Pisters Peter W T, Ballo Matthew T, Fenstermacher Mark J, Feig Barry W, Hunt Kelly K, Raymond Kevin A, Burgess Michael A, Zagars Gunar K, Pollock Raphael E, Benjamin Robert S, Patel Shreyaskumar R
Department of Surgical Oncology, Unit 444, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030-4009, USA.
J Clin Oncol. 2003 Aug 15;21(16):3092-7. doi: 10.1200/JCO.2003.01.143.
The primary objective of this phase I trial was to define the maximum-tolerated dose of external-beam radiation with concurrent fixed-dose continuous-infusion doxorubicin followed by surgical resection and electron-beam intraoperative radiation therapy (EB-IORT) for patients with localized, potentially resectable retroperitoneal sarcomas (RPS).
Thirty-five patients with radiographically resectable primary or recurrent intermediate- or high-grade RPS were treated. Doxorubicin was administered each week for 4 or 5 weeks as an initial bolus (4 mg/m2) followed by a 4-day continuous infusion (4 mg/m2/d). Concurrent radiation therapy was administered in escalating doses of 18.0, 30.6, 36.0, 41.4, 46.8, or 50.4 Gy in 1.8-Gy fractions. Radiographic restaging was performed 4 to 8 weeks after chemoradiation, and patients with localized disease underwent surgical resection with EB-IORT (15 Gy).
Chemoradiation was completed as outpatient therapy in 31 patients (89%); four patients required hospital admission during chemoradiation or in the postchemoradiation preoperative period. At the highest radiation dose of 50.4 Gy, two (18%) of 11 patients had grade 3 or 4 nausea. Twenty-nine patients (83%) underwent laparotomy; six patients had interval disease progression and did not undergo surgery. Grossly complete resection (R0 or R1) was performed in 26 (90%) of 29 patients who had surgery. EB-IORT was feasible and successfully administered to 22 patients who had R0 or R1 resections.
Preoperative chemoradiation, surgical resection, and EB-IORT are feasible for patients with RPS. Preoperative external-beam radiation can be administered to a total dose of 50.4 Gy with continuous-infusion doxorubicin.
本I期试验的主要目的是确定对于局限性、潜在可切除的腹膜后肉瘤（RPS）患者，在同步给予固定剂量持续输注阿霉素的情况下，外照射放疗的最大耐受剂量，随后进行手术切除及电子束术中放疗（EB-IORT）。
35例经影像学检查可切除的原发性或复发性中、高级别RPS患者接受了治疗。阿霉素每周给药1次，共4或5周，初始推注剂量为4mg/m²，随后进行4天的持续输注（4mg/m²/天）。同步放疗剂量逐步递增，分别为18.0、30.6、36.0、41.4、46.8或50.4Gy，每次1.8Gy。放化疗后4至8周进行影像学再分期，局限性疾病患者接受EB-IORT（15Gy）手术切除。
31例患者（89%）作为门诊患者完成了放化疗；4例患者在放化疗期间或放化疗后术前需要住院治疗。在最高放疗剂量50.4Gy时，11例患者中有2例（18%）出现3级或4级恶心。29例患者（83%）接受了剖腹手术；6例患者疾病出现进展，未进行手术。29例接受手术的患者中有26例（90%）实现了大体完全切除（R0或R1）。EB-IORT对22例R0或R1切除的患者可行且成功实施。
术前放化疗、手术切除及EB-IORT对RPS患者可行。术前外照射放疗联合持续输注阿霉素的总剂量可达50.4Gy。
