Hall Kirsten Sundby, Bruland Øyvind S, Bjerkehagen Bodil, Lidbrink Elisabet, Jebsen Nina, Hagberg Hans, Papworth Karin, Hagberg Oskar, Trovik Clement, Bauer Henrik, Eriksson Mikael
Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
Institute for Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Clin Sarcoma Res. 2020 Nov 17;10(1):22. doi: 10.1186/s13569-020-00145-5.
We recently reported outcomes from a Scandinavian Sarcoma Group adjuvant study (SSG XX group A) conducted on localized and operable high risk soft tissue sarcoma (STS) of the extremities and trunk wall. SSG XX, group B, comprised of patients in a defined cohort with locally advanced STS considered at high risk for intralesional surgery. These patients received preoperative accelerated radiotherapy, together with neoadjuvant and adjuvant chemotherapy. Herein we report the results of this group B.
Twenty patients with high-grade, locally advanced and deep STS located in lower extremities (n = 12), upper extremities (5) or trunk wall (3) were included. The median age was 59 years and 14 patients were males. The treatment regimen consisted of 6 cycles of doxorubicin (60 mg/m) and ifosfamide (6 g/m), with three cycles given neoadjuvantly, and preoperative radiotherapy (1, 8 Gyx2/daily to 36 Gy) between cycles 2 and 3. After a repeated MRI surgery was then conducted, and the remaining 3 chemotherapy cycles were given postoperatively at 3 weeks intervals. Survival data, local control, toxicity of chemotherapy and postoperative complications are presented.
Median follow-up time for metastasis-free survival (MFS) was 2.8 years (range 0.3-10.4). The 5-year MFS was 49.5% (95% confidence interval [CI] 31.7-77.4). The median follow-up time was 5.4 years (range 0.3-10.4) for overall survival (OS). The 5-year OS was 64.0% (95% CI 45.8-89.4). The median tumour size was 13 cm, with undifferentiated pleomorphic sarcoma (n = 10) and synovial sarcoma (n = 6) diagnosed most frequently. All patients completed surgery. Resection margins were R0 in 19 patients and R1 in 1 patient. No patients had evidence of disease progression preoperatively. Three patients experienced a local recurrence, in 2 after lung metastases had already been diagnosed. Eleven patients (55%) had postoperative wound problems (temporary in 8 and persistent in 3).
Preoperative chemotherapy and radiotherapy were associated with temporary wound-healing problems. Survival outcomes, local control and toxicities were deemed satisfactory when considering the locally advanced sarcoma disease status at primary diagnosis. Trial registration This study was registered at ClinicalTrials.gov Identifier NCT00790244 and with European Union Drug Regulating Authorities Clinical Trials No. EUDRACT 2007-001152-39.
我们最近报告了一项斯堪的纳维亚肉瘤小组辅助研究(SSG XX组A)的结果,该研究针对四肢和躯干壁的局限性且可手术的高危软组织肉瘤(STS)开展。SSG XX组B由特定队列中被认为在病灶内手术时具有高风险的局部晚期STS患者组成。这些患者接受了术前加速放疗,以及新辅助化疗和辅助化疗。在此,我们报告该组B的结果。
纳入了20例高级别、局部晚期且深部的STS患者,这些患者位于下肢(n = 12)、上肢(5例)或躯干壁(3例)。中位年龄为59岁,14例为男性。治疗方案包括6个周期的阿霉素(60 mg/m²)和异环磷酰胺(6 g/m²),其中3个周期为新辅助治疗,在第2和第3周期之间进行术前放疗(1次,8 Gy×2次/每日,共36 Gy)。在重复进行MRI检查后进行手术,其余3个化疗周期在术后每隔3周进行。呈现了生存数据、局部控制情况、化疗毒性和术后并发症。
无转移生存期(MFS)的中位随访时间为2.8年(范围0.3 - 10.4年)。5年MFS为49.5%(95%置信区间[CI] 31.7 - 77.4)。总生存期(OS)的中位随访时间为5.4年(范围0.3 - 10.4年)。5年OS为64.0%(95% CI 45.8 - 89.4)。中位肿瘤大小为13 cm,最常见的诊断为未分化多形性肉瘤(n = 10)和滑膜肉瘤(n = 6)。所有患者均完成了手术。19例患者的切除边缘为R0,1例为R1。术前无患者有疾病进展的证据。3例患者出现局部复发,其中2例是在已诊断出肺转移之后。11例患者(55%)有术后伤口问题(8例为暂时性,3例为持续性)。
术前化疗和放疗与暂时性伤口愈合问题相关。考虑到初诊时局部晚期肉瘤的疾病状态,生存结果、局部控制和毒性被认为是令人满意的。试验注册 本研究在ClinicalTrials.gov上注册,标识符为NCT00790244,并在欧盟药品监管当局临床试验注册,编号为EUDRACT 2007 - 001152 - 39。