The initial results for a phase III study of short-term radiotherapy plus chemotherapy vs long-term chemoradiotherapy in locally advanced rectal cancer (STELLAR trial).

Jin, Jing; Tang, Yuan; Li, Sen; Li, N; Ren, Hua; Hz, Zhang; Zhou, Zicong; Liang, Jinxiao; Zheng, Z-X; Zhao, D-B; Hm, Zhang; Zou, S-M; Fang, Hui; Chi, Y.; Yang, Lin; Wang, WH; Song, Yong-Wen; Yp, Liu; Sl, Wang

doi:10.1200/jco.2016.34.15_suppl.e15000

Cited by 7 publications

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“…In total, 2,881 potential studies were included after removing 1,993 duplicates, 2,578 were excluded from title and abstract screening, 303 studies were considered eligible for full-text assessment, 289 full-text articles were excluded, 146 studies were excluded because they were not randomized control trials, 62 lacked relevant intervention or endpoints, 54 studies were excluded as they were reviews, and 12 studies were excluded because of no available results, and our efforts were unsuccessful in contacting the authors for further data. Eight RCTs met the inclusion criteria in this analysis [16][17][18][19][20][21][22][23][24][25][26][27][28][29]. All eight studies (n = 2,196 patients) were included in this final analysis (n = 1,113 treated with TNT and n = 1,083 treated with standard CRT).…”

Section: Characteristics Of the Selected Studiesmentioning

confidence: 99%

Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis

et al. 2021

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Background. Total neoadjuvant therapy (TNT) is a novel approach for locally advanced rectal cancer (LARC), which attempts to deliver both systemic chemotherapy and neoadjuvant chemoradiotherapy prior to surgery. However, its efficacy and safety remain controversial in randomized controlled trials (RCTs). We conducted this meta-analysis to assess such concerns. Materials and Methods. Head-to-head phase II/III RCTs were searched in Embase, PubMed, Web of Science, and the Cochrane Library, as well as other sources. The primary endpoint was pathologic complete response (pCR). Secondary endpoints were disease-free survival (DFS), overall survival (OS), local recurrence-free survival, distant metastasis-free survival, and the R0 resection rate.Results. Eight phase II/III RCTs involving 2,196 patients with LARC were assessed. The primary analysis demonstrated a statistically significant improvement in the pCR rate for TNT treatment (odds ratio, 1.77; 95% confidence interval [CI], 1.28-2.45; p = .0005). TNT treatment also showed improvements in DFS and OS outcomes compared with standard chemoradiotherapy (hazard ratio [HR], 0.83; 95% CI, 0.72-0.96; p = .03 and HR, 0.88; 95% CI, 0.74-1.05; p = .15). In addition, TNT treatment showed significant efficacy in reducing the risk of distant metastasis (HR, 0.81; 95% CI, 0.68-0.95; p = .012). Conclusion.The overall pCR rate may be improved with TNT compared with standard treatment. The TNT strategy may also improve DFS and OS and reduce the risk of distant metastasis. The Oncologist 2021;26:1-12 Implications for Practice: Locally advanced rectal cancer (LARC) is a relatively common disease, with a poor prognosis because of its high metastatic potential. The role of total neoadjuvant therapy (TNT) has always been controversial. This meta-analysis found that TNT in LARC is associated with a significant improvement in overall pathologic complete response rate, disease-free survival, overall survival, and distant metastasis-free survival compared with standard treatment. TNT is a promising strategy for LARC, especially for patients who have little desire for surgery.

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Section: Characteristics Of the Selected Studiesmentioning

confidence: 99%

Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis

et al. 2021

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“…14 Results from the similarly designed and ongoing phase III RAPIDO (NCT01558921) 15 and STELLAR trials (NCT02533271) are eagerly awaited. 22,23 The COLORE trial met its primary endpoint with a pCR rate of 24.5%. Some studies have reported that patients achieving a pCR after neoadjuvant CRT may have a better prognosis (lower incidence of local and distant recurrence, higher disease-free survival and OS) compared with patients with residual pathological disease.…”

Section: Discussionmentioning

confidence: 99%

“…14 Results from the similarly designed and ongoing phase III RAPIDO (NCT01558921) 15 and STELLAR trials (NCT02533271) are eagerly awaited. 22,23…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant treatment (FOLFOX4 plus hypofractionated tomotherapy) for patients with locally advanced rectal cancer: a multicenter phase II trial

et al. 2020

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Aims: This study aims to evaluate the safety and efficacy of a new neoadjuvant regimen (FOLFOX4 plus hypofractionated tomotherapy) in patients with locally advanced rectal cancer. Methods: Patients with stage II–III rectal cancer were treated with the pre-operative chemoradiotherapy regimen comprising FOLFOX4 (two cycles), TomoTherapy (25 Gy in five consecutive fractions, one fraction per day in 5 days on the clinical target volume at the isodose of 95% of the total dose), FOLFOX4 (two cycles), followed by surgery with total mesorectal excision and adjuvant chemotherapy with FOLFOX4 (eight cycles). The primary endpoint was pathological complete response (pCR). Results: Fifty-two patients were enrolled and 50 patients were evaluable. A total of 46 (92%) patients completed chemoradiotherapy according to the study protocol and 49 patients underwent surgery. Overall, 12 patients achieved a pCR (24.5%, 95% CI 12.5–36.5). The most common grade 3 or more adverse events were neutropenia and alteration of the alvus. Adverse reactions due to radiotherapy, mainly grade 1–2 dermatitis, tenesmus, urinary dysfunction and pain, were tolerable and fully reversible. The most important surgical complications included infection, anastomotic leakage and fistula, all resolved with conservative treatment. Conclusion: FOLFOX and hypofractionated TomoTherapy is effective and safe in patients with locally advanced rectal cancer. Long-term efficacy needs to be further evaluated. Trial registration ClinicalTrials.gov identifier: NCT02000050 (registration date: 26 November 2013) https://clinicaltrials.gov/ct2/show/NCT02000050

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Current Trends in the Treatment of Locally Advanced Rectal Cancer: Where We Are and How We Got Here

Shulman¹,

Meyer²

2021

Curr Colorectal Cancer Rep

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The initial results for a phase III study of short-term radiotherapy plus chemotherapy vs long-term chemoradiotherapy in locally advanced rectal cancer (STELLAR trial).

Cited by 7 publications

References 0 publications

Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis

Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis

Neoadjuvant treatment (FOLFOX4 plus hypofractionated tomotherapy) for patients with locally advanced rectal cancer: a multicenter phase II trial

Current Trends in the Treatment of Locally Advanced Rectal Cancer: Where We Are and How We Got Here

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