• bibliometrics
• locally advanced
• preoperative
• radiotherapy
• rectal cancer

• Prognosis
• Rectal neoplasms
• Tomography
• X-ray computed

• 2022YFS0249 the Key Research Project of Sichuan Province

• Neoadjuvant therapy
• Oxaliplatin
• Radiotherapy
• Rectal cancer
• Survival

• Humans
• Rectal Neoplasms/therapy
• Rectal Neoplasms/pathology
• Rectal Neoplasms/mortality
• Female
• Male
• Middle Aged
• Retrospective Studies
• Propensity Score
• Oxaliplatin/therapeutic use
• Oxaliplatin/administration & dosage
• Chemoradiotherapy/methods
• Aged
• Antineoplastic Combined Chemotherapy Protocols/therapeutic use
• Capecitabine/therapeutic use
• Capecitabine/administration & dosage
• Adult
• Survival Rate
• Treatment Outcome
• Neoadjuvant Therapy

• PD-1 antibody
• combined positive score
• complete response
• locally advanced rectal cancer
• neoadjuvant chemoradiotherapy
• proficient mismatch repair

• Adult
• Aged
• Female
• Humans
• Male
• Middle Aged
• Antibodies, Monoclonal, Humanized/therapeutic use
• Antibodies, Monoclonal, Humanized/administration & dosage
• Antibodies, Monoclonal, Humanized/adverse effects
• Antineoplastic Combined Chemotherapy Protocols/therapeutic use
• Chemoradiotherapy/methods
• DNA Mismatch Repair
• Immune Checkpoint Inhibitors/therapeutic use
• Immune Checkpoint Inhibitors/administration & dosage
• Neoadjuvant Therapy/methods
• Programmed Cell Death 1 Receptor/antagonists & inhibitors
• Programmed Cell Death 1 Receptor/immunology
• Rectal Neoplasms/therapy
• Rectal Neoplasms/immunology
• Rectal Neoplasms/pathology
• Rectal Neoplasms/drug therapy
• Neoplasm Staging

• Rectal cancer
• chemotherapy
• neoadjuvant therapy
• oxaliplatin
• radiotherapy

• Colorectal disease
• Neoadjuvant therapy
• Network meta-analysis
• Rectal neoplasms
• Total neoadjuvant therapy

The presence of mesorectal fascia (MRF) invasion, grade 4 extramural venous invasion (EMVI), tumour deposits (TD) or extensive or bilateral extramesorectal (lateral) lymph nodes (LLN) on MRI has been suggested to identify patients with indisputable, extensive locally advanced rectal cancer (LARC), at high risk of treatment failure. The aim of this study is to evaluate whether or not intensified chemotherapy prior to neoadjuvant chemoradiotherapy improves the complete response (CR) rate in these patients.

This multicentre, single-arm, open-label, phase II trial will include 128 patients with non-metastatic high-risk LARC (hr-LARC), fit for triplet chemotherapy. To ensure a study population with indisputable, unfavourable prognostic characteristics, hr-LARC is defined as LARC with on baseline MRI at least one of the following characteristics; MRF invasion, EMVI grade 4, enlarged bilateral or extensive LLN at high risk of an incomplete resection, or TD. Exclusion criteria are the presence of a homozygous DPD deficiency, distant metastases, any chemotherapy within the past 6 months, previous radiotherapy within the pelvic area precluding standard chemoradiotherapy, and any contraindication for the planned treatment. All patients will be planned for six two-weekly cycles of FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) prior to chemoradiotherapy (25 × 2 Gy or 28 × 1.8 Gy with concomitant capecitabine). A resection will be performed following radiological confirmation of resectable disease after the completion of chemoradiotherapy. A watch and wait strategy is allowed in case of a clinical complete response. The primary endpoint is the CR rate, described as a pathological CR or a sustained clinical CR one year after chemoradiotherapy. The main secondary objectives are long-term oncological outcomes, radiological and pathological response, the number of resections with clear margins, treatment-related toxicity, perioperative complications, health-related costs, and quality of life.

This trial protocol describes the MEND-IT study. The MEND-IT study aims to evaluate the CR rate after intensified chemotherapy prior to concomitant chemoradiotherapy in a homogeneous group of patients with locally advanced rectal cancer and indisputably unfavourable characteristics, defined as hr-LARC, in order to improve their prognosis.

Clinicaltrials.gov: NCT04838496, registered on 02–04-2021 Netherlands Trial Register: NL9790.

Version 3 dd 11–4-2022.

