Updated use of first-line chemotherapy for advanced pancreatic cancer: FOLFIRINOX versus gemcitabine.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6607-6607
Author(s):  
Thomas H. Cartwright ◽  
Aimee Ginsburg Arlen ◽  
Lalan S. Wilfong ◽  
Robyn K. Harrell ◽  
J. Russell Hoverman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Advanced Pancreatic Cancer ◽  
Community Setting ◽  
Standard Of Care ◽  
The United States ◽  
Age At Diagnosis ◽  
Phase Iii ◽  
Combination Regimen ◽  
First Line ◽  
Asco 2012

6607 Background: Pancreatic cancer (PC) is the fourth leading cause of death in the United States. It is estimated that 45,220 patients will be diagnosed in 2013 and 38,460 will die (Siegel, CA Cancer J Clin 2013). Gemcitabine has long been the standard of care chemotherapy. Recent advances in treatment created a combination regimen (oxaliplatin, irinotecan, leucovorin, fluorouracil [FOLFIRINOX]) for patients with good Karnofsky performance status (PS) (Conroy, NEJM 2011). This retrospective analysis was conducted as an update to results reported at ASCO 2012 (Ginsburg Arlen, JCO 2012) to evaluate characteristics and overall survival (OS) of patients receiving FOLFIRINOX and gemcitabine-based treatments in a large outpatient community setting. This is the largest study describing FOLFIRINOX patients to date. Methods: Patients with advanced PC treated within The US Oncology Network entered into the iKnowMed (iKM) database between June 2010 and November 2012 were included. Patterns of treatment were characterized by the median age at diagnosis, sex, PS, and first-line metastatic chemotherapy prescribed. The primary endpoints of the analysis were OS and uptake of FOLFIRINOX within the network. Results: Compared to ASCO 2012 results, 1,000 additional patients were identified in iKM. Of the 1,714 total patients, 24% received FOLFIRINOX (up from 13% in 2012) and 76% gemcitabine-based therapy (87% in 2012). Increased utilization of FOLFIRINOX for patients with good PS began in June 2010. For all patients (55% male), the median age at diagnosis was 67 years and the majority (85%) had a PS of 70% or greater. The OS was significantly longer for FOLFIRINOX (9.6 mos) versus gemcitabine (6.3 mos) (p<0.0001). This held true for PS of 70% or greater patient given FOLFIRINOX (9.6 mos) versus gemcitabine (7 mos) (p<0.0001). Conclusions: Utilization of FOLFIRINOX has continued to expand after the publication of phase III trials. Our data in a community setting supports a survival advantage for FOLFIRINOX. Although the magnitude of benefit may be smaller in the community, we agree that FOLFIRINOX should become a standard of care for good PS patients.

Use of first-line chemotherapy for advanced pancreatic cancer: FOLFIRINOX versus gemcitabine.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16536-e16536 ◽  
Author(s):  
Aimee Ginsburg Arlen ◽  
Thomas H. Cartwright ◽  
Lalan S. Wilfong ◽  
J. Russell Hoverman ◽  
Greg C Nelson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Community Setting ◽  
Standard Of Care ◽  
The United States ◽  
Age At Diagnosis ◽  
Phase Iii ◽  
Combination Regimen ◽  
First Line

e16536 Background: Pancreatic cancer (PC) is the fourth leading cause of death in the United States. It is estimated that 43,920 patients will be diagnosed in 2012 and 37,390 will die (Siegel, CA Cancer J Clin, 2012). Gemcitabine has long been the standard of care chemotherapy. Recent advances in treatment options have led to the utilization of a combination regimen (oxaliplatin, irinotecan, leucovorin, fluorouracil [FOLFIRINOX]) in patients with good Karnofsky performance status (PS). This regimen was compared to single-agent gemcitabine, presented at ASCO 2010 and recently published (Conroy, NEJM, 2011). This retrospective analysis was conducted to evaluate characteristics and overall survival (OS) of patients receiving FOLFIRINOX and gemcitabine-based treatments in a large outpatient community setting. Methods: Patients with advanced PC treated within The US Oncology Network and entered into the iKnowMed (iKM) database between June 2010 and November 2011 were included. Patterns of treatment were characterized by the median age at diagnosis, sex, PS, and first-line metastatic chemotherapy prescribed. The primary endpoints of the analysis were OS and uptake of FOLFIRINOX within the network. Results: Of the 717 patients identified within the iKM database, 13% received FOLFIRINOX and 87% gemcitabine-based therapy. Increased utilization of FOLFIRINOX for patients with good PS began in June 2010. For all patients (54% male), the median age at diagnosis was 67 years and the majority of patients (89%) had a PS of 70% or greater. The OS was significantly longer for FOLFIRINOX (8.4 months) versus gemcitabine (6.4 months) (p=0.036). OS was also significantly longer for PS of 70% or greater given FOLFIRINOX (9.0 months) versus gemcitabine (6.7 months) (p=0.022). After controlling for PS, the use of gemcitabine led to a shorter OS (HR 1.4; 95% CI: 1.02-2.01). Conclusions: Utilization of FOLFIRINOX has rapidly been adopted in patients with good PS after the publication of phase III trials. Our data in a community setting supports a survival advantage for FOLFIRINOX. Although the magnitude of benefit may be smaller in the community setting, we agree that should FOLFIRINOX become a standard of care for good PS patients.

