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Cost-effectiveness analysis of long-course oxaliplatin and bolus of fluorouracil based preoperative chemoradiotherapy vs. 5x5Gy radiation plus FOLFOX4 for locally advanced resectable rectal cancer.
Wang, S, Wen, F, Zhang, P, Wang, X, Li, Q
Radiation oncology (London, England). 2019;(1):113
Abstract
PURPOSE To evaluate the cost-effectiveness of preoperative short-course radiotherapy (SCRT, 5 × 5 Gy) plus FOLFOX4 versus long-course oxaliplatin and bolus of fluorouracil based preoperative long-course chemoradiotherapy (LCCRT, 50.4 Gy in 28 fractions) in the management of cT4 or advanced cT3 rectal cancer (RC), both of which have been reported to achieve similar clinical effect in the NCT00833131 trial. MATERIALS AND METHODS A Markov decision-analytic model compared SCRT plus chemotherapy and LCCRT, by simulating three health states (disease-free survival (DFS), progressive disease (PD) and death). The primary outcomes were quality-adjusted life months (QALMs), costs, and incremental cost-effectiveness ratios (ICERs). Transition probabilities were based on the NCT00833131 trial. The costs were calculated from a Chinese payers' perspective. Strategies were evaluated with a willingness-to-pay (WTP) threshold of $2370.47 (3 × GDP) per QALM gained. Sensitivity analysis was performed to model uncertainty in these parameters. RESULTS The overall costs for SCRT plus chemotherapy and LCCRT were $78,937 and $38,140 with effectiveness of 29.92 QALMs and 22.99 QALMs, respectively. SCRT plus chemotherapy increased costs and QALM by $40,797.34 and 6.93 compared to LCCRT, resulting in an ICER of $5884.56/QALM gained. In the DFS state, the whole cost for SCRT plus chemotherapy and LCCRT were $11,490.03 and $10,794.06 with an effectiveness of 21.70 QALMs and 19.65 QALMs, respectively. SCRT plus chemotherapy increased cost and QALM by $695.97 and 2.05 compared to LCCRT, resulting in a ICER of $339.50/QALM gained, which below the WTP. The utility associated with the DFS state was the most influential factor on the cost-effectiveness of SCRT plus chemotherapy. When the cost of PD state below $1920, the ICER of SCRT compared with LCCRT below the WTP. CONCLUSION Compared with LCCRT, SCRT plus chemotherapy is a more cost-effective strategy for locally advanced resectable RC in the DFS state as well as in the all states when the cost of PD state below $1920.
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Nigella sativa L. for prevention of acute radiation dermatitis in breast cancer: A randomized, double-blind, placebo-controlled, clinical trial.
Rafati, M, Ghasemi, A, Saeedi, M, Habibi, E, Salehifar, E, Mosazadeh, M, Maham, M
Complementary therapies in medicine. 2019;:102205
Abstract
OBJECTIVE The present study aimed to evaluate the effectiveness of Nigella sativa L. (N. sativa) extract on preventing the incidence of acute radiation dermatitis (ARD) in breast cancer patients. METHODS Sixty-two breast cancer patients undergoing radiotherapy (RT) were randomly assigned to receiveN. sativa 5% gel or placebo. Patients were instructed to apply the medications twice daily during RT period. The severity of ARD, the incidence of moist desquamation, worst experienced pain, and skin-related quality of life (SRQOL) scores were assessed weekly during RT. RESULTS Patients who were treated with the N. sativa gel developed ARD significantly less frequently compared to those who used the placebo (p < 0.05 for all weeks except week 2, p = 0.36). The incidence time of grade 2 and 3 of Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) toxicity was prolonged significantly with N. sativa gel as compared to placebo (35 vs. 29 days, p = 0.00 and 42 vs. 40 days, p = 0.01, respectively). Furthermore, the occurrence of moist desquamation was delayed in the N. sativa gel group compared with the placebo group (37 vs. 33 days, p = 0.01). The mean score of the worst pain that patients experienced in the placebo group was significantly higher than that of the N. sativa gel group at week 3 (2.5 ± 0.5 vs. 1.2 ± 0.3, p < 0.05). Nonetheless, the application of N. sativa gel had no significant effect on the SRQOL of patients at any week. CONCLUSION N. sativa extract significantly decreases the severity of ARD and delays the onset of moist desquamation in breast cancer patients.
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Early and late adverse renal effects after potentially nephrotoxic treatment for childhood cancer.
