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Outcome of 98 patients with epithelioid sarcoma treated in curative intent: A retrospective study from the French Sarcoma Group (GSF-GETO)
abstracts
Annals of Oncology PharmaMar; Research grant / Funding (institution): Amgen, Bayer, Novartis, Roche, MEI-Pharma. T. Rordorf: Advisory / Consultancy: Bristol-Myers Squibb and Merck KGaA. N. Mach: Honoraria (institution), Advisory / Consultancy: Amgen, AstraZeneca, Bristol-Myers Squibb, F. Hoffmann-La Roche, Merck Sharp and Dohme, Merck Serono, Novartis, Pharma Mar, as well as honorarium for talks in a company’s organised public event from Bristol-Myers Squibb and Pharma Mar. C.A. Rothermundt: Advisory / Consultancy: BMS, Astellas Pharma Schweiz, GSK, Novartis, Roche, Pfizer, PharmaMar; Research grant / Funding (institution): Research Funding Recipient Institution. All other authors have declared no conflicts of interest.
1689P
M. Pedrono1, O. Mir2, L. Chaltiel3, M. Brahmi4, A. Italiano5, G. Decanter6, P. Boudou Rouquette7, M. Ropars8, E. Bompas9, N. Firmin10, N. Isambert11, T. Valentin12, F. Duffaud13, J. Gantzer14, A. Thyss15, C. Guillemet16, J-Y. Blay4, A. Le Cesne2, C.M. Chevreau12, C. Perrin1 1 Medical Oncology, Centre Eugene - Marquis, Rennes, France, 2De´partement de Me´decine oncologique, Institut Gustave Roussy, Villejuif, France, 3Biostatistics Unit, Institut Claudius Regaud - Institut Universitaire du Cancer de Toulouse (IUCT) – Oncopole, Toulouse, France, 4Medical Oncology, Centre Le´on Be´rard, Lyon, France, 5 Medical Oncology, Institute Bergonie´, Bordeaux, France, 6Surgery, Centre Oscar Lambret, Lille, France, 7Medical Oncology, Hoˆpital Cochin - APHP, Paris, France, 8 Orthopedic Surgery, CHU Pontchaillou, Rennes, France, 9Medical Oncology, ICO Institut de Cancerologie de l’Ouest Rene´ Gauducheau, Saint-Herblain, France, 10Medical Oncology, Institut du Cancer de Montpellier, Montpellier, France, 11Department of Medical Oncology, Centre Georges-Franc¸ois Leclerc (Dijon), Dijon, France, 12Medical Oncology, IUCT-Oncopoˆle Institut Claudius Regaud, Toulouse, France, 13Medical Oncology, CHU La Timone Adultes, Marseille, France, 14Medical Oncology, C.H.U. Strasbourg-Nouvel Hopital Civil, Strasbourg, France, 15Medical Oncology, Centre Antoine Lacassagne, Nice, France, 16Medical Oncology, Centre Henri Becquerel, Rouen, France Background: Epithelioid sarcoma (ES) is a rare soft-tissue sarcoma (STS) (1%). Few recent studies describe pathological and clinical characteristics of ES. Little is known about management and outcomes of patients with localized diseases. The objectives are to study tumor characteristics and clinical management of ES patients with local and locally-advanced disease. Methods: This is a retrospective study from the nation-wide French sarcoma network (NetSarc). From 2000 to 2016, patients with confirmed ES by expert pathologists, and with a localized disease were included. R2 were excluded. Results: A total of 98 patients were analysed from 13 centres. Median age was 38 years (range 9-90) with male predominance (56%). The median size was 4 cm (0.3-72). Most common location was distal upper limb (40%). Pre-surgical biopsy was performed in 46% of patients. R0 resection was obtained for 64 patients (79%), R1 for 17 patients (21%). Margins revision surgery has been performed in 51% of patients. Limb-sparing was possible in 73% patients and amputation in 27%. Twenty-five patients (26%) received neoadjuvant treatments mainly chemotherapy with doxorubin-based regimen or isolated limb perfusion in 8 patients (10%). After surgery, 40 patients (43%) received adjuvant treatment, mainly