Wolf Gregory T, Fisher Susan Gross, Hong Waun Ki, Hillman Robert, Spaulding Monica, Laramore George E, Endicott James W, McClatchey Kenneth, Henderson William G
N Engl J Med. 1991 Jun 13;324(24):1685-90. doi: 10.1056/NEJM199106133242402.
We performed a prospective, randomized study in patients with previously untreated advanced (Stage III or IV) laryngeal squamous carcinoma to compare the results of induction chemotherapy followed by definitive radiation therapy with those of conventional laryngectomy and postoperative radiation.
Three hundred thirty-two patients were randomly assigned to receive either three cycles of chemotherapy (cisplatin and fluorouracil) and radiation therapy or surgery and radiation therapy. The clinical tumor response was assessed after two cycles of chemotherapy, and patients with a response received a third cycle followed by definitive radiation therapy (6600 to 7600 cGy). Patients in whom ther was no tumor response or who had locally recurrent cancers after chemotherapy and radiation therapy underwent salvage laryngectomy.
After two cycles of chemotherapy, the clinical tumor response was complete in 31 percent of the patients and partial in 54 percent. After a median follow-up of 33 months, the estimated 2-year survival was 68 percent (95 percent confidence interval, 60 to 76 percent) for both treatment groups (P = 0.9846). Patterns of recurrence differed significantly between the two groups, with more local recurrences (P = 0.0005) and fewer distant metastases (P = 0.016) in the chemotherapy group than in the surgery group. A total of 59 patients in the chemotherapy group (36 percent) required total laryngectomy. The larynx was preserved in 64 percent of the patients overall and 64 percent of the patients who were alive and free of disease.
These preliminary results suggest a new role for chemotherapy in patients with advanced laryngeal cancer and indicate that a treatment strategy involving induction chemotherapy and definitive radiation therapy can be effective in preserving the larynx in a high percentage of patients, without compromising overall survival.
我们对先前未经治疗的晚期（III期或IV期）喉鳞状癌患者进行了一项前瞻性随机研究，以比较诱导化疗后行根治性放疗与传统喉切除术及术后放疗的效果。
332例患者被随机分配接受三个周期的化疗（顺铂和氟尿嘧啶）及放疗或手术加放疗。在两个周期化疗后评估临床肿瘤反应，有反应的患者接受第三个周期化疗，随后进行根治性放疗（6600至7600 cGy）。化疗后无肿瘤反应或化疗及放疗后局部复发的患者接受挽救性喉切除术。
两个周期化疗后，31%的患者临床肿瘤反应完全缓解，54%部分缓解。中位随访33个月后，两个治疗组的估计2年生存率均为68%（95%可信区间，60%至76%）（P = 0.9846）。两组的复发模式有显著差异，化疗组的局部复发更多（P = 0.0005），远处转移更少（P = 0.016）。化疗组共有59例患者（36%）需要行全喉切除术。总体上64%的患者保留了喉，存活且无疾病的患者中这一比例为64%。
这些初步结果表明化疗在晚期喉癌患者中具有新的作用，并表明一种包括诱导化疗和根治性放疗的治疗策略可有效使高比例患者保留喉，且不影响总体生存率。
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