Number of included patients:
Oncology. 2009 Sep 4;77(3-4):217-223.
Do Recurrent and Metastatic Pancreatic Cancer Patients Have the Same Outcomes with Gemcitabine Treatment?
Hashimoto K, Ueno H, Ikeda M, Kojima Y, Hagihara A, Kondo S, Morizane C, Okusaka T.
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division, Tokyo, Japan.
Whether recurrence after surgery and primary metastatic pancreatic
cancer should be included in the same category when conducting
gemcitabine-based clinical trials remains controversial. Objective: To
clarify the outcomes of recurrent and metastatic pancreatic cancers.
Methods: 326 patients who received gemcitabine monotherapy as a
first-line treatment for advanced pancreatic cancer between 2001 and
2007 were reviewed. Multivariate analysis was performed to determine
the prognostic relevance of recurrence or metastasis in relation to
other factors possibly influencing treatment outcomes with respect to
overall survival. Differences in response to chemotherapy, drug
delivery and adverse events were also analyzed. Results: There were 65
recurrent and 261 metastatic cancer patients. Recurrent cancer patients
had a significantly longer time to treatment failure and survival
(respective medians 138 and 77 days, p = 0.017) than the metastatic
patients (respective medians 270 and 185 days, p = 0.0003).
Multivariate analysis revealed poor Karnofsky performance status
(<80), presence of liver or peritoneal metastasis, elevated lactate
dehydrogenase (>220 U/l), elevated alkaline phosphatase (>330
U/l) and elevated C-reactive protein (>1.0 mg/dl) to be
significantly correlated with short survival, while neither recurrent
nor metastatic status were related to survival (hazard ratio 0.76, 95%
CI 0.53-1.09, p = 0.14). The response rates and dose intensities of
gemcitabine were similar in these groups, although leukopenia was more
frequently observed in the recurrence group (p = 0.008). Conclusion:
When conducting clinical trials, it appears to be acceptable to treat
recurrent pancreatic cancer after surgery and pancreatic cancer with
primary metastasis under the same category. Copyright © 2009 S. Karger