Lack of Activity of Docetaxel in Soft Tissue Sarcomas: Results of a Phase II Study of the Italian Group on Rare Tumors

Purpose. The prognosis of advanced soft tissue sarcoma is poor, only a few drugs showing some activity with response rates around 15– 25%. Consequently drug development seems mandatory to improve treatment outcome. Following previous favourable EORTC experience, the Italian Group on Rare Tumors started a phase II study with docetaxel to confirm the activity of this drug in soft tissue sarcoma

Crizotinib in MET-Deregulated or ROS1-Rearranged Pretreated Non-Small Cell Lung Cancer (METROS): A Phase II, Prospective, Multicenter, Two-Arms Trial.

PURPOSE: MET-deregulated NSCLC represents an urgent clinical need because of unfavorable prognosis and lack of specific therapies. Although recent studies have suggested a potential role for crizotinib in patients harboring MET amplification or exon 14 mutations, no conclusive data are currently available. This study aimed at investigating activity of crizotinib in patients harboring MET or ROS1 alterations. PATIENTS AND METHODS: Patients with pretreated advanced NSCLC and evidence of ROS1 rearrangements (cohort A) or MET deregulation (amplification, ratio MET/CEP7 >2.2 or MET exon 14 mutations, cohort B) were treated with crizotinib 250 mg twice daily orally. The coprimary endpoint was objective response rate in the two cohorts. RESULTS: From December 2014 to March 2017, 505 patients were screened and a total of 52 patients (26 patients per cohort) were enrolled onto the study. At data cutoff of September 2017, in cohort A, objective response rate was 65%, and median progression-free survival and overall survival were 22.8 months [95% confidence interval (CI) 15.2-30.3] and not reached, respectively. In cohort B, objective response rate was 27%, median progression-free survival was 4.4 months (95% CI 3.0-5.8), and overall survival was 5.4 months (95% CI, 4.2-6.5). No difference in any clinical endpoint was observed between MET-amplified and exon 14-mutated patients. No response was observed among the 5 patients with cooccurrence of a second gene alteration. No unexpected toxicity was observed in both cohorts. CONCLUSIONS: Crizotinib induces response in a fraction of MET-deregulated NSCLC. Additional studies and innovative therapies are urgently needed

Screening for Distress in Oncological Patients: The Revised Version of the Psychological Distress Inventory (PDI-R)

Background: Psychological research in oncological settings is steadily increasing and the construct of psychological distress has rapidly gained popularity—leading to the development of questionnaires aimed at its measurement. The Psychological Distress Inventory (PDI) is one of the most used instruments, but its psychometric properties were not yet deeply evaluated. The present studies aimed at investigating the psychometric properties of the PDI (Study 1) and providing a revised version of the tool (Study 2). Methods: Oncological outpatients were enrolled at the Department of Medical Oncology of the Presidio Ospedaliero of Saronno, ASST Valle Olona, Italy. For the first study (N = 251), an Exploratory Graph Analysis was used to explore the item structure of the PDI. In the second study (N = 902), the psychometric properties of the revised PDI (PDI-R) were deeply assessed. Results: Study 1 showed that the PDI has a not clear structure and it should be reconsidered. On the opposite, Study 2 showed that the revised version (PDI-R) has a solid factorial structure, it is invariant across gender and age, and it has good psychometric properties. Conclusion: Results suggest that the PDI-R is a reliable measure of psychological distress in different samples of oncological patients, with stronger psychometric properties than the original version. Its use in the clinical and research field is therefore recommended to improve the quality of both assessment and treatment of psychological distress in patients with oncological problems

From Fear to Hopelessness: The Buffering Effect of Patient-Centered Communication in a Sample of Oncological Patients during COVID-19

Background: COVID-19 represents a threat both for the physical and psychological health of oncological patients experiencing heightened distress levels to which the fear of the virus is also added. Moreover, fear of COVID-19 could lead oncological patients to experience feelings of hopelessness related to their medical care. Patient-centered communication may act as a buffer against the aforementioned variables. This study aimed to test the role of doctor–patient communication in the relationship between fear of COVID-19 and hopelessness. Methods: During the COVID-19 pandemic, a sample of 90 oncological outpatients was recruited (40 males (44.4%) and 50 females (55.6%), mean age = 66.08 (SD = 12.12)). A structured interview was developed and used during the pandemic to measure the patients’ perceived (A) fear of COVID-19, and (B) feelings of hopelessness, and (C) physicians’ use of empathetic and (D) clear language during the consultation. A multiple mediation model was tested, and the effects between males and females were also compared. Results: Empathetic and clear doctor–patient communication buffered the adverse effect of the fear of COVID-19 on hopelessness through a full-mediation model. The effects did not differ between males and females in the overall model but its indirect effects. Discussions: Patient-centered communication using empathy and clear language can buffer the adverse effect of the fear of COVID-19 and protect oncological patients from hopelessness during the pandemic. These findings might help to improve clinical oncological practice

