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1. New drugs and combinations for the treatment of soft-tissue sarcoma: a review

Author

von Mehren M and Somaiah N

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Neeta Somaiah,1 Margaret von Mehren21Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USAAbstract: Sarcomas are a heterogeneous group of solid tumors arising from either soft tissues or bone, accounting for approximately 1% of all cancers in adults. Management of these diseases has changed little over the past 10 years, with the exception of treatment of gastrointestinal stromal tumors. Reasons for this stagnation include multiple histologies commonly grouped together in clinical trials limiting the understanding of benefit of treatment and limited investigation of molecular targeted therapies. More recently, advances in molecular pathogenesis, the advent of novel and targeted therapeutics, and increasing collaborations between sarcoma investigators has helped move the field forward in the right direction. Here, we review the recent data on novel agents tested for the management of adult soft-tissue sarcomas, excluding gastrointestinal stromal tumors.Keywords: soft tissue sarcoma, clinical trials, trabectedin, palifosfamide, pazopanib

Published
2012

3. Circulating tumor DNA analysis of the phase III VOYAGER trial: KIT mutational landscape and outcomes in patients with advanced gastrointestinal stromal tumor treated with avapritinib or regorafenib

Author

Serrano, C., Bauer, S., Gómez-Peregrina, D., Kang, Y.-K., Jones, R.L., Rutkowski, P., Mir, O., Heinrich, M.C., Tap, W.D., Newberry, K., Grassian, A., Shi, H., Bialick, S., Schöffski, P., Pantaleo, M.A., von Mehren, M., Trent, J.C., and George, S.

Published
2023
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4. Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals

Author

Kurzrock, R, Gurski, LA, Carlson, RW, Ettinger, DS, Horwitz, SM, Kumar, SK, Million, L, von Mehren, M, and Benson, AB

Subjects
Cancer, Prevention, Clinical Research, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, Antineoplastic Agents, Drug Approval, Evidence-Based Medicine, Humans, Neoplasms, Off-Label Use, Patient Care Management, Practice Guidelines as Topic, Prognosis, Randomized Controlled Trials as Topic, United States, United States Food and Drug Administration, oncology, guidelines, off-label drug use, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundA previous analysis of 113 National Comprehensive Cancer Network® (NCCN®) recommendations reported that NCCN frequently recommends beyond Food and Drug Administration (FDA)-approved indications (44 off-label recommendations) and claimed that the evidence for these recommendations was weak.MethodsIn order to determine the strength of the evidence, we carried out an in-depth re-analysis of the 44 off-label recommendations listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).ResultsOf the 44 off-label recommendations, 14 were later approved by the FDA and/or are supported by randomized controlled trial (RCT) data. In addition, 13 recommendations were either very minor extrapolations from the FDA label (n = 8) or were actually on-label (n = 5). Of the 17 remaining extrapolations, 8 were for mechanism-based agents applied in rare cancers or subsets with few available treatment options (median response rate = 43%), 7 were based on non-RCT data showing significant efficacy (>50% response rates), and 2 were later removed from the NCCN Guidelines because newer therapies with better activity and/or safety became available.ConclusionOff-label drug use is a frequent component of care for patients with cancer in the United States. Our findings indicate that when the NCCN recommends beyond the FDA-approved indications, the strength of the evidence supporting such recommendations is robust, with a significant subset of these drugs later becoming FDA approved or supported by RCT. Recommendations without RCT data are often for mechanism-based drugs with high response rates in rare cancers or subsets without effective therapies.

Published
2019

5. 62P Updated overall survival and safety with ripretinib vs sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib and harboring KIT exon 11 + 17/18 mutations: ctDNA analysis from INTRIGUE

Author

Blay, J-Y., primary, Jones, R.L., additional, Gelderblom, H., additional, George, S., additional, Schöffski, P., additional, von Mehren, M., additional, Zalcberg, J.R., additional, Kang, Y-K., additional, Razak, A.R. Abdul, additional, Trent, J.C., additional, Attia, S., additional, Le Cesne, A., additional, Davis, E., additional, Sprott, K., additional, Cox, P., additional, Sherman, M.L., additional, Ruiz-Soto, R., additional, Heinrich, M., additional, and Bauer, S., additional

Published
2024
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6. Diagnosis and management of tropomyosin receptor kinase (TRK) fusion sarcomas: expert recommendations from the World Sarcoma Network

