scholarly journals Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial

2019 ◽  
Vol 149 (7) ◽  
pp. 1133-1139 ◽  
Author(s):  
Lynne M Howells ◽  
Chinenye O O Iwuji ◽  
Glen R B Irving ◽  
Shaun Barber ◽  
Harriet Walter ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Adverse Event ◽  
Metastatic Colorectal Cancer ◽  
Gynecologic Oncology Group ◽  
Life Questionnaire ◽  
European Organization ◽  
Significant Difference ◽  
Folfox Chemotherapy

ABSTRACT Background Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties. Objectives This phase IIa open-labelled randomized controlled trial aimed to assess safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1) in patients receiving folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) compared with FOLFOX + 2 g oral curcumin/d (CUFOX). Methods Twenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer were randomly assigned (1:2) to receive either FOLFOX or CUFOX. Safety was assessed by Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS). Quality of life and neurotoxicity were assessed using questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment of Cancer Treatment-Gynecologic Oncology Group-Neurotoxicity). Plasma curcuminoids were determined with liquid chromatography (LC) electrospray ionization tandem mass spectrometry and CXCL1 by ELISA. Results Addition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable (primary outcome). Similar adverse event profiles were observed for both arms. In the intention-to-treat population, the HR for PFS was 0.57 (95% CI: 0.24, 1.36; P = 0.2) (median of 171 and 291 d for FOLFOX and CUFOX, respectively) and for OS was 0.34 (95% CI: 0.14, 0.82; P = 0.02) (median of 200 and 502 d for FOLFOX and CUFOX, respectively). There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223). Curcumin glucuronide was detectable at concentrations >1.00 pmol/mL in 15 of 18 patients receiving CUFOX. Curcumin did not significantly alter CXCL1 over time (P = 0.712). Conclusion Curcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer. This trial was registered at clinicaltrials.gov as NCT01490996 and at www.clinicaltrialsregister.eu as EudraCT 2011-002289-19.

Impact of protracted venous infusion fluorouracil with or without interferon alfa-2b on tumor response, survival, and quality of life in advanced colorectal cancer.

1995 ◽  
Vol 13 (9) ◽  
pp. 2317-2323 ◽  
Author(s):  
M Hill ◽  
A Norman ◽  
D Cunningham ◽  
M Findlay ◽  
M Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Symptomatic Improvement ◽  
Interferon Alfa ◽  
Life Questionnaire ◽  
European Organization ◽  
Significant Difference ◽  
Venous Infusion

PURPOSE The aim of this study was to investigate the effects of adding interferon alfa-2b (IFN) to protracted venous infusion fluorouracil (PVI 5-FU) from the start of treatment in patients with advanced colorectal cancer. PATIENTS AND METHODS Patients who attended our unit with histologically confirmed advanced colorectal cancer were randomized to receive either PVI 5-FU 300 mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly, or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks, with a 2-week gap for reassessment of all parameters. Quality of life (QL) was measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatment and every 6 weeks thereafter. RESULTS A total of 160 patients were randomized, with 155 eligible for assessment. Radiologic response was observed in 43 patients (28%): 17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and 26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22 PRs) (difference not significant). Symptomatic improvement occurred in the majority of patients, and equally in both arms: 61% to 80% depending on the symptom. There was no significant difference between the two groups in failure-free survival (median, 161 v 193 days) or overall survival (median, 328 v 357 days). However, patients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .001), neutropenia (P = .04), mucositis (P = .008), and alopecia (P = .0002). There were no toxic deaths and few notable differences in QL between the two arms. CONCLUSION This study confirms that PVI 5-FU is effective in treating the symptoms associated with metastatic colorectal carcinoma, with only mild to moderate toxicity and maintenance of QL. IFN 5 MU three times weekly does not enhance these palliative benefits.

scholarly journals PSYCHOMETRIC VALIDATION OF THE BAHASA MALAYSIA VERSION OF THE EORTC QLQ-C30 IN MALAYSIAN COLORECTAL CANCER PATIENTS