Kooijmans, EC, Bökenkamp, A, Tjahjadi, NS, Tettero, JM, van Dulmen-den Broeder, E, van der Pal, HJ, Veening, MA
The Cochrane database of systematic reviews. 2019;(3):CD008944
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Abstract
BACKGROUND Improvements in diagnostics and treatment for paediatric malignancies resulted in a major increase in survival. However, childhood cancer survivors (CCS) are at risk of developing adverse effects caused by multimodal treatment for their malignancy. Nephrotoxicity is a known side effect of several treatments, including cisplatin, carboplatin, ifosfamide, radiotherapy and nephrectomy, and can cause glomerular filtration rate (GFR) impairment, proteinuria, tubulopathy, and hypertension. Evidence about the long-term effects of these treatments on renal function remains inconclusive. It is important to know the risk of, and risk factors for, early and late adverse renal effects, so that ultimately treatment and screening protocols can be adjusted. This review is an update of a previously published Cochrane Review. OBJECTIVES To evaluate existing evidence on the effects of potentially nephrotoxic treatment modalities on the prevalence of renal dysfunction in survivors treated for childhood cancer with a median or mean survival of at least one year after cessation of treatment, where possible in comparison with the general population or CCS treated without potentially nephrotoxic treatment. In addition, to evaluate evidence on associated risk factors, such as follow-up duration, age at time of diagnosis and treatment combinations, as well as the effect of doses. SEARCH METHODS On 31 March 2017 we searched the following electronic databases: CENTRAL, MEDLINE and Embase. In addition, we screened reference lists of relevant studies and we searched the congress proceedings of the International Society of Pediatric Oncology (SIOP) and The American Society of Pediatric Hematology/Oncology (ASPHO) from 2010 to 2016/2017. SELECTION CRITERIA Except for case reports, case series and studies including fewer than 20 participants, we included studies with all study designs that reported on renal function (one year or longer after cessation of treatment), in CCS treated before the age of 21 years with cisplatin, carboplatin, ifosfamide, radiation involving the kidney region, a nephrectomy, or a combination of two or more of these treatments. When not all treatment modalities were described or the study group of interest was unclear, a study was not eligible for the evaluation of prevalence. We still included it for the assessment of risk factors if it had performed a multivariable analysis. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction using standardised data collection forms. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS Apart from the remaining 37 studies included from the original review, the search resulted in the inclusion of 24 new studies. In total, we included 61 studies; 46 for prevalence, six for both prevalence and risk factors, and nine not meeting the inclusion criteria, but assessing risk factors. The 52 studies evaluating the prevalence of renal dysfunction included 13,327 participants of interest, of whom at least 4499 underwent renal function testing. The prevalence of adverse renal effects ranged from 0% to 84%. This variation may be due to diversity of included malignancies, received treatments, reported outcome measures, follow-up duration and the methodological quality of available evidence.Seven out of 52 studies, including 244 participants, reported the prevalence of chronic kidney disease, which ranged from 2.4% to 32%.Of these 52 studies, 36 studied a decreased (estimated) GFR, including at least 432 CCS, and found it was present in 0% to 73.7% of participants. One eligible study reported an increased risk of glomerular dysfunction after concomitant treatment with aminoglycosides and vancomycin in CCS receiving total body irradiation (TBI). Four non-eligible studies assessing a total cohort of CCS, found nephrectomy and (high-dose (HD)) ifosfamide as risk factors for decreased GFR. The majority also reported cisplatin as a risk factor. In addition, two non-eligible studies showed an association of a longer follow-up period with glomerular dysfunction.Twenty-two out of 52 studies, including 851 participants, studied proteinuria, which was present in 3.5% to 84% of participants. Risk factors, analysed by three non-eligible studies, included HD cisplatin, (HD) ifosfamide, TBI, and a combination of nephrectomy and abdominal radiotherapy. However, studies were contradictory and incomparable.Eleven out of 52 studies assessed hypophosphataemia or tubular phosphate reabsorption (TPR), or both. Prevalence ranged between 0% and 36.8% for hypophosphataemia in 287 participants, and from 0% to 62.5% for impaired TPR in 246 participants. One non-eligible study investigated risk factors for hypophosphataemia, but could not find any association.Four out of 52 studies, including 128 CCS, assessed the prevalence of hypomagnesaemia, which ranged between 13.2% and 28.6%. Both non-eligible studies investigating risk factors identified cisplatin as a risk factor. Carboplatin, nephrectomy and follow-up time were other reported risk factors.The prevalence of hypertension ranged from 0% to 50% in 