Preliminary single-dose clinical pharmacokinetics of an anti–PD-L1 Probody therapeutic (Pb-Tx) in cancer patients.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e14558-e14558
Author(s):  
Mark Stroh ◽  
Laura Serwer ◽  
Hong Lu ◽  
Vanessa Huels ◽  
Chihunt Wong ◽  
...  
Keyword(s):  
Single Dose ◽  
Cancer Patients ◽  
Clinical Pharmacokinetics

scholarly journals Changes in peripheral immune cells after intraoperative radiation therapy in low-risk breast cancer

2020 ◽  
Vol 62 (1) ◽  
pp. 110-118
Author(s):  
Isabel Linares-Galiana ◽  
Miguel Angel Berenguer-Frances ◽  
Rut Cañas-Cortés ◽  
Monica Pujol-Canadell ◽  
Silvia Comas-Antón ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Single Dose ◽  
Cancer Patients ◽  
Antitumor Immunity ◽  
Low Risk ◽  
Intraoperative Radiation Therapy ◽  
Breast Cancer Patients ◽  
Intraoperative Radiation ◽  
Risk Breast Cancer

Abstract A detailed understanding of the interactions and the best dose-fractionation scheme of radiation to maximize antitumor immunity have not been fully established. In this study, the effect on the host immune system of a single dose of 20 Gy through intraoperative radiation therapy (IORT) on the surgical bed in low-risk breast cancer patients undergoing conserving breast cancer has been assessed. Peripheral blood samples from 13 patients were collected preoperatively and at 48 h and 3 and 10 weeks after the administration of radiation. We performed a flow cytometry analysis for lymphocyte subpopulations, natural killer cells (NK), regulatory T cells (Treg) and myeloid-derived suppressor cells (MDSCs). We observed that the subpopulation of NK CD56+high CD16+ increased significantly at 3 weeks after IORT (0.30–0.42%, P < 0.001), while no changes were found in immunosuppressive profile, CD4+CD25+Foxp3+Helios+ Treg cells, granulocytic MDSCs (G-MDSCs) and monocytic MDSCs (Mo-MDSCs). A single dose of IORT may be an effective approach to improve antitumor immunity based on the increase in NK cells and the non-stimulation of immunosuppressive cells involved in immune escape. These findings support future combinations of IORT with immunotherapy, if they are confirmed in a large cohort of breast cancer patients.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

scholarly journals PO-0740: MR-guided single dose pre-operative radiotherapy in low-risk breast cancer patients: first results

2018 ◽  
Vol 127 ◽  
pp. S379-S380
Author(s):  
J. Vasmel ◽  
R. Charaghvandi ◽  
A. Houw eling ◽  
M. Philippens ◽  
W. Veldhuis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Single Dose ◽  
Cancer Patients ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
First Results ◽  
Risk Breast Cancer

Pharmacokinetics, Single-Dose Tolerance, and Biological Activity of Recombinant Gamma-Interferon in Cancer Patients

Oncology ◽  
1985 ◽  
Vol 42 (1) ◽  
pp. 41-50 ◽  
Author(s):  
Razelle Kurzrock ◽  
Michael G. Rosenblum ◽  
Stephen A. Sherwin ◽  
Adan Rios ◽  
Moshe Talpaz ◽  
...  
Keyword(s):  
Biological Activity ◽  
Single Dose ◽  
Cancer Patients ◽  
Gamma Interferon ◽  
Dose Tolerance

Trends in the use of bone agents in metastatic cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20672-e20672
Author(s):  
Jurgen Wilhelm Kogler ◽  
William J. Hrushesky ◽  
Dinah Huff ◽  
Laura Rose Bobolts ◽  
Akhil Kumar ◽  
...  
Keyword(s):  
Single Dose ◽  
Zoledronic Acid ◽  
Linear Regression ◽  
Cancer Patients ◽  
Metastatic Cancer ◽  
Chi Square ◽  
Frequency Of Use ◽  
Skeletal Related Events ◽  
Care Costs ◽  
Over Time

