Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial.
Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial.
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DOI：
10.1093/jnci/94.3.173
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发表时间：
2002-02
期刊：
影响因子：
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通讯作者：
C. Langer;J. Manola;P. Bernardo;J. Kugler;P. Bonomi;D. Cella;David H. Johnson
中科院分区：
文献类型：
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作者：
C. Langer;J. Manola;P. Bernardo;J. Kugler;P. Bonomi;D. Cella;David H. Johnson
背景老年患者，即使身体健康，通常也被认为不能耐受铂类药物的全身治疗。我们对美国东部肿瘤协作组（ECOG）5592进行了回顾性分析，这是一项针对非小细胞肺癌（NSCLC）的含铂化疗方案的III期随机试验，并比较了70岁及以上入组者与年轻患者的结局。方法ECOG开展了一项顺铂联合依托泊苷或紫杉醇治疗未经化疗的III期（B）或IV期NSCLC患者的随机III期试验。比较了不同年龄组的毒性反应、反应率和存活率。所有P值均为双侧。结果从1993年8月至1994年12月共纳入574例患者可评价。86例（15%）为70岁或以上。老年患者心血管（P = 0.009）和呼吸系统（P = 0.04）合并症和非镇痛药物使用（P = 0.02）的发生率较高。白细胞减少症（P<0.001）和神经精神毒性（P = 0.002）在老年男性中比年轻男性更常见。老年妇女比年轻妇女体重减轻更多（P = 0.006）。其他毒性作用在老年和年轻患者中相似。临床部分或完全缓解的比例（21.5% vs 23.3%; Fisher精确检验，P = 0.66），中位至进展时间（4.37 vs 4.30个月;对数秩检验，P = 0.29）和生存分布（对数秩检验，P = 0.29;中位生存期，9.05对8.53个月; 1年生存率，38%对29%; 2年生存率，14%对12%）在70岁以下和70岁或以上的患者中相似。基线生活质量和治疗结果指数相似。随着时间的推移，两组的功能健康状况出现了同等程度的下降。结论：接受铂类药物治疗的老年NSCLC患者的缓解率、毒性和生存率与年轻患者相似，尽管70岁或以上的患者有更多的合并症，可以预期更多的白细胞减少和神经精神毒性。仅高龄不应妨碍适当的NSCLC治疗。
BACKGROUND Older patients, even if fit, are often considered incapable of tolerating platinum-based systemic therapy. We performed a retrospective analysis of Eastern Cooperative Oncology Group (ECOG) 5592, a phase III randomized trial of platinum-based chemotherapy regimens for non-small-cell lung cancer (NSCLC), and compared outcomes in enrollees 70 years of age and older with those in younger patients. METHODS ECOG carried out a randomized phase III trial of cisplatin plus either etoposide or paclitaxel in chemotherapy-naïve NSCLC patients with stages III(B) or IV disease. Toxic effects, response rates, and survival rates were compared between age groups. All P values were two-sided. RESULTS A total of 574 patients enrolled from August 1993 through December 1994 were evaluable. Eighty-six (15%) were 70 years old or older. Older patients had a higher incidence of cardiovascular (P =.009) and respiratory (P =.04) comorbidities and nonanalgesic medication use (P =.02). Leukopenia (P<.001) and neuropsychiatric toxicity (P =.002) were more common in elderly men than in younger men. Elderly women lost more weight than younger women (P =.006). Other toxic effects were similar in older and younger patients. The proportions with clinical partial or complete response (21.5% versus 23.3%; Fisher's exact test, P =.66), median time to progression (4.37 versus 4.30 months; log-rank test, P =.29), and survival distribution (log-rank test, P =.29; median survival, 9.05 versus 8.53 months; 1-year survival, 38% versus 29%; and 2-year survival, 14% versus 12%) were similar in patients younger than 70 years and 70 years old or older. Baseline quality-of-life and treatment-outcome indices were similar. Equivalent declines over time in functional well-being occurred in both groups. CONCLUSION Response rate, toxicity, and survival in fit, elderly NSCLC patients receiving platinum-based treatment appear to be similar to those in younger patients, although patients 70 years old or older have more comorbidities and can expect more leukopenia and neuropsychiatric toxicity. Advanced age alone should not preclude appropriate NSCLC treatment.