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1. Machine learning for rhabdomyosarcoma histopathology

Author: Frankel, Arthur O., Lathara, Melvin, Shaw, Celine Y., Wogmon, Owen, Jackson, Jacob M., Clark, Mattie M., Eshraghi, Navah, Keenen, Stephanie E., Woods, Andrew D., Purohit, Reshma, Ishi, Yukitomo, Moran, Nirupama, Eguchi, Mariko, Ahmed, Farhat Ul Ain, Khan, Sara, Ioannou, Maria, Perivoliotis, Konstantinos, Li, Pin, Zhou, Huixia, Alkhaledi, Ahmad, Davis, Elizabeth J., Galipeau, Danielle, Randall, R. L., Wozniak, Agnieszka, Schoffski, Patrick, Lee, Che-Jui, Huang, Paul H., Jones, Robin L., Rubin, Brian P., Darrow, Morgan, Srinivasa, Ganapati, Rudzinski, Erin R., Chen, Sonja, Berlow, Noah E., and Keller, Charles
Published: 2022
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2. Correction to: Machine learning for rhabdomyosarcoma histopathology

Author: Frankel, Arthur O., Lathara, Melvin, Shaw, Celine Y., Wogmon, Owen, Jackson, Jacob M., Clark, Mattie M., Eshraghi, Navah, Keenen, Stephanie E., Woods, Andrew D., Purohit, Reshma, Ishi, Yukitomo, Moran, Nirupama, Eguchi, Mariko, Ahmed, Farhat Ul Ain, Khan, Sara, Ioannou, Maria, Perivoliotis, Konstantinos, Li, Pin, Zhou, Huixia, Alkhaledi, Ahmad, Davis, Elizabeth J., Galipeau, Danielle, Randall, R. L., Wozniak, Agnieszka, Schoffski, Patrick, Lee, Che-Jui, Huang, Paul H., Jones, Robin L., Rubin, Brian P., Darrow, Morgan, Srinivasa, Ganapati, Rudzinski, Erin R., Chen, Sonja, Berlow, Noah E., and Keller, Charles
Published: 2022
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3. Gastrointestinal stromal tumours

Author: Casali, P.G., Blay, J.Y., Abecassis, N., Bajpai, J., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Boye, K., Brodowicz, T., Buonadonna, A., Alava, E. de, Tos, A.P. dei, Muro, X.G. del, Dufresne, A., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gouin, F., Grignani, G., Haas, R., Hassan, A.B., Hindi, N., Hohenberger, P., Joensuu, H., Jones, R.L., Jungels, C., Jutte, P., Kasper, B., Kawai, A., Kopeckova, K., Krakorova, D.A., Cesne, A. le, Grange, F. le, Legius, E., Leithner, A., Lopez-Pousa, A., Martin-Broto, J., Merimsky, O., Messiou, C., Miah, A.B., Mir, O., Montemurro, M., Morosi, C., Palmerini, E., Pantaleo, M.A., Piana, R., Piperno-Neumann, S., Reichardt, P., Rutkowski, P., Safwat, A.A., Sangalli, C., Sbaraglia, M., Scheipl, S., Schoffski, P., Sleijfer, S., Strauss, D., Strauss, S.J., Hall, K.S., Trama, A., Unk, M., Sande, M.A.J. van de, Graaf, W.T.A. van der, Houdt, W.J. van, Frebourg, T., Gronchi, A., Stacchiotti, S., ESMO Guidelines Comm, EURACAN, GENTURIS, Casali P.G., Blay J.Y., Abecassis N., Bajpai J., Bauer S., Biagini R., Bielack S., Bonvalot S., Boukovinas I., Bovee J.V.M.G., Boye K., Brodowicz T., Buonadonna A., De Alava E., Dei Tos A.P., Del Muro X.G., Dufresne A., Eriksson M., Fedenko A., Ferraresi V., Ferrari A., Frezza A.M., Gasperoni S., Gelderblom H., Gouin F., Grignani G., Haas R., Hassan A.B., Hindi N., Hohenberger P., Joensuu H., Jones R.L., Jungels C., Jutte P., Kasper B., Kawai A., Kopeckova K., Krakorova D.A., Le Cesne A., Le Grange F., Legius E., Leithner A., Lopez-Pousa A., Martin-Broto J., Merimsky O., Messiou C., Miah A.B., Mir O., Montemurro M., Morosi C., Palmerini E., Pantaleo M.A., Piana R., Piperno-Neumann S., Reichardt P., Rutkowski P., Safwat A.A., Sangalli C., Sbaraglia M., Scheipl S., Schoffski P., Sleijfer S., Strauss D., Strauss S.J., Hall K.S., Trama A., Unk M., van de Sande M.A.J., van der Graaf W.T.A., van Houdt W.J., Frebourg T., Gronchi A., Stacchiotti S., Medical Oncology, Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Public Health Research (PHR), and Man, Biomaterials and Microbes (MBM)
Subjects: GIST, clinical practice guidelines, gastrointestinal stromal tumour, surgery, tyrosine kinase inhibitor, Oncology, Medizin, Hematology, clinical practice guideline
Abstract: Gastrointestinal stromal tumours (GISTs) are malignant mesenchymal tumours with a variable clinical behaviour, marked by differentiation towards the interstitial cells of Cajal.1 GISTs belong to the family of soft tissue sarcomas (STSs) but are treated separately due to their peculiar histogenesis, clinical behaviour and specific therapy. This European Society for Medical Oncology (ESMO)–European Reference Network for Rare Adult Solid Cancers (EURACAN)–European Reference Network for Genetic Tumour Risk Syndromes (GENTURIS) Clinical Practice Guideline (CPG) will cover GISTs while other STSs are covered in the ESMO–EURACAN–European Reference Network for Paediatric Oncology (ERN PaedCan)–GENTURIS STS CPG.
Published: 2022
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4. Bone sarcomas: ESMO–EURACAN–GENTURIS–ERN PaedCan Clinical Practice Guideline for diagnosis, treatment and follow-up

Author: Strauss, S.J., Frezza, A.M., Abecassis, N., Bajpai, J., Bauer, S., Biagini, R., Bielack, S., Blay, J.Y., Bolle, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Boye, K., Brennan, B., Brodowicz, T., Buonadonna, A., Alava, E. de, Tos, A.P. dei, Muro, X.G. del, Dufresne, A., Eriksson, M., Fagioli, F., Fedenko, A., Ferraresi, V., Ferrari, A., Gaspar, N., Gasperoni, S., Gelderblom, H., Gouin, F., Grignani, G., Gronchi, A., Haas, R., Hassan, A.B., Hecker-Nolting, S., Hindi, N., Hohenberger, P., Joensuu, H., Jones, R.L., Jungels, C., Jutte, P., Kager, L., Kasper, B., Kawai, A., Kopeckova, K., Krakorova, D.A., Cesne, A. le, Grange, F. le, Legius, E., Leithner, A., Pousa, A.L., Martin-Broto, J., Merimsky, O., Messiou, C., Miah, A.B., Mir, O., Montemurro, M., Morland, B., Morosi, C., Palmerini, E., Pantaleo, M.A., Piana, R., Piperno-Neumann, S., Reichardt, P., Rutkowski, P., Safwat, A.A., Sangalli, C., Sbaraglia, M., Scheipl, S., Schoffski, P., Sleijfer, S., Strauss, D., Hall, K.S., Trama, A., Unk, M., Sande, M.A.J. van de, Graaf, W.T.A. van der, Houdt, W.J. van, Frebourg, T., Ladenstein, R., Casali, P.G., Stacchiotti, S., ESMO Guidelines Comm, EURACAN, GENTURIS, ERN PaedCan, European Society for Medical Oncology, Strauss S.J., Frezza A.M., Abecassis N., Bajpai J., Bauer S., Biagini R., Bielack S., Blay J.Y., Bolle S., Bonvalot S., Boukovinas I., Bovee J.V.M.G., Boye K., Brennan B., Brodowicz T., Buonadonna A., de Alava E., Dei Tos A.P., Garcia del Muro X., Dufresne A., Eriksson M., Fagioli F., Fedenko A., Ferraresi V., Ferrari A., Gaspar N., Gasperoni S., Gelderblom H., Gouin F., Grignani G., Gronchi A., Haas R., Hassan A.B., Hecker-Nolting S., Hindi N., Hohenberger P., Joensuu H., Jones R.L., Jungels C., Jutte P., Kager L., Kasper B., Kawai A., Kopeckova K., Krakorova D.A., Le Cesne A., Le Grange F., Legius E., Leithner A., Lopez Pousa A., Martin-Broto J., Merimsky O., Messiou C., Miah A.B., Mir O., Montemurro M., Morland B., Morosi C., Palmerini E., Pantaleo M.A., Piana R., Piperno-Neumann S., Reichardt P., Rutkowski P., Safwat A.A., Sangalli C., Sbaraglia M., Scheipl S., Schoffski P., Sleijfer S., Strauss D., Sundby Hall K., Trama A., Unk M., van de Sande M.A.J., van der Graaf W.T.A., van Houdt W.J., Frebourg T., Ladenstein R., Casali P.G., Stacchiotti S., Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Public Health Research (PHR), and Man, Biomaterials and Microbes (MBM)
Subjects: medicine.medical_specialty, diagnosis, Medizin, bone sarcoma, Bone Neoplasm, Bone Sarcoma, Follow-Up Studie, 03 medical and health sciences, 0302 clinical medicine, follow-up, medicine, 030304 developmental biology, Osteosarcoma, 0303 health sciences, treatment, business.industry, Sarcoma, Hematology, Guideline, clinical practice guideline, management, 3. Good health, Clinical Practice, diagnosi, Oncology, Diagnosis treatment, 030220 oncology & carcinogenesis, Radiology, business, Human
Abstract: A. Kawai43, K. Kopeckova44, D. A. Krakorova45, A. Le Cesne46, F. Le Grange1, E. Legius47, A. Leithner48, A. Lopez Pousa49, J. Martin-Broto36, O. Merimsky50, C. Messiou51, A. B. Miah52, O. Mir53, M. Montemurro54, B. Morland55, C. Morosi56, E. Palmerini57, M. A. Pantaleo58, R. Piana59, S. Piperno-Neumann60, P. Reichardt61, P. Rutkowski62, A. A. Safwat63, C. Sangalli64, M. Sbaraglia19, S. Scheipl48, P. Schoffski65, S. Sleijfer66, D. Strauss67, K. Sundby Hall13, A. Trama68, M. Unk69, M. A. J. van de Sande70, W. T. A. van der Graaf66,71, W. J. van Houdt72, T. Frebourg73x, R. Ladenstein41z, P. G. Casali2,74z &
Published: 2021
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5. Soft tissue and visceral sarcomas

