Gemcitabine chemotherapy until symptomatic disease progression in advanced pancreatic cancer: A retrospective analysis.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 372-372 ◽  
Author(s):  
Yuk Ting Ma ◽  
Syed A. Hussain ◽  
Philip James Johnson ◽  
Daniel H. Palmer
Keyword(s):  
Pancreatic Cancer ◽  
Disease Progression ◽  
Retrospective Analysis ◽  
Median Survival ◽  
Metastatic Disease ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
First Line ◽  
Symptomatic Disease

372 Background: Gemcitabine was established as the standard first-line therapy for patients with advanced pancreatic cancer in 1997 after a randomized phase III study showed a statistically significant improvement in clinical benefit response and a modest improvement in median survival time, compared to bolus 5FU chemotherapy. The natural history of advanced pancreatic cancer is characterised by the rapid and relentless progression of tumor-related symptoms, thus we have analysed the outcome of our patients with advanced pancreatic cancer who have been treated with gemcitabine until symptomatic disease progression, without the use of regular radiological assessment. Methods: A retrospective analysis was conducted on all patients with advanced pancreatic cancer who were treated with first-line gemcitabine chemotherapy between January 2008 – December 2009. Results: A total of 50 patients were identified (21 with locally advanced disease, 29 with metastatic disease). The overall median survival was 10.4 months (11.3 months for patients with locally advanced disease, 7.2 months for patients with metastatic disease). Conclusions: Our single centre experience suggests that clinical decision-making based on symptomatic disease progression in advanced pancreatic cancer, results in survival outcomes that are comparable to published trial data.

Treatment of unresectable or metastatic pancreatic cancer in the VA population: Does it improve survival?

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15121-15121
Author(s):  
S. F. Mekan ◽  
R. S. Komrokji ◽  
M. S. Beg ◽  
Z. A. Nahleh ◽  
M. M. Safa
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Metastatic Disease ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Current Treatment ◽  
Treatment Modalities ◽  
Unresectable Disease ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Poor Outcomes

15121 Background: Locally advanced and metastatic pancreatic adenocarcinoma present as a treatment challenge because of poor outcomes with current treatment modalities. Therapy of unresectable or metastatic disease has not been studied in the VA population. Methods: We reviewed all cases of pancreatic cancer presenting to the system from 1995–2005. Cases were extracted from the VA Cancer Registry (VACCR). Results: There were 5522 cases identified; 5218 were adenocarcinomas. Out of these, there were 263 (5.1%) patients with unresectable locally advanced disease and 2778 (53.2%) patients with metastatic disease. Median survival for patients with unresectable disease was 5.6 months. Chemotherapy was administered to 94 patients and chemoradiation to 31 patients. No difference in survival was noted between the two groups (8.4 vs. 7.9 months, P = 0.434). In patients with metastatic disease, median survival was 2.2 months. Chemotherapy was administered to 760 (27%) patients in this group and showed improved survival as compared to patients who did not receive chemotherapy (5.3 vs. 1.5 months, p = 0.000). Conclusions: In VA patients with locally advanced unresectable disease, there is no difference in survival in patients treated with chemoradiation versus chemotherapy alone. In patients with metastatic disease, chemotherapy conferred a survival advantage. No significant financial relationships to disclose.

Anlotinib Plus Toripalimab and Nab-Paclitaxel in Patients with Locally Advanced or Metastatic Pancreatic Cancer: Study Protocol for An Open-Label, Non-Randomized, Phase II Study (ATNPA)

2021 ◽  
Author(s):  
Jingwen Chen ◽  
Yiqian Liu ◽  
Yizhi Zhu ◽  
Shiyun Cui ◽  
Chongqi Sun ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Maintenance Therapy ◽  
Kinase Inhibitor ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Metastatic Pancreatic Cancer ◽  
Second Line ◽  
First Line ◽  
Open Label ◽  
Combination Strategy