2020 ◽  
Vol 20 (3) ◽  
pp. 109-116
Author(s):  
Bello Arkilla Magaji ◽  
Foong Ming Moy ◽  
Chee Wei Law ◽  
Ismail Sagap ◽  
April Camilla Roslani
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Discriminant Validity ◽  
Statistical Significance ◽  
Psychometric Validation ◽  
P Value ◽  
Life Questionnaire ◽  
European Organization ◽  
Significant Difference

This study aimed to assess the validity and reliability of the Bahasa Malaysia (BM) version of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire core (QLQ-C30) (version 3.0) in Malaysian patients with colorectal cancer. A cross sectional study design was used to obtain data from patients receiving treatment at two teaching hospitals in Kuala Lumpur, Malaysia. Self-administered method was used. Statistical analysis included reliability, convergent and discriminant validity and known-groups comparisons. Statistical significance was based on p value ≤ 0.05. The internal consistency Cronbach’s alpha coefficient (α) was acceptable (> 0.70) in all scales but cognitive (α = 0.56) and pain in patients with stoma bag (α = 0.35). Test-retest coefficients were high (r = 0.93 to 1.00). All items showed adequate convergent validity (r > 0.40) except for questionnaire item 5 “needs help in eating/dressing/washing”. Similarly, criteria for discriminant validity were achieved in all but item 10 “need rest”. Patients with high Karnofsky Performance Scores (KPS) scores reported significantly less dyspnoea (p = 0.021) and appetite loss (p = 0.047) compared to patients with low KPS scores. There was no significant difference between patients with and without stomas. The psychometric properties of the BM version of the QLQ-C30 were comparable to previous studies in other settings. Therefore, the questionnaire could be used to measure quality of life in Malaysian patients with colorectal cancer.

Hypofractionated Palliative Radiotherapy (17 Gy per two fractions) in Advanced Non–Small-Cell Lung Carcinoma Is Comparable to Standard Fractionation for Symptom Control and Survival: A National Phase III Trial

2004 ◽  
Vol 22 (5) ◽  
pp. 801-810 ◽  
Author(s):  
Stein Sundstrøm ◽  
Roy Bremnes ◽  
Ulf Aasebø ◽  
Steinar Aamdal ◽  
Reidulv Hatlevoll ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Symptom Relief ◽  
Small Cell ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Small Cell Lung ◽  
European Organization ◽  
Significant Difference

Purpose To investigate whether the effect of hypofractionated thoracic radiotherapy (TRT) is comparable to more standard fractionated radiotherapy (RT) in advanced non–small-cell lung cancer (NSCLC). Patients and Methods A total of 421 patients with locally advanced stage III or stage IV NSCLC tumors were included. Inclusion criteria were inoperable, disease too advanced for curative radiotherapy, and chest symptoms or central tumor threatening the airways. Patients were randomly assigned to three arms: A, 17 Gy per two fractions (n = 146); B, 42 Gy per 15 fractions (n = 145); and C, 50 Gy per 25 fractions (n = 130). Four hundred seven patients were eligible for the study; 395 patients (97%) participated in the health-related quality-of-life (HRQOL) study. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-lung cancer–specific module (LC13) were used to investigate airway symptom relief and changes in HRQOL. Assessments were performed before TRT and until week 54. Clinicians' assessments of symptom improvement were at 2, 6, and 14 weeks after completion of TRT. The patients were observed for a minimum of 3 years. Results Baseline prognostic data were equally distributed in the treatment groups. Patient compliance with respect to the HRQOL investigation was minimum 74%. HRQOL and symptom relief were equivalent in the treatment arms. No significant difference in survival among arms A, B, and C was found, with median survival 8.2, 7.0, and 6.8 months, respectively. Conclusion Our data indicate that protracted palliative TRT renders no improvement in symptom relief, HRQOL, or survival when compared with short-term hypofractionated treatment in advanced NSCLC.