Author: Gronchi, A., Miah, A.B., DeiTos, A.P., Abecassis, N., Bajpai, J., Bauer, S., Biagini, R., Bielack, S., Blay, J.Y., Bolle, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Boye, K., Brennan, B., Brodowicz, T., Buonadonna, A., DeAlava, E., Muro, X.G. del, Dufresne, A., Eriksson, M., Fagioli, F., Fedenko, A., Ferraresi, V., Ferrari, A., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gouin, F., Grignani, G., Haas, R., Hassan, A.B., Hecker-Nolting, S., Hindi, N., Hohenberger, P., Joensuu, H., Jones, R.L., Jungels, C., Jutte, P., Kager, L., Kasper, B., Kawai, A., Kopeckova, K., Krakorova, D.A., Cesne, A. le, LeGrange, F., Legius, E., Leithner, A., Lopez-Pousa, A., Martin-Broto, J., Merimsky, O., Messiou, C., Mir, O., Montemurro, M., Morland, B., Morosi, C., Palmerini, E., Pantaleo, M.A., Piana, R., Piperno-Neumann, S., Reichardt, P., Rutkowski, P., Safwat, A.A., Sangalli, C., Sbaraglia, M., Scheipl, S., Schoffski, P., Sleijfer, S., Strauss, D., Strauss, S., SundbyHall, K., Trama, A., Unk, M., VandeSande, M.A.J., VanderGraaf, W.T.A., Houdt, W.J. van, Frebourg, T., Casali, P.G., Stacchiotti, S., ESMO Guidelines Comm, EURACAN, GENTURIS, Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Public Health Research (PHR), Man, Biomaterials and Microbes (MBM), Gronchi A., Miah A.B., Dei Tos A.P., Abecassis N., Bajpai J., Bauer S., Biagini R., Bielack S., Blay J.Y., Bolle S., Bonvalot S., Boukovinas I., Bovee J.V.M.G., Boye K., Brennan B., Brodowicz T., Buonadonna A., De Alava E., Del Muro X.G., Dufresne A., Eriksson M., Fagioli F., Fedenko A., Ferraresi V., Ferrari A., Frezza A.M., Gasperoni S., Gelderblom H., Gouin F., Grignani G., Haas R., Hassan A.B., Hecker-Nolting S., Hindi N., Hohenberger P., Joensuu H., Jones R.L., Jungels C., Jutte P., Kager L., Kasper B., Kawai A., Kopeckova K., Krakorova D.A., Le Cesne A., Le Grange F., Legius E., Leithner A., Lopez-Pousa A., Martin-Broto J., Merimsky O., Messiou C., Mir O., Montemurro M., Morland B., Morosi C., Palmerini E., Pantaleo M.A., Piana R., Piperno-Neumann S., Reichardt P., Rutkowski P., Safwat A.A., Sangalli C., Sbaraglia M., Scheipl S., Schoffski P., Sleijfer S., Strauss D., Strauss S., Sundby Hall K., Trama A., Unk M., van de Sande M.A.J., van der Graaf W.T.A., van Houdt W.J., Frebourg T., Casali P.G., and Stacchiotti S.
Subjects: sarcoma, uterine sarcoma, treatment, diagnosis, desmoid, Medizin, Sarcoma, Soft Tissue Neoplasms, Hematology, Clinical Practice Guideline, Soft tissue sarcomas, retroperitoneal sarcoma, Retroperitoneal Sarcoma, soft tissue sarcomas, Follow-Up Studie, Desmoid, Uterine Sarcoma, follow-up, management, Oncology, soft tissue sarcoma, Human
Abstract: ispartof: ANNALS OF ONCOLOGY vol:32 issue:11 pages:1348-1365 ispartof: location:England status: published
Published: 2021

6. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma

Author: Wolchok, JD, Chiarion-Sileni, V, Gonzalez, R, Grob, J-J, Rutkowski, P, Lao, CD, Cowey, CL, Schadendorf, D, Wagstaff, J, Dummer, R, Ferrucci, PF, Smylie, M, Butler, MO, Hill, A, Marquez-Rodas, I, Haanen, JBAG, Guidoboni, M, Maio, M, Schoffski, P, Carlino, MS, Lebbe, C, McArthur, G, Ascierto, PA, Daniels, GA, Long, G, Bas, T, Ritchings, C, Larkin, J, Hodi, FS, Wolchok, JD, Chiarion-Sileni, V, Gonzalez, R, Grob, J-J, Rutkowski, P, Lao, CD, Cowey, CL, Schadendorf, D, Wagstaff, J, Dummer, R, Ferrucci, PF, Smylie, M, Butler, MO, Hill, A, Marquez-Rodas, I, Haanen, JBAG, Guidoboni, M, Maio, M, Schoffski, P, Carlino, MS, Lebbe, C, McArthur, G, Ascierto, PA, Daniels, GA, Long, G, Bas, T, Ritchings, C, Larkin, J, and Hodi, FS
Abstract: PURPOSE: In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND METHODS: Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary end points were progression-free survival and overall survival (OS) with nivolumab plus ipilimumab or nivolumab versus ipilimumab. Secondary end points included objective response rate, descriptive efficacy assessments of nivolumab plus ipilimumab versus nivolumab alone, and safety. Melanoma-specific survival (MSS; descriptive analysis), which excludes deaths unrelated to melanoma, was also evaluated. RESULTS: Median OS (minimum follow-up, 6.5 years) was 72.1, 36.9, and 19.9 months in the combination, nivolumab, and ipilimumab groups, respectively. Median MSS was not reached, 58.7, and 21.9 months, respectively; 6.5-year OS rates were 57%, 43%, and 25% in patients with BRAF-mutant tumors and 46%, 42%, and 22% in those with BRAF-wild-type tumors, respectively. In patients who discontinued treatment, the median treatment-free interval was 27.6, 2.3, and 1.9 months, respectively. Since the 5-year analysis, no new safety signals were observed. CONCLUSION: These 6.5-year CheckMate 067 results, which include the longest median OS in a phase III melanoma trial reported to date and the first report of MSS, showed durable, improved clinical outcomes with nivolumab plus ipilimumab or nivolumab versus ipilimumab in patients with advanced melanoma and, in descriptive analyses, with the combination over nivolumab monotherapy.
Published: 2022

7. A post hoc analysis of the EPAZ trial: The prognostic role of geriatric variables in elderly soft tissue sarcoma (STS) patients

Author: Hamacher, R. W., Liu, X., Schuler, M. K., Hentschel, L., Schoffski, P., Kopp, H-G., Bauer, S., Kasper, B., Lindner, L. H., Chemnitz, J-M., Crysandt, M., Stein, A., Steffen, B., Richter, S., Egerer, G., Ivanyi, P., Kunitz, A., Gruenwald, V., Hamacher, R. W., Liu, X., Schuler, M. K., Hentschel, L., Schoffski, P., Kopp, H-G., Bauer, S., Kasper, B., Lindner, L. H., Chemnitz, J-M., Crysandt, M., Stein, A., Steffen, B., Richter, S., Egerer, G., Ivanyi, P., Kunitz, A., and Gruenwald, V.
Published: 2021

