Uptake and patterns of use of gemcitabine for stage IV pancreatic cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15074-e15074
Author(s):  
Paul Eliezer Oberstein ◽  
Dawn L. Hershman ◽  
John A. Chabot ◽  
Lauren Khanna ◽  
Beverly J. Insel ◽  
...  

e15074 Background: Gemcitabine was approved by the FDA in 1996 and subsequently became the standard of care for patients with advanced pancreatic cancer. We investigated the frequency and predictors of gemcitabine use among the elderly with stage IV pancreatic cancer. Methods: We used the SEER-Medicare database to identify subjects >65 years who were diagnosed with stage IV pancreatic cancer between 1/1/98-12/31/05, and survived for >30 days following diagnosis. After excluding patients who received non-gemcitabine chemotherapy, we used multivariate logistic regression models to analyze the association between patient and tumor characteristics and receipt of gemcitabine compared to no chemotherapy. Results: Among 3,208 patients analyzed, 1,614 (50.3%) received gemcitabine chemotherapy, 1,480 (46.1%) received no chemotherapy; 114 (3.5%) received non-gemcitabine therapy and were excluded from multivariate analysis. Among patients diagnosed early in the study period (1998-2000) the rate of gemcitabine use was 44.9%. In multivariate analysis, gemcitabine use was not associated with gender, race, tumor histology, or increasing comorbidities. Unmarried patients were less likely to receive gemcitabine (OR=0.65, 95% CI 0.55-0.76), and use decreased with increasing age (for those 75-79, OR=0.72. 95% CI 0.58-0.90, for those 80-84, OR=0.38, 95% CI 0.30-0.49, for those >84, OR=0.21 95%CI 0.15-0.30) compared to those 65-69. Patients diagnosed in 2004-2005 (OR= 1.51, 95% CI 1.23-1.84) were more likely to receive gemcitabine compared to those diagnosed in 1998-2000. Higher socioeconomic status were associated with increased utilization of gemcitabine (highest quintile OR=2.14, 95% CI 1.60-2.85, second and third quintile OR=1.45, 95%CI 1.10-1.93, compared to lowest quintile.) Conclusions: Although chemotherapy for stage IV pancreatic cancer confers a small survival benefit, uptake of gemcitabine was rapid with 55% of elderly patients receiving this therapy by 2004-2005. Future studies should explore the reasons behind the increased use in patients with higher socioeconomic status.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 257-257
Author(s):  
Naomi Whittaker ◽  
Kristin Hueftle ◽  
Mary Warlaumont ◽  
Lauren Brin ◽  
David C. Olson ◽  
...  

257 Background: Palliative chemotherapy is the standard of care for stage IV pancreatic cancer patients (SFPC). Methods: This study compares the amount of chemotherapy given for SFPC across insurance types using the National Cancer Database (NCDB), which contains 70% of U.S. cancer cases. Results: The NCDB reported 115,512 patients diagnosed with SFPC from 2000 to 2009. Overall, 38.3% of SFPC patients received chemotherapy. The VAH (28.3%) and Medicare (29.7%) provided significantly less chemotherapy to SFPC patients as compared to Managed Care (48.2%), Private Insurance (46.7%), Tricare/Military (42.8%), Medicaid (37.8%), Medicare Plus Supplement (35.5%), and Uninsured (34.4%). From 2000 to 2009, the rate of chemotherapy for SFPC increased for both VAH (22.9% to 34.3%) and non-VAH (31.1% to 44.1%). At time of diagnosis, the percent of patients less than 60 at the VAH was 32%, non-VAH was 25.5% and Medicare was 7%. From age 20 to 59, the rate of chemo was stable at approximately 49%, but each successive decade demonstrated a marked reduction in use of chemotherapy (from 44% for 60 to 69 years of age to 21% for 80 to 89 and 5% for >90). The VAH PC population diagnosed with PC included 71.1% whites (W), 21.1% blacks (B), 4.8% Hispanics (H), 0.8% Asian-Pacific Islander (API), and 0.6% Native American (NA). Among all insurance types, only Medicaid (25%* B, 14%* H, 6%* API) and Uninsured (20% B, 15%* H, 4%* API) had a greater percentage of minorities. Compared to the average of all patients treated for SFPC (38.3%), blacks (34.7%*) and Hispanics (35.7%*) received less chemotherapy and whites received more (39.1%*). Conclusions: This is the largest study to analyze the use of chemotherapy in stage IV pancreatic cancer. Patients treated within the VAH were less likely to receive chemotherapy compared to all other patients except those with Medicare, who tend to be older at time of diagnosis. As age increases above 59, chemotherapy treatment for SFPC decreases. VAH patients receive less chemotherapy than Medicaid and Uninsured patients, though Medicaid and Uninsured have a greater percentage of minorities, who tend to get less chemotherapy for SFPC.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 358-358
Author(s):  
Kuniyasu Irie ◽  
Makoto Ueno ◽  
Satoshi Kobayashi ◽  
Yoshihiro Gouda ◽  
Shinichi Ohkawa ◽  
...  