Effectiveness of brief-focused cognitive behavioral therapy in the reduction of cancer-related distress and emotive problems: A comparative study

Background. In recent years, there was an increase of cognitive-behavioral therapy (CBT) oriented brief-focused psychological intervention protocols for the reduction of cancer-related emotive difficulties that oncological patients have to face almost every day and that could have a negative impact on medical treatment (Di Matteo, Lepper & Croghan, 2006; NCCN, 2015). Thus, this study aimed to determine the effectiveness of a 10-session brief CBT (B-CBT-P) compared with a control group (CG). Methods. Participants (n = 67; mean age = 63.11, SD = 12.1, 35 female) enrolled at the Oncology Day Hospital at the \u201cPresidio Ospedaliero\u201d of Saronno, ASST Valle Olona, Italy who undertook (B-CBT-P: n = 34) or non-undertook (CG: n = 33) a psychotherapy intervention \u2013 with one of two different psychologists (authors MM and MI) to avoid potential biases. Participants were tested with the Distress Thermometer and the Problem List (DT&PL) at the baseline (T1; overall McDonald\u2019s omega = .90), at the end of the 10-sessions B-CBT-P (T2; overall McDonald\u2019s omega = .89). Results. A multilevel-multivariate repeated measure regression analysis was performed \u2013 controlling for age, type and localization of tumor, and therapist. In line with psychotherapy protocol, results showed no statistical significant changes for \u2018practical problems\u2019 (p = 0.0497 ns), \u2018spiritual problems\u2019 (p = 0.321 ns), and \u2018physical problems\u2019 (p = 0.206). Results revealed a statistical significance reduction of \u2018relationships problems\u2019 (p = 0.015; pooled Cohen\u2019s d = 0.341), \u2018emotive problems\u2019 (p = 0.012; pooled Cohen\u2019s d = 0.349), and the distress thermometer (p = 0.008; pooled Cohen\u2019s d = 0.373). Conclusions. Considering that emotive and relational problems, as well as distress, occurs frequently among oncological patients, this study is into an important area. Results suggest that B-CBT-P is statistically and clinically effective to improve the emotive and relational sphere of oncological patients. However, the small effect sizes found suggest that these short protocols may not be sufficient to bring important changes in the patient's life. This study opens up to the idea of improving these protocols so that the cancer patient can improve his quality of life \u2013 even with a few psychotherapy sessions

Effectiveness of psychological distress reduction with cognitive behavioral therapy for oncological patients: A one-year follow-up study

Background: Distress has a negative impact on medical treatment (Di Matteo, Lepper & Croghan, 2006) and it is considered one of the most important indexes of psychological suffering in oncological patients (NCCN, 2015). Thus, the purpose of this study was to determine the long term effectiveness of brief Cognitive Behavioral Therapy for patients with cancer (CBT-C) compared with a control group (CG) of oncological patients without any psychotherapy intervention - at one year after a chemotherapy treatment. Methods: Participants (n = 80; mean age = 63.3, SD = 13.4; 54 female) enrolled at the Oncology Day Hospital at the \u201cPresidio Ospedaliero\u201d of Saronno, ASST Valle Olona, Italy who undertook (CBT-C: n = 40) or non-undertook (CG: n = 40) a psychotherapy intervention. Individual psychotherapy sessions strictly followed the IPOS guidelines (Watson & Kissane, 2017). Participants were tested with the Psychological distress Inventory (PDI) at the baseline (T1; Cronbach \u3b1 = .88) at the end of the chemotherapy treatment (T2; Cronbach \u3b1 = .87), at the end of the psychotherapy intervention (T3; Cronbach \u3b1 = .88), 6-month follow-up (T4; Cronbach \u3b1 = .85), and 1-year follow-up (T5; Cronbach \u3b1 = .84). Results: Multilevel growth curve modeling \u2013 controlling for age, number of sessions, type and localization of tumor \u2013 showed a sharper reduction of distress for CBT-C participants that continue after posttreatment until 1-year follow-up (p < .001); whereas for CG participants it reduced more gradually from pretreatment to 1-year follow-up (p < .001). The results revealed a significant difference between the linear slopes for each treatment condition (p < .001). The overall Hedges\u2019 g comparing the two groups for distress reduction between pretreatment and 1-year follow-up was 2.14 (p < .001) in favor of CBT-C. Conclusions: Given that psychological distress occurs frequently among oncological patients this study is into an important area of study. Results suggest that CBT-C is statistically and clinically effective in treating psychological distress 1 year after the chemotherapy treatment. These findings revealed a kind of long-term effectiveness psychological intervention able both to reduce psychological suffering and improve a better quality of life in oncological settings