8. 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

9. 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

10. Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up

Author: Casali, P.G., Abecassis, N., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Brodowicz, T., Broto, J.M., Buonadonna, A., Alava, E., Tos, A.P., Muro, X.G., Dileo, P., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L., Hannu, A., Hassan, B., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S., Kasper, B., Kopeckova, K., Krakorova, D.A., Cesne, A., Lugowska, I., Merimsky, O., Montemurro, M., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schoffski, P., Sleijfer, S., Stacchiotti, S., Hall, K.S., Unk, M., Coevorden, F., Graaf, W.D., Whelan, J., Wardelmann, E., Zaikova, O., Blay, J.Y., ESMO Guidelines Comm EURACAN, Casali, P.G., Abecassis, N., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Brodowicz, T., Broto, J.M., Buonadonna, A., De Álava, E., Dei Tos, A.P., Del Muro, X.G., Dileo, P., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L., Hannu, A., Hassan, B., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S., Kasper, B., Kopeckova, K., Krákorová, D.A., Le Cesne, A., Lugowska, I., Merimsky, O., Montemurro, M., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schöffski, P., Sleijfer, S., Stacchiotti, S., Sundby Hall, K., Unk, M., Van Coevorden, F., Van Der Graaf, W., Whelan, J., Wardelmann, E., Zaikova, O., Blay, J.Y., Man, Biomaterials and Microbes (MBM), Public Health Research (PHR), Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Heikki Joensuu / Principal Investigator, Department of Oncology, Clinicum, HUS Comprehensive Cancer Center, [Casali, P. G.] Fdn IRCCS Ist Nazl Tumori, Milan, Italy, [Frezza, A. M.] Fdn IRCCS Ist Nazl Tumori, Milan, Italy, [Gronchi, A.] Fdn IRCCS Ist Nazl Tumori, Milan, Italy, [Casali, P. G.] Univ Milan, Milan, Italy, [Frezza, A. M.] Univ Milan, Milan, Italy, [Gronchi, A.] Univ Milan, Milan, Italy, [Abecassis, N.] EPE, Inst Portugues Oncol Lisboa Francisco Gentil, Lisbon, Portugal, [Bauer, S.] Univ Hosp Essen, Essen, Germany, [Biagini, R.] Regina Elena Inst Canc Res, IFO, Musculoskeletal Tissue Bank, Dept Oncol Orthoped, Rome, Italy, [Bielack, S.] Olga Hosp, Klinikum Stuttgart, Stuttgart, Germany, [Bonvalot, S.] Inst Curie, Paris, France, [Piperno-Neumann, S.] Inst Curie, Paris, France, [Boukovinas, I.] NORDIX, Athens, Greece, [Bovee, J. V. M. G.] Leiden Univ, Med Ctr, Dept Pathol, Leiden, Netherlands, [Brodowicz, T.] Med Univ Wien, Vienna Gen Hosp AKH, Vienna, Austria, [Broto, J. M.] Hosp Univ Virgen Rocio, CIBERONC, Seville, Spain, [De Alava, E.] Hosp Univ Virgen Rocio, CIBERONC, Seville, Spain, [Buonadonna, A.] Ctr Riferimento Oncol Aviano, Aviano, Italy, [Dei Tos, A. P.] Osped Reg Treviso S Maria Ca Foncello, Treviso, Italy, [Del Muro, X. G.] HUB, ICO Hosp, Integrated Unit, Barcelona, Spain, [Dileo, P.] Univ Coll London Hosp, Sarcoma Unit, London, England, [Eriksson, M.] Skane Univ Hosp Lund, Lund, Sweden, [Fedenko, A.] NN Blokhin Russian Canc Res Ctr, Moscow, Russia, [Ferraresi, V.] Inst Sci Hosp Care, Regina Elena Natl Canc Inst, IRCCS, Rome, Italy, [Ferrari, A.] Fdn IRCCS Ist Nazl Tumori, Pediat Oncol Unit, Milan, Italy, [Ferrari, S.] Ist Ortoped Rizzoli, Bologna, Italy, [Picci, P.] Ist Ortoped Rizzoli, Bologna, Italy, [Gasperoni, S.] Univ Careggi Firenze, Azienda Osped, Florence, Italy, [Gelderblom, H.] Leiden Univ, Med Ctr, Dept Med Oncol, Leiden, Netherlands, [Gil, T.] Inst Jules Bordet, Brussels, Belgium, [Grignani, G.] IRCCS, FPO, Candiolo Canc Inst, Candiolo, Italy, [Haas, R. L.] Netherlands Canc Inst, Dept Radiotherapy, Amsterdam, Netherlands, [Haas, R. L.] Leiden Univ, Med Ctr, Dept Radiotherapy, Leiden, Netherlands, [Hannu, A.] Turku Univ Hosp, Turun Yliopistollinen Keskussairaala, Turlu, Finland, [Hassan, B.] Oxford Univ Hosp NHS Fdn Trust, Oxford, England, [Hohenberger, P.] Mannheim Univ, Med Ctr, Mannheim, Germany, [Kasper, B.] Mannheim Univ, Med Ctr, Mannheim, Germany, [Issels, R.] Ludwig Maximilians Univ Munchen, Univ Hosp, Dept Med 3, Munich, Germany, [Joensuu, H.] Univ Helsinki, Cent Hosp, HUCH, Helsinki, Finland, [Jones, R. L.] Royal Marsden Hosp, London, England, [Van der Graaf, W.] Royal Marsden Hosp, London, England, [Judson, I.] Inst Canc Res, London, England, [Jutte, P.] Univ Med Ctr Groningen, Groningen, Netherlands, [Kaal, S.] Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands, [Kopeckova, K.] Univ Hosp Motol, Prague, Czech Republic, [Krakorova, D. A.] Masaryk Mem Canc Inst, Brno, Czech Republic, [Le Cesne, A.] Gustave Roussy Canc Campus, Villejuif, France, [Lugowska, I.] Marie Sklodowska Curie Inst, Oncol Ctr, Warsaw, Poland, [Rutkowski, P.] Marie Sklodowska Curie Inst, Oncol Ctr, Warsaw, Poland, [Merimsky, O.] Tel Aviv Sourasky Med Ctr Ichilov, Tel Aviv, Israel, [Montemurro, M.] Univ Hosp Lausanne, Med Oncol, Lausanne, Switzerland, [Pantaleo, M. A.] Univ Bologna, Policlin S Orsola Malpighi, Azienda Osped, Bologna, Italy, [Piana, R.] Univ Cita Salute & Sci Torino, Azienda Osped, Turin, Italy, [Pousa, A. L.] Hosp Santa Creu & Sant Pau, Fundacio Gestio Sanitaria, Barcelona, Spain, [Reichardt, P.] Helios Klinikum Berlin Buch, Berlin, Germany, [Robinson, M. H.] Weston Pk Hosp NHS Trust, Dept Clin Oncol, YCRC, Sheffield, S Yorkshire, England, [Safwat, A. A.] Aarhus Univ Hosp, Aarhus, Denmark, [Schoffski, P.] Leuven Canc Inst, Leuven, Belgium, [Sleijfer, S.] Erasmus MC Canc Inst, Dept Med Oncol, Rotterdam, Netherlands, [Stacchiotti, S.] Ist Nazl Tumori, Fdn Ist Ricovero & Cura Carattere Sci, Milan, Italy, [Hall, K. Sundby] Norwegian Radium Hosp, Oslo Univ Hosp, Dept Oncol, Oslo, Norway, [Unk, M.] Inst Oncol Ljubljana, Ljubljana, Slovenia, [Van Coevorden, F.] Netherlands Canc Inst Antoni van Leeuwenhoek, Amsterdam, Netherlands, [Whelan, J.] Univ Coll Hosp, London, England, [Wardelmann, E.] Univ Klinikum Munster, Gerhard Domagk Inst Pathol, Munster, Germany, [Zaikova, O.] Norwegian Radium Hosp, Oslo Univ Hosp, Oslo, Norway, [Blay, J. Y.] Ctr Leon Bernard, Lyon, France, [Blay, J. Y.] UCBL1, Lyon, France, Amgen Dompe, AROG Bayer, Blueprint Medicines, Eli Lilly, Daiichi Sankyo Pharma, Epizyme, GlaxoSmithKline, Novartis, Pfizer, PharmaMar, Incyte, Lilly, Bayer, Janssen-Cilag, Eisai, Loxo Oncology, Nanobiotix, Bristol-Myers Squibb, Merck Sharp Dohme, Roche, Amgen, EuroSarc, CoBioRes, Exelixis, Plexxikon, Sixth Element Capital, Adaptaimmune, Amcure, AstraZeneca, Boehringer Ingelheim, Cristal Therapeutics, Daichii Sankyo Pharma, Genzyme, Ipsen, Medpace, Nektar, Philogen, Piqur Therapeutics, Swedish Orphan Biovitrium, Advenchen, Epizyme Inc., PharmarMar, Novartis Oncology, Milestone, Menarini, and Medical Oncology
Subjects: SURGERY, medicine.medical_treatment, Medizin, Aftercare, Medical Oncology, law.invention, DOSE IMATINIB, Endosonography, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Antineoplastic Combined Chemotherapy Protocols, Medicine, Digestive System Surgical Procedures, Societies, Medical, Adjuvant imatinib, NEOADJUVANT/ADJUVANT IMATINIB MESYLATE, GiST, Progression, Incidence, Stomach, Margins of Excision, KIT, Hematology, Gastrointestinal stromal tumours, 3. Good health, Clinical Practice, Europe, Intestines, Self-Help Groups, Treatment Outcome, Diagnosis treatment, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, ADJUVANT IMATINIB, Neoadjuvant/adjuvant imatinib mesylate, PHASE-II TRIAL, Mutations, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], GIST, Adult, Image-Guided Biopsy, medicine.medical_specialty, Gastrointestinal Stromal Tumors, education, 3122 Cancers, 03 medical and health sciences, Stomach surgery, Carney-stratakis, CARNEY-STRATAKIS, Humans, Gist, Neoplasm Staging, Chemotherapy, business.industry, MUTATIONS, General surgery, ta3121, RANDOMIZED-TRIAL, digestive system diseases, Imatinib mesylate, Phase-ii trial, 3121 General medicine, internal medicine and other clinical medicine, Surgery, Laparoscopy, Patient Participation, business, Dose imatinib, Tomography, X-Ray Computed
Abstract: Gastrointestinal stromal tumours (GISTs) are rare tumours, with an estimated unadjusted incidence of around 1/100 000/year. This only covers clinically relevant GISTs, since, if investigated, amuch higher number of lesions ≤ 1 cmin diameter (microGISTs) can be found at histopathological examination of stomach tissue in middle-aged and elderly individuals. There is a slight prevalence in males. The median age is around 60–65 years, with a wide range. Occurrence in children is very rare. Paediatric GIST represents a clinically and molecularly distinct subset, marked by female predominance, absence of KIT/platelet- derived growth factor alpha (PDGFRA) mutations, frequent mutations or silencing of the four genes that encode the subunits of the succinate dehydrogenase (SDH) enzyme complex, gastric multicentric location and possible lymph node metastases. Some syndromes are linked to GISTs: • The Carney triad syndrome, marked by gastric GISTs, paraganglioma and pulmonary chondromas (these may occur at different ages); • Carney–Stratakis syndrome, marked by a dyad of GIST and paraganglioma; and • Neurofibromatosis type 1(NF1), possibly leading to wild-type (WT), often multicentric GIST, predominantly located in the small bowel Families with germline autosomal dominant mutations of KIT are an extremely rare finding, presenting with multiple GISTs at an early age, possibly along with other associated features such as pigmented skin macules, urticaria pigmentosa and diffuse hyperplasia of the interstitial cells of Cajal in the gut wall.
Published: 2018

11. A phase I dose-escalation and pharmacokinetic study of a micellar nanoparticle with entrapped docetaxel (CPC634) in patients with advanced solid tumours

