Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma.

This multicenter, single-arm, open-label non-randomized phase II trial (NCT00744991) was conducted in patients with recurrent/refractory mycosis fungoides (MF), stage IB-IVB, or Sézary syndrome (SS). A Simon two-stage design required 25 patients enrolled in stage 1 with ≥7 confirmed objective responses for expansion into stage 2. Patients were treated with oral enzastaurin (250 mg twice daily) until disease progression or intolerable toxicity. The primary endpoint was investigator-assessed response rate; secondary endpoints were time to objective response, response duration, time-to-progression, patient-reported pruritus, and safety/tolerability. Twenty-five patients were enrolled. A partial response was observed in one patient with MF. Median time-to-progression was 78 and 44 days in MF and SS, respectively. Self-reported pruritus relief and improved composite pruritus-specific symptom scores were documented in six and four patients, respectively. Enzastaurin was well tolerated with mostly grade 1-2 adverse events, mainly diarrhea and fatigue. There were two adverse event-related drug discontinuations with one possibly treatment-related.

Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology.

Programmed, notebook-style, personal computers ("e/Tablets") can collect symptom and quality-of-life (QOL) data at the point of care. Patients use an e/Tablet in the clinic waiting area to complete electronic surveys. Information then travels wirelessly to a server, which generates a real-time report for use during the clinical visit. The objective of this study was to determine whether academic oncology patients find e/Tablets logistically acceptable and a satisfactory means of communicating symptoms to providers during repeated clinic visits. Sixty-six metastatic breast cancer patients at Duke Breast Cancer Clinic participated. E/Tablets were customized to electronically administer a satisfaction/acceptability survey, several validated questionnaires, and the Patient Care Monitor (PCM) review of symptoms survey. At each of the four visits within six months, participants completed the patient satisfaction/acceptability survey, which furnished data for the current analysis. Participant demographics were: mean age of 54 years, 77% Caucasian, and 47% with less than a college education. Participants reported that e/Tablets were easy to read (94%), easy to navigate (99%), and had a comfortable weight (90%); they found it easy to respond to questions using the e/Tablet (98%). Seventy-five percent initially indicated satisfaction with PCM for reporting symptoms; this proportion increased over time. By the last visit, 88% of participants indicated that they would recommend the PCM to other patients; 74% felt that the e/Tablet helped them remember symptoms to report to their clinician. E/Tablets offered a feasible and acceptable method for collecting longitudinal patient-reported symptom and QOL data within an academic, tertiary care, breast cancer clinic.

Cancer surveillance behaviors and psychosocial factors among long-term survivors of breast cancer. Cancer and Leukemia Group B 79804.

BACKGROUND: Little is known about cancer surveillance (mammography, clinical breast examination, and pelvic examination) behaviors in long-term (9-16 years) breast cancer survivors. This report describes the relation of these behaviors to demographic and clinical characteristics, psychological symptoms, body satisfaction, and social support. METHODS: Survivors who had participated in Cancer and Leukemia Group B treatment Trial 8541 completed a survey that included questions on breast cancer surveillance and pelvic examination, psychological well being, body satisfaction, and social support. RESULTS: The participation rate was 78% and included 245 breast cancer survivors. Survivors (n = 107; 44%) reported completing breast cancer surveillance (mammography and clinical breast examination) and completing pelvic examination (n = 162; 68%) within recommended guidelines. There were no significant associations between breast cancer surveillance and breast cancer anxiety, depression, stressful life events, body satisfaction, social support, or demographic characteristics. Survivors within recommended guidelines for pelvic examinations were younger (P = .05), married (P = .003), had health insurance (P = .004), and had lower depression scores (P = .005) than survivors who underused or overused pelvic examination. In addition, survivors within recommended pelvic examination guidelines had significantly lower levels of breast cancer anxiety (P = .03) compared with survivors who underused pelvic examination. CONCLUSIONS: Many long-term breast cancer survivors were not within recommended cancer surveillance guidelines. Private health insurance was associated with following recommendations for pelvic examinations, although such a relation did not exist for breast cancer surveillance. The results of this study have implications for the development of educational programs to improve cancer surveillance among the growing population of long-term breast cancer survivors.

Exercise and dietary change after diagnosis and cancer-related symptoms in long-term survivors of breast cancer: CALGB 79804.

