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Objectives: Adjuvant chemotherapy is not recommended for patients with average-risk stage II (T3N0) colon cancer. Nevertheless, a subgroup of these patients who are CDX2-negative might benefit from adjuvant chemotherapy. We evaluated the cost-effectiveness of testing for the absence of CDX2 expression followed by adjuvant chemotherapy (fluorouracil combined with oxaliplatin [FOLFOX]) for patients with stage II colon cancer., Methods: We developed a decision model to simulate a hypothetical cohort of 65-year-old patients with average-risk stage II colon cancer with 7.2% of these patients being CDX2-negative under 2 different interventions: (1) test for the absence of CDX2 expression followed by adjuvant chemotherapy for CDX2-negative patients and (2) no CDX2 testing and no adjuvant chemotherapy for any patient. We derived disease progression parameters, adjuvant chemotherapy effectiveness and utilities from published analyses, and cancer care costs from the Surveillance, Epidemiology, and End Results (SEER)-Medicare data. Sensitivity analyses were conducted., Results: Testing for CDX2 followed by FOLFOX for CDX2-negative patients had an incremental cost-effectiveness ratio of $5500/quality-adjusted life-years (QALYs) compared with no CDX2 testing and no FOLFOX (6.874 vs 6.838 discounted QALYs and $89 991 vs $89 797 discounted US dollar lifetime costs). In sensitivity analyses, considering a cost-effectiveness threshold of $100 000/QALY, testing for CDX2 followed by FOLFOX on CDX2-negative patients remains cost-effective for hazard ratios of <0.975 of the effectiveness of FOLFOX in CDX2-negative patients in reducing the rate of developing a metastatic recurrence., Conclusions: Testing tumors of patients with stage II colon cancer for CDX2 and administration of adjuvant treatment to the subgroup found CDX2-negative is a cost-effective and high-value management strategy across a broad range of plausible assumptions., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Recently, patients who received induction chemotherapy plus concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma were found to have survival advantages compared with those receiving concurrent chemoradiotherapy alone in two large randomized trials. Based on these two trials, we present a cost-effectiveness analysis to compare gemcitabine and cisplatin (GP) versus cisplatin, fluorouracil, and docetaxel (TPF) for induction chemotherapy to treat locoregionally advanced nasopharyngeal carcinoma., Methods: We constructed a Markov model to compare the cost and effectiveness of GP versus TPF. Clinical data including the frequency of adverse events, recurrence and death obtained from two randomized phase III trials were used to calculate transition probabilities and costs. Health utilities were estimated from the literature. Incremental cost-effectiveness ratios, expressed as dollars per quality-adjusted life-year (QALY), were calculated, and incremental cost-effectiveness ratios less than $27,534.25/QALY (3 × the per capita GDP of China, 2018) were considered cost-effective. One-way sensitivity and probabilistic sensitivity analyses explored the robustness of the model., Results: Our base case model found that the total cost was $53,082.68 in the GP group and $45,482.66 in the TPF group. The QALYs were 6.82 and 4.11, respectively. The incremental cost-effectiveness ratio favoured the GP regimen, at an incremental cost of $2,804.44 per QALY. The probabilistic sensitivity analysis found that treatment with the GP regimen was cost-effective 100% of the time at a willingness-to-pay threshold of $27,534.25‬/QALY., Conclusion: In this model, GP was estimated to be cost-effective compared with cisplatin, fluorouracil, and docetaxel for patients with locoregionally advanced nasopharyngeal carcinoma from the payer's perspectives in the China., Competing Interests: Declaration of Competing Interest All the authors declare no conflicts of interest., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: The aim was to compare health-related quality-of-life (HRQOL) and cost-effectiveness between cytoreductive surgery with intraperitoneal chemotherapy (CRS + IPC) and systemic chemotherapy for patients with colorectal peritoneal metastases., Methods: Patients included in the Swedish Peritoneal Trial comparing CRS + IPC and systemic chemotherapy completed the EORTC QLQ-C30 and SF-36 questionnaires at baseline, 2, 4, 6, 12, 18, and 24 months. HRQOL