This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.

开始日期2024-03-29

申办/合作机构

Italian Sarcoma Group

NCT04274023 / Terminated临床2期IIT

Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma

Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).

开始日期2024-01-29

申办/合作机构

Italian Sarcoma Group

[+1]

NCT04383119 / Recruiting临床2期IIT

A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy

Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator.
In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option.
In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.

开始日期2021-10-29

申办/合作机构

Italian Sarcoma Group

[+1]

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2023-02-01·Tumori Journal4区 · 医学

Lung metastasectomy for osteosarcoma in children, adolescents, and young adults: proof of permanent cure

4区 · 医学

Article

作者: Leuzzi, Giovanni ; Pastorino, Ugo ; Picci, Piero ; Porcu, Luca ; Massimino, Maura ; Scanagatta, Paolo ; Meazza, Cristina ; Luksch, Roberto ; Palmerini, Emanuela

Introduction Surgical resection of pulmonary metastases has been associated with increased survival at 5 years for osteosarcoma, but limited information is available on long-term outcome, role of repeated metastasectomies, and surgical sequelae in a pediatric population. We analyzed a consecutive series of children, adolescents, and young adults (AYA) treated by repeated lung metastasectomies during a period >40 years to estimate the clinical benefit and potential cure rate of salvage surgery. Methods All patients who underwent lung metastasectomy for osteosarcoma at the IRCCS Istituto Ortopedico Rizzoli of Bologna, University of Modena, and IRCCS Istituto Nazionale Tumori of Milan from May 1973 to January 2014 were included. Overall survival (OS) at 20 years from the first metastasectomy was calculated. Results A total of 463 consecutive children and AYA were analyzed. Median age was 15.9 years (range 0.2–23.2 years) and median follow-up 18.6 years. The 5- and 20-year OS were 34.0% and 29.7% (95% CI 25.5–34.0%). Among the 138 (29.8%) alive patients, 42 (30.4%) had disease recurrence cured by repeated metastasectomies. Disease-free interval from primary tumor, number of metastases, and complete resection were the most relevant survival predictors at multivariable model analysis. Discussion The extended follow-up of this consecutive series shows that repeated lung metastasectomy can achieve a permanent cure when offered to properly selected patients with metastases from osteosarcoma.

2021-07-01·European Journal of Cancer1区 · 医学

Outcome in dedifferentiated chondrosarcoma for patients treated with multimodal therapy: Results from the EUROpean Bone Over 40 Sarcoma Study

1区 · 医学

Article

作者: Smeland, Sigbjørn ; Blattmann, Claudia ; Brosjø, Otte ; Setola, Elisabetta ; Schwarz, Rudolf ; Kühne, Thomas ; Picci, Pierro ; Heydrich, Björn-N ; Flörcken, Anne ; Hecker-Nolting, Stefanie ; Bjerkehagen, Bodil ; Krasniqi, Fatime ; Bertulli, Rossella ; Ferraresi, Virginia ; Hall, Kirsten S ; Baumhoer, Daniel ; Hansson, Lina ; Eriksson, Mikael ; Ferrari, Stefano ; Kager, Leo ; Ruggieri, Pietro ; Comandone, Alessandro ; Reichardt, Peter ; Hompland, Ivar ; Gambarotti, Marco ; Kessler, Torsten ; Bielack, Stefan ; Kevric, Matthias ; Apice, Gaetano ; Casali, Paolo ; Palmerini, Emanuela ; Donati, Davide M ; Hofmann-Wackersreuther, Gerda ; Biagini, Roberto ; Staals, Eric

