scholarly journals Association of Neutrophil, Platelet, and Lymphocyte Ratios with the Prognosis in Unresectable and Metastatic Pancreatic Cancer

2020 ◽  
Vol 9 (10) ◽  
pp. 3283
Author(s):  
Jessica Allen ◽  
Colin Cernik ◽  
Suhaib Bajwa ◽  
Raed Al-Rajabi ◽  
Anwaar Saeed ◽  
...  
Keyword(s):  
Lymphocyte Count ◽  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Absolute Lymphocyte Count ◽  
Rate Of Change ◽  
Ductal Adenocarcinoma ◽  
Cancer Center ◽  
Trend Test ◽  
The Mean

We examined the relationship between the daily rate of change of cancer antigen 19-9 (CA19-9) over the first 90 days of treatment (DRC90) and the pretreatment levels of neutrophils, lymphocytes, and platelets with the overall survival (OS) and progression-free survival (PFS) in patients with stage IV pancreatic ductal adenocarcinoma (PDA) who received chemotherapy. We retrospectively evaluated 102 locally advanced and metastatic PDA patients treated at the University of Kansas Cancer Center (KUCC) between January 2011 and September 2019. We compared the ratio of the pretreatment absolute neutrophil count to the pretreatment absolute lymphocyte count (NLR) and the ratio between the pretreatment platelet count to the pretreatment absolute lymphocyte count (PLR) with the OS and PFS. We compared the DRC90 to the OS and PFS. The ratios were analyzed using the log-rank trend test using the mean of the NLR, PLR, and DRC90 as the threshold for two groups within each variable. Patients with ≥mean NLR (4.6 K/µL) had a significantly lower OS (p = 0.0444) and PFS (p = 0.0483) compared with patients below the mean. Patients with PLR ≥ mean (3.9 K/µL) did not have a significantly different OS (p = 0.507) or PFS (p = 0.643) compared with patients below the mean. Patients with DRC90 ≥ mean (−1%) did not have a significantly different OS (p = 0.342) or PFS (p = 0.313) compared with patients below the mean. Patients with NLR ≥ mean (4.6 K/µL) had a significantly lower OS and PFS compared with patients with NLR below the mean. This implies the possibility of NLR as a prognostic marker in PDA that could guide treatment approaches but still requires validation in a larger cohort.

Association of neutrophil, platelet, and lymphocyte ratios with prognosis in metastatic pancreatic cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 767-767
Author(s):  
Jessica Allen ◽  
Colin Cernik ◽  
Suhaib Bajwa ◽  
Anwaar Saeed ◽  
Anup Kasi
Keyword(s):  
Lymphocyte Count ◽  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Absolute Lymphocyte Count ◽  
Rate Of Change ◽  
Ductal Adenocarcinoma ◽  
Cancer Center ◽  
Trend Test ◽  
The Mean

767 Background: High mortality associated with pancreatic ductal adenocarcinoma (PDA) warrants research into prognostic factors. We examined the relationship between the daily rate of change of CA19-9 over the first 90 days of treatment (DRC90) and pretreatment levels of neutrophils, lymphocytes, and platelets with overall survival (OS) and progression free survival (PFS) in patients with stage IV PDA that received chemotherapy. Methods: We retrospectively evaluated 102 locally advanced and metastatic PDA patients treated at KU Cancer Center between Jan 2011 and Sep 2019. We compared the ratio of pretreatment absolute neutrophil count to pretreatment absolute lymphocyte count (NLR) and the ratio between pretreatment platelet count to pretreatment absolute lymphocyte count (PLR) with OS and PFS. We also compared DRC90 to OS and PFS. Log-rank trend test using the mean of NLR, PLR, and DRC90 as the threshold for two groups within each variable. Results: Baseline demographics are shown in the table. Pts with ≥ mean NLR (4.6) had significantly lower OS [p = 0.0444] and PFS [p = 0.0483] than Pts below the mean. Pts with PLR ≥ mean (3.9) did not have significantly different OS [p = 0.507] or PFS [p = 0.643] than Pts below the mean. Pts with DRC90 ≥ mean (-1%) did not have significantly different OS [p = 0.342] or PFS [p = 0.313] than Pts below the mean. Conclusions: Pts with NLR ≥ mean (4.6) had significantly lower OS and PFS than Pts with NLR below the mean. This implies the possibility of NLR as a prognostic marker in PDA that could guide treatment approach but needs validation in a larger cohort. [Table: see text]