at 24 months was the primary endpoint. EORTC sum score, SF-36 physical and mental component scores at 24 months were calculated and compared for each arm and then referenced against general population values. Two quality-adjusted life-year (QALY) indices were applied (EORTC-8D and SF-6D) and an incremental cost-effectiveness ratio (ICER) per QALY gained was calculated. A projected life-time ICER per QALY gained was calculated using predicted survival according to Swedish population statistics., Results: No statistical differences in HRQOL between the arms were noted at 24 months. Descriptively, survivors in the surgery arm had higher summary scores than the general population at 24 months, whereas survivors in the chemotherapy arm had lower scores. The projected life-time QALY benefit was 3.8 QALYs in favor of the surgery arm (p=0.06) with an ICER per QALY gained at 310,000 SEK (EORTC-8D) or 362,000 SEK (SF-6D) corresponding to 26,700-31,200 GBP., Conclusion: The HRQOL in patients with colorectal peritoneal metastases undergoing CRS + IPC appear similar to those receiving systemic chemotherapy. Two-year survivors in the CRS + IPC arm have comparable HRQOL to a general population reference. The treatment is cost-effective according to NICE guidelines., (Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background: This study aimed to investigate the pharmaco-economic implications of FOLFOX4 or sorafenib for advanced hepatocellular carcinoma in China., Methods: To conduct the analysis, we performed a Markov model to simulate the process of advanced HCC treated with sorafenib or FOLFOX4. Clinical data were obtained from the ORIENTAL trial and the EACH trial. Incremental cost-effectiveness ratio was regarded as the primary outcome in the analysis. One-way sensitivity analysis as well as probabilistic sensitivity analysis was performed to explore the impact of essential variables on the results of the analysis., Results: Treatment with sorafenib provided an effectiveness gain of 0.3935 quality-adjusted life year at an average cost of $18,748.00, whereas chemotherapy of FOLFOX4 brought 0.3808 quality-adjusted life year at a cost of $6876.02. The incremental cost-effectiveness ratio of FOLFOX4 versus sorafenib was $934,801.57/QALY. In a probabilistic sensitivity analysis based on a Monte Carlo simulation of 1000 items, the probabilities of FOLFOX4 and sorafenib being cost-effective were 100% and 0% using a willingness-to-pay threshold of $20,301.00 per quality-adjusted life year., Conclusions: FOLFOX4 chemotherapy is likely to be a cost-effective option compared with sorafenib in the treatment of advanced hepatocellular carcinoma in China., (Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Evidence suggests that CAPOX (capecitabine and oxaliplatin) has efficacy similar to 5-fluorouracil and oxaliplatin (mFOLFOX6) in the adjuvant treatment of colon cancer. CAPOX is partly administered orally and associated with a 3-week rather than a 2-week treatment cycle. A population-based cost-minimization analysis was conducted from the health care payer and societal perspectives to evaluate the potential cost savings of replacing mFOLFOX6 with CAPOX., Methods: We applied treatment and toxicity data from phase III trials of CAPOX and FOLFOX-based regimens to the adjuvant colon cancer population in British Columbia, Canada. In this cost-minimization analysis we compared the total costs associated with chemotherapy medications, drug administration and delivery, hospital and clinic visits, treatment-related toxicities, and central venous access devices. Costs to patients in terms of lost time and travel were also considered. It was assumed that patients would receive either 8 cycles of CAPOX or 12 cycles of mFOLFOX6., Results: From the payer perspective, the use of CAPOX resulted in cost savings of $5339 CAD per patient compared with the use of mFOLFOX6. From a societal perspective, CAPOX was also associated with savings of $6080 CAD per patient. The greatest cost savings with CAPOX were attributed to fewer visits for chemotherapy treatment and decreased central venous access device usage. CAPOX was also associated with reduced loss of time and decreased travel for patients because of the requirement of fewer clinic visits., Conclusions: Replacement of mFOLFOX6 with CAPOX in the adjuvant treatment of colon cancer might be associated with potential cost savings from the payer and societal perspectives., (Copyright © 2015 Elsevier Inc. All rights reserved.)

