A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing?
OBJECTIVE
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.
Clayton
Alison J
AJ
Gastrointestinal Disease Orientated Group, Christie Hospital NHS Trust, Manchester, United Kingdom.
Mansoor
Abdul W
AW
Jones
Eileen T
ET
Hawkins
Robert E
RE
Saunders
Mark P
MP
Swindell
Ric
R
Valle
Juan W
JW
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity*; D002945:Cisplatin / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D016019:Survival Analysis; D013997:Time Factors; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine