Treatment of patients with refractory metastatic cancer according to molecular profiling on tumor tissue in the clinical routine: an interim-analysis of the ONCO-T-PROFILE project

Seeber, Andreas; Gastl, Guenther; Ensinger, Christian; Spizzo, Gilbert; Willenbacher, Wolfgang; Kocher, Florian; Leitner, Christoph; Willenbacher, Ella; Amann, Arno; Steiner, Normann; Eisterer, Wolfgang; Voß, Andreas; Russell, Kenneth J.; Zwierzina, Heinz

doi:10.18632/genesandcancer.121

Cited by 17 publications

(21 citation statements)

References 17 publications

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“…To further validate the clinical significance of patients experiencing SD, we compared the PFS of the previous line of therapy (PFS1) to the PFS of the treatment recommended by the MTB (PFS2). A PFS2 to PFS1 ratio of 1.3 or higher is established as marker indicating benefit of a molecular-guided treatment in advanced cancer patients [ 17 , 54 , 55 , 56 , 57 , 58 ]. According to the modified progression-free survival ratio (mPFSr) [ 59 ], we excluded three patients from this analysis.…”

Section: Resultsmentioning

confidence: 99%

Transitioning the Molecular Tumor Board from Proof of Concept to Clinical Routine: A German Single-Center Analysis

Hoefflin

Lazarou

Hess

et al. 2021

Cancers

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Molecular precision oncology faces two major challenges: first, to identify relevant and actionable molecular variants in a rapidly changing field and second, to provide access to a broad patient population. Here, we report a four-year experience of the Molecular Tumor Board (MTB) of the Comprehensive Cancer Center Freiburg (Germany) including workflows and process optimizations. This retrospective single-center study includes data on 488 patients enrolled in the MTB from February 2015 through December 2018. Recommendations include individual molecular diagnostics, molecular stratified therapies, assessment of treatment adherence and patient outcomes including overall survival. The majority of MTB patients presented with stage IV oncologic malignancies (90.6%) and underwent an average of 2.1 previous lines of therapy. Individual diagnostic recommendations were given to 487 patients (99.8%). A treatment recommendation was given in 264 of all cases (54.1%) which included a molecularly matched treatment in 212 patients (43.4%). The 264 treatment recommendations were implemented in 76 patients (28.8%). Stable disease was observed in 19 patients (25.0%), 17 had partial response (22.4%) and five showed a complete remission (6.6%). An objective response was achieved in 28.9% of cases with implemented recommendations and for 4.5% of the total population (22 of 488 patients). By optimizing the MTB workflow, case-discussions per session increased significantly while treatment adherence and outcome remained stable over time. Our data demonstrate the feasibility and effectiveness of molecular-guided personalized therapy for cancer patients in a clinical routine setting showing a low but robust and durable disease control rate over time.

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Section: Resultsmentioning

confidence: 99%

Transitioning the Molecular Tumor Board from Proof of Concept to Clinical Routine: A German Single-Center Analysis

Hoefflin

Lazarou

Hess

et al. 2021

Cancers

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“…At the time of analysis, 50 patients have been profiled and in 98% one or more druggable targets were detected. Of 19 patients treated according to MP a PFS-ratio ≥ 1.3 was achieved in 42% ( n = 8) [ 22 ].…”

Section: Multiplatform Profilingmentioning

confidence: 99%

Treatment According to Molecular Profiling in Relapsed/Refractory Cancer Patients: A Review Focusing on Latest Profiling Studies

Zimmer

Kocher

Spizzo

et al. 2019

Computational and Structural Biotechnology Journal

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In this review we aim to summarize studies investigating the impact of a molecular profiling (MP)-guided treatment approach in heavily pretreated cancer patients. In summary, many independent single- and multicenter studies showed a significant benefit of MP-guided treatment regarding response rates and survival. However, in the only randomized trial conducted so far, no benefit of MP-guided targeted therapy was observed. Notably, various profiling approaches were conducted in the respective studies: some studies used a single analytic approach (i.e. next-generation sequencing), others applied multiple analytic methods to perform comprehensive molecular profiling. It seems that multiplatform profiling analyses, detected an increased number of druggable molecular targets or signaling pathway alterations and that a higher proportion of patients was treated according to the molecular cancer profile. Even though no randomized study has shown a benefit of molecular profiling so far, many studies indicate that MP-guided treatment can be beneficial in patients with relapsed and/or refractory cancer. Currently ongoing large randomized trials (i.e. NCI-MATCH, TAPUR) will add evidence to the role of profiling-guided cancer treatment.

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“…The treatments administered following profiling were collected from 11 studies using Caris Molecular Intelligence [6–11]. In five of these studies, the treatment that was planned in the absence of profiling (i.e.…”

Section: Methodsmentioning

confidence: 99%

Cost-comparison analysis of a multiplatform tumour profiling service to guide advanced cancer treatment

Spizzo

Siebert²,

Gastl

et al. 2019

Cost Eff Resour Alloc

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Background Tumor profiling is increasingly used in advanced cancer patients to define treatment options, especially in refractory cases where no standard treatment is available. Caris Molecular Intelligence (CMI) is a multiplatform tumor profiling service that is comprehensive of next-generation sequencing (NGS) of DNA and RNA, immunohistochemistry (IHC) and in situ hybridisation (FISH). The aim of this study is to compare costs of CMI-guided treatment with prior or planned treatment options in correlation with outcome results. Methods Retrospective data from five clinical trials were collected to define the treatment decision prior to the receipt of the CMI report (n = 137 patients). A systematic review of treatment data from 11 clinical studies of CMI (n = 385 patients) allowed a comparison of planned vs actual (n = 137) and prior vs actual (n = 229) treatment costs. Results Treatment plan was changed in 88% of CMI-profiled cases. The actual CMI guided treatment cost per cycle was £995 in 385 treated patients. Planned treatment costs were comparable to actual treatment costs (£979 vs £945; p = 0.7123) and prior treatment costs were not significantly different to profiling-guided treatments (£892 vs £850; p = 0.631). Conclusions Caris Molecular Intelligence guided treatment cost per cycle was in the range of prior or planned treatment cost/cycle. Due to beneficial overall survival the additional cost of performing CMI’s multiplatform testing to the treatment costs seems to be cost-effective.

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Treatment of patients with refractory metastatic cancer according to molecular profiling on tumor tissue in the clinical routine: an interim-analysis of the ONCO-T-PROFILE project

Cited by 17 publications

References 17 publications

Transitioning the Molecular Tumor Board from Proof of Concept to Clinical Routine: A German Single-Center Analysis

Transitioning the Molecular Tumor Board from Proof of Concept to Clinical Routine: A German Single-Center Analysis

Treatment According to Molecular Profiling in Relapsed/Refractory Cancer Patients: A Review Focusing on Latest Profiling Studies

Cost-comparison analysis of a multiplatform tumour profiling service to guide advanced cancer treatment

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