Neoadjuvant chemotherapy with gemcitabine and S-1 for resectable and borderline pancreatic ductal adenocarcinoma: A prospective, multi-institutional, phase II trial.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 283-283 ◽  
Author(s):  
Masamichi Mizuma ◽  
Fuyuhiko Motoi ◽  
Kazuyuki Ishida ◽  
Fumiyoshi Fujishima ◽  
Shigeru Ottomo ◽  
...  
Keyword(s):  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Surgical Resection ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Distant Metastases ◽  
Ductal Adenocarcinoma ◽  
Institutional Setting ◽  
Resection Rate

283 Background: Although surgical resection is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC), recurrence rates are very high even if complete resection is performed. Accordingly, a new therapeutic strategy against PDAC is needed. Combination with gemcitabine and S-1 (GS) as first line chemotherapy is promising. The purpose of this study is to evaluate the feasibility and efficacy of GS for resectable and borderline PDAC in the neoadjuvant chemotherapy (NAC). Methods: This study is a prospective, multi-institutional, single-arm, phase II trial. Neoadjuvant chemotherapy with gemcitabine and S-1(NAC-GS) for resectable and borderline PDAC was performed as follows. Gemcitabine was given at a dose of 1,000 mg/m2 on days 1 and 8 of each cycle. S-1 was administered orally at a dose of 40 mg/m2 twice daily for the first 14 consecutive days followed by a 7-day rest. Each cycle was repeated every 21 days. The primary endpoint was the 2-year survival rate. Secondary endpoints were feasibility, resection rate, pathological effect, recurrence-free survival and tumor marker status. Results: 36 patients were enrolled between 2008 and 2010. 35 were eligible for participation in this trial. The most common toxicity was neutropenia in response to 90% of the relative dose intensity. Radiological tumor shrinkage and decreases of CA19-9 levels were seen in 69% and 89%, respectively. R0 resection rate was 87%, and the morbidity rate (40%) was acceptable. The 2-year survival rate of the total cohort was 45.7%. Patients undergoing surgical resection without distant metastases after NAC-GS (n=27) showed an increased median overall survival (34.7 months), compared with 10.0 months for resection with distant metastases or non-resection (p=0.0017). Conclusions: NAC-GS is safe and well tolerated in a multi-institutional setting. NAC-GS is encouraging patients with resectable and borderline PDAC because of better outcomes. Clinical trial information: UMIN-000001504.

Did neoadjuvant chemotherapy provide better long term outcomes in borderline resectable with arterial involvement (BR-A PC)?

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 434-434
Author(s):  
Kei Saito ◽  
Yousuke Nakai ◽  
Yoshihiro Sakamoto ◽  
Kazunaga Ishigaki ◽  
Naminatsu Takahara ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Palliative Chemotherapy ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
R0 Resection ◽  
Long Term Outcomes ◽  
Resection Rate ◽  
Arterial Involvement

434 Background: Recently high rates of conversion (or adjuvant) surgery were reported after neoadjuvant chemo(radiation)therapy (NAC) for borderline or locally advanced pancreatic cancer (BR/LA PC) including our phase II trial of gemcitabine, S-1 and leucovorin (GSL) combination therapy for BR PC with arterial involvement (BR-A PC) and LA PC. In our phase II trial, a high recurrence rate of 78% was noted despite a high R0 resection of 76%. Herein, we conducted a retrospective analysis of BR-A PC who underwent NAC, upfront surgery and palliative chemotherapy to evaluate the long term outcomes of NAC. Methods: Consecutive patients with BR-A PC at the University of Tokyo Hospital were retrospectively studied. Clinical outcomes in patients who underwent (NAC group) were compared with those in patients who underwent upfront surgery or palliative chemotherapy (non-NAC group). NAC was introduced in our institution from January 2014. Results: A total of 45 patients (22 non-NAC and 23 NAC group) were diagnosed with BR-A PC between January 2008 and December 2016. There were no significant differences in patient characteristics between non-NAC group and NAC group: Median age of 63 vs. 64, male in 72% vs. 52%, Performance status of 0 in 63% vs. 65%, median pretreatment CA19-9 of 175 vs. 205 U/ml. In non-NAC group, 17 underwent palliative chemotherapy as follows 8 gemcitabine alone, 3 gemcitabine and S-1 combination chemotherapy and 6 other regimens. The remaining 5 patients underwent upfront surgery with an R0 resection rate of 80%. In NAC group, a median duration of neoadjuvant chemotherapy was 4 months. A total of 14 patients underwent surgical resection with an R0 resection rate of 76%. The remaining 9 patients had disease progression during NAC and received 2nd line chemotherapy. The median follow-up time was 16.5 months in non-NAC group and 15.3 months in NAC group. The median overall survival (OS) were 19.3 vs. 21.9 months (p = 0.25). Conclusions: Both R0 resection rate and the median OS were comparable between non-NAC group and NAC group. An ideal regimen of NAC or its duration needs further investigation to prolong OS in BR-A PC.