OBJECTIVE: Improving diet and exercise can reduce survivors' risk of cancer-related fatigue, poor physical functioning, and potential recurrence. A cancer diagnosis can represent a 'teachable moment', leading survivors to make positive changes in diet and exercise behaviors; however, little is known about how often this occurs or about factors that enhance or limit survivors' ability to make these changes. This cross-sectional descriptive study investigated both the prevalence and clustering of self-reported changes in diet and exercise and how these changes related to ongoing cancer-related symptoms, social support, and stressful life events among long-term breast cancer survivors. METHODS: Survivors (n=227, response rate=72%) of a prior Cancer and Leukemia Group B treatment trial, on average 12 years post-diagnosis, completed a mailed survey assessing health behavior changes since diagnosis and current symptoms, social support, and stressful life events. RESULTS: Over half of survivors reported making positive exercise or diet changes since diagnosis: over 25% reported making exercise and diet changes. Analyses of covariance models showed that survivors who reported increasing their exercise also reported lower fatigue. Trends were also found between increased fruit and vegetable intake and decreased fatigue and between increased exercise and increased social support. CONCLUSIONS: These results underscore the need for health promotion efforts among survivors. Exercise promotion is especially needed since more survivors attempted to change dietary behaviors than exercise on their own. Further, fatigue may limit survivors' ability to change their health behaviors; alternatively, survivors who increase their exercise may experience less fatigue.

Arm/hand swelling and perceived functioning among breast cancer survivors 12 years post-diagnosis: CALGB 79804.

INTRODUCTION: Lymphedema is an under-reported and debilitating consequence of axillary node dissection among breast cancer survivors. This study describes the characteristics of arm and hand swelling in relation to perceived physical and mental health functioning among breast cancer survivors 9-16 years post-diagnosis who previously participated in a clinical trial coordinated by the Cancer and Leukemia Group B (CALGB 8541). METHODS: Eligible survivors of CALGB 8541 completed questionnaires assessing demographics, arm/hand swelling, perceived physical functioning, and mental health. RESULTS: Two hundred forty-five women (94% white, mean age = 63, on average 12.4 years post-diagnosis) completed questionnaires (participation rate = 78%). Seventy-five women (31%) reported arm/hand swelling since their surgery. Of these women, 76% reported current swelling and half reported constant swelling, mainly in the upper arm. Swelling was reported as mild or moderate in 88% of the women. Women who reported severe swelling had significantly worse physical functioning and trended toward worse depressive symptoms and poorer mental health (lower mental SF-36 scores) as well. Activity-limiting swelling was also significantly associated with worse physical functioning. Although swelling interfered with wearing clothing (36%) and perceptions about general appearance (32%), only 37% of women sought treatment for swelling. CONCLUSIONS: Arm/hand swelling is a chronic problem for a subgroup of long-term survivors of breast cancer, negatively affecting physical functioning. IMPLICATIONS FOR CANCER SURVIVORS: Educational efforts are needed as part of a comprehensive survivorship care plan to raise awareness about lymphedema so that survivors may identify this complication, seek treatment early, and potentially improve their physical functioning.

Induction therapy for poor-prognosis anal canal carcinoma: a phase II study of the cancer and Leukemia Group B (CALGB 9281).

PURPOSE: Although most patients with anal canal cancer are cured with sphincter-preserving, nonsurgical, combined-modality therapy, those with large tumors and lymph node involvement have a poor prognosis. To establish the safety and efficacy of induction chemotherapy with infusional fluorouracil (FU) plus cisplatin followed by FU plus mitomycin C with concurrent radiation in patients with poor-prognosis squamous cell cancers of the anal canal. METHODS: Patients with previously untreated anal canal cancers with T3 or T4 tumors and/or extensive nodal involvement (bulky N2 or N3) received two 28-day cycles of induction treatment with infusional FU plus cisplatin followed by two 28-day cycles of FU plus mitomycin C with concurrent split-course radiation. A third cycle of FU and cisplatin with radiation boost was given to patients with persistent primary site disease or bulky N2 or N3 disease at presentation. RESULTS: Forty-five assessable patients received protocol therapy. Treatment was generally well tolerated, and gastrointestinal and hematologic toxicities were the most common. Induction chemotherapy resulted in eight complete and 21 partial responses. After induction, combined-modality, and boost therapy, 37 (82%) of 45 assessable high-risk patients achieved a complete response. After 4 years of follow-up, 68% of patients are alive, 61% are disease-free, and 50% are colostomy- and disease-free. CONCLUSION: A combined-modality approach that includes induction treatment with FU and cisplatin followed by combined-modality therapy with FU, mitomycin C, and concurrent radiation results in long-term disease control in the majority of patients with poor-prognosis anal canal cancer.

Applying a conceptual model for examining health-related quality of life in long-term breast cancer survivors: CALGB study 79804.

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.