Author: Atrafi, F., Dumez, H. (Herlinde), Mathijssen, A.H.J. (Ron), van Oordt, C., Rijcken, C.J.F., Hanssen, R., Eskens, F.A.L.M. (Ferry), Schoffski, P, Atrafi, F., Dumez, H. (Herlinde), Mathijssen, A.H.J. (Ron), van Oordt, C., Rijcken, C.J.F., Hanssen, R., Eskens, F.A.L.M. (Ferry), and Schoffski, P
Abstract: Background: CPC634 is docetaxel entrapped in core-cross linked polymeric micelles. In preclinical studies, CPC634 demonstrated enhanced pharmacokinetics and improved therapeutic index. This phase I dose escalation study is the first-in-human study with CPC634. Methods: adult patients with advanced solid tumours received CPC634 intravenously either 3-weekly (Q3W) (part 1, dose range 15–100 mg/m2 ), 2-weekly (Q2W) (part 2, 45 mg/m2 ) or Q3W with dexamethasone premedication (part 3, 60 mg/m2 ). Results: thirty-three patients were enrolled. Skin toxicity was dose limiting (DLT) at ≥60 mg/m2 in part 1 and at 45 mg/m2 in part 2 and was the most common CPC634 related grade ≥ 3 adverse event (24%). With dexamethasone premedication no DLTs were observed at 60 mg/m2 Q3W. CPC634 exhibited a dose-proportional pharmacokinetic profile. At 60 mg/m2 , the plasma area under the curve was 4067.5 ± 2974.0 ng/h/mL and the peak plasma level 217.3 ± 91.9 ng/mL with a half-life of 39.7 ± 9.4 h for released docetaxel. Conclusion: CPC634 could be administered safely upon pretreatment with dexamethasone. Cumulative skin toxicity was the main DLT. The recommended phase 2 dose was determined at 60 mg/m2 Q3W with dexamethasone premedication.
Published: 2020
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12. Diagnosis and management of tropomyosin receptor kinase (TRK) fusion sarcomas: expert recommendations from the World Sarcoma Network

Author: Demetri, GD, Antonescu, CR, Bjerkehagen, B, Bovee, JVMG, Boye, K, Chacon, 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, Y-K, Kawai, A, Lazar, AJ, Le Cesne, A, Maestro, R, Maki, RG, Martin, J, Patel, S, Penault-Llorca, F, Raut, CP, Rutkowski, P, Safwat, A, Sbaraglia, M, Schaefer, I-M, Shen, L, Serrano, C, Schoffski, 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, J-Y, Demetri, GD, Antonescu, CR, Bjerkehagen, B, Bovee, JVMG, Boye, K, Chacon, 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, Y-K, Kawai, A, Lazar, AJ, Le Cesne, A, Maestro, R, Maki, RG, Martin, J, Patel, S, Penault-Llorca, F, Raut, CP, Rutkowski, P, Safwat, A, Sbaraglia, M, Schaefer, I-M, Shen, L, Serrano, C, Schoffski, 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, J-Y
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

13. Phase III Trial of Gemcitabine Plus Tipifarnib Compared With Gemcitabine Plus Placebo in Advanced Pancreatic Cancer

Author: Van Cutsem, E, van de Velde, H, Karasek, P, Oettle, H, Vervenne, W L., Szawlowski, A, Schoffski, P, Post, S, Verslype, C, Neumann, H, Safran, H, Humblet, Y, Perez Ruixo, J, Ma, Y, and Von Hoff, D
Published: 2004
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14. XELOX: Mature results of a multinational, phase-II trial of capecitabine plus oxaliplatin, an effective 1st-line option for patients (pts) with metastatic colorectal cancer (MCRC): 1023

Author: Van Cutsem, E., Twelves, C., Tabernero, J., Schoffski, P., Figer, A., Diaz-Rubio, E., de Braud, F., Conroy, T., Cassidy, J., and Butts, C.
Published: 2003

15. Role of surgery in patients (pts) with liver metastases (LM) from testicular germ cell tumors (GCT): 279

Author: Hartmann, J. T., Oechsle, K., Rick, O., Gauler, T., Schoffski, P., Schleicher, J., Kanz, L., and Bokemeyer, C.
Published: 2002

16. Ten-Year Progression-Free and Overall Survival in Patients With Unresectable or Metastatic GI Stromal Tumors: Long-Term Analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup Phase III Randomized Trial on Imatinib at Two Dose Levels

Author: Casali, P.G., Zalcberg, J., Cesne, A. le, Reichardt, P., Blay, J.Y., Lindner, L.H., Judson, I.R., Schoffski, P., Leyvraz, S., Italiano, A., Grunwald, V., Pousa, A.L., Kotasek, D., Sleijfer, S., Kerst, J.M., Rutkowski, P., Fumagalli, E., Hogendoorn, P., Litiere, S., Marreaud, S., Graaf, W. van der, Gronchi, A., Verweij, J., European Org Res Treatment Canc So, Italian Sarcoma Grp, Australasian Gastrointestinal Tria, and Medical Oncology
Subjects: 0301 basic medicine, Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Gastrointestinal Stromal Tumors, Antineoplastic Agents, Kaplan-Meier Estimate, Disease-Free Survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, SDG 3 - Good Health and Well-being, law, Survivorship curve, Internal medicine, medicine, Humans, Neoplasm Metastasis, Aged, Gastrointestinal Neoplasms, Cross-Over Studies, Performance status, GiST, Dose-Response Relationship, Drug, business.industry, Hazard ratio, Middle Aged, medicine.disease, Prognosis, Crossover study, Surgery, 030104 developmental biology, Imatinib mesylate, Editorial, 030220 oncology & carcinogenesis, Imatinib Mesylate, Female, Sarcoma, business, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract: Purpose To report on the long-term results of a randomized trial comparing a standard dose (400 mg/d) versus a higher dose (800 mg/d) of imatinib in patients with metastatic or locally advanced GI stromal tumors (GISTs). Patients and Methods Eligible patients with advanced CD117-positive GIST from 56 institutions in 13 countries were randomly assigned to receive either imatinib 400 mg or 800 mg daily. Patients on the 400-mg arm were allowed to cross over to 800 mg upon progression. Results Between February 2001 and February 2002, 946 patients were accrued. Median age was 60 years (range, 18 to 91 years). Median follow-up time was 10.9 years. Median progression-free survival times were 1.7 and 2.0 years in the 400- and 800-mg arms, respectively (hazard ratio, 0.91; P = .18), and median overall survival time was 3.9 years in both treatment arms. The estimated 10-year progression-free survival rates were 9.5% and 9.2% for the 400- and 800-mg arms, respectively, and the estimated 10-year overall survival rates were 19.4% and 21.5%, respectively. At multivariable analysis, age (< 60 years), performance status (0 v ≥ 1), size of the largest lesion (smaller), and KIT mutation (exon 11) were significant prognostic factors for the probability of surviving beyond 10 years. Conclusion This trial was carried out on a worldwide intergroup basis, at the beginning of the learning curve of the use of imatinib, in a large population of patients with advanced GIST. With a long follow-up, 6% of patients are long-term progression free and 13% are survivors. Among clinical prognostic factors, only performance status, KIT mutation, and size of largest lesion predicted long-term outcome, likely pointing to a lower burden of disease. Genomic and/or immune profiling could help understand long-term survivorship. Addressing secondary resistance remains a therapeutic challenge.
Published: 2017
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17. Endogenous serum levels of thrombopoietic cytokines in healthy whole-blood and platelet donors: implications for plateletpheresis

Author: Tacke, F., Schoffski, P., Trautwein, C., Martin, M. U., Stangel, W., Seifried, E., Manns, M. P., Ganser, A., and Petersen, D.
Published: 1999

18. Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up (vol 29, pg 51, 2018)

Author: Casali, P.G., Abecassis, N., Aro, H.T., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Brodovvicz, T., Broto, J.M., Buonadonna, A., Alava, E. de, Tos, A.P.D., Muro, X.G. del, Dileo, P., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L., Hassan, B., Hohenberger, P., Lssels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S., Kasper, B., Kopeckova, K., Krakorova, D.A., Cesne, A. le, Lugowska, I., Merimsky, O., Montemurro, M., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkovvski, P., Safwat, A.A., Schoffski, P., Sleijfer, S., Stacchiotti, S., Hall, K.S., Unk, M., Coevorden, F. van, Graaf, W.T.A. van der, Whelan, J., Wardelmann, E., Zaikova, O., Blay, J.Y., ESMO Guidelines Comm, and EURACAN
Published: 2018
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19. METEOR Studie: Retrospektive Analyse von Patienten mit fortgeschrittenem Nierenzellkarzinom bezüglich der Wirksamkeit von Cabozantinib (CABO) vs Everolimus (EVE) in Abhängigkeit vom Nephrektomiestatus

Author: Schönheit, J, Powles, T, Tannir, N, Escudier, B, Donskov, F, Grünwald, V, Sternberg, C, Schmidinger, M, Schoffski, P, Szcylik, C, Peltola, KJ, Nosov, D, Melchiar, B, Clary, D, Scheffold, C, Motzer, R, and Choueiri, T
Subjects: ddc: 610, 610 Medical sciences, Medicine
Abstract: Fragestellung: Die Mehrzahl der Patienten mit fortgeschrittenem Nierenzellkarzinom (RCC) erhalten eine Nephrektomie (Nx) als kurative oder palliative Therapie. In einer retrospektiven Analyse von Patienten mit zielgerichteter Therapie erhielten solche höheren Alters und mit mehr Komorbiditäten,[zum vollständigen Text gelangen Sie über die oben angegebene URL], 44. gemeinsamen Tagung der Bayerischen Urologenvereinigung und der Österreichischen Gesellschaft für Urologie und Andrologie
Published: 2018
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20. Molecular Comparison of Imatinib-Naive and Resistant Gastrointestinal Stromal Tumors: Differentially Expressed microRNAs and mRNAs

