Concomitant Administration of Weekly Oxaliplatin, Fluorouracil Continuous Infusion, and Radiotherapy After 2 Months of Gemcitabine and Oxaliplatin Induction in Patients With Locally Advanced Pancreatic Cancer: A Groupe Coordinateur Multidisciplinaire en Oncologie Phase II Study

2008 ◽  
Vol 26 (7) ◽  
pp. 1080-1085 ◽  
Author(s):  
Laurence Moureau-Zabotto ◽  
Jean-Marc Phélip ◽  
Pauline Afchain ◽  
Laurent Mineur ◽  
Thierry André ◽  
...  

Background According to previously reported Groupe Coordinateur Multidisciplinaire en Oncologie (GERCOR) studies in locally advanced pancreatic cancer (LAPC), concomitant chemoradiotherapy (CCRT) may be recommended for patients who do not experience disease progression after systemic induction chemotherapy (CT). To further improve patient outcome with classical fluorouracil (FU)-based CCRT, this study was designed to prospectively investigate a CCRT with FU infusion and weekly oxaliplatin after 2 months of gemcitabine and oxaliplatin (GEMOX) induction chemotherapy. Patients and Methods Nonpretreated patients with LAPC having WHO performance status (PS) of 0 to 2 received four induction cycles of GEMOX (gemcitabine 1 g/m2 on day 1 and oxaliplatin 100 mg/m2 on day 2; day 1 of a 15-day cycle). One month after cycle 4, patients who did not experience disease progression with PS 0 to 2 received 45 Gy over 5 weeks + 10 Gy (as a concomitant boost during the last 2 weeks) of radiotherapy (RT), with daily 250 mg/m2 FU as a continuous infusion and 60 mg/m2of oxaliplatin weekly. Results Of 59 patients, 50 patients (84.7%) received CCRT, whereas nine patients did not because of disease progression (seven patients), CT toxicity (one patient), or personal decision (one patient). Forty-four patients (74.5%) completed the fully planned CCRT. Median progression-free survival and overall survival durations were 7.6 and 12.2 months, respectively, for the whole population and 9.4 and 12.6 months, respectively, for patients who completed CCRT. CCRT grade 3 to 4 toxicities (National Cancer Institute Common Toxicity Criteria) were neutropenia (10.4%), thrombocytopenia (8.4%), nausea and vomiting (16.7%), and diarrhea (12.5%). Conclusion Concomitant administration of weekly oxaliplatin, continuous-infusion FU, and RT in patients with LAPC is feasible, with an acceptable acute and late safety profile. The encouraging results observed despite a nonoptimal patient selection (owing to the short induction time) indicates that further randomized evaluation to better define the specific role of oxaliplatin in CCRT is deserved.

HPB ◽  
2018 ◽  
Vol 20 (7) ◽  
pp. 605-611 ◽  
Author(s):  
Eran van Veldhuisen ◽  
Jantien A. Vogel ◽  
Sjors Klompmaker ◽  
Olivier R. Busch ◽  
Hanneke W.M. van Laarhoven ◽  
...  

Pancreatology ◽  
2017 ◽  
Vol 17 (4) ◽  
pp. S45
Author(s):  
Eran van Veldhuisen ◽  
Jantien A. Vogel ◽  
Olivier R.C. Busch ◽  
Hanneke W.M. van Laarhoven ◽  
Krijn P. van Lienden ◽  
...  

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16731-e16731
Author(s):  
Mariacristina Di Marco ◽  
Claudio Ricci ◽  
Riccardo Carloni ◽  
Elisa Grassi ◽  
Stefania De Lorenzo ◽  
...  

e16731 Background: Locally advanced pancreatic cancer (LAPC) is usually treated with chemoradiotherapy with poor results, thus additional therapies have been proposed. Of the latter, electrochemotherapy (ECT) represents a non-thermal ablation method, which combines the administration of chemotherapeutic drugs with permeabilizing electric pulses for cell membrane electroporation. The present study is the first to assess the short and long-term results, and the quality of life of the patients who underwent ECT for LAPC. Methods: Observational study of patients affected by LAPC who underwent intraoperative ECT after chemoradiotherapy. The inclusion criteria were: 1- patients with LAPC (defined according to the National Comprehensive Cancer Network 2019), 2- previous chemoradiotherapy and 3- absence of disease progression at restaging. Data at diagnosis and at restaging were collected for each patient. The Quality of life was evaluated using the Euro Quality of Life Group Association Questionnaire (EQ-5D-5L). The questionnaire was administered to all patients before and after ECT. Results: From May 25, 2018 to November 26, 2019 five patients underwent ECT: in 4 cases, the tumors were located in the head and, in one, in the body of the pancreas. Preoperative chemotherapy consisted mainly of 6 cycles of modified folfirinox, while the radiotherapy consisted of 54 Gy (27 fractions). At restaging, the serum value of CA 19-9 and tumor size were reduced; however, the vascular involvement did not change. No downstaging was recorded. Intravenous bleomycin 15,000IU/m2 was given as a bolus, the ECT procedure was performed using at least 4 needles with a mean duration time of 27 minutes, (range 15-40). No postoperative mortality or major complications were reported. The mean length of stay was 8 days (range 5-14). Four patients were alive and well at the end of the study while one patient died from disease progression. The mean follow-up was 20.8 months (range 9-34) from diagnosis and 9.4 months (range 2-19) from ECT. The quality of life was good (EQ-5D-5L scale > 50 in all cases) and there was improvement in pain/discomfort with respect to the pre-treatment period in 3 out of 5 patients. Conclusions: Electrochemotherapy can be considered a simple, feasible and safe palliative additional treatment in LAPC without progression after chemoradiotherapy, and it seems to allow a good quality of life and pain improvement.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4039-4039 ◽  
Author(s):  
L. Moureau-Zabotto ◽  
J. Phélip ◽  
P. Afchain ◽  
L. Mineur ◽  
T. André ◽  
...  