Author

Demetri, G.D., Antonescu, C.R., Bjerkehagen, B., Bovée, J.V.M.G., Boye, K., Chacón, M., Dei Tos, A.P., Desai, J., Fletcher, J.A., Gelderblom, H., George, S., Gronchi, A., Haas, R.L., Hindi, N., Hohenberger, P., Joensuu, H., Jones, R.L., Judson, I., Kang, Y.-K., Kawai, A., Lazar, A.J., Le Cesne, A., Maestro, R., Maki, R.G., Martín, J., Patel, S., Penault-Llorca, F., Premanand Raut, C., Rutkowski, P., Safwat, A., Sbaraglia, M., Schaefer, I.-M., Shen, L., Serrano, C., Schöffski, P., Stacchiotti, S., Sundby Hall, K., Tap, W.D., Thomas, D.M., Trent, J., Valverde, C., van der Graaf, W.T.A., von Mehren, M., Wagner, A., Wardelmann, E., Naito, Y., Zalcberg, J., and Blay, J.-Y.

Published
2020
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7. Targeting ErbB2 and ErbB3 with a bispecific single-chain Fv enhances targeting selectivity and induces a therapeutic effect in vitro

Author

Robinson, MK, Hodge, KM, Horak, E, Sundberg, ÅL, Russeva, M, Shaller, CC, von Mehren, M, Shchaveleva, I, Simmons, HH, Marks, JD, and Adams, GP

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Animals, Antibodies, Bispecific, Antigens, Neoplasm, Cell Line, Tumor, Dimerization, Humans, Immunoglobulin Fc Fragments, Male, Mice, Mice, Inbred ICR, Neoplasms, Receptor, ErbB-2, Receptor, ErbB-3, engineered antibody, bispecific, ErbB, Receptor, erbB-2, Receptor, erbB-3, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Inappropriate signalling through the EGFR and ErbB2/HER2 members of the epidermal growth factor family of receptor tyrosine kinases is well recognised as being causally linked to a variety of cancers. Consequently, monoclonal antibodies specific for these receptors have become increasingly important components of effective treatment strategies for cancer. Increasing evidence suggests that ErbB3 plays a critical role in cancer progression and resistance to therapy. We hypothesised that co-targeting the preferred ErbB2/ErbB3 heterodimer with a bispecific single-chain Fv (bs-scFv) antibody would promote increased targeting selectivity over antibodies specific for a single tumour-associated antigen (TAA). In addition, we hypothesised that targeting this important heterodimer could induce a therapeutic effect. Here, we describe the construction and evaluation of the A5-linker-ML3.9 bs-scFv (ALM), an anti-ErbB3/ErbB2 bs-scFv. The A5-linker-ML3.9 bs-scFv exhibits selective targeting of tumour cells in vitro and in vivo that co-express the two target antigens over tumour cells that express only one target antigen or normal cells that express low levels of both antigens. The A5-linker-ML3.9 bs-scFv also exhibits significantly greater in vivo targeting of ErbB2'+'/ErbB3'+' tumours than derivative molecules that contain only one functional arm targeting ErbB2 or ErbB3. Binding of ALM to ErbB2'+'/ErbB3'+' cells mediates inhibition of tumour cell growth in vitro by effectively targeting the therapeutic anti-ErbB3 A5 scFv. This suggests both that ALM could provide the basis for an effective therapeutic agent and that engineered antibodies selected to co-target critical functional pairs of TAAs can enhance the targeting specificity and efficacy of antibody-based cancer therapeutics.

Published
2008

9. P61 Health State Utility Values and Quality of Life in Patients Receiving Ripretinib in the Phase 3 Invictus Trial and a Real-World Evidence Study in China

Author

Jones, RL, primary, Blay, JY, additional, Chi, P, additional, Bauer, S, additional, Gelderblom, H, additional, Shen, L, additional, He, YL, additional, Heinrich, MC, additional, Schöffski, P, additional, Zalcberg, JR, additional, Harrow, B, additional, Sherman, ML, additional, Ruiz-Soto, R, additional, Becker, C, additional, and von Mehren, M, additional

Published
2022
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11. INTRIGUE : eine randomisierte, offene Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Ripretinib im Vergleich zu Sunitinib bei Patienten mit fortgeschrittenem gastrointestinalem Stromatumor, die zuvor mit Imatinib behandelt wurden

Author

Bauer, Sebastian, Jones, R. L., Gelderblom, H., George, S., Schöffski, P., von Mehren, M., Zalcberg, J., Kang, Y.-K., Razak, A. A., Trent, J., Attia, S., Le Cesne, A., Su, Y., Meade, J., Wang, T., Sherman, M. L., Ruiz-Soto, R., Blay, J.-Y., and Heinrich, M. C.

