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 ◽  
...  

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.

2020 ◽  
Vol 20 (3) ◽  
pp. 109-116
Author(s):  
Bello Arkilla Magaji ◽  
Foong Ming Moy ◽  
Chee Wei Law ◽  
Ismail Sagap ◽  
April Camilla Roslani

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.


2019 ◽  
Vol 149 (7) ◽  
pp. 1133-1139 ◽  
Author(s):  
Lynne M Howells ◽  
Chinenye O O Iwuji ◽  
Glen R B Irving ◽  
Shaun Barber ◽  
Harriet Walter ◽  
...  

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.


2004 ◽  
Vol 22 (5) ◽  
pp. 801-810 ◽  
Author(s):  
Stein Sundstrøm ◽  
Roy Bremnes ◽  
Ulf Aasebø ◽  
Steinar Aamdal ◽  
Reidulv Hatlevoll ◽  
...  

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.


2021 ◽  
Author(s):  
Lidya Genene Abebe ◽  
Abigiya Wondimagegnehu ◽  
Aynalem Abraha Woldemariam ◽  
Bizu Gelaye ◽  
Eva Johanna Kantelhardt ◽  
...  

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.


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Nicoletta De Rosa ◽  
Giada Lavitola ◽  
Pierluigi Giampaolino ◽  
Ilaria Morra ◽  
Carmine Nappi ◽  
...  

Background. Cervical cancer (CC) treatments impact quality of life (QoL) and sexual function (SF) of survivors. Treatment options to reduce sexual dysfunction are limited. The aim of this study was to assess the effectiveness of ospemifene in CC survivors with clinical signs and symptoms of vulvovaginal atrophy (VVA) focusing on their QoL and SF. Materials and Methods. Fifty-two patients with previous diagnosis of stage I-IIa CC suffering from VVA and treated with ospemifene were enrolled into a single arm prospective study. Patient underwent 6 months of therapy. At baseline and after 6 months all subjects performed Vaginal Health Index (VHI). The SF and QoL were measured by The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) and the Cervical Cancer Module (CXC-24). Results. After treatment a significant improvement of each parameter of VHI has been demonstrated. Global health status and emotional and social functioning scores improved significantly. On the contrary, general symptoms scales did not show significant difference from baseline data. Sexual activity, sexual vaginal functioning, body image, and sexual enjoyment scores increased significantly. Conclusion. Ospemifene seems to be effective in decreasing the VVA symptoms in CC survivors.


2020 ◽  
pp. 21-27
Author(s):  
Arezou Sourmeh ◽  
Ali Mashhadi ◽  
Zohre Sepehri Shamloo

Introduction: This study aimed to examine the effectiveness of group-based compassion-focused therapy (CFT) on depression, anxiety, and improving the quality of life (QoL) in women with feminine cancers. Methods: A pretest-posttest control‐grouped, quasi‐experimental study was carried out on all women with cancer who were referred to the Omid Hospital of Mashhad in 2019. Thirty patients with various types of feminine cancers were randomly assigned to 12 weeks of group-based compassion-focused therapy (CFT) (n=15) or sham control (n=15). Participants in both conditions completed measures of Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI-II), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at pretest and posttest. Analysis of covariance was used for data analysis. Results: Our results showed that there was a significant difference between experimental and sham control groups in depression (F= 4/499, P<0.05, d=1.60 large) and anxiety (F=19/99, P<0.01, d=1.96 large), but there was no significant difference in participants’ QoL scale. Conclusions: Group-based CFT could be considered a promising and potentially useful intervention to alleviate the depression and anxiety in cancer patients but it did not affect their QoL. Nevertheless, future randomized trials are needed.


2019 ◽  
Author(s):  
Juan Ignacio Arraras ◽  
Gemma Asin ◽  
José Juan Illarramendi ◽  
Ana Manterola ◽  
Esteban Salgado ◽  
...  

2020 ◽  
Vol 48 (12) ◽  
pp. 030006052097987
Author(s):  
Umesh Jayarajah ◽  
Thisaru Widyarathne ◽  
Metthananda Nawarathne ◽  
Sivananthan Raguvaran ◽  
Nishanthan Subramaniam ◽  
...  

Objective We aimed to describe the clinical characteristics of chronic pancreatitis (CP) and patient quality of life (QOL) in a resource-limited setting. Methods We performed a cross-sectional study including patients with clinical and radiological features of CP. We collected clinical data and assessed QOL using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire. Results We included 103 patients (median age 44 years, 84 men). Median age at symptom onset was 36 (4–78) years. Around 70% of patients had diabetes mellitus and 62.1% had consumed alcohol; 36 (35%) were current smokers. The mean overall global QOL score was 68.7. Most patients (91.3%) sought treatment from multiple centers. Nineteen (18.5%) had pancreatic stone disease, 38 (36.9%) had persistent abdominal pain (median severity 7.8/10, 59 (57.3%) had steatorrhea, and 56 (54.4%) had jaundice. Poor QOL was significantly associated with weight loss, loss of appetite, and intractable pain. No correlation with age, sex, or alcohol consumption was noted. Conclusion A considerable proportion of patients with CP had troublesome symptoms. Intractable pain, loss of appetite, and weight loss were significantly associated with poor QOL. Further assessment is needed of patients’ psychosocial well-being and its association with QOL.


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