Author: Amirnasr, A. (Azadeh), Gits, C.M.M. (Caroline), Kuijk, P.F. (Patricia) van, Smid, M. (Marcel), Vriends, A.L.M. (Anne), Rutkowski, P. (Piotr), Sciot, R. (Raf), Schoffski, P, Debiec-Rychter, M. (Maria), Sleijfer, S. (Stefan), Wiemer, E.A.C. (Erik), Amirnasr, A. (Azadeh), Gits, C.M.M. (Caroline), Kuijk, P.F. (Patricia) van, Smid, M. (Marcel), Vriends, A.L.M. (Anne), Rutkowski, P. (Piotr), Sciot, R. (Raf), Schoffski, P, Debiec-Rychter, M. (Maria), Sleijfer, S. (Stefan), and Wiemer, E.A.C. (Erik)
Abstract: Despite the success of imatinib in advanced gastrointestinal stromal tumor (GIST) patients, 50% of the patients experience resistance within two years of treatment underscoring the need to get better insight into the mechanisms conferring imatinib resistance. Here the microRNA and mRNA expression profiles in primary (imatinib-naïve) and imatinib-resistant GIST were examined. Fifty-three GIST samples harboring primary KIT mutations (exon 9; n = 11/exon 11; n = 41/exon 17; n = 1) and comprising imatinib-naïve (IM-n) (n = 33) and imatinib-resistant (IM-r) (n = 20) tumors, were analyzed. The microRNA expression profiles were determined and from a subset (IM-n, n = 14; IM-r, n = 15) the mRNA expression profile was established. Ingenuity pathway analyses were used to unravel biochemical pathways and gene networks in IM-r GIST. Thirty-five differentially expressed miRNAs between IM-n and IM-r GIST samples were identified. Additionally, miRNAs distinguished IM-r samples with and without secondary KIT mutations. Furthermore 352 aberrantly expressed genes were found in IM-r samples. Pathway and network analyses revealed an association of differentially expressed genes with cell cycle progression and cellular proliferation, thereby implicating genes and pathways involved in imatinib resistance in GIST. Differentially expressed miRNAs and mRNAs between IM-n and IM-r GIST were identified. Bioinformatic analyses provided insight into the genes and biochemical pathways involved in imatinib-resistance and highlighted key genes that may be putative treatment targets.
Published: 2019
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21. Molecular Comparison of Imatinib-Naive and Resistant Gastrointestinal Stromal Tumors: Differentially Expressed microRNAs and mRNAs

Author: Amirnasr, Azadeh, Gits, Caroline, van Kuijk, Patricia, Smid, Marcel, Vriends, Anne, Rutkowski, P, Sciot, R, Schoffski, P, Debiec-Rychter, M, Sleijfer, Stefan, Wiemer, Erik, Amirnasr, Azadeh, Gits, Caroline, van Kuijk, Patricia, Smid, Marcel, Vriends, Anne, Rutkowski, P, Sciot, R, Schoffski, P, Debiec-Rychter, M, Sleijfer, Stefan, and Wiemer, Erik
Published: 2019

22. Soft tissue and visceral sarcomas: ESMO–EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up

Author: Casali, P.G., Abecassis, N., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Brodowicz, T., Broto, J.M., Buonadonna, A., Alava, E. de, Tos, A.P.D., Muro, X.G. del, Dileo, P., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L., Hannu, A., Hassan, B., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S., Kasper, B., Kopeckova, K., Krakorova, D.A., Cesne, A. le, Lugowska, I., Merimsky, O., Montemurro, M., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schoffski, P., Sleijfer, S., Stacchiotti, S., Hall, K.S., Unk, M., Coevorden, F. van, Graaf, W. van der, Whelan, J., Wardelmann, E., Zaikova, O., Blay, J.Y., ESMO Guidelines Comm EURACAN, Heikki Joensuu / Principal Investigator, Department of Oncology, Clinicum, Medical Oncology, Man, Biomaterials and Microbes (MBM), Public Health Research (PHR), Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Casali, P.G., Abecassis, N., Bauer, S., Biagini, R., Bielack, S., Bonvalot, S., Boukovinas, I., Bovee, J.V.M.G., Brodowicz, T., Broto, J.M., Buonadonna, A., De Álava, E., Dei Tos, A.P., Del Muro, X.G., Dileo, P., Eriksson, M., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L., Hannu, A., Hassan, B., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S., Kasper, B., Kopeckova, K., Krákorová, D.A., Le Cesne, A., Lugowska, I., Merimsky, O., Montemurro, M., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schöffski, P., Sleijfer, S., Stacchiotti, S., Sundby Hall, K., Unk, M., Van Coevorden, F., Van Der Graaf, W., Whelan, J., Wardelmann, E., Zaikova, O., and Blay, J.Y.
Subjects: 0301 basic medicine, medicine.medical_specialty, medicine.medical_treatment, education, 3122 Cancers, Medizin, CASE-SERIES ANALYSIS, ENDOMETRIAL STROMAL SARCOMA, Preoperative care, RPS WORKING GROUP, 03 medical and health sciences, 0302 clinical medicine, Biopsy, medicine, DESMOID-TYPE FIBROMATOSIS, RETROPERITONEAL SARCOMA, Endometrial stromal sarcoma, Uterine sarcoma, medicine.diagnostic_test, business.industry, Soft tissue, NECROSIS-FACTOR-ALPHA, Hematology, medicine.disease, ISOLATED LIMB PERFUSION, ta3122, Surgery, Radiation therapy, 030104 developmental biology, Oncology, Diagnosis treatment, 030220 oncology & carcinogenesis, Sarcoma, Radiology, RARE CANCER NETWORK, business, RANDOMIZED PHASE-II, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], ADJUVANT RADIATION-THERAPY
Abstract: Soft tissue sarcomas (STSs) gather over 80 histological entities, with even more molecular subsets, characterised by a low to very low incidence in all populations. The majority of sarcomas arise from the soft tissue (close to 75%), with ~15% gastrointestinal stromal tumours (GISTs) and 10% bone sarcomas. These ESMO–EURACAN (European Society for Medical Oncology– European Reference Network for rare adult solid cancers) Clinical Practice Guidelines cover STSs, while GISTs are covered by dedicated ESMO–EURACAN Clinical Practice Guidelines. Kaposi’s sarcoma is not considered in the present document. Extraskeletal Ewing and Ewing-like sarcoma is covered by ESMO Clinical Practice Guidelines on bone sarcomas. In general, the same principles for these tumours in children apply to adults. This is also the case for embryonal and alveolar rhabdomyosarcomas, which are exceedingly rare in adults. On the other hand, pleomorphic rhabdomyosarcoma is viewed as a high-grade, adult-type STS. Extraskeletal osteosarcoma is also a high-grade STS, whose clinical resemblance with osteosarcoma of bone is doubtful (prospective collection of data is encouraged to generate evidence on the therapeutic implications of such a diagnosis). Adult STS pathological subtypes occurring in adolescents should be managed the same way as in adult patients, though the same histotypemight display clinical peculiarities when occurring at different ages.
Published: 2018

23. Bone sarcomas: ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up

Author: Casali, P.G., Bielack, S., Abecassis, N., Aro, H.T., Bauer, S., Biagini, R., Bonvalot, S., Boukovinas, I., Bovee, J., Brennan, B., Brodowicz, T., Broto, J.M., Brugieres, L., Buonadonna, A., Alava, E. De, Tos, A.P. Dei, Muro, X.G. del, Dileo, P., Dhooge, C., Eriksson, M., Fagioli, F., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gaspar, N., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L.M., Hassan, B., Hecker-Nolting, S., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S.E., Kager, L., Kasper, B., Kopeckova, K., Krakorova, D.A., Ladenstein, R., Cesne, A. Le, Lugowska, I., Merimsky, O., Montemurro, M., Morland, B., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schoffski, P., Sleijfer, S., Stacchiotti, S., Strauss, S.J., Hall, K., Unk, M., Coevorden, F. van, Graaf, W.T.A. van der, Whelan, J., Wardelmann, E., Zaikova, O., Blay, J.Y., Casali, P.G., Bielack, S., Abecassis, N., Aro, H.T., Bauer, S., Biagini, R., Bonvalot, S., Boukovinas, I., Bovee, J., Brennan, B., Brodowicz, T., Broto, J.M., Brugieres, L., Buonadonna, A., Alava, E. De, Tos, A.P. Dei, Muro, X.G. del, Dileo, P., Dhooge, C., Eriksson, M., Fagioli, F., Fedenko, A., Ferraresi, V., Ferrari, A., Ferrari, S., Frezza, A.M., Gaspar, N., Gasperoni, S., Gelderblom, H., Gil, T., Grignani, G., Gronchi, A., Haas, R.L.M., Hassan, B., Hecker-Nolting, S., Hohenberger, P., Issels, R., Joensuu, H., Jones, R.L., Judson, I., Jutte, P., Kaal, S.E., Kager, L., Kasper, B., Kopeckova, K., Krakorova, D.A., Ladenstein, R., Cesne, A. Le, Lugowska, I., Merimsky, O., Montemurro, M., Morland, B., Pantaleo, M.A., Piana, R., Picci, P., Piperno-Neumann, S., Pousa, A.L., Reichardt, P., Robinson, M.H., Rutkowski, P., Safwat, A.A., Schoffski, P., Sleijfer, S., Stacchiotti, S., Strauss, S.J., Hall, K., Unk, M., Coevorden, F. van, Graaf, W.T.A. van der, Whelan, J., Wardelmann, E., Zaikova, O., and Blay, J.Y.
Abstract: Item does not contain fulltext
Published: 2018

24. Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 'CREATE'

Author: Schoffski, P., Wozniak, Agnieszka, Kasper, B., Aamdal, S., Leahy, M.G., Rutkowski, P., Graaf, W.T.A. van der, Collette, S., Stacchiotti, S., Schoffski, P., Wozniak, Agnieszka, Kasper, B., Aamdal, S., Leahy, M.G., Rutkowski, P., Graaf, W.T.A. van der, Collette, S., and Stacchiotti, S.
Abstract: Contains fulltext : 190897.pdf (publisher's version ) (Closed access)
Published: 2018

25. European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Experience with Advanced/Metastatic Epithelioid Sarcoma Patients Treated in Prospective Trials: Clinical Profile and Response to Systemic Therapy