To evaluate, from a US payer perspective, the cost-effectiveness of treatment strategies for metastatic colorectal cancer (mCRC), we performed a systematic review of published cost-effectiveness analyses. We identified 14 papers that fulfilled our search criteria and revealed varying levels of value among current treatment strategies. Older agents such as 5-fluorouracil, irinotecan, and oxaliplatin provide high-value treatments. More modern agents targeting the EGFR or VEGF pathways, such as bevacizumab, cetuximab, and panitumumab, do not appear to be cost-effective treatments at their current costs. The analytical methods used within the papers varied widely, and this variation likely plays a significant role in the heterogeneity in incremental cost-effectiveness ratios. The cost-effectiveness of current treatment strategies for mCRC is highly variable. Drugs recently approved by the US Food and Drug Administration for mCRC are not cost-effective, and this is primarily driven by high drug costs., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To evaluate the cost-effectiveness of adjuvant FOLFOX therapy versus 5-fluorouracil/leucovorin (FU/LV) for patients with stage III colorectal cancer., Methods: We performed the cost-effectiveness of FOLFOX compared with standard FU/LV treatment by the retrospective analysis of patient-level data from the randomized controlled Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial. Predicted mean time spent in each disease state was calculated by our statistical model, which takes into account the cure rate and treats death from causes other than colon cancer as a competing risk. We performed this analysis from the perspective of the health-care payer. Using a time horizon of 30 years, both cost and effectiveness were discounted by 3% per year., Results: Estimated cure rates for colon cancer were 0.715 (FOLFOX) and 0.622 (FU/LV). Estimated medical costs of FOLFOX were JPY 3.1 million (USD 34,000) compared with JPY 1.9 million (USD 22,000) of FU/LV. The mean estimated quality-adjusted life-year was 9.83 with FOLFOX and 9.07 with that of FU/LV. The incremental cost-effectiveness ratio of FOLFOX was JPY 1.5 million (USD 17,000) per quality-adjusted life-year compared with FU/LV, which was supported by sensitivity analysis. Even if we assume that Japanese outcomes were better than those reported by the MOSAIC trial, which would reduce the difference between cure rates for each treatment to 5%, the incremental cost-effectiveness ratio remained below 5.0 million (USD 56,000) per quality-adjusted life-year., Conclusions: Adjuvant FOLFOX is a cost-effective treatment for stage III colon cancer in Japan compared with FU/LV therapy. Even when parameters were changed to reflect smaller improvements with FOLFOX, the conclusion is the same., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: To assess the value for money of alternative chemotherapy strategies for managing advanced colorectal cancer using irinotecan or oxaliplatin, either in sequence or in combination with fluorouracil., Methods: A cost-effectiveness model was developed using data from the U.K. fluorouracil, oxaliplatin, and CPT11 (irinotecan)--use and sequencing (FOCUS) trial. The analysis adopted the perspective of the U.K. National Health Service. Input parameters were derived using a system of risk equations (for probabilities), count data regression models (for resource use), and generalized linear models (for utilities). Parameter estimates were obtained using Markov chain Monte Carlo methods, propagating the simulation values through the state-transition model to characterize appropriately the joint distributions of expected cost, survival and quality-adjusted life years for each treatment strategy. An acceptability frontier was used to represent the probability that the optimal option is cost-effective at different values of the cost-effectiveness threshold., Results: The base-case analysis used drug unit costs provided by a typical English hospital. First-line doublet therapy combination therapy fluorouracil (5FU) plus irinotecan was the most cost-effective strategy at standard thresholds, with an incremental cost-effectiveness ratio (ICER) of £14,877 (pound sterling) compared with first-line 5FU until treatment failure followed by single agent irinotecan. Other strategies were all subject to