radiotherapy (93%) and 20% received chemotherapy. After a median follow-up of 66.2 months (IC 95 48.4-74.7), 52% patients relapsed : locoregional relapse for 25 patients (52%), distant metastases for 35 patients (75%). The median disease-free-survival (DFS) was 54.5 months (IC95 33.7-105.6). Five-year overall survival (OS) rate was 71% (IC95 59-80). By univariate analyses, locally advanced disease and size larger than 5 cm were identified as a poor-prognosis factors for DFS and OS. R1 surgical margins were prognostic for OS. Proximal location, necrosis, mitosis index had no significant prognostic impact. Conclusions: ES have a high rate of recurrence, particularly as locoregional relapse. Locally advanced disease, size larger than 5 cm, R1 surgical margins were identified as a poor-prognosis factors. Legal entity responsible for the study: Perrin Christophe. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1690P
Comparison of filgrastim and pegfilgrastim prophylaxis in sarcoma patients receiving highly myelosuppressive chemotherapy
P. Tarantino1, P. Zagami1, P. Trillo1, F. Conforti2, L. Pala2, S. Morganti1, E. Ferraro1, G. Viale1, B.A. Duso1, P. D’Amico1, A. Marra1, D. Trapani1, T.M. De Pas2 1 Department of Hematology and Oncology, University of Milan, Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy, 2Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institute of Oncology IRCCS, Milan, Italy Background: Highly myelosuppressive chemotherapy (HMC) is the standard treatment for several types of sarcoma. Severe neutropenia is a common adverse event, which can lead to febrile neutropenia (FN) and major infections requiring hospitalization, with up to 15% mortality rate. Several trials showed an equal efficacy of filgrastim (F) and Peg-filgrastim (Peg-F) for preventing FN in many cancer types, but limited
Volume 30 | Supplement 5 | October 2019
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Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe
V. Ostafiichuk, S.I. Korovin, M.N. Kukus Skin Tumors and Soft Tissue Tumors, Background: Soft tissue sarcomas are oncological diseases. Since the 1970s, therapeutic agent for the treatment of and primary localized sarcoma has agents have been identified in this this problem in general and vative medicines. We performed clinical trials for soft tissue sarcoma Methods: Based on data from that have been performed in 2009-20 20 in Eastern countries). Clinical type, stage of disease and status were Results: The vast majority of soft Europe (401/467) and of those country was 40, ranging from 30 (Switzerland) to 92 (France). In Eastern Europe the average number of trials per country was 3 with a maximum of 23 (Poland); 45.5% of trials were phase III. Clinical trials in adults (> 18 years) in Eastern Europe and Western Europe (78.8% vs 75.3%), in patients younger than 18 years (21.2% vs 24.7%), respectively. For soft tissue sarcoma stages I-II, III, (unresectable)/IV 1.0, 17.5 and 81.5% trials, respectively, have been held in Western Europe, 0, 18.2 and 81.8% trials in Eastern Europe. The most frequent clinical trials studies of targeted therapy, chemotherapy and combination treatment, constituting 35.9%, 20.4% and 17.2% trials in Western Europe and in 18.2%, 27.3% and 16.7% trials in Eastern Europe, respectively. Only 14.1% of trials are currently recruiting patients in Eastern Europe while 85.9% of recruitment is in Western Europe. Conclusions: Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe is quite different. Participation in clinical trials could help as patients from countries with low access to innovative medicines or oncologists could get necessary experience. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Treatment outcomes for adult patients with localized osteosarcoma treated with chemotherapy without methotrexate
