A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing?
dc.contributor.author | Clayton, Alison J | |
dc.contributor.author | Mansoor, Was | |
dc.contributor.author | Jones, Eileen T | |
dc.contributor.author | Hawkins, Robert E | |
dc.contributor.author | Saunders, Mark P | |
dc.contributor.author | Swindell, Ric | |
dc.contributor.author | Valle, Juan W | |
dc.date.accessioned | 2009-07-07T15:56:24Z | |
dc.date.available | 2009-07-07T15:56:24Z | |
dc.date.issued | 2006-01 | |
dc.identifier.citation | A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing? 2006, 32 (1):51-7 Pancreas | en |
dc.identifier.issn | 1536-4828 | |
dc.identifier.pmid | 16340744 | |
dc.identifier.uri | http://hdl.handle.net/10541/72869 | |
dc.description.abstract | OBJECTIVES: A phase 2 study to assess the activity of the cisplatin-gemcitabine combination in patients with advanced pancreatic cancer. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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. | |
dc.language.iso | en | en |
dc.subject | Haematologic Diseases | en |
dc.subject | Cancer Staging | en |
dc.subject | Pancreatic Cancer | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject.mesh | Cisplatin | |
dc.subject.mesh | Deoxycytidine | |
dc.subject.mesh | Drug Administration Schedule | |
dc.subject.mesh | Female | |
dc.subject.mesh | Hematologic Diseases | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Neoplasm Staging | |
dc.subject.mesh | Pancreatic Neoplasms | |
dc.subject.mesh | Survival Analysis | |
dc.subject.mesh | Time Factors | |
dc.title | A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing? | en |
dc.type | Article | en |
dc.contributor.department | Gastrointestinal Disease Orientated Group, Christie Hospital NHS Trust, Manchester, United Kingdom. | en |
dc.identifier.journal | Pancreas | en |
html.description.abstract | OBJECTIVES: A phase 2 study to assess the activity of the cisplatin-gemcitabine combination in patients with advanced pancreatic cancer. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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. |