scholarly journals Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2

2016 ◽  
Vol 34 (24) ◽  
pp. 2866-2873 ◽  
Author(s):  
Lucio Crinò ◽  
Myung-Ju Ahn ◽  
Filippo De Marinis ◽  
Harry J.M. Groen ◽  
Heather Wakelee ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Brain Metastases ◽  
Patient Reported Outcomes ◽  
Overall Response Rate ◽  
Response Rate ◽  
Whole Body ◽  
Prior Therapy ◽  
Patient Reported ◽  
Previously Treated

Purpose Phase I data (ASCEND-1) showed ceritinib efficacy in patients with ALK-rearranged non–small-cell lung cancer (NSCLC), regardless of brain metastases status and with or without prior therapy with an inhibitor of the ALK protein. Data are presented from a phase II trial (ASCEND-2) in which ceritinib efficacy and safety were evaluated in patients who had ALK-rearranged NSCLC previously treated with at least one platinum-based chemotherapy and who had experienced progression during crizotinib treatment as their last prior therapy. Patients and Methods Patients with advanced ALK-rearranged NSCLC, including those with asymptomatic or neurologically stable baseline brain metastases, received oral ceritinib 750 mg/d. Whole-body and intracranial responses were investigator assessed (according to RECIST version 1.1). Patient-reported outcomes were evaluated with the Lung Cancer Symptom Scale and European Organisation for Research and Treatment of Cancer surveys (the core-30 and the 13-item lung cancer–specific quality-of-life questionnaires). Results All 140 patients enrolled had received two or more previous treatment regimens, and all patients had received crizotinib. The median duration of exposure and the follow-up time with ceritinib were 8.8 months (range, 0.1 to 19.4 months) and 11.3 months (range, 0.1 to 18.9 months), respectively. Investigator-assessed overall response rate was 38.6% (95% CI, 30.5% to 47.2%). Secondary end points, all investigator assessed, included disease control rate (77.1%; 95% CI, 69.3% to 83.8%), time to response (median, 1.8 months; range, 1.6 to 5.6 months), duration of response (median, 9.7 months; 95% CI, 7.1 to 11.1 months), and progression-free survival (median, 5.7 months; 95% CI, 5.4 to 7.6 months). Of 100 patients with baseline brain metastases, 20 had active target lesions at baseline; investigator-assessed intracranial overall response rate was 45.0% (95% CI, 23.1% to 68.5%). The most common adverse events (majority, grade 1 or 2) for all treated patients were nausea (81.4%), diarrhea (80.0%), and vomiting (62.9%). Patient-reported outcomes showed a trend toward improved symptom burden. The global quality-of-life score was maintained during treatment. Conclusion Consistent with its activity in ASCEND-1, ceritinib treatment provided clinically meaningful and durable responses with manageable tolerability in chemotherapy- and crizotinib-pretreated patients, including those with brain metastases.

scholarly journals An Evidence-Based Determination of Issues Affecting Quality of Life and Patient-Reported Outcomes in Lung Cancer: Results of a Survey of 660 Patients

2014 ◽  
Vol 9 (9) ◽  
pp. 1243-1248 ◽  
Author(s):  
Richard J. Gralla ◽  
Patricia J. Hollen ◽  
Pavlos Msaouel ◽  
Beverly Vincent Davis ◽  
Judith Petersen
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Patient Reported Outcomes ◽  
Evidence Based ◽  
Patient Reported

scholarly journals Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer

2020 ◽  
Vol 38 (22) ◽  
pp. 2530-2542 ◽  
Author(s):  
Martin Reck ◽  
Thomas Wehler ◽  
Francisco Orlandi ◽  
Naoyuki Nogami ◽  
Carlo Barone ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Patient Reported Outcomes ◽  
Small Cell ◽  
Small Cell Lung ◽  
Patient Reported ◽  
Eortc Qlq ◽  
Nonsquamous Nsclc

PURPOSE Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non–small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC. METHODS Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13. RESULTS Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly. CONCLUSION ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.

