Compassionate use program with FDT-TPI (trifluridine-tipiracil) in pre-treated metastatic colorectal cancer patients: Spanish real world data.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15019-e15019 ◽  
Author(s):  
Pilar Garcia-Alfonso ◽  
Ana Ruiz ◽  
Alfredo Carrato ◽  
Jose M Vieitez ◽  
Cristina Gravalos ◽  
...  
Keyword(s):  
Real World ◽  
Compassionate Use ◽  
Real World Data ◽  
Disease Treatment ◽  
World Data ◽  
Medical Needs ◽  
Grade 3 ◽  
Colorectal Cancer Patients ◽  
Ecog Ps ◽  
To Receive

e15019 Background: Trifluridine/tipiracil (FTD-TPI) is comprised of an antineoplastic nucleoside analog, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil. Compassionate use programs (CUPs) provide a treatment option for patients with unmet medical needs and an early opportunity to obtain data on efficacy, safety and use in a real-world setting. Methods: Patients were registered and approved to receive 2 cycles of trifluridine/tipiracil treatment, which could be renewed as necessary, we analysed baseline characteristics, safety results and exposure to the treatment with trifluridine/tipiracil (FTD-TPI) in the Spanish CUP. Results: A total 636 were registered in Spain and 538 received treatment with trifluridine/tipiracil. Median age was 64 years, of which 25% were older than 70 years old and 60% were male, 67% of pts were ECOG PS 1. Oral trifluridine/tipiracil was initiated at 35 mg/m2 bid. Most pts had received 2, 3, or ≥4 lines of prior treatment for metastatic disease (27%, 28%, and 38%, respectively); and 4% unknown. 275 (47%) patients had KRAS mutated and 209 (36%) had KRAS wild type. 35% received adjuvant chemotherapy and 20% of the patients were treated with regorafenib in previous lines. The main reasons for not initiating treatment included cancellation of request due to worsening condition and progressive disease. Treatment was generally well tolerated. A total of 173 AEs were reported in the Spanish CUP, the majority were myelosuppressive AEs; febrile neutropenia (grade ≥3) was reported in 6 pts (1.3%), grade _ > 3 neutropenia was reported in 56 (33%), grade 4 neutropenia in 16 (9%). Grade 3 anemia was reported in 8 (15% of the total AEs reported).The majority of pts 306 (56%) were allocated 3-4 cycle of treatment, 95(17.3%) 5-6 cycles, and 30(5. 5%) between 7-8 cycles. Conclusions: Thisreal-world data analysis is consistent with those reported in phase 3 trials of trifluridine/tipiracil (FDT-TP)in pretreated mCRC. The efficacy analyses of this population is planned.

Value of cabozantinib in the treatment of advanced metastatic clear cell renal cell carcinoma (ccRCC): Real-world data from a single Korean institution.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16578-e16578
Author(s):  
Seoyoung Lee ◽  
Seul-Gi Kim ◽  
Sejung Park ◽  
Jeehyun Lee ◽  
Seung-Hoon Beom ◽  
...  
Keyword(s):  
Real World ◽  
Response Rate ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Cancer Center ◽  
Second Line ◽  
Real World Data ◽  
World Data ◽  
Third Line ◽  
Grade 3

e16578 Background: Cabozantinib is a multitarget tyrosine kinase inhibitor and getting attention in these days through its combination with immune checkpoint inhibitors. In this article, we analyze the efficacy of cabozantinib in patients with metastatic ccRCC in Korean who had progression after 1 or more VEGFR TKI therapies. Methods: Seventy-five patients from Jan.2019 to Dec. 2021 at Yonsei Cancer Center who had received cabozantinib treatment in second to fourth line of therapy were retrospectively reviewed. The primary endpoint was PFS. The secondary outcomes were the response rate, disease control rate (DCR), and OS. The evaluable subjects for efficacy were those who had at least one response evaluation. Results: Among 75 patients, 57 (76.0%) were male and median age was 59 years (range 33-81). Median follow up time was 12.1 months. There were 22 (29.3%) patients of second line, 38 (50.7%) of third line and 15 (20.0%) of fourth line of treatment. Median PFS was 5.6 months (95% CI, 4.6-6.6). Median OS was 13.6 months (95% CI, 5.0-22.2). The PFS based on the line of treatment was 4.7 months for second line, 5.6 months for third line and 12.0 months for 4th line. Proportion of patients who were previously treated with ICI was different between treatment line groups and showed increasing trend toward later line; 13.6% of second line, 31.6% of third line, and 66.7% of fourth line, respectively. The objective response rate was 8.0% with 6 patients of partial response. The DCR was 69.3%. The major toxicities were similar with the western population and most of them were less than CTCAE grade 3. Most common grade 3 or 4 AEs were anemia, hand-foot syndrome, fatigue, and stomatitis. There were no grade 5 AEs. Conclusions: Our results demonstrate that cabozantinib is an effective treatment option after first line TKI in Korean ccRCC patients with manageable toxicities. Notably, its tolerability in the advanced line of treatment and synergy with ICIs are suggested in this study despite heterogeneous patients of real world setting. This is the first real world data with cabozantinib in Asian patients.