extended dominance. A sensitivity analysis using published drug (list) prices found the most cost-effective strategy would be first-line fluorouracil until failure followed by 5FU plus irinotecan (ICER: £19,753)., Conclusions: The combination of 5FU and irinotecan (whether used first or second line) appears to be more cost-effective than the single agent sequential therapies used in the FOCUS trial, or 5FU plus oxaliplatin., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: To assess the cost-effectiveness of oral capecitabine compared with intravenous bolus 5-fluorouracil/leucovorin (5-FU/LV) in the adjuvant treatment of stage III colon cancer in Taiwan from payer (Bureau of National Health Insurance [BNHI]) perspectives., Methods: A health state-transition model was developed to estimate the incremental costs and effectiveness of capecitabine versus 5-FU/LV. The time horizons studied were: treatment duration (24 weeks) plus 36 months, 48 months, 60 months, 120 months, and lifetime. Costs were expressed in Taiwanese new dollars (NT$). Clinical outcomes, medical resource use, and utilities were extracted from published sources. Unit costs were estimated from BNHI fee schedules, published sources, and local expert opinion. Outcomes and future costs were discounted at 3%. Cost-effectiveness was expressed as cost per quality-adjusted life-month (QALM). The effects of uncertainty were explored through a one-way sensitivity analysis., Results: For the 24-week time period, drug acquisition costs were higher for capecitabine than 5-FU/LV (NT$114,405 vs. NT$4,904 per patient); however, these were offset by the higher administration costs of 5-FU/LV (NT$2,573 vs. NT$204,201 per patient). Overall direct costs for the 24-week treatment period were less with capecitabine than 5-FU/LV (NT$129,327 vs. NT$233,873 per patient). Cost savings with capecitabine were also evident when longer time horizons were considered. Over a lifetime, the projected survival benefit for capecitabine was 7 QALMs., Conclusions: From the perspectives of the BNHI and society in Taiwan, capecitabine not only saves costs but also improves health outcomes compared with 5-FU/LV in the adjuvant treatment of stage III colon cancer., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Introduction: This study quantified the costs associated with the acquisition of chemotherapy, its administration, and the management of chemotherapy-related complications, and their effect on total patient expenditures., Patients and Methods: Patients with locally advanced and metastatic colorectal cancer treated with capecitabine or 5-fluorouracil/leucovorin (5-FU/LV) as monotherapy or combination therapy with oxaliplatin from 2003-2006 were identified in the Thomson Reuters MarketScan® databases. Selection bias between treatment groups was addressed by propensity score matching, assessment of the risk of complications using Cox models, and an estimate of expenditures using general linear models., Results: In respect to monotherapy, capecitabine users (n = 1272) were propensity score matched to 5-FU/LV users on a 1:1 ratio. The adjusted mean monthly cost was significantly lower for patients treated with capecitabine versus 5-FU/LV ($6683 vs. $9304, respectively; P < .0001). Although the cost of drug acquisition was significantly higher for capecitabine than for 5-FU/LV (unadjusted P < .0001), significantly lower costs of capecitabine administration (unadjusted P < .0001) and management of complications (adjusted costs, P < .0001) offset the difference, and drove a lower overall cost. In regard to combination therapy, capecitabine/oxaliplatin users (n = 263) were propensity score matched to 5-FU/LV/oxaliplatin users (n = 526) on a 1:2 ratio. The adjusted mean monthly cost was significantly lower for capecitabine/oxaliplatin than for 5-FU/LV/oxaliplatin ($11,436 vs. $14,320, respectively; P < .0001). The cost difference was driven by the significantly lower administration costs of capecitabine-based chemotherapy (unadjusted P < .0001) and management of complications (adjusted P < .0001)., Conclusion: The monthly cost per patient during capecitabine or capecitabine/oxaliplatin treatment is significantly lower than during 5-FU/LV or 5-FU/LV/oxaliplatin treatment because of lower costs for the administration of chemotherapy and for the management of complications.