The prognostic significance of exosomal marker (CD63) expression using immunohistochemistry (IHC) in patients with pancreatic ductal adenocarcinoma (PDAC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15730-e15730
Author(s):  
Moh'd M. Khushman ◽  
Arun Bhardwaj ◽  
Girijesh K. Patel ◽  
Javier Laurini ◽  
Kelly Roveda ◽  
...  
Keyword(s):  
Cancer Progression ◽  
Prognostic Significance ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Staining Intensity ◽  
Ductal Adenocarcinoma ◽  
Positive Correlation ◽  
The Mean ◽  
Metastatic Sites ◽  
Cd63 Expression

e15730 Background: Exosomes are important mediators of intercellular communication, and play pivotal roles in cancer progression, metastasis and chemoresistance. Exosomal membranes are enriched in endosomes-specific tetraspanins (CD63 and CD9). In patients with PDAC, positive correlation between CD9 expression and overall survival (OS) was reported. However, CD63 expression was conserved in all patients without reported prognostic significance. Here, we explored the prognostic significance of CD63 expression using IHC in patients with PDAC of mixed gender and racial background. Methods: Between 2012 and 2016, 49 patients with PDAC treated at Mitchell Cancer Institute had available tissue (pancreatic resected tissue/biopsy [N = 29] or metastatic site biopsy liver, omentum or bone (N = 20)) for CD63 staining using IHC. Two pathologists independently scored the expression of CD63. Staining intensity was graded from 1-3. Staining percentage was estimated in 10% increments. Mean Quick-score (Intensity X Percentage of staining) was calculated. Unpaired t test was used for statistical analysis. Results: Median age was 64 years (range 42-85). 53% are males. 67% white, 27% African Americans (AA) and 6% are other ethnicities. 41% had stage IV disease while 49% had stage I, II and III. Tumor involved the head (51%), body (20%) and tail (29%). The mean CD63 Q score is slightly higher in AA compared to white (157 vs 149, P = 0.76). The mean CD63 Q score is higher in the pancreatic tissues compared to metastatic sites tissues (185 Vs 102, P = 0.0002). In our cohort, patients with mean CD63 Q score > = 140 had longer median OS compared to patients with mean Q score of < 140 (19 months Vs 3 months, P = 0.0003) and progression free survival (PFS) (12 months vs 1 month, P = 0.0043). Conclusions: In our cohort of patients with PDAC, there was no racial difference in CD63 expression between white and AA. The expression of CD63 is higher in the pancreas compared to metastatic sites (liver, omentum and bone). There is positive correlation between CD63 expression and PFS and OS. To our knowledge, this is the first study to show prognostic significance of CD63 expression in patients with PDAC using IHC.

Absolute Lymphocyte Count Recovery during Standard Chemotherapy Predicts Superior Survival and Is Independent of the Hasenclever Index for Hodgkin’s Disease.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2667-2667
Author(s):  
Mustaqeem Siddiqui ◽  
Luis F. Porata ◽  
Kay Ristow ◽  
Thomas M. Habermann ◽  
Joseph P. Colgan ◽  
...  
Keyword(s):  
Hodgkin's Disease ◽  
Lymphocyte Count ◽  
Independent Predictor ◽  
Hodgkin’S Disease ◽  
Critical Role ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Absolute Lymphocyte Count ◽  
Standard Chemotherapy

