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The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).
Lund, CM, Vistisen, KK, Olsen, AP, Bardal, P, Schultz, M, Dolin, TG, Rønholt, F, Johansen, JS, Nielsen, DL
British journal of cancer. 2021;(12):1949-1958
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Abstract
BACKGROUND Older patients with colorectal cancer (CRC) experience chemotherapy dose reductions or discontinuation. Comprehensive geriatric assessment (CGA) predicts survival and chemotherapy completion in patients with cancer, but the benefit of geriatric interventions remains unexplored. METHODS The GERICO study is a randomised Phase 3 trial including patients ≥70 years receiving adjuvant or first-line palliative chemotherapy for CRC. Vulnerable patients (G8 questionnaire ≤14 points) were randomised 1:1 to CGA-based interventions or standard care, along with guideline-based chemotherapy. The primary outcome was chemotherapy completion without dose reductions or delays. Secondary outcomes were toxicity, survival and quality of life (QoL). RESULTS Of 142 patients, 58% received adjuvant and 42% received first-line palliative chemotherapy. Interventions included medication changes (62%), nutritional therapy (51%) and physiotherapy (39%). More interventional patients completed scheduled chemotherapy compared with controls (45% vs. 28%, P = 0.0366). Severe toxicity occurred in 39% of controls and 28% of interventional patients (P = 0.156). QoL improved in interventional patients compared with controls with the decreased burden of illness (P = 0.048) and improved mobility (P = 0.008). CONCLUSION Geriatric interventions compared with standard care increased the number of older, vulnerable patients with CRC completing adjuvant chemotherapy, and may improve the burden of illness and mobility. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT02748811.
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Potential of novel colchicine dosage schedule for the palliative treatment of advanced hepatocellular carcinoma.
Lin, ZY, Yeh, ML, Huang, CI, Chen, SC, Huang, CF, Huang, JF, Dai, CY, Yu, ML, Chuang, WL
The Kaohsiung journal of medical sciences. 2021;(7):616-623
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Previous in vitro and in vivo experiments had demonstrated dose-dependent anti-cancer effects of clinical plasma colchicine concentrations on hepatocellular carcinoma (HCC) cells. This phase IIa trial was to evaluate the potential efficiency and safety of our novel colchicine dosage schedule for the palliative treatment of advanced HCC. The dosage schedule started from oral intake of 1 mg colchicine three times per day for 4 days and discontinuation in the following 3 days (one cycle). The treatment cycle was repeated and the dosage was adjusted ranging from 3 to 1.5 mg/day according to the condition of the participant. The control group was originated from chart review of 86 HCC patients treated by sorafenib for more than 2 months. Fifteen participants signed the inform consent. Two participants were excluded due to screening failure in one and less than four treatment cycles in another. For severe adverse events, the colchicine group demonstrated higher incidence of biliary tract obstruction (p = 0.0184) than the sorafenib group. Comparison grade 1 or 2 adverse events between two groups, the colchicine group had higher incidence of diarrhea (p = 0) and the sorafenib group had higher incidence of palmar-plantar erythrodysesthesia syndrome (p = 0.0045). There was no significant difference in mortality, median survival, and overall survival between two groups (all p > 0.2). In conclusion, our novel colchicine dosage schedule is clinically feasible and has the potential to be applied in the palliative treatment of advanced HCC especially based on the cost-effectiveness consideration.
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Palliative short-course hypofractionated radiotherapy followed by chemotherapy in esophageal adenocarcinoma: the phase II PALAESTRA trial.
Borg, D, Sundberg, J, Brun, E, Kjellén, E, Petersson, K, Hermansson, M, Johansson, J, Eberhard, J, Johnsson, A
Acta oncologica (Stockholm, Sweden). 2020;(2):212-218
Abstract
Background: The majority of patients with incurable esophageal adenocarcinoma suffer from dysphagia. We assessed a novel treatment strategy with initial short-course radiotherapy followed by chemotherapy with the primary aim to achieve long-term relief of dysphagia.Methods: This phase II trial included treatment-naîve patients with dysphagia due to esophageal adenocarcinoma not eligible for curative treatment. External beam radiotherapy with 20 Gy in five fractions to the primary tumor was followed by four cycles of chemotherapy (FOLFOX regimen). Dysphagia was assessed using a five-grade scale.Results: From October 2014 to May 2018 a total of 29 patients were enrolled. The rate of dysphagia improvement was 79%, median duration of improvement 6.7 months (12.2 months for responders) and median overall survival 9.9 months. In the pre-specified per protocol analysis (23 patients) the rate of dysphagia improvement was 91%, median duration of improvement 12.2 months (14.0 months for responders) and median overall survival 16.0 months. The most common grade 3-4 adverse events were neutropenia (29%), infection (25%), anorexia (11%), esophagitis (11%) and fatigue (11%).Conclusion: Initial palliative short-course radiotherapy followed by chemotherapy is a promising treatment strategy that can provide long-lasting relief of dysphagia in patients with esophageal adenocarcinoma.
