Argiris Athanassios, Li Yi, Murphy Barbara A, Langer Corey J, Forastiere Arlene A
Feinberg School of Medicine, Division of Hematology-Oncology, Northwestern University, Chicago, IL 60611, USA.
J Clin Oncol. 2004 Jan 15;22(2):262-8. doi: 10.1200/JCO.2004.08.039.
To evaluate the outcome of elderly patients with head and neck cancer undergoing palliative chemotherapy.
We analyzed combined data from two mature phase III randomized trials conducted by the Eastern Cooperative Oncology Group (ECOG; trial E1393, which compared cisplatin plus paclitaxel at two dose levels, and trial E1395, which compared cisplatin plus fluorouracil to cisplatin plus paclitaxel) to evaluate the toxicity, objective response rates, and survival of patients 70 years or older versus their younger counterparts. All patients had previously untreated recurrent or metastatic squamous cell carcinoma of the head and neck and ECOG performance status 0 or 1.
Fifty-three elderly patients were enrolled from a total of 399 eligible participants (13%). Elderly patients had similar objective response rates (28% v 33%) and median time to progression (5.25 v 4.8 months) compared with younger patients. The median survival was 5.3 v 8 months (Wilcoxon P =.06; log-rank P =.17) and the 1-year survival 26% v 33% for elderly and younger patients, respectively. Elderly patients had a significantly higher incidence of severe nephrotoxicity, diarrhea, and thrombocytopenia. A higher rate of toxic deaths was noted in the elderly but did not reach statistical significance (13% v 8%; P =.29).
Elderly patients were underrepresented in these studies. Fit elderly patients with recurrent or metastatic head and neck cancer sustained increased toxicities with cisplatin-based doublets but had comparable survival outcomes compared with younger patients. Strategies to ameliorate toxicities should be pursued in the elderly.
评估老年头颈部癌患者接受姑息化疗的疗效。
我们分析了东部肿瘤协作组(ECOG)进行的两项成熟的III期随机试验的合并数据(试验E1393,比较了两种剂量水平的顺铂加紫杉醇;试验E1395,比较了顺铂加氟尿嘧啶与顺铂加紫杉醇),以评估70岁及以上患者与年轻患者相比的毒性、客观缓解率和生存率。所有患者均为先前未经治疗的复发性或转移性头颈部鳞状细胞癌,ECOG体能状态为0或1。
在总共399名符合条件的参与者中,有53名老年患者入组(13%)。与年轻患者相比,老年患者的客观缓解率(28%对33%)和中位疾病进展时间(5.25个月对4.8个月)相似。老年患者和年轻患者的中位生存期分别为5.3个月对8个月(Wilcoxon检验P = 0.06;对数秩检验P = 0.17),1年生存率分别为26%对33%。老年患者严重肾毒性、腹泻和血小板减少症的发生率显著更高。老年患者的毒性死亡发生率较高,但未达到统计学显著性(13%对8%;P = 0.29)。
这些研究中老年患者的代表性不足。适合的老年复发性或转移性头颈部癌患者接受基于顺铂的双联化疗时毒性增加,但与年轻患者相比生存结果相当。应寻求改善老年患者毒性的策略。