Phase I/II study of the CAPABLE regimen for patients with poorly differentiated carcinoma of the nasopharynx
Phase I/II study of the CAPABLE regimen for patients with poorly differentiated carcinoma of the nasopharynx
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DOI：
10.1200/jco.1998.16.7.2514
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发表时间：
1998-07-01
影响因子：
45.3
通讯作者：
Tannock, IF
中科院分区：
文献类型：
--
作者：
Siu, LL;Czaykowski, PM;Tannock, IF
目的：评价侵袭性联合化疗在低分化鼻咽癌（NPC）患者中的作用。患者和方法：在一项前瞻性I/II期研究中，90例未经化疗的NPC患者（21例患有非常晚期的局部疾病，18例患有局部持续性和/或放射治疗后复发性疾病，51例患有转移性疾病）用环磷酰胺，多柔比星，顺铂，甲氨蝶呤和博莱霉素（CAPABLE）。该方案的两个时间表使用了超过9年的时间，第二个时间表是一个修改的第一次尝试，以尽量减少治疗相关的toxicity.Results：21例非常先进的局部疾病，有一个完全反应（CR）和17个部分反应（PRs）（反应率，86%）。这21例患者中有17例接受了后续放疗。在17例放射治疗后持续和/或复发的可测量局部疾病患者中，有4例CR和3例PR（缓解率，41%）。在44例可测量转移性疾病的患者中，有3例CR和32例PR（缓解率，80%）。这三组患者的中位生存期分别为47、16和14个月。两种化疗方案具有相似的接受剂量强度（RDIs），并产生相似的反应率和生存率。毒性严重，伴有频繁的粘膜炎和骨髓抑制。总体而言，37名患者需要至少一次住院以管理毒副作用，并且有7名药物相关死亡。三个死亡是由于暴发性肝炎，可能从再激活的B型肝炎。结论：这种积极的方案提供了一个高的肿瘤反应率，但有限的姑息治疗大多数复发或转移性鼻咽癌患者。对于非常晚期的局部疾病患者，先化疗后放疗的结果令人鼓舞，但需要在随机试验中进行评估。(C)1998年美国临床肿瘤学会。
Purpose: To evaluate the role of aggressive combination chemotherapy in patients with poorly differentiated carcinoma of the nasopharynx (NPC).Patients and Methods: In a prospective phase I/II study, 90 chemotherapy-naive patients with NPC (21 with very advanced locoregional disease, 18 with locoregional persistent and/or recurrent disease postradiotherapy, and 51 with metastatic disease) were treated with cyclophosphamide, doxorubicin, cisplatin, methotrexate, and bleomycin (CAPABLE). Two schedules of this regimen were used over a 9-year period, with the second schedule being a modification of the first in an attempt to minimize treatment-related toxicity.Results: Of 21 patients with very advanced local disease, one had a complete response (CR) and 17 had partial responses (PRs) (response rate, 86%). Seventeen of these 21 patients had subsequent radiotherapy. Of 17 patients with measurable locoregional disease either persistent and/or recurrent postradiotherapy, there were four CRs and three PRs (response rate, 41%). Of 44 patients with measurable metastatic disease, there were three CRs and 32 PRs (response rate, 80%). The median survival durations for these three groups of patients were 47, 16, and 14 months, respectively. The two chemotherapy schedules had similar received dose-intensities (RDIs) and produced similar response rates and survival. toxicity was severe with frequent mucositis and myelosuppression, Overall, 37 patients required at least one hospital admission for management of toxic side effects and there were seven drug-related deaths. Three of the deaths were due to fulminant hepatitis, likely from reactivation of hepatitis B.Conclusion: This aggressive regimen provides a high rate of tumor response, but limited palliation for most patients with recurrent or metastatic NPC. The results with chemotherapy followed by radiotherapy for patients with very advanced local disease are encouraging, but proof of benefit would require evaluation in a randomized trial. (C) 1998 by American Society of Clinical Oncology.