IORT in Integrated Treatment of High-Risk Rectal Cancers

Author(s):  
L. Sofo ◽  
C. Ratto ◽  
V. Valentini ◽  
A. Piermattei ◽  
L. Trodella ◽  
...  
2014 ◽  
Vol 61 (2) ◽  
pp. 9-16
Author(s):  
Vincenzo Valentini ◽  
Francesco Cellini

Results of the management of rectal cancer have enormously improved over the last almost forty years, by the progressive development of new integrated treatment options. nevertheless an optimization of the results is needed to raise the still sub-optimal outcome in terms of survival. several national and international guidelines address the best treatment choice overall evaluating the evidence basis available from literature. Still a certain degree of disagreement is present, particularly about the preferable preoperative rt treatment schedule. randomized trials represent the main landmark and most important tool for the scientific scenario: defining a potentially established standard of care, or suggesting the more promising approach to focus the re- search into, thus orienting the efforts of clinicians and researchers. This manuscript will mainly focus on the evidences derived from randomized clinical trial describing the main issues about the multimodal integrated treatment for rectal cancers. It will focus on both locally advanced (LA)/primary unresectable (UR), and resectable rectal cancers; some non-randomized trials of relevant the dissertation will also be mentioned.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. TPS879-TPS879
Author(s):  
Ramakrishnan Ayloor Seshadri ◽  
Trivadi S. Ganesan ◽  
Arunkumar M N ◽  
Shirley Sundersingh

TPS879 Background: Patients with rectal cancers treated with neoadjuvant chemoradiation followed by surgery and adjuvant chemotherapy are not exposed to systemic doses of chemotherapy until very late in the treatment schedule. Preoperative chemotherapy, either in the neoadjuvant or interval setting can lead to early treatment of micrometastasis, improve the tumor response and possibly the overall survival. Phase II studies of neoadjuvant chemotherapy in rectal cancer have shown good response to chemotherapy with no tumor progression and good compliance. A phase II study evaluating the effect of giving chemotherapy in the interval waiting period between chemoradiation and surgery has shown acceptable toxicity and high pathological complete response rates. Methods: This single centre, randomized, open label, phase II trial compares the safety and efficacy of two pre-operative regimens in locally advanced MRI defined high-risk rectal cancers. Based on the Simon optimal two-stage design, 94 patients will be randomised to either Arm A [3 cycles of neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by chemoradiation (50.4 Gy with capecitabine) and then surgery] or Arm B [neoadjuvant chemoradiation followed by 3 cycles of interval chemotherapy and then surgery]. Patients in both arms receive 3 cycles of adjuvant chemotherapy. The primary end-point is the pathological complete response rate. Secondary end-points include frequency and severity of adverse events, RO resection rates, tumor regression grading and compliance to treatment. The inclusion criteria: age 18 to 70 years; ECOG performance status 0-2; non-metastatic, locally advanced rectal cancer with any one of the following features on high-resolution thin slice MRI: any T3/T4 tumor in the lower rectum, T3c/T3d/T4 tumor in the mid rectum, N2 disease, threatened mesorectal fascia, or extramural vascular invasion. Patients are randomly assigned to one of the two intervention arms in a 1:1 ratio. Prespecified activity goal for the first stage of accrual was met; second stage accrual began in July 2017. Clinical trial information: CTRI/2015/01/005385.


2021 ◽  
Vol 39 (6) ◽  
pp. 631-641
Author(s):  
Timothy J. Iveson ◽  
Alberto F. Sobrero ◽  
Takayuki Yoshino ◽  
Ioannis Souglakos ◽  
Fang-Shu Ou ◽  
...  

PURPOSE: As oxaliplatin results in cumulative neurotoxicity, reducing treatment duration without loss of efficacy would benefit patients and healthcare providers. PATIENTS AND METHODS: Four of the six studies in the International Duration of Adjuvant Chemotherapy (IDEA) collaboration included patients with high-risk stage II colon and rectal cancers. Patients were treated (clinician and/or patient choice) with either fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) and randomly assigned to receive 3- or 6-month treatment. The primary end point is disease-free survival (DFS), and noninferiority of 3-month treatment was defined as a hazard ratio (HR) of < 1.2- v 6-month arm. To detect this with 80% power at a one-sided type one error rate of 0.10, a total of 542 DFS events were required. RESULTS: 3,273 eligible patients were randomly assigned to either 3- or 6-month treatment with 62% receiving CAPOX and 38% FOLFOX. There were 553 DFS events. Five-year DFS was 80.7% and 83.9% for 3-month and 6-month treatment, respectively (HR, 1.17; 80% CI, 1.05 to 1.31; P [for noninferiority] .39). This crossed the noninferiority limit of 1.2. As in the IDEA stage III analysis, the duration effect appeared dependent on the chemotherapy regimen although a test of interaction was negative. HR for CAPOX was 1.02 (80% CI, 0.88 to 1.17), and HR for FOLFOX was 1.41 (80% CI, 1.18 to 1.68). CONCLUSION: Although noninferiority has not been demonstrated in the overall population, the convenience, reduced toxicity, and cost of 3-month adjuvant CAPOX suggest it as a potential option for high-risk stage II colon cancer if oxaliplatin-based chemotherapy is suitable. The relative contribution of the factors used to define high-risk stage II disease needs better understanding.


1998 ◽  
Vol 41 (12) ◽  
pp. 1494-1499 ◽  
Author(s):  
Reiping Tang ◽  
Yet-Sen Ho ◽  
Hong-Hua Chen ◽  
Lai-Chu See ◽  
Jeng-Yi Wang

2021 ◽  
Vol 22 (1) ◽  
pp. 2-3
Author(s):  
Avanish Saklani ◽  
Diwakar Pandey ◽  
Swapnil Patel

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S497-S498
Author(s):  
Lauren A Correia ◽  
Christopher C Tseng ◽  
Mario Portilla ◽  
Shobha Swaminathan

Abstract Background Treatment of Hepatitis C virus (HCV) infection for persons with Human Immunodeficiency Virus (HIV) is dependent on consistent outpatient follow-up. We sought to identify factors that are associated with lower HCV treatment rates in HIV/HCV co-infected patients followed at Rutgers Infectious Diseases Practice (IDP), an integrated urban clinic. Methods Retrospective chart reviews were conducted for HIV/HCV co-infected patients treated at IDP in Newark, New Jersey between January 2017 and July 2018. We assessed factors associated with lack of HCV treatment in this practice. Data collected included demographics, HIV disease markers, liver function tests, HCV treatment history and response. Factors with p&lt; 0.05, age and race were included in the multivariate analysis. Results We included 317 HIV/HCV co-infected patients with at least one visit between January 2017 and July 2018. Fifty eight percent were male, 79% black, 10% hispanic, 6% white, and 5% other; 21% reported heterosexual and 79% drug use (injection and non-injection) as their HIV risk factor The median CD4 was 522 cells/cm3, and 74% of patients had HIV viral load (VL) &lt; 40 copies/ml. HCV treatment was started at IDP in 142 (45%) and of those 87% were cured. Data are awaited on 6%. Univariate analyses showed those not treated for HCV were more likely to be born female (57% vs 42%), have a CD4 count &lt; 200 cells/cm3 (9% vs 27%), HIV VL &gt;40 copies/ml (43% vs 17%), currently (58% vs 30%) or previously (89% vs 74%) used drugs, and have a higher APRI score (0.43 vs 1.6). Multivariate logistic regression showed that patients with untreated HCV were more likely to be female (OR 2.93, p&lt; 0.001), report current drug/alcohol use (OR 2.43, p=0.004), and have HIV VL ≥40 copies/ml (OR 2.11, p&lt; 0.001). Table 1: Demographics/Risk Factors of Study Group Table 2: Laboratory Studies Table 3: Logistic Regression of Significant HCV Treatment Factors Conclusion Our results show that despite the availability of integrated treatment programs, concerted efforts need to be made for patients at high risk for not receiving HCV treatment, and who therefore remain at high risk for complications from HCV. Provider perceptions may play a role in withholding treatment for those with high HIV VL and current drug or alcohol use; whereas the rationale for why women were less likely to be treated is less clear and may be related to trauma and other factors not captured by this project that may negatively impact their access to care. Disclosures All Authors: No reported disclosures


2019 ◽  
Vol 120 (5) ◽  
pp. 858-863 ◽  
Author(s):  
Mark A. Healy ◽  
Selvi Thirumurthi ◽  
Y. Nancy You

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