Abstract Absolute lymphocyte count (ALC) post-autologous stem cell transplantation is an independent predictor for survival in Hodgkin’s Disease (HD). Lymphopenia at diagnosis is associated with worse prognosis in patients with newly diagnosed HD. The role of ALC recovery during standard chemotherapy for HD is unknown. We analyzed all patients managed for HD at the Mayo Clinic from 1986 to 2003. Of the 141 consecutive patients, two patients were excluded due to missing ALC data. Of the 139 patients, 63 patients were females and 76 males. The median age of patients at diagnosis was 31 years (range 6–75 years). 118 (85%) patients presented with nodular sclerosis HD, 10 (7%) with mixed cellularity, 2 (1%) with lymphocyte predominance, 1(1%) with lymphocyte depletion, 4 (3%) with lymphocyte predominant (nodular variant), and 4 (3%) unclassified. Frontline chemotherapy included ABVD (N = 79), MOPP-ABV (N = 47), COPP-ABV (N = 8), BEACOPP (N = 3), and Stanford V (N =2). The median number of cycles was 6 (range: 2–10). The median follow-up for the cohort was 62 months (range: 4–221 months). The ALC recovery was analyzed during the first 4 cycles as 90% of the patients received at least 4 cycles of therapy. Patients with an ALC ≥ 1.3 x 109/l at any time point within the first four cycles of chemotherapy (N = 93) demonstrated improved overall survival (OS) and progression-free survival (PFS) compared to patients with an ALC &lt; 1.3 x 109/L at all time points within the first four cycles of chemotherapy (N =46) (10 years OS and PFS: 91% vs 51%, p &lt; 0.0001; 85% vs 52%, p &lt; 0.0001, respectively). Both groups were balanced for the Hasenclever Index: albumin &lt; 4g/dl (p = 0.1), hemoglobin &lt; 10.5 g/dl (p = 0.46), male gender (p =0.21), age ≥ 45 years (p = 0.06), stage IV disease (p = 0.68), leukocytosis ≥ 15 x 109/L (p = 0.58), and lymphopenia &lt; 600 cell/ml (p = 0.211). Multivariate analysis demonstrated ALC recovery to be independent predictor of OS and PFS when compared to the Hasenclever index. These data suggest a critical role of lymphocyte (immune) recovery during standard chemotherapy in HD.

scholarly journals Ultra-low Input Circulating Tumor DNA Detection by MED-Amp in Early-Stage Pancreatic Cancer

2021 ◽  
Author(s):  
Erica D Pratt ◽  
David B Zhen ◽  
Robert W Cowan ◽  
Heather Cameron ◽  
Kara Schradle ◽  
...  
Keyword(s):  
Early Stage ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Circulating Tumor Dna ◽  
Fold Change ◽  
Diagnostic Sensitivity ◽  
Ductal Adenocarcinoma ◽  
Kras Mutations ◽  
The Relationship ◽  
Tumor Dna

Purpose: The clinical utility of circulating tumor DNA (ctDNA) has been shown in advanced pancreatic ductal adenocarcinoma (PDA). However, diagnostic sensitivity of many ctDNA assays is low in resectable and locally advanced disease, where tumor burden is substantially lower. We have previously described Multiplex Enrichment using Droplet Pre-Amplification (MED-Amp), a multiplexed panel for the detection of the most common oncogenic KRAS mutations in PDA. In this study, we aimed to assess the diagnostic sensitivity of MED-Amp for detection of rare mutant alleles present in the plasma of patients with localized PDA. Experimental Design: We retrospectively analyzed ninety-eight plasma samples from 51 patients with various stages of localized disease. For comparison, we measured ctDNA levels in 20 additional patients with metastatic PDA. The MED-Amp assay was used to measure the abundance of the four most common KRAS codon 12 mutations (G12C/D/R/V). We correlated the presence and quantity of ctDNA with overall survival (OS) as well as progression-free survival (PFS). Using serial plasma draws, we also assessed the relationship between changes in ctDNA allelic frequency and progression. Results: KRAS-positive ctDNA was detected in 52.9% of localized PDA and 75% of metastatic samples tested using DNA inputs as low as 2 ng. As previously reported, the presence of KRAS mutant ctDNA was correlated with worse OS for all disease stages (p = 0.02). In patients with localized PDA high ctDNA levels also correlated with significantly worse median OS (533 days vs 1090 days) and PFS (192 days vs 787 days). We also studied a small cohort of serial plasma draws to observe the relationship between ctDNA fold change and PFS. We found 83% of patients with increased fold change in mutant KRAS experienced disease progression (n=6). In contrast, 75% (n=4) of patients with decreased fold change remained disease-free (p=0.03). Conclusions: MED-Amp is a flexible and cost-effective approach for measurement of ctDNA in patients with localized cancer. Though this study focused on KRAS mutation detection, this assay could be adapted for a number of common oncogenic alterations.