Second-Line Oxaliplatin, Folinic Acid, and Fluorouracil Versus Folinic Acid and Fluorouracil Alone for Gemcitabine-Refractory Pancreatic Cancer: Outcomes From the CONKO-003 Trial

2014 ◽  
Vol 32 (23) ◽  
pp. 2423-2429 ◽  
Author(s):  
Helmut Oettle ◽  
Hanno Riess ◽  
Jens M. Stieler ◽  
Gerhard Heil ◽  
Ingo Schwaner ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Folinic Acid ◽  
Karnofsky Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Gemcitabine Refractory

Purpose To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid–modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy. Patients and Methods A randomized, open-label, phase III study was conducted in 16 institutions throughout Germany. Recruitment ran from January 2004 until May 2007, and the last follow-up concluded in December 2012. Overall, 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil (FF) or oxaliplatin and FF (OFF). Patients were stratified according to the presence of metastases, duration of first-line therapy, and Karnofsky performance status. Results Median follow-up was 54.1 months, and 160 patients were eligible for the primary analysis. The median overall survival in the OFF group (5.9 months; 95% CI, 4.1 to 7.4) versus the FF group (3.3 months; 95% CI, 2.7 to 4.0) was significantly improved (hazard ratio [HR], 0.66; 95% CI, 0.48 to 0.91; log-rank P = .010). Time to progression with OFF (2.9 months; 95% CI, 2.4 to 3.2) versus FF (2.0 months; 95% CI, 1.6 to 2.3) was significantly extended also (HR, 0.68; 95% CI, 0.50 to 0.94; log-rank P = .019). Rates of adverse events were similar between treatment arms, with the exception of grades 1 to 2 neurotoxicity, which were reported in 29 patients (38.2%) and six patients (7.1%) in the OFF and FF groups, respectively (P < .001). Conclusion Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer.

A randomized second line trial in patients with gemcitabine refractory advanced pancreatic cancer - CONKO 003

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4517-4517 ◽  
Author(s):  
H. Riess ◽  
U. Pelzer ◽  
J. Stieler ◽  
I. Schwaner ◽  
G. Heil ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Side Effects ◽  
Disease Progression ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
The Impact

4517 Objective: For nearly ten years gemcitabine (G) was standard first line therapy for patients (pts) with advanced pancreatic cancer (APC). There is no consensus about second line therapy after disease progression while receiving G, but 5-FU-based regimens are considered. Results about randomized second line studies in APC are very rare. Our phase II study (ASCO 2002) showed activity of the OFF (oxaliplatin/folinic Acid (FA)/5-fluorouracil (FU) [24h] ) regimen in 23 pts. To examine the impact and the side effects of oxaliplatin we initiated a multicenter phase III study to compare OFF and FF in pts with G refractory APC. Methods: Pts with CT/ MRT confirmed failure with G in first line therapy, Karnofsky Performance Status (KPS) >60%, controlled pain, adequate hematological, renal and liver functions were eligible. Pts were stratified according to duration of first line therapy, KPS and tumor stage. We randomized pts to outpatient treatment with FF (FU 2g/m2 (24h)/ FA 200 mg/m2 (30min) on d1, d8, d15 and d22) or OFF (FF+Oxaliplatin 85mg/m2, d8, d22). In both arms the next cycle started on day 43. Pts were followed with regular staging every 3 months or at any signs of disease progression. Results: Until now we randomized 161 of 165 (planned) pts between 02/2004 and 01/2007. So we expect to present first results (side effects, progression free survival, overall survival) at the meeting. No significant financial relationships to disclose.

Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Single-Agent Gemcitabine As First-Line Treatment of Patients With Advanced Pancreatic Cancer: The GIP-1 Study

2010 ◽  
Vol 28 (10) ◽  
pp. 1645-1651 ◽  
Author(s):  
Giuseppe Colucci ◽  
Roberto Labianca ◽  
Francesco Di Costanzo ◽  
Vittorio Gebbia ◽  
Giacomo Cartenì ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Trial ◽  
First Line Treatment

PurposeSingle-agent gemcitabine became standard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil. The Gruppo Italiano Pancreas 1 randomized phase III trial aimed to compare gemcitabine plus cisplatin versus gemcitabine alone (ClinicalTrials.gov ID NCT00813696).Patients and MethodsPatients with locally advanced or metastatic pancreatic cancer, age 18 to 75 years, and Karnofsky performance status (KPS) ≥ 50, were randomly assigned to receive gemcitabine (arm A) or gemcitabine plus cisplatin (arm B). Arm A: gemcitabine 1,000 mg/m2weekly for 7 weeks, and, after a 1-week rest, on days 1, 8, and 15 every 4 weeks. Arm B: cisplatin 25 mg/m2added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 8% power of detecting a 0.74 hazard ratio (HR) of death, with bilateral α .05, 355 events were needed and 400 patients planned.ResultsFour hundred patients were enrolled (arm A: 199; arm B: 201). Median age was 63, 59% were male, 84% had stage IV, and 83% had KPS ≥ 80. Median overall survival was 8.3 months versus 7.2 months in arm A and B, respectively (HR, 1.10; 95% CI, 0.89 to 1.35; P = .38). Median progression-free survival was 3.9 months versus 3.8 months in arm A and B, respectively (HR, 0.97; 95% CI, 0.80 to 1.19; P = .80). The objective response rate was 10.1% in A and 12.9% in B (P = .37). Clinical benefit was experienced by 23.0% in A and 15.1% in B (P = .057). Combination therapy produced more hematologic toxicity, without relevant differences in nonhematologic toxicity.ConclusionThe addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer.

Comparative efficacy of commonly used first-line chemotherapy regimens in advanced pancreatic cancer: A network meta-analysis.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 403-403
Author(s):  
Philip A. Haddad ◽  
Kevin Michael Gallagher ◽  
Dalia Hammoud
Keyword(s):  
Pancreatic Cancer ◽  
English Language ◽  
Meta Analysis ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Response Rates ◽  
The United States ◽  
First Line ◽  
Treatment Regimens ◽  
Inconsistency Analysis

403 Background: Pancreatic adenocarcinoma is one of the deadliest cancers, ranking fourth in mortality and accounting for up to 7% of all cancer related deaths in the United States. For many years, Gemcitabine and its combinations have been the standard first-line treatments for patients with unresectable locally advanced or metastatic pancreatic cancer (aPC). Recently, FOLFIRINOX was shown to be associated with a survival advantage as well. These chemotherapy combinations have not been compared to each other. We conducted this network meta-analysis to evaluate the relative efficacy of the commonly used chemotherapy regimens in patients with aPC. Methods: A review of the medical literature was conducted using online databases. Inclusion criteria consisted of English language; diagnosis of aPC; treatment with Gemcitabine (GEM) combined with Capecitabine (CAPE), Erlotinib (ERLO), or nab-Paclitaxel (NABPAC) and treatments with FOLFIRINOX; and randomized studies reporting survival and response rates. A frequentists network meta-analysis was conducted using netmeta package and random-effects model. Results: Six studies comprising a total of 2,717 participants were included. FOLFIRINOX demonstrated a significantly better relative risk (RR) of progression and death (P&D) followed by GEM+NABPAC, GEM+ERLO, GEM+CAPE, and GEM in a decreasing order. When compared to GEM-based combination as a group, FOLFIRINOX maintained its superior RR for P&D. Moreover, FOLFIRINOX and GEM+NABPAC had significantly better response rates than GEM+CAPE and GEM+ERLO. Inconsistency analysis did not reveal any significant differences between direct and indirect estimates. Conclusions: This network meta-analysis is the first to compare and rank commonly used treatment regimens in aPC. It indicates that FOLFIRINOX combination seems to be superior to GEM-based combinations with respect to P&D as well as response rates. Nevertheless, among GEM-based combinations, GEM+NABPAC seems to have the best profile given its lower RR for P&D and higher response rates.

Trends in pancreatic cancer chemotherapy treatment in the United States from 2008 through 2016.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15734-e15734
Author(s):  
Shirley Hui ◽  
David Bernstein ◽  
Vinod P. Balachandran ◽  
Henry J. Henk
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
Combination Therapy ◽  
Combined Therapy ◽  
Advanced Pancreatic Cancer ◽  
Disease Status ◽  
The United States ◽  
Opioid Use ◽  
First Line ◽  
Opioid Dose