scholarly journals Establishment of inflammation biomarkers-based nomograms to predict prognosis of advanced colorectal cancer patients based on real world data

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208547 ◽  
Author(s):  
Guifang Guo ◽  
Xiuxing Chen ◽  
Wenzhuo He ◽  
Haohua Wang ◽  
Yixing Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Advanced Colorectal Cancer ◽  
Real World Data ◽  
World Data ◽  
Colorectal Cancer Patients

scholarly journals P1.01-07 Real World Data of Docetaxel Plus Nintedanib for Pretreated NSCLC Patients: 4 Yrs Update Compassionate Use Program Single Institution in Mexico

2019 ◽  
Vol 14 (10) ◽  
pp. S357
Author(s):  
S. Campos-Gomez ◽  
K. Campos-Gomez ◽  
J.J. Valdéz-Andrade ◽  
J. Esquivel Gutierrez
Keyword(s):  
Real World ◽  
Compassionate Use ◽  
Single Institution ◽  
Real World Data ◽  
World Data ◽  
Nsclc Patients

Real-world incidence, duration, and severity of treatment-emergent (TE) neutropenia among patients (pts) with metastatic breast cancer (MBC) treated with ribociclib (RIB) or palbociclib (PAL).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13048-e13048
Author(s):  
Lee S. Schwartzberg ◽  
Juan Pablo Zarate ◽  
David Chandiwana ◽  
Chu-Ling Yu ◽  
Sanjeev Balu ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Real World ◽  
Rate Ratio ◽  
Small Sample ◽  
Administrative Claims ◽  
Health Record ◽  
Real World Data ◽  
World Data ◽  
Electronic Health ◽  
Grade 3

e13048 Background: Neutropenia is the most common adverse event following administration of CDK4/6 inhibitors RIB and PAL for hormone receptor–positive (HR+) MBC. There are limited comparative real-world data on TE neutropenia in pts receiving these agents. Here we report incidence, duration, and severity data on TE neutropenia in such pts from an electronic health record dataset and administrative claims. Methods: This retrospective study comprised 2 mutually exclusive cohorts of pts with MBC receiving RIB or PAL. Pts were matched 1:1 based on age and year of treatment start. Prior baseline activity of ≥6 mo was required. The MarketScan claims databases was used to evaluate incidence rates of TE neutropenia from Jan 1, 2015, to Dec 31, 2018, in pts receiving RIB or PAL. Rate ratio was calculated using a Poisson model. Data on neutropenia severity and duration were obtained from Optum de-identified Electronic Health Record dataset. Neutropenia severity was defined by neutrophil counts from lab tests (grade 1/2, 1000- < 1500/μL; grade 3, 500- < 1000/μL; grade 4 < 500/μL) within the first 180 days of treatment. Neutropenia duration was estimated using Kaplan-Meier analysis and defined as the time between first abnormal neutrophil result and a lab result demonstrating neutropenia resolution. Results: After 1:1 matching, 152 pts from the MarketScan database were included in both the PAL and RIB cohorts; 168 matched pts were included from the Optum dataset. Neutropenia was reported in 38 pts (25%) in the PAL group and 25 pts (17%) in the RIB group. The rate of neutropenia per person–treatment year was 0.5 (95% CI, 0.4-0.7) in PAL pts vs 0.4 (95% CI, 0.3-0.6) in RIB pts. The rate ratio of neutropenia between treatments (PAL vs RIB) was 1.4 (95% CI, 0.8-2.3), which was not statistically significant, likely due to small sample size. Rates of neutropenia by severity with PAL vs RIB were 32% vs 32% for grade 1/2, 35% vs 26% for grade 3, and 4% vs 4% for grade 4, respectively. The rate ratio for grade 3 or grade 4 neutropenia (PAL vs RIB) was 1.3 (95% CI, 0.9-1.8). Median neutropenia duration was 29 vs 20 days ( P< .01) with PAL vs RIB. Conclusions: Treatment of HR+ MBC with RIB and PAL requires optimal management of TE neutropenia. Real-world data showed that pts with MBC receiving PAL had a numerically higher rate of neutropenia than pts receiving RIB. Rates of grade 3 neutropenia were higher with PAL vs RIB, and duration of neutropenia was longer with PAL vs RIB. Economic burden analyses of neutropenia will be presented.

scholarly journals Facilitated Subcutaneous Immunoglobulin (fSCIG) Administration in Secondary Immune Deficiency (SID) Due to Hematological Malignancies. Efficacy and Safety Real-World Data from a Single-Center in Greece

