Moving Beyond Conventional Clinical Trial End Points in Treatment-refractory Metastatic Colorectal Cancer: A Composite Quality-of-life and Symptom Control End Point

Gong, Jun; Wu, Daniel; Chuang, Jeremy; Tuli, Richard; Simard, John; Hendifar, Andrew Eugene

doi:10.1016/j.clinthera.2017.09.015

Cited by 13 publications

(11 citation statements)

References 49 publications

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“…The second question was what are the main survival predictors for refractory mCRC? Many refractory mCRC patients will have experienced deteriorations in physical health and the toxicities of prior therapies, for whom symptom control and quality of life are important considerations . Presumably, some of these patients would also be deemed ineligible for treatments being tested in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Real‐world treatment patterns and outcomes in refractory metastatic colorectal cancer

Chiang

Choi

Lam

et al. 2019

Asia-Pac J Clncl Oncology

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Aim To investigate treatment patterns and outcomes of metastatic colorectal cancer (mCRC) patients beyond second progression (PD2) since regorafenib and TAS‐102 became available in Hong Kong. Methods The clinical records of consecutive mCRC patients who were treated beyond PD2 at Department of Clinical Oncology, Queen Mary Hospital between June 2013 and February 2018, were retrospectively reviewed. Results Of 176 PD2 patients (76.7% Eastern Cooperative Oncology Group performance status 0/1 and a median follow‐up time of 6.6 [range, 0.4–37.2] months), 104 (59%) underwent palliative care only and 72 (41%) received active third‐line (3L) treatment: regorafenib (n = 22), TAS‐102 (n = 6), chemotherapy + antiepidermal growth factor receptor (n = 12), chemotherapy + antivascular endothelial growth factor (n = 28) or clinical trials (n = 4). Patients on active 3L treatment had significantly longer OS than those on palliative care only: 11.7 versus 5.5 months (adjusted hazard ratio = 0.41, 95% confidence interval: 0.28–0.61, P < 0.001). For those on active treatment, OS was significantly associated with the time from diagnosis of metastasis to PD2 (P < 0.001) and post‐3L treatments (P = 0.009). When analyzing treatment eligibility according to trial criteria, half of the eligible patients (54/109) did not receive active treatment, but both eligible and ineligible patients achieved better OS when receiving active 3L treatment versus palliative care only (P < 0.001 and P = 0.002). No unexpected toxicity was reported. Conclusion Active 3L and beyond treatment significantly prolonged OS versus palliative care, even in selected “trial ineligible” patients. Given a high rate of palliation only care in eligible patients, improved patient access to medicine and counseling may be needed to maximize outcomes.

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Section: Introductionmentioning

confidence: 99%

Real‐world treatment patterns and outcomes in refractory metastatic colorectal cancer

Chiang

Choi

Lam

et al. 2019

Asia-Pac J Clncl Oncology

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“…The review was conducted according to the PRISMA guidelines. 23 (4) HRQoL was adopted as an outcome; (5) HRQoL was evaluated using self-assessment questionnaires; and (6) comparative studies or epidemiological studies (prospective observational, cohort, crosssectional or retrospective). Exclusion criteria: (1) patients with a history of psychiatric disorders such as schizophrenia, bipolar disorder, or dementia; (2) patients with a history of antipsychotic drugs in-take;…”

Section: Methodsmentioning

confidence: 99%

“…The Johanna Briggs Institute (JBI) critical appraisal checklists [24][25][26] were adopted in this review to assess the trustworthiness, relevance, and results of studies (Table 1). Data which was recorded from articles in the final set includes: (1) study characteristics (author, year of publication, country of origin, study design); (2) sample demographics (target population, sample size in each group, age range and mean age, chemotherapy); (3) treatment of olanzapine; (4) instrument used to measure HRQoL; (5) follow-up time; and (6) summary of findings. Meta-analysis of the data was not feasible because of heterogeneity in the designs, interventions, and outcome measures used in studies identified.…”

Section: Data Extraction and Synthesismentioning

confidence: 99%

“…Besides, an increasing body of evidence supports that HRQoL are predictive of survival in metastatic and advanced cancer. Some studies even suggest that HRQoL may be better prognostic indicators of survival than conventional clinical parameters for malignancies patients . For a patient's baseline HRQoL can predict overall survival (OS) across different cancer types .…”

