Stanford Cancer Institute, Stanford University, Stanford, California, United States of America.
Division of Medical Oncology, Stanford Cancer Center, Stanford University, Stanford, California, United States of America.
PLoS One. 2023 Feb 2;18(2):e0276651. doi: 10.1371/journal.pone.0276651. eCollection 2023.
A phase II = design is used to evaluate the efficacy and feasibility of full dose docetaxel, platinum, and 5-fluorouracil (TPF) in a sequential chemoradiation treatment locally advanced (LA) or oligometastatic (OM) NPC patients.
Twenty patients with LANPC (M0 cohort) and six patients with OMNPC (M1 cohort) received induction standard dose T (75 mg/m2) P (75 mg/m2) F (750 mg/m2 IVCI x 5days) x 3 followed by weekly cisplatin (40 mg/m2) or carboplatin (AUC 1.5) x 6 concurrent with radiation therapy of 70 Gy over 6.5-7 weeks. The first five patients received bevacizumab as part of an exploratory objective of hypoxia modification using correlative fluoromisonidasole (18F-MISO) PET CT scanning.
The 18F-MISO imaging failed to reveal adequate levels of baseline hypoxia necessary to evaluate for changes with chemotherapy and bevacizumab. Ninety percent of M0 patients and 83% of M1 patients received the full-intended TPF and radiation dose. Eighty-five percent of M0 patients and all M1 patients received at least 60% of the full-intended concurrent platinum dose. The 2-year progression free survival (PFS) rate for the M0 cohort was 90% (95% CI: 77.8%- 100%), and was sustained at 5 years. The 2-year PFS rate for the M1 cohort was 66.7% (95% CI: 37.9%- 100%). The 2-year overall survival (OS) rates for the M0 and M1 cohorts were 100% and 83.3% (95% CI: 58.3%- 100%), respectively. At five years, OS was 94.4% for the M0 cohort.
Administration of standard-dose TPF as induction chemotherapy in this NPC patient population is both feasible and effective when coupled with definitive concurrent chemoradiation.
CLINICALTRIALS.GOV IDENTIFIER: NCT00896181.
采用 II 期设计评估全剂量多西他赛、铂类药物和 5-氟尿嘧啶（TPF）在局部晚期（LA）或寡转移（OM）NPC 患者序贯放化疗中的疗效和可行性。
20 例 LANPC 患者（M0 队列）和 6 例 OMNPC 患者（M1 队列）接受诱导标准剂量 T（75mg/m2）P（75mg/m2）F（750mg/m2 IVCI x 5 天）x 3 随后每周顺铂（40mg/m2）或卡铂（AUC 1.5）x 6 与 70Gy 的放射治疗同时进行，共 6.5-7 周。前五例患者接受贝伐单抗作为使用相关氟米索硝唑（18F-MISO）PET CT 扫描进行缺氧修饰的探索性目标的一部分。
18F-MISO 成像未能显示出足够的基线缺氧水平，无法评估化疗和贝伐单抗的变化。90%的 M0 患者和 83%的 M1 患者接受了全剂量 TPF 和放射剂量。85%的 M0 患者和所有 M1 患者接受了至少 60%的全剂量同期铂类药物剂量。M0 队列的 2 年无进展生存率（PFS）为 90%（95%CI：77.8%-100%），并在 5 年内持续。M1 队列的 2 年 PFS 率为 66.7%（95%CI：37.9%-100%）。M0 和 M1 队列的 2 年总生存率（OS）分别为 100%和 83.3%（95%CI：58.3%-100%）。5 年时，M0 队列的 OS 为 94.4%。
在局部晚期 NPC 患者人群中，标准剂量 TPF 作为诱导化疗与确定性同期放化疗联合应用是可行且有效的。
临床试验.gov 标识符：NCT00896181。
