[The Physical and Psychological Impacts and Supportive Care Needs of Patients With Cancer Undergoing Immunotherapy and Their Family Caregivers].

New, science-based cancer treatments have proliferated in recent years. Immunotherapy provides new hope for prolonging survival in patients with advanced-stage cancers. However, patients with cancer must not only face their disease progression, physical, and psychological symptoms, but also deal with the side effects and efficacy of immunotherapy. Patients with cancer may experience complex emotions such as fear, anxiety, depression, or uncertainty relatively frequently and may have many unmet care needs specific to immunotherapy. However, articles on the physical and psychological impacts and supportive care needs experienced by patients with advanced-stage cancers undergoing immunotherapy and their family caregivers are limited in the literature. Thus, this paper was developed to present (1) a brief introduction to cancer immunotherapy; (2) the physical and psychological impacts experienced by patients with cancer undergoing immunotherapy and their caregivers; (3) the status of the supportive care needs of patients and family caregivers during the immunotherapy process; and (4) an assessment of and intervention to address the supportive care needs of these patients with cancer and their caregivers. We hope this article will help clinical healthcare providers understand the physical and psychological impacts and supportive care needs of advanced patients with cancer and their family caregivers during the immunotherapy process. Furthermore, we suggest that appropriate medical care be provided or developed in the future to improve their quality of life during the immunotherapy process and to enhance clinical practices.

Patient expectations are better for immunotherapy than traditional chemotherapy for cancer.

PURPOSE: The main aim of the study was to explore the expectations and knowledge of advanced-stage cancer patients about immunotherapy. METHODS: This mixed methods study included 53 cancer patients on immune checkpoint inhibitors (ICIs), 55 cancer patients undergoing chemotherapy (CT), and 53 non-cancer patients. Participants' expectations about ICIs and CT were compared. Additional qualitative data were derived from semi-structured interviews. RESULTS: Among patients who did not receive ICIs, 63 (58%) had never heard of ICIs and 94 (87%) had large gaps in their knowledge of ICIs. Among ICI patients, 33 (62%) simply described ICIs without errors. ICI perception was positive, regardless of whether respondents received or had heard of ICIs, which became particularly evident when compared to CT. ICIs were rated as more promising, and all adverse effects were expected to be significantly lower than those of CT. Knowledge about ICIs was also limited in the interviewed ICI patients. Some patients reported adverse effects of ICIs that were mostly mild and well-tolerated or easily treated. CONCLUSIONS: The lack of understanding of ICIs should be improved by activities to increase the knowledge of ICI patients and the general population. In contrast to CT, ICIs invoked fewer negative associations with efficacy and toxicity. Therefore, attention should be paid to risk awareness when educating patients. (Clinical trial registration number: DRKS00011868) Trial Registration: German clinical trials register, www.germanctr.de , number DRKS00011868.

Balancing the Hype with Reality: What Do Patients with Advanced Melanoma Consider When Making the Decision to Have Immunotherapy?