M.P.M. Silva1, R.R.D.C.C. Bonadio1, G.D.R. Matos2, V.P. Camargo1 Medical Oncology, ICESP - Instituto do C^ ancer do Estado de S~ ao Paulo, Sao Paulo, Brazil, 2Medical Oncology, Hospital Sırio Liban^es, Brasılia, Brazil
1
Background: In pediatric patients (pts) with localized osteosarcoma, cure rates higher than 60% have been reported. A chemotherapy (CT) regimen frequently suggested as standard in this scenario is the three-drug regimen MAP (methotrexate [MTX], doxorubicin, and cisplatin). However, the addition of MTX remains controversial, especially
doi:10.1093/annonc/mdz283 | v693
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz283.022/5577131 by guest on 20 October 2019
Outcome of 98 patients with epithelioid sarcoma treated in curative intent: A retrospective study from the French Sarcoma Group (GSFGETO)
evidence is available in adult sarcoma patients (pts). We retrospectively compared the incidence of FN and hospitalization due to neutropenic infections in sarcoma pts treated with HMC with the support of either F or Peg-F. Methods: We reviewed data of pts consecutively treated in our institution from Sep 2014 to Mar 2019. Inclusion criteria were: age >18 years; diagnosis of soft tissue sarcoma; at least 1 cycle of HMC supported by prophylactic F or Peg-F. Included HMC regimens were: doxorubicin 60 mg/m2 (D) þ ifosfamide 9 g/m2 (IFO) þ/- vincristine; high-dose IFO (12 g/m); IFO 9 g/m2 þ etoposide. Neutropenia prophylaxis included F (5-7 doses) or Peg-F (1 dose) according to physician‘s choice. v2-Test was used to compare the outcomes; p 0.05 was considered significant. Results: 79 pts were found eligible, receiving 330 cycles of HMC. F and peg-F were used as prophylaxis in 66.6% (n ¼ 220) and 33.3% (n ¼ 110) of cases, respectively. The rate of FN was higher in the Peg-F group compared to the F group (11.8% vs 6.8, p ¼ 0.12), while the rate of cycles complicated by a hospitalization was 9% and 3.2% (p ¼ 0.02), respectively. 8/16 hospitalizations were due to pneumonia. One death during hospitalization occurred in the Peg-F group. 70% of hospitalizations occurred in metastatic pts, whereas 30% occurred during adjuvant treatments. Conclusions: The use of peg-F was associated with a significantly higher rate of neutropenic infections requiring hospitalization compared with F in adult sarcoma pts receiving HMC. FN rate was numerically higher in pts receiving peg-F, not reaching statistical significance. These data suggest that F prophylaxis may be preferred in this setting to peg-F. Overall, prophylaxis with both agents provided a relatively low rate of hospitalizations and FN, compared with the myelosuppressive potential of the regimens. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology PharmaMar; Research grant / Funding (institution): Amgen, Bayer, Novartis, Roche, MEI-Pharma. T. Rordorf: Advisory / Consultancy: Bristol-Myers Squibb and Merck KGaA. N. Mach: Honoraria (institution), Advisory / Consultancy: Amgen, AstraZeneca, Bristol-Myers Squibb, F. Hoffmann-La Roche, Merck Sharp and Dohme, Merck Serono, Novartis, Pharma Mar, as well as honorarium for talks in a company’s organised public event from Bristol-Myers Squibb and Pharma Mar. C.A. Rothermundt: Advisory / Consultancy: BMS, Astellas Pharma Schweiz, GSK, Novartis, Roche, Pfizer, PharmaMar; Research grant / Funding (institution): Research Funding Recipient Institution. All other authors have declared no conflicts of interest.