Subjects
Medizin
Published
2022

13. 1540P Ripretinib as ≥4th-line treatment in patients with advanced gastrointestinal stromal tumor: Long-term update from the phase III INVICTUS study

Author

von Mehren, M., primary, Heinrich, M.C., additional, George, S., additional, Zalcberg, J.R., additional, Bauer, S., additional, Gelderblom, H., additional, Schöffski, P., additional, Serrano, C., additional, Jones, R.L., additional, Attia, S., additional, D'Amato, G., additional, Chi, P., additional, Reichardt, P., additional, Meade, J.N., additional, Reichert, V.L., additional, Shi, K., additional, Ruiz-Soto, R., additional, and Blay, J-Y., additional

Published
2021
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16. Clinical Benefit of Ripretinib Dose Escalation After Disease Progression in Advanced Gastrointestinal Stromal Tumor: An Analysis of the INVICTUS Study.

Author

Zalcberg, JR, Heinrich, MC, George, S, Bauer, S, Schöffski, P, Serrano, C, Gelderblom, H, Jones, RL, Attia, S, D'Amato, G, Chi, P, Reichardt, P, Somaiah, N, Meade, J, Reichert, V, Shi, K, Sherman, ML, Ruiz-Soto, R, von Mehren, M, Blay, J-Y, Zalcberg, JR, Heinrich, MC, George, S, Bauer, S, Schöffski, P, Serrano, C, Gelderblom, H, Jones, RL, Attia, S, D'Amato, G, Chi, P, Reichardt, P, Somaiah, N, Meade, J, Reichert, V, Shi, K, Sherman, ML, Ruiz-Soto, R, von Mehren, M, and Blay, J-Y

Abstract

BACKGROUND: Ripretinib 150 mg once daily (QD) is indicated for advanced gastrointestinal stromal tumors (GISTs) as at least fourth-line therapy. In INVICTUS, ripretinib intrapatient dose escalation (IPDE) to 150 mg b.i.d. was allowed after progressive disease (PD) on 150 mg QD by blinded independent central review using modified RECIST 1.1. We report the efficacy and safety of ripretinib IPDE to 150 mg b.i.d. after PD among patients randomized to ripretinib 150 mg QD in the INVICTUS study. MATERIALS AND METHODS: Tumor imaging was performed every 28-day cycle for the first four cycles in the ripretinib 150 mg QD period and then every other cycle, including the 150 mg b.i.d. PERIOD: Among the ripretinib IPDE patients, progression-free survival (PFS)1 was the time from randomization until PD; PFS2 was the time from the first dose of ripretinib 150 mg b.i.d. to PD or death. RESULTS: Among 43 ripretinib IPDE patients, median PFS1 was 4.6 months (95% confidence interval [CI], 2.7-6.4) and median PFS2 was 3.7 months (95% CI, 3.1-5.3). Median overall survival was 18.4 months (95% CI, 14.5-not estimable). Ripretinib 150 mg b.i.d. (median duration of treatment 3.7 months) was well tolerated with new or worsening grade 3-4 treatment-emergent adverse events (TEAEs) of anemia in six (14%) and abdominal pain in three (7%) patients. Ripretinib 150 mg b.i.d. was discontinued because of TEAEs in seven (16%) patients. CONCLUSION: Ripretinib 150 mg b.i.d. after PD on 150 mg QD may provide additional clinically meaningful benefit with an acceptable safety profile in patients with at least fourth-line GISTs. IMPLICATIONS FOR PRACTICE: Of the 85 patients with advanced gastrointestinal stromal tumor having received at least three prior anticancer therapies randomized to ripretinib 150 mg once daily (QD) in the phase III INVICTUS study, 43 underwent ripretinib intrapatient dose escalation (IPDE) to 150 mg b.i.d. after progressive disease (PD). Median progression-free survival was 4.6 month