358 Background: A combination of gemcitabine+erlotinib is one of the standard chemotherapies in advanced pancreatic cancer (APC). Since APC patients often take antiulcer drugs to prevent gastritis (e.g., NSAIDs to reduce cancer pain), erlotinib concentration is generally decreased through the mechanism of CYP3A4. Furthermore, unlike lung cancer, the biomarkers for APC are not obvious except rash. Here, we examined biomarkers of gemcitabine+erlotinib treatment in APC patients including the presence of antiulcer drugs. Methods: The subjects were 59 advanced pancreatic cancer patients. They were treated with gemcitabine+erlotinib starting from Nov. 2011 to Apr. 2013. Gemcitabine was administered at 1000 mg/m2, on days 1, 8, and 15 for every 4 weeks, and erlotinib was taken 100 mg daily. The progression-free survival (PFS), UICC stage, sex, age, CRP concentration, performance status (PS), rash, and presence of antiulcer drugs were examined. The PFS curve was plotted according to the method of Kaplan and Meier. The difference in the PFS was calculated using the log-rank test, and a multivariate analysis was conducted using Cox hazard model. Results: UICC stages were as follows; i.e., stage II: 1, stage III: 8, and stage IV: 50. There were 36 males and 23 females, and their ages ranged from 41 to 82 years old (median: 65). The CRP concentrations ranged from 0.02 to 11.5 mg/dl (median: 0.57). 37 patients received antiulcer drugs, and 48 patients had rash. The univariate analysis revealed that the CRP concentration and rash were significant (p=0.009 and p=0.005, respectively). Low CRP (<0.57mg/dl) and presence of rash were related to good PFS. The multivariate analysis also revealed that the CRP concentration (HR, 0.34; 95%CI, 0.16-072; p=0.005) and rash (HR, 0.40; 95%CI, 0.16-0.96; p=0.04) were significant. The presence of antiulcer drugs on PFS was insignificant. Conclusions: The CRP concentration and rash were biomarkers of gemcitabine+erlotinib treatment in APC patients.


2021 ◽  
Vol 10 (8) ◽  
pp. 1609
Author(s):  
Zainab L. Rai ◽  
Roger Feakins ◽  
Laura J. Pallett ◽  
Derek Manas ◽  
Brian R. Davidson

Locally advanced pancreatic cancer (LAPC) accounts for 30% of patients with pancreatic cancer. Irreversible electroporation (IRE) is a novel cancer treatment that may improve survival and quality of life in LAPC. This narrative review will provide a perspective on the clinical experience of pancreas IRE therapy, explore the evidence for the mode of action, assess treatment complications, and propose strategies for augmenting IRE response. A systematic search was performed using PubMed regarding the clinical use and safety profile of IRE on pancreatic cancer, post-IRE sequential histological changes, associated immune response, and synergistic therapies. Animal data demonstrate that IRE induces both apoptosis and necrosis followed by fibrosis. Major complications may result from IRE; procedure related mortality is up to 2%, with an average morbidity as high as 36%. Nevertheless, prospective and retrospective studies suggest that IRE treatment may increase median overall survival of LAPC to as much as 30 months and provide preliminary data justifying the well-designed trials currently underway, comparing IRE to the standard of care treatment. The mechanism of action of IRE remains unknown, and there is a lack of data on treatment variables and efficiency in humans. There is emerging data suggesting that IRE can be augmented with synergistic therapies such as immunotherapy.


Author(s):  
Amrallah A. Mohammad

Presentation of pancreatic cancer is localized, locally advanced or metastatic. With the later represented the main bulk (more than 80%). Despite the significant innovation in molecular analysis and therapeutic approach in many types of cancer in the last two decades, still the outcome of advanced pancreatic cancer is disappointing and the mortality rate approximately unchanged. In this mandated review we intended to highlight the standard of care and emerging agents for advanced pancreatic cancer treatment.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14075-14075
Author(s):  
M. Haenel ◽  
D. Quietzsch ◽  
V. Heinemann ◽  
S. Boeck ◽  
R. M. Schmid ◽  
...  