BACKGROUND: Immunotherapy has resulted in unprecedented improvements in survival and maintained quality of life for many patients with advanced melanoma. However, durable responses are observed in only a minority of patients, and severe treatment side effects are experienced by 5%-30%. There are no reliable tests that can differentiate between patients who are likely to respond to immunotherapy and those who will not. Hence, new challenges have arisen as clinicians try to facilitate patients in their decision-making regarding immunotherapy. Furthermore, little is known about the real-world patients' experience and understanding of immunotherapy outside the clinical trial setting. Here, we explore the perspectives of patients undergoing immunotherapy for melanoma and focus on factors that influenced their treatment decision-making. MATERIALS AND METHODS: Twenty-three in-depth semistructured interviews were conducted with patients receiving pembrolizumab for stage IV melanoma at an Australian public cancer hospital. Patients were recruited at a range of time points after commencing therapy, and their experience of treatment was explored. Interviews were audio recorded, transcribed verbatim, coded, and analyzed thematically. RESULTS: Immunotherapy is viewed as a symbol of hope, with high-profile anecdotes reinforcing this perception. Only a minority of patients expressed a good understanding of the likely efficacy and potential treatment side effects. Patients are reliant on their clinicians' recommendation regarding immunotherapy treatment decisions. CONCLUSION: Novel treatments such as immunotherapy provide significant hope for patients. This may influence their preference for immunotherapy over and above the usual considerations of the trade-off between efficacy and toxicity. Careful counsel and individualized patient resources may further facilitate treatment decision-making. IMPLICATIONS FOR PRACTICE: This study highlighted some of the misconceptions held by patients that need to be addressed when discussing the possibility of receiving treatment with immunotherapy for advanced melanoma. Patients placed a lot of importance on high-profile anecdotes rather than truly understanding likely outcomes of treatment based on personal circumstances. The majority of patients had a poor understanding of the potential side effects and long-term implications of treatment with immunotherapy. Careful counsel is required in order to facilitate informed decision-making about treatment and to ensure possible side effects are known and appreciated. Further research is needed to develop tools to aid decision-making in everyday clinical practice.

Certainty within uncertainty: a qualitative study of the experience of metastatic melanoma patients undergoing pembrolizumab immunotherapy.

OBJECTIVE: Little is known about the lived experiences of patients with metastatic melanoma undergoing checkpoint inhibitor treatment. We conducted a feasibility study of a supportive care intervention for melanoma patients being treated with pembrolizumab. Here, we report a secondary objective of the study, which was to explore the lived experience of being on pembrolizumab treatment for advanced melanoma. METHODS: Twenty-eight participants with metastatic melanoma were recruited across two cohorts, all receiving 3-weekly immunotherapy treatment. Semi-structured interviews were conducted with 26 participants once at 9 weeks. Thematic analysis using interpretative phenomenological analysis (IPA) was performed with multiple iterations of data review to achieve consensus. RESULTS: Three overarching themes were identified; here, we report the first and most dominant theme: how metastatic melanoma patients live within uncertain spaces. Although immunotherapy increases overall survival, metastatic melanoma patients live within an uncertain spectrum. They confront uncertainty related to immunotherapy treatment, their disease trajectory, family relationships, and decision-making. Melanoma patients attempt to normalize their lives, engaging in their usual activities. Uncertainty increases prior to active treatment and intensifies during investigation phases. CONCLUSIONS: Despite progress in melanoma patient treatment and outcomes, these patients face sustained uncertainty about their disease trajectory.

Reasons for Declining Venom Immunotherapy.

INTRODUCTION: Hymenoptera venom allergy is associated with significant morbidity and deterioration in health-related quality of life, and risk of fatal systemic reactions. Although venom immunotherapy is safe and the only effective treatment in allergic individuals, some patients prefer not to pursue this treatment. Since 2011, when the 50% reimbursement was stopped, patients must fully support the cost of immunotherapy. This study aimed to ascertain the reasons why patients decline immunotherapy. MATERIAL AND METHODS: A medical records review of all patients proposed to receive venom immunotherapy at an Allergy and Clinical Immunology Department in Porto, Portugal, between 2006 and 2015, followed by a phone interview to patients refusing treatment. RESULTS: A total of 83 subjects were enrolled, with a mean (± SD) age of 44.4 (14.7) years and 55 (66%) males; 27 refused venom immunotherapy between 2006 and 2015. Nineteen were interviewed and 14 of those stated price as the main reason for declining treatment. The only identified risk factor associated with immunotherapy refusal was being proposed after 2011 (OR: 3.29; 95% CI: 1.12 - 9.68; p = 0.03). DISCUSSION: The number of patients refusing venom immunotherapy doubled since reimbursement was withdrawn. Price was identified as the major obstacle to treatment completion. Immunotherapy proposal after reimbursement was stopped was associated with a 3-fold increase in the risk of refusing treatment. CONCLUSION: These findings show how economic decisions may have a detrimental effect on patient care, as immunotherapy refusal left them exposed to an avoidable life-threatening risk.