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Combined endovascular brachytherapy, sorafenib, and transarterial chemobolization therapy for hepatocellular carcinoma patients with portal vein tumor thrombus.
Zhang, ZH, Liu, QX, Zhang, W, Ma, JQ, Wang, JH, Luo, JJ, Liu, LX, Yan, ZP
World journal of gastroenterology. 2017;(43):7735-7745
Abstract
AIM: To evaluate the safety and efficacy of combined endovascular brachytherapy (EVBT), transarterial chemoembolization (TACE), and sorafenib to treat hepatocellular carcinoma (HCC) patients with main portal vein tumor thrombus (MPVTT). METHODS This single-center retrospective study involved 68 patients with unresectable HCC or those who were unfit for liver transplantation and percutaneous frequency ablation according to the BCLC classification. All patients had Child-Pugh classification grade A or B, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and MPVTT. The patients received either EVBT with stent placement, TACE, and sorafenib (group A, n = 37), or TACE with sorafenib (group B, n = 31). The time to progression (TTP) and overall survival (OS) were evaluated by propensity score analysis. RESULTS In the entire cohort, the 6-, 12-, and 24-mo survival rates were 88.9%, 54.3%, and 14.1% in group A, and 45.8%, 0%, and 0% in group B, respectively (P < 0.001). The median TTP and OS were significantly longer in group A than group B (TTP: 9.0 mo vs 3.4 mo, P < 0.001; OS: 12.3 mo vs 5.2 mo, P < 0.001). In the propensity score-matched cohort, the median OS was longer in group A than in group B (10.3 mo vs 6.0 mo, P < 0.001). Similarly, the median TTP was longer in group A than in group B (9.0 mo vs 3.4 mo, P < 0.001). Multivariate Cox analysis revealed that the EVBT combined with stent placement, TACE, and sorafenib strategy was an independent predictor of favorable OS (HR = 0.18, P < 0.001). CONCLUSION EVBT combined with stent placement, TACE, and sorafenib might be a safe and effective palliative treatment option for MPVTT.
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Intratumor cisplatin nephrotoxicity in combined laser-induced thermal therapy for cancer treatment.
Palumbo, MN, Cervantes, O, Eugênio, C, Hortense, FTP, Ribeiro, JC, Paolini, AAP, Tedesco, AC, Sercarz, JA, Paiva, MB
Lasers in surgery and medicine. 2017;(8):756-762
Abstract
INTRODUCTION Thermal ablation of tumors by Nd:YAG laser has been growing as a multidisciplinary subspecialty defined as laser-induced thermal therapy (LITT), and has been increasingly accepted as a minimally invasive method for palliation of advanced or recurrent cancer. Previous studies have shown that adjuvant chemotherapy can potentiate laser thermal ablation of tumors leading to improved palliation in advanced cancer patients. OBJECTIVE Evaluate nephrotoxicity by early markers of renal function in treating head and neck cancer using intra-tumor injections of cisplatin combined with laser-induced thermal therapy (CDDP-LITT). METHODS Nine patients with recurrent head and neck tumors were treated by CDDP-LITT in order to determine nephrotoxicity related to this synergistic association. Among the tests requested to detect early were creatinine, magnesium, creatinine clearance, serum urea-BUN, type I urine, and proteinuria at 24 hours. RESULTS Twelve recurrent tumors in nine patients were treated by CDDP-LITT. Pain was the major complaint (four patients), while other symptoms included dysphagia, dyspnea, bleeding, and difficulties in chewing. Fifteen laser procedures were performed and maximal CDDP dose was 50 mg. None of the markers for nephrotoxicity showed changes at these levels of CDDP intra-tumor injections. CONCLUSION This initial experience with (CDDP-LITT) indicates both safety and therapeutic potential for palliation of advanced head and neck cancer. However, safety and feasibility must be confirmed by longer follow-up and further escalation of CDDP doses in a Phase I study to determine maximum tolerated dose (MTD) and demonstrate tangible benefits for patients. Lasers Surg. Med. 49:756-762, 2017. © 2017 Wiley Periodicals, Inc.