2464 participants (30/52 studies). Risk factors reported by one eligible study were older age at screening and abdominal radiotherapy. A non-eligible study also found long follow-up time as risk factor. Three non-eligible studies showed that a higher body mass index increased the risk of hypertension. Treatment-related risk factors were abdominal radiotherapy and TBI, but studies were inconsistent.Because of the profound heterogeneity of the studies, it was not possible to perform meta-analyses. Risk of bias was present in all studies. AUTHORS' CONCLUSIONS The prevalence of adverse renal effects after treatment with cisplatin, carboplatin, ifosfamide, radiation therapy involving the kidney region, nephrectomy, or any combination of these, ranged from 0% to 84% depending on the study population, received treatment combination, reported outcome measure, follow-up duration and methodological quality. With currently available evidence, it was not possible to draw solid conclusions regarding the prevalence of, and treatment-related risk factors for, specific adverse renal effects. Future studies should focus on adequate study designs and reporting, including large prospective cohort studies with adequate control groups when possible. In addition, these studies should deploy multivariable risk factor analyses to correct for possible confounding. Next to research concerning known nephrotoxic therapies, exploring nephrotoxicity after new therapeutic agents is advised for future studies. Until more evidence becomes available, CCS should preferably be enrolled into long-term follow-up programmes to monitor their renal function and blood pressure.
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Merging Orthovoltage X-Ray Minibeams spare the proximal tissues while producing a solid beam at the target.
Dilmanian, FA, Krishnan, S, McLaughlin, WE, Lukaniec, B, Baker, JT, Ailawadi, S, Hirsch, KN, Cattell, RF, Roy, R, Helfer, J, et al
Scientific reports. 2019;(1):1198
Abstract
Conventional radiation therapy of brain tumors often produces cognitive deficits, particularly in children. We investigated the potential efficacy of merging Orthovoltage X-ray Minibeams (OXM). It segments the beam into an array of parallel, thin (~0.3 mm), planar beams, called minibeams, which are known from synchrotron x-ray experiments to spare tissues. Furthermore, the slight divergence of the OXM array make the individual minibeams gradually broaden, thus merging with their neighbors at a given tissue depth to produce a solid beam. In this way the proximal tissues, including the cerebral cortex, can be spared. Here we present experimental results with radiochromic films to characterize the method's dosimetry. Furthermore, we present our Monte Carlo simulation results for physical absorbed dose, and a first-order biologic model to predict tissue tolerance. In particular, a 220-kVp orthovoltage beam provides a 5-fold sharper lateral penumbra than a 6-MV x-ray beam. The method can be implemented in arc-scan, which may include volumetric-modulated arc therapy (VMAT). Finally, OXM's low beam energy makes it ideal for tumor-dose enhancement with contrast agents such as iodine or gold nanoparticles, and its low cost, portability, and small room-shielding requirements make it ideal for use in the low-and-middle-income countries.
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The Effects of Probiotic Supplementation on the Incidence of Diarrhea in Cancer Patients Receiving Radiation Therapy: A Systematic Review with Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials.
Devaraj, NK, Suppiah, S, Veettil, SK, Ching, SM, Lee, KW, Menon, RK, Soo, MJ, Deuraseh, I, Hoo, FK, Sivaratnam, D
Nutrients. 2019;(12)
Abstract
The protective effects of probiotic supplementation against radiation-induced diarrhea (RID) have been reported in previous systematic reviews; however so far, only non-conclusive results have been obtained. The objective of this study was to systematically update and evaluate the available evidence for probiotic supplementation. The protocol of this systematic review has been registered (CRD42018106059) with the International Prospective Register of Systematic Reviews (PROSPERO). The primary efficacy outcome was the incidence of RID. Secondary outcomes were the incidence of watery stool, soft stool, and antidiarrheal medication use. There were eight trials, and a total of 1116 participants were included in the primary analysis. Compared with placebo, probiotics were associated with a lower risk of RID [risk ratio (RR) = 0.62, 95% CI = 0.46, 0.83]. A requisite heterogeneity-adjusted trial sequential analysis indicated conclusive evidence for this beneficial effect. No statistically significant reduction in RID (RR = 0.52, 95% CI = 0.14, 1.91) was observed on subgroup analysis in patients receiving both radiation therapy and chemotherapy. However, those patients receiving only radiation therapy (RT) demonstrated significant benefit (RR = 0.61, 95% CI = 0.48, 0.78). There was a significant difference in the antidiarrheal medication use (RR = 0.54, 95% CI = 0.35, 0.84) observed with the use of probiotics. However, no significant difference was observed for the incidence of soft and watery stool. The use of probiotics is beneficial in preventing RID in patients receiving RT.
