Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups

被引：185

作者：

Gronchi, Alessandro ^{[1
]}

Palmerini, Emanuela ^{[2
]}

Quagliuolo, Vittorio ^{[3
]}

Martin Broto, Javier ^{[4
,5
]}

Lopez Pousa, Antonio ^{[6
]}

Grignani, Giovanni ^{[7
]}

Brunello, Antonella ^{[8
]}

Blay, Jean-Yves ^{[9
,10
]}

Tendero, Oscar ^{[11
]}

Diaz Beveridge, Robert ^{[12
]}

Ferraresi, Virginia ^{[13
]}

Lugowska, Iwona ^{[14
]}

Merlo, Domenico Franco ^{[15
]}

Fontana, Valeria ^{[16
,17
]}

Marchesi, Emanuela ^{[18
]}

Braglia, Luca ^{[15
]}

Donati, Davide Maria ^{[19
]}

Palassini, Elena ^{[20
]}

Bianchi, Giuseppe ^{[19
]}

Marrari, Andrea ^{[21
]}

Morosi, Carlo ^{[22
]}

Stacchiotti, Silvia ^{[20
]}

Bague, Silvia ^{[23
]}

Coindre, Jean Michel ^{[24
]}

Dei Tos, Angelo Paolo ^{[25
,26
]}

Picci, Piero ^{[27
]}

Bruzzi, Paolo ^{[16
,17
]}

Casali, Paolo Giovanni ^{[20
,28
]}

机构：

[1] Ist Nazl Tumori, Fdn Ist Ricovero & Cura Carattere Sci IRCCS, Dept Surg, Milan, Italy

[2] IRCCS, Ist Ortoped Rizzoli, Chemotherapy Unit, Bologna, Italy

[3] Ist Clin Humanitas, Dept Surg, Rozzano, Italy

[4] Univ Hosp Virgen Rocio, Med Oncol Dept, Seville, Spain

[5] Univ Seville, Inst Biomed Sevilla, Seville, Spain

[6] Hosp Santa Creu & Sant Pau, Dept Canc Med, Barcelona, Spain

[7] IRCCS, Fdn Piemonte Oncol, Dept Canc Med, Turin, Italy

[8] IRCCS, Ist Oncol Veneto, Med Oncol Unit 1, Dept Oncol, Padua, Italy

[9] Ctr Leon Berard Canc Ctr, Dept Canc Med, Lyon, France

[10] Univ Claude Beranrd Lyon 1, Lyon, France

[11] Hosp Univ Son Espases, Dept Surg, Palma De Mallorca, Spain

[12] Hosp Univ & Politecn La Fe, Dept Canc Med, Valencia, Spain

[13] Ist Regina Elena, Dept Canc Med, Rome, Italy

[14] Inst Marii Sklodowskiej Curie, Ctr Onkol, Dept Soft Tissue Bone Sarcoma & Melanoma, Warsaw, Poland

[15] IRCCS, Azienda Unit Sanit Locale, Res & Stat Infrastruct, Reggio Emilia, Italy

[16] IRCCS Azienda Osped Univ San Martino, IST Ist Nazl Ric Canc, Clin Trial Ctr, Genoa, Italy

[17] IRCCS Azienda Osped Univ San Martino, IST Ist Nazl Ric Canc, Dept Epidemiol, Genoa, Italy

[18] Italian Sarcoma Grp, Clin Trial Ctr, Bologna, Italy

[19] Ist Ortoped Rizzoli, Dept Orthoped Oncol, Bologna, Italy

[20] Fdn IRCCS Ist Nazl Tumori, Dept Canc Med, Milan, Italy

[21] Ist Clin Humanitas, Dept Canc Med, Rozzano, Italy

[22] Fdn IRCCS Ist Nazl Tumori, Dept Radiol, Milan, Italy

[23] Hosp Santa Creu & Sant Pau, Dept Pathol, Barcelona, Spain

[24] Inst Bergonie, Dept Pathol, Bordeaux, France

[25] Treviso Gen Hosp Treviso, Dept Pathol, Padua, Italy

[26] Univ Padua, Padua, Italy

[27] Ist Ortoped Rizzoli, Lab Oncol Res, Bologna, Italy

[28] Univ Milan, Dept Oncol & Hemato Oncol, Milan, Italy

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2020年 / 38卷 / 19期

关键词：

TUMOR RESPONSE ASSESSMENT; ADJUVANT CHEMOTHERAPY; CLINICAL-TRIAL; PHASE-II; IFOSFAMIDE; SURVIVAL; THERAPY; ADULTS; TRUNK; RADIOTHERAPY;

D O I：

10.1200/JCO.19.03289

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSE To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A1I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall. PATIENTS AND METHODS This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, >= 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176). RESULTS Between May 2011 and May 2016, 287 patients (UPS: n 5 97 [33.8%]; HG-MLPS: n 5 65 [22.6%]; SS: n=70 [24.4%]; MPNST: n=27 [9.4%]; and LMS: n=28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank P = .323) and 0.76 and 0.66 (log-rank P = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed. CONCLUSION In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A1I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS. (C) 2020 by American Society of Clinical Oncology.

引用

页码：2178 / +

页数：10

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