Efficacy and safety of bevacizumab in nonsquamous non-small cell lung cancer with brain metastases.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19134-e19134
Author(s):  
Masao Ichiki ◽  
Tsukasa Yoshida ◽  
Masayuki Nakamura ◽  
Tomomi Kumano ◽  
Tomoaki Hoshino
Keyword(s):  
Brain Metastases ◽  
Response Rate ◽  
Concurrent Chemotherapy ◽  
Bleeding Events ◽  
Mutation Status ◽  
Prior Therapy ◽  
Mri Scans ◽  
Previously Treated ◽  
Grade 3 ◽  
Extracranial Metastases

e19134 Background: Patients (pts) with brain metastases were excluded from bevacizumab (Bev) therapy due to a case of fatal cerebral hemorrhage in 1997. However, several trials showed the safety of Bev in pts with inactive (previously treated or asymptomatic) brain metastases, and Bev therapy was recently permitted as practical care for brain metastases in Japan. Methods: We retrospectively identified pts treated with Bev for inactive brain metastases from NSCLC. CT or MRI scans performed at least 6 weeks after Bev therapy were assessed for response. Results: There were 17 pts. All pts had adenocarcinoma. Median age was 66 (range 57-74), male/female= 8/9, PS0/1/2= 3/10/4, 1st-/2nd-/3rd-/4th-line chemotherapy with Bev = 8/4/4/1, EGFR mutation status; mutated/wild type/unknown=8/7/2; concurrent chemotherapy with Bev: amrubicin (1), pemtrexed (2), cisplatin (carboplatin) + pemetrexed (10), carboplatin + paclitaxel (3), cisplatin + gemcitabine (1); prior chemotherapy: gefitinib (6), erlotinib (3), docetaxel (1), carboplatin + paclitaxel (2), cisplatin + pemetrexed (2), pemetrexed (1); prior therapy for brain metastases: surgery (1), surgery + WBRT (2),WBRT (8), SRS (4), none (2). In 14 pts with evaluable target brain metastases, the response rate for intracranial metastases was 78.6% (95% CI, 49.2-95.4%), and in 15 pts with evaluable target lesions except brain metastases, the response rate for extracranial metastases was 40.0% (95% CI, 16.3-67.7%). Serious toxicities (grade 3/4): hypertension (2/0), proteinuria (0/-). There were 2 bleeding events: one was grade 1 intracraninal hemorrhage, the other was grade 1 bronchopulumonary hemorrhage. Conclusions: Chemotherapy+Bev is effective for pts with inactive brain metastases and is a well-tolerated regimen with a favorable toxicity profile. The updated data including PFS and OS will be presented at the Annual Meeting.

scholarly journals A Systematic Review and Meta-Analysis to Assess Patient-Reported Outcomes after Lung Cancer Surgery

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Sayf Gazala ◽  
Jean-Sébastien Pelletier ◽  
Dale Storie ◽  
Jeffrey A. Johnson ◽  
Demetrios J. Kutsogiannis ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Meta Analysis ◽  
Lung Cancer Surgery ◽  
Risk Of Bias ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

The main objective of this review was to systematically review, assess, and report on the studies that have assessed health related quality of life (HRQOL) after VATS and thoracotomy for resection of lung cancer. We performed a systematic review of six databases. The Downs and Black tool was used to assess the risk of bias. Five studies were included. In general, patients undergoing VATS have a better HRQOL when compared to thoracotomy; however, there was a high risk of bias in the included studies. The consistent use of a lung cancer specific questionnaire for measuring HRQOL after surgery is encouraged.

Cancer anorexia-cachexia syndrome in advanced lung cancer: An exploratory analysis of patient-reported outcomes data.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17521-e17521
Author(s):  
Ryan David Nipp ◽  
Susan C. Locke ◽  
Gregory Samsa ◽  
Arif Kamal ◽  
Amy Pickar Abernethy ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Weight Loss ◽  
Patient Reported Outcomes ◽  
Advanced Lung Cancer ◽  
Small Cell Lung ◽  
Patient Reported ◽  
Cancer Anorexia ◽  
Cachexia Syndrome