Introdução: A alergia a veneno de himenópteros está associada a uma significativa morbilidade e diminuição da qualidade de vida, bem como a risco de reações alérgicas fatais. Apesar da imunoterapia com veneno de himenópteros ser um tratamento seguro e o único eficaz nesta patologia, alguns doentes decidem não o realizar. Desde 2011, quando a comparticipação de 50% terminou, o custo da imunoterapia é totalmente suportado pelos doentes. Este trabalho pretendeu identificar os motivos da recusa desta terapêutica. Material e Métodos: Revisão dos registos clínicos de todos os doentes propostos para imunoterapia com veneno de himenópteros num serviço de Imunoalergologia, no período 2006 - 2015, seguida de entrevista telefónica aos que a recusaram. Resultados: Foram incluídos 83 doentes, com uma idade média (± DP) de 44,4 (14,7) anos. Cinquenta e cinco (66%) eram homens; 27 recusaram imunoterapia entre 2006 e 2015. Dezanove foram entrevistados e 14 identificaram o preço como principal motivo de recusa. O único fator de risco identificado para a recusa de imunoterapia foi ser proposta depois de 2011 (OR: 3,29; 95% CI: 1,12 ­ 9,68; p = 0,03). Discussão: O número de doentes a recusar imunoterapia duplicou desde que a comparticipação foi retirada. O preço foi o principal obstáculo à realização do tratamento. Ser proposto após o término da comparticipação do tratamento aumentou em três vezes o risco de recusa. Conclusão: Estes achados revelam o impacto negativo de uma decisão económica na saúde e segurança destes doentes, já que a recusa da imunoterapia os manteve expostos a um risco de vida evitável.

Psychosocial Mediators of Change and Patient Selection Factors in Oral Immunotherapy Trials.

Health-related quality of life (HRQL) is influenced by physiological, psychological, and environmental variables and can be best understood by considering the interactions of factors that cut across multiple levels. One of the most important issues relating to treatment in food allergy is to identify, describe, and define predictors that may contribute to modify HRQL outcomes. The research presented demonstrates that measures of HRQL are able to distinguish key features of known groups (e.g. relating to reaction severity, treatment, allergen type/number, expectation of outcome) and delineate impact on hitherto unknown groups (e.g. relating to personality types and coping styles). This heterogeneity may explain why HRQL or other patient-related outcomes may differ in individuals during, or following any treatment or intervention. Patient-reported outcomes are relatively poorly defined to date. Since HRQL has only been studied in relatively few oral immunotherapy trials to date, primarily looking at caregiver HRQL, it is unclear which factors, measures, or subscales are most predictive of short- and/or long-term treatment outcomes for which type of patient, and which time points for measurement are most informative. A standardised protocol that incorporates HRQL and other relevant patient-related outcome measures and agreed definitions of outcomes would allow for the comparison of efficacy of food allergy treatments between centres, trials, or countries. Further evidence-based research aimed at exploring the effects of interventions on outcomes in food allergy is needed, including the influence of patient and parent factors on protocol design. To this end, it is vital that patient-related outcomes such as improved HRQL are seen as a primary outcome and are measured at multiple intervals during the trial duration and beyond. The creative use of methods and designs (both qualitative and quantitative) to better understand the role of HRQL in immunotherapy treatment trials will enable improved modelling of the costs, risks, and benefits of any treatment. Systematic analysis and modelling of antecedent factors, mediators, and outcomes will be important to boost intervention effects and to maximise the overall benefits of treatment.

Awareness, understanding, attitude and barriers toward prescribing modern cancer immunotherapies in the Arabian Gulf countries.

