The effects of delay in standard treatment due to induction chemotherapy in two randomized prospective studies
The effects of delay in standard treatment due to induction chemotherapy in two randomized prospective studies
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两项随机前瞻性研究中诱导化疗导致标准治疗延迟的影响
DOI：
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发表时间：
1987
期刊：
影响因子：
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通讯作者：
M. Fischer
中科院分区：
文献类型：
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作者：
R. Toohill;J. Duncavage;Thomas W. Grossmam;T. Malin;Robert W. Teplin;J. Wilson;R. Byhardt;J. Haas;J. Cox;T. Anderson;P. Holoye;P. Ritch;C. Haas;J. Libnoch;R. Hoffmann;M. Fischer
通常认为，肿瘤对诱导化疗有反应，可改善头颈部鳞状细胞癌患者的生存率。在过去的6年里，两种诱导化疗方案在不同的随机前瞻性试验中被研究。83例晚期疾病患者进入第一组(43例化疗；40例对照组)，60例进入第二组(27例化疗；33例对照组)。患者按分期(III/IV)和部位(口腔、口咽、鼻咽、下咽、喉、鼻窦)分层。第一项研究使用博莱霉素、环磷酰胺、甲氨蝶呤和5-氟尿嘧啶分两个周期(如果没有肿瘤反应，一个周期)，然后进行标准治疗，包括联合放疗和手术，或在某些情况下，仅进行首次放疗。第二项研究在标准治疗前的三个周期中使用顺铂和5-氟尿嘧啶。在第一项研究中，有68%的人观察到对化疗的客观肿瘤反应，在第二项研究中，有85%的人对化疗有客观的反应。在两项研究中，控制组患者的生存期(第一组为24个月，第二组为19个月)好于试验组(43%对31%；69%对46%)。在第二项研究中，标准治疗的平均延迟时间比第一项研究更长(95天比66天；P<；0.02)。结果结合两项研究的P值表明，接受化疗的患者患持续性疾病的相对风险是前者的2.9倍。虽然化疗的毒性不是生存的一个因素，但在化疗组中，退出研究的患者和不遵守治疗的患者数量更多。除了非常有希望的新药方案外，建议未来的研究设计为在完成标准治疗的同时或之后进行化疗。
It is often suggested that tumors will respond to induction chemotherapy and result in improved survival for patients with squamous cell carcinoma of the head and neck. Two regimens of induction chemotherapy were studied in separate randomized, prospective trials over the last 6 years. Eighty‐three patients with advanced disease were entered into the first study (43/chemotherapy; 40/control), and 60 into the second (27/chemotherapy; 33/control). Patient randomization was stratified by stage (III/IV) and site (oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, paranasal sinuses). The first study utilized bleomycin, Cytoxan,® methotrexate and 5‐fluorouracil in two cycles (one cycle if no tumor response), followed by standard treatment which consisted of combined irradiation and surgery or, in some instances, primary irradiation alone. The second study utilized cisplatin and 5‐fluorouracil in three cycles prior to standard treatment. An objective tumor response to chemotherapy was observed in 68% in the first study and 85% in the second. The patient survival in both studies @ 24 months in the first; @ 19 in the second) was better in the control than that in the experimental groups (43% to 31%; 69% to 46%). In the second study, the average length of delay of standard treatment was longer than in the first study (95 days vs. 66 days; P<.02). Results combining the P‐values of both studies indicate that the relative risk of having persistent disease was 2.9 times greater for patients who received chemotherapy. While toxicity to chemotherapy was not a factor in survival, the number of patients who withdrew from the studies and those who did not comply with treatment were greater in the chemotherapy groups. Except for new drug regimens of exceptional promise, it is recommended that future studies be designed so that chemotherapy is given concurrent with, or following the completion of standard treatment.