Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With <i>RAS</i> Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial

Qin, Shukui; Li, Jin; Wang, Liwei; Xu, Jianming; Cheng, Ying; Bai, Yuxian; Li, Wei; Xu, Nong; Lin, Lizhu; Wu, Qiong; Li, Yunfeng; Yang, Jun; Pan, Hongming; Ouyang, Xin; Qiu, Wensheng; Wu, Kaichun; Xiong, Jianping; Dai, Guanghai; Liang, Houjie; Hu, Chunhong; Zhang, Jun; Tao, Min; Yao, Qiang; Wang, Junyuan; Chen, Jiongjie; Eggleton, S. Peter; Liu, Tianshu

doi:10.1200/jco.2018.78.3183

Cited by 189 publications

(138 citation statements)

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“…The benefit from cetuximab was limited to left-sided tumors, which were also associated with a trial randomized mCRC patients to receive FOLFOX with or with panitumumab. 52 The benefit from panitumumab was limited to RAS 50 The study recapitulated the prior findings from CRYSTAL and PRIME, confirming a significant improvement in RR, PFS, and OS in left-sided RAS wild-type patients ( Table 5). (Table 5).…”

Section: First Line Anti-egfr Therapysupporting

confidence: 74%

“…The benefit from cetuximab was limited to left‐sided tumors, which were also associated with a favorable outcome in comparison to right‐sided tumors. The combination of FOLFOX with or without anti‐EGFR therapy was evaluated in two randomized phase III clinical trials . The PRIME trial randomized mCRC patients to receive FOLFOX with or with panitumumab .…”

Section: Biological and Targeted Therapy In Mcrcmentioning

confidence: 99%

“…Within the RAS wild‐type population, only patients with left‐sided tumors experienced an improvement in RR, PFS, and OS. Finally, the Chinese TAILOR trial randomized untreated RAS wild‐type mCRC patients to receive FOLFOX or FOLFOX plus cetuximab . The study recapitulated the prior findings from CRYSTAL and PRIME, confirming a significant improvement in RR, PFS, and OS in left‐sided RAS wild‐type patients (Table ).…”

Section: Biological and Targeted Therapy In Mcrcmentioning

confidence: 99%

“…Three randomized phase III clinical trials have reported a positive survival advantage to the addition of anti-EGFR therapy to chemotherapy in untreated patients with RAS wild-type mCRC ( Table 5). [50][51][52] The CRYSTAL trial randomized patients to FOLFIRI chemotherapy or FOLFIRI plus cetuximab. 51 The addition of cetuximab resulted in a significant improvement in RR, PFS, and OS in the RAS wild-type population only.…”

Section: First Line Anti-egfr Therapymentioning

confidence: 99%

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Systemic treatment for metastatic colorectal cancer in the era of precision medicine

Sandhu

Lavingia

Fakih

2019

Journal of Surgical Oncology

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Section: First Line Anti-egfr Therapysupporting

confidence: 74%

Section: Biological and Targeted Therapy In Mcrcmentioning

confidence: 99%

Section: Biological and Targeted Therapy In Mcrcmentioning

confidence: 99%

Section: First Line Anti-egfr Therapymentioning

confidence: 99%

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Systemic treatment for metastatic colorectal cancer in the era of precision medicine

Sandhu

Lavingia

Fakih

2019

Journal of Surgical Oncology

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“…The process of the literature selection and reasons for study exclusion are shown in Figure . We identified 3906 potentially relevant records through electronic search and 18 RCTs were ultimately included in this review after removal of duplicate publications and ineligible studies.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Sun