Published
2021

17. Ultra-rare sarcomas: A consensus paper from the Connective Tissue Oncology Society community of experts on the incidence threshold and the list of entities

Author

Stacchiotti, S, Frezza, AM, Blay, J-Y, Baldini, EH, Bonvalot, S, Bovee, JVMG, Callegaro, D, Casali, PG, Chiang, RC-J, Demetri, GD, Demicco, EG, Desai, J, Eriksson, M, Gelderblom, H, George, S, Gounder, MM, Gronchi, A, Gupta, A, Haas, RL, Hayes-Jardon, A, Hohenberger, P, Jones, KB, Jones, RL, Kasper, B, Kawai, A, Kirsch, DG, Kleinerman, ES, Le Cesne, A, Lim, J, Chirlaque Lopez, MD, Maestro, R, Marcos-Gragera, R, Martin Broto, J, Matsuda, T, Mir, O, Patel, SR, Raut, CP, Razak, ARA, Reed, DR, Rutkowski, P, Sanfilippo, RG, Sbaraglia, M, Schaefer, I-M, Strauss, DC, Sundby Hall, K, Tap, WD, Thomas, DM, van der Graaf, WTA, van Houdt, WJ, Visser, O, von Mehren, M, Wagner, AJ, Wilky, BA, Won, Y-J, Fletcher, CDM, Dei Tos, AP, Trama, A, Stacchiotti, S, Frezza, AM, Blay, J-Y, Baldini, EH, Bonvalot, S, Bovee, JVMG, Callegaro, D, Casali, PG, Chiang, RC-J, Demetri, GD, Demicco, EG, Desai, J, Eriksson, M, Gelderblom, H, George, S, Gounder, MM, Gronchi, A, Gupta, A, Haas, RL, Hayes-Jardon, A, Hohenberger, P, Jones, KB, Jones, RL, Kasper, B, Kawai, A, Kirsch, DG, Kleinerman, ES, Le Cesne, A, Lim, J, Chirlaque Lopez, MD, Maestro, R, Marcos-Gragera, R, Martin Broto, J, Matsuda, T, Mir, O, Patel, SR, Raut, CP, Razak, ARA, Reed, DR, Rutkowski, P, Sanfilippo, RG, Sbaraglia, M, Schaefer, I-M, Strauss, DC, Sundby Hall, K, Tap, WD, Thomas, DM, van der Graaf, WTA, van Houdt, WJ, Visser, O, von Mehren, M, Wagner, AJ, Wilky, BA, Won, Y-J, Fletcher, CDM, Dei Tos, AP, and Trama, A

Abstract

BACKGROUND: Among sarcomas, which are rare cancers, many types are exceedingly rare; however, a definition of ultra-rare cancers has not been established. The problem of ultra-rare sarcomas is particularly relevant because they represent unique diseases, and their rarity poses major challenges for diagnosis, understanding disease biology, generating clinical evidence to support new drug development, and achieving formal authorization for novel therapies. METHODS: The Connective Tissue Oncology Society promoted a consensus effort in November 2019 to establish how to define ultra-rare sarcomas through expert consensus and epidemiologic data and to work out a comprehensive list of these diseases. The list of ultra-rare sarcomas was based on the 2020 World Health Organization classification, The incidence rates were estimated using the Information Network on Rare Cancers (RARECARENet) database and NETSARC (the French Sarcoma Network's clinical-pathologic registry). Incidence rates were further validated in collaboration with the Asian cancer registries of Japan, Korea, and Taiwan. RESULTS: It was agreed that the best criterion for a definition of ultra-rare sarcomas would be incidence. Ultra-rare sarcomas were defined as those with an incidence of approximately ≤1 per 1,000,000, to include those entities whose rarity renders them extremely difficult to conduct well powered, prospective clinical studies. On the basis of this threshold, a list of ultra-rare sarcomas was defined, which comprised 56 soft tissue sarcoma types and 21 bone sarcoma types. CONCLUSIONS: Altogether, the incidence of ultra-rare sarcomas accounts for roughly 20% of all soft tissue and bone sarcomas. This confirms that the challenges inherent in ultra-rare sarcomas affect large numbers of patients.