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125I brachytherapy in the palliation of painful bone metastases from lung cancer after failure or rejection of conventional treatments.
Xiang, Z, Mo, Z, Li, G, Gilani, S, Zhong, Z, Zhang, T, Zhang, F, Gao, F
Oncotarget. 2016;(14):18384-93
Abstract
PURPOSE This study sought to assess the safety and effect of 125I seed implantation for palliation of painful bone metastases from lung cancer after failure or rejection of conventional treatments. MATERIALS AND METHODS 89 patients with painful bone metastases secondary to lung cancer were consented and enrolled in this study from June 2013 to May 2015. All patients had failed or refused conventional treatments underwent percutaneous CT-guided 125I seed implantation. The Brief Pain Inventory (BPI) was used to measure pain intensity prior to treatment (T0), 2, 4, 6, 8 and 12 weeks (T2, T4, T6, T8 and T12) after treatment in a 24-hour period. Analgesic, quality of life (QOL) scores and complications were also recorded. Four patients were excluded as they were lost to follow-up or had incomplete data. RESULTS 85 patients with 126 bone metastases from lung cancer were treated. There were significantly lower scores after treatment in the visual analog scale (VAS) and analgesic. The VAS scores for worst pain was 6.3±1.8 at T0. At T2, T4, T6, T8 and T12, the score in a 24-hour period decreased to 4.9±1.2 (P<0.01), 3.7±1.3 (P<0.01), 3.4±1.2 (P<0.01), 2.6±0.9 (P<0.01), and 1.4±0.8 (P<0.01) respectively. Comparison of QOL scores showed improvements including sleep, appetite, spiritual state, and fatigue at T2, T4, T6, T8 and T12 when compared to T0. No serious complications or massive bleeding were observed. CONCLUSIONS 125I brachytherapy is a safe and effective method for palliation of painful bone metastases from lung cancer after failure or rejection of conventional treatments.
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Comparative study of self-expanding metal stent and intraluminal radioactive stent for inoperable esophageal squamous cell carcinoma.
Tian, D, Wen, H, Fu, M
World journal of surgical oncology. 2016;(1):18
Abstract
BACKGROUND We compared the effectiveness of self-expanding metal stent alone vs. radioactive stent embedded with 125I seeds implantation insertion in patients of inoperable esophageal squamous cell cancer combined with malignant esophageal stenosis. METHODS We studied two groups of patients with stenosis attribute to inoperable esophageal squamous cell carcinoma. Group A had placed self-expanding metal stent alone insertion; group B encountered radioactive stent embedded with 125I seeds. Patients were followed up by monthly home visits or telephone interview. Survival time was analyzed with Kaplan-Meier analysis. Log rank test was used to analyze factors of survival time for all significant differences. RESULTS There was no significant difference between the two groups of all baseline characteristics. There was no statistical difference in complications including massive hematemesis, pain more than 1 month, stent migration, and restenosis. Survival time and causes of death such as tumor metastasis, massive hemorrhage, non-tumor-related factors, and restenosis were comparable between the two groups (P>0.05). The medical costs were significantly less in group A than those in group B (P<0.01). CONCLUSIONS Radioactive stent embedded with (125)I seeds was not significant in improving survival rate, but showed to increase hospitalization costs compared to self-expandable metal stent alone in treating inoperable esophageal squamous cell carcinoma stricture.
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The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06).