Abstract Background There have not been standard second-line or maintenance regimens with definite survival benefits so far for patients with pancreatic carcinoma who have lost the opportunity of curable resections or failed first-line chemotherapy. Anlotinib, a potent small-molecule tyrosine kinase inhibitor, exhibits anti-angiogenic and anti-tumour effects by specifically binding to multiple targets such as VEGFR, FGFR, PDGFR, c-Kit and Ret. Toripalimab, a novel anti-PD-1 mAb, has been proved to significantly prolong progression-free survival (PFS) and overall survival (OS) in various solid tumours with manageable toxicities when combining with cytotoxic chemotherapy. We design this study to assess the combination of anlotinib, toripalimab and nab-paclitaxel as a second-line or maintenance therapy for locally advanced pancreatic cancer (LAPC) or metastatic pancreatic cancer (MPC). Patients and Methods: This is an open-label, non-randomized, single-arm phase Ⅱ study, aimed at evaluating the efficacy and safety profile of the above-mentioned combination strategy in first-line therapy-failed LAPC or MPC. Totally 53 patients are to be enrolled and receive anlotinib (12 mg, po. qd.) plus toripalimab (240 mg, ivgtt. q3w.) and nab-paclitaxel (125 mg/m2, ivgtt, d1, d8) every 3 weeks as a cycle until disease progression or intolerable adverse events. The primary endpoint is PFS. Secondary end points include OS, disease control rate (DCR), object response rate (ORR), quality of life (QoL) and safety. Enrollment started in April 2021, and follow-up will be finished in April 2023. Discussion and Significance: Combination of anlotinib, toripalimab and nab-paclitaxel may promote vessel normalization and drug delivery, and activate the immune response, thus exerting synergistic anti-tumour effects and counteracting the immunosuppressive microenvironment of pancreatic cancer. As the first intending to assess this combination in pancreatic cancer, this study will provide comprehensive evidence for second-line or maintenance therapy of LAPC and MPC. Trial registration: ClinicalTrials.gov: ATNPA, NCT04718701. Registered January 22, 2021. (https://clinicaltrials.gov/ct2/show/NCT04718701?term=NCT04718701&draw=2&rank=1)

Irreversible Electroporation: Expanding the Armamentarium against Pancreatic Cancer

2019 ◽  
Vol 03 (02) ◽  
pp. 138-142
Author(s):  
Gray R. Lyons ◽  
Brian J. Schiro ◽  
Govindarajan Narayanan
Keyword(s):  
Pancreatic Cancer ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Irreversible Electroporation ◽  
Treatment Algorithm ◽  
Advanced Pancreatic Cancer ◽  
Invasive Approach ◽  
Anticancer Treatment ◽  
Minimal Damage

AbstractLocally advanced pancreatic cancer is often refractory to conventional therapy, thus warranting new approaches. Irreversible electroporation is an ablative modality that has the potential to deliver targeted anticancer treatment with minimal damage to surrounding structures. Indications for irreversible electroporation in pancreatic cancer patients include palliation for metastatic disease, downstaging for surgery in locally advanced disease, and treatment of local recurrence following operative resection. Benefits of the modality in pancreatic cancer include a minimally invasive approach, precise delivery that minimizes nontarget ablation, and upregulation of anticancer immune response. Early studies have demonstrated an acceptable safety profile for irreversible electroporation; however, more data are needed to define the role of IRE in the treatment algorithm of pancreatic cancer.

Concurrent radiotherapy with gemcitabine in patients with locally advanced pancreatic cancer: A retrospective analysis

Pancreatology ◽  
2016 ◽  
Vol 16 (4) ◽  
pp. S174
Author(s):  
Tomohiro Nomoto ◽  
Katsuya Kitamura ◽  
Tadashi Honma ◽  
Yu Ishii ◽  
Akira Yamamiya ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Retrospective Analysis ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Concurrent Radiotherapy

scholarly journals Resection of Locally Advanced Pancreatic Neoplasms after Neoadjuvant Chemotherapy with Nab-Paclitaxel and Gemcitabine following FOLFIRINOX Failure

2017 ◽  
Vol 11 (2) ◽  
pp. 422-427 ◽  
Author(s):  
Sarah Hahn ◽  
Ahmet Ayav ◽  
Anthony Lopez
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Neoplasms ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Response Rates ◽  
Vascular Involvement ◽  
Hematologic Toxicity ◽  
First Line ◽  
The Past ◽  
Single Center Experience

