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Study 1: Creation of
evidence for new preoperative treatment for pancreatic cancer.
Introduction: Along with the
development of chemotherapy for unresectable pancreatic cancer, attempts have
been made to apply to surgeon-led preoperative treatment.
Methods: We demonstrate the
role of surgery in creating stronger evidence for meta-analyses and multicenter
collaborative phase II trials from clinical trials of new preoperative
anticancer drug treatments led by surgeons.
Results: We conducted a
pilot trial of preoperative FOLFILINOX therapy for BR pancreatic cancer and
reported the safety and efficacy of the treatment. This study provides an
international collaborative study of meta-analysis in the form of data
providing 283 patients with BR pancreatic cancer who received preoperative
FOLFIRINOX therapy with a median overall survival of 22.2 months, an ablation
rate of 68% and 84%. We report a high R0 resection rate and good results as
stronger evidence (JNCI2019). It became clear that it should be verified in the
randomized controlled trial as the next task. In addition, we report phase I
clinical trial results of preoperative GEM+nab-Paclitaxel treatment for BR
pancreatic cancer at the center and are currently verifying the same treatment
in multi-center joint phase II trial.
Study 2: Diffusion-weighted
MRI predicts the histologic response for neoadjuvant therapy in patients with
pancreatic cancer; a prospective phase II studies (DIFFERENT trial).
Background: Preoperative
prediction of histological response to neoadjuvant therapy aids decisions
regarding surgical management of borderline resectable pancreatic cancer
(BRPC). We elucidate correlation between pre/post-treatment whole tumor
apparent diffusion coefficient (ADC) value and rate of tumor cell destruction.
We verify whether post-treatment ADC value on site of vascular contact predicts
negative surgical margin (NSM) of BRPC.
Methods: We prospectively
reviewed 28 patients with BRPC who underwent diffusion-weighted magnetic
resonance imaging before neoadjuvant chemotherapy and surgery. Correlation
between percentage of tumor cell destruction and various parameters was
analyzed. Strong parameters were assessed for their ability to predict
therapeutic histological response and NSM.
Results: Pre/post-treatment
whole tumor ADC value correlated with tumor cell destruction rate by all
parameters (R=0.630/0.714, P<0.001/<0.0001). The post-treatment cut-off
value of ADC on site of vascular contact for discriminating between grade
Conclusion: Post-treatment
whole tumor or ADC value on site of vascular contact may be a predictor of NSM
in patients with BRPC. There was significant correlation between
pre/post-treatment whole tumor ADC values and rates of tumor cell destruction
after neoadjuvant therapy.
Trial registration: This trial is
registered at UMIN Clinical Trials Registry, UMIN000022010, 000028030 and at
ClinicalTrials.gov, NCT02777463.
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