TP1 REAL-WORLD TREATMENT PATTERNS AMONG PATIENTS WITH METASTATIC UROTHELIAL CANCER RECEIVING SECOND-LINE THERAPY IN THE US VETERAN POPULATION

e16058 Background: Metastatic urothelial cancer progressing on or after first-line platinum-based chemotherapy is incurable and has a very poor prognosis. There is no standard second-line therapy, but the taxanes including paclitaxel, have previously shown activity. Abraxane (ABI-007) is a novel well tolerated albumin-bound nanoparticle formulation of paclitaxel. The goal of this study was to determine the efficacy and tolerability of single agent Abraxane in the second-line metastatic urothelial cancer setting. Methods: Patients with measureable metastatic urothelial cancer, who progressed on or after first-line cisplatin based chemotherapy were enrolled onto this phase II, two-stage multicenter trial. Patients received Abraxane 260 mg/m2 intravenously every 3 weeks. Clinical evaluation, CBC and blood chemistries were performed every cycle and restaging CT scans every 2 cycles. Results: Fourteen patients have been enrolled to date. Patient demographics: M: F 12:2; mean age 64 (range 45–80); ECOG 0:1:2 4:5:5. A total of 57 cycles, avg 4 cycles/ patient (range 1–9) have been administered. There were three dose delays due to neuropathy, pain, and low neutrophil count respectively. There were two dose reductions due to fatigue and neuropathy. Most frequent adverse events (AE) were fatigue, alopecia, anorexia, cough and joint pain; the most frequent grade 3+ AE were fatigue, joint pain, hypertension, joint stiffness and back pain. Fourteen patients are currently evaluable for best response using RECIST criteria. There have been 5 partial responses (PR), 5 stable disease (SD) and 4 progressive disease (PD). Conclusions: Single agent Abraxane was well tolerated in the 2nd line, cisplatin refractory/resistant metastatic urothelial cancer setting. Preliminary efficacy results are encouraging with a clinical benefit rate of 71% (10 out of 14 evaluable pts having either SD or PR). Stage 1 response criteria have been met and accrual is ongoing to a total of 48 patients. No significant financial relationships to disclose.

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Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Blood ◽

10.1182/blood.v126.23.2125.2125 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2125-2125

Author(s):

Sudeep Karve ◽

Victoria Divino ◽

Andrew Gaughan ◽

Mitch DeKoven ◽

Guozhi Gao ◽

...

Keyword(s):

Health Plan ◽

Real World ◽

Index Date ◽

Treatment Patterns ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

First Line Therapy ◽

Line Therapy

Abstract Background and Objective : Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database. Methods : This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature. Results : The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy. Conclusion : The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. Disclosures Karve: AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

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Real-world survival and treatment patterns of patients with locally advanced or metastatic urothelial carcinoma treated with second-line therapy after platinum-based chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.466 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 466-466

Author(s):

Jason C Simeone ◽

Beth L Nordstrom ◽

Ketan Patel ◽

Alyssa B Klein ◽

Laura Horne

Keyword(s):