Investigate the efficacy of immunotherapy for treatment of pancreatic adenocarcinoma (PDAC) with mismatch repair deficiency (dMMR).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 415-415
Author(s):  
Arish Noor ◽  
Luis E. Aguirre ◽  
Kirsten Blue ◽  
Trenton Avriett ◽  
Estrella M. Carballido ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Metastatic Disease ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Cancer Center ◽  
Duration Of Response

415 Background: Immune checkpoint inhibitors (ICI) have been approved in solid tumors with dMMR. However, only limited data are available for PDAC with dMMR given the rarity of dMMR in PDAC. We evaluated efficacy of ICIs in PDAC with dMMR. Methods: Retrospective clinical and pathologic data were collected for patients (pts) with pancreatic adenocarcinoma from May 2017 to June 2020 at Moffitt cancer center. Results: We identified 10 pts with dMMR PDAC. The median age was 64.5 years (range: 42-86) and 4 pts were male. 4 pts had resectable disease, 3 had locally advanced and 3 had metastatic disease at initial diagnosis. MSH6 deficiency (def) was found in 2 cases, PMS2 def in 2, MLH/PMS2 def in 5, and MSH2/MSH6 in 1. 7 pts were treated with ICIs. 3 pts had locally advanced and 4 had metastatic disease when they started ICIs. 5 received Pembrolizumab (pem), 1 received ipilimumab/ nivolumab (ipi/nivo), and 1 received pem then ipi/nivo after progressive disease (PD) on pem. The median number of prior lines of chemotherapy was 1 (range 0-2). 6 pts were evaluable, and 1 had rapid disease progression after 1 dose of pem. Among 6 evaluable pts, 3 had an objective response (1: complete response and 2: partial response), and 2 had stable disease (SD). Median progression-free survival was 8.2 mo, and median overall survival was not reached with median follow-up (FU) of 6.8 mo. The median duration of response was not reached with a median FU of 22.6 mo. The pt with CR remained disease-free for up to 22 months. The pt whose treatment was switched to ipi/nivo after PD on pem achieved SD > 4mo on ipi/nivo. While on immunotherapy, one patient with ipi/nivo developed immunotherapy associated rash requiring systemic steroids, and another on pem developed hypothyroidism requiring levothyroxine. Conclusions: This series suggest ICIs can provide durable clinical efficacy in pts with dMMR PDAC.

scholarly journals Homologous Recombination Deficiency in Patients With Pancreatic Ductal Adenocarcinoma and Response to Chemotherapy

2018 ◽  
pp. 1-11 ◽  
Author(s):  
Safi Shahda ◽  
Kirsten M. Timms ◽  
Ashley A. Ibrahim ◽  
Julia E. Reid ◽  
Harvey M. Cramer ◽  
...  
Keyword(s):  
Homologous Recombination ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Needle Aspiration ◽  
Response To Therapy ◽  
Ductal Adenocarcinoma ◽  
Response To Chemotherapy ◽  
Formalin Fixed Paraffin Embedded ◽  
Mutation Data