e17521 Background: The cancer anorexia-cachexia syndrome (CACS) is a debilitating syndrome of involuntary weight loss, anorexia, declining function, muscle catabolism, and inflammation. It affects many patients with cancer, especially those with advanced disease. We aimed to describe the experience of a group of patients with advanced lung cancer who meet published weight-based criteria for CACS. Methods: Tablet computers were used to collect patient-reported outcomes data from 97 patients with advanced non-small cell lung cancer, using the Patient Care Monitor v2.0 and the FACIT family of questionnaires. 25 patients met published weight criteria for CACS (>=5% weight loss in the past 6 months). 51 patients with stable weights were used as a comparison group; those lacking weight data were excluded. Statistical comparisons were made between these groups to explore differences in symptoms, quality of life, and survival. Results: Patients meeting weight criteria for CACS had lower serum albumins (median 3.7 vs. 3.9, p=0.006) and worse performance status by Karnofsky and ECOG (70 vs. 80, p=0.004, and 2 vs. 1, p=0.027). CACS patients had worse FAACT anorexia-cachexia subscale scores (34.5 vs. 38.5, p=0.018) but were not statistically more likely to be prescribed CACS therapies; only 17% of patients in the CACS group were on medication for this (N=4). FACIT fatigue subscale scores were not statistically different between groups, nor was quality of life by FACT-G. Grip strength and 6-minute walk distance were also not statistically different. Patients in the CACS group had a significantly shorter survival (HR 2.066 [95% CI=1.229,3.474], p=0.005). Conclusions: Patients with advanced non-small cell lung cancer who meet standard weight-based criteria for CACS have inferior survival compared to a similar population without weight loss. Though traditional descriptions of CACS presume a general impairment in quality of life, we did not find statistical differences here aside from the anorexia-cachexia subscale score of FAACT. Few patients were prescribed medication to address symptomatic anorexia/cachexia, suggesting it may be an unmet need in patients with advanced lung cancer.

A digital oncology patient-reported outcomes platform: Building innovative electronic patient symptom assessments in epic mychart to improve the quality of life and survival of patients with advanced cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18312-e18312 ◽  
Author(s):  
Sidharth Anand ◽  
Anne Margaret Walling ◽  
Sarah F. DAmbruoso ◽  
Neil Wenger ◽  
Jennifer Singer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Advanced Cancer ◽  
Patient Reported Outcomes ◽  
Best Practice ◽  
Response Rate ◽  
Assessment System ◽  
Patient Reported ◽  
Practice Advisory

e18312 Background: Establishing a system to monitor patient reported outcomes (“PRO”) has been demonstrated to be essential for a well-functioning cancer system. Studies have shown that routine collection of PROs allows providers to address medical issues earlier and impacts a patient’s overall survival. Unmet needs for symptom management are prevalent in the cancer population, especially patients with advanced cancer. Approximately 35% of UCLA Hematology-Oncology patients with advanced cancer in 2016 presented to Emergency Rooms for symptom-related complaints such as nausea, pain, constipation, dehydration, and fatigue. We hypothesize that the creation of an electronic PRO platform through EPIC MyChart will ensure patients receive timely evaluation of their symptoms, resulting in improved quality of life, and decreased ER and hospital utilization. Methods: We developed an innovative PRO platform through Epic MyChart along with a Best Practice Advisory alert system to identify patients at risk for worsening symptoms, ER visits, and inpatient admissions. We then built an electronic version of the Edmonson Symptoms Assessment System, which providers can push to patients through Epic MyChart, with results stored within the Flowsheets section of Epic. We also built a passive alert using Epic’s Best Practice Advisory (“BPA”) system, to notify providers when a patient’s MyChart ESAS Assessment Scores have exceeded a defined threshold. Results: Preliminary data from surveys sent to a series of advanced cancer patients seen in an outpatient palliative oncology clinic over 1 month, demonstrated a 100% response rate (6/7) surveys completed when sent one week prior to patient’s being seeing in clinic, and 17% response rate (1/6) when sent two to three weeks prior to clinic visit. The average total ESAS score reported was 40, with average individual score of 4/10 for any given symptom. Conclusions: We will implement this electronic PRO platform in multiple oncology clinics at UCLA, and measure provider and patient satisfaction, completion rates, and monitor outcomes such as ED visits and inpatient admissions. We hope this system will lead to an overall survival benefit. This project demonstrates the potential of developing innovative PRO platforms through Epic MyChart and the importance of clinical workflows in the implementation process.

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