Elotuzumab, pomalidomide, and dexamethasone is a very well tolerated regimen associated with durable remission even in very advanced myeloma: a retrospective study from two academic centers.

BACKGROUND: The anti-SLAMF7 monoclonal antibody, elotuzumab (elo), plus lenalidomide (len) and dexamethasone (dex) is approved for relapsed/refractory MM in the U.S. and Europe. Recently, a small phase 2 study demonstrated an advantage in progression-free survival (PFS) for elo plus pomalidomide (pom)/dex compared to pom/dex alone and resulted in licensing of this novel triplet combination, but clinical experience is still limited. PURPOSE: To analyze the efficacy and safety of elo/pom/dex in a "real world" cohort of patients with advanced MM, we queried the databases of the university hospitals of Würzburg and Vienna. FINDINGS: We identified 22 patients with a median number of five prior lines of therapy who received elo/pom/dex prior to licensing within an early access program. Patients received a median number of 5 four-week treatment cycles. Median PFS was 6.4 months with 12-month and 18-month PFS rates of 35% and 28%, respectively. The overall response rate was 50% and 64% of responding patients who achieved a longer PFS with elo/pom/dex compared to their most recent line of therapy. Objective responses were also seen in five patients who had been pretreated with pomalidomide. Low tumor burden was associated with improved PFS (13.5 months for patients with ISS stage I/II at study entry v 6.4 months for ISS III), although this difference did not reach statistical significance. No infusion-related reactions were reported. The most frequent grade 3/4 adverse events were neutropenia and pneumonia. CONCLUSION: Elo/pom/dex is an active and well-tolerated regimen in highly advanced MM even after pretreatment with pomalidomide.

Clinical and biological characteristics of myeloma patients influence response to elotuzumab combination therapy.

Based on ELOQUENT-2, combination therapy with the monoclonal antibody elotuzumab was approved for relapsed/refractory multiple myeloma in the US and Europe. However, outside clinical trials, the optimal integration of elotuzumab into the sequence of treatment lines remains to be determined. Therefore, we analyzed safety and efficacy of elotuzumab/immunomodulatory drug combinations in a real-life cohort of 33 patients from our institution. The most frequent grade 3/4 adverse event was lymphopenia which did not increase the incidence of viral reactivations. After a median of four prior treatment lines, an overall response rate of 60% and a median progression-free survival (PFS) of 8 months were observed. The presence of cytogenetic high-risk status had no impact on PFS while low disease burden and high numbers of natural killer (NK)-cells at treatment initiation were associated with longer PFS. We observed an extramedullary relapse in three patients, associated with reduced expression of the elotuzumab target antigen SLAMF7 on extramedullary myeloma cells in one patient. Thus, biomarkers like disease burden, NK-cell count and SLAMF7 expression on myeloma cells may help to define myeloma patients with high likelihood to respond to elotuzumab treatment. Prospective trials investigating these biomarkers in larger patient cohorts are highly warranted.

Patient-doctor relationship and adherence to capecitabine in outpatients of a German comprehensive cancer center.

PURPOSE: The prescribing of oral chemotherapy agents has introduced the new challenge of ensuring patients' adherence to therapy. Aspects of a close patient-doctor relationship are reported to be correlated with adherence to oral anticancer drugs, but data on capecitabine are scarce. PATIENTS AND METHODS: Sixty-four outpatients with a diagnosis of cancer and prescribed capecitabine were recruited from a German Comprehensive Cancer Center. We used the Patient-Doctor Relationship Questionnaire (PDRQ-9), the Medical Adherence Rating Scale (MARS), the Beliefs about Medicines Questionnaire (BMQ), and the Satisfaction with Information about Medicines Scale (SIMS) to assess patients' perceptions and behavior. Medical data were extracted from the charts. RESULTS: Non-adherence was reported by 20% of the 64 participants. The perceived quality of the patient-doctor relationship was high in general, but it did not emerge as a predictor of adherence in our survey (odds ratio [OR]=0.915, P=0.162, 95% CI=0.808-1.036). However, beliefs about medicine (OR=1.268, P<0.002; 95% CI=1.090-1.475) as well as satisfaction with information about medicine (OR=1.252, P<0.040, 95% CI=1.010-1.551) were predictors of adherence and the quality of the patient-doctor relationship was correlated with both variables (r=0.373, P=0.002 for SIMS sum score; r=0.263, P=0.036 for BMQ necessity/concern difference). Overall, adherence to capecitabine was high with a conviction that the therapy is necessary. However, concerns were expressed regarding the long-term effect of capecitabine use. Patients have unmet information needs regarding interactions of capecitabine with other medicines and the impairment of their intimate life. CONCLUSIONS: In order to ensure adherence to capecitabine, our results seem to encourage the default use of modern and perhaps more impersonal means of information brokerage (eg, email, internet). However, the contents of some of patients' informational needs as well as the associations of patients' beliefs and satisfaction about the information received suggest a benefit from a trustful patient-doctor relationship.