Published
2021

20. Mutational analysis of plasma DNA from patients (pts) in the phase III GRID study of regorafenib (REG) versus placebo (PL) in tyrosine kinase inhibitor (TKI)-refractory GIST: Correlating genotype with clinical outcomes: ID 011

Author

Reichardt, P., Demetri, G. D., Jeffers, M., Kang, Y.-K., Blay, J.-Y., Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M. G., von Mehren, M., Joensuu, H., Badalamenti, G., Blackstein, M. E., Le Cesne, A., Schoffski, P., Maki, R. G., Xu, J.-M., Nishida, T., Kuss, I., and Casali, P. G.

Published
2014

21. Results from a phase III trial (GRID) evaluating regorafenib (REG) in metastatic gastrointestinal stromal tumour (GIST): Subgroup analysis of outcomes based on pretreatment characteristics: ID 010

Author

Reichardt, P., Joensuu, H., Casali, P. G., Kang, Y.-K., Blay, J.-Y., Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M. G., von Mehren, M., Badalamenti, G., Blackstein, M. E., Le Cesne, A., Schoffski, P., Maki, R. G., Xu, J.-M., Nishida, T., Kappeler, C., Kuss, I., and Demetri, G. D.

Published
2014

23. Diagnosis and management of tropomyosin receptor kinase (TRK) fusion sarcomas: expert recommendations from the World Sarcoma Network

Author

Demetri, GD, Antonescu, CR, Bjerkehagen, B, Bovée, JVMG, Boye, K, Chacón, M, Dei Tos, AP, Desai, J, Fletcher, JA, Gelderblom, H, George, S, Gronchi, A, Haas, RL, Hindi, N, Hohenberger, P, Joensuu, H, Jones, RL, Judson, I, Kang, YK, Kawai, A, Lazar, AJ, Le Cesne, A, Maestro, R, Maki, RG, Martín, J, Patel, S, Penault-Llorca, F, Premanand Raut, C, Rutkowski, P, Safwat, A, Sbaraglia, M, Schaefer, IM, Shen, L, Serrano, C, Schöffski, P, Stacchiotti, S, Sundby Hall, K, Tap, WD, Thomas, DM, Trent, J, Valverde, C, van der Graaf, WTA, von Mehren, M, Wagner, A, Wardelmann, E, Naito, Y, Zalcberg, J, Blay, JY, Demetri, GD, Antonescu, CR, Bjerkehagen, B, Bovée, JVMG, Boye, K, Chacón, M, Dei Tos, AP, Desai, J, Fletcher, JA, Gelderblom, H, George, S, Gronchi, A, Haas, RL, Hindi, N, Hohenberger, P, Joensuu, H, Jones, RL, Judson, I, Kang, YK, Kawai, A, Lazar, AJ, Le Cesne, A, Maestro, R, Maki, RG, Martín, J, Patel, S, Penault-Llorca, F, Premanand Raut, C, Rutkowski, P, Safwat, A, Sbaraglia, M, Schaefer, IM, Shen, L, Serrano, C, Schöffski, P, Stacchiotti, S, Sundby Hall, K, Tap, WD, Thomas, DM, Trent, J, Valverde, C, van der Graaf, WTA, von Mehren, M, Wagner, A, Wardelmann, E, Naito, Y, Zalcberg, J, and Blay, JY

Abstract

Sarcomas are a heterogeneous group of malignancies with mesenchymal lineage differentiation. The discovery of neurotrophic tyrosine receptor kinase (NTRK) gene fusions as tissue-agnostic oncogenic drivers has led to new personalized therapies for a subset of patients with sarcoma in the form of tropomyosin receptor kinase (TRK) inhibitors. NTRK gene rearrangements and fusion transcripts can be detected with different molecular pathology techniques, while TRK protein expression can be demonstrated with immunohistochemistry. The rarity and diagnostic complexity of NTRK gene fusions raise a number of questions and challenges for clinicians. To address these challenges, the World Sarcoma Network convened two meetings of expert adult oncologists and pathologists and subsequently developed this article to provide practical guidance on the management of patients with sarcoma harboring NTRK gene fusions. We propose a diagnostic strategy that considers disease stage and histologic and molecular subtypes to facilitate routine testing for TRK expression and subsequent testing for NTRK gene fusions.

