapy and assessment of patients' emotional well-being by second office visit. Three tiers of achievement were set for each goal. A formula combining VC goals into year-end payout was driven by three levels of percent base salary: 8%, 12%, and 24%, with probability of achievement of each goal of 90%, 50%, and 10%, respectively. Practice leadership was educated about QOPI acceptance in the oncology community. RESULTS: The division participated in QOPI during spring and fall 2012. With systems-based improvements, 40.54% of medical records audited had treatment summaries, resulting in achievement of tier III compensation. Documentation of emotional well-being increased, yielding 63% of patient cases compliant; however, the national benchmark concurrently improved, making this insufficient to achieve tier I. CONCLUSION: QOPI metrics can be used as a quality incentive for oncologists in a VC plan. Non-oncologists can appreciate the strength of QOPI as a quality tool. The combination of a QOPI program through ASCO and use of various QOPI metrics can drive continuous improvement in an oncology group.

Using process elicitation and validation to understand and improve chemotherapy ordering and delivery.

BACKGROUND: Chemotherapy ordering and administration, in which errors have potentially severe consequences, was quantitatively and qualitatively evaluated by employing process formalism (or formal process definition), a technique derived from software engineering, to elicit and rigorously describe the process, after which validation techniques were applied to confirm the accuracy of the described process. METHODS: The chemotherapy ordering and administration process, including exceptional situations and individuals' recognition of and responses to those situations, was elicited through informal, unstructured interviews with members of an interdisciplinary team. The process description (or process definition), written in a notation developed for software quality assessment purposes, guided process validation (which consisted of direct observations and semistructured interviews to confirm the elicited details for the treatment plan portion of the process). RESULTS: The overall process definition yielded 467 steps; 207 steps (44%) were dedicated to handling 59 exceptional situations. Validation yielded 82 unique process events (35 new expected but not yet described steps, 16 new exceptional situations, and 31 new steps in response to exceptional situations). Process participants actively altered the process as ambiguities and conflicts were discovered by the elicitation and validation components of the study. Chemotherapy error rates declined significantly during and after the project, which was conducted from October 2007 through August 2008. DISCUSSION: Each elicitation method and the subsequent validation discussions contributed uniquely to understanding the chemotherapy treatment plan review process, supporting rapid adoption of changes, improved communication regarding the process, and ensuing error reduction.

Relapsed acute promyelocytic leukemia in a hemodialysis-dependent patient treated with arsenic trioxide: a case report.

INTRODUCTION: In the relapsed setting, arsenic trioxide remains the backbone of treatment. Scant literature exists regarding treatment of relapsed acute promyelocytic leukemia in patients with renal failure. To the best of our knowledge we are the first to report a safe and effective means of treatment for relapsed acute promyelocytic leukemia in the setting of advanced renal failure, employing titration of arsenic trioxide based on clinical parameters rather than arsenic trioxide levels. CASE PRESENTATION: A 33-year-old Caucasian man with a history of acute promyelocytic leukemia in remission for 3 years, as well as dialysis-dependent chronic renal failure secondary to a solitary kidney and focal segmental glomerulosclerosis and human immunodeficiency virus infection, receiving highly active antiretroviral therapy presented to our hospital with bone marrow biopsy-confirmed relapsed acute promyelocytic leukemia. Arsenic trioxide was begun at a low dose with dose escalation based only on side effect profile monitoring and not laboratory testing for induction as well as maintenance without undue toxicity. Our patient achieved and remains in complete hematologic and molecular remission as of this writing. CONCLUSION: Arsenic trioxide can be used safely and effectively to treat acute promyelocytic leukemia in patients with advanced renal failure using careful monitoring of side effects rather than blood levels of arsenic to guide therapeutic dosing.

Chronic diarrhea associated with persistent norovirus excretion in patients with chronic lymphocytic leukemia: report of two cases.

BACKGROUND: Chronic diarrhea in patients treated with immunosuppressive agents or suffering from immunosuppressive disease can represent a diagnostic and therapeutic challenge to the clinician. Norovirus infection, a major cause of acute epidemic diarrhea, has been described as a cause of chronic diarrhea in patients who are immunosuppressed, including transplant recipients and the very young. CASE PRESENTATIONS: We describe two patients, a 64 year-old man and a 59 year-old woman, both suffering from chronic lymphocytic leukemia and hypogammaglobulinemia, who developed chronic diarrhea resistant to therapy. In both cases, after months of symptoms, persistent norovirus infection--documented by repeatedly-positive high-sensitivity stool enzyme immunoassay--was found to be the cause. Both patients died with active diarrheal symptoms. CONCLUSIONS: We describe the first cases of advanced chronic lymphocytic leukemia to suffer from chronic symptomatic norovirus infection. Clinicians caring for such patients, particularly those with concomitant hypogammaglobulinema, who have chronic unexplained diarrhea, should consider norovirus infection in the differential diagnosis.