Strasser, F, Blum, D, von Moos, R, Cathomas, R, Ribi, K, Aebi, S, Betticher, D, Hayoz, S, Klingbiel, D, Brauchli, P, et al
Annals of oncology : official journal of the European Society for Medical Oncology. 2016;(2):324-32
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BACKGROUND Patients with advanced, incurable cancer receiving anticancer treatment often experience multidimensional symptoms. We hypothesize that real-time monitoring of both symptoms and clinical syndromes will improve symptom management by oncologists and patient outcomes. PATIENTS AND METHODS In this prospective multicenter cluster-randomized phase-III trial, patients with incurable, symptomatic, solid tumors, who received new outpatient chemotherapy with palliative intention, were eligible. Immediately before the weekly oncologists' visit, patients completed the palm-based E-MOSAIC assessment (Edmonton-Symptom-Assessment-Scale, ≤3 additional symptoms, estimated nutritional intake, body weight change, Karnofsky Performance Status, medications for pain, fatigue, nutrition). A cumulative, longitudinal monitoring sheet (LoMoS) was printed immediately. Eligible experienced oncologists were defined as one cluster each and randomized to receive the immediate print-out LoMoS (intervention) or not (control). Primary analysis limited to patients having uninterrupted (>4/6 visits with same oncologist) patient-oncologist sequences was a mixed model for the difference in patients global quality of life (G-QoL; items 29/30 of EORTC-QlQ-c30) between baseline (BL) and week 6. Intention-to-treat (ITT) analysis included all eligible patients. RESULTS In 8 centers, 82 oncologists treated 264 patients (median 66 years; overall survival intervention 6.3, control 5.4 months) with various tumors. The between-arm difference in G-QoL of 102 uninterrupted patients (intervention: 55; control: 47) was 6.8 (P = 0.11) in favor of the intervention; in a sensitivity analysis (oncologists treating ≥2 patients; 50, 39), it was 9.0 (P = 0.07). ITT analysis revealed improvement in symptoms (difference last study visit-BL: intervention -5.4 versus control 2.1, P = 0.003) and favored the intervention for communication and coping. More patients with high symptom load received immediate symptom management (chart review, nurse-patient interview) by oncologists getting the LoMoS. CONCLUSION Monitoring of patient symptoms, clinical syndromes and their management clearly reduced patients' symptoms, but not QoL. Our results encourage the implementation of real-time monitoring in the routine workflow of oncologist with a computer solution.
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Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study.
Nikles, J, Mitchell, GK, Hardy, J, Agar, M, Senior, H, Carmont, SA, Schluter, PJ, Good, P, Vora, R, Currow, D
Palliative medicine. 2015;(10):967-74
Abstract
BACKGROUND Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. AIM: This study aimed to test the feasibility of using n-of-1 trials to test pilocarpine drops compared to placebo, for patients of palliative care units with advanced cancer, who experienced dry mouth. DESIGN This was an N-of-1 study, in which each participant was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. SETTING/PARTICIPANTS Participants were patients of specialist palliative care services with advanced cancer assessed as having a dry mouth, defined as having a score of ⩾ 3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. Patients self-completed a diary using validated symptom and quality-of-life scores. The randomisation order was unmasked at the end of each person's trial by a clinician independent of the trial to allow a treatment decisions for individual patients to be made. RESULTS Nine patients completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four patients completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. CONCLUSION The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom.
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Palliative Cancer Patients' Experiences of Participating in a Lifestyle Intervention Study While Receiving Chemotherapy.
Mikkelsen, HE, Brovold, KV, Berntsen, S, Kersten, C, Fegran, L
Cancer nursing. 2015;(6):E52-8
Abstract
BACKGROUND Lifestyle interventions have promise in terms of their potential health benefits and as an empowerment tool for cancer patients. Nevertheless, documentation of palliative cancer patients experiences of participating in lifestyle interventions remains poor. OBJECTIVE The objective of this study was to explore how palliative cancer patients experience participation in a feasibility study focusing on multiple lifestyle interventions (physical, nutritional, smoking cessation, and stress management) while receiving chemotherapy. METHODS This was a qualitative design with semistructured interviews of 9 palliative cancer patients 3 to 4 months after inclusion to the lifestyle intervention. Data were analyzed according to a qualitative content analysis within a hermeneutic approach. RESULTS Three main themes emerged: (1) adopting a healthier lifestyle, (2) taking on a more active role, and (3) boosting confidence. Participation made some participants feel guilty when they were not able to reach their own lifestyle goals. CONCLUSIONS Participation in lifestyle interventions is valued by palliative cancer patients and may strengthen their coping abilities. However, some of the participants also expressed feelings of guilt and inadequacy. Thus, the organizational aspects of interventions need to be considered carefully to minimize the possibility of causing increased strain on the participants, who already experience the burden of coping with their disease. IMPLICATIONS FOR PRACTICE This study provides a unique insight into the palliative cancer patients experiences of participating in a trial focusing on multiple lifestyle interventions while receiving chemotherapy. The results may provide guidance for healthcare professionals in their efforts to help palliative cancer patients adopt a healthier lifestyle and to help patients increase their coping abilities.