Author: Touati, N., Schoffski, P., Litiere, S., Judson, I., Sleijfer, S., Graaf, W.T.A. van der, Italiano, A., Isambert, N., Gil, T., Blay, J.Y., Stark, D., Brodowicz, T., Marreaud, S., Gronchi, A., Touati, N., Schoffski, P., Litiere, S., Judson, I., Sleijfer, S., Graaf, W.T.A. van der, Italiano, A., Isambert, N., Gil, T., Blay, J.Y., Stark, D., Brodowicz, T., Marreaud, S., and Gronchi, A.
Abstract: Item does not contain fulltext, AIMS: Epithelioid sarcoma is a soft tissue sarcoma associated with a high rate of local recurrence after wide resection and high incidence of distant metastasis. Little is known about the clinical course and response to systemic treatments in epithelioid sarcoma patients. We carried out a retrospective analysis of clinical data from epithelioid sarcoma patients to provide a reference for the design of future epithelioid sarcoma-specific studies. PATIENTS AND METHODS: Data from patients with epithelioid sarcoma entered in prospective multi-sarcoma phase II/III trials were pooled: EORTC trial 62012 (doxorubicin versus doxorubicin/ifosfamide), 62043 (pazopanib), 62072 (pazopanib versus placebo) and 62091 (doxorubicin versus trabectedin). Patients had either a local or a centrally confirmed diagnosis of epithelioid sarcoma, had inoperable/metastatic disease at study entry and were eligible for the according trial. Response was assessed according to RECIST 1.1. Progression-free survival (PFS) and overall survival were calculated from date of entry. RESULTS: Among 976 patients with advanced sarcomas, 27 epithelioid sarcoma patients (2.8%) were eligible for the analysis (17 men, median age at diagnosis 50 years, range 19-72). Eighteen (66.7%) received chemotherapy as first-line treatment (five doxorubicin, eight doxorubicin/ifosfamide, two pazopanib, three trabectedin) and nine (33.3%) received pazopanib as second line or later. The primary tumour was located in the lower extremity (n = 8; 29.6%), upper extremity (n = 5; 18.5%), retro/intra-abdominal (n = 4; 14.8%) and in other locations (n = 10; 37.0%). At entry, metastases were mainly found in lung (n = 17; 63%), lymph nodes (n = 9; 33.3%), bone (n = 8; 29.6%) and soft tissue (n = 7; 25.9%). The best response for first-line patients was four partial responses (22.2%), 10 stable disease (55.6%) and four progressive disease (22.2%). In subsequent lines, pazopanib achieved one partial response (11.1%), four stable disease (
Published: 2018

26. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid- induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors

Author: Tran, B, Carvajal, RD, Marabelle, A, Patel, SP, LoRusso, PM, Rasmussen, E, Juan, G, Upreti, VV, Beers, C, Ngarmchamnanrith, G, Schoffski, P, Tran, B, Carvajal, RD, Marabelle, A, Patel, SP, LoRusso, PM, Rasmussen, E, Juan, G, Upreti, VV, Beers, C, Ngarmchamnanrith, G, and Schoffski, P
Abstract: BACKGROUND: This open-label, first-in-human, phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of AMG 228, an agonistic human IgG1 monoclonal antibody targeting glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), in patients with refractory advanced solid tumors. METHODS: AMG 228 was administered intravenously every 3 weeks (Q3W). Dose escalation was in two stages: single-patient cohorts (3, 9, 30, and 90 mg), followed by "rolling six" design (n = 2-6; 180, 360, 600, 900, and 1200 mg). Primary endpoints included incidence of dose-limiting toxicities (DLTs), AEs, and pharmacokinetics. Additional endpoints were objective response and pharmacodynamic response. RESULTS: Thirty patients received AMG 228, which was well tolerated up to the maximum planned dose (1200 mg). No DLTs occurred; the MTD was not reached. The most common treatment-related AEs were fatigue (13%), infusion-related reaction (7%), pyrexia (7%), decreased appetite (7%), and hypophosphatemia (7%). Two patients had binding anti-AMG 228 antibodies (one at baseline); no neutralizing antibodies were detected. AMG 228 exhibited target-mediated drug disposition, and serum exposure was approximately dose proportional at 180-1200 mg and greater than dose proportional at 3-1200 mg. Doses > 360 mg Q3W achieved serum trough coverage for 95% in vitro GITR occupancy. Despite GITR coverage in peripheral blood and tumor biopsies, there was no evidence of T-cell activation or anti-tumor activity. CONCLUSIONS: In patients with advanced solid tumors, AMG 228 Q3W was tolerable up to the highest tested dose (1200 mg), exhibited favorable pharmacokinetics, and provided target coverage indicating a pharmacokinetic profile appropriate for longer intervals. However, there was no evidence of T-cell activation or anti-tumor activity with AMG 228 monotherapy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02437916 .
Published: 2018

27. EORTC experience with advanced/metastatic epithelioid sarcoma patients treated in prospective trials: Clinical profile and response to systemic therapy

Author: Touati, N., primary, Schoffski, P., additional, Litière, S., additional, Judson, I., additional, Sleijfer, S., additional, van der Graaf, W.T.A., additional, Italiano, A., additional, Isambert, N., additional, Gil, T., additional, Blay, J.-Y., additional, Stark, D., additional, Brodowicz, T., additional, Marreaud, S., additional, and Gronchi, A., additional
Published: 2017
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28. Follow-up strategies for patients with gastrointestinal stromal tumour treated with or without adjuvant imatinib after surgery

Author: Joensuu, H., Martin-Broto, J., Nishida, T., Reichardt, P., Schoffski, P., Maki, R. G., Clinicum, Heikki Joensuu / Principal Investigator, and Department of Oncology
Subjects: education, 3122 Cancers
Published: 2015

29. Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 'CREATE'

Author: Schoffski, P., Wozniak, Agnieszka, Stacchiotti, S., Rutkowski, P., Blay, J.Y., Lindner, L.H., Graaf, W.T.A. van der, Collette, L., Bauer, S., Schoffski, P., Wozniak, Agnieszka, Stacchiotti, S., Rutkowski, P., Blay, J.Y., Lindner, L.H., Graaf, W.T.A. van der, Collette, L., and Bauer, S.
Abstract: Item does not contain fulltext
Published: 2017

30. Abstract P4-03-01: The footprint of the aging stroma in older breast cancer patients

Author: Brouwers, B, primary, Fumagalli, D, additional, Brohee, S, additional, Hatse, S, additional, Govaere, O, additional, Floris, G, additional, Van den Eynde, K, additional, Schoffski, P, additional, Smeets, A, additional, Neven, P, additional, Lambrechts, D, additional, Sotiriou, C, additional, and Wildiers, H, additional
Published: 2017
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31. Outcome of uterine sarcoma patients treated with pazopanib: A retrospective analysis based on two European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG) clinical trials 62043 and 62072

Author: Benson, C., Ray-Coquard, I., Sleijfer, S., Litiere, S., Blay, J.Y., Cesne, A. Le, Papai, Z., Judson, I., Schoffski, P., Chawla, S., Gil, T., Piperno-Neumann, S., Marreaud, S., Dewji, M.R., Graaf, W.T.A. van der, Benson, C., Ray-Coquard, I., Sleijfer, S., Litiere, S., Blay, J.Y., Cesne, A. Le, Papai, Z., Judson, I., Schoffski, P., Chawla, S., Gil, T., Piperno-Neumann, S., Marreaud, S., Dewji, M.R., and Graaf, W.T.A. van der
Abstract: Item does not contain fulltext, BACKGROUND: Uterine sarcomas are a group of mesenchymal tumours comprising several histologies. They have a high recurrence rate following surgery, modest outcome to systemic therapy, and poor overall survival. Pazopanib is a multi-targeted tyrosine kinase inhibitor approved for non-adipocytic advanced soft tissue sarcomas (STS). Here we investigated whether response to pazopanib in patients with uterine sarcomas differs from that of patients with non-uterine sarcomas. PATIENTS AND METHODS: Uterine sarcoma patients were retrieved from all soft tissue sarcoma patients treated with pazopanib in EORTC Phase II (n=10) and Phase III (PALETTE) (n=34) studies. Patient and tumour characteristics, response, progression free and overall survival data were compared. RESULTS: Forty-four patients with uterine sarcoma were treated with pazopanib. The majority of patients had uterine leiomyosarcoma (LMS) (n=39, 88.6%) with high grade tumours (n=37, 84.1%) compared to 54.8% (n=164) in the non-uterine population. The median age was 55years (range 33-79) and median follow up was 2.3years. Uterine patients were heavily pre-treated, 61.3% having >/=2 lines of chemotherapy prior to pazopanib compared to 40.8% in the non-uterine population. Five patients (11%), all LMS, had a partial response (95% CI 3.8-24.6). Median progression free survival (PFS) 3.0months (95% CI 2.5-4.7) in uterine versus 4.5 (95% CI 3.7-5.1) in non-uterine STS. Median overall survival (OS) was 17.5months (95% CI 11.1-19.6), longer than the non-uterine population, 11.1months (95% CI 10.2-12.0) (p=0.352). CONCLUSIONS: Despite heavy pre-treatment, pazopanib shows signs of activity in patients with uterine sarcoma with the similar outcomes to patients with non-uterine STS.
Published: 2016

32. 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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33. Subgroup analysis of leiomyosarcoma (LMS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced liposarcoma (LPS) and LMS

Author: Blay, J.-Y., primary, Schoffski, P., additional, Bauer, S., additional, Krarup-Hansen, A., additional, Benson, C., additional, D'Adamo, D.R., additional, Guo, M., additional, and Maki, R., additional
Published: 2016
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34. Updated safety and efficacy of durvalumab (MEDI4736), an anti-PD-L 1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort

Author: Segal, N.H., primary, Ou, S.-H.I., additional, Balmanoukian, A.S., additional, Massarelli, E., additional, Brahmer, J.R., additional, Weiss, J., additional, Schoffski, P., additional, Antonia, S.J., additional, Massard, C., additional, Zandberg, D.P., additional, Maher, C., additional, Khleif, S., additional, Jin, X., additional, Rebelatto, M., additional, Steele, K., additional, Antal, J., additional, Gupta, A., additional, and Spreafico, A., additional
Published: 2016
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35. Randomized phase 3, multicenter, open-label study comparing evofosfamide (Evo) in combination with doxorubicin (D) vs. D alone in patients (pts) with advanced soft tissue sarcoma (STS): Study TH-CR-406/SARC021

Author: Tap, W., primary, Papai, Z., additional, van Tine, B., additional, Attia, S., additional, Ganjoo, K., additional, Jones, R.L., additional, Schuetze, S., additional, Reed, D., additional, Chawla, S.P., additional, Riedel, R., additional, Krarup-Hansen, A., additional, Italiano, A., additional, Hohenberger, P., additional, Grignani, G., additional, Cranmer, L., additional, Alcindor, T., additional, Lopez-Pousa, A., additional, Pearce, T., additional, Kroll, S., additional, and Schoffski, P., additional
Published: 2016
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36. Mutational analysis of plasma DNA from patients (pts) in the phase III GRID study of regorafenib vs placebo in tyrosine kinase inhibitor (TKI)-refractory GIST: Correlating genotype with clinical outcomes

