Modified FOLFOX6 with or without radiation in neoadjuvant treatment of locally advanced rectal cancer: Final results of the Chinese FOWARC multicenter randomized trial.

Deng, Yanhong; Chi, Pan; Lan, Ping; Wang, Lei; Chen, Weiqing; Cui, Long; Daoda, Chen; Cao, Jie; H, Wei; Xiang, Peng; Huang, Zong-hai; Cai, Guanfu; Zhao, Ren; Huang, Zhongcheng; Luo, Yiding; Zhou, Hang; Wei, Yisheng; Zhang, Hao; Zheng, Jian; Wang, Jianping

doi:10.1200/jco.2018.36.15_suppl.3502

Cited by 16 publications

(16 citation statements)

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“…Full manuscripts were available for nine trials, whereas the results of the PETACC-6 trial were available as a detailed presentation from the American Society of Clinical Oncology 2018 conference (23). Furthermore, the data from the publications of the STAR-01 and FOWARC trials were amended by additional information on long-term outcomes from sufficiently detailed conference proceedings, respectively (24,44). Additionally, the authors of four trials (23,35,36,41) were contacted to clarify some ambiguities in the published reports or to provide additional information.…”

Section: Systematic Literature Search and Trial Selectionmentioning

confidence: 99%

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Addition of Platinum Derivatives to Fluoropyrimidine-Based Neoadjuvant Chemoradiotherapy for Stage II/III Rectal Cancer: Systematic Review and Meta-Analysis

Hüttner¹,

Probst²,

Kalkum³

et al. 2019

JNCI: Journal of the National Cancer Institute

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Background Current guidelines recommend neoadjuvant therapy for patients with stage II or III rectal cancer. The addition of platinum derivatives to fluoropyrimidine-based chemoradiotherapy has been frequently investigated, but their role in this setting remains controversial. Methods PubMed, Cochrane Library, and Web of Science were systematically searched for randomized trials comparing chemoradiotherapy with or without platinum agents in stage II or III rectal cancer. Main outcome parameters were overall and disease-free survival, additional outcomes included pathological complete response, isolated local recurrence, distant recurrence, toxicity, and perioperative morbidity. Time-to-event data were pooled as hazard ratios (HRs) by the inverse variance method and binary outcomes as odds ratios (ORs) by the Peto method with their respective 95% confidence interval (CI). All statistical tests were two-sided. Results Ten randomized controlled trials with data on 5599 patients were included in the meta-analysis. Platinum derivatives did not statistically significantly improve overall survival (HR = 0.93, 95% CI = 0.82 to 1.05, P = .23), disease-free survival (HR = 0.91, 95% CI = 0.83 to 1.01, P = .07), or local recurrence (OR = 0.83, 95% CI = 0.66 to 1.05, P = .12). However, it led to a statistically significant increase of pathological complete response (OR = 1.31, 95% CI = 1.10 to 1.55, P = .002) and a statistically significant reduction of distant recurrence (OR = 0.78, 95% CI = 0.66 to 0.92, P = .004). Benefits were accompanied by higher rates of grade 3 or 4 toxicities. Conclusions Intensified neoadjuvant chemoradiotherapy with the addition of platinum derivatives cannot be recommended routinely because it did not improve overall or disease-free survival and was associated with increased toxicity. It needs to be elucidated whether the benefits in distant recurrence and pathological complete response may be advantageous for selected high-risk patients.

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Section: Systematic Literature Search and Trial Selectionmentioning

confidence: 99%

“…Therefore, current guidelines do not recommend the routine addition of platinum agents to neoadjuvant chemoradiotherapy (2). Recently, long-term results of some of these trials have been published with contradictory results (21)(22)(23)(24).…”

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confidence: 99%

Addition of Platinum Derivatives to Fluoropyrimidine-Based Neoadjuvant Chemoradiotherapy for Stage II/III Rectal Cancer: Systematic Review and Meta-Analysis

Hüttner¹,

Probst²,

Kalkum³

et al. 2019

JNCI: Journal of the National Cancer Institute

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“…Although tumour downstaging was comparable between the standard CRT and chemotherapy‐alone arms (37·1 and 35·5 per cent respectively), the pCR rate was inferior with chemotherapy alone (14·0 versus 6·6 per cent). It was reported recently that there was no difference in DFS or overall survival between the three arms. At present, there is more evidence to support the replacement of neoadjuvant CRT with chemotherapy using DFS as the primary endpoint, than for a cCR/organ preservation endpoint.…”