Does therapeutic touch ease the discomfort or distress of patients undergoing stereotactic core breast biopsy? A randomized clinical trial.

OBJECTIVE: To determine whether therapeutic touch administered at the time of stereotactic core biopsy of suspicious breast lesions results in a reduction in anxiety and pain. DESIGN: Randomized, patient-blinded, controlled trial of either Krieger-Kunz therapeutic touch administered by a trained practitioner or a sham intervention mimicking therapeutic touch delivered during core biopsy. SETTING: Stereotactic breast biopsy unit of a comprehensive breast center. PATIENTS: Women with mammographically detected, nonpalpable breast lesions requiring biopsy. OUTCOME MEASURES: Changes in pain and anxiety measured by visual analog scales immediately before and after stereotactic core biopsy. RESULTS: A total of 82 patients were accrued: 42 received actual therapeutic touch and 40 sham therapeutic touch. No significant differences were found between the arms for age, ethnicity, educational background, or other demographic data. The sham arm had a preponderance of left breast biopsies (48% vs 58%; P = 0.07) and received a slightly higher volume of epinephrine-containing local anesthetic (6.5 +/- 6.1 vs 4.5 +/- 4.5 mL; P = 0.09). Therapeutic touch patients were more likely to have an upper breast lesion location (57% vs 53%; P = 0.022). No significant differences between the arms were seen regarding postbiopsy pain (P = 0.95), anxiety (P = 0.66), fearfulness, or physiological parameters. Similarly, no differences were seen between the arms when change in parameters from prebiopsy to postbiopsy was considered for any of the psychological or physiological variables measured. These findings persisted when confounding variables were controlled for. CONCLUSIONS: Women undergoing stereotactic core breast biopsy received no significant benefit from therapeutic touch administered during the procedure. Therapeutic touch cannot be routinely recommended for patients in this setting.

Longitudinal patterns of weight gain after breast cancer diagnosis: observations beyond the first year.

Many, but not all patients experience weight gain 1 year after a breast cancer diagnosis; clearly defined, clinically relevant groups at risk of weight gain have yet to be described. We set out to determine the factors associated with weight gain over time in patients with invasive breast cancer during a period of predominantly anthracycline-based adjuvant chemotherapy and to identify groups with differing weight gain risks. Breast cancer patients (stage I-IIIB) were identified in a retrospective chart review. Evaluated parameters included weight at diagnosis and 1, 2, and 3 years later, height, body mass index (BMI), age, menopausal and change in menopausal status, as well as therapy and pathologic stage. Regression models identified significant independent predictors of weight change. Recursive partitioning analysis (RPA) was employed to divide the dataset into relevant and significant groups. In 185 identified patients, regression models and RPA demonstrated that weight gain at 1 year was associated with younger age, adjuvant chemotherapy, and lower BMI. Weight gain at 2 years (n = 176) was greater than at year 1, and in addition to weight gain at year 1, was associated with younger age and adjuvant chemotherapy in regression analysis; RPA found that anthracycline therapy, age, and BMI were important. Weights at 3 years were similar to those seen at 2 years. Early-stage breast cancer patients treated with chemotherapy continue to gain weight 2 years after diagnosis, and this weight gain appears to be persistent at year 3. Observation beyond 1 year is needed to adequately evaluate weight gain in early-stage breast cancer patients, particularly for those receiving contemporary adjuvant chemotherapy.

Can a cancer program-sponsored spiritual event meet with acceptance from patients and other attendees?