Published
2020

29. 115MO Long-term efficacy, tolerability and overall survival in patients (pts) with unresectable or metastatic (U/M) PDGFRA D842V-mutant gastrointestinal stromal tumour (GIST) treated with avapritinib: NAVIGATOR phase I trial update

Author

Kang, Y-K., primary, Jones, R.L., additional, von Mehren, M., additional, Serrano, C., additional, George, S., additional, Heinrich, M.C., additional, Schöffski, P., additional, Mir, O., additional, Cassier, P.A., additional, Eskens, F., additional, Rutkowski, P., additional, Tap, W.D., additional, Chawla, S.P., additional, Shi, H., additional, Roche, M., additional, and Bauer, S., additional

Published
2020
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30. 1621MO Long-term efficacy, tolerability and overall survival in patients (pts) with unresectable or metastatic (U/M) PDGFRA D842V-mutant gastrointestinal stromal tumour (GIST) treated with avapritinib: NAVIGATOR phase I trial update

Author

Jones, R.L., primary, Serrano, C., additional, von Mehren, M., additional, George, S., additional, Heinrich, M., additional, Kang, Y-K., additional, Schoeffski, P., additional, Cassier, P., additional, Mir, O., additional, Chawla, S.P., additional, Eskens, F.A., additional, Rutkowski, P., additional, Tap, W.D., additional, Zhou, T., additional, Roche, M., additional, and Bauer, S., additional

Published
2020
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31. 1623MO Ripretinib intra-patient dose escalation (IPDE) following disease progression provides clinically meaningful progression-free survival (PFS) in gastrointestinal stromal tumor (GIST) in phase I study

Author

Janku, F., primary, Chi, P., additional, Heinrich, M., additional, von Mehren, M., additional, Jones, R.L., additional, Ganjoo, K., additional, Trent, J., additional, Gelderblom, H., additional, Razak, A. Abdul, additional, Gordon, M., additional, Somaiah, N., additional, Jennings, J., additional, Shi, K., additional, Ruiz-Soto, R., additional, and George, S., additional

Published
2020
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32. 1630P Clinical efficacy comparison of avapritinib versus other tyrosine kinase inhibitors (TKIs) in gastrointestinal stromal tumours (GIST) with PDGFRA D842V mutation: A retrospective analysis of clinical trial and real-world data

Author

von Mehren, M., primary, Heinrich, M., additional, Shi, H., additional, Iannazzo, S., additional, Mankoski, R., additional, Dimitrijević, S., additional, Hoehn, G., additional, Chiroli, S., additional, and George, S., additional

Published
2020
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33. 1622MO Clinical benefit with ripretinib as ≥4th line treatment in patients with advanced gastrointestinal stromal tumors (GIST): Update from the phase III INVICTUS study

Author

Zalcberg, J.R., primary, Heinrich, M., additional, George, S., additional, Bauer, S., additional, Gelderblom, H., additional, Schöffski, P., additional, Serrano, C., additional, Jones, R.L., additional, Attia, S., additional, D'Amato, G., additional, Chi, P., additional, Reichardt, P., additional, Meade, J.N., additional, Reichert, V., additional, Shi, K., additional, Ruiz-Soto, R., additional, von Mehren, M., additional, and Blay, J-Y., additional

Published
2020
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35. INVICTUS: A phase III, interventional, double-blind, placebo-controlled study to assess the safety and efficacy of ripretinib as ≥ 4th-line therapy in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior anticancer therapies (NCT03353753)

Author

von Mehren, M., primary, Serrano, C., additional, Bauer, S., additional, Gelderblom, H., additional, George, S., additional, Heinrich, M., additional, Schöffski, P., additional, Zalcberg, J., additional, Chi, P., additional, Jones, R.L., additional, Reichardt, P., additional, Attia, S., additional, D’Amato, G., additional, Meade, J., additional, Shi, K., additional, Ruiz-Soto, R., additional, and Blay, J.-Y., additional

Published
2019
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36. Correlation of ctDNA and response in patients (pts) with PDGFRα D842 GIST treated with avapritinib

Author

George, S., primary, Bauer, S., additional, Jones, R.L., additional, Serrano, C., additional, von Mehren, M., additional, Kang, Y.-K., additional, Schöffski, P., additional, Cassier, P., additional, Eskens, F.A., additional, Mir, O., additional, Tap, W.D., additional, Chawla, S.P., additional, Rutkowski, P., additional, Shi, H., additional, Schmidt-Kittler, O., additional, Mar, B., additional, and Heinrich, M., additional