INTRODUCTION: The use of modern immunotherapy has been evolving over the past few years, and various new agents have been developed for new indications at multiple primary sites in oncology. It is important for physicians who are involved in cancer care to be aware and updated about new therapeutic agents and their indications, potential benefits, and side effects. PATIENTS AND METHODS: From October to November 2017, we conducted a survey on the awareness, understanding, attitude, and barriers associated with prescribing modern cancer immunotherapies among physicians in the Arabian Gulf countries. The study included practicing physicians who delivered chemotherapy; trainees were not eligible. A total of 460 physicians were contacted and invited to complete an online survey, of which approximately 74.8% did not respond, and 4 (3.4%) were excluded because they had not recently treated patients with cancer. 112 (24.3%) physicians completed the survey (completion rate = 25.2%). An online electronic survey questionnaire was developed via Planet Surveys. The survey was designed with multidisciplinary inputs of the study investigators practicing in the Arabian Gulf countries, piloted, and subsequently revised on the basis of feedback from 10 additional oncologists. The final survey included 23 questions and took 8-10 minutes for completion. RESULTS: All respondents were aware of modern immunotherapies, but 62.5% reported having limited experience in implementing them, whereas 31.3% reported good experience. The overall physicians' attitudes toward modern immunotherapy were favorable, with a mean score of 7.4 (scale of 1-10, with 10 being extremely favorable). Efficacy, clear indications, and good safety profile were perceived as key potential benefits. Cost, lack of experience, and lack of access to specific testing were the major barriers. DISCUSSION AND CONCLUSION: There was a high level of awareness and an overall positive attitude toward modern cancer immunotherapy among oncologists in the Arabian Gulf countries, but there was a limited experience in prescribing cancer immunotherapeutic agents. Efficacy, clear indications, and good safety profile were perceived as key potential benefits, whereas cost, lack of experience, and lack of access to specific testing prior to prescription were the major barriers. Patients were likely to be receptive to modern immunotherapy as a therapeutic option for cancer treatment. Long-term efficacy data, financial support programs, and educational activities for prescribers may increase the access to modern immunotherapy.

[Psychological aspects of immunotherapies in the treatment of malignant melanoma]. / Immunterápiák pszichológiai vonatkozásai a melanoma komplex és multidiszciplináris kezelésében.

Psychological problems may arise in connection with oncomedical treatments in three ways: 1. acute and/or 2. chronic ways, as well as 3. co-morbid psychiatric diseases that already exist must also be taken into account. Immunotherapies have the most common and also clinically relevant psychological side effects. Fatigue, anhedonia, social isolation, psychomotor slowness is reported during treatment. Anti-CTLA-4 antibody (ipilimumab) immunotherapy can present one of the most modern opportunities for adequate treatment for patients having distant metastasis or unresectable tumour. In relation to immunotherapies, acute psychological side effects (acute stress) emerging during treatments develop in a way that can mostly be linked to environmental factors, e.g. notification of diagnosis, hospitalisation, progression, deterioration in quality of life, imminent dates of control. Crisis is a temporary and threatening condition that endangers psychological balance. In such conditions, enhanced psychological vulnerability must be taken into account and doctors play a key role in the rapid recognition of the condition. Chronic psychological problems, which may arise from the depressogenic effect of the applied treatment or originated from a pre-melanoma psychiatric condition, may exceed the diagnostic and psychotherapeutic competences of a clinical psychologist. Even in case of a well-defined depressogenic biological mechanism such as the activation of the pro-inflammatory cytokine pathway, positive environmental effects can reduce symptoms and thus increase compliance. Side effects can be treated successfully using psychotherapeutic methods and/or psychiatric medicines. The application of routinely used complex psychosocial screening packages can provide the easiest method to identify worsening psychological condition during immunotherapy and give rapid feedback to the oncologist and the patient. Team work is of particular importance in a situation like this as it requires complex, interdisciplinary and high-level professional collaboration. Multidisciplinarity is the basic framework for modern tumour therapy where, under the guidance of oncologists, the work of specialist nurses, social workers, physiotherapists, dieticians and last but not least psychiatrists/psychologists are indispensable and play a significant role.

