scholarly journals Ibrutinib in combination with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma: phase III RESOLVE study

2021 ◽  
Author(s):  
M. Tempero ◽  
D.-Y. Oh ◽  
J. Tabernero ◽  
M. Reni ◽  
E. Van Cutsem ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
First Line Treatment

Second-line treatment of modified FOLFIRINOX or nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 458-458 ◽  
Author(s):  
Masato Ozaka ◽  
Takashi Sasaki ◽  
Ikuhiro Yamada ◽  
Ryo Kanata ◽  
Dai Akiyama ◽  
...  
Keyword(s):  
Disease Control ◽  
Pancreatic Adenocarcinoma ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Significant Difference ◽  
Similar Disease ◽  
First Line Treatment

458 Background: Both FOLFIRINOX (FFX) and Nab-paclitaxel plus Gemcitabine(GnP) standard treatment in first-line treatment of metastatic pancreatic adenocarcinoma (MPA). It could be of interest to use them consecutively, knowing that there is currently no standard for second-line treatments for MPA. The aim of this study was to compare second-line modified FFX (mFFX) after GnP failure with second-line GnP after mFFX failure. Methods: From January 2015 to Jul 2017, medical records were retrospectively reviewed for consecutive patients receiving mFFX or GnP for a histologically proven MPA after failure of GnP or mFFX respectively. Patients were treated with mFFX (intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 h, no bolus 5-FU) or GnP (Gemcitabine 1000 mg/m2/, nab-paclitaxel 125mg/m2 d1,8 15) until disease progression, patient refusal or unacceptable toxicity. Results: Second-line mFFX was administered to 50 patients and GnP was 25 patients. At baseline of second-line treatment, there was no difference in patient’s characteristics between mFFX group and GnP group. No significant difference in the response rate (mFFX, 16.6% vs. GnP, 10.5%, P = 0.63) or the disease control rate (mFFX, 50% vs. GnP, 64%, P = 0.82) was seen between the two groups. Median Progression free survival of GnP/mFFx were 4.3 months/4.6 months (p=0.89) and median survival (OS) from the 2nd line treatment of GnP/mFFx were 10.4 months/10.8 months (p=0.65) and OS from the first-line treatment of GnP/mFFx were 20.6 months/16.5 months (p=0.34). No toxic death occurred in both groups. There was no difference in the incident of adverse event between mFFX group and GnP group. Conclusions: Second-line mFFX and GnP achieved similar disease control and survival in unresectable pancreatic cancer. The use of the FFX and GnP in sequence is an attractive option to maximize disease control and survival. We need the clinical trial to compare with mFFX and GnP in sequence to guide the selection of initial chemotherapy.

Modified FOLFIRINOX for metastatic pancreatic adenocarcinoma after failure of nab-paclitaxel plus gemcitabine.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 467-467
Author(s):  
Masato Ozaka ◽  
Takashi Sasaki ◽  
Seita Kataoka ◽  
Ryo Kanata ◽  
Kazunaga Ishigaki ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Objective Response ◽  
Kidney Injury ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Start Date ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Head Of The Pancreas ◽  
Grade 3

467 Background: Both FOLFIRINOX and Nab-paclitaxel plus Gemcitabine standard treatment in first-line treatment of metastatic pancreatic adenocarcinoma (MPA). It could be of interest to use them consecutively, knowing that there is currently no standard for 2nd line treatments for MPA. The aim of this study was to evaluate the efficacy and tolerability of modified FOLFIRINOX after gemcitabine plus Nab-paclitaxel failure in MPA. Methods: From January 2015 to March 2016, medical records were retrospectively reviewed for consecutive patients receiving modified FOLFIRINOX for a histologically proven MPA after failure of Nab-paclitaxel plus Gemcitabine. Patients were treated with modified FOLFIRINOX every 2 weeks as follows: intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 h, no bolus 5-FU, until disease progression, patient refusal or unacceptable toxicity. Results: Modified FOLFIRINOX was administered to 23 pts. Among these patients, median age was 64 years (range 42.4 - 74.2). 83% of the patients had a PS 0, the primary site of the tumor was the head of the pancreas in 39% of patients, and 26% of patients experienced recurrence after resection. Disease control rate was 66.7% (n = 17) with a 23.8 % (n = 17) objective response rate (RECIST). Within the whole cohort, median PFS was 4.3 months (95% CI: 3.1-5.3) and median overall survival (OS) was 9.3 months (95% CI: 3.8-14.8). Since the start date of first line chemotherapy with Nab-paclitaxel plus Gemcitabine, median OS was 18.8 months (95% CI: 9.6-27.9). No toxic death occured. Grade 3-4 toxicities were reported in 30% of patients and were neutropenia (17%), anemia (8%), cholangitis (8%) and acute kidney injury (4%). Conclusions: Modified FOLFIRINOX seems promising with a manageable toxicity profile after Nab-paclitaxel plus Gemcitabine failure, in selected patients able to receive second line treatment for a MPA. These promising results have now to be confirmed in a phase III randomized trial.

A phase I dose escalation study of eryaspase in combination with modified FOLFIRINOX in locally advanced and metastatic pancreatic ductal adenocarcinoma.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS453-TPS453
Author(s):  
Marcus Smith Noel ◽  
Philip Agop Philip ◽  
Mohamedtaki Abdulaziz Tejani ◽  
John Marshall ◽  
Aiwu Ruth He ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase I ◽  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
First Line Treatment

TPS453 Background: FOLFIRINOX remains the standard of care for the first line treatment of patients with locally advanced and metastatic pancreatic adenocarcinoma, however the prognosis remains poor, thus novel treatment options are indicated. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. A randomized phase IIb study in patients with advanced pancreatic cancer whose disease progressed following first-line treatment (NCT02195180) was previously conducted. Eryaspase in combination with gemcitabine monotherapy or FOLFOX combination therapy improved overall survival (OS) and progression free survival (PFS). The safety profile of eryaspase was acceptable. A second line pivotal randomized phase III trial (Trybeca-1) is currently enrolling (NCT03665441). We design this phase I study to determine the safety of mFOLFIRINOX combined with Eryaspase in the first line of treatment. Methods: Patients with locally or metastatic biopsy proven pancreatic adenocarcinoma will be treated with the combination of mFOLFIRINOX plus Eryaspase. This will be a standard 3+3 design with 4 possible doing levels. mFOLFIRINOX dosing will include 5-Fluorouracil 2400 mg/m2 over 46 hours, Oxaliplatin 85 mg/m2, Irinotecan 150 mg/m2 plus Eryaspase 75 Units/kg at dose level 0. Eryaspase will be dose escalated up to 100 Units/kg. The study will enroll at three academic centers. Key eligibility criteria include performance status 0 or 1; locally advanced or metastatic tumor disease; adequate organ function. The primary objective is to determine the maximum tolerated dose and safety of this novel combination. Key secondary objectives include objective response rate, progression-free survival, overall survival, pharmacokinetics, pharmacodynamics, and biomarker research. A data safety monitoring committee will review data every 3 months. Clinical trial information: 04292743.

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