Bevacizumab and Combination Chemotherapy in rectal cancer Until Surgery (BACCHUS): a phase II, multicentre, open-label, randomised study of neoadjuvant chemotherapy alone in patients with high-risk cancer of the rectum

Glynne‐Jones, Rob; Hava, N.; Goh, Vicky; Bosompem, S.; Bridgewater, John; Chau, Ian; Gaya, A.; Wasan, Harpreet; Moran, Brendan; Melcher, L.; Macdonald, Alistair; Osborne, M.; Beare, Sandy; Jitlal, Mark; Lopes, Andre; Hall, Marcia; West, Nicholas P.; Quirke, Philip; Wong, Wai-Lup; Harrison, Mark

doi:10.1186/s12885-015-1764-1

Cited by 32 publications

(7 citation statements)

References 53 publications

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“…Although adjuvant chemotherapy is given as a systemic treatment after surgery, compliance with adjuvant chemotherapy has been poor. Approximately half of patients who are eligible for adjuvant chemotherapy initiate treatment after a significant delay or do not receive planned chemotherapy[ 26 , 27 ]. The long-term treatment outcomes from these strategies have been disappointing, thus, a more effective systemic treatment is required[ 2 , 20 ].…”

Section: Discussionmentioning

confidence: 99%

Predictive factors for early distant metastasis after neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Park

2021

WJGO

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BACKGROUND Distant relapse is the leading cause of cancer-related death in locally advanced rectal cancer. Neoadjuvant chemoradiation (NACRT) followed by surgery inevitably delays delivery of systemic treatment. Some patients show early distant metastasis before systemic treatment. AIM To identify the most effective treatments. We investigated prognostic factors for distant metastasis, especially early distant metastasis, using the standard treatment paradigm to identify the most effective treatments according to recurrence risk. METHODS From January 2015 through December 2019, rectal cancer patients who underwent NACRT for having clinical T 3-4 or clinical N 1-2 disease according to the 8 th American Joint Committee on Cancer staging system were included. Radiotherapy was delivered to the whole pelvis with concomitant chemotherapy. Patients received surgery 6-8 wk after completion of NACRT. Adjuvant chemotherapy was administered at the physician’s discretion. RESULTS A total of 127 patients received NACRT. Ninety-three patients (73.2%) underwent surgery. The R0 resection rate was 89.2% in all patients. Pathologic tumor and node downstaging rates were 41.9% and 76.3%. Half the patients ( n = 69) received adjuvant chemotherapy after surgery. The 3-year distant metastasis-free survival (DMFS) and overall survival (OS) rates were 81.7% and 83.5%. On univariate analyses, poorly differentiated tumors, > 5 cm, involvement of mesorectal fascia (MRF), or presence of extramural involvement (EMVI) were associated with worse DMFS and OS. Five patients showed distant metastasis at their first evaluation after NACRT. Patients with early distant metastasis were more likely to have poorly differentiated tumor ( P = 0.025), tumors with involved MRF ( P = 0.002), and EMVI ( P = 0.012) than those who did not. CONCLUSION EMVI, the involvement of MRF, and poor histologic grade were associated with early distant metastasis. In order to control distant metastasis and improve treatment outcome, selective use of neoadjuvant treatment according to individualized risk factors is necessary. Future studies are required to determine effective treatment strategies for patients at high risk for distant metastasis.

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Section: Discussionmentioning

confidence: 99%

Predictive factors for early distant metastasis after neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Park

2021

WJGO

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“…Many new neoadjuvant treatments have been tried, including CRT with induction chemotherapy,4 preoperative CRT with chemotherapy,5 bevacizumab with CRT,6 and others. However, the most efficacious CRT treatment has not been determined.…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant chemoradiation for locally advanced rectal cancer: a systematic review of the literature with network meta-analysis

Chen¹,

Chen²,

Xu³

et al. 2019

CMAR

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BackgroundNeoadjuvant chemoradiotherapy (CRT) prior to surgery is a standard therapy for locally advanced rectal cancer, but the optimum regime is not conclusive. This meta-analysis evaluated various CRT regimens with regard to the rate of pathologic complete response (pCR) and toxic effects of grade ≥3.MethodsThe databases PubMed, Cochrane Library, and Embase were searched for randomized controlled trials (RCTs) that compared neoadjuvant CRT regimes for treating patients with locally advanced rectal cancer, published before 28 December 2017. The primary end points were pCR and toxic effects. A network meta-analysis was applied.ResultsFourteen RCTs (with 5,599 participants) involving the following eight regimens were included: fluorouracil (5FU) alone, or 5FU with oxaliplatin (OXA), cisplatin, or irinotecan (CPT-11); capecitabine (CAP) alone, or CAP with OXA or CPT-11; and CPT-11 with combined tegafur, 5-chloro-2,4-dihydroxypyridine, and potassium oxonate. The rate of pCR associated with CAP + OXA was significantly higher compared with 5FU alone; there were no significant differences among the other regimens. The toxicity of 5FU + OXA or CAP + OXA was significantly worse than that of 5FU alone or CAP alone. CAP + OXA and CAP were ranked, respectively, the most and second most effective regimens in terms of pCR rate. 5FU alone and CAP alone likely had the lowest and second lowest toxicity, respectively.ConclusionAmong the currently available CRT regimens for locally advanced rectal cancer, this meta-analysis indicated that CAP + OXA provides the superior clinical results. Adding OXA to 5FU or CAP significantly increases toxicity.

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“…The primary endpoint for the trial is DFS. Along the same lines, the phase 2 BACCHUS trial will evaluate whether patients who respond to FOLFOX‐based neoadjuvant ChT regimens can forego RT before TME . These efforts to tailor neoadjuvant therapy based on initial response might help allow an eligible subset of patients to defer RT without compromising outcomes.…”

Section: Future Directionsmentioning

confidence: 99%

Total neoadjuvant therapy for rectal cancer: An emerging option

Ludmir

Palta

Willett

et al. 2017

Cancer

166

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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Bevacizumab and Combination Chemotherapy in rectal cancer Until Surgery (BACCHUS): a phase II, multicentre, open-label, randomised study of neoadjuvant chemotherapy alone in patients with high-risk cancer of the rectum

Cited by 32 publications

References 53 publications

Predictive factors for early distant metastasis after neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Predictive factors for early distant metastasis after neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Neoadjuvant chemoradiation for locally advanced rectal cancer: a systematic review of the literature with network meta-analysis

Total neoadjuvant therapy for rectal cancer: An emerging option

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