Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer.
Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer.
复制标题
晚期头颈癌新辅助顺铂和氟尿嘧啶输注随后放疗与联合治疗的随机比较。
DOI：
10.1200/jco.1994.12.2.385
复制
发表时间：
1994
期刊：
影响因子：
--
通讯作者：
J. Hutchinson
中科院分区：
文献类型：
--
作者：
S G Taylor;A K Murthy;J. Vannetzel;P. Colin;M. Dray;D D Caldarelli;S. Shott;E. Vokes;J. Showel;J. Hutchinson
目的
比较两个已发表的顺铂加氟尿嘧啶 (5-FU) 输注和放疗方案作为序贯或联合治疗对不可切除的头颈癌患者的毒性和疗效。
患者和方法
这是一项随机试验，第 1 天顺铂 100 mg/m2 持续 15 分钟加 5-FU 1.0 g/m2 在第 1 至 5 天连续输注，每 3 周重复一次，共三个周期，随后在 7 至 8 周内接受 70 Gy 放射治疗，与第 1 天顺铂 60 mg/m2 15 分钟持续输注加 5-FU 800 mg/m2 在第 1 天连续输注第 1 至 5 天加上第 1 至 5 天的辐射 2 Gy，每隔一周重复一次，共七个周期。将先前未接受放疗或化疗且体能状态为 0 至 2 的不可切除的头颈鳞状癌患者按肿瘤 (T) 和淋巴结 (N) 分组以及体能状态进行分层并随机化。
结果
研究共纳入 214 名患者并进行分析，每组 107 名。所有治疗后，总体缓解率不同 (P = .003)，完全缓解率相似，但部分缓解较多，伴随治疗后无变化或进展的患者较少。无进展生存期的 Cox 回归分析确定伴随治疗 (P = .003)、放射治疗肿瘤学组 (RTOG) III 期分组 (P < .0001)、体能状态 (P = .0002)、伴随治疗 (P = .003) 和治疗机构 (P = .006) 具有显着性。序贯治疗和联合治疗显示相似的远端失败模式（分别为 10% 和 7%），但区域失败率不同（55% 和 39%）。治疗方案之间的严重和更严重的毒性事件相似，但放射诱发的粘膜炎与顺铂诱发的失水性肾病（仅在联合治疗组中）需要更多的支持治疗。治疗组之间的生存时间相似，但序贯治疗组中死于癌症的患者明显更多 (P = .011)。
结论
伴随治疗改善了疾病控制，主要是区域疾病，但疗效取决于治疗机构的经验。这种益处转化为生存率改善的效果尚不明显，伴随治疗组中其他原因导致的死亡人数过多。
PURPOSE
To compare two published schedules of cisplatin plus fluorouracil (5-FU) infusion and radiation as either sequential or concomitant treatment for toxicity and efficacy in patients with unresectable head and neck cancer.
PATIENTS AND METHODS
This was a randomized trial between cisplatin 100 mg/m2 over 15 minutes on day 1 plus 5-FU 1.0 g/m2 by continuous infusion on days 1 to 5, repeated every 3 weeks for three cycles, followed by 70 Gy of radiation in 7 to 8 weeks, versus cisplatin 60 mg/m2 over 15 minutes on day 1 plus 5-FU 800 mg/m2 by continuous infusion on days 1 to 5 plus radiation 2 Gy on days 1 to 5, repeated every other week for seven cycles. Unresectable head and neck squamous cancer patients not previously treated with radiation or chemotherapy and with a performance status of 0 to 2 were stratified by tumor (T) and node (N) groupings and performance status and randomized.
RESULTS
Two hundred fifteen patients were entered and 214 analyzed, 107 on each arm. After all treatment, overall response rates were different (P = .003), with similar complete response rates, but more partial responses and fewer patients with no change or progression with concomitant treatment. Cox regression analysis for progression-free survival identified concomitant treatment (P = .003), Radiation Therapy Oncology Group (RTOG) stage III grouping (P < .0001), performance status (P = .0002), concomitant treatment (P = .003), and treating institution (P = .006) as significant. The sequential and concomitant treatments showed similar distant failure patterns (10% and 7%, respectively), but divergent regional failure rates (55% and 39%). Severe and worse toxic events were similar between the treatment programs, but radiation-induced mucositis combined with cisplatin-induced water-losing nephropathy, in the concomitant arm only, demanded more supportive care. Survival duration was similar between the treatment arms, but significantly more patients in the sequential arm died of their cancer (P = .011).
CONCLUSION
Concomitant treatment offered improved disease control, predominantly of regional disease, but benefit was dependent on the experience of the treating institution. Translation of this benefit into improved survival is not yet evident, with an excess of deaths from other causes in the concomitant arm.
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DOI：
--
发表时间：
1972
期刊：
--
影响因子：
--
作者：
D. Cox
通讯作者：
D. Cox
联合顺铂/氟尿嘧啶化疗和分程放疗治疗头颈癌。
DOI：
10.1200/jco.1989.7.7.846
发表时间：
1989
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Taylor4th,SG;Murthy,AK;Caldarelli,DD;Showel,JL;Kiel,K;Griem,KL;Mittal,BB;Kies,M;HutchinsonJr,JC;Holinger,LD
通讯作者：
Holinger,LD
顺铂耐药对细胞辐射反应的影响。
DOI：
10.1016/0360-3016(87)90076-9
发表时间：
1987
期刊：
International journal of radiation oncology, biology, physics
影响因子：
--
作者：
Wallner,KE;Li,GC
通讯作者：
Li,GC
影响因子：
3.1
作者：
WITHERS, HR;TAYLOR, JMG;MACIEJEWSKI, B
通讯作者：
MACIEJEWSKI, B