et al. 2019

J Evidence Based Medicine

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Objectives To investigate the efficacy and safety of adding anti‐epidermal growth factor receptor [EGFR] MoAbs to various chemotherapy regimens in patients with RAS wild‐type metastasized colorectal cancer (RAS WT metastatic colorectal cancer [mCRC]) and to identify the optimal combination regimens. Methods We searched MEDLINE, EMBASE, and CENTRAL from the inception date to 20th May 2019. Randomized clinical trials investigating chemotherapy with or without anti‐EGFR MoAbs in treatment of patients with RAS WT mCRC were included. Results Eighteen studies involving 8848 participants were eligible. Comparing with oxaliplatin‐based chemotherapy, adding anti‐EGFR MoAbs benefited only in progression‐free survival (PFS) (hazard ratio [HR] = 0.80, 95% confidence interval [CI]: 0.67 to 0.94), but not in overall survival (OS) (HR = 0.89, 95% CI: 0.78 to 1.02). Further sensitivity analysis indicated that adding anti‐EGFR MoAbs to FOLFOLX regimen as a first‐line treatment showed benefits in both PFS and OS (PFS: HR = 0.74, 95% CI: 0.64 to 0.84; OS: HR = 0.83, 95% CI: 0.73 to 0.95, respectively). Comparing with irinotecan‐based chemotherapy or best supportive care, adding anti‐EGFR MoAbs revealed an improvement in both PFS (HR = 0.77, 95% CI: 0.69 to 0.86; HR = 0.46, 95% CI: 0.40 to 0.54, respectively) and OS (HR = 0.89, 95% CI: 0.80 to 0.98; HR = 0.65, 95% CI: 0.54 to 0.78, respectively). Conclusion Anti‐EGFR MoAbs as a monotherapy or in combination with either irinotecan‐based chemotherapy or FOLFOX in patients with RAS wild‐type mCRC have better response and survival outcome, whereas OS does not benefit from adding anti‐EGFR MoAbs to another oxaliplatin‐based regimen. Anti‐EGFR MoAbs have increased the risk of adverse effects than chemotherapy alone. More high‐quality randomized controlled trials for RAS wild type are necessary.

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Diagnosis and Treatment of Metastatic Colorectal Cancer

Biller

Schrag

2021

JAMA

1,458

851

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ImportanceColorectal cancer (CRC) is the third most common cause of cancer mortality worldwide with more than 1.85 million cases and 850 000 deaths annually. Of new colorectal cancer diagnoses, 20% of patients have metastatic disease at presentation and another 25% who present with localized disease will later develop metastases.ObservationsColorectal cancer is the third most common cause of cancer mortality for men and women in the United States, with 53 200 deaths projected in 2020. Among people diagnosed with metastatic colorectal cancer, approximately 70% to 75% of patients survive beyond 1 year, 30% to 35% beyond 3 years, and fewer than 20% beyond 5 years from diagnosis. The primary treatment for unresectable metastatic CRC is systemic therapy (cytotoxic chemotherapy, biologic therapy such as antibodies to cellular growth factors, immunotherapy, and their combinations.) Clinical trials completed in the past 5 years have demonstrated that tailoring treatment to the molecular and pathologic features of the tumor improves overall survival. Genomic profiling to detect somatic variants is important because it identifies the treatments that may be effective. For the 50% of patients with metastatic CRC with KRAS/NRAS/BRAF wild-type tumors, cetuximab and panitumumab (monoclonal antibodies to the epithelial growth factor receptor [EGFR]), in combination with chemotherapy, can extend median survival by 2 to 4 months compared with chemotherapy alone. However, for the 35% to 40% of patients with KRAS or NRAS sequence variations (formerly termed mutations), effective targeted therapies are not yet available. For the 5% to 10% with BRAF V600E sequence variations, targeted combination therapy with BRAF and EGFR inhibitors extended overall survival to 9.3 months, compared to 5.9 months for those receiving standard chemotherapy. For the 5% with microsatellite instability (the presence of numerous insertions or deletions at repetitive DNA units) or mismatch repair deficiency, immunotherapy may be used in the first or subsequent line and has improved treatment outcomes with a median overall survival of 31.4 months in previously treated patients.Conclusions and RelevanceAdvances in molecular profiling of metastatic CRC facilitate the ability to direct treatments to the biologic features of the tumor for specific patient subsets. Although cures remain uncommon, more patients can anticipate extended survival. Genomic profiling allows treatment selection so that more patients derive benefit and fewer are exposed to toxicity from ineffective therapies.

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Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial

Cited by 189 publications

References 34 publications

Systemic treatment for metastatic colorectal cancer in the era of precision medicine

Systemic treatment for metastatic colorectal cancer in the era of precision medicine

Efficacy and safety of anti‐EGFR monoclonal antibodies combined with different chemotherapy regimens in patients with RAS wild‐type metastatic colorectal cancer: A meta‐analysis

Diagnosis and Treatment of Metastatic Colorectal Cancer

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