Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck: A phase I/II trial
Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck: A phase I/II trial
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DOI：
10.1200/jco.1998.16.4.1331
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发表时间：
1998-04-01
影响因子：
45.3
通讯作者：
Posner, MR
中科院分区：
文献类型：
--
作者：
Colevas, AD;Busse, PM;Posner, MR
用途：一项针对局部晚期头颈部鳞状细胞癌（SCCHN）患者进行多西他赛、顺铂、氟尿嘧啶（5-FU）和亚叶酸（TPFL 5）诱导化疗的I/II期试验。患者和方法：23名既往未经治疗的III期或IV期SCCHN患者以及东部肿瘤协作组功能状态小于或等于2的患者接受了TPFL 5治疗。化疗后的家庭支持包括静脉输液、抗生素和粒细胞集落刺激因子（G-CSF）。递增多西他赛剂量以确定最大耐受剂量（MTD）。15例患者接受了3个周期的MTD TPFLS治疗。对三个周期的TPFL 5达到部分反应（PR）或完全反应（CR）的患者然后接受确定的每日两次放射治疗。毒性和临床和病理反应TPFL 5进行了assessed.Results：23例患者共接受了69个周期的TPFL 5。MTD确定为多西他赛60 mg/m2。剂量限制性毒性（DLT）为中性粒细胞减少。MTD时的其他显著毒性为恶心、粘膜炎、腹泻、周围神经病变和钠消耗性肾病。TPFL 5的总体缓解率为100%，其中包括23例临床CR中的14例（61%）和23例临床PR中的9例（39%）。原发部位临床和病理CR率分别为19/22（86%）CR和20/22（91%）CR。战斗的患者不到CR在颈部化疗，因此，有postradiation颈部解剖，其中四个是阳性的残留tumor.Conclusion：TPFL 5是一个可以耐受的诱导方案，患者具有良好的性能状态。DLT为中性粒细胞减少伴显著粘膜炎、腹泻、周围神经病变和钠消耗性肾病。对TPFL 5的高应答率证明了在正式临床试验的背景下进一步评价这种药物组合的合理性。(C)1998年，美国临床肿瘤学会。
Purpose: A phase I/II trial of docetaxel, cisplatin, fluorouracil (5-FU), and leucovorin (TPFL5) induction chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).Patients and Methods: Twenty-three previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophytactic antibiotics, and granulocyte colony-stimulating factor (G-CSF). Docetaxel dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen patients were treated with three cycles of TPFLS at MTD. patients who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. Toxicity and clinical and pathologic response to TPFL5 were assessed.Results: Twenty-three patients received a total of 69 cycles of TPFL5. The MTD was determined to be docetaxel 60 mg/m(2). Dose-limiting toxicity (DLT) was neutropenia. Additional significant toxicities at MTD were nausea, mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The overall response rate to TPFL5 was 100%, which included 14 of 23 (61%) clinical CRs and nine of 23 (39%) clinical PRs. primary-site clinical and pathologic CR rates were 19 of 22 (86%) CRs and 20 of 22 (91%) CRs, respectively. Fight patients had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for residual tumor.Conclusion: TPFL5 is a tolerable induction regimen in patients with good performance status. The DLT is neutropenia with significant mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials. (C) 1998 by American Society of Clinical Oncology.