14075 Background: (E)-5-(2-bromovinyl)-2’-deoxyuridine (BVDU, RP101), was initially tested in a phase 1 pilot study in pancreatic cancer. Patients (n=13) received gemcitabine (1000 mg/m2), cisplatin (50 mg/m2) and RP101 (500 mg/day). The median survival was 447 days and the TTP was 280 days. Ten of the 13 pts lived longer than one year, 4 nearly two years. Based on these promising results a phase 2 study was initiated to explore varying doses of RP101 used with a fixed dose of GEM. Methods: Pts with advanced pancreatic adenocarcinoma were eligible for treatment in this single arm study. 22 pts (16 stage IV and 5 stage III) received GEM 1000 mg/m2 on days 1, 8 and 15 of a 28-day schedule. RP101 treatment, at doses of 500, 625, 750, 875 or 1000 mg/day, was on the same day and for three days after chemotherapy. The mean age was 60 years and 73% of pts were males. Results: The results are based on interim data from an ongoing study and patients at the 2 highest dose groups are still being treated. All RP101 dose groups were combined for analyses, which included all enrolled pts. The data on the 6-month survival status show that 41% are alive; 23% dead; and 36% followed less than 6 months. The median survival (95% CI) is 7.1 months (5.9, not calculated) and 14/22 pts (64%) are still alive. The 6 month survival rate (95% CI) is 0.69 (0.52, 0.85). This compares very favorably with a large recent randomized trial in which pts who received GEM alone had a median survival (95%CI) of 5.9 months (5.1–6.7). PFS and TTP continue to be assessed in this ongoing trial. There appears to be a dose dependent increase in peak GEM levels as a function of the dose of RP101. To date, adverse events are consistent with those observed with GEM or the underlying disease. Conclusion: RP101 may improve treatment of advanced pancreatic cancer when used with gemcitabine. Updated data on survival, PFS, and safety will be presented based on available data. [Table: see text]


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 ◽  
...  

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.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14642-e14642
Author(s):  
David C. Olson ◽  
Khaled Mohamed Abou El-Ezz ◽  
Peter T. Silberstein

e14642 Background: Insurance status has been shown to affect adherence to guidelines in the treatment of colon cancer1. This study aims to investigate trends in management of colon cancer and time to first treatment in patients with various insurance types using the National Cancer Database (NCDB). Methods: Treatment data for 845,121 patients and time to first treatment data for 497,993 patients diagnosed with colon cancer between 2000 and 2010 were identified using the NCDB. Reported utilization of treatment and time to first treatment were analyzed by insurance status. Results: Among all stages of colon cancer, no treatment was received more often by Veteran Affairs (10.5%) and Medicare (10.9%) patients than uninsured (8.8%), managed care (4.5%), private insurance (4.7%), Medicaid (8.4%) or Medicare with supplement (7.7%). Among stage I colon cancer, surgery was received less often by uninsured (90.9%) than other insurance types. Stage III colon cancer patients enrolled in Medicare with/without supplement received chemotherapy less often than other insurance types (49.9% and 46%). Stage IV Medicare patients with/without supplement also received chemotherapy less than other insurance types (59.5% and 52.9%). Surgery as monotherapy was the most common treatment received among all insurance types and stages. More uninsured patients received treatment within 3 days than any other insurance types (61%). A delay of at least 17days occurred more in Veteran Affairs patients than other insurance types (40.6%). Conclusions: This is the largest study to date to have examined treatment trends and time to first treatment. Among all insurance types, Medicare without supplement and Veteran Affairs patients were most likely to receive no treatment. Uninsured were less likely to receive the standard of care treatment with stage I cancers. Medicare patients were less likely to receive the standard of care for stage III and stage IV cancers than other insurance types. Veteran Affairs patients had treatment delayed significantly more than other insurance types. Future studies are needed to assess factors leading to receipt of substandard care.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 212-212
Author(s):  
Narjust Perez-Florez ◽  
Larysa Jessica Gromko ◽  
Eric Yoon ◽  
Andrew Jennis ◽  
Zubin M. Bamboat ◽  
...  