Published
2018
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37. Initial results of phase I study of DCC-2618, a broad-spectrum KIT and PDGFRa inhibitor, in patients (pts) with gastrointestinal stromal tumor (GIST) by number of prior regimens

Author

George, S., primary, Heinrich, M., additional, Chi, P., additional, Razak, A., additional, von Mehren, M., additional, Gordon, M., additional, Ganjoo, K.N., additional, Somaiah, N., additional, Trent, J.C., additional, Rodon Ahnert, J., additional, Wolf, J., additional, Ruiz-Soto, R., additional, Rosen, O., additional, and Janku, F., additional

Published
2018
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38. Efficacy and tolerability of trabectedin in elderly patients with sarcoma: subgroup analysis from a phase III, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma

Author

Jones, R.L., primary, Demetri, G.D., additional, Schuetze, S.M., additional, Milhem, M., additional, Elias, A., additional, Van Tine, B.A., additional, Hamm, J., additional, McCarthy, S., additional, Wang, G., additional, Parekh, T., additional, Knoblauch, R., additional, Hensley, M.L., additional, Maki, R.G., additional, Patel, S., additional, and von Mehren, M., additional

Published
2018
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39. A phase 2 study of CMB305 and atezolizumab in NY-ESO-1+ soft tissue sarcoma: Interim analysis of immunogenicity, tumor control and survival

Author

Chawla, S., primary, Van Tine, B.A., additional, Pollack, S., additional, Ganjoo, K., additional, Elias, A., additional, Riedel, R.F., additional, Attia, S., additional, Choy, E., additional, Okuno, S., additional, Agulnik, M., additional, von Mehren, M., additional, Livingston, M., additional, Keedy, V., additional, Verschraegen, C., additional, Philip, T., additional, Bohac, C., additional, Lu, H., additional, Chen, M., additional, and Maki, R., additional

Published
2017
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40. Preliminary safety and activity in a first-in-human phase 1 study of BLU-285, a potent, highly-selective inhibitor of KIT and PDGFRα activation loop mutants in advanced gastrointestinal stromal tumor (GIST)

Author

Heinrich, M., primary, Jones, R., additional, Schoffski, P., additional, Bauer, S., additional, von Mehren, M., additional, Eskens, F., additional, Cassier, P., additional, Mir, O., additional, Shi, H., additional, Alvarez-Diez, T., additional, Healy, M.E., additional, Wolf, B., additional, and George, S., additional

Published
2016
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41. LBA87 - INVICTUS: A phase III, interventional, double-blind, placebo-controlled study to assess the safety and efficacy of ripretinib as ≥ 4th-line therapy in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior anticancer therapies (NCT03353753)

Author

von Mehren, M., Serrano, C., Bauer, S., Gelderblom, H., George, S., Heinrich, M., Schöffski, P., Zalcberg, J., Chi, P., Jones, R.L., Reichardt, P., Attia, S., D’Amato, G., Meade, J., Shi, K., Ruiz-Soto, R., and Blay, J.-Y.

Published
2019
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42. Consensus meeting for the management of gastrointestinal stromal tumors. Report of the GIST Consensus Conference of 20-21 March 2004, under the auspices of ESMO

