Goldberg Melvyn, Farma Jeffrey, Lampert Craig, Colarusso Patrick, Coia Lawrence, Frucht Harold, Goosenberg Eric, Beard Mary, Weiner Louis M
Fox Chase Cancer Center, Division of Thoracic Surgical Oncology, 7701 Burholme Ave, Philadelphia, PA 19111, USA.
J Thorac Cardiovasc Surg. 2003 Oct;126(4):1168-73. doi: 10.1016/s0022-5223(03)00977-2.
To assess the benefits of aggressive chemoradiation therapy followed by surgery in resectable esophageal carcinoma.
Twenty-nine patients with resectable carcinoma were treated with 60 Gy of radiation (2 Gy daily for 6 weeks) and concurrent chemotherapy consisting of continuous infusion of 5-fluorouracil (200-225 mg/m(2)/d), paclitaxel (25, 40, 50, or 60 mg/m(2)) weekly over 1 hour, and cisplatin (25 mg/m(2)) weekly immediately following paclitaxel throughout radiation. Patients received either 4 cycles of postoperative paclitaxel 175 mg/m(2) over 3 hours and cisplatin 75 mg/m(2) every 3 weeks or paclitaxel 175 mg/m(2) over 3 hours and cisplatin 75 mg/m(2) every 3 weeks prior to the initiation of chemoradiation. After induction therapy and restaging, esophagectomy was performed 4 to 6 weeks later.
Twenty-seven patients were eligible for study (26 men, 23 with adenocarcinoma). Median age was 58 years (range 30-73). The maximum tolerated dose combination was paclitaxel 50 mg/m(2) over 1 hour weekly, cisplatin 25 mg/m(2) over 1 hour weekly, 5-fluorouracil 200 mg/m(2)/d by continuous infusion throughout radiotherapy and radiation to 60 Gy. Twenty-two patients completed therapy and underwent surgical resection. Four patients had complete pathological responses and 18 had partial responses with no mortality. The commonest dose-limiting toxicity was mucositis and esophagitis (n = 7). Median follow-up of 27 patients was 150 weeks (range 7-303). At 2-year follow-up 16/27 (59%) were alive and 15/27 (56%) were free of disease. At 4-year follow-up 12/27 (44%) were alive and free of disease. Median follow-up of 22 patients undergoing esophagectomy was 205 weeks (range 26-303). At 4-year follow-up 10/22 (45%) were alive and free of disease. For the 18 patients treated at or above the maximum tolerated dose, median follow-up was 151 weeks (range 35-206) and at 3-year follow-up 9/18 (50%) were alive and free of disease.
Aggressive combined modality therapy of esophageal carcinoma was associated with excellent long-term survival in this phase I trial.
评估在可切除食管癌中先行积极放化疗再行手术的益处。
29例可切除癌患者接受60 Gy放疗（每日2 Gy，共6周），同时进行化疗，包括持续输注5-氟尿嘧啶（200 - 225 mg/m²/d）、每周1小时静脉滴注紫杉醇（25、40、50或60 mg/m²）以及在整个放疗期间紫杉醇滴注后立即每周静脉滴注顺铂（25 mg/m²）。患者在术后接受4个周期的紫杉醇175 mg/m²静脉滴注3小时和顺铂75 mg/m²每3周一次，或者在放化疗开始前接受紫杉醇175 mg/m²静脉滴注3小时和顺铂75 mg/m²每3周一次。诱导治疗及重新分期后，4至6周后进行食管切除术。
27例患者符合研究条件（26例男性，23例腺癌）。中位年龄为58岁（范围30 - 73岁）。最大耐受剂量组合为每周1小时静脉滴注紫杉醇50 mg/m²、每周1小时静脉滴注顺铂25 mg/m²、放疗期间持续输注5-氟尿嘧啶200 mg/m²/d以及放疗至60 Gy。22例患者完成治疗并接受手术切除。4例患者达到完全病理缓解，18例部分缓解，无死亡病例。最常见的剂量限制性毒性为黏膜炎和食管炎（n = 7）。27例患者的中位随访时间为150周（范围7 - 303周）。在2年随访时，27例中有16例（59%）存活，27例中有15例（56%）无疾病。在4年随访时，27例中有12例（44%）存活且无疾病。22例行食管切除术患者的中位随访时间为205周（范围26 - 303周）。在4年随访时，22例中有10例（45%）存活且无疾病。对于18例接受最大耐受剂量或以上治疗的患者，中位随访时间为151周（范围35 - 206周），在3年随访时，18例中有9例（50%）存活且无疾病。
在这项I期试验中，食管癌积极联合治疗模式与良好的长期生存相关。
