Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial

Feng, Yanru; Zhu, Yuan; Liu, Luying; Wang, Weihu; Wang, Shulian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yueping; Ren, Hua; Fang, Hui; Zhang, Shiping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Yexiong; Jin, Jing

doi:10.18632/oncotarget.8226

Cited by 11 publications

(7 citation statements)

References 19 publications

(32 reference statements)

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“…As described previously in detail, 27 patients eligible for this RCT had stage II to III (M0) rectal cancer according to the staging system set by the American Joint Committee on Cancer in 2002. Patients had undergone curative surgical procedures (total mesorectal excision) with negative resection margins (R0 resection).…”

Section: Methodsmentioning

confidence: 99%

Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer

Zhu

Liu

et al. 2021

JAMA Netw Open

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IMPORTANCE Several studies have explored the efficacy and toxic effects of concurrent 5-fluorouracil (5-FU)-or capecitabine-based chemoradiotherapy (CRT) with or without oxaliplatin in the neoadjuvant setting. Addition of oxaliplatin to 5-FU or capecitabine elicited similar outcomes but with significantly increased toxic effects; however, there is a need for randomized clinical trials comparing 2 CRT regimens for patients receiving CRT in the adjuvant setting. OBJECTIVE To explore the efficacy and toxic effects of oxaliplatin combined with postoperative concurrent capecitabine and radiotherapy (RT) for pathological stage II and III rectal cancer.

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Section: Methodsmentioning

confidence: 99%

Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer

Zhu

Liu

et al. 2021

JAMA Netw Open

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“…All of the rectal cancer patients recruited between May 2008 and June 2015 were treated with TME followed by a total radiation dose of 45–50.4 Gy in 25–28 fractions at 1.8–2.0 Gy per daily fraction concurrently with capecitabine or capecitabine plus oxaliplatin. The details of adjuvant chemoradiotherapy were described previously 2. Patient eligibility criteria included as following: (1) pathological stage II or III rectal adenocarcinoma; (2) R0 TME; (3) Karnofsky Performance Score (KPS) ≥70; (4) 18–75 years old; (5) with no history of cancer excluding carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin; and (6) with adequate organ function.…”

Section: Methodsmentioning

confidence: 99%

“…However, for patients with locally advanced rectal cancer treated by primary surgery, adjuvant chemoradiotherapy is recommended 1. Broad variations of survival and adverse events (AEs) have been reported in response to the adjuvant chemoradiotherapy 2. In our previous studies, genetic variations in mismatch repair genes and microRNA seed regions could predict the risk of AEs and prognosis 3,4…”

Section: Introductionmentioning

confidence: 99%

<p>Systemic inflammation score in locally advanced rectal cancer patients following total mesorectal excision</p>

Feng¹,

Liu²,

Zhu³

2019

OTT

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ObjectiveThe objective of the study was to evaluate whether any association exists between systemic inflammation score (SIS) and adverse events (AEs) and survival of locally advanced rectal cancer patients treated with total mesorectal excision (TME) followed by adjuvant chemoradiotherapy.Patients and methodsAll of the 109 rectal cancer patients recruited between May 2008 and June 2015 were treated with TME followed by adjuvant chemoradiotherapy. The prognostic ability of SIS for overall survival (OS) was calculated by the receiver operating characteristic (ROC) curves.ResultsAccording to the classification of the SIS, 22 (20.2%), 59 (54.1%) and 28 (25.7%) patients were classified as a score of 2, 1 and 0, respectively. With an area under the curve (AUC) of 0.616, the SIS score of 1 was defined as the optimal cut-off value. Therefore, we divided the patients into the SIS-low group (SIS score of 1 or 0, n=87) and SIS-high group (SIS score of 2, n=22). Multivariate analysis indicated that SIS was associated with OS (HR 0.390, 95% CI 0.186–0.817, P=0.012). The 5-year OS rate in patients without adjuvant chemotherapy was lower than the patients with adjuvant chemotherapy (53.3% vs 75.8%, P=0.010). Multivariate analysis showed that adjuvant chemotherapy was associated with OS (HR 0.217, 95% CI 0.089–0.529, P=0.001). A marginal statistically significant difference was observed in terms of leukopenia during adjuvant chemoradiotherapy between the SIS-low group and the SIS-high group (P=0.05).ConclusionThese results suggest that SIS might serve as an independent biomarker for predicting AEs and prognosis in locally advanced rectal cancer treated with TME followed by adjuvant chemoradiotherapy. Strengthening treatment may be administered to locally advanced rectal cancer with high SIS score obtained before adjuvant chemoradiotherapy.

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“…Interim results showed increase in grade 3/4 toxicity, with no difference in 3-year DFS, OS, local or distant recurrences. 65…”

Section: Concurrent Chemotherapy With Radiationmentioning

confidence: 99%

Non-operative management of rectal cancer: understanding tumor biology

Wei

Garcia‐Aguilar

2018

Minerva Chir

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The management of locally advanced rectal cancer involves a combination of chemotherapy, chemoradiation, and surgical resection to provide excellent local tumor control and overall survival. However, aspects of this multimodality approach are associated with significant morbidity and long-term sequelae. In addition, there is growing evidence that patients with a clinical complete response to chemotherapy and chemoradiation treatments may be safely offered initial non-operative management in a rigorous surveillance program. Developing effective methods, such as molecular biomarkers, to predict a patient’s response to therapies are therefore needed to help guide personalized treatment strategies. The treatment of locally advanced rectal cancer focuses on a multimodality approach of systemic chemotherapy, radiation, and total mesorectal excision to maximize oncologic outcomes. While combined modality treatment for LARC results in excellent local tumor control and patient survival, the treatments are associated with significant morbidity and long-term functional complications that can impair quality of life. In addition, the tumor response to neoadjuvant therapy is quite variable. Weighed against the morbidity and significant sequelae of rectal resection, recognizing how to best optimize non-operative strategies without compromising oncologic outcomes is critical to our understanding and treatment of this disease.

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Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial

Cited by 11 publications

References 19 publications

Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer

Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer

<p>Systemic inflammation score in locally advanced rectal cancer patients following total mesorectal excision</p>

Non-operative management of rectal cancer: understanding tumor biology

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