Section: Alternatives To Standard Radiotherapy Strategiesmentioning

confidence: 93%

Systematic review of treatment intensification using novel agents for chemoradiotherapy in rectal cancer

Clifford

Govindarajah

Parsons

et al. 2018

British Journal of Surgery

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BackgroundWith the well established shift to neoadjuvant treatment for locally advanced rectal cancer, there is increasing focus on the use of radiosensitizers to improve the efficacy and tolerability of radiotherapy. There currently exist few randomized data exploring novel radiosensitizers to improve response and it is unclear what the clinical endpoints of such trials should be.MethodsA qualitative systematic review was performed according to the PRISMA guidelines using preset search criteria across the PubMed, Cochrane and Scopus databases from 1990 to 2017. Additional results were generated from the reference lists of included papers.ResultsA total of 123 papers were identified, of which 37 were included; a further 60 articles were obtained from additional referencing to give a total of 97 articles. Neoadjuvant radiosensitization for locally advanced rectal cancer using fluoropyrimidine‐based chemotherapy remains the standard of treatment. The oral derivative capecitabine has practical advantages over 5‐fluorouracil, with equal efficacy, but the addition of a second chemotherapeutic agent has yet to show a consistent significant efficacy benefit in randomized clinical assessment. Preclinical and early‐phase trials are progressing with promising novel agents, such as small molecular inhibitors and nanoparticles.ConclusionDespite extensive research and promising preclinical studies, a definite further agent in addition to fluoropyrimidines that consistently improves response rate has yet to be found.

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“…5‐FU or capecitabine)‐based regimens and RT, is expected to both enhance primary tumor shrinkage and reduce micro metastases at distant sites for rectal cancer. The regimen including OX in nCRT has been tested in several large phase III studies (Table ) …”

Section: Current Status Of Ncrtmentioning

confidence: 99%

“…The trial aimed to examine the additive effect of OX in nCRT and safety and efficacy without RT in neoadjuvant chemotherapy in the mFOLFOX 6 group. Compared with the 5‐FU‐RT group, the mFOLFOX 6‐RT group had a higher pCR rate (27.5% vs 14.0%, OR = 0.428, 95% CI: 0.237‐0.776, P = 0.005) and higher but acceptable toxicities …”

Section: Current Status Of Ncrtmentioning

confidence: 99%

Recent advances of neoadjuvant chemoradiotherapy in rectal cancer: Future treatment perspectives

Yamashita

Matsuda

Hasegawa

et al. 2018

Annals of Gastroent Surgery

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Neoadjuvant chemoradiotherapy (nCRT) has been widely used as a multidisciplinary approach for stage II/III rectal cancer. However, its safety and efficacy are controversial because previous studies have shown conflicting outcomes. The present review aimed to elucidate the benefits and limitations of nCRT for patients with rectal cancer. Future perspectives of nCRT are also described. No recent randomized trials have been able to show a survival benefit, although many studies have demonstrated good local control with the use of fluoropyrimidine (e.g. 5‐fluorouracil [FU] or capecitabine)‐based nCRT. Addition of oxaliplatin (OX) to FU‐based nCRT might improve overall survival by preventing distant metastasis, as shown in recent meta‐analyses. However, control of adverse effects is an important concern with this treatment. New treatment strategies such as nonoperative management (watch and wait policy) and total neoadjuvant therapy (TNT) are promising, but the establishment of reliable diagnostic methods of metastasis is essential. Development of new biomarkers is also necessary to select patients who are more likely to benefit from nCRT.

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Modified FOLFOX6 with or without radiation in neoadjuvant treatment of locally advanced rectal cancer: Final results of the Chinese FOWARC multicenter randomized trial.

Cited by 16 publications

References 0 publications

Addition of Platinum Derivatives to Fluoropyrimidine-Based Neoadjuvant Chemoradiotherapy for Stage II/III Rectal Cancer: Systematic Review and Meta-Analysis

Addition of Platinum Derivatives to Fluoropyrimidine-Based Neoadjuvant Chemoradiotherapy for Stage II/III Rectal Cancer: Systematic Review and Meta-Analysis

Systematic review of treatment intensification using novel agents for chemoradiotherapy in rectal cancer

Recent advances of neoadjuvant chemoradiotherapy in rectal cancer: Future treatment perspectives

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