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A Meta-Analysis on the Efficacy of Zinc in Oral Mucositis during Cancer Chemo and/or Radiotherapy-An Evidence-Based Approach.
Chaitanya, NC, Shugufta, K, Suvarna, C, Bhopal, T, Mekala, S, Ponnuru, H, Madathanapalle, R, Patel, M, Abhyankar, S, Reddy, C, et al
Journal of nutritional science and vitaminology. 2019;(2):184-191
Abstract
Zinc in various therapeutic doses was used on patients suffering from oral mucositis during cancer treatment. A meta-analysis was conducted to probe the role of oral zinc as a possible treatment option for oral mucositis. A literature search was done using PubMed, EBSCO, Cochrane, MedLine, ScienceDirect, ResearchGate and Google Scholar with key words. The analysis was directed to recognize and identify the use of zinc supplementations at a confidence interval (CI) 95% with p value significance taken as <0.05. A total number of 21,428 articles was retrieved. After thorough screening and assessment of the eligibility criteria, 10 articles were included in qualitative and quantitative analysis in the study. The 10 articles constituted a total sample size of 299 in the case group and 294 in the control group. Oral zinc doses used were 25 mg, 30 mg, 50 mg and 220 mg capsules and mouthwash of 0.2% zinc, as well as 0.5 g of granules dissolved in 5% sodium alginate solution. Two studies showed no significance, with the overall effect 1.61. Eight studies favored zinc over a placebo with an overall effect size of -0.89 at 95% CI of -1.08 and -0.70 which was statistically significant (Z=9.27, p<0.00001). This analysis suggests that zinc usage has shown significant reduction in the severity of oral mucositis but not prevention. The onset of the reaction was delayed and hastened healing. Pharyngeal mucositis, pain and quality of life of the individuals received no effect from zinc therapy.
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Topical application of honey in the management of chemo/radiotherapy-induced oral mucositis: A systematic review and network meta-analysis.
Yang, C, Gong, G, Jin, E, Han, X, Zhuo, Y, Yang, S, Song, B, Zhang, Y, Piao, C
International journal of nursing studies. 2019;:80-87
Abstract
BACKGROUND Mucositis is an inflammatory response of mucosal epithelial cells to the cytotoxic effects of chemotherapy and radiation therapy. To assess the comparative efficacy of honey for patients with cancer undergoing chemo/radiotherapy-induced oral mucositis through a systematic review and network meta-analysis. METHODS A network meta-analysis was used to identify evidence from relevant randomized controlled trials (RCTs). We searched PubMed, Embase, and the Cochrane Library for publications up to November 2017. The prespecified primary efficacy outcome was the treatment effect of moderate-severe oral mucositis with honey. We performed subgroup analyses and meta-regressions according to the age group, cancer type, mucositis cause, honey type, control arm and type of assessment scale. Moreover, secondary efficacy outcomes were treatment completed, onset time of mucositis, swallowing diary, fungal colonization, bacterial colonisation and analgesic use. And, we did standardize meta-analyses using the random-effects model, later completing the random-effects network meta-analyses by different treatment/control arms. RESULTS A total of 17 RCTs were eligible (22 analyses), involving 1265 patients and 13 arms. Honey treatment arm significantly increased the therapeutic effect of chemo/radiotherapy-induced moderate-severe oral mucositis (0.25, 0.14-0.46); significant efficacy was observed in a large proportion of subgroups. The meta-regression may have identified the causes of heterogeneity as the honey type (P = 0.038). Therefore, we need to perform further comparisons of difference in honey types and controls by network meta-analysis, and the results from network meta-analysis revealed that pure natural honey was superior in therapeutic effect (0.05, 0.01-0.46). For secondary outcomes, significant effect was found in decreasing onset time of mucositis (0.41, 0.08-0.73), while no increase in adverse effects was observed. The study is registered with PROSPERO (CRD42017070873). CONCLUSIONS The adjuvant treatment honey is effective and safe for patients with cancer undergoing chemo/radiotherapy-induced oral mucositis, especially applied pure natural local honey can be invoked as a first-line adjuvant therapy agent.