Background: Although full costs (including direct and indirect costs) that incurred during the process of chemotherapy administration should be measured, many studies estimate only direct labor and medication costs associated with various chemotherapy delivery systems., Objectives: To estimate the total costs for dispensing and administration of fluorouracil when administered with leucovorin, by intravenous infusion or bolus, using a microcosting approach from the perspective of a provider or health system., Methods: A time-and-motion study was used to measure the time spent by (1) pharmacy staff in the handling, admixture, and dispensing of fluorouracil and (2) patients in the clinic. The study was performed at The Cancer Institute of New Jersey for an 8-month period. Costs of dispensing and administering fluorouracil were calculated per patient visit on the basis of resources used in the processing of fluorouracil and time spent by pharmacy staff and patient. All costs were standardized to 2005 dollars., Results: A total of 275 observations were made, and 74 (26.9%) of these were associated with fluorouracil-based chemotherapy. Pharmacy staff spent an average of 11 minutes for bolus fluorouracil with leucovorin infusion (fluorouracil/LCV-IV) and 8 minutes for bolus fluorouracil with bolus leucovorin (fluorouracil/LCV-B). Patients who received fluorouracil/LCV-IV spent an average of 203 minutes in the clinic, whereas patients who received fluorouracil/LCV-B spent 110 minutes. The average cost of administering fluorouracil/LCV-IV was $933, which comprised drug costs ($279), dispensing costs ($189), and administration costs ($465). The average cost of fluorouracil/LCV-B was $474, which comprised drug costs ($65), dispensing costs ($141), and administration costs ($268)., Conclusions: This is the first study to formally demonstrate the high cost of administering the injectable form of fluorouracil chemotherapy with leucovorin, despite relatively low drug acquisition cost. Therefore, reimbursement rates for fluorouracil should be calculated in such a way that covers all costs, including overhead costs for the department., (Copyright 2010 Elsevier Inc. All rights reserved.)

The X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial compared the efficacy and safety of the oral fluoropyrimidine capecitabine with bolus 5-fluorouracil (5-FU)/leucovorin (LV; Mayo Clinic regimen) as adjuvant therapy for stage III colon cancer. A total of 1987 patients were enrolled at 164 centers worldwide. Disease-free survival (primary study endpoint) in the capecitabine arm was at least equivalent to that in the 5-FU/LV arm; the upper limit of the hazard ratio was significantly (P < 0.001) below the predefined margins for noninferiority. Capecitabine was also associated with significantly fewer fluoropyrimidine-related grade 3/4 adverse events (AEs; P < 0.001) and fewer AE-related hospital admissions/days than 5-FU/LV. Pharmacoeconomic analyses performed in several countries show that the savings in direct costs (drug administration and AE-related costs) associated with capecitabine versus 5-FU/LV offset the acquisition costs of the drug. Furthermore, capecitabine reduces patient travel time and costs, making it a "dominant" strategy (ie, less costly and more effective) in the adjuvant setting. In conclusion, efficacy, safety, convenience, and cost findings from the X-ACT trial show that capecitabine offers at least equivalent clinical benefit compared with bolus 5-FU/LV and can replace intravenous 5-FU/LV in the adjuvant treatment of stage III colon cancer. The X-ACT trial has not only helped to better define the role of capecitabine but has also broadened the options available to patients with early-stage disease to include a uniquely effective oral outpatient treatment.

The aim of this study is to perform a review of the literature on economic (or medico-economic) studies in the area of chemotherapy for colorectal cancer. French and international literature has been reviewed on this topic. Colorectal cancer represents a major public health problem due to high mortality, prevalence and costs. Up to now chemotherapy can be used at the adjuvant stage or at the palliative one. This work provides a synthesis of the main results of economic publications devoted to adjuvant and palliative chemotherapies, as well as a reflection on the limits frequently associated with such studies.

