A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing?

Pancreas. 2006 Jan;32(1):51-7. doi: 10.1097/01.mpa.0000188306.67420.0f.

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.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / toxicity*
  • Cisplatin / administration & dosage*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Drug Administration Schedule
  • Female
  • Hematologic Diseases / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / pathology*
  • Pancreatic Neoplasms / surgery
  • Survival Analysis
  • Time Factors

Substances

  • Deoxycytidine
  • gemcitabine
  • Cisplatin