Impact of therapy and disease-related symptoms on health-related quality of life in patients with follicular lymphoma: results of the population-based PHAROS-registry.

OBJECTIVES: The increasing number of longer living patients with follicular lymphoma (FL) and serious side effects of treatment urged us to study the health-related quality of life (HRQoL) and persistent (treatment-related) symptoms in unselected patients after different treatment modalities and compare HRQoL of patients with a normative population. METHODS: The population-based Eindhoven Cancer Registry was used to select patients diagnosed with FL during 2004-2010. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was completed twice, with a 1-yr interval. This questionnaire was also completed by an age- and sex-matched normative population (N = 580). Detailed data on treatment were extracted from the cancer registry and Population-based HAematological Registry for Observational Studies (PHAROS). RESULTS: Of the 181 patients who were invited, 148 responded (82%, T1). Patients treated with immunochemotherapy reported clinically relevant higher mean fatigue scores than those who underwent radiotherapy (P = 0.02). No differences were observed on the other HRQoL scales between treatment groups. Mean HRQoL scores were worse for FL patients treated with immunochemotherapy compared with a normative population (P < 0.01). A quarter to 50% of patients persistently reported to be slowed down, lethargic, or persistently worried about future health or was limited in social activities. Subsequently, patients reporting these symptoms/worries had a lower global health status/HRQoL. CONCLUSION: Alertness for persistent symptoms that occur during and after treatment of FL patients is needed and may help to avoid lasting negative influence on their HRQoL.

Fear of repeated injections in children younger than 4 years receiving subcutaneous allergy immunotherapy.

BACKGROUND: Allergy immunotherapy during early childhood may have potential benefits for the prevention of asthma and allergy morbidity. However, subcutaneous immunotherapy has not yet been prospectively researched in children younger than 4 years, primarily because of safety concerns, including the fear and psychological distress young children may experience with repeated needle injections. OBJECTIVE: To quantify fear in atopic children younger than 4 years with a history of wheezing who are receiving subcutaneous immunotherapy. METHODS: Fear of injection was graded during a total of 788 immunotherapy injection visits in 18 children (age, 37 months; SD, 9 months) receiving subcutaneous allergy immunotherapy. The parent and the injection nurse assigned fear scores on a scale of 0 to 10 after each injection visit. RESULTS: At the time of analysis, children had a median of 49 injection visits (range, 12-88) during a median study period of 81.5 weeks (range, 15-165 weeks). Fifteen children (83%) lost their fear of injections during the study. A fear score of 0 was achieved after a mean of 8.4 visits (SD, 7.4). The more injection visits were missed, the more likely children were to retain fear of injections (hazard ratio, 0.13; 95% confidence interval, 0.02-1.02; P=.05). Age, adverse events, number of injections at each visit, and change of injection personnel were not associated with increased fear. CONCLUSION: Our analysis suggests that most children receiving weekly subcutaneous immunotherapy lose their fear of injections during the treatment course. Children with increased intervals between visits may be at higher risk of experiencing fear of injections. CLINICAL TRIAL REGISTRATION: clinicaltrial.gov identifier NCT01028560.

Exacerbation history is associated with medication and appointment adherence in MS.

Disease-modifying treatments are designed to prevent exacerbations in multiple sclerosis (MS). To date, few studies have examined the relationship between disease activity and treatment adherence in MS. The primary aim of this study was to examine the association between disease activity (e.g., annualized relapse rates), medication adherence, and appointment adherence in relapsing-remitting MS. Retrospective exacerbation and appointment data were collected and used to predict prospective medication adherence. Results indicated that patients with higher annualized relapse rates missed fewer doses of medication and were less likely to miss appointments. Conversely, patients with relatively stable disease were more likely to demonstrate poor medication adherence and poor appointment adherence. Patients who missed more appointments also missed more doses of their disease modifying medication. Future studies may wish to examine clinical methods designed to improve immunotherapy adherence among patients who are in relatively symptom-free stages of relapsing-remitting MS.

