Rectal Cancer: Nonoperative Watch and Wait vs Standard of Care Surgical Total Mesorectal Excision after Complete Clinical Response to Chemoradiation, a Prospective Cohort Study

2017 ◽  
Vol 225 (4) ◽  
pp. S45
Author(s):  
Andrew Schumacher ◽  
Aroor Rao ◽  
Bryan D. Loh ◽  
Haig Dudukgian ◽  
Armen Aboulian ◽  
...  
2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3610-3610 ◽  
Author(s):  
Jin Gu ◽  
Changzheng Du ◽  
Ming Li ◽  
Yifan Peng ◽  
Yunfeng Yao ◽  
...  

3610 Background: It has been reported that non-operative treatment (wait and see) is feasible for the selected rectal cancer cases with a complete clinical response (cCR) following neoadjuvant therapy (NT). The aim of this study is to determine whether "wait and see" policy is efficient for the cCR patients in China. Methods: We designed a prospective cohort study in China (ChiCTR-TRC-12002488). From Jul 2012 to August 2016, totally 45 patients with locally advanced rectal cancer who were cCR following NT were enrolled in the study; within whom, 32 patients were assigned to wait and see group, and the remaining 13 patients were assigned to surgery group (intent-to-treat grouping). Results: The median follow-up time was 24 months (range: 3-51). Of the patients who were followed up more than 12 months (n=37), 8 patients developed tumor progression (7 in wait and see group and 1 in surgery group, respectively). In the wait and see group, the local regrowth took an account of 23.1% (6/26), while the distant metastasis rate was 3.8% (1/26). In the surgery group, there were 23.1% (3/13) of patients who has residual cancer confirmed by postoperative pathological assessment. All the patients with tumor regrowth underwent radical surgery and no body died of cancer. Conclusions: Wait and see policy has an acceptable safety and efficiency, it may become an alternative treatment for the patients who were cCR following NT. Clinical trial information: ChiCTR-TRC-12002488. [Table: see text]


Author(s):  
Christina Liu Cui ◽  
William Yu Luo ◽  
Bard Clifford Cosman ◽  
Samuel Eisenstein ◽  
Daniel Simpson ◽  
...  

Abstract Background Watch and wait (WW) protocols have gained increasing popularity for patients diagnosed with locally advanced rectal cancer and presumed complete clinical response after neoadjuvant chemoradiation. While studies have demonstrated comparable survival and recurrence rates between WW and radical surgery, the decision to undergo surgery has significant effects on patient quality of life. We sought to conduct a cost-effectiveness analysis comparing WW with abdominoperineal resection (APR) and low anterior resection (LAR) among patients with stage II/III rectal cancer. Methods In this comparative-effectiveness study, we built Markov microsimulation models to simulate disease progression, death, costs, and quality-adjusted life-years (QALYs) for WW or APR/LAR. We assessed cost effectiveness using the incremental cost-effectiveness ratio (ICER), with ICERs under $100,000/QALY considered cost effective. Probabilities of disease progression, death, and health utilities were extracted from published, peer-reviewed literature. We assessed costs from the payer perspective. Results WW dominated both LAR and APR at a willingness to pay (WTP) threshold of $100,000. Our model was most sensitive to rates of distant recurrence and regrowth after WW. Probabilistic sensitivity analysis demonstrated that WW was the dominant strategy over both APR and LAR over 100% of iterations across a range of WTP thresholds from $0–250,000. Conclusions Our study suggests WW could reduce overall costs and increase effectiveness compared with either LAR or APR. Additional clinical research is needed to confirm the clinical efficacy and cost effectiveness of WW compared with surgery in rectal cancer.


Author(s):  
Annika Svanström Röjvall ◽  
Christian Buchli ◽  
Angelique Flöter Rådestad ◽  
Anna Martling ◽  
Josefin Segelman

2020 ◽  
Author(s):  
Berhanu Elfu Feleke ◽  
Teferi Elfu Feleke ◽  
Melkamu Beyene Kassahun ◽  
Wondemu Gebrekirose Adane ◽  
Abere Genetu ◽  
...  

Abstract Background: This work aimed to describe the clinical presentation of TB in patient with DM, to determine the effects of DM on TB treatment outcomes, to identify the effects of TB on glycemic control, and to describe the lipid profile of TB and DM patients. Methods: This prospective cohort study design was conducted. The data were collected from September 2018 to June 2020 using patient interviews, examining the patients, chart review, and collecting blood samples. Binary logistic regression was used to identify the determinants of TB treatment outcomes in the context of DM. Kaplan Meier survival curve was used to see the effects of DM on TB clinical response. Linear regression was used to identify the determinants of the HbA1c level during TB infection. Results: A total of 1092 study participants were included giving for the response rate at 93.81 %. Good TB treatment outcome was observed in 72.5 % of the patients [95 % CI: 69 % - 76 %]. The odds of good TB treatment outcomes were at 75 % lower in the presence of DM (AOR 0.25 [95 % CI: 0.08 – 0.73]). The median time of clinical response in TB and DM patients was 45 days interquartile range (IQR) of 8 days; the median time of clinical response in DM free TB patients was 9 days [IQR 2 days]. TB increased the HbA1c level of DM patients by 1.22 % (B 1.22 [95% CI: 1.11 – 1.34]). In six months period, 60 % of TB and DM patients had got 3 episodes of acute complications. Conclusion: DM significantly decreases the favorable treatment outcome of DOTS. TB predisposed DM patients for bad glycemic control and increased episodes of acute DM complications.


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