Psychosocial care for adult cancer patients: guidelines of the Italian Medical Oncology Association

SIMPLE SUMMARY: People with cancer often experience psychological and social needs, related to their disease and treatments, that can negatively impact quality of life. Various social interventions can be helpful but are not always offered to patients who would benefit from them. This guideline aims to help oncology professionals address the psychosocial aspects of their adult patients and of those who care for them. It was compiled by a multidisciplinary panel, including patients, using rigorous methodology. Topics include patient information and communication, screening and management of psychosocial needs, and caregiver support. In particular, evidence emphasizes that nurses play a central role in providing psychosocial care and information for cancer patients, and that Physician communication skills must be improved with specific evidence-based training. In addition, psychosocial needs must be promptly detected and managed, especially with appropriate non-pharmacological interventions. ABSTRACT: Psychosocial morbidity can have negative consequences for cancer patients, including maladaptive coping, poor treatment adherence, and lower quality of life. Evidence shows that psychosocial interventions can positively impact quality of life, as well as symptoms and side effects; however, they are not always offered to patients who might benefit from them. These guidelines were produced by a multidisciplinary panel of 16 experts, including patients, following GRADE methodology. The panel framed clinical questions and voted on outcomes to investigate. Studies identified by rigorous search strategies were assessed to rate certainty of evidence, and recommendations were formulated by the panel. Although the quality of the evidence found was generally moderate, interventions could be recommended aimed at improving patient information, communication with healthcare professionals and involvement in decision-making; detecting and managing patient psychosocial needs, particularly with non-pharmacological therapy; and supporting families of patients with advanced cancer. The role of nurses as providers of information and psychosocial care is stressed. Most recommended interventions do not appear to necessitate new services or infrastructures, and therefore do not require allocation of additional resources, but predominantly involve changes in clinical staff behavior and/or ward organization. Patients should be made aware of psychosocial care standards so that they can expect to receive them

Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged 65 65 years: New lessons for clinical practice from the EVA study

BACKGROUND: The present analysis focuses on real-world data of Everolimus-Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and {greater than or equal to} 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel-Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged {greater than or equal to} 65 years, of whom 87 were {greater than or equal to} 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged {greater than or equal to} 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (>7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged {greater than or equal to} 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones

Pemetrexed single agent chemotherapy in previously treated patients with locally advanced or metastatic non-small cell lung cancer

<p>Abstract</p> <p>Background</p> <p>The main objective of this study was to evaluate the safety of second-line pemetrexed in Stage IIIB or IV NSCLC.</p> <p>Methods</p> <p>Overall, 95 patients received pemetrexed 500 mg/m²i.v. over Day 1 of a 21-day cycle. Patients also received oral dexamethasone, oral folic acid and i.m. vitamin B12 supplementation to reduce toxicity. NCI CTC 2.0 was used to rate toxicity. All the adverse events were graded in terms of severity and relation to study treatment. Dose was reduced in case of toxicity and treatment was delayed for up to 42 days from Day 1 of any cycle to allow recovering from study drug-related toxicities. Tumor response was measured using the RECIST criteria.</p> <p>Results</p> <p>Patients received a median number of 4 cycles and 97.8% of the planned dose. Overall, 75 patients (78.9% of treated) reported at least one adverse event: 34 (35.8%) had grade 3 as worst grade and only 5 (5.2%) had grade 4. Drug-related events occurred in 57.9% of patients. Neutropenia (8.4%) and leukopenia (6.3 %) were the most common grade 3/4 hematological toxicities. Grade 3 anemia and thrombocytopenia were reported in 3.2% and 2.1% of patients, respectively. Diarrhea (6.3%), fatigue (3.2%) and dyspnea (3.2%) were the most common grade 3/4 non-hematological toxicities. The most common drug-related toxicities (any grade) were pyrexia (11.6%), vomiting, nausea, diarrhea and asthenia (9.5%) and fatigue (8.4%). Tumor Response Rate (CR/PR) in treated patients was 9.2%. The survival at 4.5 months (median follow-up) was 79% and the median PFS was 3.1 months. Twenty patients (21.1%) died mainly because of disease progression.</p> <p>Conclusion</p> <p>Patients with locally advanced or metastatic NSCLC could benefit from second-line pemetrexed, with a low incidence of hematological and non-hematological toxicities.</p

Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial

Background: Platinum/fluoropyrimidine regimens are the backbone of first-line chemotherapy for advanced gastric cancer (AGC). However response rates to first line chemotherapy range from 30 to 50% and disease progression occurs after 4\u20136 cycles. The optimal duration of first-line therapy is still unknown and its continuation until disease progression represents the standard. However this strategy is often associated with cumulative toxicity and rapid development of drug resistance. Moreover, only about 40% of AGC pts. are eligible for second-line treatment. Methods: This is a randomized, open-label, multicenter phase III trial. It aims at assessing whether switch maintenance to ramucirumab plus paclitaxel will extend the progression-free survival (PFS) of subjects with HER-2 negative AGC who have not progressed after 3 months of a first-line with a platinum/fluoropyrimidine regimen (either FOLFOX4, mFOLFOX6 or XELOX). The primary endpoint is to compare Progression-Free Survival (PFS) of patients in ARM A (switch maintenance to ramucirumab and placlitaxel) versus ARM B (continuation of the same first-line therapy with oxaliplatin/fluoropyrimidine). Secondary endpoints are: overall survival, time-to-treatment failure, overall response rate, duration of response, percentage of patients that will receive a second line therapy according to arm treatment, safety, quality of life. Exploratory studies including Next-Generation Sequencing (NGS) in archival tumor tissues are planned in order to identify potential biomarkers of primary resistance and prognosis. (Continued on next page) Discussion: The ARMANI study estimates if patients treated with early swich with ramucirumab plus paclitaxel received benefit when compared to those treated with continuation of first line therapy. The hypothesis is that the early administration of an active, non-cross resistant second-line regimen such as ramucirumab plus paclitaxel may prolong the time in which patients are progression-free, and consequently have a better quality of life. Moreover, this strategy may rescue all those subjects that become ineligible for second-line therapy due to the rapid deterioration of health status after the first disease progression. Trial registration: ARMANI is registered at ClinicalTrials.gov (NCT02934464, October 17, 2016) and EudraCT(2016\u2013001783-12, April 202,016)

Profiling cancer-related needs and the role of physical, practical and psychological difficulties: A latent class analysis approach

Background: There was an increasing attention to the humanization of oncological cares that focused on patients\u2019 needs \u2013 which have a strong impact on quality of life. Cancer-related needs seem to be related both to physical, practical and psychological difficulties as well as gender and age. Using a Latent Class Analysis (LCA) the aim of the study was to identify a latent structure accounting for the covariance between cancer-related needs. A one-factor model with two classes was hypothesized, which comprised needs as indicators and difficulties as external variables that moderate the latent structure. Methods: Patients (N = 171, 50.3% female, mean age = 64.6, SD = 12.7) were enrolled at the Department of Medical Oncology, \u201cPresidio Ospedaliero\u201d of Saronno, ASST Valle Olona, Italy. Using a standardized checklist patients were tested for physical issues, practical problems and distress (Psychological Distress Inventory: PDI; \u3b1 = .88). Then, patients were tested with the Need Evaluation Questionnaire (NEQ) measuring: (A) communicative (\u3b1 = .78) and (B) relational needs (\u3b1 = .74); needs of information related to (C) the diagnosis (\u3b1 = .72) and (D) treatments (\u3b1 = .70). Results: A CFA was performed to confirm the original factorial structure of the NEQ (RMSEA = .059; CFI = .913) and the PDI (RMSEA = 0.72; CFI = .902). Then, the LCA (5000 bootstrap) shows the goodness-of-model fit [\u3c72 (6) = 9.06; p = .17; LR\u3c72 (6) = 10.64; p = .10] and the goodness-of-classification quality [Entropy = .84 ( > .7); Average-Latent-Class-Assignment-Probability: .950 and .964 for Class1 and Class2, respectively]. The LCA identified a latent variable with two classes (VLMR = 161.33; p < .001; Class1 = .54%; Class2 = .46%). In addition, interactions with the latent variable were found only for distress (\u3b2 = .892; p = .019), practical (\u3b2 = 1.26; p = .010) and physical (\u3b2 = .983; p = .012) issues. Conclusions: These results provide a better understand of cancer-related needs: each class represents a specific \u201cprofile\u201d that are moderated by physical, practical and psychological difficulties. These findings suggest paying more attention to the specific need expressed by the patient proposing new ways to improve quality of life

When the loss of spirituality leads to the loss of the path: The moderating role of spirituality in a multiple-step-mediation process from physical suffering to distress

Background: A diagnosis of Cancer often leads patients to experience a breakdown in spirituality that could undermine his/hers life. Spirituality troubles seem to be related with emotional problems \u2013 triggered by physical and practical difficulties \u2013 that lead to experience psychological distress. However, there aren\u2019t definitive results on these relationships. This study aimed to test a multiple step mediation moderated analysis in which spirituality moderates the process that leads to distress. Methods: Patients (N = 200, 54.6% female, mean age = 64.3, SD = 12.3) were consecutively enrolled at \u201cPresidio Ospedaliero\u201d of Saronno, ASST Valle Olona, Italy \u2013 Department of Medical Oncology. Patients were tested with NCCN\u2019s Distress Thermometer and Problem List (DT&PL; NCCN, 2003) assessing: (A) distress and (B) physical (\u3b1 = .77), (C) practical (\u3b1 = .68), (D) social (\u3b1 = .70), (E) emotional (\u3b1 = .85) and (F) spirituality problems. Results: First, a CFA was performed to test the factorial structure of the PL. The factor structure was confirmed: RMSEA = .064; CFI = .904. Then, a multiple step mediation moderated analysis (5000 bootstrap resampling) shows model\u2019s significance [F = 59.9; p < .001; R2 = .49; Eff.Size = .364]. Surprisingly, in absence of spiritualty problems, the relationship between physical problems and distress was partially mediated (path c\u2019: \u3b2 = .118, p = .016) by practical problems (path a1: \u3b2 = .061, p = .001) by relationships problems (path d1: \u3b2 = .281, p .05) \u2013 showing effects of interaction on each of these paths. Conclusions: These surprising results highlight the role of spirituality. The process from physical difficulties to psychological distress follows a specific path only in absence of spirituality issues. These findings suggest new ways in which psycho-oncologists should structure interventions to improve quality of life and reduce psychological suffering paying attention to the spirituality sphere of the oncological patient

Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial

BACKGROUND: Doublet chemotherapy is more effective than single-agent as first line treatment of advanced non-small-cell lung cancer (NSCLC). No reliable information instead is available on the effect of doublets in second line treatment. The aim of DISTAL-2 study was to compare two doublets containing docetaxel with single agent docetaxel as second line treatment of patients with NSCLC (ClinicalTrials.gov id.:.NCT00345059). METHODS: NSCLC patients, aged &lt;75, PS 0-2, who had failed platinum-based chemotherapy, were randomly assigned with a 3:1:1 ratio to: arm A, weekly docetaxel (33.3mg/m(2) on days 1, 8, 15 q 4 weeks); arm B, weekly docetaxel (30 mg/m(2) on days 1, 8, 15) plus gemcitabine (800 mg/m(2) on days 1, 8 q 4 weeks) or plus vinorelbine (20mg/m(2) on days 1, 8 q 4 weeks) depending on which of the two had been used in first line; arm C, weekly docetaxel (as in arm B) plus capecitabine (625 mg/m(2) twice daily on days 5-18 q 4 weeks). Primary end-point was overall survival (OS). Two comparisons were planned: arm B vs. A and arm C vs. A. Overall, 375 patients had to be randomized. Response was assessed by RECIST, quality of life (QoL) by EORTC questionnaires. RESULTS: 84 patients were randomized from May 2005 to December 2006, when the trial was prematurely stopped due to the slow accrual. After 62 deaths, median OS was 40.0 weeks in arm A, 32.6 weeks in arm B (p=0.18 vs. A) and 39.7 weeks in arm C (p=0.90 vs. A). Response rate was 6.4, 16.7 and 5.3%, and median progression-free survival was 12.4, 13.1 and 11.9 weeks, for arms A, B and C, respectively. Patients in arm B had significantly more grade 3-4 haematological and non-haematological toxicity compared to arm A, and patients in arm C had significantly more grade 3-4 non-haematological toxicity compared to arm A. No relevant differences were found in QoL analysis, with the exception of significant worsening in appetite, vomiting and hemoptysis for patients in arm B. CONCLUSION: Due to early termination, the trial does not have the planned statistical power. However, available data do not support the role of docetaxel-based combination chemotherapy as second line in advanced NSCLC

Capecitabine, oxaliplatin and irinotecan in combination, with bevacizumab (COI-B regimen) as first-line treatment of patients with advanced colorectal cancer. An Italian Trials of Medical Oncology phase II study.

Background A dose-finding phase I/II trial that evaluated the maximum tolerated doses of a combination of three drugs with irinotecan, oxaliplatin and capecitabine (COI regimen) has been conducted in patients with metastatic colorectal cancer (mCRC). In this study the safety and activity of the combination of COI regimen plus bevacizumab (COI-B) were assessed. Methods Patients judged to be unresectable for metastatic disease, were enrolled in a phase II, open-label study and treated with the combination of bevacizumab (5 mg/kg on day 1) and COI regimen (irinotecan 180 mg/mq on day 1, oxaliplatin 85 mg/mq on day 2, capecitabine 2000 mg d2-6; q14) as first-line treatment. Induction treatment was administered for a maximum of 8 cycles, followed by maintenance treatment with bevacizumab (7.5 mg/kg on d1, q21) until progression. Results Fifty-one patients were enrolled in six Italian centres. The primary end-point of overall response rate was met, reaching the value of 62% in the per-protocol population and 57% in the intent-to-treat population, patients with stable disease were also taken into account, the clinical benefit rate was 94%. In the intention-to-treat population, median progression-free and overall survivals were 10.3 and 22 months, respectively. Toxicity was different from 5-fluorouracil-based triplet regimens, with 31% of severe diarrhoea, but a low incidence of grade 3/4 neutropenia (6%) and mucositis (4%). Conclusions Our results show the feasibility and promising activity of the combination of capecitabine, oxaliplatin, irinotecan and bevacizumab