Initial Results Of Preoperative Gemcitabine (GEM)-Based Chemoradiation For Resectable Pancreatic Adenocarcinoma

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 21, 2002

Presenter: Robert A Wolff
Presenter's Affiliation: UT MD Anderson Cancer Ctr, Houston, TX
Type of Session: Scientific


  • The recurrence rate in patients with adenocarcinoma of the pancreas following pancreaticoduodenectomy with curative intent is > 80%
  • Preoperative Chemoradiotherapy increases the proportion of patients that undergo potentially curative resections for their local disease and prevents a delay in the systemic treatment of subclinical distant disease

Materials and Methods

  • A chemoradiotherapy regimen consisting of 7 cycles of weekly gemcitabine (400 mg/m2) with 30 Gy of radiotherapy (3 Gy / fraction) delivered in two weeks beginning 3 days after the first dose of gemcitabine was delivered in patients with biopsy proven, potentially resectable adenocarcinoma of the pancreatic head or uncinate process
  • Patients were re-staged with chest radiographs and CAT scans 4-6 weeks after the last chemotherapy
  • Those without tumor progression and good performance status underwent pancreaticoduodenectomy
  • The effectiveness of the preoperative therapy was evaluated on histopathologic analysis of the surgical specimen


  • 86 patients were enrolled in the trial over 3 years
  • All patients completed the preoperative portion of the treatment
  • The planned dose of radiotherapy was delivered in 100% of the patients
  • The planned dose of gemcitabine was delivered in 39 patients (45%)
  • Among patients that did not received the planned dose of gemcatibine, 23% (11/47) required a dose reduction and 77% (36/47) missed > 1 doses
  • The main reasons for chemotherapy modification were: gastrointestinal (34%), hematologic (53%), and endobiliary stent occlusion (12%)
  • 37 patients (43%) required hospitalization prior to the planned surgery but no chemoradiotherapy-associated deaths were observed
  • Patients were restaged following chemoradiotherapy
  • 15% of patients did not undergo surgery because of disease progression at restaging
  • Resection was attempted in 85%, of which 6/7th underwent a successful pancreaticoduodenectomy (this represents 73% of all patients completing the preoperative portion of the treatment) and 1/7th were found to have metastatic disease at exploration
  • More than 50% of tumor cells were deemed ?not viable? upon histopathologic examination in 60% of the surgical specimens
  • No viable tumor cells were identified in 2 (~ 3%) specimens

Author's Conclusions

  • Adverse effects, especially hematologic, were common but manageable
  • Adverse effects were attributable to the chemotherapy portion of the regimen and did not interfere with compliance of either radiotherapy or surgery
  • No chemoradiation-associated deaths were observed with this gemcitabine-based regimen
  • The rate of preoperative disease progression with this neoadjuvant therapy was low and allowed a substantial portion of the patients with pancreatic cancer to proceed to potentially curative resection
  • High rates of local pathologic response were observed with this gemcitabine-based chemoradiotherapy approach

Clinical/Scientific Implications

    The high proportion (73%) of patients in which a successful pancreaticoduodenectomy was attained after this regimen compares favorably with other reported preoperative regimens for pancreatic cancer (~ 60%). Most patients with pancreatic cancer are seen postoperatively after a Whipple Procedure for chemoradiotherapy. Other studies are evaluating the use of Gemcytabine in the postoperative setting in association with radiation therapy.

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