Author: Reichardt, P., Demetri, G., Kang, Y-K, Blay, J-Y, Joensuu, H., Robert G. Maki, Rutkowski, P., Hohenberger, P., Gelderblom, H., Leahy, M. G., Mehren, M., Schoffski, P., Blackstein, M. E., Le Cesne, A., Badalamenti, G., Xu, J., Nishida, T., Kuss, I., and Casali, P. G.
Published: 2013

37. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial

Author: Demetri, G.D., Reichardt, P., Kang, Y.K., Blay, J.Y., Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M., Mehren, M. von, Joensuu, H., Badalamenti, G., Blackstein, M., Cesne, A. le, Schoffski, P., Maki, R.G., Bauer, S., Nguyen, B.B., Xu, J., Nishida, T., Chung, J., Kappeler, C., Kuss, I., Laurent, D., Casali, P.G., Graaf, W.T.A. van der, Demetri, GD, Reichardt, P, Kang, YK, Blay, JY, Rutkowski, P, Gelderblom, H, Hohenberger, P, Leahy, M, von Mehren, M, Joensuu, H, Badalamenti, G, Blackstein, M, Le Cesne, A, Schöffski, P, Maki, RG, Bauer, S, Nguyen, BB, Xu, J, Nishida, T, Chung, J, Kappeler, C, Kuss, I, Laurent, D, Casali, PG, Demetri, Gd, Kang, Yk, Blay, Jy, Maki, Rg, Nguyen, Bb, Casali, Pg, Biasco, G, and study investigators, Grid
Subjects: Oncology, Male, Indoles, Pyridines, Settore MED/06 - Oncologia Medica, SU11248, Medizin, Piperazines, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Clinical endpoint, Sunitinib, Treatment Failure, regorafenib, gastrointestinal stromal tumours, imatinib and sunitinib, Gastrointestinal Neoplasms, education.field_of_study, GiST, KIT, Age-related aspects of cancer Quality of hospital and integrated care [ONCOL 2], General Medicine, Middle Aged, Survival Rate, Benzamides, Imatinib Mesylate, Female, ADJUVANT IMATINIB, TYROSINE KINASE INHIBITOR, Colorectal Neoplasms, Life Sciences & Biomedicine, medicine.drug, GROWTH-FACTOR, medicine.medical_specialty, Gastrointestinal Stromal Tumors, Population, MESYLATE, Antineoplastic Agents, IMATINIB, Article, MECHANISMS, Medicine, General & Internal, Double-Blind Method, Translational research [ONCOL 3], General & Internal Medicine, Regorafenib, Internal medicine, MANAGEMENT, medicine, Humans, Pyrroles, education, Protein Kinase Inhibitors, Aged, Science & Technology, GASTROINTESTINAL STROMAL TUMOURS, MUTATIONS, business.industry, Phenylurea Compounds, GIST, regorafenib, imatinib, sunitinib, phase III trial, Surgery, Clinical trial, Imatinib mesylate, Pyrimidines, chemistry, business, RESISTANCE
Abstract: Contains fulltext : 118365.pdf (Publisher’s version ) (Closed access) BACKGROUND: Until now, only imatinib and sunitinib have proven clinical benefit in patients with gastrointestinal stromal tumours (GIST), but almost all metastatic GIST eventually develop resistance to these agents, resulting in fatal disease progression. We aimed to assess efficacy and safety of regorafenib in patients with metastatic or unresectable GIST progressing after failure of at least imatinib and sunitinib. METHODS: We did this phase 3 trial at 57 hospitals in 17 countries. Patients with histologically confirmed, metastatic or unresectable GIST, with failure of at least previous imatinib and sunitinib were randomised in a 2:1 ratio (by computer-generated randomisation list and interactive voice response system; preallocated block design (block size 12); stratified by treatment line and geographical region) to receive either oral regorafenib 160 mg daily or placebo, plus best supportive care in both groups, for the first 3 weeks of each 4 week cycle. The study sponsor, participants, and investigators were masked to treatment assignment. The primary endpoint was progression-free survival (PFS). At disease progression, patients assigned placebo could crossover to open-label regorafenib. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01271712. RESULTS: From Jan 4, to Aug 18, 2011, 240 patients were screened and 199 were randomised to receive regorafenib (n=133) or matching placebo (n=66). Data cutoff was Jan 26, 2012. Median PFS per independent blinded central review was 4.8 months (IQR 1.4-9.2) for regorafenib and 0.9 months (0.9-1.8) for placebo (hazard ratio [HR] 0.27, 95% CI 0.19-0.39; p
Published: 2013

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

Author: Bauer, S., Joensuu, H., Casali, P., Reichardt, P., Kang, Y-K, Blay, J-Y, Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M., Mehren, M., Badalamenti, G., Blackstein, M., Le Cesne, A., Schoffski, P., Robert G. Maki, Xu, J., Nishida, T., Kappeler, C., Kuss, I., and Demetri, G. D.
Subjects: Medizin
Published: 2013

39. Detection of oncogenic kinase mutations in circulating plasma DNA and correlation with clinical benefit in the phase III GRID study of regorafenib vs placebo in TKI-refractory metastatic GIST

Author: Demetri, G.D., Jeffers, M., Reichardt, P., Kang, Y.K., Blay, J.Y., Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M., Mehren, M. von, Joensuu, H., Badalamenti, G., Blackstein, M., Cesne, A. le, Schoffski, P., Maki, R.G., Bauer, S., Nguyen, B.B., Xu, J.M., Nishida, T., Chung, J., Lathia, C.D., Kappeler, C., Kuss, I., Laurent, D., and Casali, P.G.
Subjects: Medizin
Published: 2013

40. Randomized phase 3 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: Reichardt, P., Demetri, G., Y-K, Kang, J-Y, Blay, Heikki Joensuu, Maki, R., Rutkowski, P., Hohenberger, P., Gelderblom, H., Leahy, M., Mehren, M., Schoffski, P., Blackstein, M., Le Cesne, A., Badalamenti, G., Xu, J., Nishida, T., Laurent, D., Oliver Kuss, and Casali, P.
Published: 2012

41. RANDOMIZED PHASE 3 TRIAL OF REGORAFENIB IN PATIENTS (PATIENTS) WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMOR (GIST) PROGRESSING DESPITE PRIOR TREATMENT WITH AT LEAST IMATINIB (IM) AND SUNITINIB (SU) : GRID TRIAL

Author: Nishida, T., Casali, P. G., Reichardt, P., Kang, Y. K., Jean-Yves Blay, Joensuu, H., Maki, R. G., Rutkowski, P., Hohenberger, P., Gelderblom, H., Leahy, M. G., Mehren, M., Schoffski, P., Blackstein, M. E., Cesne, A. L., Badalamenti, G., Xu, J. M., Laurent, D., Kuss, I., Demetri, G. D., and Investigators, Grid
Published: 2012

42. PALETTE: Final overall survival (OS) data and predictive factors for OS of EORTC 62072/GSK VEG110727, a randomized double-blind phase III trial of pazopanib versus placebo in advanced soft tissue sarcoma (STS) patients

Author: Graaf, W.T.A. van der, Blay, J.Y., Chawla, S.P., Kim, D.W., Nguyen, B.B., Casali, P.G., Schoffski, P., Aglietta, M., Staddon, A.P., Beppu, Y., Cesne, A. le, Gelderblom, H., Judson, I.R., Araki, N., Ouali, M., Marreaud, S., Hodge, R., Dewji, M., Tos, A.P. dei, and Hohenberger, P.
Published: 2012

43. Single-dimension CT measurements with RECIST 1.1 to evaluate liver metastases in GIST patients on imatinib (Abstract)

Author: Schiavon, G., Ruggiero, A., Sleijfer, S., Bekers, D.J., Holt, B. van der, Kloth, J.S.L., Krestin, G.P., Schoffski, P., Verweij, J., and Mathijssen, R.H.J.
Subjects: TS - Technical Sciences, Physics & Electronics, RT - Radar Technology, Biomedical Innovation, Healthy Living
Abstract: Background: Tumor response assessment to therapy is crucial in oncology, both in daily practice and research.We analyzed the morphology of liver metastases (LM) in gastrointestinal stromal tumors (GIST). Aims were to 1) determine whether uni-dimensional measurements of tumor lesions (according to RECIST 1.1) are accurate reflections of their volumes and 2) estimate eventual bias in volume change calculations, as introduced by using only the longest diameter. Methods: 78 GIST patients with LM were evaluated at baseline (n=139 lesions), 3 (n=129), 6 (n=128), and 12 months (n=108) after imatinib therapy. LM were segmented semi-automatically on standard CT scans. All measurements at baseline were obtained by 2 independent investigators and agreement between observers was assessed with Bland-Altman plots. Values for segmented volume (Vs; mL), maximum transaxial diameter (MTD; mm), and elongation value (EV, defined as 1 - [width/length], where EV of 1 = fully ellipsoidal and 0 = fully spherical) were reported for each lesion at several time-points. A calculated volume (Vc) of each LM was also generated using the MTD, with the hypothesis that metastases were fully spherical. Results: At baseline, 44% (61/139) of the LM was spherical and 56% (78/139) was ellipsoidal. Their EV ranged from 0.08 to 0.94 (mean, 0.53±0.17). During treatment, overall 42% of the lesions kept their morphology (spherical or ellipsoidal) and the other half changed from spherical to ellipsoidal or vice versa. At baseline, there was strong inter-observer agreement in the determination of Vs, with mean inter-observer variability of 1.5% (95% CI, -14.5% to 17.5%). The difference between Vs and Vc was highly significant (P
Published: 2012

