A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent - pilot study
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ABSTRACT:
DISEASE(S): Cancer (neoplasms): Rectum,Cancer (neoplasms): Colon
PROVIDER: 2420669 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:See http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-followup-after-colorectal-surgery
| 2417211 | ecrin-mdr-crc
Project description:OBJECTIVE: To determine the cost effectiveness of intensive follow up compared with conventional follow up in patients with colorectal cancer. DESIGN: Incremental cost effectiveness analysis recognising differences in follow up strategies, based on effectiveness data from a meta-analysis of five randomised trials. SETTING: United Kingdom. MAIN OUTCOME MEASURES: Taking a health service perspective, estimated incremental costs effectiveness ratios for each life year gained for five trials and four trials designed for early detection of extramural recurrences (targeted surveillance). RESULTS: Based on five year follow up, the numbers of life years gained by intensive follow up were 0.73 for the five trial model and 0.82 for the four trial model. For the five trials, the adjusted net (extra) cost for each patient was 2479 pounds sterling (3550 euros; 4288 dollars) and for each life year gained was 3402 pounds sterling, substantially lower than the current threshold of NHS cost acceptability (30 000 pounds sterling). The corresponding values for the four trial model were 2529 pounds sterling and 3077 pounds sterling, suggesting that targeted surveillance is more cost effective. The main predictor of incremental cost effectiveness ratios was surveillance costs rather than treatment costs. Judged against the NHS threshold of cost acceptability, the predicted incremental cost threshold was ninefold and the effectiveness threshold was 3%. CONCLUSIONS: Based on the available data and current costs, intensive follow up after curative resection for colorectal cancer is economically justified and should be normal practice. There is a continuing need to evaluate the efficacy of specific surveillance tools: this study forms the basis for economic evaluations in such trials.
| S-EPMC314047 | biostudies-literature
Project description:Large-scale screening trials have demonstrated that early diagnosis of lung cancer results in a significant reduction in lung cancer mortality. Despite improvements in detecting more lung cancers at early stages, the 5-year survival rates of lung cancers diagnosed before widespread disease is only 30-50%. High rates of recurrence, despite early diagnosis, suggest the need to improve treatment strategies based on the likelihood of recurrence in patient subsets, as well as explore the role of predictive markers for therapy selection in the adjuvant setting. In the era of personalized medicine, there have been a wide array of molecular alterations and signatures studied for their potential prognostic and predictive utility, however most have failed to translate into clinical tools. This review will discuss progress made in clinical management of lung cancer, and recent progress in the development of patient selection tools for the refinement of early stage lung cancers.
| S-EPMC5635255 | biostudies-literature
Project description:ObjectiveThe cost-effectiveness of exercise interventions in lung cancer survivors is unknown. We performed a model-based cost-effectiveness analysis of an exercise intervention in lung cancer survivors.DesignWe used Markov modeling to simulate the impact of the Lifestyle Interventions and Independence for Elders exercise intervention compared with usual care for stage I-IIIA lung cancer survivors after curative-intent treatment. We calculated and considered incremental cost-effectiveness ratios of less than US $100,000/quality-adjusted life-year as cost-effective and assessed model uncertainty using sensitivity analyses.ResultsThe base-case model showed that the Lifestyle Interventions and Independence for Elders exercise program would increase overall cost by US $4740 and effectiveness by 0.06 quality-adjusted life-years compared with usual care and have an incremental cost-effectiveness ratio of US $79,504/quality-adjusted life-year. The model was most sensitive to the cost of the exercise program, probability of increasing exercise, and utility benefit related to exercise. At a willingness-to-pay threshold of US $100,000/quality-adjusted life-year, Lifestyle Interventions and Independence for Elders had a 71% probability of being cost-effective compared with 27% for usual care. When we included opportunity costs, Lifestyle Interventions and Independence for Elders had an incremental cost-effectiveness ratio of US $179,774/quality-adjusted life-year, exceeding the cost-effectiveness threshold.ConclusionsA simulation of the Lifestyle Interventions and Independence for Elders exercise intervention in lung cancer survivors demonstrates cost-effectiveness from an organization but not societal perspective. A similar exercise program for lung cancer survivors may be cost-effective.