New insights into frequency and contents of fear of cancer progression/recurrence (FOP/FCR) in outpatients with colorectal carcinoma (CRC) receiving oral capecitabine: a pilot study at a comprehensive cancer center.

BACKGROUND: Fear of cancer progression/recurrence (FOP/FCR) is considered one of the most prevalent sources of distress in cancer survivors and associated with lower quality of life and functional impairment. Detailed measures of FOP/FCR are needed because little is known about the knowledge of FOP/FCR, its associations with the patient-doctor relationship, and the rate of adequate therapy. Colorectal cancer (CRC) is one of the most prevalent cancer entities, and oral capecitabine is widely prescribed as treatment. Therefore, we initiated a pilot study to expand the literature on FOP/FCR in CRC outpatients receiving capecitabine and to generate hypotheses for future investigations. METHODS: This study included 58 patients treated at a comprehensive cancer center. FOP/FCR was assessed with the Fear of Progression Questionnaire (FOP-Q-SF). Satisfaction with the relationships with doctors was assessed with the Patient-Doctor Relationship Questionnaire-9 (PRDQ-9). Levels of side effects were rated by the patients on a visual analog scale. Clinical data were extracted from the charts. RESULTS: A total of 19 out of 58 patients (36%) suffered from FOP/FCR according to our assessment. Levels of FOP/FCR seemed to be mostly moderate to high. Only four out of the 19 distressed patients (21%) were treated accordingly. Typical side effects of oncological treatment were associated with higher FOP/FCR. Satisfaction with doctor-patient relationships was not associated with FOP/FCR. Regarding single items of FOP/FCR, three out of the five most prevalent fears were associated with close relatives. DISCUSSION: FOP/FCR occurred frequently in more than one in three patients, but was mostly untreated in this sample of consecutive outpatients with CRC receiving oral capecitabine. In detail, most fears were related to family and friends. In addition to an unmet need of patients, our data indicate sources of distress not considered thus far. If replicated in larger studies, results may help to inform intervention development and improve patient care.

Adherence and Coping Strategies in Outpatients With Chronic Myeloid Leukemia Receiving Oral Tyrosine Kinase Inhibitors.

PURPOSE/OBJECTIVES: To assess adherence and coping strategies in outpatients with chronic myeloid leukemia (CML) on oral tyrosine kinase inhibitors (TKIs).
. DESIGN: Prospective, descriptive.
. SETTING: An interdisciplinary oncology outpatient clinic in Germany.
. SAMPLE: 35 outpatients with CML on oral TKIs.
. METHODS: Adherence and coping strategies were assessed with questionnaires. Clinical data were extracted from medical charts.
. MAIN RESEARCH VARIABLES: Adherence rates, main coping strategies, and frequency and contents of single coping strategies.
. FINDINGS: 18 patients showed adherence according to the applied screening instrument. Main coping strategies were spirituality and search for meaning. The two single items most frequently specified were adhering to medical instructions and trusting in the medical personnel involved.
. CONCLUSIONS: The low adherence rate of 51% most likely resulted from using the Basel Assessment of Adherence Scale as the questionnaire of choice. The relevance of spirituality and search for meaning as main coping strategies has not been shown previously in outpatients with CML. Most patients wish to obey medical instructions accurately and put trust in their oncologists; this introduces a resource that should gain relevance considering the increasing number of oral anticancer drugs.
. IMPLICATIONS FOR NURSING: Nurses are encouraged to routinely assess adherence and spiritual needs in outpatients with CML. Spirituality and search for meaning represent pivotal coping strategies in this group, which has an excellent prognosis. Oncology nurses may help provide tailored support, thereby ameliorating care for these patients.

Fear of Progression in Outpatients With Chronic Myeloid Leukemia on Oral Tyrosine Kinase Inhibitors.

PURPOSE/OBJECTIVES: To assess fear of progression (FoP) in outpatients with chronic myeloid leukemia (CML) on oral tyrosine kinase inhibitors (TKIs).
 DESIGN: Prospective and descriptive.
 SETTING: A university-based outpatient cancer clinic in Wuerzburg, Germany. 
 SAMPLE: 37 outpatients with CML on oral TKIs. 
. METHODS: FoP was assessed with a questionnaire. Clinical data were extracted from the medical charts.
. MAIN RESEARCH VARIABLES: Frequency and contents of FoP.
 FINDINGS: Sum scores and levels of FoP in the sample population (N = 37) were as high as in cancer populations with more unfavorable life expectancies. Regarding single items, fear that medication may harm the body was most prevalent, regardless of group affiliation. The actual fear of disease progression was only ranked sixth out of 12 items for the total sample and was ranked second by the second-generation TKI group. 
 CONCLUSIONS: In a sample of outpatients with CML, FoP was frequent and most often generated by fears of treatment side effects.
 IMPLICATIONS FOR NURSING: Nurses should be vigilant about FoP in this population. Established questionnaires may help to identify and evaluate this frequent source of distress. Specific communication could reveal unmet informational needs and may help to initiate interventions. Additional studies are needed to confirm the numbers in a larger cohort of patients, to examine the prevalence during the course of disease, to search for potential influences on the outcome (i.e., via adherence), and to extract the best interventions.