[Health-related quality of life in children with Hymenoptera venom allergy treated with VIT and quality of life of their parents]. / Jakosc zycia warunkowana stanem zdrowia dzieci z alergia na jad owadów blonkoskrzydlych leczonych VIT oraz jakosc zycia ich rodziców.

UNLABELLED: Hymenoptera venom allergy, although rare in children, by its potential fatalities, leads to many psychosocial consequences, influencing quality of life of children and their parents. Aim of this paper is the estimation of health-related quality of life of venom allergic children treated with specific immunotherapy, and their parents. Assessment of factors influencing health-related quality of life levels was also performed. MATERIAL AND METHODS: Sample under study consisted of 73 children: mean age 10.6, SD 2, 4, treated because of Hymenoptera venom allergy in 5 clinical allergy centers in Poland. Data was collected using VQLQ questionnaire adapted for children and their parents. Determinants of quality of life were assessed with multivariate linear and logistic regression models. Analysis were done with SPSS 15 for Windows package. RESULTS: Girls reported higher level of anxiety than boys (B = 0.47; 95% CI = (0.01; 0.94)). Level of caution in children increased along with increase of their anxiety against re-sting (B = 0.49; 95% CI = (0.27; 0.71)). Level of anxiety of children who were under treatment from 6 months to 2 years was lower than level of anxiety of parents of children treated shorter than 6 months (B = -1.21; 95% CI = (-2.16; -0.25)). The lowest level of caution was reported by parents of children aged 10 year or less (B = -0.86; 95% CI = (-1.67; -0.05)), while the highest was reported by parents of children aged 11 years (B = 0.86; 95% CI = (0.20; 1.53)) in comparison to parents of children aged 12 years or more. Parents' caution increased along with increase of their anxiety (B = 0.61; 95% CI = (0.40; 0.83)). Higher level of limitations was imposed by parents of children treated with rush or ultra rush method, in comparison to parents of children treated with conventional method (B = 1.27; 95% CI = (0.21; 2.33)). Levels of quality of life in children and their parents were strongly dependent in the same dimensions. CONCLUSIONS: 1. Levels of quality of life in particular dimension in children is related to level of the same dimension in parents. 2. Age of children influenced level of caution of their parents. 3. Treatment duration influenced level of anxiety of parents. 4. Safety feeling acquired by parents at the beginning of treatment improves their quality of life in all dimensions.

Debilitating beliefs and emotional distress in patients given immunotherapy for insect sting allergy: a prospective study.

Patients who receive venom immunotherapy (VIT) for systemic reactions (SRs) to insect stings are advised that once they reach the maintenance dose they are almost 100% protected against future SRs. However, initial evidence indicates that some patients continue to perceive themselves as highly debilitated by the allergy and are preoccupied with the allergic event. These factors have significant impact on their emotional well-being and allergy-related quality of life (ARQOL). We aimed to explore prospectively whether patients would experience these adverse psychological outcomes after receiving VIT coupled with professional explanation and reassurance of protection. Thirty-four patients who received VIT for systemic insect allergy and were under close medical surveillance were included. Before and 1 year after initiation of treatment, patients completed a questionnaire that measured debilitating beliefs, preoccupation with the SR event, emotional distress ARQOL, and QOL in general. Physician-graded severity of the reaction was recorded as well. VIT had a beneficial effect on all allergy-related variables. Self-imposed debilitating beliefs, preoccupation with the anaphylactic event, and ARQOL significantly but modestly improved over time. No association was found between ARQOL and QOL in general. The later variable as well as emotional distress remained unchanged after the VIT. This study shows that patients with sting allergy guided by trained personnel and treated with VIT show a reduction in dysfunctional beliefs and an improvement in ARQOL. Disputing medically unfounded beliefs that persist in some patients might improve their ARQOL.

Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial.

BACKGROUND AND PURPOSE: To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy. METHODS: Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline. RESULTS: The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful. CONCLUSIONS: Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process.

[Immune activation and depression in the elderly]. / Immuunactivatie en depressie bij ouderen.

Besides the monoamine hypothesis, the stress hypothesis and the vascular hypothesis, the inflammatory hypothesis might be an etiological explanation for late-life depression. There is a growing amount of evidence to support this hypothesis. In animal studies, injection with cytokines was shown to cause behavioural changes ('sickness behaviour') similar to depressive symptoms in humans. Cytokine treatment of certain tumours and chronic hepatitis can also cause depressive symptoms. The prevalence of depression in patients with autoimmune diseases is higher than in the general population. Etanercept had a favourable effect on the depressive symptoms in patients with psoriasis, independent of improvement of physical symptoms. Cytokines affect the hypothalamus-pituitary-adrenal axis and cerebral neurotransmitter systems, both of which are thought to be involved in depression. Immune activation has been associated with depression, and several anti-depressive treatments affect immune parameters, although inconsistently. Since the aging process is associated with a dysregulation of the immune system, the inflammation hypothesis might be particularly true in late-life depression.

Compliance, adherence, and the treatment of multiple sclerosis.

With the availability of disease-modifying, immunomodulatory therapies (DMT) for multiple sclerosis (MS) and the first long-term studies, it became obvious that problems of compliance to complex treatment regimens under chronic conditions would also apply to these approaches. In a selective overview, problems and findings of adherence research are depicted. Based on a discussion of basic concepts, issues of operationally defining and measuring adherence are outlined. Descriptive findings on adherence to DMTs and empirical predictors of nonadherence are then discussed. Referring to theoretical models of treatment motivation, selected problems (e. g., indication) and strategies of promoting adherence are described. Finally, implications of modern concepts of the patient-therapist relationship for the issue of patient adherence are considered.

Efficacy of IL-2 immunotherapy in metastatic renal cell carcinoma in relation to the psychic profile as evaluated using the Rorschach test.

BACKGROUND: Despite the well-documented importance of the psycho-emotional status in modulating the anticancer immunity, at present no study has been performed to analyse the influence of the psychological condition on the efficacy of IL-2 cancer immunotherapy. Previous clinical studies have already suggested that the evidence of anxiety may negatively affect the therapeutic efficacy of IL-2 immunotherapy of cancer. Moreover, previous psycho-oncological investigations showed that the suppression of sexual pleasure and sexual identity would represent one of the most frequent psychological profiles in cancer patients. On this basis, a study was planned in an attempt to evaluate relations existing between psychological status, analysed using the Rorschach test and efficacy of IL-2 immunotherapy in the treatment of metastatic renal cell cancer patients. PATIENTS AND METHODS: The study included 30 consecutive metastatic RCC patients. IL-2 was injected s.c. at a dose of 3 million IU twice/day 5 days/week for 4 consecutive weeks, corresponding to one complete immunotherapeutic cycle, followed by a second cycle after a 21-day rest period. RESULTS: A complete response (CR) was achieved in only 1/30 (3%) patients; a partial response (PR) was obtained in 6/30 (20%) patients. The tumor response rate (CR +PR) was 7/30 (23%) patients. The performance of a psychological analysis was accepted by 24/30 (80%) patients. A normal sexual identity was present in 7/24 (29%) patients. The tumor response rate achieved in patients with sexual identity was significantly higher compared to these who had no sexual identity or who refused the psychological investigation (p<0.05 and p<0.01, respectively). In the same way, the increase in mean lymphocyte number obtained in patients with sexual identity was significantly higher compared to that found in the other two groups of patients. CONCLUSION: This study demonstrated that the psychological status prior to treatment may be associated with the clinical response to IL-2 cancer immunotherapy.