吉西他滨+卡培他滨治疗晚期胆道癌二期临床

Background: Biliary tract carcinoma is an aggressive cancer with median survivals rarely exceeding 6 months. While surgery provides the only curative treatment, most patients are unresectable due to advanced stages of disease. There is currently no established palliative standard of care for the treatment of advanced biliary cancer. Recent phase II trials suggest that newer agents such as gemcitabine or capecitabine have activity in this disease. We conducted a phase II trial to study the efficacy and toxicity of both drugs in combination in patients with advanced or metastatic biliary cancer.

Methods: Patients with unresectable cholangiocarcinoma or gallbladder cancer were enrolled from July 2001 and ongoing. Eligible patients had histologically or cytologically confirmed adenocarcinoma, no prior systemic therapy, ECOG PS < 2, serum total bilirubin up to 3 x normal and measurable disease. Treatment consisted of gemcitabine 1000 mg/m2 IV day 1, 8 concurrent with capecitabine 650 mg/m2 PO BID day 1 to 14, on a 3 week cycle. Tumor response was assessed by RECIST criteria.

Results: Of the 35 patients enrolled to date 16 (46%) had cholangiocarcinoma and 19 (54%) had gallbladder cancer. Median age was 62 (range 42-84). ECOG PS: 0 (16), 1 (16), 2 (3). A total of 212 cycles of chemotherapy have been administered, for a median of 4 cycles per patient (range 1-17). At median follow-up of 6 months, 35 patients are evaluable for toxicity and 31 for response. There are 9 patients with partial responses (26 %), plus an additional 13 patients with stable disease > 3 cycles (37 %). To date, response rates for gallbladder carcinoma are 24 (95 % C.I. 7-50) and cholangiocarcinoma is 36 (95% C.I. 7-50). The overall median time to disease progression is 6.8 months. Overall survival is estimated at 10.3 months. No grade 4 toxicity was seen. Transient grade 3 neutropenia (no febrile neutropenia) and manageable hand-foot syndrome were the most common toxicity (see table below.) Across all cycles patients received an average of 95% of the initially prescribed chemotherapy dose.

Conclusions: GemCap is an active and extremely well tolerated chemotherapy regimen in patients with advanced biliary tract cancer. The durable disease control rate of over 60% (partial response plus stable disease) together with mild toxicity in a fairly morbid patient population may account for the encouraging median survival of over 10 months. Anticipating that this regimen may have clear patient benefit, randomized studies are planned. Patient accrual is ongoing and updated results will be presented.

http://www.asco.org/ASCOv2/Meeti ... &abstractID=285

有效率超过60%。因为没用到铂类，这是一个相对副作用小的化疗方案，适合身体差的患者。

关注了，谢谢。  
再跟楼主的置顶主题贴对照比较。