Adelstein D J, Lavertu P, Saxton J P, Secic M, Wood B G, Wanamaker J R, Eliachar I, Strome M, Larto M A
Department of Hematology and Medical Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Cancer. 2000 Feb 15;88(4):876-83. doi: 10.1002/(sici)1097-0142(20000215)88:4<876::aid-cncr19>3.0.co;2-y.
The current study presents mature results from a Phase III randomized trial comparing radiation therapy and concurrent chemoradiotherapy in patients with resectable American Joint Committee on Cancer Stage III and IV disease.
One hundred patients were randomized to receive either radiation therapy alone (Arm A) (at a dose of between 66-72 grays [Gy] at 1.8-2 Gy per day) and the identical radiation therapy with concurrent chemotherapy (Arm B) (5-fluorouracil, 1000 mg/m(2)/day, and cisplatin, 20 mg/m(2)/day, both given as continuous intravenous infusions over 4 days beginning on Days 1 and 22 of the radiation therapy). Primary site resection was planned for patients with residual or recurrent local disease. Cervical lymph node dissection was performed for regional persistent disease or recurrence, or if N2-3 disease was present at the time of presentation.
After completing all therapy including surgery, 82% of the patients in Arm A and 98% of the patients in Arm B had been rendered disease free (P = 0.02). At a median follow-up of 5 years (range, 3-8 years), the 5-year Kaplan-Meier projections for overall survival for Arm A versus Arm B were 48% versus 50% (P = 0.55). Kaplan-Meier projections for the recurrence free interval were 51% versus 62% (P = 0.04), projections for a distant metastasis free interval were 75% versus 84% (P = 0. 09), projections for overall survival with primary site preservation were 34% versus 42% (P = 0.004), and projections for local control without surgical resection were 45% versus 77% (P < 0.001). Salvage surgery proved to be successful in 63% and 73%, respectively, of the Arm A and Arm B patients with primary site failure. Unrelated death while free of disease occurred in 22% and 32%, respectively, of Arm A and Arm B patients (P = 0.26).
The addition of concurrent chemotherapy to definitive radiation in patients with resectable Stage III and IV squamous cell carcinoma of the head and neck improves the likelihood of disease clearance, a recurrence free interval, and primary site preservation. However, overall survival does not appear to be improved, reflecting both effective surgical salvage after local recurrence and competing causes of death.
本研究展示了一项III期随机试验的成熟结果，该试验比较了可切除的美国癌症联合委员会III期和IV期疾病患者接受放射治疗与同步放化疗的疗效。
100名患者被随机分为两组，分别接受单纯放射治疗（A组）（每天剂量为1.8 - 2 Gy，总剂量66 - 72格雷 [Gy]）和相同放射治疗联合同步化疗（B组）（5-氟尿嘧啶，1000 mg/m²/天，顺铂，20 mg/m²/天，均从放射治疗的第1天和第22天开始持续静脉输注4天）。对于残留或复发的局部疾病患者计划进行原发部位切除。对于区域持续性疾病或复发患者，或初诊时存在N2 - 3期疾病的患者进行颈部淋巴结清扫。
完成包括手术在内的所有治疗后，A组82%的患者和B组98%的患者实现了疾病缓解（P = 0.02）。中位随访5年（范围3 - 8年），A组与B组的5年总生存Kaplan - Meier预测值分别为48%和50%（P = 0.55）。无复发生存期的Kaplan - Meier预测值分别为51%和62%（P = 0.04），无远处转移生存期的预测值分别为75%和84%（P = 0.09），保留原发部位的总生存预测值分别为34%和42%（P = 0.004），未进行手术切除的局部控制预测值分别为45%和77%（P < 0.001）。对于原发部位失败的A组和B组患者，挽救性手术的成功率分别为63%和73%。A组和B组分别有22%和32%的患者在无疾病状态下发生无关死亡（P = 0.26）。
对于可切除的头颈部III期和IV期鳞状细胞癌患者，在根治性放疗中加入同步化疗可提高疾病清除率、无复发生存期和原发部位保留率。然而，总生存期似乎并未改善，这反映了局部复发后有效的手术挽救以及其他竞争死亡原因。
