Arúajo António M F, Mendez Jose C, Coelho Ana L, Sousa Berta, Barata Fernando, Figueiredo Ana, Amaro Teresina, Azevedo Isabel, Soares Marta
Department of Medical Oncology, Portuguese Institute of Oncology Francisco Gentil, Porto, Portugal.
Cancer Invest. 2009 May;27(4):391-6. doi: 10.1080/07357900802232756.
We performed a phase II trial to test whether a cyclooxygenase (COX-2) inhibitor, celecoxib, added to standard first-line combination chemotherapy (CT) and as maintenance therapy would improve outcomes in extensive-stage (ES) small-cell lung cancer (SCLC). This was a multicenter trial in CT-naive patients with ES-SCLC. They received standard cisplatin and etoposide (EP) up to 6 cycles and celecoxib 400 mg PO bid continuously until disease progression. Primary end points were response rate (RR), time to progression (TTP), and toxicity. Secondary were overall survival (OS) and quality of life. Of 74 expected patients, only 24 were enrolled and the study stopped earlier because of the published safety concerns about celecoxib. The patients, all male, were between 38 and 74 years. A total of 130 cycles of CT were administered. Toxicity associated with celecoxib was minimal. The RR was 56.5%. Median TTP and OS were 8.6 and 11.3 months, respectively. These data suggest that celecoxib may safely be combined with EP for treatment of ES-SCLC. This combination showed a promising activity and, despite the safety concerns regarding celecoxib, it would be interesting to further evaluate this regimen.
我们进行了一项II期试验，以测试将环氧化酶（COX-2）抑制剂塞来昔布添加到标准一线联合化疗（CT）中并作为维持治疗是否会改善广泛期（ES）小细胞肺癌（SCLC）的治疗结果。这是一项针对初治ES-SCLC患者的多中心试验。他们接受标准的顺铂和依托泊苷（EP）治疗，最多6个周期，同时持续口服塞来昔布400 mg，每日两次，直至疾病进展。主要终点是缓解率（RR）、疾病进展时间（TTP）和毒性。次要终点是总生存期（OS）和生活质量。在预期的74例患者中，仅24例入组，由于已公布的关于塞来昔布的安全性问题，该研究提前终止。患者均为男性，年龄在38至74岁之间。共进行了130个周期的CT治疗。与塞来昔布相关的毒性极小。RR为56.5%。TTP和OS的中位数分别为8.6个月和11.3个月。这些数据表明，塞来昔布可安全地与EP联合用于治疗ES-SCLC。这种联合显示出有前景的活性，尽管存在对塞来昔布的安全性担忧，但进一步评估该方案将是有意义的。
