Intercalated Dosing Schedule of Erlotinib and Docetaxel as a Therapeutic Strategy to Avoid Antagonism and Optimize Its Benefits in Advanced Non-Small-Cell Lung Cancer. A Randomized Phase II Clinical Trial.

INTRODUCTION: The purpose of this study was to assess whether an intercalated dosing schedule of erlotinib and docetaxel could avoid possible negative interactions and optimize the benefit obtained as second-line therapy in non-small-cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: A phase II randomized clinical trial was designed for advanced NSCLC patients in whom previous chemotherapy treatment had failed. The experimental arm with 33 patients consisted of erlotinib 150 mg/d orally, intermittent administration on days 2 to 16 every 21 days, combined with docetaxel 75 mg/m(2) every 21 days; the control arm with 35 patients consisted of erlotinib 150 mg/d orally, administered continuously. The study's primary end point was the proportion of patients who remained progression-free at 6 months in the 2 arms. RESULTS: The proportion of patients who remained progression-free at 6 months was of 5 patients (15%) in the intercalated arm and 3 patients (9%) in the erlotinib monotherapy arm respectively. Median progression-free survival (PFS) was 3.0 versus 2.1 months (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.39-1.06; P = .086). Median overall survival (OS) was 7.5 and 5.2 months (HR, 0.70; 95% CI, 0.41-1.19; P = .19). Disease control rates were 51.7% and 36.4%, respectively. No new safety signals were observed. CONCLUSION: Erlotinib and docetaxel with intermittent administration of erlotinib improved PFS, OS, and disease control rates compared with erlotinib alone. All of our results indicated that an intercalated dosing schedule of erlotinib and docetaxel could be more efficient than erlotinib treatment alone. Therefore, further studies should be developed in a larger number of patients. This study has shown the absence of antagonism between docetaxel and erlotinib when given in an intercalated fashion.

Darbepoetin alfa administered once every three weeks for the treatment of anemia in elderly patients with non-myeloid tumors receiving chemotherapy.

AIMS AND BACKGROUND: The present study aims to describe the hematological response to darbepoetin alfa (DA) under daily clinical practice conditions in anemic elderly patients with non-myeloid tumors receiving chemotherapy. METHODS AND STUDY DESIGN: This was a prospective, observational, multicenter study in elderly (≥65 years) patients with non-myeloid cancer receiving DA (500 µg every 3 weeks) for chemotherapy-induced anemia (hemoglobin [Hb] level ≤11.0 g/dL). RESULTS: A total of 102 anemic patients with solid tumors and 51 with hematological malignancies were included in 28 centers in Spain. Mean age (±SD) was 73.4 (±5.8) years, and mean baseline Hb level was 10.0 (±0.8) g/dL. DA was administered for a median of 8 weeks. Of the 115 subjects with a post-baseline Hb value, the percentage of patients who achieved a hematopoietic response (Hb increase ≥2 g/dL or reaching ≥12 g/dL without transfusions in the previous 28 days) was 69.7% (95% CI 56.1% to 83.3%). Functional Assessment of Cancer Therapy-Fatigue subscale scores increased during the study (median change 1.0 [Q1 -5.0, Q3 9.0], P = 0.04). One patient (0.7%) experienced a non-serious adverse reaction (cutaneous rash). CONCLUSION: The study results suggest that DA is an effective and well-tolerated therapy for the treatment of chemotherapy-induced anemia in elderly patients.

A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility.

PURPOSE: This study presents data on the feasibility and possible benefits of a psychological intervention that uses virtual reality to induce positive emotions on adult hospitalized patients with metastatic cancer. The patient's satisfaction and perceived utility was also examined. METHOD: The sample was composed of 19 patients (53 % men, aged from 29 to 85 years old; x = 60.9; standard deviation = 14.54). The intervention consisted of four 30-min sessions during 1 week in which patients navigated through virtual environments designed to induce joy or relaxation. Mood was assessed before and after each session using the Visual Analog Scale. Patient satisfaction was assessed after each session and at the end of the intervention. Qualitative data were also collected with open-ended questions. RESULTS: There were no major difficulties with the use of devices, and any difficulties that did arise were solved through practice. There were adequate levels of pleasantness and perceived utility of the proposed intervention. The main perceived benefits were distraction, entertainment, and promotion of relaxation states. Regarding mood changes, an increase in positive emotions and a decrease in negative emotions were also detected. CONCLUSIONS: The intervention was positively assessed and rated as minimally uncomfortable. Future actions are discussed as well as the need to implement brief interventions that take into account the patients' medical state and physical discomfort level, especially with those in the advanced stages of disease.

