Satram-Hoang Sacha, Lee Luen, Yu Shui, Guduru Sridhar R, Gunuganti Ashokvardhan R, Reyes Carolina, McKenna Edward
Q.D. Research, Inc, 8789 Auburn Folsom Road C501, Granite Bay, CA 95746, USA.
J Gastrointest Cancer. 2013 Mar;44(1):79-88. doi: 10.1007/s12029-012-9450-x.
Treatment advances have improved outcomes in clinical trials of patients with metastatic colorectal cancer (mCRC). Less is known about these effects for patients in real-world settings. This study evaluated treatment patterns and survival in older, demographically diverse patients with mCRC.
A retrospective cohort analysis was performed for 4,250 patients from January 1, 2000 to December 31, 2007 using linked Surveillance, Epidemiology, and End Results-Medicare database. Patients were ≥ 66 years, enrolled in Medicare parts A and B, and received first-line treatment with fluorouracil and leucovorin (5-FU/LV), capecitabine (CAP), 5-FU/LV plus oxaliplatin (FOLFOX), or CAP and oxaliplatin (CAPOX). Cox regression with backward elimination and propensity score-weighted Cox regression estimated relative risk of death. Date of last follow-up was December 2009. Statistical comparisons were made between 5-FU/LV vs. CAP and FOLFOX vs. CAPOX.
Compared to 5-FU/LV, patients treated with CAP were older (mean age 78 vs. 76; P<0.0001) and more likely female (61 vs. 54 %; P=0.0017), while patients receiving CAPOX and FOLFOX were similar in age (mean age 74 vs. 73; P=0.0924). Complications requiring medical resource utilization following initiation of therapy were significantly higher among patients administered with 5-FU/LV (54 %) vs. CAP (17 %; P<0.0001) and FOLFOX (75 %) vs. CAPOX (57 %; P<0.0001). The multivariate analysis revealed no significant differences in survival between 5-FU/LV and CAP and between FOLFOX and CAPOX.
Overall survival was comparable between CAP and 5-FU/LV and between CAPOX and FOLFOX with fewer complications requiring medical resource utilization associated with CAP and CAPOX, thus confirming clinical trial results.
治疗进展改善了转移性结直肠癌(mCRC)患者临床试验的结果。对于现实环境中的患者,这些影响鲜为人知。本研究评估了年龄较大、人口统计学特征多样的mCRC患者的治疗模式和生存率。
使用关联的监测、流行病学和最终结果 - 医疗保险数据库,对2000年1月1日至2007年12月31日期间的4250例患者进行回顾性队列分析。患者年龄≥66岁,参加了医疗保险A部分和B部分,并接受氟尿嘧啶和亚叶酸钙(5 - FU/LV)、卡培他滨(CAP)、5 - FU/LV加奥沙利铂(FOLFOX)或CAP与奥沙利铂(CAPOX)的一线治疗。采用逐步回归的Cox回归和倾向评分加权的Cox回归估计死亡相对风险。最后随访日期为2009年12月。对5 - FU/LV与CAP以及FOLFOX与CAPOX进行统计学比较。
与5 - FU/LV相比,接受CAP治疗的患者年龄更大(平均年龄78岁对76岁;P<0.0001),女性比例更高(61%对54%;P = 0.0017),而接受CAPOX和FOLFOX治疗的患者年龄相似(平均年龄74岁对73岁;P = 0.0924)。在开始治疗后需要医疗资源利用的并发症方面,接受5 - FU/LV治疗的患者(54%)显著高于接受CAP治疗的患者(17%;P<0.0001)以及接受FOLFOX治疗的患者(75%)高于接受CAPOX治疗的患者(57%;P<0.0001)。多因素分析显示,5 - FU/LV与CAP之间以及FOLFOX与CAPOX之间在生存率上无显著差异。
CAP与5 - FU/LV之间以及CAPOX与FOLFOX之间的总生存率相当,且CAP和CAPOX相关的需要医疗资源利用的并发症较少,从而证实了临床试验结果。