The incidence of pancreatic cancer has dramatically increased over the past years, but the prognosis has not improved. Between 30 and 40% of tumors are considered locally advanced, essentially due to vascular involvement. In recent years, new chemotherapy protocols with high response rates have been developed. FOLFIRINOX seems to be an interesting option in this situation, but hematologic toxicity could be an obstacle to its prescription. Nab-paclitaxel and gemcitabine offer significant response rates with a reasonable safety profile. We report here a single-center experience of 2 cases with a locally advanced pancreatic cancer initially considered unresectable, progressive after first-line neoadjuvant FOLFIRINOX chemotherapy, and then treated with second-line nab-paclitaxel/gemcitabine chemotherapy.

Phase I trial of gene-mediated cytotoxic immunotherapy in combination with chemoradiation for locally advanced pancreatic cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 195-195 ◽  
Author(s):  
M. Bloomston ◽  
C. Marsh ◽  
J. Walker ◽  
W. Coyle ◽  
H. Marx ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Tumor Vaccine ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Tumors ◽  
Kinase Gene ◽  
Early Results ◽  
Cell Immunity ◽  
Dose Levels

195 Background: More than 80% of patients with pancreatic cancer present with locally advanced or metastatic disease and have a median survival of only 6 months. Immunotherapy approaches may improve outcomes. Gene Mediated Cytotoxic Immunotherapy (GMCI) is an approach that generates a systemic anti-tumor vaccine effect through intra-tumoral delivery of an adenoviral vector expressing the HSV-thymidine kinase gene (AdV-tk) followed by anti-herpetic prodrug and synergy with chemoradiation. The mechanisms of action involve tumor cytotoxicity, activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Safety with potential efficacy has been demonstrated in multiple clinical studies. This is the first application of GMCI in pancreatic cancer. Methods: This study evaluated 4 dose levels of AdV-tk (3x1010 to 1x1012 vector particles) injected into locally advanced tumors via EUS or CT-guidance before and during week 3 of standard 5-FU-chemoradiation. Valacyclovir (Valtrex, GSK) prodrug was given for 14 days after each of 2 AdV-tk injections. Results: The study completed accrual with 13 patients enrolled and 12 completing therapy with 3 at each of the 4 dose levels. One patient refused further participation during course 1 after recovering from azotemia. Median age was 64 years (range 55-81) and median baseline CA19-9 was 1634 U/ml. No dose limiting toxicities and no injection related complications occurred. Possibly related grade 3-4 toxicities, all of which were transient, included dehydration, azotemia and worsening elevation of bilirubin and AST. Kaplan-Meier estimated median survival is 12.2 months with 6 patients still alive at 8-20 months. Two patients achieved a partial response by RECIST criteria. One occurred in week 6 despite discontinuing 5-FU/radiation during week 1. The other had gradual decrease of a 7 cm tumor over 11 months. Serum CA19-9 levels decreased in 8/8 evaluable patients by 32-91% at 3 months after treatment initiation. Conclusions: AdV-tk can be safely injected into pancreatic tumors and combined with standard chemoradiation. Early results are highly encouraging and justify further evaluation in a phase II study. [Table: see text]

Updated results of the GEST study: Randomized phase III study of gemcitabine plus S-1 (GS) versus S-1 versus gemcitabine (GEM) in unresectable advanced pancreatic cancer in Japan and Taiwan.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4035-4035 ◽  
Author(s):  
Akira Fukutomi ◽  
Takuji Okusaka ◽  
Kazuya Sugimori ◽  
Hideki Ueno ◽  
Tatsuya Ioka ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Primary Endpoint ◽  
Advanced Disease ◽  
Performance Status ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Locally Advanced Disease ◽  
Phase Iii Study