Recurrent Tako-Tsubo cardiomyopathy (TTC) in a pre-menopausal woman: late sequelae of a traumatic event?

BACKGROUND: "Tako-Tsubo cardiomyopathy" (TTC) is a syndrome characterized by left ventricular (LV) wall motion abnormalities, usually without coronary artery disease, mimicking the diagnosis of acute coronary syndrome. It most often affects post-menopausal women and TTC tends to run a benign course with very low rates of recurrence, complications or mortality. The condition is also called "stress-induced cardiomyopathy" because acute physical or emotional stress appears to be frequently related to its onset. The pathogenic role of premorbid or comorbid psychiatric illnesses has been discussed controversially. For the first time, we present a case of fourfold recurrent TTC with severe complications in a pre-menopausal woman. Furthermore, a long history of flaring posttraumatic stress symptoms anteceded the first event. CASE PRESENTATION: A 43-year old, pre-menopausal Caucasian woman was hospitalized with symptoms of acute coronary syndrome. Clinical examination revealed hypokinetic wall motion in the apical ventricular region with no signs of coronary artery disease and diagnosis of TTC was established. She experienced recurrence three times within the following ten months, which led to thrombembolism and myocardial scarring among others. The circumstances of chronic distress were striking. 16 years ago she miscarried after having removed a myoma according to her doctor's suggestion. Since then, she has suffered from symptoms of posttraumatic distress which peaked annually at the day of abortion. Chronic distress became even more pronounced after the premature birth of a daughter some years later. The first event of TTC occurred after a family dispute about parenting. CONCLUSION: This is the first case report of fourfold TTC in a pre-menopausal woman. From somatic perspectives, the course of the disease with recurrences and complications underlines the fact that TTC is not entirely benign. Furthermore, it is the first case report of long lasting symptoms of traumatic stress anteceding TTC. Close connections between adrenergic signaling and late onset of clinical stress symptoms are well known in the psychopathology of traumatization. Although larger clinical trials are needed to elucidate possible interactions of premorbid psychiatric illnesses and TTC, cardiologists should be vigilant especially in cases of recurrent TTC.

Sensitivity and specificity of hypnosis effects on gastric myoelectrical activity.

OBJECTIVES: The effects of hypnosis on physiological (gastrointestinal) functions are incompletely understood, and it is unknown whether they are hypnosis-specific and gut-specific, or simply unspecific effects of relaxation. DESIGN: Sixty-two healthy female volunteers were randomly assigned to either a single session of hypnotic suggestion of ingesting an appetizing meal and an unappetizing meal, or to relax and concentrate on having an appetizing or unappetizing meal, while the electrogastrogram (EGG) was recorded. At the end of the session, participants drank water until they felt full, in order to detect EGG-signal changes after ingestion of a true gastric load. During both conditions participants reported their subjective well-being, hunger and disgust at several time points. RESULTS: Imagining eating food induced subjective feelings of hunger and disgust as well as changes in the EGG similar to, but more pronounced than those seen with a real gastric water load during both hypnosis and relaxation conditions. These effects were more pronounced when imagining an appetizing meal than with an unappetizing meal. There was no significant difference between the hypnosis and relaxation conditions. CONCLUSION: Imagination with and without hypnosis exhibits similar changes in subjective and objective measures in response to imagining an appetizing and an unappetizing food, indicating high sensitivity but low specificity.

Six-year follow-up of patients with functional bowel disorders, with and without previous psychotherapy.

INTRODUCTION: Long-term follow-up studies in patients with functional bowel disorders are rare. METHODS: Of 85 patients with functional bowel disorders diagnosed in 2000, forty-eight patients responded to a postal questionnaire 6 years later (2006). RESULTS: Gastrointestinal symptom severity was similar to that at the initial diagnosis. Anxiety and depression (HADS) were significantly decreased, however, depending on previous psychotherapy (PT) experience. Men but not women that had participated in PT exhibited reduced symptoms more pronounced than did patients without PT. DISCUSSION: Anxiety and depression may determine consulting behaviour, but this appears unrelated to intestinal symptoms and their severity. Short-term PT contributes to long-term well-being especially in men.