Real world treatment patterns of gastrointestinal stromal tumor patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15602-e15602
Author(s):  
J. A. Morgan ◽  
A. Guo ◽  
D. Williams ◽  
A. Guérin ◽  
D. Latremouille-Viau ◽  
...  
Keyword(s):  
Gastrointestinal Stromal Tumor ◽  
Dose Escalation ◽  
Real World ◽  
Kinase Inhibitor ◽  
Treatment Patterns ◽  
Stromal Tumor ◽  
Data Availability ◽  
Dose Increase ◽  
First Line ◽  
Long Term Treatment

e15602 Background: Imatinib is accepted as the standard first-line therapy to treat gastrointestinal stromal tumor (GIST) in patients with unresectable or metastatic disease. In the case of disease progression, physicians may consider increasing imatinib dose or switching to another second-line agent, such as sunitinib. The aim of this study was to analyze the real-world long term treatment patterns of GIST patients. Methods: Two large claims databases from 01/1999 to 03/2008 were combined (MarketScan and Ingenix Impact) to extract patients diagnosed with GIST who initiated on imatinib ≥400 mg/day. Patients were followed from the first observed imatinib prescription to the end of data availability. Patients who dose increased during the study period were defined as dose escalators, while patients who later switched to sunitinib with or without dose escalation were defined as switchers. Kaplan Meier analyses were used to estimate the rate of treatment changes over time including imatinib discontinuation, defined as a lack of imatinib supply for ≥60 days, and switching back to initial treatment. Results: Among the 1,508 GIST patients who initiated on imatinib, 253 patients had a dose increase and 153 patients switched to sunitinib during the study period. 20.1% patients on imatinib discontinued by the end of the first year, and 43.0% discontinued by the end of the third year. Among the 153 switchers, 61 patients had a dose escalation prior to the switch, of which 82.0% reached 800 mg before switching. Among all the switchers, 20.3% switched back to imatinib within 6 months. Conclusions: These claims-based findings on the duration of first-line imatinib therapy of GIST patients supports data on imatinib efficacy in treating GIST from formal clinical research studies. Most of GIST patients who initiated imatinib continued on this therapy without undergoing dose increase or switch to sunitinib. Among switchers, most did not dose escalate before switching and many eventually switched back to imatinib. It appears that physicians tend to not always follow clinical practice guidelines developed based on expert consensus, with respect to decision rules for dose escalation, or for the appropriate time to change kinase inhibitor therapy. [Table: see text]

Treatment patterns of chronic myelogenous leukemia patients with suboptimal responses to imatinib

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7090-7090
Author(s):  
A. Guérin ◽  
A. Guo ◽  
D. Williams ◽  
A. P. Yu ◽  
E. Wu ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Dose Escalation ◽  
Real World ◽  
Philadelphia Chromosome ◽  
Treatment Patterns ◽  
Data Availability ◽  
Myelogenous Leukemia ◽  
Administrative Claims ◽  
Dose Increase ◽  
The Real

7090 Background: Imatinib is the first-line therapy for Philadelphia chromosome-positive chronic myelogenous leukemia (CML). Patients with suboptimal responses may have the dose of imatinib escalated or may be switched to an alternative kinase inhibitor such as dasatinib. The aim of this study is to examine the real-world treatment patterns of imatinib and dasatinib in CML patients. Methods: Two large U.S. administrative claims databases from January 1999 to March 2008 were combined (MarketScan and Ingenix Impact) to extract de-identified information of patients diagnosed with CML (ICD-9 code: 205.1) who were initiated on imatinib. Patients were followed from the first observed imatinib prescription to the end of data availability. Patients who increased imatinib dose to >400 mg/day were defined as dose escalators, while patients who initiated on imatinib and further switched to dasatinib were considered as switchers. Rates of imatinib dose escalation and switching to dasatinib were estimated. Kaplan-Meier (KM) survival analyses were used to estimate the rate of imatinib discontinuation, defined as a lack of imatinib supply for at least 90 days. Among switchers, the rate of switching back to imatinib was also estimated using KM survival analysis. Results: Among the 5,159 CML patients initiated with imatinib, 1,144 patients either had dose escalation of imatinib (839) or were switched to dasatinib (305) during the study period. Of the 5,159 patients, 12.1% patients discontinued imatinib by the end of the first year, and 25.4% discontinued by the end of the third year. Among the 305 switchers, 115 (37.7%) had an imatinib dose increase prior to the switch, and 66 (21.6%) were escalated to 800 mg of imatinib before switching. 51 patients (16.7%) had used imatinib for <6 months before switching, and 17.1% switched back to imatinib within 6 months of dasatinib treatment. Conclusions: This study showed that great variability was observed in the real world treatment pattern of CML patients. Most CML patients who initiated on imatinib did not dose increase or switch during the study period. Of those who switched to dasatinib, most did not attempt to increase the dose before switching, and a sizeable portion of patients had to switch back to imatinib. [Table: see text]

