Clayton Alison J, Mansoor Abdul W, Jones Eileen T, Hawkins Robert E, Saunders Mark P, Swindell Ric, Valle Juan W
Gastrointestinal Disease Orientated Group, Christie Hospital NHS Trust, Manchester, United Kingdom.
Pancreas. 2006 Jan;32(1):51-7. doi: 10.1097/01.mpa.0000188306.67420.0f.
A phase 2 study to assess the activity of the cisplatin-gemcitabine combination in patients with advanced pancreatic cancer.
Chemotherapy-naive patients with locally advanced/metastatic/relapsed adenocarcinoma of the pancreas received cisplatin 25 mg/m2 followed by gemcitabine 1000 mg/m2 intravenously on days 1, 8, and 15 of a 28-day cycle. Radiologic response was assessed after 3 cycles, and treatment continued for up to 6 cycles in the absence of disease progression.
Thirty-six patients were enrolled, 35 patients were evaluable for toxicity. Hematological toxicity was significant but mostly asymptomatic with grade 3 to 4 (% of patients): leucopenia, 40%; neutropenia, 60%; thrombocytopenia, 60%. There were only 3 episodes of neutropenic sepsis and 2 significant bleeding episodes. Grade 3 to 4 nonhematological toxicities were uncommon but included constipation, infection without neutropenia, lethargy, and thromboembolic events. Of 32 evaluable patients, 62.8% achieved stable disease (SD) or better (SD, 53.4%; partial response, 9.4%). Twenty-nine patients were evaluable for clinical benefit response: 11 (31%) were clinical benefit responders, whereas 13 (36%) remained stable. With complete follow-up, the median time to disease progression was 5.75 months; median survival was 9.5 months, 6-month survival was 72.2%, and 1-year survival was 41.7%.
The combination of gemcitabine and cisplatin is clearly an active regimen and may improve survival based on our 1-year and median survival findings and results from other institutions. However, only an adequately powered randomized controlled trial will assess any real survival benefit over single agent gemcitabine.
一项2期研究，评估顺铂 - 吉西他滨联合方案对晚期胰腺癌患者的疗效。
既往未接受过化疗的局部晚期/转移性/复发性胰腺腺癌患者，在28天周期的第1、8和15天静脉注射顺铂25mg/m²，随后静脉注射吉西他滨1000mg/m²。3个周期后评估影像学反应，若无疾病进展，治疗持续至6个周期。
共纳入36例患者，35例患者可评估毒性。血液学毒性显著，但大多无症状，3 - 4级（患者百分比）：白细胞减少，40%；中性粒细胞减少，60%；血小板减少，60%。仅发生3例中性粒细胞减少性败血症和2例严重出血事件。3 - 4级非血液学毒性不常见，但包括便秘、非中性粒细胞减少性感染、嗜睡和血栓栓塞事件。在32例可评估患者中，62.8%达到疾病稳定（SD）或更好（SD，53.4%；部分缓解，9.4%）。29例患者可评估临床获益反应：11例（31%）为临床获益反应者，13例（36%）病情稳定。经完整随访，疾病进展的中位时间为5.75个月；中位生存期为9.5个月，6个月生存率为72.2%，1年生存率为41.7%。
基于我们的1年和中位生存期结果以及其他机构的结果，吉西他滨和顺铂联合方案显然是一种有效的治疗方案，可能改善生存期。然而，只有一项有足够样本量的随机对照试验才能评估其相对于单药吉西他滨是否有真正的生存获益。
