Chen Jiezhong, Kaley Kristin, Garcon Marie Carmel, Rodriguez Teresa, Saif Muhammad Wasif
School of Biomedical Sciences and Australian Institute of Bioengineering and Nanotechnology, University of Queensland, QLD, Australia.
School of Medicine, New Haven, CT, USA.
Therap Adv Gastroenterol. 2016 Mar;9(2):162-8. doi: 10.1177/1756283X15622779.
The objective of this study was to report a case series on the efficacy and safety of capecitabine 7/7 schedule combined with erlotinib (CAP-ERL) in patients with advanced pancreatic cancer (APC) who have failed prior therapies.
We retrospectively evaluated 13 patients with locally advanced or metastatic pancreatic cancer previously treated with gemcitabine or oxaliplatin-irinotecan-based first-line regimens. Treatment consisted of capecitabine (Xeloda) at a flat dose of 1000 mg orally twice daily on days 1-7 out of 14 days (7/7 schedule) and erlotinib (Tarceva) 100 mg orally once daily until unacceptable toxicity or disease progression. Tumor assessments were repeated every two cycles (8 weeks) and serum tumor markers were measured every 4 weeks.
All patients (median age: 63 years; 7 female/3 male) had various previous lines of treatments of chemotherapies. Median number of cycles with CAP-ERL was 4 (range 2-12). The overall response rate was 20%. CA19-9 was reduced more than 25% in 40% patients. The median overall survival and progression-free survival from the start of CAP-ERL were 4.5 months (range 3-7.5) and 2 months (range 1.5-4), respectively. The most common grade 3 toxicities included hand-foot syndrome, nausea, vomiting, diarrhea, rash, and fatigue.
Our result suggests that the combination of a fixed low dose of CAP-ERL 7/7 schedule was tolerated with manageable toxicity and showed encouraging activity as salvage treatment in patients with refractory APC with ECOG performance status 0-2. Further prospective studies are warranted to evaluate this combination.
本研究的目的是报告一组病例,阐述卡培他滨7/7方案联合厄洛替尼(CAP-ERL)用于先前治疗失败的晚期胰腺癌(APC)患者的疗效和安全性。
我们回顾性评估了13例局部晚期或转移性胰腺癌患者,这些患者先前接受过基于吉西他滨或奥沙利铂-伊立替康的一线治疗方案。治疗方案为卡培他滨(希罗达),在14天中的第1 - 7天,每日口服2次,固定剂量为1000 mg(7/7方案),厄洛替尼(特罗凯)每日口服100 mg,直至出现不可耐受的毒性或疾病进展。每两个周期(8周)重复进行肿瘤评估,每4周检测血清肿瘤标志物。
所有患者(中位年龄:63岁;7名女性/3名男性)之前都接受过多种化疗方案。CAP-ERL的中位周期数为4(范围2 - 12)。总缓解率为20%。40%的患者CA19-9降低超过25%。从开始使用CAP-ERL起,中位总生存期和无进展生存期分别为4.5个月(范围3 - 7.5)和2个月(范围1.5 - 4)。最常见的3级毒性包括手足综合征、恶心、呕吐、腹泻、皮疹和疲劳。
我们的结果表明,固定低剂量的CAP-ERL 7/7方案联合用药耐受性良好,毒性可控,对于东部肿瘤协作组(ECOG)体能状态为0 - 2的难治性APC患者作为挽救治疗显示出令人鼓舞的活性。有必要进行进一步的前瞻性研究来评估这种联合用药方案。