Pisters K M, Ginsberg R J, Giroux D J, Putnam J B, Kris M G, Johnson D H, Roberts J R, Mault J, Crowley J J, Bunn P A
Department of Thoracic/ Head & Neck Medical Oncology, U.T.M.D. Anderson Cancer Center, Houston, TX 77030-4095, USA.
J Thorac Cardiovasc Surg. 2000 Mar;119(3):429-39. doi: 10.1016/s0022-5223(00)70120-6.
This phase II trial assessed the feasibility, as measured by response rate, toxicity, resectability rate, and surgical morbidity and mortality rates, of perioperative paclitaxel and carboplatin chemotherapy in patients with early-stage non-small cell lung carcinoma.
All patients required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patients were excluded. Chemotherapy consisted of paclitaxel 225 mg/m(2) over 3 hours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection.
Between June 1996 and July 1998, 94 patients were entered into the study. Sixty-five (69%) were men, and the median age was 64 years (range, 34-79 years). After induction chemotherapy, 53 of 94 (56%; 95% confidence interval, 46%-67%) had a major objective response, 88 (94%) underwent surgical exploration, and 81 (86%; 95% confidence interval, 78%-92%) underwent complete resection. Reasons for not undergoing an operation included disease progression (n = 3), clinically unresectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1). Two postoperative deaths occurred. Six (6%; 95% confidence interval, 0%-13%) pathologic complete responses were observed. Ninety (96%) patients received the planned preoperative chemotherapy versus 45% receiving postoperative chemotherapy. No unexpected chemotherapy or surgical morbidity occurred. The 1-year survival is currently estimated at 85%, and the median survival has not yet been reached.
Induction chemotherapy with paclitaxel and carboplatin is feasible and produces a high response rate with acceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction chemotherapy and surgery with surgery alone in early-stage non-small cell lung carcinoma is planned.
本II期试验评估了围手术期使用紫杉醇和卡铂化疗对早期非小细胞肺癌患者的可行性，评估指标包括缓解率、毒性、可切除率以及手术并发症和死亡率。
所有患者均需纵隔镜检查结果为阴性且具备适当的医学参数才能接受诱导化疗和手术。肺上沟瘤患者被排除。化疗方案为术前每21天静脉滴注紫杉醇225mg/m²，持续3小时，同时静脉滴注卡铂（曲线下面积=6），共2个周期。计划对完全切除的患者进行3个周期的术后化疗。
1996年6月至1998年7月期间，94例患者进入本研究。65例（69%）为男性，中位年龄为64岁（范围34 - 79岁）。诱导化疗后，94例中有53例（56%；95%置信区间，46% - 67%）有主要客观缓解，88例（94%）接受了手术探查，81例（86%；95%置信区间，78% - 92%）实现了完全切除。未进行手术的原因包括疾病进展（n = 3）、临床不可切除状态（n = 1）、死亡（n = 1）和患者失访（n = 1）。术后发生2例死亡。观察到6例（6%；95%置信区间，0% - 13%）病理完全缓解。90例（96%）患者接受了计划的术前化疗，而接受术后化疗的患者为45%。未发生意外的化疗或手术并发症。目前估计1年生存率为85%，中位生存期尚未达到。
紫杉醇和卡铂诱导化疗在早期非小细胞肺癌中是可行的，缓解率高，并发症和死亡率可接受。计划开展一项前瞻性随机试验，比较早期非小细胞肺癌患者3个周期诱导化疗加手术与单纯手术的疗效。