4039 Background: According to previous GERCOR studies in LAPC, concomitant chemoradiation therapy (CCRT) is indicated for non-progressive patients (pts) after systemic chemotherapy (CT). In order to improve the results of a classical 5FU-based CCRT, this study was designed to assess the efficacy and toxicity of weekly oxaliplatin (Ox), 5FU continuous infusion (c.i.) and radiation therapy (RT) in LAPC pts. Methods: Eligibility criteria included non resectable pathologically-proven LAPC, age > 18 yrs, PS < 2, and no prior CT or RT. All patients were first treated with 4 cycles of GEMOX (gemcitabine 1000 mg/m2, 100 min IV, d1; Ox 100 mg/m2, 2h IV, d2, every 2 wk). One month after cycle 4, non-progressive pts with PS < 2 received 45 Gy (25 fractions, 5 d/wk) + 10 Gy (concomitant boost in macroscopic tumor during wks 4 & 5, six hours apart large volume irradiation), combined with 250 mg/m2/d 5FU c.i. and weekly Ox. Initial 50 mg/m2 Ox dose was increased to 60 mg/m2 in absence of unacceptable toxicity after the 3 first included pts. Results: 60 pts were included (29 F/ 31 M, age 65.8 ± 9.6 yrs, range 37 - 80). 50 pts (83%) received CCRT, while 10 did not for the following reasons: metastatic progression (7 pts), OMS>2 (1), and CT toxicity (2). 44 pts (73 %) received the full planned CCRT dose-intensity. NCI-CTC grade 3–4 toxicities during CCRT and the following month (% of pts) were : neutropenia (14%), thrombocytopenia (10%), nausea-vomiting (20%), diarrhea (12%) and neuropathy (2%). 2 toxic deaths occurred during CCRT. With a median follow up of 15 mo, median progression-free survival (PFS) and overall survival (OS) of the whole population were 7.6 mo and 13.8 mo, respectively. For pts who received CCRT, median PFS and OS were 9.4 and 13.9 mo, respectively (2.6 and 9.9 mo, respectively, for pts who did not received CCRT). Conclusion: Chemotherapy before CCRT can identify pts who might potentially benefit of CCRT. Concomitant administration of weekly Ox, continuous IV FU and RT in LAPC is feasible with an acceptable toxicity. The results in terms of PFS and OS compare favourably with a classical 5FU-based CCRT. [Table: see text]


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 259-259
Author(s):  
C. Lin ◽  
B. M. Kos ◽  
A. R. Sasson ◽  
J. L. Meza ◽  
J. L. Grem

259 Background: We designed this phase II trial to determine the efficacy and safety of a neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with locally advanced pancreatic adenocarcinoma Methods: Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT. Upon completion of CRT, surgical candidates underwent a pancreatoduodenectomy. Response rate was assessed according to RECIST criteria 4 weeks after the end of CRT. CTC AE v3 was used to grade the acute side effects. The failure-free survival (FFS), overall survival (OS) and median survival were analyzed by the Kaplan Meier method. Results: Twenty-nine patients who had borderline resectable pancreatic adenocarcinoma at the UNMC were enrolled and received induction CT. Twenty-four patients completed CRT. Nineteen patients had surgical exploration: 4 were unresectable, 6 had intra-abdominal metastases, and 9 had resection (seven had R0 resection, 2 had R1 resection, and 6 had negative nodes). The median follow up was 27 months. There were maximum 48% acute grade 3-4 toxicities during induction CT and CRT. The median FFS and OS were 7 and 10 months and the 2-year FFS and OS were 17% and 28%. Median OS and FFS for patients with and without resection was 26 vs. 9 months, p=0.06; and 19 vs. 5 months, p=0.01. Patients with CA19-9 above 90 U/L throughout treatment had significantly shorter FFS and OS than patients with CA19-9 less than 90 throughout treatment or had a decline from baseline to less than 90 after treatment. Conclusions: Induction gemcitabine/5-FU followed by 5-FU/oxaliplatin concurrent with RT led to down staging in 31% patients with subsequent resection. Further innovative strategies are needed to improve the outcome of patients with locally advanced pancreatic cancer. No significant financial relationships to disclose.


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