A phase II single arm feasibility trial of neoadjuvant chemotherapy (NAC) with oxaliplatin/fluorouracil (OxMdG) then short-course preoperative radiotherapy (SCPRT) then immediate surgery in operable rectal cancer (ORC): COPERNICUS (NCT01263171).

Gollins, Simon; Sebag‐Montefiore, David; Adams, Richard; Saunders, Mark; Grieve, Robert; Scott, Nigel; Brown, Gina; Quirke, Philip; Butlin, Laura; Ray, Ruby; Griffiths, Gareth; Hurt, Chris

doi:10.1200/jco.2015.33.15_suppl.3609

Cited by 9 publications

(3 citation statements)

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“…The GCR3 phase II trial ( n = 108) of pre‐ vs postoperative OxCap demonstrated lower toxicity and better compliance when given preoperatively (Fernandez‐Martos et al ., ). The CRUK‐funded phase II COPERNICUS pilot trial ( n = 60) showed that 8 weeks oxaliplatin/fluorouracil (OxFU) prior to SCPRT and surgery is feasible with a high response rate (Gollins et al ., ).…”

Section: Multidisciplinary Managementmentioning

confidence: 97%

Association of Coloproctology of Great Britain & Ireland (ACPGBI): Guidelines for the Management of Cancer of the Colon, Rectum and Anus (2017) – Multidisciplinary Management

et al. 2017

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Section: Multidisciplinary Managementmentioning

confidence: 97%

Association of Coloproctology of Great Britain & Ireland (ACPGBI): Guidelines for the Management of Cancer of the Colon, Rectum and Anus (2017) – Multidisciplinary Management

et al. 2017

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“…The primary outcome of this trial is expected by next year (NCT01804790). Similarly, the preliminary results of the completed phase 2 trial of COPERNICUS in the UK reported the promising efficacy of 4 cycles of neoadjuvant oxaliplatin and fluorouracil followed by short-course preoperative radiotherapy and immediate surgery for resectable rectal cancer (NCT01263171) 31 .…”

Section: Discussionmentioning

confidence: 99%

Potential predictive factors for pathologic complete response after the neoadjuvant treatment of rectal adenocarcinoma: a single center experience

Letaief

Nasri

Ayadi

et al. 2017

Cancer Biology & Medicine

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Objective: To assess the response rate of patients with rectal adenocarcinoma to neoadjuvant therapy and to identify the predictors of histological regression after neoadjuvant radiotherapy (RT) or concurrent chemoradiotherapy (CCRT). Methods: This study recruited 64 patients. The patients had resectable cancer of the lower and the middle rectum (T3/T4 and/or N+) without distant metastasis and received neoadjuvant RT or CCRT followed by radical surgery with total mesorectal excision (TME) between January 2006 and December 2011. The patients were classified into non-response (NR), partial response (PR), and pathologic complete response (pCR) based on the Dworak tumor regression grading system.Results: The median age of patients was 57 years (ranging from 22 to 85). A total of 24 patients were treated with neoadjuvant CCRT, whereas 40 patients were treated with RT alone. Abdominoperineal resection (APR) was performed on 29 patients (45%). Anterior resection with TME was performed on 34 patients (53%). One patient had local resection. Histologically, 12 (19%), 24 (73%), and 28 (44%) patients exhibited pCR, PR, and NR, respectively. Univariate analysis revealed that the predictors of tumor regression were as follows: the absence of lymph node involvement from initial imaging (cN0) (P=0.021); normal initial carcinoembryonic antigen (CEA) level (P=0.01); hemoglobin level ≥12 g/dl (P=0.009); CCRT (P=0.021); and tumor downstaging in imaging (P=0.001). Multivariate analysis showed that the main predictors of pCR were CT combined with neoadjuvant RT, cN0 stage, and tumor regression on imaging. Conclusions: Identifying the predictors of pCR following neoadjuvant therapy aids the selection of responsive patients for non-aggressive surgical treatment and possible surveillance.

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“…UK investigators are also attempting to assess the role of NAC combined with neoadjuvant SC-RT in the COPERNICUS trial: preliminary results reported 95% NAC completion rates, and all patients underwent R0 resection. 61 These results are now being used to support the CREATE trial, a phase 3 trial with the objective of determining whether induction NAC before neoadjuvant SC-RT or LC-CRT can improve 3-year DFS. 62 It is also noteworthy that these trials have been designed with well defined parameters for the delivery of adjuvant ChT after surgery.…”

Section: Future Directionsmentioning

confidence: 99%

Total neoadjuvant therapy for rectal cancer: An emerging option

Ludmir

Palta

Willett

et al. 2017

Cancer

162

109

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The treatment of locally advanced rectal cancer (LARC) has benefited from improved surgical techniques and from the implementation of neoadjuvant chemoradiotherapy (CRT), which have markedly decreased the rates of local recurrence. However, distant metastatic disease remains the most significant cause of death for these patients. Although adjuvant chemotherapy (ChT) after neoadjuvant CRT and definitive surgery is commonly recommended, the value of adjuvant systemic therapy remains less clear. Trials evaluating adjuvant ChT for rectal cancer have been handicapped by poor compliance rates and inconsistent survival results. Shifting systemic therapy delivery to the neoadjuvant setting has the promise to improve compliance rates, reduce toxicity, and decrease distant relapse rates. Recently, multiple prospective trials have reported on the use of total neoadjuvant therapy (TNT) for patients with LARC, incorporating both ChT and CRT in the neoadjuvant setting. Here, the authors review the promising results from those trials. Because the studies have largely focused on pathologic outcomes (primarily pathologic complete response rates), ongoing phase 2 and 3 trials are now underway assessing the long-term disease-related outcomes with TNT. In addition to improving survival, TNT has the potential to increase the pool of patients with LARC who are eligible for organ preservation, which is also being evaluated. Cancer 2017;123:1497-1506. © 2017 American Cancer Society.

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A phase II single arm feasibility trial of neoadjuvant chemotherapy (NAC) with oxaliplatin/fluorouracil (OxMdG) then short-course preoperative radiotherapy (SCPRT) then immediate surgery in operable rectal cancer (ORC): COPERNICUS (NCT01263171).

Cited by 9 publications

References 0 publications

Association of Coloproctology of Great Britain & Ireland (ACPGBI): Guidelines for the Management of Cancer of the Colon, Rectum and Anus (2017) – Multidisciplinary Management

Association of Coloproctology of Great Britain & Ireland (ACPGBI): Guidelines for the Management of Cancer of the Colon, Rectum and Anus (2017) – Multidisciplinary Management

Potential predictive factors for pathologic complete response after the neoadjuvant treatment of rectal adenocarcinoma: a single center experience

Total neoadjuvant therapy for rectal cancer: An emerging option

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