Clinical Study Chemotherapy 2013;59:232–238 DOI: 10.1159/000354539

Received: May 23, 2013 Accepted after revision: July 16, 2013 Published online: December 13, 2013

Gemcitabine plus Cisplatin versus Capecitabine plus Cisplatin as First-Line Chemotherapy for Advanced Biliary Tract Cancer: A Retrospective Cohort Study Sang Myung Woo Woo Jin Lee Ji Hun Kim Dong Hwan Kim Sung-Sik Han Sang-Jae Park Tae Hyun Kim Ju Hee Lee Young Hwan Koh Eun Kyung Hong Center for Liver Cancer, National Cancer Center, Goyang, Republic of Korea

Key Words Biliary tract cancer · Gemcitabine · Capecitabine · Cisplatin

Abstract Background and Aim: Gemcitabine plus cisplatin (GP) is a standard chemotherapy option for patients with advanced biliary tract cancer (BTC). We compared the efficacy and safety of capecitabine plus cisplatin (XP) versus GP in advanced BTC. Methods: The records of all patients treated with GP or XP chemotherapy for unresectable, metastatic, or recurrent BTC at the National Cancer Center between December 2001 and August 2012 were reviewed retrospectively. Patients with histologically confirmed intrahepatic cholangiocarcinoma, gallbladder cancer, or extrahepatic cholangiocarcinoma were enrolled. Results: Of the 344 patients enrolled, 127 received GP and 217 received XP. At a median follow-up time of 8.9 months, the median time to progression was longer in the GP group than in the XP group (5.6 vs. 4.7 months), but the difference was not statistically significant (p = 0.081). The median overall survival (OS) was 8.4 months (95% CI 6.2–10.7) in the GP group and 7.6 months (95% CI 6.8–8.7) in the XP group (p = 0.024), with statistical significance retained following multivariate analysis (HR 0.72; 95% CI 0.527–0.987; p = 0.004). Grade 3/4 toxicities were significantly more frequent in the GP group than in the XP group (40.9 vs. 24.9%, p = 0.002). Conclusions: GP was superior to XP in prolonging OS, despite increasing the rate of grade 3/4 adverse events. © 2013 S. Karger AG, Basel

© 2013 S. Karger AG, Basel 0009–3157/13/0593–0232$38.00/0 E-Mail [email protected] www.karger.com/che

Introduction

Biliary tract cancers (BTCs) are invasive carcinomas that arise from the epithelial lining of the gallbladder and bile ducts and include intrahepatic and extrahepatic biliary tree cancers as well as carcinomas arising from the gallbladder [1]. Due to their rarity and the lack of characteristic early symptoms, BTC is difficult to diagnose and the prognosis of patients with BTC is poor [2]. This group of tumors is characterized by regional lymph node metastasis, vascular encasement, and distant metastases. BTC is more common in Asia than in Western countries; in 2009, almost 4,800 patients were newly diagnosed with BTC in South Korea [3]. Although surgery remains the only curative treatment modality, less than one third of patients are candidates for curative resection at diagnosis [4]. Moreover, the majority of patients who undergo curative resection experience tumor recurrence or metastasis [5]. Therefore, systemic chemotherapy has become a mainstay of treatment for most patients with BTC [6, 7]. The combination of gemcitabine plus cisplatin (GP) has been a standard treatment option for patients with advanced BTC [8, 9], and randomized controlled trials have shown that frontline combination chemotherapy regimens, consisting of gemcitabine and either cisplatin or oxaliplatin, are relatively effective in patients with BTC [9–11]. However, treatment outcomes remain poor, and there have been no diWoo Jin Lee, MD, PhD Center for Liver Cancer National Cancer Center, 111 Jungbalsan-ro, Ilsandong-gu Goyang-si, Gyeonggi-do, 410-769 (Republic of Korea) E-Mail lwj @ ncc.re.kr

rect comparisons of GP with fluoropyrimidine-based chemotherapy plus platinum. Moreover, previous studies have included patients with ampullary carcinomas, which are considered a different clinical entity, with different chemosensitivity and management, as some of these tumors may develop from cells in the small bowel [12, 13]. 5-Fluorouracil (5-FU) and 5-FU-based regimens are the backbone of chemotherapy regimens tested in patients with gastrointestinal cancers. In addition, cisplatin has been found to have a synergistic effect with 5-FU in advanced BTC [8, 14]. However, 5-FU administration requires hospitalization and central venous access for continuous infusion. In contrast, capecitabine is an orally administered systemic 5-FU prodrug that is absorbed as an intact molecule via the gastrointestinal tract [15]. Capecitabine plus cisplatin (XP) has shown promising antitumor activity and tolerable safety profiles in patients with advanced BTC [16, 17]. We recently reported that XP combination chemotherapy was well tolerated and had moderate activity against advanced BTC [18]. To our knowledge, two retrospective studies [19, 20] and one randomized phase II trial [21] have directly compared GP to fluoropyrimidine-based chemotherapy plus platinum. The fluoropyrimidine used in the two retrospective studies [19, 20] was 5-FU or capecitabine, and the number of patients who received GP chemotherapy was small. The randomized phase II trial evaluated the efficacy of the combination of cisplatin plus S1, an orally administered combination of the 5-FU prodrug tegafur and two biochemical modulators, i.e. 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo) [21]. We therefore retrospectively compared the efficacy and safety of XP and GP chemotherapy in patients with advanced BTC.

≥1,500/mm3, platelet count ≥100,000/mm3), and adequate renal and hepatic function (serum creatinine

Gemcitabine plus cisplatin versus capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective cohort study.

Gemcitabine plus cisplatin (GP) is a standard chemotherapy option for patients with advanced biliary tract cancer (BTC). We compared the efficacy and ...
155KB Sizes 0 Downloads 0 Views

Recommend Documents