Author

Blay, J.-Y., Bonvalot S, Casali P, Choi H, Debiec-Richter M, Dei Tos AP, Emile J-F, Gronchi A, Hogendoorn PCW, Joensuu H, Le Cesne A, Mac Clure J, Maurel J, Nupponen N, Ray-Coquard I, Reichardt P, Sciot R, Stroobants S, van Glabbeke M, van Oosterom A, Demetri GD, Boukovinas I, Meeus P, Janinis J, Bertulli R, Colecchia M, Messina A, Tamborini E, Hirota S, Nishida T, Martin J, Poveda A, Ramos R, Guillou L, Leyvraz S, Leahy M, Corless C, DeMatteo R, Zalcberg J, Knufer D, Schultz A, Judson I, Fervers B, Bui B, Van Coevorden F, Benjamin R, Maki R, Verweij J, Nielsen O, Heinrich M, Van Geel B, Baker L, von Mehren M, Alvegard T, Coindre JM, Antman K, Hohenberger P, Sundby-Hall K, Rutkowski P, Blay, J., -Y., Bonvalot, S, Casali, P, Choi, H, Debiec-Richter, M, Dei Tos, Ap, Emile, J-F, Gronchi, A, Hogendoorn, Pcw, Joensuu, H, Le Cesne, A, Mac Clure, J, Maurel, J, Nupponen, N, Ray-Coquard, I, Reichardt, P, Sciot, R, Stroobants, S, van Glabbeke, M, van Oosterom, A, Demetri, Gd, Boukovinas, I, Meeus, P, Janinis, J, Bertulli, R, Colecchia, M, Messina, A, Tamborini, E, Hirota, S, Nishida, T, Martin, J, Poveda, A, Ramos, R, Guillou, L, Leyvraz, S, Leahy, M, Corless, C, Dematteo, R, Zalcberg, J, Knufer, D, Schultz, A, Judson, I, Fervers, B, Bui, B, Van Coevorden, F, Benjamin, R, Maki, R, Verweij, J, Nielsen, O, Heinrich, M, Van Geel, B, Baker, L, von Mehren, M, Alvegard, T, Coindre, Jm, Antman, K, Hohenberger, P, Sundby-Hall, K, and Rutkowski, P

Published
2005

45. Phase II SWOG-directed Intergroup Trial (S0505) of Sorafenib in Advanced Soft Tissue Sarcomas

Author

von Mehren, M., Rankin, C., Goldblum, J.R., Demetri, G.D., Bramwell, V., Ryan, C.W., and Borden, E.

Subjects
Adult, Aged, 80 and over, Leiomyosarcoma, Male, Niacinamide, Pyridines, Phenylurea Compounds, Benzenesulfonates, Antineoplastic Agents, Sarcoma, Liposarcoma, Middle Aged, Sorafenib, Prognosis, Article, Vascular Neoplasms, Survival Rate, Humans, Female, Aged
Abstract

Patients with advanced soft tissue sarcomas (STS) have limited therapeutic options. Sorafenib (BAY 43-9006) is a multitargeted tyrosine kinase inhibitor of raf, vascular endothelial growth factor receptors 1 (VEGFR1) through 3, platelet-derived growth factor B, fms-like tyrosine kinase 3, and c-kit, and some of these may be relevant in STS.The authors tested sorafenib at a dose of 400 mg twice daily in patients with advanced vascular sarcoma (VS), high-grade liposarcomas, and leiomyosarcomas who had received 0 or 1 previous regimens for advanced disease.Fifty-one patients were accrued to the study, and 37 were evaluable for toxicity and response. There were no unexpected side effects and no confirmed responses. The median progression-free survival was 3 months, and the median overall survival was 17 months. Six of 8 patients in the VS cohort had prolonged clinical benefit (stable disease or better), resulting in a median progression-free survival of 5 months compared with 2 to 3 months for the patients who had liposarcoma and leiomyosarcomas.Sorafenib at the dose and schedule studied did not result in any responses in the VS, liposarcoma, or leiomyosarcoma cohort according to Response Evaluation Criteria in Solid Tumors.

Published
2011

47. Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU): GRID trial

Author

Casali, P.G., primary, Reichardt, P., additional, Kang, Y., additional, Blay, J., additional, Joensuu, H., additional, Maki, R.G., additional, Rutkowski, P., additional, Hohenberger, P., additional, Gelderblom, H., additional, Leahy, M.G., additional, von Mehren, M., additional, Schoffski, P., additional, Blackstein, M.E., additional, Le Cesne, A., additional, Badalamenti, G., additional, Xu, J., additional, Nishida, T., additional, Laurent, D., additional, Kuss, I., additional, and Demetri, G.D., additional

Published
2015
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48. 1321 Efficacy and safety of trabectedin (T) or dacarbazine (D) in an elderly patient subgroup (65 years) with advanced leiomyosarcoma (LMS) or liposarcoma (LPS) after prior chemotherapy

Author

Von Mehren, M., primary, Demetri, G.D., additional, Schuetze, S.M., additional, Jones, R.L., additional, Milhem, M., additional, Elias, A., additional, Van Tine, B.A., additional, Hamm, J., additional, Khokhar, N.Z., additional, McCarthy, S., additional, Park, Y.C., additional, Knoblauch, R.E., additional, Parekh, T.V., additional, Maki, R.G., additional, and Patel, S.R., additional

Published
2015
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