A phase II trial of preoperative FOLFIRINOX followed by gemcitabine-based chemoradiotherapy in patients with borderline resectable pancreatic ductal adenocarcinoma (BR PDAC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4638-4638
Author(s):  
Michael Wysota ◽  
Amanda Jirgal ◽  
Ana Acuna-Villaorduna ◽  
Shankar Viswanathan ◽  
Andreas Kaubisch ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Ductal Adenocarcinoma ◽  
R0 Resection ◽  
Second Phase ◽  
Preoperative Treatment ◽  
Resection Rate ◽  
Borderline Resectable ◽  
Study Results

4638 Background: Preoperative (preop) therapy is widely accepted as the standard of care for patients (pt) with BR PDAC with limited evidence for a specific regimen. This study aimed to assess the efficacy of FOLFIRINOX (FOL) chemotherapy followed by gemcitabine-based chemo-radiotherapy (RT) as preop therapy in pt with BR-PDAC. Methods: This single arm Simon two stage phase II trial in pt with BR PDAC was conducted in two phases. The first phase included 4 cycles of FOL, and the second included weekly gemcitabine (1000 mg/m2) for 6 cycles with concomitant intensity-modulated RT (50.4 Gy in 28 fractions)(Gem/RT).The primary aim was to compare R0 resection rate (H0: ≤40% vs Ha≥60%) using one-sample one-sided Z test. Secondary outcomes, including overall survival (OS) and progression-free survival (PFS) were assessed using Kaplan-Meier method. Results: Of 22 enrolled pt, 18 (81.8%) completed preoperative treatment. Median age at diagnosis was 63.4 years and 12 (54.5%) were female. There were 10 (45.5%) Hispanics, 4 (18.2%) non-Hispanic black, and 8 (36.4%) non-Hispanic white. Tumor location was predominantly head/neck (21, 95.5%), 15 (68.1%) had T2/3, and 9 (40.9%) had N2 (clinical) disease. Fourteen (64.6%) pt, had venous involvement, 5 (22.7%) had arterial, and 3 (13.6%), both. In the first phase, 20 (90.9%) completed 4 cycles of FOL, 6 (27.3%) required dose-reduction and dose was delayed in 12 (54.5%). Stable disease (SD) was achieved in 10 (52.6%), partial response (PR) in 8 (42.1%) and disease progression (PD) in 1 (5.3%) pt. Of 21 pt that entered the second phase, 18 (85.7%) completed 6 cycles of Gem/RT, 5 (26.3%) required dose-reduction and dose was delayed in 6 (31.6%). SD was achieved in 10 (55.6%), PR in 3 (16.7%) and PD in 5 (27.8%). All pt experienced at least one grade 1 adverse event (AE) and 12 (54.5%) at least one grade 3/4 AE, of which neutropenia was the most common-11 (50%). Of the 15 (68.1%) pt who underwent surgical resection, 12 (80%) achieved R0 margins and 5 (33.3%) required vascular reconstruction. The R0 rate among pt that received >1 cycle of FOLFIRINOX was 54.5%. Adjuvant chemotherapy was offered to 6/15 pt (40%). The PFS and OS will be reported. Conclusions: An R0 resection rate of 54.5% with this limited sample size is significant at the 10% level. Neoadjuvant FOLFIRINOX followed by concomitant Gem/RT was well-tolerated. The study will be amended to include adjuvant FOL in line with the PRODIGE intergroup adjuvant study results. Clinical trial information: NCT01897454 .

scholarly journals Circulating tumour cells as an indicator of early and systemic recurrence after surgical resection in pancreatic ductal adenocarcinoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yejong Park ◽  
Hye Ryeong Jun ◽  
Hwi Wan Choi ◽  
Dae Wook Hwang ◽  
Jae Hoon Lee ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Surgical Resection ◽  
Distant Metastases ◽  
Early Recurrence ◽  
Tumour Cells ◽  
Ductal Adenocarcinoma ◽  
Circulating Tumour Cells ◽  
Active Monitoring ◽  
Systemic Recurrence ◽  
Recurrence Patterns

AbstractEarly recurrence in pancreatic ductal adenocarcinoma (PDAC) is a decisive factor in determining a patient's prognosis. We determined in our current study whether circulating tumour cells (CTCs) exist in the blood of PDAC patients and can be used as a predictor of recurrence patterns (i.e. time and site) after surgical resection. Between December 2017 and November 2018, the mononuclear cell layer was obtained from the peripheral blood of 36 patients diagnosed with PDAC. CTCs were then isolated using the CD-PRIME™ platform and detected via immunostaining. The patient records were analyzed to correlate these data with survival and recurrence patterns. Twelve patients were CTC-positive (33.3%) and showed a significantly frequent rate of systemic recurrence (distant metastases and peritoneal dissemination) (p = 0.025). On multi-variable logistic regression analysis, CTC positivity was an independent risk factor for early recurrence (p = 0.027) and for systemic recurrence (p = 0.033). In summary, the presence or absence of CTC in the blood of the patients with PDAC could help predict the recurrence pattern after surgery. PDAC patients with CTC positivity at tumour diagnosis should therefore undergo a comprehensive strategy for systemic therapy and active monitoring to detect possible early recurrence.

scholarly journals Is neoadjuvant chemotherapy always justified in clinical T1 pancreatic ductal adenocarcinoma?

HPB ◽  
2021 ◽  
Vol 23 ◽  
pp. S233
Author(s):  
H.S. Kim ◽  
K. Nakagawa ◽  
T. Akahori ◽  
K. Nakamura ◽  
T. Takagi ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Ductal Adenocarcinoma
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