INTRODUCTIONThe role of chemotherapy for patients with dedifferentiated chondrosarcoma (DDCS) is still under discussion. Here, we present the outcome in patients with DDCS treated with intensive chemotherapy from the EUROpean Bone Over 40 Sarcoma Study.MATERIALS AND METHODSThe chemotherapy regimen included doxorubicin, ifosfamide and cisplatin. Postoperative methotrexate was added in case of poor histological response. Toxicity was graded based on the National Cancer Institute expanded common toxicity criteria, version 2.0, and survival was analysed using Kaplan-Meier curves, log-rank tests and univariate Cox regression models.RESULTSFifty-seven patients with DDCS (localised, 34 [60%]; metastatic, 23 [40%]) aged 42-65 years were included. Surgical complete remission (SCR) was achieved in 36 (63%) patients. The median overall survival (OS) was 24 months (95% confidence interval, 22-25), and the 5-year OS was 39%. Patients with extremity localisation had a 5-year OS of 49% compared with 29% in patients with a central tumour (P = 0.08). Patients with localised disease had a 5-year OS of 46%, whereas patients with metastatic disease had a 5-year OS of 29% (P = 0.12). Patients in SCR had a 5-year OS of 49%, whereas patients not in SCR had a 5-year OS of 23% (P = 0.004). Chemotherapy toxicity was considerable but manageable. There was no treatment-related death, and 39 (70%) patients received ≥6 cycles of the planned nine chemotherapy cycles.CONCLUSIONSAdding intensive chemotherapy to surgery for treatment of DDCS is feasible and shows favourable survival data compared with previous reports. With the limitations of data from a non-controlled trial, we conclude that chemotherapy could be considered in the management of patients aged >40 years.

2021-05-20·Journal of Clinical Oncology

ABCB1/P-glycoprotein (Pgp) expression as stratification factor for treatment of patients with non-metastaticextremity high-grade osteosarcoma: A merged analysis of an Italian (ISG) and a Spanish (GEIS) sarcoma groups' multicentric prospective trials.

作者: Picci, Piero ; Mata, Cristina ; Asaftei, Sebastian Dorin ; Bertulli, Rossella ; Canete, Adela ; Meazza, Cristina ; Echebarria, Aizpea ; Sirvent, Francisco José Bautista ; Ferrari, Stefano ; Luksch, Roberto ; Quintero, Víctor ; Longhi, Alessandra ; Marquez, Catalina ; Hindi, Nadia ; Milano, Giuseppe Maria ; Tamburini, Angela ; Palmerini, Emanuela ; Fagioli, Franca ; Bisogno, Gianni ; Ferraresi, Virginia

11527 Background: Overexpression of ABCB1/P-glycoprotein (Pgp) predicts poor outcome in retrospective osteosarcoma series.Two prospective trials with Pgp expression and post-induction histologic response as stratification factors were activated in Italy (ISG/OS-2) and Spain (GEIS-33). Methods: Patients ≤ 40 years with extremity non-metastatic high-grade osteosarcoma were eligible. Analysisi of Pgp expression from diagnostic biopsy was centralized. Preoperatively, all patients received methotrexate, adriamycin, cisplatinum (MAP). Surgery was performed at week 8. All patients received a dose of adriamycin following surgery. In case of Pgp overexpression (Pgp+), mifamurtide (2 mg/m2 twice/week for 3 months then weekly for 6 months) was added after surgery, with 4 consecutive cycles of ifosfamide 3 gr/m2/day, day 1-5 (HDIFO) in case of poor histologic response (necrosis < 90%) to MAP. Patients without overexpression of Pgp (Pgp-) received MAP postoperatively, regardless the pathological response. From March 2013, an amendment increased high dose methotrexate cumulative dose from 60 g/m2 (5 cycles) to 120 mg/m2 (10 cycles). The post-amendment regimen was adopted in the observational prospective study by GEIS. Here we present the merged analysis of ISG/OS-2 patients treated post-amendment and GEIS-33. Results: From March 2013 to April 2018, 274 patients were included. Median age was 14 years (range 4-38), male/female: 163/111; 90 were Pgp-, 164 were Pgp+, 20 not evaluable. With a median follow-up of 48 months (1.3-78.5 months), the 3-year EFS and OS were 71.9% (95%CI 66-76.9) and 88% (95%CI: 83.2-91.5) respectively, with no inferior survival for Pgp positive patients and improved survival for good responders (Table). Conclusions: In this prospective uncontrolled study with a risk-adapted strategy for non-metastatic osteosarcoma, survival is superior to that of all ISG/GEIS previous series. The 3-year EFS of 71.9% compares favorably with other reports. Pgp+ patients performed well in this study, in which mifamurtide and HDIFO were added after a poor response to MAP. Clinical trial information: NCT01459484; NCT04383288. [Table: see text]

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