| S-EPMC6982544 | biostudies-literature
Project description:Hepatocellular carcinoma (HCC) presentation is heterogeneous necessitating a variety of therapeutic interventions with varying efficacies and associated prognoses. Poor prognostic patients often undergo non-curative palliative interventions including transarterial chemoembolization (TACE), sorafenib, chemotherapy, or purely supportive care. The decision to pursue one of many palliative interventions for HCC is complex and an economic evaluation comparing these interventions has not been done. This study evaluates the cost-effectiveness of non-curative palliative treatment strategies such as TACE alone or TACE+sorafenib, sorafenib alone, and non-sorafenib chemotherapy compared with no treatment or best supportive care (BSC) among patients diagnosed with HCC between 2007 and 2010 in a Canadian setting. Using person-level data, we estimated effectiveness in life years and quality-adjusted life years (QALYs) along with total health care costs (2013 US dollars) from the health care payer's perspective (3% annual discount). A net benefit regression approach accounting for baseline covariates with propensity score adjustment was used to calculate incremental net benefit to generate incremental cost-effectiveness ratio (ICER) and uncertainty measures. Among 1,172 identified patients diagnosed with HCC, 4.5%, 7.9%, and 5.6%, received TACE alone or TACE+sorafenib, sorafenib, and non-sorafenib chemotherapy clone, respectively. Compared with no treatment or BSC (81.9%), ICER estimates for TACE alone or TACE+sorafenib was $6,665/QALY (additional QALY: 0.47, additional cost: $3,120; 95% CI: -$18,800-$34,500/QALY). The cost-effectiveness acceptability curve demonstrated that if the relevant threshold was $50,000/QALY, TACE alone or TACE+sorafenib, non-sorafenib chemotherapy, and sorafenib alone, would have a cost-effectiveness probability of 99.7%, 46.6%, and 5.5%, respectively. Covariates associated with the incremental net benefit of treatments are age, sex, comorbidity, and cancer stage. Findings suggest that TACE with or without sorafenib is currently the most cost-effective active non-curative palliative treatment approach to HCC. Further research into new combination treatment strategies that afford the best tumor response is needed.
| S-EPMC5634563 | biostudies-literature
Project description:The introduction of immunotherapy has fundamentally transformed the treatment landscape in cancer, providing long-term survival benefit for patients with advanced disease across multiple tumor types, including non-small cell lung cancer (NSCLC). In the placebo-controlled phase 3 PACIFIC trial, the PD-L1 inhibitor durvalumab demonstrated significant improvements in progression-free survival and overall survival in patients with unresectable, stage III NSCLC who had not progressed after platinum-based chemoradiotherapy (CRT). These findings have led to the widespread acceptance of the 'PACIFIC regimen' (durvalumab after CRT) as the standard of care in this setting. Moreover, the PACIFIC trial is the first study to demonstrate a proven survival advantage with an immunotherapy in a curative-intent setting, thereby providing a strong rationale for further investigation of durvalumab in early-stage cancers. Herein, we describe the extensive clinical development program for durvalumab across multiple tumor types in curative-intent settings, outlining the scientific rationale(s) for its use and highlighting the innovative research (e.g., personalized cancer monitoring) advanced by these trials.
| S-EPMC8190020 | biostudies-literature
Project description:ImportanceFollow-up assessment of patients who had treatment for head and neck cancer is critical and an important part of the overall treatment program. During each visit to the hospital, patients are evaluated by a physician and may undergo additional tests. Because it has been observed that the symptoms mentioned by patients often guide the treating clinicians in identifying cancer recurrence, an appropriately constructed questionnaire can help clinicians determine which patients need further testing as a result of a recurrence and which patients can continue to be monitored remotely.ObjectiveTo evaluate the role of a symptom-based telephone questionnaire in detecting recurrences in patients with radically treated oral cancer.Design, setting, and participantsThis prospective diagnostic cohort study was conducted from October 1, 2018, to February 28, 2019. This study took place at Tata Memorial Centre, an apex referral cancer center in India. A total of 615 consecutive patients with oral cancer were screened, of whom 400 patients consented to be a part of the study. After completion of curative treatment, these patients were followed up for 2 months to 2 years. We excluded patients younger than 18 years or older than 80 years, those with Eastern Cooperative Oncology Group status greater than 2, and those who had already been diagnosed with recurrent disease.Interventions/exposuresThe patients were contacted 2 weeks before their clinic appointment, and a telephone interview was conducted using a predefined questionnaire. Based on patients' responses to these questions, their disease status was estimated. Subsequently, during the actual follow-up visit, a trained head and neck surgeon, who was blinded to the questionnaire result, examined them.Main outcomes and measuresThe sensitivity and specificity of the telephone questionnaire were calculated by comparing its results with those of the trained head and neck surgeon after the clinical evaluation.ResultsOf the 615 patients screened, 400 consented to be part of the study. Participants had a median (interquartile range) age of 49 (41-56) years, and 334 (83.5%) were men. Recurrence was noted in 20 patients (5.0%). The telephone-based questionnaire was found to have sensitivity of 90.0%, specificity of 74.2%, positive predictive value of 15.5%, and negative predictive value of 99.3%. Clinical examination values were 100.0%, 92.9%, 42.5%, and 100.0%, respectively. A total of 124 patients (31.0%) said that they would prefer such a telephone follow-up compared with an actual physical follow-up visit.Conclusions and relevanceThis diagnostic cohort study found that a symptom-based telephone questionnaire had good sensitivity and negative predictive value for detecting recurrences in patients with oral cancer on follow-up evaluation after completion of definitive treatment.