44. Tumor Volume as an Alternative Response Measurement for Imatinib Treated GIST Patients

Author: Schiavon, G., Ruggiero, A., Schoffski P., Holt, B. van der, Bekers, D.J., and et al
Subjects: TS - Technical Sciences, Physics & Electronics, Health, RT - Radar Technology, Biomedical Innovation, sense organs, Healthy Living
Abstract: Background: Assessment of tumor size changes is crucial in clinical trials and patient care. We compared imatinib-induced volume changes of liver metastases (LM) from gastro-intestinal stromal tumors (GIST) to RECIST and Choi criteria and their association with overall survival (OS). Methods: LM from 84 GIST patients (training and validation set) were evaluated using manual and semi-automated Computed Tomography measurements at baseline, after 3, 6 and 12 months of imatinib. The ability of uni-dimensional (1D) and three-dimensional (3D) measurements to detect size changes (increase/decrease) >/=20% was evaluated. Volumetric response cut-offs were derived from minimally relevant changes (+20/230%) by RECIST, considering lesions as spherical or ellipsoidal. Results: 3D measurements detected size changes >/=20% more frequently than 1D at every time-point (P>/=0.008). 3D and Choi criteria registered more responses than RECIST at 3 and 6 months for 3D-spheres (P>/=0.03) and at all time-points for 3D-ellipsoids and Choi criteria (P
Published: 2012

45. Intrinsic cell memory reinforces myogenic commitment of pericyte-derived iPS

Author: Quattrocelli, Mattia, Palazzolo, G., Floris, G., Schoffski, P., Anastasia, L., Orlacchio, Aldo, Vandendriessche, T., Chuah, M. K. L., Cossu, G., Verfaillie, C., and Sampaolesi, M.
Subjects: muscular dystrophy, epigenetic memory, iPSCs, CD56, iPSCs, pericytes, muscular dystrophy, CD56, epigenetic memory, pericytes
Published: 2011

46. Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial

Author: Hristova, I.N., Boellaard, R., Vogel, W., Mottaghy, F., Marreaud, S., Collette, S., Schoffski, P., Sanfilippo, R., Dewji, R., Graaf, W.T.A. van der, Oyen, W.J.G., Hristova, I.N., Boellaard, R., Vogel, W., Mottaghy, F., Marreaud, S., Collette, S., Schoffski, P., Sanfilippo, R., Dewji, R., Graaf, W.T.A. van der, and Oyen, W.J.G.
Abstract: Contains fulltext : 153884.pdf (Publisher’s version ) (Open Access), PURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 +/- 0.33 at baseline and 2.27 +/- 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 +/- 1.04 at baseline and 2.18 +/- 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations.
Published: 2015

47. Hypertension (HTN) as a potential biomarker of efficacy in pazopanib-treated patients with advanced non-adipocytic soft tissue sarcoma. A retrospective study based on European Organisation for Research and Treatment of Cancer (EORTC) 62043 and 62072 trials

Author: Duffaud, F., Sleijfer, S., Litiere, S., Ray-Coquard, I., Cesne, A. Le, Papai, Z., Judson, I., Schoffski, P., Chawla, S.P., Dewji, R., Marreaud, S., Verweij, J., Graaf, W.T.A. van der, Duffaud, F., Sleijfer, S., Litiere, S., Ray-Coquard, I., Cesne, A. Le, Papai, Z., Judson, I., Schoffski, P., Chawla, S.P., Dewji, R., Marreaud, S., Verweij, J., and Graaf, W.T.A. van der
Abstract: Item does not contain fulltext, BACKGROUND: Reliable biomarkers of pazopanib's efficacy in soft tissue sarcoma (STS) are lacking. Hypertension (HTN) is an on-target effect of vascular endothelial growth factor (VEGF)-receptor inhibitors such as pazopanib. We evaluated the association of pazopanib-induced HTN with antitumour efficacy in patients with metastatic non-adipocytic STS. METHODS: Associations between pazopanib-induced-HTN and antitumour efficacy were retrospectively assessed across 2 prospective studies (European Organisation for Research and Treatment of Cancer (EORTC) study 62043 and 62072) in metastatic STS patients who received pazopanib 800mg daily. Only patients with baseline blood pressure (BP)<150/90mmHg, were included. BP was measured monthly. HTN was reported according to National Cancer Institute-Common Toxicity Criteria Adverse Events (NCI-CTC AE) grading (v3.0), and as absolute differences compared to baseline. The effect of HTN developing in patients without baseline anti-hypertensive medication was assessed on progression-free (PFS) and overall survival (OS) using a landmark analysis stratified by study; univariately using the Kaplan-Meier method and a log-rank test, and in a multivariate Cox regression model after adjustment for important prognostic factors. RESULTS: Of the 337 patients eligible for this analysis, 21.7% received anti-hypertensive medication at baseline and had a similar PFS and OS compared to those who did not. In patients without baseline anti-hypertensive medication, 38.6% developed HTN. As the majority of patients developing HTN did so within 5weeks after initiation of pazopanib (68.6%), this time point was used as landmark. Univariately, there was no effect on PFS or OS from occurrence of HTN within 5weeks of treatment expressed either in NCI-CTC AE criteria or as maximal differences from baseline in systolic and diastolic BP. Also in multivariate analysis, after adjusting for important prognostic factors, the occurrence of HTN expressed in the differe
Published: 2015

48. Follow-up strategies for patients with gastrointestinal stromal tumour treated with or without adjuvant imatinib after surgery

Author: University of Helsinki, Clinicum, Joensuu, H., Martin-Broto, J., Nishida, T., Reichardt, P., Schoffski, P., Maki, R. G., University of Helsinki, Clinicum, Joensuu, H., Martin-Broto, J., Nishida, T., Reichardt, P., Schoffski, P., and Maki, R. G.
Published: 2015

49. Efficacy and safety of biweekly i.v. administrations of the Aurora kinase inhibitor danusertib hydrochloride in independent cohorts of patients with advanced or metastatic breast, ovarian, colorectal, pancreatic, small-cell and non-small-cell lung cancer: a multi-tumour, multi-institutional phase II study

Author: Schoffski, P, Besse, B, Gauler, T, De Jonge, Mja, Scambia, Giovanni, Santoro, A, Davite, C, Jannuzzo, Mg, Petroccione, A, Delord, J., Scambia, Giovanni (ORCID:0000-0003-2758-1063), Schoffski, P, Besse, B, Gauler, T, De Jonge, Mja, Scambia, Giovanni, Santoro, A, Davite, C, Jannuzzo, Mg, Petroccione, A, Delord, J., and Scambia, Giovanni (ORCID:0000-0003-2758-1063)
Abstract: inhibitor danusertib hydrochloride (PHA-739358) in breast (BC), ovarian (OC), pancreatic (PC), colorectal (CRC), small-cell (SCLC) and non-small-cell lung (NSCLC) cancers. METHODS: Consenting adult patients with good performance and organ function with advanced/metastatic tumours who had failed systemic therapy were treated in independent, disease-specific cohorts with danusertib 500 mg/m(2) given as 24-h i.v. infusion every 14 days with until progression or unacceptable toxicity. A two-stage design was applied. Primary end point was the progression-free rate (PFR) at 4 months (RECIST1.1). RESULTS: A total of 223 patients were enrolled with 219 actively treated. The median relative dose intensity of danusertib was similar for all tumour types (84.6%-99.6%). The median number of biweekly treatment cycles ranged from 3 to 4/patient (maximum 5-40 cycles/entity) and the median treatment duration varied between 7.6 and 10.0 weeks per histotype. Danusertib did not meet pre-specified protocol criteria for clinically relevant activity in any of the treated cancers. The PFR at 4 months was 18.4% in BC, 12.1% in OC, 10.0% in PC, 10.4% in NSCLC (all histotypes), 16.1% in squamous NSCLC and 0% in SCLC and CRC. Some radiological and/or biochemical indication of antitumor activity was seen in BC, OC, PC and NSCLC, including two confirmed partial responses. The most frequent drug-related non-laboratory adverse events (AEs) were fatigue/asthenia, nausea, diarrhoea, anorexia, vomiting, alopecia, constipation and pyrexia. Common laboratory AEs included haematological toxicity, hypalbuminaemia and increases in liver enzymes. Treatment was discontinued due to AEs in only 5.5% of patients. Plasma concentrations of danusertib were in line with results from earlier studies. CONCLUSION: Single-agent danusertib did show only marginal anti-tumour activity in common solid tumours after failure of prior systemic therapies. The safety and PK profile was consistent with previous experience.
Published: 2015

50. Coactivated Platelet-Derived Growth Factor Receptor alpha and Epidermal Growth Factor Receptor Are Potential Therapeutic Targets in Intimal Sarcoma

Author: Dewaele, B., Floris, G., Finalet-Ferreiro, J., Fletcher, C.D., Coindre, J.M., Guillou, L., Hogendoorn, P.C.W., Wozniak, A., Vanspauwen, V., Schoffski, P., Marynen, P., Vandenberghe, P., Sciot, R., and Debiec-Rychter, M.
Subjects: comparative-genomic-hybridization gastrointestinal stromal tumors squamous-cell carcinoma human colon-carcinoma kinase-inhibitor pulmonary-artery tyrosine-kinases lung-cancer pdgfr-alpha kit, digestive system diseases
Abstract: Intimal sarcoma (IS) is a rare, malignant, and aggressive tumor that shows a relentless course with a concomitant low survival rate and for which no effective treatment is available. In this study, 21 cases of large arterial blood vessel IS were analyzed by immunohistochemistry and fluorescence in situ hybridization and selectively by karyotyping, array comparative genomic hybridization, sequencing, phospho-kinase antibody arrays, and Western immunoblotting in search for novel diagnostic markers and potential molecular therapeutic targets. Ex vivo immunoassays were applied to test the sensitivity of IS primary tumor cells to the receptor tyrosine kinase (RTK) inhibitors imatinib and dasatinib. We showed that amplification of platelet-derived growth factor receptor a (PDGFRA) is a common finding in IS, which should be considered as a molecular hallmark of this entity. This amplification is consistently associated with PDGFRA activation. Furthermore, the tumors reveal persistent activation of the epidermal growth factor receptor (EGFR), concurrent to PDGFRA activation. Activated PDGFRA and EGFR frequently coexist with amplification and overexpression of the MDM2 oncogene. Ex vivo immunoassays on primary IS cells from one case showed the potency of dasatinib to inhibit PDGFRA and downstream signaling pathways. Our findings provide a rationale for investigating therapies that target PDGFRA, EGFR, or MDM2 in IS. Given the clonal heterogeneity of this tumor type and the potential cross-talk between the PDGFRA and EGFR signaling pathways, targeting multiple RTKs and aberrant downstream effectors might be required to improve the therapeutic outcome for patients with this disease. Cancer Res; 70(18); 7304-14. (C) 2010 AACR.
Published: 2010

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