BACKGROUND: While many cancer patients derive strength from spiritual or religious faith, concern often remains regarding how different patient subgroups and other community members might react to faith-based services when sponsored by a secular health care organization. METHODS: "A Sacred Gathering for Those Touched by Cancer" was presented in 2 Catholic and 2 Protestant churches. The service included key themes (surrendering fear, peace, hope, community support, and God's love) reinforced by Scripture, music, ritual, and prayer. Patients, clergy, and staff participated. Questionnaires evaluating attendee characteristics, emotional response to the service, and satisfaction with service components were distributed. RESULTS: Attendees (women: 80%; Catholic: 71%; half older than 50 years) returned 450 questionnaires. Most found the service very (83%) or somewhat (14%) helpful. Multivariate regression of perceptions indicated (1) the opinion that the service was helpful was associated with the perception that the service made the respondent feel hopeful (P < .0001), that respondents found inspirational messages important (P = .058), and that the respondent was a current patient (P = .018) and (2) an angry response reported by respondents was associated with current patient status (P = .0044). Men tended to feel less loved by God (P = .012) and people (P = .034) and less hopeful (P = .057) than women did. Men liked music less (P = .048), liked Scripture and prayers concerning community less (P = .040), and found prayer (P = .0035) less important. However, men felt the gatherings were as helpful as women did. Past patients felt less sadness than did others (P = .0084). Increased perceived helpfulness of the service was associated in a multivariate analysis with current patient status, feeling hopeful as a result of the service, increased appreciation of the service's inspirational message, and the perception that the service was not too long. CONCLUSIONS: While almost all attendees found the service somewhat or very helpful, distinct preferences and reactions to the service were noted for gender, patient status, and religious affiliation. This evaluation will help tailor future events to better meet the spiritual needs of cancer patients and their loved ones.

Docetaxel and cyclooxygenase-2 inhibition with celecoxib for advanced non-small cell lung cancer progressing after platinum-based chemotherapy: a multicenter phase II trial.

PURPOSE: To assess the overall and progression-free survival, response rate, and toxicity of combined docetaxel and celecoxib in the treatment of patients with non-small cell lung cancer progressing after initial chemotherapy for advanced disease. PATIENTS AND METHODS: Patients with non-small cell lung cancer and either measurable or evaluable disease experiencing progression after one or more platinum-based chemotherapy regimens given for advanced or metastatic disease, ECOG performance status 0-2, and adequate hematologic and biochemistry parameters were eligible for study inclusion; exclusion criteria included symptomatic brain metastases and full dose anti-coagulation. Therapy consisted of docetaxel 75 mg/m(2) every 21 days for a maximum of six cycles and celecoxib 400 mg orally twice daily commencing 7 days prior to docetaxel and continuing until disease progression. RESULTS: A total of 41 patients were enrolled of whom 39 were deemed eligible and received at least one course of docetaxel. The mean age of enrolled patients was 60.5 years (range, 44-77); 67% were men and 79% white. All but one patient had an Eastern Clinical Oncology Group (ECOG) performance status of 0 or 1. Most (72%) had been treated with a prior taxane. Overall survival was 11.3 months (95% confidence interval [CI]: 7.9, 15.7) and progression-free survival 19.6 weeks (95% CI: 13.5, 25.0). A response rate of 10.2% (95% CI: 3%, 24%) for all eligible and treated patients was found. Grade 3 or 4 neutropenia occurred in 10/39 patients (25.6%); one death due to neutropenic sepsis occurred. No grade 3 or 4 renal or hepatic toxicities were documented. CONCLUSION: Treatment with combination celecoxib and docetaxel is a safe regimen with a toxicity profile similar to that of docetaxel alone. Survival data are encouraging compared to historical controls and may prolong time to disease progression compared with single-agent docetaxel.

Association of admission date with cancer patient survival at a regional hospice: utility of a statistical process control analysis.

Previously published multivariate analyses have not considered date of entry as a possible factor associated with length of stay (LOS), nor has the pattern of decreasing LOS been analyzed. We set out to assess mean LOS over time and to determine the factors, including date of death, which are independently associated with LOS. Cancer patients admitted to our hospice from 1996 through 2001 were assessed for dates of admission/discharge/death, age, gender race, specific cancer diagnosis, referring physician characteristics, place of death, and heath insurance type. Statistical process control (SPC) charts and proportional hazard models were constructed for patients prioritized by date of admission, with active or discharged patients censored. A total of 2126 patients were analyzed. An abrupt and significant drop in mean LOS was seen for all cancer patients and for most cancer sites from April to December 1998 (temporally associated with a "Special Fraud Alert" issued by the Office of Inspector General) and again in the second and third quarter of 2000. A proportional hazards model revealed that LOS was associated with cancer site (p < 0.0001), quarter in which patient was admitted (p = 0.0020), and sex (women surviving longer, p = 0.013), age (older patients surviving longer, p 0.0149), and insurance (p = 0.071). Mean LOS is associated with date of admission to hospice independent of other associated factors. LOS decreases do not occur in a gradual, continuous fashion but suddenly and intermittently, and they are not associated with changes in referral numbers or readmissions. SPC charts proved to be an effective method of tracking and evaluating hospice LOS on an ongoing basis.