Targeted therapy in gastrointestinal stromal tumor (GIST): A nationwide database analysis from Taiwan.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 437-437
Author(s):  
I-Jen Chiang ◽  
Wen-Yi Shau ◽  
Wei-Tse Fang ◽  
Chi-Hui Fang ◽  
Yen-Yang Chen
Keyword(s):  
Targeted Therapy ◽  
Gastrointestinal Stromal Tumor ◽  
Dose Escalation ◽  
Targeted Therapies ◽  
Standard Dose ◽  
Stromal Tumor ◽  
Treatment Modalities ◽  
Research Database ◽  
Line Treatment ◽  
First Line

437 Background: Gastrointestinal stromal tumor (GIST) is a visceral sarcoma that arises from the gastrointestinal tract. Currently, imatinib (first-line) and sunitinib (second-line) are two reimbursed targeted therapies for GIST in Taiwan. This study aimed to evaluate the real world data of targeted therapies in GIST treatment among Taiwanese population. Methods: We conducted a nationwide retrospective cohort study based on data from the National Health Insurance Research Database (NHIRD) between January 2005 and December 2010. NHIRD is a comprehensive database of administrative and claim data which covers over 99% of entire population in Taiwan. Patients were selected with ICD codes and targeted therapy utilization, imatinib (IMA) or sunitinib (SUN). Time to treatment discontinuation (DC) due to any reasons (such as death, intolerance and disease progression) was estimated using Kaplan-Meier analysis. Results: From 2005 to 2010, the incidence rate of GIST in Taiwan was between 20 and 30 cases per million. A total of 3,436 GIST patients were identified; the mean age was 63.2 years and 57 % were male. Most patients (94.7%) received standard dose IMA (…400mg/day). Among these patients, 136 patients (4.0%) required IMA dose escalation and 44 (1.3%) patients switched to SUN after IMA. The probability of the 1st-line treatment DC was 20%, 30.7%, 38.9%, 43.2%, and 47.1% for years 1 to 5, respectively. The probability of a change in treatment pattern (defined as either IMA dose escalation or switch to SUN) was 4% 6.8%, 9.6%, 10.5% and 11.7% for years 1 to 5. Lastly, the probability of the 2nd-line treatment DC was 20.5%, 33.7%, 41.1%, 44.8%, 51.7% for years 1 to 5, respectively. Conclusions: First-line IMA plus other treatment modalities may provide additional benefits to progression-free survival. Taiwanese GIST patients who failed first-line treatment still gained benefit from either IMA dose escalation or a switch to SUN. Additional analysis is required for the detailed comparison in different treatment patterns.

scholarly journals Real World Treatment Patterns and Toxicity Among Elderly Patients with Multiple Myeloma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5571-5571
Author(s):  
Jesus D Gonzalez-Lugo ◽  
Ana Acuna-Villaorduna ◽  
Joshua Heisler ◽  
Niyati Goradia ◽  
Daniel Cole ◽  
...  
Keyword(s):  
Side Effects ◽  
Real World ◽  
Research Funding ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Event Free Survival ◽  
First Line ◽  
Treatment Change ◽  
Free Survival ◽  
First Line Treatment