Purpose Mutations or copy number abnormalities of genes involved in homologous recombination (HR) occur in pancreatic ductal adenocarcinoma (PDAC). DNA-based measures of HR deficiency (HRD) have been developed and may help identify tumors with better response to DNA-damaging agents. This study aimed to describe the HR pathway mutations and HRD status and determine their association with treatment response and outcome in patients with PDAC. Patients and Methods We performed a retrospective analysis of tumor samples from patients treated at Indiana University for locally advanced or metastatic PDAC. Patients were included if they received gemcitabine plus nanoparticle albumin-bound paclitaxel (control) or fluorouracil, oxaliplatin, leucovorin, and irinotecan (FOLFIRINOX) and had adequate follow-up to assess survival and response to therapy. Tumor analysis generated a three-biomarker HRD score and mutation data for 44 genes. Results Ninety-one samples met inclusion criteria, and 78 samples (formalin-fixed paraffin-embedded, n = 15; fine-needle aspiration, n = 63) generated mutation data. HRD analysis was successful for 57 samples (HRD score: median, 18; range, 5 to 61); the primary cause of failure was low tumor cellularity. Six BRCA1/ 2 mutations were detected, four with HRD scores in the top decile ( P = .011). There was no statistically significant correlation between HRD score and radiographic response (odds ratio per interquartile range, 1.40; P = .32 adjusted for treatment) in either treatment group. In patients treated with FOLFIRINOX, HRD score dichotomized at the median was not associated with progression-free survival (median, 5.3 v 9.4 months for low v high HRD score, respectively; P = .083) or overall survival (median, 11.9 v 10.7 months for low v high HRD score, respectively; P = .76). Conclusion Mutations in DNA repair genes occur in PDAC, and HRD scores can be generated in the majority of patients. The HRD score was not significantly associated with higher response rate or prolonged survival in patients treated with FOLFIRINOX.

Effectiveness of combined induction chemotherapy and radiotherapy in advanced nasopharyngeal carcinoma.

1993 ◽  
Vol 11 (10) ◽  
pp. 1919-1928 ◽  
Author(s):  
I W Dimery ◽  
L J Peters ◽  
H Goepfert ◽  
W H Morrison ◽  
R M Byers ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Continuous Infusion ◽  
Induction Chemotherapy ◽  
Survival Rates ◽  
Prospective Trial ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Complete Response ◽  
Dose Schedule ◽  
Cancer Center

PURPOSE This prospective trial was conducted with the goal of achieving an improvement in both overall and progression-free survival in previously untreated patients with stage IV nasopharyngeal carcinoma who received an induction chemotherapy regimen of fluorouracil (5-FU) and cisplatin followed by radiotherapy. PATIENTS AND METHODS From January 1985 to January 1990, 47 patients with T1-4N2-3M0 squamous cell carcinoma of the nasopharynx were treated at The University of Texas M.D. Anderson Cancer Center with two to three cycles of 5-FU (1,000 mg/m2 continuous infusion per day x 5 days) plus cisplatin (100 mg/m2 continuous infusion on day 1 only) followed by radiotherapy using the conventional time/dose schedule. RESULTS The response rate to chemotherapy was 93.2% (20.5% complete response [CR]; 72.7% partial response [PR]), and the overall CR rate after radiotherapy was 86%. With a median follow-up period of 53 months, the 2-, 4-, and 6-year survival rates were 80%, 71.6%, and 67.4%; the overall treatment failure rate was 27%. Treatment was well tolerated and without significant acute or chronic toxic effects. CONCLUSION The results of this prospective study demonstrate that 5-FU plus cisplatin followed by radiotherapy can induce a durable remission in a high proportion of patients with poor-prognosis stage IV nasopharyngeal carcinoma.

scholarly journals Cytoreductive Nephrectomy and Overall Survival of Patients with Metastatic Renal Cell Carcinoma Treated with Targeted Therapy—Data from the National Renis Registry

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2911
Author(s):  
Alexandr Poprach ◽  
Milos Holanek ◽  
Renata Chloupkova ◽  
Radek Lakomy ◽  
Michal Stanik ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Locally Advanced ◽  
Treatment Algorithm ◽  
Progression Free Survival ◽  
Cancer Center ◽  
Cytoreductive Nephrectomy

The role of cytoreductive nephrectomy (CN) in treatment of locally advanced or metastatic renal cell carcinoma (mRCC) in the era of targeted therapies (TT) is still not clearly defined. The study population consisted of 730 patients with synchronous mRCC. The RenIS (Renal carcinoma Information System) registry was used as the data source. The CN/TT cohort included patients having CN within 3 months from the mRCC diagnosis and subsequently being treated with TT, while the TT cohort included patients receiving TT upfront. Median progression-free survival from the first intervention was 6.7 months in the TT arm and 9.3 months in the CN/TT patients (p < 0.001). Median overall survival was 14.2 and 27.2 months, respectively (p < 0.001). Liver metastasis, high-grade tumor, absence of CN, non-clear cell histology, and MSKCC (Memorial Sloan-Kettering Cancer Center) poor prognosis status were associated with adverse treatment outcomes. According to the results of this retrospective study, patients who underwent CN and subsequently were treated with TT had better outcomes compared to patients treated with upfront TT. The results of the study support the use of CN in the treatment algorithm for mRCC.

