Department of Internal Medicine III, Klinikum Grosshadern Medical Centre, Ludwig-Maximilians-University-Munich, Germany.
Int J Hyperthermia. 2010;26(2):127-35. doi: 10.3109/02656730903335995.
We report data from phase II trials examining the efficacy of multimodality treatment with neoadjuvant chemotherapy, hyperthermia, surgery, radiation and postoperative thermochemotherapy in adult patients with high-risk sarcomas of the extremities.
From 1991 to 2001 47 patients with high risk soft tissue sarcoma of the extremities were prospectively treated in two clinical trials with a treatment plan of four cycles of etoposide, ifosfamide and doxorubicin combined with regional hyperthermia followed by surgery, radiation and adjuvant chemotherapy.
Objective response rate assessable in 39 patients was 21% (one complete and seven partial responses). A favourable histological response (>75% tumour necrosis) was observed in 34% of the 35 evaluable patients who had surgical resection. Median overall survival (OS) was 105 months. The five-year probability of local failure-free survival (LFFS), distant disease-free survival (DDFS), event-free survival (EFS) and OS were 48%, 55%, 35% and 57%, respectively. There were no significant differences between responders and non-responders of minimum temperatures (Tmin) and time-averaged temperatures achieved in 50% (T(50)) and 90% (T(90)) at all measured tumour sites. Response to this neoadjuvant regimen predicted for prolonged LFFS (p = 0.0123), but not for OS (p = 0.2). Limb preservation was achieved in 37 patients (79%) and did not result in inferior DDFS (52% versus 50%) or OS (61% versus 50%) at five years (p = 0.8) in comparison to patients who underwent amputation.
Response to combined modality treatment with RHT and neoadjuvant chemotherapy was predictive for an improved LFFS and led to limb preservation in 79% of patients with extremity sarcomas.
我们报告了两项Ⅱ期临床试验的数据，这些试验评估了新辅助化疗、高温、手术、放疗和术后热化疗联合治疗成人四肢高危肉瘤的疗效。
1991 年至 2001 年，47 例四肢高危软组织肉瘤患者前瞻性入组两项临床试验，接受了四个周期依托泊苷、异环磷酰胺和多柔比星联合区域高温治疗，然后行手术、放疗和辅助化疗。
39 例可评估的客观缓解率为 21%（完全缓解 1 例，部分缓解 7 例）。35 例可手术切除患者中，有 34%的患者组织学缓解良好（>75%肿瘤坏死）。中位总生存期（OS）为 105 个月。局部无失败生存率（LFFS）、远处无病生存率（DDFS）、无事件生存率（EFS）和 OS 的 5 年概率分别为 48%、55%、35%和 57%。在所有测量的肿瘤部位，最低温度（Tmin）和达到 50%（T（50））和 90%（T（90））的时间平均温度（Taver）的 responders和非 responders之间，没有显著差异。对新辅助方案的反应预测了较长的 LFFS（p=0.0123），但对 OS 没有影响（p=0.2）。与截肢患者相比，37 例（79%）患者实现了保肢，其 5 年的 DDFS（52%比 50%）和 OS（61%比 50%）无显著差异（p=0.8）。
对 RHT 和新辅助化疗联合治疗的反应预测了更好的 LFFS，并使 79%的四肢肉瘤患者实现了保肢。