Promotion of emotional wellbeing in oncology inpatients using VR.

INTRODUCTION: In Psycho-oncology, VR has been utilized mainly to manage pain and distress associated to medical procedures and chemotherapy, with very few applications aimed at promotion of wellbeing in hospitalized patients. Considering this, it was implemented a psychological intervention that uses VR to induce positive emotions on adult oncology inpatients with the purpose of evaluating its utility to improve emotional wellbeing in this population. METHOD: Sample was composed of 33 patients (69.7% men, aged from 41 to 85 years old; X=62.1; SD=10.77). Intervention lasted 4 sessions of 30 minutes, along one week. In these sessions, two virtual environments designed to induce joy or relaxation were used. Symptoms of depression and anxiety (Hospital Anxiety and Depression Scale, HADS) and level of happiness (Fordyce Scale) were assessed before and after the VR intervention. Also, Visual Analogue Scales (VAS) were used to assess emotional state and physical discomfort before and after each session. RESULTS: There were significant improvements in distress and level of happiness after the VR intervention. Also, it was detected an increment in positive emotions and a decrease in negative emotions after sessions. CONCLUSIONS: Results emphasize the potential of VR as a positive technology that can be used to promote wellbeing during hospitalization, especially considering the shortness of the intervention and the advanced state of disease of the participants. Despite the encouraging of these results, it is necessary to confirm them in studies with larger samples and control groups.

Effectiveness of darbepoetin alfa in a cohort of oncology patients with chemotherapy-induced anaemia. Relationship between variation in three fatigue-specific quality of life questionnaire scores and change in haemoglobin level.

BACKGROUND: Cancer patients with chemotherapy-induced anaemia (CIA) often experience cancer-related fatigue (CRF). Darbepoetin alfa (DA) once every 3 weeks (q3w) is an effective and well tolerated erythropoiesis-stimulating agent. This study evaluated DA effectiveness and psychometric properties of the Functional Assessment of Cancer Therapy Fatigue-Subscale (FACT-F) and the Fatigue Symptom Inventory (FSI) in CIA patients. METHODS: This was a single-centre, prospective study in 100 patients with solid tumour and moderate to severe CRF (visual analogue scale [VAS-F] ≥ 30 mm) who received DA 500 µg q3w during chemotherapy (CT). Clinical data, VAS-F, FACT-F and FSI scores were collected at the beginning and at the end of CT (EOCT). RESULTS: Mean age was 62.7 years (SD: 12.1), 53.0% were women, 92.0% had ECOG 0-1 and 64% had stage IV tumours. Mean haemoglobin (Hb) significantly increased from baseline 10.2 g/dl to 11.3 g/dl at EOCT. Sixty-five percent of patients showed haematopoietic response at any study point (Hb ≥ 12 g/dl or an increase of ≥ 2 g/dl from baseline), 77% achieved Hb ≥ 11 g/dl and 7% required blood transfusions from week 5 to EOCT. CRF improvement was demonstrated by significant changes in VAS-F, FACT-F and FSI scores (decreases of 21.54, 3.56 and 12.97 points, respectively). FACT-F and FSI questionnaires showed high internal consistency (Cronbach's alpha of 0.98 and 0.98 for FACT-F and FSI, respectively, at the end of study) and satisfactory intra-class coefficients (FACT-F, r=0.73; FSI, r=0.83). There were significant correlations between scores and Hb changes (FACT-F, r=-0.44; FSI, r=-0.54). CONCLUSIONS: DA 500 µg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF.

Complete remission in a pancytopenic HIV negative, HHV-8 positive patient with Multicentric Castleman’s Disease induced with anti-CD20

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A 75-year-old woman was diagnosed of MCD plasmacell (PC) variant with B symptoms. Diffuselymph-node enlargement, splenomegaly and pancytopeniawere detected. Induction with Rituximabwas made because pancytopenia was present.Actually patient is free of disease. This is the firstcomplet reponse of MCD published, VIH negative,induced with anti CD20