A Retrospective Single Center Comparison of Cyclophosphamide Plus G-CSF Versus G-CSF Alone for Peripheral Blood Stem Cell (PBSC) Mobilisation Following First Line Therapy in Patients with Multiple Myeloma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1898-1898
Author(s):  
Richard S Whitmill ◽  
David J Lewis ◽  
David John Sutton ◽  
Jahanzeb Khawaja ◽  
Georgina Mayer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stem Cell ◽  
Lymphocyte Count ◽  
Progression Free Survival ◽  
Absolute Lymphocyte Count ◽  
Initial Therapy ◽  
Single Center ◽  
Free Survival ◽  
Neutropenic Sepsis ◽  
Cd34 Cells

Abstract Introduction Autologous transplantation is considered standard therapy for young and fit myeloma patients after initial therapy. Cyclophosphamide+ G-CSF is considered standard therapy for collection even though there is evidence for minimal anti-myeloma effect of cyclophosphamide, some increased short term toxicity and potential concerns regarding long term toxicity. There have been a few retrospective comparisons and one randomized study comparing cyclophosphamide based and G-CSF alone based PBSC collection. To our best knowledge they have not reported any impact in progression free survival (PFS) or overall survival (OS). We have compared here our myeloma patient cohort to explore these important endpoints. Patients and methods 89 patients (55 male and 34 female) who underwent first autologous transplant for myeloma between 2003 and 2010 were analysed in our study. Mobilization was with G-CSF alone in 45 patients (median age 58 yrs, range 38-70 yrs.) and cyclophosphamide and G-CSF in 44 (median age 58 yrs, range 41-74 yrs.). Cyclophosphamide was used at 3g/m2 and in both cases G-CSF used was lenogastrim at 10mcg/kg. There were 7 patients with ISS stage 3 in the G-CSF only group as compared to 10 in the Cyclophosphamide group. Prior chemotherapy was cyclophosphamide, thalidomide and dexamethasone in majority of cases (n=55) with no difference across both groups. Data regarding high risk genetics and pre-transplant response was unavailable. We collected data progression free survival, overall survival, harvest dose and engraftment kinetics. Data was analyzed using SPSS and log rank test. Results The median dose of stem cells collected with G-CSF alone was 3.59×106 CD34 cells/kg (range 1.84-8.09) where as with cyclophosphamide and G-CSF it was 3.8×106 CD34 cells/kg (range 1.6-13). There was no difference in engraftment between the two groups with median neutrophil engraftment (Absolute neutrophil count>0.20×109/L) at day 14 and platelet engraftment (>50×109/L) at day 15 and 16 respectively. Progression free survival was significantly better in G-CSF alone cohort (46 months vs. 38 months, P=0.016) (fig. a) Overall survival was better in the GCSF only group as well (113 months vs. 75 months, P=0.029) (fig b). In the 17 high risk patients PFS was much better in the G-CSF group (60months vs. 22 months, P=0.02) (Fig c). There were 4 (9%) admissions in the cyclophosphamide group due to neutropenic sepsis as compared to none in the G-CSF group. Discussion Cyclophosphamide and G-CSF may be associated with slightly higher stem cell yields but this margin is becoming smaller and not significant in the era of liberal plerixafor usage. In addition some patients are hospitalized due to neutropenic sepsis with this regimen. Our data shows anti-myeloma effects of cyclophosphamide +G-CSF is not demonstrated. There are ongoing studies from the Finland group which show no difference in the number of CD34+ cells collected after initial therapy with lenalidomide. The only difference is the number of days required for apheresis. In addition to above our single center experience shows both PFS and OS benefit for G-CSF only PBSC mobilization. . This may partially be explained by the slight difference in ISS risk stages in our patients but on censoring for ISS stage 3 these results were more pronounced. This is the first time we have seen any report point out towards a PFS and OS difference between two widely used mobilization regimens. This needs testing in a large randomized multi-center study to see if there is a difference and if so is this due to a change in milieu of lymphocytes. We have previously reported that absolute lymphocyte count on day 15 post autograft was reflective of a higher lymphocyte count in the apheresis bag in case of G-CSF only mobilizations as compared to cyclophosphamide +G-CSF. The absolute lymphocyte count on day 30 was a predictor for better OS. Figure 1. Progression free Survival Figure 1. Progression free Survival Figure 2. Overall survival Figure 2. Overall survival Figure 3. progression free survival for ISS score 3 Figure 3. progression free survival for ISS score 3 Disclosures Sutton: bayer: Honoraria. Paneesha:Janssen: Consultancy. Nikolousis:Alexion: Honoraria. Kishore:Jazz pharma: Honoraria; Celgene: Honoraria.