• Clinical complete response
• Complete response
• Induction chemotherapy
• Locally advanced rectal cancer
• Neoadjuvant chemotherapy
• Neoadjuvant treatment
• Pathological complete response

Distant metastasis has been the main failure pattern for locoregionally advanced rectal cancer (LARC) patients, and intensified neoadjuvant chemotherapy has become a popular research topic. The present study aimed to compare the survival outcomes, acute toxicities and surgical complications in LARC patients who received preoperative chemoradiotherapy with triweekly oxaliplatin and capecitabine (triweekly XELOX) or capecitabine.

Methods: Between 2007 and 2017, patients with clinically staged II-III rectal cancer who were treated with preoperative chemoradiotherapy using either triweekly XELOX (oxaliplatin 130 mg/m² plus capecitabine 825 mg/m²) or capecitabine were included. Variables potentially influencing chemotherapy treatment selection were used to generate propensity scores (PS). The association between chemotherapy regimens and survival endpoints, including distant metastasis-free survival (DMFS), overall survival (OS) and disease-free survival (DFS), were evaluated and adjusted with PS. The acute toxicities and surgical complications were also compared.

A total of 810 patients were included in the analysis; 277 (34.2%) patients received triweekly XELOX, and 533 (65.8%) received capecitabine. The pathological complete response (pCR) rates were 20.2 and 19.9% (P = 0.912) for the groups treated with triweekly XELOX and capecitabine, respectively. The 5-year DMFS, OS and DFS with triweekly XELOX versus capecitabine were 75.6% vs. 77.6% (P = 0.555), 79.2% vs. 83.3% (P = 0.101), and 69.9% vs. 73.7% (P = 0.283), respectively. Triweekly XELOX was not associated with an increased risk of severe toxicity during chemoradiotherapy, but it increased the risk of postoperative complications compared to capecitabine. After PS adjustment, the differences between the two groups remained insignificant in pCR rate, survival outcomes, and acute toxicities, and the difference in surgical complications disappeared.

Triweekly XELOX or capecitabine concurrent with neoadjuvant radiotherapy leads to similar long-term survival outcomes, acute toxicities and surgical complications in LARC patients.

The online version contains supplementary material available at 10.1186/s12885-022-09855-z.

• Capecitabine
• Chemoradiotherapy
• Oxaliplatin
• Rectal cancer

• chemoradiation therapy
• chemotherapy
• disease-free survival (DFS)
• pathological complete response (pCR)
• rectal cancer
• sphincter preservation

• Antineoplastic Combined Chemotherapy Protocols/therapeutic use
• Chemoradiotherapy
• Humans
• Induction Chemotherapy
• Multicenter Studies as Topic
• Neoadjuvant Therapy
• Neoplasm Recurrence, Local/drug therapy
• Neoplasm Recurrence, Local/radiotherapy
• Quality of Life
• Randomized Controlled Trials as Topic
• Rectal Neoplasms/diagnostic imaging
• Rectal Neoplasms/therapy

• SCAF/19/01 Chief Scientist Office
• Netherlands Organization for Health Research and Development (ZonMw)

Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The “Tratamiento de Tumores Digestivos” group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response).

We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years.

Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks).

In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%).

the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term.

EudraCT number: 2009–010192-24.

Clinicaltrials.gov number: NCT01043484.

The online version contains supplementary material available at 10.1186/s12885-020-07661-z.

• Bevacizumab
• Chemoradiotherapy
• Locally-advanced rectal cancer
• Neoadjuvant

Many clinical studies for the long-term survival or efficacy of capecitabine plus oxaliplatin (XELOX) in colon cancer have already been studied, but its clinical benefit is controversial.

To evaluate the long-term efficacy of XELOX regimen in comparison with other adjuvant chemotherapy protocols in colon cancer.

By searching the PubMed, EMBASE and Cochrane databases, a total of 12 randomized controlled trials involving 6698 stage III colon cancer cases (XELOX protocol: n = 3298 cases; other adjuvant chemotherapy protocol: n = 3268 cases) were included. The parameter outcomes included the overall survival and the disease-free survival. The quality control of selected literature was based on the Jadad scale and the GRADE system.

In comparison to other adjuvant chemotherapy regimen, XELOX regimen showed a better overall survival (odds ratio = 1.29, 95% confidence interval: 1.15-1.44, P < 0.0001) and a better disease-free survival (odds ratio = 1.32, 95% confidence interval: 1.18-1.46, P < 0.0001) for colon cancer patients, suggesting the XELOX regimen can be a good option for postoperative treatment of stage III colon cancer.

The XELOX regimen can be a preferred option for adjuvant treatment of stage III colon cancer after surgery.

• Capecitabine plus oxaliplatin chemotherapy
• Colon cancer
• Meta-analysis
• Long-term effect