Neoadjuvant hypofractionated radiotherapy and chemotherapy for extremity soft tissue sarcomas: Safety, feasibility, and early oncologic outcomes of a phase 2 trial.

Autor: Gobo Silva ML; Department of Radiation Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: leticia.silva@accamargo.org.br., Lopes de Mello CA; Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: celso.mello@accamargo.org.br., Aguiar Junior S; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: samuel.aguiar@accamargo.org.br., D'Almeida Costa F; Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: felipe.costa@accamargo.org.br., Stevanato Filho PR; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: paulo.stevanato@accamargo.org.br., Santoro Bezerra T; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: tiago.bezerra@accamargo.org.br., Nakagawa SA; Division of Surgery, Department of Orthopedics, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: suely.nakagawa@accamargo.org.br., Nascimento AG; Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: nascimento.antonio@accamargo.org.br., Werneck da Cunha I; Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: isabela.werneck@rededor.com.br., Spencer Sobreira Batista RM; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ranyell.spencer@gmail.com., Nicolau Daher UR; Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ulisses.nicolau@accamargo.org.br., Da Cruz Formiga MN; Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: nirvana.formiga@accamargo.org.br., Germano JN; Department of Statistics, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: janaina.germano@accamargo.org.br., Catin Kupper BE; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: bruna.catin@accamargo.org.br., De Assis Pellizzon AC; Department of Radiation Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: acapellizzon@accamargo.org.br., Lopes A; Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ademar.lopes@accamargo.org.br.
Jazyk: angličtina
Zdroj: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology [Radiother Oncol] 2021 Jun; Vol. 159, pp. 161-167. Date of Electronic Publication: 2021 Mar 31.
DOI: 10.1016/j.radonc.2021.03.033
Abstrakt: Background and Purpose: Optimal treatment of extremity soft tissue sarcomas (ESTS) is controversial. The aim of this study was to evaluate neoadjuvant chemotherapy (ChT) plus concomitant hypofractionated RT (hypo-RT) in local and distant disease relapse. Here we report safety, feasibility and early outcomes.
Materials and Methods: This was a prospective, single arm study with a goal accrual of 70 patients. Between 2015 and 2018, 18 patients with histologically confirmed nonmetastatic ESTS were assigned to receive doxorubicin and ifosfamide for three neoadjuvant cycles, concomitant with hypo-RT (25 Gy in 5 fractions) followed by surgery. The primary endpoint was disease-free survival (DFS). Secondary outcomes were pathologic response, wound complications (WC), and morbidity rates.
Results: Median follow-up was 29 months. At last follow-up, 13/18 patients were alive without evidence of local or systemic disease (DFS 72%), 1 had died due to metastatic disease, and 3 were alive with distant metastasis. One patient presented with local relapse within the irradiated field. Mean DFS time was 48.6 months (95% CI: 37.3-59.9). Six patients (33%) had no residual viable tumor detected in pathologic specimens (3 of these myxoid liposarcomas). There was a significant difference in WC among patients with acute RT skin toxicity. Six patients (33%) developed major WC. No grade 3 or 4 ChT adverse events were reported.
Conclusion: Despite the limited sample size, these early outcomes demonstrate that this treatment regimen is feasible and well tolerated with high rates of limb preservation, local control, and pathologic complete response, supporting further investigation in a multi-institutional setting.
Trial Registration: ClinicalTrials.gov NCT02812654; https://clinicaltrials.gov/ct2/show/NCT02812654.
(Copyright © 2021 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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