Clark J R, Busse P M, Norris C M, Andersen J W, Dreyfuss A I, Rossi R M, Poulin M D, Colevas A D, Tishler R B, Costello R, Lucarini J W, Lucarini D, Thornhill L, Lackey M, Peters E, Posner M R
Division of Clinical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.
J Clin Oncol. 1997 Sep;15(9):3100-10. doi: 10.1200/JCO.1997.15.9.3100.
A phase II trial of cisplatin, fluorouracil, and leucovorin (PFL) induction chemotherapy in patients with locally advanced squamous cell carcinomas of the head and neck region (HNCA).
One hundred two patients (stage III/IV, previously untreated) were treated with induction PFL. Patients with resectable primary tumor site lesions and clinical complete response (CR) were offered radiotherapy (RT) without surgery to the primary tumor site. Response, toxicity, local-regional therapy, survival, and preservation of the primary tumor site were assessed.
Among 279 courses, the overall response rate was 81%. Nineteen (19%) failed to respond, including three who died during therapy. Sixty-seven (69%) of 97 with assessable primary lesions had a clinical CR at the primary tumor site. Pathologic CR was recorded in 46 of 55 (84%) clinical CR patients who had biopsies performed on the primary tumor site. Toxicities resulted in unexpected hospitalizations in 19% of cases. After definitive local-regional therapy, 84 (82%) were disease-free including 71 (69%) with preserved primary tumor site anatomy. With a median follow-up time of 63 months, the cause-specific, overall (OS), and failure-free survival (FFS) rates at 5 years are 58%, 52%, and 51%. Local failure occurred in 29 of 102 (29%) and the local control rate at 5 years was 68%.
PFL has significant activity with acceptable toxicity in patients with advanced disease who have a good performance status. Preservation of the primary tumor site could be achieved without apparent loss of local control or survival. Management of neck disease by surgery or RT must be individualized and separate from management of primary tumor. Survival compares favorably with similar trials of induction chemotherapy or chemoradiotherapy.
对头颈部局部晚期鳞状细胞癌（HNCA）患者进行顺铂、氟尿嘧啶和亚叶酸钙（PFL）诱导化疗的II期试验。
102例患者（III/IV期，既往未接受过治疗）接受了PFL诱导化疗。对于可切除的原发肿瘤部位病变且临床完全缓解（CR）的患者，给予原发肿瘤部位放疗（RT）而非手术治疗。评估反应、毒性、局部区域治疗、生存率以及原发肿瘤部位的保留情况。
在279个疗程中，总体缓解率为81%。19例（19%）未缓解，其中3例在治疗期间死亡。97例可评估原发病变的患者中，67例（69%）在原发肿瘤部位达到临床CR。55例临床CR患者中有46例（84%）在原发肿瘤部位进行活检后记录为病理CR。毒性反应导致19%的病例意外住院。在确定性局部区域治疗后，84例（82%）无疾病，其中71例（69%）保留了原发肿瘤部位的解剖结构。中位随访时间为63个月，5年时的病因特异性生存率、总生存率（OS）和无失败生存率（FFS）分别为58%、52%和51%。102例中有29例（29%）发生局部失败，5年局部控制率为68%。
PFL对身体状况良好的晚期疾病患者具有显著活性且毒性可接受。在不明显丧失局部控制或生存率的情况下可实现原发肿瘤部位的保留。颈部疾病通过手术或放疗的管理必须个体化，且与原发肿瘤的管理分开。生存率与诱导化疗或放化疗的类似试验相比具有优势。