212 Background: Gastric cancer is a prevalent global disease with significant mortality. Nearly 22,220 patients are diagnosed annually in the US, with approximately 50% of them presenting with disease that extends beyond loco-regional confines, and only a small percentage undergoing curative resection. We aim to study the clinical characteristics and survival benefit of surgery in stage IV gastric cancer. Methods: We reviewed the records of all patients diagnosed with gastric cancer in our cancer center from 1999 to 2013. A total of 272 stage IV cases were identified. Demographics, tumor characteristics, treatment modalities (surgical vs. non-surgical) and survival rate were analyzed. Kaplan-Meier was used for survival analysis and Cox regression for univariate and multivariate analysis. Results: Within the cohort 70 (26%) patients received surgery and 202 (74%) were treated with chemotherapy ± radiation. Mean age at diagnosis was 64 years in the surgical (S) patients and 66 years in the non-surgical (NS). Non-Hispanics whites were more likely to receive surgery vs. all other ethnic groups combined, representing 77% vs. 23% of the S subgroup (p<0.0001). Patients with proximal tumors were more likely to receive surgery when compared with distal tumors (37 (53%) vs. 14 (20%), p<0.0001). Total gastrectomy was the most common surgical procedure 33 (47%). There was a significant difference in disease specific survival between the two groups, being 17.3 months for S (95%CI: 11.1-23.4) and 5.3 months for NS (95%CI: 3.8-6.7) (p<0.0001). Age > 70 years (OR: 1.74, p<0.02), proximal tumor location (OR: 0.75, p<0.04), surgery (OR: 0.37, p<0.0001) and extended lymphadenectomy (D2) (OR: 0.26, p<0.02) were independent and significant predictors of survival by multivariate analysis. Conclusions: In our cohort, non-Hispanic whites and patients with proximal tumors were more likely to undergo surgery. A major survival benefit was observed for the surgical subgroup when compared to non-surgical treatment for stage IV gastric cancer. Future research should aim to further elucidate the specific role of surgery, as this could potentially impact management and transform the standard of care in stage IV gastric cancer.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 265-265
Author(s):  
Shuichi Mitsunaga ◽  
Kumiko Umemoto ◽  
Kazuo Watanabe ◽  
Hiroyuki Okuyama ◽  
Yusuke Hashimoto ◽  
...  

265 Background: The serum tumor-marker in monitoring response to chemotherapy is not valid in advanced pancreatic cancer (PC). S100 calcium-binding protein P (S100P) has been reported as a predictive diagnostic index for PC and may serve as an early marker to activity of chemotherapy. The aim of this study was to analyze the correlation between the efficacies of chemotherapy and the kinetics of tumor-markers including serum S100P, carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9) in prospective cohort of advanced PC. Methods: Patients who were treatment naïve for advanced PC with liver mets were eligible. Serum levels of S100P, CEA, and CA19-9 were measured at baseline and at one month later. The patients without monitoring of tumor-markers were excluded. A response of tumor-marker was defined as a decrease of at least 25%. Clinical data including radiological response according to the Response Evaluation Criteria In Solid Tumors ver. 1.1 were prospectively collected. S100P, CEA, and CA19-9 responses were tested in association with progression free survival (PFS) and overall survival (OS). Results: Fifty patients were analyzed in this study (male: 64%, median age: 67 years, Eastern Cooperative Oncology Group performance status [PS] 0: 60%). All of 50 patients received chemotherapy (gemcitabine [GEM]: 13 pts, GEM doublets: 34 pts, 5FU-based regimen: 3 pts). PFS and OS were 2.8 and 6.1 months. Responses of S100P, CEA, and CA19-9 were founded in 50%, 16%, and 32% of all, respectively. Multivariate analysis for PFS in Cox regression hazard model was performed using age, gender, PS, CEA, CA19-9, and S100P, and revealed that the independent predictors to longer PFS were responses of S100P (HR to progression: 0.47, P=0.02) and CEA (HR: 0.29, P=0.01). S100P or CEA responders showed better OS in univariate analysis using log-rank test, compared to non-responders of S100P (responder vs. non-responder: 8.4 vs. 3.7 months, P=0.04) or CEA (12.0 vs. 5.9 months, P=0.02), but not in multivariate analysis. Conclusions: Biochemical response of S100P might be useful for monitoring response to chemotherapy in advanced PC, which warranted further study in relationship between serum S100P response and treatment efficacies.


2021 ◽  
Vol 8 ◽  
Author(s):  
Masayuki Shimizu ◽  
Shin Takayama ◽  
Akiko Kikuchi ◽  
Ryutaro Arita ◽  
Rie Ono ◽  
...  

Aims: The present report aims to investigate the use of Kampo medicine for advanced pancreatic cancer patients in order to prolong survival.Methods: We retrospectively reviewed medical records of patients with pancreatic cancer who presented to our Shimizu Clinic from 2000 to 2020. Patients who survived at least twice as long as the initial prognostic estimate were selected and their treatment was reviewed. The Kampo formula and crude drugs were selected according to the Kampo diagnosis and treatment strategy, which included qi and blood supplementation; qi, blood and water smoothing; and inflammation (termed “heat”) and cancer suppression.Results: Ten patients aged 45–80 years (six males and four females) with stage IV advanced cancer were selected. All patients received hozai, which is a tonic formula, of juzentaihoto (JTT) or hochuekkito (HET) decoction. Anti-cancer crude drugs were included in the decoctions of nine patients. At the first visit, the estimated life expectancy for all patients was no more than 1 year; however, treatment with Western and Kampo medicine led to a relatively long survival period of over 2 years. Three patients were still living at the time of this writing, more than 2, 6, and 14 years after treatment initiation.Conclusion: Our results suggest that Kampo medicine may be useful for disease control and supportive care for patients with advanced pancreatic cancer.


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