Taking a "leap of faith": acceptance and value of a cancer program-sponsored spiritual event.

Investigations of spiritual interventions for cancer patients are disproportionately few compared to the reported importance of religion to Americans. We report on the implementation and evaluation of a spiritual, community-based intervention developed with interdenominational community clergy. Approximately 1200 people attended a total of 3 gatherings: 2 at Roman Catholic and another at a Protestant Church. Respondents to questionnaires evaluating attendee characteristics and satisfaction (n = 209) were predominantly women (85%); 50% were patients and 45% were aged 60 years and older. Men were more likely to be currently under treatment for cancer, while women were more likely to be past patients or friends. Fewer than 2% felt anger or anxiety; attendees felt the service was very (90%) or somewhat (9.5%) helpful and expressed appreciation for cancer program clinician attendance and for hospital sponsorship of the event. Components in order of preference were prayer, music, Scripture, and litany. Logistic regression models reveal that music was most appreciated by previously treated patients, and prayer by currently treated patients. Secular healthcare systems can offer a religious service that comforts and links attendees to a broader community, including clergy and cancer program clinicians. Surveys can identify service components that appeal to differing groups and can facilitate service development.

Contralateral breast cancer: factors associated with stage and size at presentation.

Few reports have evaluated factors associated with the stage at presentation of contralateral breast cancer and whether contralateral cancer presentation has changed in recent years, during which increased screening and enhanced adjuvant therapy of the initial tumor has been introduced. Patients with initial cancers staged 0-IIIB diagnosed between 1980 and 1999 who subsequently developed contralateral breast cancer were evaluated for stage, primary tumor size and histologic features, patient age and year of diagnosis, synchronous or metachronous presentation, and time from initial tumor to diagnosis of contralateral breast cancer. Tumor presentation was compared with contemporaneously diagnosed unilateral breast cancer patients. A total of 171 patients were diagnosed with contralateral breast cancer; 161 cases if lobular carcinoma in situ for either the initial or the contralateral tumor were excluded. Contralateral tumors were of significantly smaller size and of earlier stage than initial tumors. Contralateral cancers demonstrated earlier stage distributions with more recent year of diagnosis; initial tumors in contralateral patients did not. Earlier stage at presentation of contralateral tumors was associated in a multivariate model with more recent year of contralateral tumor diagnosis and earlier stage at presentation of the initial tumor; contralateral tumor size was associated with the size of the initial tumor. More recently diagnosed contralateral breast cancers are presenting with earlier stages of disease. The stages of initial tumors in these patients have not undergone such an improvement. Initial tumor size and stage is strongly associated with contralateral breast cancer size and stage; this association is independent of the year of diagnosis. Increased compliance with screening might be expected to improve both initial tumor stage and tumor size presentations in contralateral tumor patients, as well as the presentation of contralateral cancers.

Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines.

PURPOSE: To evaluate the effect of performance and outcomes feedback on adherence to clinical practice guidelines regarding chemotherapy-induced nausea and emesis (CINE). METHODS: Institutional CINE clinical practice guidelines were developed based on American Society of Clinical Oncology guidelines. Consecutive administrations of moderately/highly emetogenic chemotherapy were assessed for errors. Baseline statistical process control (SPC) charts were created and mean errors per administration were calculated. Prospective SPC charts were used to measure the effect of guideline development and distribution, a visiting lecturer, and ongoing feedback regarding compliance with guidelines employing SPC charts. Patients were surveyed regarding the extent and severity of CINE for 5 days postadministration. These outcomes were then shared with physicians. RESULTS: Baseline compliance was poor (mean, 0.87 omissions per chemotherapy administration), largely because of inadequate adherence to recommendations for delayed CINE management. Most patients experienced delayed nausea, particularly on day 3 postchemotherapy. Physician prescribing performance did not undergo sustained improvement despite guideline development or distribution, a lecture by a visiting expert, or sharing of adherence data with clinicians. Once patient outcomes were shared, physicians accepted the need for compliance and instituted nurse practitioner antiemetic prescribing, with almost complete compliance and concurrent measurable reduction in day 3 nausea. SPC charts documented improvements in both outcomes. CONCLUSIONS: SPC charts effectively monitor ongoing compliance and patient symptoms and represent appropriate outcome measurement and change facilitation tools. However, physician participation in guideline development and evidence of poor compliance alone did not improve prescribing performance. Only evidence of patient CINE experience coupled with noncompliance improved results.