Introduction: Multiple Myeloma (MM) is a disease of the elderly; with approximately two-thirds of cases diagnosed at ages older than 65 years. However, this population has been underrepresented in clinical trials. Hence, there are no evidence-based guidelines to select the most appropriate treatment that would balance effectiveness against risk for side effects in the real world. Currently, guidelines advise that doublet regimens should be considered for frail, elderly patients; but more detailed recommendations are lacking. This study aims to describe treatment patterns in older patients with MM and compare treatment response and side effects between doublet and triplet regimens. Methods: Patients diagnosed with MM at 70 years or older and treated at Montefiore Medical Center between 2000 and 2017 were identified using Clinical Looking Glass, an institutional software tool. Recipients of autologous stem cell transplant were excluded. We collected demographic data and calculated comorbidity burden based on the age-adjusted Charlson Comorbidity Index (CCI). Laboratory parameters included cell blood counts, renal function, serum-protein electrophoresis and free kappa/lambda ratio pre and post first-line treatment. Treatment was categorized into doublet [bortezomib/dexamethasone (VD) and lenalidomide/dexamethasone (RD)] or triplet regimens [lenalidomide/bortezomib/dexamethasone (RVD) and cyclophosphamide/bortezomib/dexamethasone (CyborD)]. Disease response was reported as VGPR, PR, SD or PD using pre-established criteria. Side effects included cytopenias, diarrhea, thrombosis and peripheral neuropathy. Clinical and laboratory data were obtained by manual chart review. Event-free survival was defined as time to treatment change, death or disease progression. Data were analyzed by treatment group using Stata 14.1 Results: A total of 97 patients were included, of whom 46 (47.4%) were males, 47 (48.5%) were Non-Hispanic Black and 23 (23.7%) were Hispanic. Median age at diagnosis was 77 years (range: 70-90). Median baseline hemoglobin was 9.4 (8.5-10.5) and 14 (16.1%) had grade 3/4 anemia. Baseline thrombocytopenia and neutropenia of any grade were less common (18.4% and 17.7%, respectively) and 11 patients (20%) had GFR ≤30. Treatment regimens included VD (51, 52.6%), CyborD (18, 18.6%), RD (15, 15.5%) and RVD (13, 13.4%). Overall, doublets were more commonly used than triplets (66, 68% vs 31, 32%). Baseline characteristics were similar among treatment regimen groups. There was no difference in treatment selection among patients with baseline anemia or baseline neutropenia; however, doublets were preferred for those with underlying thrombocytopenia compared to triplets (93.8% vs 6.2%, p<0.01). Median first-line treatment duration was 4.1 months and did not differ among treatment groups (3.9 vs. 4.3 months; p=0.88 for doublets and triplets, respectively). At least a partial response was achieved in 47 cases (63.5%) and it did not differ between doublets and triplets (61.7% vs 66.7%). In general, first line treatment was changed in 50 (51.5%) patients and the change frequency was higher for triplets than doublets (71% vs 42.4%, p<0.01). Among patients that changed treatment, 17(34.7%) switched from a doublet to a triplet; 15 (30.6%) from a triplet to a doublet and 17 (34.7%) changed the regimen remaining as doublet or triplet, respectively. There was no difference in frequency of cytopenias, diarrhea, thrombosis or peripheral neuropathy among groups. Median event-free survival was longer in patients receiving doublet vs. triplet therapy, although the difference was not statistically significant (7.3 vs 4.3 months; p=0.06). Conclusions: We show a real-world experience of an inner city, elderly MM cohort, ineligible for autologous transplantation. A doublet combination and specifically the VD regimen was the treatment of choice in the majority of cases. In this cohort, triplet regimens did not show better response rates and led to treatment change more often than doublets. Among patients requiring treatment, approximately a third switched from doublet to triplet or viceversa which suggest that current evaluation of patient frailty at diagnosis is suboptimal. Despite similar frequency of side effects among groups, there was a trend towards longer event-free survival in patients receiving doublets. Larger retrospective studies are needed to confirm these results. Disclosures Verma: Janssen: Research Funding; BMS: Research Funding; Stelexis: Equity Ownership, Honoraria; Acceleron: Honoraria; Celgene: Honoraria.

scholarly journals 630 Oncologists' perspectives on evolution of first-line immune checkpoint inhibitor maintenance therapy in management of advanced urothelial carcinoma in the US

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A660-A660
Author(s):  
Petros Grivas ◽  
Phani Veeranki ◽  
Kevin Chiu ◽  
Vivek Pawar ◽  
Jane Chang ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Control ◽  
Urothelial Carcinoma ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Treatment Patterns ◽  
First Line ◽  
Platinum Based Chemotherapy