1689P
M. Pedrono1, O. Mir2, L. Chaltiel3, M. Brahmi4, A. Italiano5, G. Decanter6, P. Boudou Rouquette7, M. Ropars8, E. Bompas9, N. Firmin10, N. Isambert11, T. Valentin12, F. Duffaud13, J. Gantzer14, A. Thyss15, C. Guillemet16, J-Y. Blay4, A. Le Cesne2, C.M. Chevreau12, C. Perrin1 1 Medical Oncology, Centre Eugene - Marquis, Rennes, France, 2De´partement de Me´decine oncologique, Institut Gustave Roussy, Villejuif, France, 3Biostatistics Unit, Institut Claudius Regaud - Institut Universitaire du Cancer de Toulouse (IUCT) – Oncopole, Toulouse, France, 4Medical Oncology, Centre Le´on Be´rard, Lyon, France, 5 Medical Oncology, Institute Bergonie´, Bordeaux, France, 6Surgery, Centre Oscar Lambret, Lille, France, 7Medical Oncology, Hoˆpital Cochin - APHP, Paris, France, 8 Orthopedic Surgery, CHU Pontchaillou, Rennes, France, 9Medical Oncology, ICO Institut de Cancerologie de l’Ouest Rene´ Gauducheau, Saint-Herblain, France, 10Medical Oncology, Institut du Cancer de Montpellier, Montpellier, France, 11Department of Medical Oncology, Centre Georges-Franc¸ois Leclerc (Dijon), Dijon, France, 12Medical Oncology, IUCT-Oncopoˆle Institut Claudius Regaud, Toulouse, France, 13Medical Oncology, CHU La Timone Adultes, Marseille, France, 14Medical Oncology, C.H.U. Strasbourg-Nouvel Hopital Civil, Strasbourg, France, 15Medical Oncology, Centre Antoine Lacassagne, Nice, France, 16Medical Oncology, Centre Henri Becquerel, Rouen, France Background: Epithelioid sarcoma (ES) is a rare soft-tissue sarcoma (STS) (1%). Few recent studies describe pathological and clinical characteristics of ES. Little is known about management and outcomes of patients with localized diseases. The objectives are to study tumor characteristics and clinical management of ES patients with local and locally-advanced disease. Methods: This is a retrospective study from the nation-wide French sarcoma network (NetSarc). From 2000 to 2016, patients with confirmed ES by expert pathologists, and with a localized disease were included. R2 were excluded. Results: A total of 98 patients were analysed from 13 centres. Median age was 38 years (range 9-90) with male predominance (56%). The median size was 4 cm (0.3-72). Most common location was distal upper limb (40%). Pre-surgical biopsy was performed in 46% of patients. R0 resection was obtained for 64 patients (79%), R1 for 17 patients (21%). Margins revision surgery has been performed in 51% of patients. Limb-sparing was possible in 73% patients and amputation in 27%. Twenty-five patients (26%) received neoadjuvant treatments mainly chemotherapy with doxorubin-based regimen or isolated limb perfusion in 8 patients (10%). After surgery, 40 patients (43%) received adjuvant treatment, mainly radiotherapy (93%) and 20% received chemotherapy. After a median follow-up of 66.2 months (IC 95 48.4-74.7), 52% patients relapsed : locoregional relapse for 25 patients (52%), distant metastases for 35 patients (75%). The median disease-free-survival (DFS) was 54.5 months (IC95 33.7-105.6). Five-year overall survival (OS) rate was 71% (IC95 59-80). By univariate analyses, locally advanced disease and size larger than 5 cm were identified as a poor-prognosis factors for DFS and OS. R1 surgical margins were prognostic for OS. Proximal location, necrosis, mitosis index had no significant prognostic impact. Conclusions: ES have a high rate of recurrence, particularly as locoregional relapse. Locally advanced disease, size larger than 5 cm, R1 surgical margins were identified as a poor-prognosis factors. Legal entity responsible for the study: Perrin Christophe. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1690P
Comparison of filgrastim and pegfilgrastim prophylaxis in sarcoma patients receiving highly myelosuppressive chemotherapy
P. Tarantino1, P. Zagami1, P. Trillo1, F. Conforti2, L. Pala2, S. Morganti1, E. Ferraro1, G. Viale1, B.A. Duso1, P. D’Amico1, A. Marra1, D. Trapani1, T.M. De Pas2 1 Department of Hematology and Oncology, University of Milan, Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy, 2Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institute of Oncology IRCCS, Milan, Italy Background: Highly myelosuppressive chemotherapy (HMC) is the standard treatment for several types of sarcoma. Severe neutropenia is a common adverse event, which can lead to febrile neutropenia (FN) and major infections requiring hospitalization, with up to 15% mortality rate. Several trials showed an equal efficacy of filgrastim (F) and Peg-filgrastim (Peg-F) for preventing FN in many cancer types, but limited
Volume 30 | Supplement 5 | October 2019
1691P
Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe
V. Ostafiichuk, S.I. Korovin, M.N. Kukus Skin Tumors and Soft Tissue Tumors, Background: Soft tissue sarcomas are oncological diseases. Since the 1970s, therapeutic agent for the treatment of and primary localized sarcoma has agents have been identified in this this problem in general and vative medicines. We performed clinical trials for soft tissue sarcoma Methods: Based on data from that have been performed in 2009-20 20 in Eastern countries). Clinical type, stage of disease and status were Results: The vast majority of soft Europe (401/467) and of those country was 40, ranging from 30 (Switzerland) to 92 (France). In Eastern Europe the average number of trials per country was 3 with a maximum of 23 (Poland); 45.5% of trials were phase III. Clinical trials in adults (> 18 years) in Eastern Europe and Western Europe (78.8% vs 75.3%), in patients younger than 18 years (21.2% vs 24.7%), respectively. For soft tissue sarcoma stages I-II, III, (unresectable)/IV 1.0, 17.5 and 81.5% trials, respectively, have been held in Western Europe, 0, 18.2 and 81.8% trials in Eastern Europe. The most frequent clinical trials studies of targeted therapy, chemotherapy and combination treatment, constituting 35.9%, 20.4% and 17.2% trials in Western Europe and in 18.2%, 27.3% and 16.7% trials in Eastern Europe, respectively. Only 14.1% of trials are currently recruiting patients in Eastern Europe while 85.9% of recruitment is in Western Europe. Conclusions: Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe is quite different. Participation in clinical trials could help as patients from countries with low access to innovative medicines or oncologists could get necessary experience. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1692P
Treatment outcomes for adult patients with localized osteosarcoma treated with chemotherapy without methotrexate
M.P.M. Silva1, R.R.D.C.C. Bonadio1, G.D.R. Matos2, V.P. Camargo1 Medical Oncology, ICESP - Instituto do C^ ancer do Estado de S~ ao Paulo, Sao Paulo, Brazil, 2Medical Oncology, Hospital Sırio Liban^es, Brasılia, Brazil
1
Background: In pediatric patients (pts) with localized osteosarcoma, cure rates higher than 60% have been reported. A chemotherapy (CT) regimen frequently suggested as standard in this scenario is the three-drug regimen MAP (methotrexate [MTX], doxorubicin, and cisplatin). However, the addition of MTX remains controversial, especially
doi:10.1093/annonc/mdz283 | v693
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz283.022/5577131 by guest on 20 October 2019
Outcome of 98 patients with epithelioid sarcoma treated in curative intent: A retrospective study from the French Sarcoma Group (GSFGETO)
evidence is available in adult sarcoma patients (pts). We retrospectively compared the incidence of FN and hospitalization due to neutropenic infections in sarcoma pts treated with HMC with the support of either F or Peg-F. Methods: We reviewed data of pts consecutively treated in our institution from Sep 2014 to Mar 2019. Inclusion criteria were: age >18 years; diagnosis of soft tissue sarcoma; at least 1 cycle of HMC supported by prophylactic F or Peg-F. Included HMC regimens were: doxorubicin 60 mg/m2 (D) þ ifosfamide 9 g/m2 (IFO) þ/- vincristine; high-dose IFO (12 g/m); IFO 9 g/m2 þ etoposide. Neutropenia prophylaxis included F (5-7 doses) or Peg-F (1 dose) according to physician‘s choice. v2-Test was used to compare the outcomes; p 0.05 was considered significant. Results: 79 pts were found eligible, receiving 330 cycles of HMC. F and peg-F were used as prophylaxis in 66.6% (n ¼ 220) and 33.3% (n ¼ 110) of cases, respectively. The rate of FN was higher in the Peg-F group compared to the F group (11.8% vs 6.8, p ¼ 0.12), while the rate of cycles complicated by a hospitalization was 9% and 3.2% (p ¼ 0.02), respectively. 8/16 hospitalizations were due to pneumonia. One death during hospitalization occurred in the Peg-F group. 70% of hospitalizations occurred in metastatic pts, whereas 30% occurred during adjuvant treatments. Conclusions: The use of peg-F was associated with a significantly higher rate of neutropenic infections requiring hospitalization compared with F in adult sarcoma pts receiving HMC. FN rate was numerically higher in pts receiving peg-F, not reaching statistical significance. These data suggest that F prophylaxis may be preferred in this setting to peg-F. Overall, prophylaxis with both agents provided a relatively low rate of hospitalizations and FN, compared with the myelosuppressive potential of the regimens. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.