e15734 Background: Pancreatic cancer is the third leading cause of cancer death in the United States. 55% of patients present with advanced disease at diagnosis and are treated with chemotherapy, with gemcitabine and 5FU-backbone based therapies both demonstrating efficacy. However, data on the adoption of these of therapies in academic and non-academic centers is scarce. The goal of this study is to examine the aggregate adoption of these therapeutic regimens in widespread clinical practice from 2008 through 2016 using health plan claims data. Methods: Privately insured and Medicare patients with advanced pancreatic cancer treated with chemotherapy from 2008 through 2016 were identified from the OptumLabs Data Warehouse. First-line treatment regimen and duration were correlated with age, sex, race, Charlson Comorbidiy Index (CCI) score, and opioid use measured by morphine milligram equivalents (MME) (as a proxy for pain) in the 6 months prior to starting chemotherapy. Disease status was classified as advanced, adjuvant or neo-adjuvant. Results: For 14,301 patients treated with chemotherapy primarily, the use of monotherapy has significantly decreased from 73% to 27% (p < 0.001) between 2008 and 2016, while combination therapy using two antineoplastic agents (20% to 41%; p < 0.001) and three or more agents (6% to 32%; p < 0.001) increased. Since 2013, patients receiving combination therapy vs. monotherapy are significantly younger (mean 66 vs. 70; p < 0.001), have higher CCI (6.3 vs. 6.1; p = 0.002), and have similar daily opioid dose prior to chemotherapy (5.2 vs. 3.8 MMEs; p = 0.086). Duration on first-line regimen was greater in patients receiving combined therapy, compared to those on gemcitabine monotherapy (median 130 vs. 119 days; p < 0.001) after adjusting for CCI, disease status, and demographics. Conclusions: The use of combined therapy for the treatment of pancreatic cancer has increased over time, with patients on combined therapy appearing to be younger. [Table: see text]

scholarly journals Outstanding Outcome of Pancreatic Cancer: What Lessons Do We Learn

2020 ◽  
Vol 4 (1) ◽  
pp. e1-e2
Author(s):  
Muhammad W. Saif ◽  
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Advanced Pancreatic Cancer ◽  
The United States ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

The American Cancer Society’s estimates that 57,600 people (30,400 men and 27,200 women) will be diagnosed with pancreatic cancer in the United States for 2020 and approximately 47,050 people (24,640 men and 22,410 women) will die of pancreatic cancer in 2020.1 Despite advances in first-line therapy such as gemcitabine/nab-paclitaxel and fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) in advanced pancreatic cancer (aPC), median overall survival remains less than 12-months.2

scholarly journals Randomized Phase III Multi-Institutional Study of TNFerade Biologic With Fluorouracil and Radiotherapy for Locally Advanced Pancreatic Cancer: Final Results

2013 ◽  
Vol 31 (7) ◽  
pp. 886-894 ◽  
Author(s):  
Joseph M. Herman ◽  
Aaron T. Wild ◽  
Hao Wang ◽  
Phuoc T. Tran ◽  
Kenneth J. Chang ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Gene Transfer ◽  
Endoscopic Ultrasound ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Locally Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Necrosis Factor Alpha

Purpose TNFerade biologic is a novel means of delivering tumor necrosis factor alpha to tumor cells by gene transfer. We herein report final results of the largest randomized phase III trial performed to date among patients with locally advanced pancreatic cancer (LAPC) and the first to test gene transfer against this malignancy. Patients and Methods In all, 304 patients were randomly assigned 2:1 to standard of care plus TNFerade (SOC + TNFerade) versus standard of care alone (SOC). SOC consisted of 50.4 Gy in 28 fractions with concurrent fluorouracil (200 mg/m2 per day continuous infusion). TNFerade was injected intratumorally before the first fraction of radiotherapy each week at a dose of 4 × 1011 particle units by using either a percutaneous transabdominal or an endoscopic ultrasound approach. Four weeks after chemoradiotherapy, patients began gemcitabine (1,000 mg/m2 intravenously) with or without erlotinib (100 to 150 mg per day orally) until progression or toxicity. Results The analysis included 187 patients randomly assigned to SOC + TNFerade and 90 to SOC by using a modified intention-to-treat approach. Median follow-up was 9.1 months (range, 0.1 to 50.5 months). Median survival was 10.0 months for patients in both the SOC + TNFerade and SOC arms (hazard ratio [HR], 0.90; 95% CI, 0.66 to 1.22; P = .26). Median progression-free survival (PFS) was 6.8 months for SOC + TNFerade versus 7.0 months for SOC (HR, 0.96; 95% CI, 0.69 to 1.32; P = .51). Among patients treated on the SOC + TNFerade arm, multivariate analysis showed that TNFerade injection by an endoscopic ultrasound-guided transgastric/transduodenal approach rather than a percutaneous transabdominal approach was a risk factor for inferior PFS (HR, 2.08; 95% CI, 1.06 to 4.06; P = .032). The patients in the SOC + TNFerade arm experienced more grade 1 to 2 fever and chills than those in the SOC arm (P < .001) but both arms had similar rates of grade 3 to 4 toxicities (all P > .05). Conclusion SOC + TNFerade is safe but not effective for prolonging survival in patients with LAPC.

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