BackgroundAvelumab, a PD-L1 immune checkpoint inhibitor (ICI), was recently approved as first-line (1L) maintenance therapy for locally advanced/unresectable or metastatic urothelial carcinoma (aUC) after disease control with platinum-based chemotherapy.1 Given the evolving treatment landscape, the study aim was to gain real-world insights into clinical decision-making among oncologists for patients with aUC.MethodsIn March 2021, a cross-sectional web-based survey was administered to a sample of US oncologists treating patients with aUC. Oncologists' demographics, practice characteristics, and treatment patterns were obtained; descriptive statistics were used.ResultsThe study included 151 medical oncologists, who reported that 54% and 31% of their patients, on average, would be classified as cisplatin or carboplatin eligible for their 1L treatment, respectively. Approximately 78% of oncologists (n=118) considered using ICI maintenance in ≥40% of their patients following disease control with platinum chemotherapy and were categorized as the “high-consideration” group, for further exploratory analysis; the rest (22%) were in the low-consideration group (See table 1). Approximately, 31% and 27% of oncologists in the high- and low-consideration groups reported administering ICI maintenance with a 2–3-week gap after chemotherapy, while 45% and 46% reported administering it with a 4–6-week gap after chemotherapy, respectively.ConclusionsSurveyed oncologists reported that 85% of patients with aUC in US may be eligible for platinum-based chemotherapy. Further, 78% of the surveyed oncologists would consider 1L ICI maintenance therapy after disease control with platinum-based chemotherapy for over 40% of their patients. Future studies are warranted to evaluate real-world treatment patterns, barriers, and utilization of ICI maintenance therapy as the new 1L standard of care.AcknowledgementsThe authors would like to acknowledge all physicians at who participated and completed the survey for the study.ReferencePowles T, et al. N Engl J Med 2020;383(13):1218–1230.Ethics ApprovalThe study was reviewed and determined to be exempt by Advarra IRB.ConsentAll survey participated signed a consent form.Abstract 630 Table 1Oncologists characteristics and considerations for 1L ICI maintenance therapy

scholarly journals Switch Control Inhibition of KIT and PDGFRA in Patients With Advanced Gastrointestinal Stromal Tumor: A Phase I Study of Ripretinib

2020 ◽  
Vol 38 (28) ◽  
pp. 3294-3303 ◽  
Author(s):  
Filip Janku ◽  
Albiruni R. Abdul Razak ◽  
Ping Chi ◽  
Michael C. Heinrich ◽  
Margaret von Mehren ◽  
...  
Keyword(s):  
Phase I ◽  
Gastrointestinal Stromal Tumor ◽  
Dose Escalation ◽  
Phase I Study ◽  
Stromal Tumor ◽  
Second Line ◽  
Once Daily ◽  
Switch Control ◽  
Wide Range ◽  
Advanced Gist

PURPOSE In advanced gastrointestinal stromal tumor (GIST), there is an unmet need for therapies that target both primary and secondary mutations of pathogenic KIT/PDGFRA oncoproteins. Ripretinib is a novel switch-control kinase inhibitor designed to inhibit a wide range of KIT and PDGFRA mutations. PATIENTS AND METHODS This first-in-human, to our knowledge, phase I study of ripretinib (ClinicalTrials.gov identifier: NCT02571036) included a dose-escalation phase and subsequent expansion phase at the recommended phase II dose (RP2D). Eligible patients included those with advanced GIST, intolerant to or experienced progression on ≥ 1 line of systemic therapy, and other advanced malignancies. Safety, dose-limiting toxicities (DLTs), maximum-tolerated dose (MTD), and preliminary antitumor activity were evaluated. RESULTS At data cutoff (August 31, 2019), 258 patients (n = 184 GIST) were enrolled, with 68 patients in the dose-escalation phase. Three DLTs were reported: grade 3 lipase increase (n = 2; 100 mg and 200 mg twice a day) and grade 4 increased creatine phosphokinase (n = 1; 150 mg once daily). MTD was not reached (maximum dose evaluated, 200 mg twice a day); 150 mg once daily was established as the RP2D. The most frequent (> 30%) treatment-emergent adverse events in patients with GIST receiving ripretinib 150 mg once daily (n = 142) were alopecia (n = 88 [62.0%]), fatigue (n = 78 [54.9%]), myalgia (n = 69 [48.6%]), nausea (n = 65 [45.8%]), palmar-plantar erythrodysesthesia (n = 62 [43.7%]), constipation (n = 56 [39.4%]), decreased appetite (n = 48 [33.8%]), and diarrhea (n = 47 [33.1%]). Objective response rate (confirmed) of 11.3% (n = 16/142) ranging from 7.2% (n = 6/83; fourth line or greater) to 19.4% (n = 6/31; second line) and median progression-free survival ranging from 5.5 months (fourth line or greater) to 10.7 months (second line), on the basis of investigator assessment, were observed. CONCLUSION Ripretinib is a well-tolerated, novel inhibitor of KIT and PDGFRA mutant kinases with promising activity in patients with refractory advanced GIST.

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