Phase III Comparison of Two Irinotecan Dosing Regimens in Second-Line Therapy of Metastatic Colorectal Cancer

2003 ◽  
Vol 21 (5) ◽  
pp. 807-814 ◽  
Author(s):  
Charles S. Fuchs ◽  
Melvin R. Moore ◽  
Graydon Harker ◽  
Luis Villa ◽  
David Rinaldi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Significant Difference ◽  
Global Quality Of Life ◽  
Grade 3

Purpose: Randomized trials in fluorouracil (FU)-refractory colorectal cancer demonstrate significant survival advantages for patients receiving irinotecan. We prospectively compared the efficacy and tolerability of two irinotecan regimens (once a week for 4 weeks followed by a 2-week rest period [weekly] v once every 3 weeks) in such patients. Patients and Methods: This multicenter, open-label, phase III study randomly assigned patients in a 1:2 ratio to irinotecan given either weekly (125 mg/m2) or once every 3 weeks (350 mg/m2, or 300 mg/m2 in patients who were ≥ 70 years of age, who had Eastern Cooperative Oncology Group performance status equal to 2, or who had prior pelvic irradiation). Results: With median follow-up of 15.8 months, there was no significant difference in 1-year survival (46% v 41%, respectively; P = .42), median survival (9.9 v 9.9 months, respectively; P = .43), or median time to progression (4.0 v 3.0 months, respectively; P = .54) between the two regimens. Grade 3/4 diarrhea occurred in 36% of patients treated weekly and in 19% of those treated once every 3 weeks (P = .002). Grade 3/4 neutropenia occurred in 29% of patients treated weekly and 34% of those treated once every 3 weeks (P = .35). Treatment-related mortality occurred in five patients (5.3%) receiving irinotecan weekly and three patients (1.6%) given therapy once every 3 weeks (P = .12). Global quality of life was not statistically different between treatment groups. Conclusion: Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea.

How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

2004 ◽  
Vol 22 (17) ◽  
pp. 3485-3490 ◽  
Author(s):  
Erik K. Fromme ◽  
Kristine M. Eilers ◽  
Motomi Mori ◽  
Yi-Ching Hsieh ◽  
Tomasz M. Beer
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer

2021 ◽  
Author(s):  
Alberto Zaniboni ◽  
Carlo Antonio Barone ◽  
Maria Chiara Banzi ◽  
Francesca Bergamo ◽  
Livio Blasi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Performance Status ◽  
Progression Free Survival ◽  
Life Questionnaire ◽  
Safety And Efficacy ◽  
Colorectal Cancer Patients ◽  
Post Hoc

The international PRECONNECT Phase IIIb study demonstrated safety and efficacy of trifluridine/tipiracil in the management of patients with metastatic colorectal cancer. Post-hoc analyses in a national context are important because of the differences in disease management across countries. Post-hoc safety and efficacy analyses in the PRECONNECT Italian patient subset were conducted. Patients' quality of life was assessed from baseline to end of treatment. In Italy, 161 patients were enrolled. The median age was 64 years, with a performance status of 0–1. The most common hematological drug-related adverse events ≥grade 3 were neutropenia (41.0%) and anemia (13.7%). The median progression-free survival was reached at 3.0 months, with a disease control rate of 28.6%. The Quality of Life Questionnaire Core 30 score improved in 25.4% of the patients. Safety, efficacy and quality of life results confirmed trifluridine/tipiracil as a feasible and favorable treatment option for metastatic colorectal cancer patients.

scholarly journals Construct Validity and Reliability of the European Organization for Research and Treatment of Cancer Quality of Life Tool Among Colorectal Cancer Patients in Ethiopia