Overall Survival ◽

Real World ◽

Median Overall Survival ◽

Locally Advanced ◽

Treatment Patterns ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy ◽

Platinum Based Chemotherapy ◽

Metastatic Urothelial Carcinoma

466 Background: Median overall survival for patients with locally advanced/metastatic urothelial carcinoma (UC) who fail standard platinum-containing chemotherapy is 5–7 months, and there is no current standard of care for these patients. As immuno-oncology (IO) therapies are being developed for the treatment of UC, including some recent approvals, a better understanding of the current real-world treatment patterns and effectiveness of treatments is needed. Methods: Patients with locally advanced/metastatic UC receiving second-line therapy after platinum-based chemotherapy were identified from the Flatiron Oncology electronic medical record database from 2011–2016. Treatment patterns, including the most common regimens and total number of systemic therapy treatment lines, were characterized. Median overall survival (OS) and associated 95% confidence intervals (CI) were calculated from the start of second-line therapy using Kaplan-Meier curves. Results: A total of 476 patients met all study criteria; mean age was 70.1 ± 9.2 years and 74.2% were male; <3% were tested for PD-L1 during follow-up. Platinum-based chemotherapies were most commonly prescribed (Table 1), 4.4% received IO during second-line. Median OS from start of second-line therapy was 8.3 months (95% CI: 7.2–8.9). Conclusions: Real-world OS among locally advanced/metastatic UC patients who received second-line therapy after platinum-based chemotherapy was less than one year, similar to prior estimates. It remains to be seen how the introduction and increasing uptake of IO may affect OS. [Table: see text]

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Real-world treatment patterns, healthcare resource use and clinical outcomes of patients receiving second line therapy for advanced or metastatic gastric cancer

BMC Gastroenterology ◽

10.1186/s12876-020-01232-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

David Gómez-Ulloa ◽

Mayur Amonkar ◽

Smita Kothari ◽

Winson Y. Cheung ◽

Ian Chau ◽

...

Keyword(s):

Gastric Cancer ◽

Resource Use ◽

Real World ◽

Healthcare Resource ◽

Metastatic Gastric Cancer ◽

Treatment Patterns ◽

Second Line ◽

Healthcare Resource Use ◽

Second Line Therapy ◽

Line Therapy

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Depatuxizumab Mafodotin (Depatux-M) Plus Temozolomide in Recurrent Glioblastoma Patients: Real-World Experience from a Multicenter Study of Italian Association of Neuro-Oncology (AINO)

Cancers ◽

10.3390/cancers13112773 ◽

2021 ◽

Vol 13 (11) ◽

pp. 2773

Author(s):

Marta Padovan ◽

Marica Eoli ◽

Alessia Pellerino ◽

Simona Rizzato ◽

Claudia Caserta ◽

...

Keyword(s):

Real World ◽

Recurrent Glioblastoma ◽

Second Line ◽

Ocular Toxicity ◽

Phase 2 ◽

Second Line Therapy ◽

Italian Association ◽

Phase 2 Trial ◽

Line Therapy ◽

Ecog Ps

Background: Depatuxizumab Mafodotin (Depatux-M; ABT-414) is an antibody-drug conjugate consisting of a specific antibody against activated EGFR and a cytotoxic agent with antimicrotubule activity. The INTELLANCE 2/EORTC 1410 phase 2 trial produced interesting results for the combination regimen of Depatux-M and temozolomide in EGFR-amplified glioblastoma patients at first recurrence. For the first time worldwide, our work investigated the clinical outcome and safety of this combination in a real-life population. Materials and Methods: Patients were enrolled from seven AINO (Italian Association of Neuro-Oncology) Institutions. The major inclusion criteria were: histologically confirmed diagnosis of glioblastoma, EGFR-amplified, one or more prior systemic therapies and ECOG PS ≤ 2. According to the original schedule, patients received Depatux-M 1.25 mg/kg every 2 weeks combined with temozolomide. The primary endpoints of the study were overall survival and safety. Results: A total of 36 patients were enrolled. The median age was 57 years, ECOG PS was 0–1 in 28 patients (88%), MGMT methylated status was found in 22 (64%), 15 patients (42%) received the combined treatment as second-line therapy. The median OS was 8.04 months (95% CI, 5.3–10.7), the 12 month-OS was 37%. On univariate and multivariate analyses, the MGMT methylation status was the only factor resulting significantly associated with survival. Grade 3 ocular toxicity occurred in 11% of patients; no grade 4 ocular toxicity was reported. No death was considered to be drug-related. Conclusions: The study reported the first “real world” experience of Depatux-M plus temozolomide in recurrent glioblastoma patients. Encouraging clinical benefits were demonstrated, even though most patients were treated beyond second-line therapy. Overall, the results are close to those reported in the previous phase 2 trial. Toxicity was moderate and manageable.

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