| S-EPMC7489372 | biostudies-literature
Project description:BackgroundRadiation therapy (RT) confers local tumor control and survival advantages in some patients with osteosarcoma, yet pediatric and adolescent and young adult (AYA) population studies are limited.MethodsTwenty-eight patients treated with curative-intent RT (median dose, 59.4 Gy; range, 40-76 Gy) at our institution from 1990 to 2017 were retrospectively identified. Cumulative incidence (CIN) of local failure (LF) was estimated by Gray's method and overall survival (OS) by the Kaplan-Meier method. Competing-risk regression and Cox proportional hazards models determined predictors of outcome. Toxicity was reported according to CTCAE v4.0.ResultsWith a median follow-up of 99.1 months in living patients, nine patients (32.1%) developed LF. Estimated CINs of LF with competing risk of death at 5 years for the entire cohort, patients at initial diagnosis (n = 16), and recurrent/refractory patients (n = 12) were 32.7% (95% CI, 16.0-50.5%), 25.0% (95% CI, 7.3-48.0%), and 43.8% (95% CI, 13.6-71.0%), respectively (P = 0.31). Estimated 5-year OS was 42.6% (95% CI, 23.2-62.0%), 54.6% (95% CI, 29.5-79.6%), and 24.3% (95% CI, 0-52.2%), respectively (P = 0.15). No clinicopathologic features were significantly associated with LF, yet lack of chemotherapy or metastasis at the time of RT was independent significant prognostic factors of decreased OS. Eleven patients experienced RT-related morbidity, with two grade 3 toxicities and no grade 4/5 events.ConclusionsCurative-intent RT in pediatric and AYA patients was well tolerated and achieved a local tumor control rate of 75% in patients with primary disease. Local control rates were similar to those in primarily adult studies, with similar or lower doses.
| S-EPMC6588458 | biostudies-literature
Project description:Results of combining radiotherapy/chemoradiotherapy and immune checkpoint blockade have been disappointing in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). For such a potentially radiocurable disease, there remains an imperative to explore novel combination approaches. Here, we show that combining ATR inhibition with radiotherapy (ATRi/RT) increases the frequency of activated NKG2A/PD-1 double-positive T cells in animal models of HNSCC. Addition of dual anti-NKG2A/-PD-L1 blockade to ATRi/RT in the adjuvant, post-radiotherapy setting induces a robust antitumour response. Efficacy of the combination relies on CD40/CD40L costimulatory-mediated infiltration of activated/proliferative/memory CD8 and CD4 T cells with persistent or new T cell receptor (TCR) signalling, respectively. In this favourable therapeutic context, we reveal increased richness of the TCR repertoire and the emergence of numerous and large TCR clusters that share antigen specificity in response to combination therapy. Collectively, our data point towards promising combination approaches for future clinical testing in HNSCC.
2024-07-04 | GSE267158 | GEO
Project description:BACKGROUND:Pancreatic metastasis is a rare cause for pancreas surgery and often a sign of advanced disease no chance of curative-intent treatment. However, surgery for metastasis might be a promising approach to improve patients' survival. The aim of this study was to analyze the surgical and oncological outcome after pancreatic resection of pancreatic metastasis. METHODS:This is a retrospective cohort analysis of a prospectively-managed database of patients undergoing pancreatic resection at the University of Freiburg Pancreatic Center from 2005 to 2017. RESULTS:In total, 29 of 1297 (2%) patients underwent pancreatic resection due to pancreatic metastasis. 20 (69%) patients showed metastasis of renal cell carcinoma (mRCC), followed by metastasis of melanoma (n?=?5, 17%), colon cancer (n?=?2, 7%), ovarian cancer (n?=?1, 3%) and neuroendocrine tumor of small intestine (n?=?1, 3%). Two (7%) patients died perioperatively. Median follow-up was 76.4 (range 21-132) months. 5-year and overall survival rates were 82% (mRCC 89% vs. non-mRCC 67%) and 70% (mRCC 78% vs. non-mRCC 57%), respectively. Patients with mRCC had shorter disease-free survival (14 vs. 22 months) than patients with other primary tumor entities. CONCLUSION:Despite malignant disease, overall survival of patients after metastasectomy for pancreatic metastasis is acceptable. Better survival appears to be associated with the primary tumor entity. Further research should focus on molecular markers to elucidate the mechanisms of pancreatic metastasis to choose the suitable therapeutic approach for the individual patient.
| S-EPMC7138763 | biostudies-literature