A randomized phase II study of 500 mg/m2 and 1,000 mg/m2 of pemetrexed in patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had prior chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7590-7590 ◽  
Author(s):  
Y. Ichinose ◽  
K. Nakagawa ◽  
T. Tamura ◽  
K. Kubota ◽  
N. Yamamoto ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Total Sample ◽  
Median Number ◽  
Vitamin Supplementation ◽  
Toxicity Profile ◽  
Prior Chemotherapy ◽  
Line Setting

7590 Background: Pemetrexed (Pem) 500 mg/m2 (Pem 500) is currently the standard treatment for pts with locally advanced or metastatic NSCLC who had prior chemotherapy. In a recent Japanese phase I study with full vitamin supplementation, 1,000 mg/m2 was determined as the recommended dose. This study was to determine if Pem 1,000 mg/m2 (Pem 1,000) could lead to a better treatment outcome with an acceptable toxicity profile compared with Pem 500 in pts with NSCLC in a 2nd or 3rd line setting. Methods: Pts with PS 0–2, measurable, Stage III/IV NSCLC, who had previously received 1 or 2 chemotherapy regimens, were randomized to receive either Pem 500 or Pem 1,000 on day 1 of a 21-day cycle. The primary endpoint was overall response rate (ORR) based on the RECIST. Secondary endpoints included progression-free survival (PFS), duration of response (DR) and toxicity profile. The planned total sample size for the study was 214 pts. Results: From October 2004 to March 2006, 244 pts were enrolled at 28 centers, 226 pts were randomized and treated, and 216 pts were evaluable for efficacy. Baseline patient characteristics (Pem 500/Pem 1,000: 108/108) were: Males 63%/64%; median age 62/62 years (total range: 26–74); PS 0–1 94%/94%; Stage IV 81%/80%. The median number of treatment cycles completed on both arms was 3 (range 1–20+ for Pem 500 and 1–15+ for Pem 1,000). 11% of the Pem 500 pts and 6% of the Pem 1,000 pts completed at least 10 cycles. ORRs were 18.5% (90% CI: 12.6%-25.8%) for Pem 500 and 14.8% (90% CI: 9.5%- 21.6%) for Pem 1,000, and the respective disease control (PR+SD) rates were 55.6% and 46.3%. Median PFS with Pem 500 and Pem 1,000 was 3.0 and 2.4 months and median DR was 4.7 and 3.8 months, respectively. Grade 4 toxicities observed in more than 1% of pts were neutropenia (3.5% with Pem 500, 3.6% with Pem 1,000) and decreased lymphocyte count (2.6%, 1.8%). One drug related death for interstitial lung disease was reported with Pem 500. Conclusions: Pem 1,000 as well as Pem 500 showed remarkable efficacy outcomes with tolerable toxicity. Since Pem 1,000 showed treatment outcomes similar to Pem 500, this study supports the use of Pem 500 for Japanese pts with NSCLC in a 2nd or 3rd line setting. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document