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Nutritional experiences in head and neck cancer patients.
Sandmael, JA, Sand, K, Bye, A, Solheim, TS, Oldervoll, L, Helvik, AS
European journal of cancer care. 2019;(6):e13168
Abstract
OBJECTIVE Extensive research has documented the negative nutritional impact of head neck cancer (HNC) treatment, but few studies have addressed the patients' experiences. The purpose of this study was to describe how patients with HNC experience the nutritional situation and perceive nutritional support from diagnosis to the post-treatment phase. METHODS Patients with HNC were recruited from a randomised pilot study. Individual interviews were conducted after radiotherapy with 10 participants aged 49 - 70 years and analysed by qualitative content analysis. RESULTS Undergoing surgery was experienced as a poor nutritional starting point for the upcoming radiotherapy. During radiotherapy, increasing side effects made the participants customise their meals to improve food intake. About halfway through radiotherapy, virtually no food intake was experienced and hospital admissions and initiations of tube-feeding occurred in this period. Oral nutritional supplements were recommended for all, but eventually became unbearable to ingest. When radiotherapy was finally completed, the participants felt discouraged about the persistent side effects preventing them from resume eating. The participants missed tailored information about development of side effects and involvement of a dietitian when reflecting on the treatment-period. CONCLUSION The comprehensive nutritional problems experienced by patients with HNC require early nutritional assessments and improved individually tailored nutritional support.
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Zinc deficits, mucositis, and mucosal macrophage perturbation: is there a relationship?
Thomsen, M, Vitetta, L
Current opinion in clinical nutrition and metabolic care. 2019;(5):365-370
Abstract
PURPOSE OF REVIEW Mucositis is a common and therapy-limiting adverse effect of cancer treatments including radiotherapy, chemotherapy, and immunotherapy. The optimal zinc formulation, dosage, and timing of administration warrant further research as does the efficacious prevention of febrile mucositis that predisposes to febrile neutropenia. RECENT FINDINGS Metaanalyses concluded that zinc sulfate failed to significantly reduce the incidence or severity of chemotherapy-induced oral mucositis, whereas polaprezinc was associated with a significant reduction. Three new trials were published in 2018. The first trial found that zinc sulfate reduced the incidence and severity of chemotherapy-induced oral mucositis. The second reported that polaprezinc reduced oral mucositis in pediatric patients receiving high-dose chemotherapy for hematopoietic stem cell transplantation. The third trial demonstrated efficacy for a zinc lozenge for postoperative sore throat induced by an endotracheal intubation. SUMMARY Zinc deficits, dietary or induced by cancer, are common in patients with cancer. Febrile mucositis may better describe the condition linking mucositis with febrile neutropenia. Febrile mucositis disrupts treatment and may be life-threatening. A paradigm shift is needed for a more comprehensive understanding of febrile mucositis. Zinc effects on the thymic immunological network and T lymphocytes during chemoradiotherapy regimens also warrant further investigation.
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Meta-analysis of oral cryotherapy in preventing oral mucositis associated with cancer therapy.
Park, SH, Lee, HS
International journal of nursing practice. 2019;(5):e12759
Abstract
AIMS: To review scientific evidence related to oral cryotherapy to prevent oral mucositis after cancer therapy. BACKGROUND Oral mucositis is a common complication of cancer therapy. In the most severe form of oral mucositis, patients cannot eat or drink at all and must receive nutrition and fluid replacement through parenteral support. Topical cooling of the oral mucosa may be an option for the prevention of oral mucositis. DESIGN Systematic review and meta-analysis. DATA SOURCES The literature search was performed using the Ovid MEDLINE, Embase, Cochrane Library, and CINAHL Complete electronic databases for articles published up to 2017. The reference lists of all retrieved articles were manually reviewed to identify additional relevant studies. RESULTS Of 353 publications, 15 randomized controlled trials, involving 919 cancer patients, conducted between 1994 and 2017 were included in the present meta-analysis. Oral cryotherapy, applied during treatment of solid cancers, led to a statistically lower level (P < .05) of oral mucositis overall, and of the more severe grades (3-4 and 2-4). CONCLUSIONS Results of this study provide a scientific basis for oral cryotherapy as a viable nursing intervention that can significantly reduce the occurrence of severe oral mucositis.