Objective: To estimate the incidence and associated cost of hospitalizations for toxicities associated with 5-fluorouracil (5-FU) among patients with metastatic colorectal cancer., Methods: Using the 1994 Medicare 5% sample, we identified all patients with metastatic colorectal cancer who had undergone colorectal surgery. We then stratified them into those who received 5-FU therapy within 90 days of their surgery (5-FU group) and those who did not receive chemotherapy (no-chemotherapy group); patients who received chemotherapeutic agents other than 5-FU were excluded from the sample. Using techniques of survival analysis, we then compared the incidence and associated cost of all hospital admissions with listed International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic codes (primary or secondary) for conditions possibly related to 5-FU toxicity (e.g., volume depletion, stomatitis, nausea, and vomiting)., Results: A total of 441 patients met all study entry criteria, including 192 who received 5-FU and 249 who did not receive chemotherapy following surgery. Patients in the 5-FU group were younger than those in the no-chemotherapy group (p < .001). Mean (+/- SD) follow-up time was slightly longer in the 5-FU group (137 +/- 96 days vs. 117 +/- 88 days for no chemotherapy). The incidence of toxicity-related hospitalizations at 10.5 months (principally volume depletion, agranulocytosis, gastroenteritis, and nausea and vomiting) was 31% among patients who received 5-FU and 8% among those who did not receive chemotherapy. The cost of inpatient care at 10.5 months was $2716 higher among 5-FU patients., Conclusions: Hospitalization for toxicity of Medicare patients with metastatic colorectal cancer receiving 5-FU is frequent and costly.

Background: It has been shown that irinotecan is superior to infusional 5-fluorouracil (5-FU) in patients with advanced colorectal cancer after 5-FU failure. In a recent trial, median survival was 10.8 months for patients treated with irinotecan, compared to 8.5 months in patients receiving infusional 5-FU. Considering the statistically significant but clinically relatively small advantage of irinotecan over 5-FU, cost effectiveness should also be part of treatment decision., Purpose: To relate the costs of each management approach to overall survival in patients with metastatic colorectal cancer., Patients and Methods: The healthcare costs and medical benefits (treatment-added survival) of second-line chemotherapy in patients (infusional 5-FU: 129, irinotecan: 127) were compared. Data on overall survival were drawn from a multicenter randomised trial that compared infusional 5-FU (continuous infusion, AIO, or LV5-FU2 regimens) to irinotecan alone. Costs were derived from the accounting system in two university hospitals in Paris, France., Results: The range in total healthcare costs was 14,135 to 12,192 US$ patient between management approaches, with irinotecan chemotherapy costing most and 5-FU-continuous infusion least. If survival was included as a treatment benefit, the cost-effectiveness ratio of irinotecan over 5-FU ranged from 9,344 to 10,137 US$ per year of added survival., Conclusions: The least expensive management for metastatic colorectal was 5-FU infusion but the additional cost of irinotecan was balanced by the added months of survival, with a cost-effectiveness ratio close to that of other cancer treatments.

Background: Adjuvant chemotherapy (5-fluorouracil, levamisole) is now standard practice in the treatment of Dukes' B and C coloretal carcinoma (CRC), and this has increased the financial burden on health care systems world-wide., Patients and Methods: Between 1993 and 1996, 95 patients in northern Norway were included in a national randomised CRC study, and assigned to surgery plus adjuvant chemotherapy or surgery alone. In April 1996, 94 of the patients were evaluable and 82 were still alive. The total treatment costs (hospital stay, surgery, chemotherapy, administrative and travelling costs) were calculated. A questionnaire was mailed to all survivors for assessment of the quality of their lives (QoL) (EuroQol questionnaire, a simple QoL-scale, global QoL-measure of the EORTC QLQ-C30), and 62 of them (76%) responded., Results: Adjuvant chemotherapy in Dukes' B and C CRC raised the total treatment costs by 3,369 pounds. The median QoL was 0.83 (0-1 scale) in both arms. Employing a 5% discount rate and an improved survival of adjuvant therapy ranging from 5% to 15%, we calculated the cost of one gained quality-adjusted life-year (QALY) to be between 4,800 pounds and 16,800 pounds., Conclusion: Using a cut-off point level of 20,000 pounds per QALY, adjuvant chemotherapy in CRC appears to be cost-effective only when the improvement in 5-year survival is > or = 5%. Adjuvant chemotherapy does not affect short-term QoL.