Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With<i>BRAF</i>Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Klute, Kelsey; Rothe, Michael; Garrett‐Mayer, Elizabeth; Mangat, Pam K.; Nazemzadeh, Reza; Yost, Kathleen J.; Duvivier, Herbert Leon; Ahn, Eugene; Cannon, Timothy Lewis; Alese, Olatunji B.; Krauss, John C.; Thota, Ramya; Calfa, Carmen; Denlinger, Crystal S.; O'Lone, Raegan; Halabi, Susan; Grantham, Gina N.; Schilsky, Richard L.

doi:10.1200/po.22.00191

Cited by 17 publications

(19 citation statements)

References 27 publications

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“…A thorough literature search on PubMed and Embase found 4635 articles. After careful screening based on predefined inclusion and exclusion criteria, two randomized clinical trials (RCT, n = 765) [ 11 , 12 ], and nine non-randomized trials (nRCTs, n = 423) [ 3 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 ] were included, as in Figure 2 .…”

Section: Resultsmentioning

confidence: 99%

“…However, the risk of bias was high due to the open-label nature of these RCTs. The risk of bias was high in nRCTs [ 3 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 ], due to the lack of randomization and blinding, as shown in Figure 3 .…”

Section: Resultsmentioning

confidence: 99%

“…In nRCTs on two-drug regimens ( n = 72) [ 18 ], CR, PR, and OR were 1/72 (1%), 11/72 (15%), and 12/72 (17%), respectively, on treatment with two-drug BRAF-based regimens. In nRCTs on three-drug regimens ( n = 152), CR, PR, and OR were 3/152 (2%), 49/152 (32%), and 52/152 (34%), respectively, on treatment with three-drug regimens, as shown in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

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BRAF Inhibitors in BRAF-Mutated Colorectal Cancer: A Systematic Review

Aiman,

Ali,

Jumean

et al. 2023

JCM

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Colorectal cancer (CRC) is the second-leading cause of cancer-related deaths globally. BRAF mutation is present in about 10% of CRC patients and is associated with a poor response to chemotherapy. These patients have a relatively poor prognosis. This review aims to assess the efficacy and safety of BRAF inhibitors in BRAF-mutated CRC patients. A literature search was performed on PubMed and Embase, and clinical trials relevant to BRAF inhibitors in CRC were included. Data were extracted for efficacy and safety variables. Two randomized clinical trials (n = 765) and eight non-randomized trials (n = 281) were included based on inclusion criteria. In RCTs, an overall response was reported in 23% of the patients treated with BRAF inhibitor-based regimens compared to 2.5% with control regimens. The hazard ratio of overall survival was also significantly better with triplet encorafenib therapy at 0.52 (95% CI = 0.39–0.70). In single-arm trials, ORR was 17% and 34% in two-drug and three-drug regimens, respectively. BRAF inhibitor-based regimens were safe and effective in the treatment of BRAF-mutated CRC. Large-scale randomized trials are needed to find a suitable population for each regimen. PROSPERO registration No. CRD42023471627.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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BRAF Inhibitors in BRAF-Mutated Colorectal Cancer: A Systematic Review

Aiman,

Ali,

Jumean

et al. 2023

JCM

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“…Below, we will briefly review some of the processes that may be of greater clinical interest in adults. Table 4 describes a number of drugs that can cause hypophosphatemia and whose chronic use could lead to OM if phosphate levels are not monitored [ 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 ].…”

Section: Etiology Of Osteomalaciamentioning

confidence: 99%

Osteomalacia in Adults: A Practical Insight for Clinicians

Arboleya

Braña

Pardo

et al. 2023

JCM

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The term osteomalacia (OM) refers to a series of processes characterized by altered mineralization of the skeleton, which can be caused by various disorders of mineral metabolism. OM can be genetically determined or occur due to acquired disorders, among which the nutritional origin is particularly relevant, due to its wide epidemiological extension and its nature as a preventable disease. Among the hereditary diseases associated with OM, the most relevant is X-linked hypophosphatemia (XLH), which manifests in childhood, although its consequences persist into adulthood where it can acquire specific clinical characteristics, and, although rare, there are XLH cases that reach the third or fourth decade of life without a diagnosis. Some forms of OM present very subtle initial manifestations which cause both considerable diagnosis and treatment delay. On occasions, the presence of osteopenia and fragility fractures leads to an erroneous diagnosis of osteoporosis, which may imply the prescription of antiresorptive drugs (i.e., bisphosphonates or denosumab) with catastrophic consequences for OM bone. On the other hand, some radiological features of OM can be confused with those of axial spondyloarthritis and lead to erroneous diagnoses. The current prevalence of OM is not known and is very likely that its incidence is much higher than previously thought. Moreover, OM explains part of the therapeutic failures that occur in patients diagnosed with other bone diseases. Therefore, it is essential that clinicians who treat adult skeletal diseases take into account the considerations provided in this practical review when focusing on the diagnosis and treatment of their patients with bone diseases.

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“…TAPUR includes a wide variety of tumor types including advanced or metastatic solid tumors, multiple myeloma, and B-cell non-Hodgkin lymphomas ( Mangat et al, 2018 ). Results from several different arms and baskets of the TAPUR study have recently been published ( Ahn et al, 2020 ; Al Baghdadi et al, 2020 ; Al Baghdadi et al, 2019 ; Alva et al, 2021 ; Fisher et al, 2020 ; Gupta et al, 2022 ; Klute et al, 2022 ).…”

Section: Platform Trialsmentioning

confidence: 99%

Biomarker-Driven Oncology Clinical Trials: Novel Designs in the Era of Precision Medicine

C. Moore, PharmD, BCPS, BCOP, DPLA, FCCP,

S. Guinigundo, MSN, RN, CNP, ANP-BC

2023

JADPRO

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Oncology drug development historically has followed a path of sequential phase I, II, and III clinical trials using traditional trial designs, with the goal of achieving regulatory approval. These studies are often conducted with inclusion criteria that limit enrollment to a single tumor type or tumor site of origin, excluding other patients who might also respond. Increased use of precision medicine targeting biomarkers or specific oncogenic mutations has led to novel clinical trial designs that can evaluate these therapies in a less limited fashion. Master protocols such as basket trials, umbrella trials, and platform trials can, for example, evaluate histology-specific therapies targeting a common oncogenic mutation across multiple tumor types or screen for the presence of multiple different biomarkers rather than a single one. In other cases, they can lead to more rapid evaluation of a drug and evaluate targeted therapies in tumor types for which they are not yet currently indicated. As the use of complex biomarker-based master protocols increases, advanced practitioners must understand these novel trial designs, their advantages and disadvantages, and how their use may advance drug development and maximize the clinical benefits of molecular precision therapy.

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Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer WithBRAFMutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Cited by 17 publications

References 27 publications

BRAF Inhibitors in BRAF-Mutated Colorectal Cancer: A Systematic Review

BRAF Inhibitors in BRAF-Mutated Colorectal Cancer: A Systematic Review

Osteomalacia in Adults: A Practical Insight for Clinicians

Biomarker-Driven Oncology Clinical Trials: Novel Designs in the Era of Precision Medicine

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