Section: Introductionmentioning

confidence: 99%

“…Some studies even suggest that HRQoL may be better prognostic indicators of survival than conventional clinical parameters for malignancies patients. 5 For a patient's baseline HRQoL can predict overall survival (OS) across different cancer types. 6 As a result, there is a strengthening awareness among health care professionals of taking the HRQoL into consideration when they make an adequate selection in clinical practice.…”

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confidence: 99%

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Efficacy of olanzapine for quality of life improvement among patients with malignant tumor: A systematic review

Cui

et al. 2019

Cancer Reports

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Background Cancer patients always experience an ongoing deterioration in health‐related quality of life (HRQoL). There is a strengthening awareness of health care professionals of taking HRQoL, which is a patient‐reported outcome measures (PROMs), into consideration when they make an adequate selection in clinical practice. Olanzapine, an antipsychotic agent, has been demonstrated to be a safe and effective agent in improving cancer‐related symptoms. Aim To review the efficacy and safety of olanzapine in improving HRQoL among adults with malignant tumor. Methods Eligible studies were retrieved from an electronic database search of the Cochrane, Medline, CINAHL plus, Pubmed, Embase, PsycINFO, Web of Science, and Scopus. The methodological quality of selected studies was evaluated, and the relevant data were extracted and synthesized. Results While studies differed in target population, olanzapine‐based treatment regimen, and HRQoL measurement tools, results have shown that olanzapine has a positive impact on cancer patients' general HRQoL status, functional outcomes, and/or symptoms improvement. Besides, no serious toxicities attributable to olanzapine were observed in all studies included. Conclusion While further studies are needed especially which adopted the HRQoL as primary outcome through comprehensive measures, olanzapine could still be recommended in the palliative care.

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Development of a disease conceptual model of patient experience with metastatic colorectal cancer: identification of the most salient symptoms and impacts

et al. 2022

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Purpose Patients with metastatic colorectal cancer (mCRC) experience multiple symptoms and impacts affecting their health-related quality of life. However, there is limited data on self-reported experience of the most relevant and bothersome aspects of patients living with mCRC. Methods Semi-structured interviews were conducted in patients with mCRC to identify and understand the signs, symptoms and impacts experienced. Patients were also asked to rate the level of bothersomeness for each concept reported on a scale ranging from 0 (“not bothersome at all”) to 10 (“extremely bothersome”). Verbatim transcripts were analysed following a thematic analysis approach. The most salient concepts were identified (i.e. reported by > 50% of patients with a bothersome rating ≥ 5 out of 10). Results Twenty-five patients (USA; age: 26 to 72 years old) were interviewed. Patients reported 58 signs and symptoms, amongst which 8 were considered salient: fatigue, nausea, neuropathy, diarrhoea, loss of appetite, constipation, weight loss, and abdominal pain; 35 impacts were identified, and 7 were considered salient: reduced ability to work, interference with daily activities, impact on cognitive functioning, financial impact, sleep changes, impact on social life and walking difficulties. The concepts identified helped refine a literature-based disease conceptual model of patient experience with mCRC. Conclusions The interviews provided insights into the most bothersome and salient signs, symptoms and impacts affecting the HRQoL of patients living with mCRC. Implications for cancer survivors There is a need to improve clinical strategies for future clinical development and inform clinical practice decision-making for mCRC survivors.

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Moving Beyond Conventional Clinical Trial End Points in Treatment-refractory Metastatic Colorectal Cancer: A Composite Quality-of-life and Symptom Control End Point

Abstract: Future studies in treatment-refractory mCRC may be better served by evaluating improvement in symptom control and QOL, which may otherwise serve as the best predictor of survival in last-line treatment settings.

Cited by 13 publications

References 49 publications

Real‐world treatment patterns and outcomes in refractory metastatic colorectal cancer

Real‐world treatment patterns and outcomes in refractory metastatic colorectal cancer

Efficacy of olanzapine for quality of life improvement among patients with malignant tumor: A systematic review

Development of a disease conceptual model of patient experience with metastatic colorectal cancer: identification of the most salient symptoms and impacts

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