treated with cabozantinib. Methods: We systematically conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 30, 2018. Phase 3 trials that mention HRQOL events like pain, arthralgia, fatigue
Search Results
Sriman Swarup, Anita Sultan, Nusrat Jahan, Upama Sharma, Nimesh Adhikari, Yin M. Myat, Ye Aung, Myo H. Zaw, and Kyaw Z. Thein
Rudolph M. Navari, Erminio Bonizzoni, Rita Wickham, and Rebecca Clark-Snow
: Based on the current pooled analysis of Phase 3, cisplatin-based studies, oral NEPA administered on Day 1 only was more effective than a 3-day APR regimen in preventing delayed and overall CINV from HEC. NEPA, a fixed oral combination of an NK 1 RA/5HT 3
Michael Koehler, Susanne Hoppe, Siegfried Kropf, Anke Lux, Rainer Bartsch, Bernhard Holzner, Juergen Krauter, Axel Florschütz, Kathleen Jentsch-Ullrich, Joerg Frommer, Hans-Henning Flechtner, and Thomas Fischer
Background: Cancer regularly disrupts health and developmental trajectories in adolescents and young adults (AYAs). Parents have been shown to have a substantial impact on the health and cancer survivorship activities of AYA patients in the form of symptom management. However, no randomized controlled trial has evaluated a coping support intervention (CSI) program for parents of AYAs with cancer aged 18 to 40 years. Patients and Methods: From November 30, 2012, to August 29, 2016, parents of AYAs with hematologic malignancies were randomized in a phase III controlled trial (1:1 ratio, stratified sampling) to either the research-based CSI AYA-Parents group (CSI group; n=82) or the standard care (SC) group (n=70). CSI consisted of 5 sessions to achieve the enhancement of parental adaptive coping as the primary outcome (per the adaptive coping scale of the 28-item Brief COPE, a validated multidimensional self-assessment-questionnaire recommended for clinical cancer research). Measures of adaptive coping, depression, and mental health were collected at pre-CSI (measurement date T1), at the end of the intervention sessions (measurement date T2), and at follow-up (3 months). We calculated mean change scores in outcomes and estimated intervention effect sizes (Cohen’s d) for changes from T1 to T2/T3, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. All statistical tests were 2-sided. Results: In the intention-to-treat analysis, the CSI group significantly improved their adaptive coping compared with the SC group (95% CI, 0.30–2.54; P=.013; d=0.405), whereas adaptive coping in the SC group deteriorated. The CSI group also experienced a significant decrease in depressive symptoms and improved mental health with clinical significance (95% CI, –1.98 to –0.30; P=.008; d=0.433, and 95% CI, –0.19 to 3.97; P=.074; d=0.292, respectively). Sensitivity analyses confirmed the robustness of the main intention-to-treat analysis. Conclusions: CSI improved effectively adaptive coping and depression in parents of AYAs with hematologic malignancies. It may represent a novel family-based approach in AYA oncology care.
Leonard Saltz
previously treated metastatic colorectal cancer (CORRECT): an international, multicenter, randomized, placebo-controlled, phase 3 trial, Pages 303-312, Copyright© 2013, with permission from Elsevier. “What interests me more about this drug is that
Komal Jhaveri and Francisco J. Esteva
events. From Swain SM, Kim SB, Cortes J, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet
Anita Sultan, Sriman Swarup, Francis Mogollon-Duffo, Ye Aung, Yin M. Myat, Myo H. Zaw, Rachana Yendala, Nicholas D’Cunha, and Kyaw Z. Thein
metastatic solid tumors treated with cabozantinib. Methods: MEDLINE, EMBASE databases, and meeting abstracts from inception to September 2018 were queried. Phase 3 RCTs that mention GI and elevation of liver enzymes as adverse effects were incorporated in
Thanh Ho, Irbaz Bin Riaz, Maheen Akhter, Saad Ullah Malik, Anum Riaz, Muhammad Zain Farooq, Safi U. Khan, Zhen Wang, M. Hassan Murad, and Andrea Wahner Hendrickson
: Literature search was performed using Ovid MEDLINE, EMBASE, CENTRAL, and Scopus (inception through October 26, 2018). Eligible studies were phase 3, randomized, controlled trials that compared single agent PARPi to placebo or standard treatment. Number of
Jon T. Holmlund, Carryn M. Anderson, Stephen T. Sonis, Robert Beardsley, Dennis Riley, Jeffrey Mark Brill, Melissa Brookes, Kara Terry, and J. Mel Sorensen
reduction of SOM duration, and dose-dependent improvements in other SOM parameters, with acceptable safety. A confirmatory phase 3 trial (NCT03689712) is in progress. Clinical trials to reduce RT-related esophagitis are also planned.
Kyaw Z. Thein, Somedeb Ball, Sriman Swarup, Anita Sultan, Myo H. Zaw, Lukman Tijani, Sanjay Awasthi, Fred Hardwicke, and Catherine Jones
search of Embase, MEDLINE, and meeting abstracts till September 30, 2018, to find all phase 3 RCTs comparing ribociclib with other agents or placebo in patients with advanced breast cancer and reporting QTc prolongation as adverse event. Mantel
Nimesh Adhikari, Myo H. Zaw, Sriman Swarup, Anita Sultan, Upama Sharma, Wai P. Thi, Nay N. Yee, Khaing K. Htwe, Tun W. Naing, and Kyaw Z. Thein
. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase 3 RCTs that mention AF and pulmonary toxicities as adverse effects were incorporated in the analysis. Mantel
