A Phase II Study of Tumor Ablation in Patients with Metastatic Sarcoma Stable on Chemotherapy

Oncologist. 2018 Jul;23(7):760-e76. doi: 10.1634/theoncologist.2017-0536. Epub 2018 Feb 27.

Abstract
in En , Chinese

Lessons learned: Ablation therapy appears to be a reasonably safe and effective approach to obtain a significant treatment-free interval for a subset of patients with limited sites of metastatic disease for which systemic control can be obtained with six cycles of chemotherapy.

Background: Metastatic sarcoma often becomes resistant to treatment by chemotherapy. There is sometimes prolonged stable disease from active chemotherapy that provides a window of opportunity for an intervention to prolong disease-free survival.

Materials and methods: We performed a phase II study in patients with metastatic sarcoma who had been stable on six cycles of chemotherapy who then received ablation therapy to their residual disease. Histologies captured in this study included leiomyosarcoma, malignant peripheral nerve sheath tumor, pleiomorphic rhabdomyosarcoma, and myxoid liposarcoma. Sites ablated included lung metastases and retroperitoneal metastatic deposits. In this study, up to three lesions were ablated in any given interventional radiology session. After ablation, patients were not treated with any further therapy but were followed by surveillance imaging to determine progression-free rate (PFR).

Results: Although terminated early because of slow accrual, this study demonstrated a 3-month PFR of 75% for this cohort of eight patients treated with ablation performed after completion of six cycles of chemotherapy with stable disease. Median progression-free survival (PFS) was 19.74 months, and the median overall survival (OS) was not reached.

Conclusion: Our data are the first prospective study to suggest that ablation therapy in selected patients who are stable on chemotherapy can provide a significant progression-free interval off therapy and warrants further study in a randomized trial.

经验总结 消融疗法似乎是一种适度安全且有效的方法,能够使转移性病灶有限的患者亚群(已通过六周期化疗得到全身控制)获得有意义的无治疗间期。 摘要 背景.转移性肉瘤通常会对化疗治疗产生耐药性。积极化疗有时可延长病情稳定期,可为延长无病生存期的干预措施提供时机窗口。 材料和方法.我们对转移性肉瘤患者进行了II期研究,这些患者经过六周期化疗病情稳定后针对残留病灶接受了消融治疗。本研究中收集的组织学结果包括平滑肌肉瘤、恶性外周神经鞘瘤、多形性横纹肌肉瘤和粘液样脂肪肉瘤。消融部位包括肺转移瘤和腹膜后转移性沉积。在此研究中,在任何给定的介入放射治疗中最多消融三处病灶。消融后,患者未接受任何进一步的治疗,但随后接受监测成像以确定无进展率(PFR)。 结果.虽然由于招募工作进展缓慢而提前终止,但该研究表明,在完成六个化疗周期且病情稳定后进行消融治疗的八例患者组成的队列,3个月PFR为75%。中位无进展生存期(PFS)为19.74个月,未达到中位总生存期(OS)。 结论.我们的数据是首项前瞻性研究,表明针对经过化疗病情稳定的选择性患者进行的消融治疗可以提供有意义的无进展无治疗间期,需要在随机试验中进行进一步研究。

Trial registration: ClinicalTrials.gov NCT01986829.

Publication types

  • Clinical Trial, Phase II
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ablation Techniques / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Sarcoma / drug therapy
  • Sarcoma / pathology
  • Sarcoma / radiotherapy
  • Sarcoma / surgery*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01986829