2021 ◽  
Author(s):  
Lidya Genene Abebe ◽  
Abigiya Wondimagegnehu ◽  
Aynalem Abraha Woldemariam ◽  
Bizu Gelaye ◽  
Eva Johanna Kantelhardt ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Construct Validity ◽  
Cancer Patients ◽  
Life Questionnaire ◽  
Validity And Reliability ◽  
European Organization ◽  
Eortc Qlq ◽  
Colorectal Cancer Patients

Abstract Background: Colorectal cancer and its treatments can have a detrimental effect on patients’ quality of life. The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) was developed to assess quality of life among colorectal cancer patients and is used worldwide. However, the tool has not been translated into a local language or validated in the Ethiopian context. Therefore, this study aimed to examine the psychometric properties of the EORTC-QLQ in Ethiopia among colorectal cancer patients.Methods: A cross-sectional study was conducted in a major referral hospital in Addis Ababa, Ethiopia from March to May, 2020. A total of 158 colorectal cancer patients were consecutively included. The construct validity was assessed using Multitrait Scale Analysis, convergent validity, and relationship with functional outcomes. The internal consistency was examined using Cronbach’s alpha.Result: Among the participants, 52.2% were men, with a median age of 46 years (IQR = 17.7 years). The time needed to complete the EORTC-QLQ was less than 20 minutes. The item-total correlation alpha values ranged from 0.47–0.91. All item correlations within their scales were greater than 0.4 except for the Blood and Mucus in Stool scale. The value of correlation coefficients between all items and their own domain were higher than other domains, except for the Blood and Mucus in Stool scale. The correlation between the core questionnaire and the colorectal tool ranged from -0.453–0.581. The tool showed a significant difference between stoma and non-stoma patients, and between patients who had good physical function and those who did not.Conclusion: Except for the Blood and Mucus in Stool scale, the construct validity and reliability of all scales were supported. Therefore, the Amharic version of the tool can be used to assess health related quality of life in Ethiopian colorectal cancer patients. However, due to the low correlation between items in the Blood and Mucus in Stool scale, we recommend that these items are treated as a single item.

Validation of Patient's Self-Reported Social Functioning As an Independent Prognostic Factor for Survival in Metastatic Colorectal Cancer Patients: Results of an International Study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer

2008 ◽  
Vol 26 (12) ◽  
pp. 2020-2026 ◽  
Author(s):  
Fabio Efficace ◽  
Pasquale F. Innominato ◽  
Georg Bjarnason ◽  
Corneel Coens ◽  
Yves Humblet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Social Functioning ◽  
Cancer Patients ◽  
Life Questionnaire ◽  
European Organisation ◽  
Wbc Count ◽  
Colorectal Cancer Patients

Purpose A recent study identified a prognostic model for survival in metastatic colorectal cancer patients which included WBC count, alkaline phosphatase (AP), number of metastatic sites, and patients’ self-reported social functioning. The aim of this research is to validate this model on data from an independent sample. Patients and Methods This validation study is based on a prospective randomized controlled trial in patients with metastatic colorectal cancer conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Chronotherapy Group. Overall, 564 patients in 10 countries were enrolled. For the purpose of this independent validation, patients with health-related quality of life (HRQOL) baseline data were analyzed. HRQOL was assessed using the EORTC Quality of Life Questionnaire C30 (QLQ-C30). The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. Results The previous model with an additional adjustment, by stratification for sex, was replicated and its parameters were confirmed to independently predict survival: WBC count with an hazard ratio (HR) of 1.31 (95% CI, 1.021 to 1.698; P = .034); AP with an HR of 1.53 (95% CI, 1.188 to 1.979; P = .001); number of sites involved with an HR of 1.90 (95% CI, 1.531 to 2.364; P < .0001); and patients’ self-reported social functioning with an HR of 0.94 (95% CI, 0.905 to 0.976; P = .001). The latter translates into a 6% increase in the likelihood of an earlier death for every 10-point decrease in the social functioning scale of the EORTC QLQ-C30. Conclusion This study provides confirmatory evidence of the independent prognostic value of patients’ self-reported social functioning in patients with advanced colorectal cancer.

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