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3429-3429 ◽  
Author(s):  
Maria Dimou ◽  
Vasileios Pardalis ◽  
Theodoros Iliakis ◽  
Aikaterini Bitsani ◽  
Ioannis Grafakos ◽  
...  
Keyword(s):  
Immune Deficiency ◽  
Respiratory Tract ◽  
Real World ◽  
Hematological Malignancies ◽  
Subcutaneous Immunoglobulin ◽  
Single Center ◽  
Real World Data ◽  
World Data ◽  
Grade 3

Intoduction Hematological malignancies are often complicated by secondary immunodeficiency (SID), namely hypogammaglobulinemia, the cause of common and opportunistic infections, which represent the major morbidity aitiology for hematological patients (pts)(Friman V, et al. Hematol Oncol 34: 121-132, 2016). Immunoglobulin replacement with intravenous gamma globulin (IVIg) reduces the number of infections, antibiotics' need and hospitalization days (Raanani P, et al. Leuk Lymphoma 50(5): 764-772, 2009). The subcutaneous (sc) route of IgG although equally effective, presents certain constraints (reduced bioavailability, multiple injection sites, and frequent infusions). The facilitated subcutaneous immunoglobulin (fSCIg) method exploits the pharmacologic properties of recombinant human hyaluronidase (rHuPH20) and has been studied in primary immune deficiency (PID) syndromes with similar efficacy to IVIG (Wasserman RL. Immunotherapy 6(5): 553-567, 2014). fSCIg has demonstrated several advantages; self-administration, same bioavailability, long infusion intervals, few adverse drug reactions-ADRs. However, fSCIg has been less extensively studied in SID. Aim We present our single-center real-world data from fSCIg administration in hematological pts with SID, focusing on safety and efficacy issues. Patients and Methods Since 14-Oct- 2015 fSCIg has been used as the primary immunoglobulin reconstitution treatment (IgRT) in our department for hematological pts fulfilling the ESMO 2015 guidelines (Eichhorst B, et al. Ann Oncol 26(5): v78-v84, 2015): hypogammaglobulinemia with recurrent bacterial infections. No PSAF (proven specific antibody failure) is performed before IgRT initiation. Treatment goal is IgG trough levels around 600 mg/dL. The fSCIg(10% IgG) dosage is 0.4-0.8 g/Kg/month. Treatment modifications are made according to infection occurrence. fSCIg is administered with a variable rate portable pump and a sc 24G needle . First, pts receive rHuPH20 (1-2 ml/min). Ten min after rHuPH20, fSCIg(10%) is infused through the same sc needle, at the same injection site. The rate of the 1st fSCIg infusion is gradually increased from 10ml/h to 300 ml/h. If well tolerated, pts are treated with the final rate of 300 ml/h for subsequent infusions. The first 5 infusions take place at our department and the pts/relatives are instructed how to use the pump. The subsequent infusions take place outside hospital facilities. IgRT is given indefinitely to this pt population. Results Between mid-October 2015 and mid-July 2019, 45 hematological pts have been treated with fSCIg(10%) at our department according to ESMO 2015 guidelines. Baseline pts' characteristics are shown in table 1. Nine hundred sixty-two (962) infusions were administered, with median number of infusions per pt 19(3-48), median time on treatment 23.5 months(1-44.8) and median follow up 23.9 months (1.4-44.8). Thirty-nine (39) pts (86.7%) were able either to self-administer the formulation or to be treated by the aid of a relative after the 5th training session. More than 700 infusions were performed outside hospital's facilities. Thirty-nine (39) pts (86.7%) had no adverse drug reaction- ADR-, except mild edema at the site of injection for 8-24 hours after the infusion. Six patients (13.3 %) presented at least one type of ADR (table 2). In 11 pts (24.4%) at least 1 infection episode was noticed. All cases were grade 2, except an appendicitis case (grade 3) that it was surgically managed. There were 4 cases of upper respiratory tract infection, 3 cases with lower respiratory tract infections, 2 dermal infections and 1 viral gastroenteritis. fSCIg dose modification was done in 3 pts. During the follow up period 37 pts (82.2%) are ongoing and 8 pts (17.8%) have discontinued fSCIg: 6 due to death from underlying malignancy and 2 (4.4%) due to ADRs (1 with grade 3 rash and 1 with grade 3 fever and rigor). Surprisingly, there was no death from infectious complication. Conclusions Our single-center real-world data from fSCIg administration in hematological patients with hypogammaglobulinemia and recurrent infections shows that this method is very effective in reducing infections, with few ADRs. These findings compare favorably to those observed with IVIg (Raanani P, et al. Leuk Lymphoma 50(5): 764-772, 2009). Finally, fSCIg reduces the nursing staff workload in hematology wards and is preferred by the vast majority of the patients. Disclosures Panayiotidis: Bayer: Other: Support of clinical trial.

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