Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck.
Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck.
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甲氨蝶呤、长春花碱、阿霉素和顺铂治疗上呼吸道或头颈部消化道鳞状细胞癌患者的 II 期研究。
DOI：
10.1002/cncr.10442
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发表时间：
2002
期刊：
影响因子：
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通讯作者：
Kugler,JohnW
中科院分区：
文献类型：
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作者：
Okuno,ScottH;Mailliard,JamesA;Suman,VeraJ;Edmonson,JohnH;Creagan,EdwardT;Nair,Suresh;Levitt,Ralph;Kugler,JohnW
背景化疗药物甲氨蝶呤、长春碱、阿霉素和顺铂在头颈部上呼吸道或消化道复发或转移性鳞状细胞癌患者中显示出活性。本研究旨在评估甲氨蝶呤、长春碱、多柔比星和顺铂（MVAC）联合用药在该患者人群中的抗肿瘤活性和毒性特征。组织学证实的头颈部上呼吸道或消化道鳞状细胞癌的复发或转移患者接受MVAC治疗，为期4周。剂量如下：第1、15和22天甲氨蝶呤30 mg/m2;第2、15和22天长春碱3 mg/m2;第2天多柔比星30 mg/m2;第2天顺铂70 mg/m2。多柔比星的总累积剂量不超过450 mg/m2。对于那些疾病保持稳定的患者，在4个周期后停止治疗。对患者的化疗反应、无进展生存期和生存期进行了评价。1993年4月至1996年2月期间，共有36例患者参加了本研究。1例有心力衰竭病史的患者（3%）被宣布为不合格。在第一个治疗周期内，55%的患者出现重度白细胞减少症（白细胞计数< 2000个细胞/m3），在整个治疗过程中，81%的患者出现重度白细胞减少症。前4个治疗周期的总体客观缓解率为46%（90%置信区间[CI]，33-60%）。18名有反应的患者中有2名完全缓解。中位至进展时间为19周，1年无进展生存率为17%（95% CI，8-36%）。中位生存期为49周，1年生存率为43%（95% CI，29-63%）。在22例未切除残留或复发的患者中，中位至进展时间为11周，1年无进展生存率为14%（95% CI，5-39%），中位生存期为24周，1年生存率为36%（95% CI，21-63%）。在13例转移性疾病患者中，中位至进展时间为26周，1年无进展生存率为23%（95% CI，9-62%），中位生存期为54周，1年生存率为54%（95%CI，33-89%）。顺铂是一种用于复发性或转移性鳞状细胞癌患者的有效化疗方案，脖子癌症2002;94：2224-31.© 2002美国癌症协会。DOI 10.1002/cncr.10442
BACKGROUNDThe chemotherapy drugs methotrexate, vinblastine, doxorubicin, and cisplatin have shown activity in patients with recurrent or metastatic squamous cell carcinoma arising from the upper respiratory or alimentary passages of the head and neck. This study was undertaken to assess the antitumor activity and toxicity profile of the drug combination methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in this patient population.METHODSPatients with histologically confirmed unresectable, recurrent, or metastatic squamous cell carcinoma arising from the upper respiratory or alimentary passages of the head and neck were treated with MVAC over a 4‐week cycle. The doses were as follows: 30 mg/m2of methotrexate on Days 1, 15, and 22; 3 mg/m2of vinblastine on Days 2, 15, and 22; 30 mg/m2of doxorubicin on Day 2; and 70 mg/m2of cisplatin on Day 2. The total cumulative dose of doxorubicin was not to exceed 450 mg/m2. Treatment was discontinued after four cycles for those whose disease remained stable. Patients were evaluated for chemotherapy response, progression free survival, and survival.RESULTSThirty‐six patients were accrued onto this study between April 1993 and February 1996. One patient (3%) with a history of cardiac heart failure was declared ineligible. Severe leukopenia (leukocyte count < 2000 cells/m3) was observed in 55% of the patients during the first cycle of treatment and in 81% of the patients during the entire course of their treatment. The overall objective response rate over the first 4 cycles of treatment was 46% (90% confidence interval [CI], 33–60%). Two of the 18 patients who responded had a complete response. The median time to progression was 19 weeks, and 1‐year progression free survival rate was 17% (95% CI, 8–36%). The median survival was 49 weeks, and the 1‐year survival rate was 43% (95% CI, 29–63%). Among the 22 patients with unresected residual or recurrent disease, the median time to progression was 11 weeks, and 1‐year progression free survival rate was 14% (95% CI, 5–39%), and median survival was 24 weeks, and the 1‐year survival rate was 36% (95% CI, 21–63%). Among the 13 patients with metastatic disease, the median time to progression was 26 weeks, and the 1‐year progression free survival rate was 23% (95% CI, 9–62%), the median survival was 54 weeks, and the 1‐year survival rate was 54% (95% CI, 33–89%).CONCLUSIONSMethotrexate, vinblastine, doxorubicin, and cisplatin is an active chemotherapy regimen in patients with recurrent or metastatic squamous cell cancer arising from the upper respiratory or alimentary passages of the head and neck. Cancer 2002;94:2224–31. © 2002 American Cancer Society.DOI 10.1002/cncr.10442