在基于奥沙利铂的联合一线化疗后，老年晚期结直肠癌患者获得相似的益处且无过度毒性：03-TTD-01 III期研究的比较结果

Elderly patients with advanced colorectal cancer derive similar benefit without excessive toxicity after first-line chemotherapy with oxaliplatin-based combinations: comparative outcomes from the 03-TTD-01 phase III study.

作者信息

Sastre Javier, Aranda Enrique, Massutí Bartomeu, Tabernero Jose, Chaves Manuel, Abad Albert, Carrato Alfredo, Reina Juan José, Queralt Bernardo, Gómez-España Auxiliadora, González-Flores Encarnación, Rivera Fernando, Losa Ferrán, García Teresa, Sanchez-Rovira Pedro, Maestu Inmaculada, Díaz-Rubio Eduardo

机构信息

Servicio de Oncologia Medica, Hospital Clínico San Carlos, 28040 Madrid, Spain.

出版信息

Crit Rev Oncol Hematol. 2009 May;70(2):134-44. doi: 10.1016/j.critrevonc.2008.11.002. Epub 2008 Dec 25.

DOI:10.1016/j.critrevonc.2008.11.002

PMID:19111473

Abstract

PURPOSE

Healthy elderly patients with metastatic colorectal cancer may benefit from chemotherapy as much as the younger population. This analysis compares the outcomes of first-line oxaliplatin plus fluoropyrimidines in elderly versus young patients.

PATIENTS AND METHODS

348 patients were randomized to capecitabine 1000 mg/(m2 12 h), days 1-14 plus oxaliplatin 130 mg/m2 day 1, every 3 weeks or weekly infusional 5-FU 2250 mg/m2 over 48 h plus bimonthly oxaliplatin 85 mg/m2. We evaluated response rate, time to progression, overall survival and toxicity according to age.

RESULTS

ORR for elderly and young patients were 34.9% and 44.7%, respectively (p=0.081). Median TTP did not differ between the two groups: 8.3 months for patients > or =70 years and 9.6 months for those <70 years (p=0.114). Median OS was 16.8 months and 20.5 months for the > or =70 and <70 years groups, respectively (p=0.74). With XELOX, mild paresthesia and an increase in transaminase levels were more frequent for young patients, whereas grade 3/4 diarrhea was higher in those > or =70 years (25% vs. 8%, p=0.005). For FUOX, only paresthesia was significantly lower in patients > or =70 years (53% vs. 71%, p=0.032).

CONCLUSION

Elderly patients with MCRC benefit from first-line oxaliplatin-fluoropyrimidine combinations as much as younger patients, without increased toxicity.

摘要

目的

患有转移性结直肠癌的健康老年患者可能与年轻人群一样能从化疗中获益。本分析比较了老年患者与年轻患者一线使用奥沙利铂联合氟嘧啶的治疗结果。

患者与方法

348例患者被随机分为两组，一组接受卡培他滨1000mg/(m²·12小时)，第1 - 14天给药，联合奥沙利铂130mg/m²第1天给药，每3周重复一次；另一组接受每周输注5 - 氟尿嘧啶2250mg/m²共48小时，联合每两个月一次的奥沙利铂85mg/m²。我们根据年龄评估了缓解率、疾病进展时间、总生存期和毒性。

结果

老年患者和年轻患者的客观缓解率分别为34.9%和44.7%（p = 0.081）。两组的中位疾病进展时间无差异：≥70岁患者为8.3个月，＜70岁患者为9.6个月（p = 0.114）。≥70岁组和＜70岁组的中位总生存期分别为16.8个月和20.5个月（p = 0.74）。使用XELOX方案时，年轻患者轻度感觉异常和转氨酶水平升高更为常见，而≥70岁患者3/4级腹泻发生率更高（25%对8%，p = 0.005）。对于FUOX方案，仅感觉异常在≥70岁患者中显著较低（53%对71%，p = 0.032）。