e20672 Background: Bone modifying agents have been shown to delay and/or prevent skeletal-related events for a range of cancers metastatic to the bone. Various studies have identified pamidronate, zoledronic acid, and denosumab as bone modifying agents, each of which confers clinical benefit. The convenience of administration and costs of these agents differ greatly. Administration spans vary from roughly 2 hours for IV pamidronate, 15 minutes for IV zoledronic acid, and minimal time for subcutaneous denosumab. The estimated cost for a single dose of pamidronate, zoledronic acid, and denosumab are $29, $890, and $1,712, respectively. Methods: All requests for pamidronate, zoledronic acid, and denosumab authorization submitted by practicing oncologists within southeast Florida were tabulated for 2010, 2011, and 2012. Comparisons for both frequency of use and cost over time were made using ANOVA and Chi Square; p<0.05 for significance. Trends were assessed by linear regression. Results: 895 requests for pamidronate, zoledronic acid, or denosumab were examined over this three year span. The use of bone modifying agents for metastatic cancer is increasing rapidly, as treatment request totaled 171, 269, and 455 for all three agents, pamidronate, zoledronic acid, or denosumab, in 2010, 2011, and 2012, respectively. Zoledronic acid requests significantly increased (p<0.001) per year between 2010 and 2011, as with 2011 and 2012. Denosumab requests are also increasing steadily and sharply in 2012. Conclusions: Each of these three agents has demonstrated clear efficacy in delaying or preventing second skeletal events among patients with metastatic cancer already involving bone. Toxicities among these three agents are comparable in the vast majority of eligible cancer patients. Relative costs should be carefully considered when choosing which agent to use as the use of these agents in general is increasing rapidly and will have a major impact upon overall cancer care costs. [Table: see text]

The 2-13C-5-fluorouracil breath test (FUBT) as a novel, rapid method for assessment of dihydropyrimidine dehydrogenase (DPD) activity in cancer patients: Initial characterization and comparison to the 2-13C-uracil breath test (UraBT)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2551-2551
Author(s):  
J. Fourie ◽  
L. K. Mattison ◽  
T. E. Wood ◽  
J. A. Posey ◽  
A. Modak ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Single Dose ◽  
Oral Dose ◽  
Cancer Patients ◽  
Drug Administration ◽  
Breath Test ◽  
Dihydropyrimidine Dehydrogenase ◽  
Metabolite Formation ◽  
Colorectal Cancer Patients ◽  
Further Development

2551 Background: The UraBT is currently in development as a phenotypic test to screen for DPD deficiency. Following an oral dose of 2-13C-uracil, the UraBT shows a significant relationship between breath 13CO2 metabolite formation and plasma 2-13C-uracil and 2-13C-dihydrouracil pharmacokinetics. We herein describe a novel, potentially more clinically relevant test in which a small oral dose of 2-13C-5-fluorouracil (5-FU) is administered, followed by assessment of breath 13CO2 metabolite formation as previously described for the UraBT. We hypothesize that the FUBT can rapidly assess interindividual variability in 5-FU catabolism and predisposition to 5-FU toxicity. Methods: Over two sessions separated by a seven day washout, a single dose (6mg/kg, p.o.) of 2-13C-uracil or 2-13C-5-FU was administered to patients with stage III-IV colorectal cancer (n = 4). Subsequent to drug administration, in each session, 13CO2 catabolite formation was quantified in the breath over eight hours. In a separate investigation over two sessions separated by a seven day washout, a single dose (3mg/kg, p.o.) of 2-13C-uracil or 213C-5-FU was administered to colorectal cancer patients with previously documented severe (n=2) or moderate (n=2) 5-FU dose-related hematological/gastrointestinal toxicity. Following drug administration 13CO2 catabolite formation was quantified over eight hours. 13CO2 concentration was expressed as Delta Over Baseline (DOB) in all sessions. Results: Compared to the UraBT, the FUBT showed an increased Cmax (50.7 ± 6.6 DOB/mg vs. 36.8 ± 7.8 DOB/mg; mean ± SD) and decreased Tmax (25 ± 4 min vs. 45 ± 6 min) for 13CO2 formation (p<0.05). The FUBT was able to distinguish patients with previously reported severe and moderate 5- FU toxicity, with 13CO2 Cmax values of 35.5 ± 9.5 DOB/mg (mean ± SD) and 59.8 ± 7.3 DOB/mg, respectively. Importantly, FUBT Cmax values positively correlated with DPD activity (rs=1.00, p<0.01). Conclusions: These data lend support to further development of the FUBT as a rapid and informative test to assess DPD activity and to predict susceptibility to severe dose-related 5-FU toxicity. [CA116964] No significant financial relationships to disclose.

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