4035 Background: The GEST study (Ioka et al. ASCO 2011, Abstract 4007) demonstrated the non-inferiority of S-1 to GEM with respect to the primary endpoint of overall survival (OS) in patients with pancreatic cancer (PC). We now report the updated results of this study. Methods: The GEST study was a randomized, 3-arm, phase III study. Chemotherapy-naive patients with unresectable advanced PC, an ECOG Performance status (PS) of 0-1, and adequate organ functions were randomly assigned to receive GEM (1000 mg/m2, iv, d1, 8 and 15, q4w), S-1 (80/100/120 mg/day based on BSA, po, d1-28, q6w), or GS (GEM 1000 mg/m2, iv, d1 and 8 plus S-1 60/80/100 mg/day based on BSA po, d1-14, q3w). The primary endpoint was OS, used to assess the non-inferiority of S-1 and the superiority of GS to GEM. Patient information was updated in July 2011. Results: At the time of this follow-up analysis, median follow-up was 29.8 months with 795 OS events, compared with 18.4 months with 710 OS events out of 832 patients at the previous analysis. Median OS was 8.8 months (95% CI: 8.0–9.7) in the GEM group and 9.7 months (95% CI: 7.6-10.8) in the S-1 group (HR=0.96, 97.5% CI: 0.79-1.17, p<0.001 for non-inferiority), which is consistent with prior results (HR=0.96, 97.5% CI: 0.78-1.18, p<0.001). In the GS group, median OS was 9.9 months (95% CI: 9.0-11.2). The HR was 0.91 (97.5%CI: 0.75-1.11, p=0.28 for superiority versus the GEM group). On subgroup analysis, GS was associated with a non-statistically significant trend toward better OS compared with GEM among patients with locally advanced disease and those with a PS of 1. Median OS was 12.7 months (95% CI: 9.7–14.9) in the GEM group and 15.9 months (95% CI: 13.0-19.7) in the GS group (HR=0.72, 95% CI: 0.51-1.03) among patients with locally advanced disease, and 6.2 months (95% CI: 4.9–8.3) in the GEM group and 9.6 months (95% CI: 8.0-10.9) in the GS group (HR=0.62, 95% CI: 0.46-0.83) among patients with a PS of 1. Conclusions: The non-inferiority of S-1 to Gem in terms of the primary endpoint of OS was reconfirmed. Monotherapy with S-1 can be used as one of the standard treatments for advanced PC. As for GS therapy, there is room for further investigation.

FOLFIRINOX for patients with borderline and never-resectable locally advanced pancreatic cancer, with the addition of chemoradiotherapy for potentially resectable patients: A phase II study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 408-408
Author(s):  
Jon Kroll Bjerregaard ◽  
Morten Ladekarl ◽  
Anna-Lene Fromm ◽  
Per Pfeiffer
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Performance Status ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Observation Time ◽  
Stage Ii ◽  
Locally Advanced Pancreatic Cancer

408 Background: Locally advanced pancreatic cancer (LAPC) is often a mix of borderline and never-resectable tumors. Multimodality treatment might downstage these tumors to allow a potential radical resection, especially the borderline group. In this ongoing phase II study we examined the feasibility of FOLFIRINOX with or without CRT followed by surgery for both borderline and never-resectable tumors (NCT-01397019). Methods: Patients in performance status 0-1, with initially non-resectable stage II/III pancreatic cancer were offered FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2+ 2400 mg/m2) every 14 days. Every 4th series the patients were evaluated and offered CRT (50.4 Gy/27F & capecitabine) if deemed potentially resectable. Resections were performed if deemed possible by the MDT. Results: Between August 2012 and present, 58 patients have been recruited with a median observation time of 14.5 months. Median age was 65(range 38-75) years, with 47%/53% stage II/III distribution. Median CA19-9 was 299(range 2-13,432). Two-hundred-seventy-four courses of FOLFIRINOX have been given, with a median of 6.5 per patient, with a median of 2 without dose modifications. Presently twenty-one patients have been treated with CRT. Twelve patients have been resected, of which 7 received prior CRT. Median survival for all patients was 15.6 months (11-NR) with a 1-year survival of 70% (49-84). For patients not resected the median survival was 12.8 months (9-16) for resected the median survival has not yet been reached. The FOLFIRINOX was associated with adverse events similar to what is expected in metastatic patients. Conclusions: FOLFIRINOX with or without CRT in patients with LAPC shows promising efficacy in patients with both borderline and never-resectable tumors. Unmodified FOLFIRINOX had acceptable toxicity, however dose reductions are often needed. CRT following initial FOLFIRINOX was feasible and without unexpected toxicity. Clinical trial information: NCT-01397019.

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