Metastasiertes Mammakarzinom: CDK4-/6-Inhibitoren halten Einzug in die deutsche Versorgungsroutine

2021 ◽  
pp. 1-2
Author(s):  
Achim Wöckel
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Progression Free Survival ◽  
Real World Data ◽  
Metastasiertes Mammakarzinom ◽  
Hormone Receptor Positive ◽  
Her2 Breast Cancer ◽  
Third Line Therapy ◽  
Third Line

<b>Purpose:</b> Treatment with CDK4/6 inhibitors and endocrine therapy (CDK4/6i + ET) is a standard for patients with advanced hormone receptor-positive, HER2-negative (HR + HER2-) breast cancer (BC). However, real-world data on the implementation of therapy usage, efficacy, and toxicity have not yet been reported. <b>Methods:</b> The PRAEGNANT registry was used to identify advanced HR + HER2- BC patients (n = 1136). The use of chemotherapy, ET, everolimus + ET, and CDK4/6i + ET was analyzed for first-line, second-line, and third-line therapy. Progression-free survival (PFS) and overall survival (OS) were also compared between patients treated with CDK4/6i + ET and ET monotherapy. Also toxicity was assessed. <b>Results:</b> CDK4/6i + ET use increased from 38.5% to 62.7% in the first 2 years after CDK4/6i treatment became available (November 2016). Chemotherapy and ET monotherapy use decreased from 2015 to 2018 from 42.2% to 27.2% and from 53% to 9.5%, respectively. In this early analysis no statistically significant differences were found comparing CDK4/6i + ET and ET monotherapy patients with regard to PFS and OS. Leukopenia was seen in 11.3% of patients under CDK4/6i + ET and 0.5% under ET monotherapy. <b>Conclusions:</b> In clinical practice, CDK4/6i + ET has been rapidly implemented. A group of patients with a more unfavorable prognosis was possibly treated in the real-world setting than in the reported randomized clinical trials. The available data suggest that longer follow-up times and a larger sample size are required in order to identify differences in survival outcomes. Studies should be supported that investigate whether chemotherapy can be avoided or delayed in this patient population by using CDK4/6i + ET.

scholarly journals Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

2021 ◽  
Vol 28 (3) ◽  
pp. 2260-2269
Author(s):  
Daniel Tong ◽  
Lei Wang ◽  
Jeewaka Mendis ◽  
Sharadah Essapen
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Systemic Treatment ◽  
Progression Free Survival ◽  
Median Number ◽  
Current Data ◽  
Real World Data

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.

Nivolumab in second or third line setting for the treatment of metastatic renal cell carcinoma (mRCC): The real-world experience from Guy’s Hospital.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 624-624
Author(s):  
Ha Mo Linh Le ◽  
Debra Hannah Josephs ◽  
Simon Chowdhury ◽  
Sarah Maria Rudman ◽  
Deborah Enting
Keyword(s):  
Real World ◽  
Progression Free Survival ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Optimal Sequence ◽  
Entire Cohort ◽  
Visceral Metastases ◽  
Third Line ◽  
Grade 3 ◽  
Line Setting

624 Background: Nivolumab (Nivo) has been approved by the FDA for patients (pts) with mRCC who have received prior VEGF tyrosine kinase inhibition based on the Checkmate 025 study. However following various new anti-angiogenic therapies licensed over the past decade, optimal sequence of treatments in mRCC remains unknown. Methods: This is a retrospective review of mRCC pts who received nivo at Guy’s Hospital. Pts were divided based on treatment line setting. Clinical characteristics, response rate (RR), progression free survival (PFS), duration on treatment and safety are reported. Results: Between March 2016 and April 2018, 50 pts with mRCC received nivo, 25 as second line (2L) and 25 as third line treatment or beyond (3L+). In 2L setting, median age was 62 years and 68% were male. 76% had a nephrectomy, with a majority of clear cell (cc) histology (92%). 96% of pts had visceral metastases. 88% received pazopanib in the first line setting (1L). Median age for pts in 3L+ was 60 years and 88% were male. 60% had a nephrectomy and 80% had cc histology. 96% had visceral metastases. Pazopanib was given in 72% in 1L. RR was 28% and 16% in 2L and 3L+ respectively. Median duration of treatment was 4.3 months in 2L and 2.2 months in 3L+, with 11 patients (22%) still on treatment. Median follow-up time was 12.4 months in 2L and 9 months in 3L+. Median PFS was 4.8 months and 3.7 months respectively in 2L and 3L+ groups. Median OS was not reached in either group. Adverse events leading to treatment discontinuation occurred in 7 pts (14%). 5 pts experienced grade 3/4 toxicities (colitis, pneumonitis, hepatitis, arthritis and nephritis), with 4 pts in 3L+. Overall 22 pts received subsequent treatments: 8/25 (32%) had cabozantinib (cabo) and 4/25 (16%) were treated with axitinib following nivo given in 2L. For pts who received nivo in the 3L+ setting 7/25 (28%) received cabo and 2/25 (8%) had axitinib as subsequent therapy. Conclusions: Our real world data supports the efficacy and safety of nivo following VEGF inhibition for pts with mRCC. Nivo was associated with a trend towards superior clinical responses in the 2L setting. For the entire cohort no new safety signals were reported.

12-month uptake of PD-L1 testing and atezolizumab (atezo) + nab-paclitaxel (nab-pac) treatment in metastatic triple-negative breast cancer (mTNBC) following accelerated FDA-approval in the United States.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13103-e13103
Author(s):  
Leisha A. Emens ◽  
Christopher Craggs ◽  
Marcio Debiasi ◽  
Matthew Kent ◽  
Patricia Luhn ◽  
...  
Keyword(s):  
Real World ◽  
Systemic Therapy ◽  
Locally Advanced ◽  
The United States ◽  
Considerable Proportion ◽  
Real World Data ◽  
Fda Approval ◽  
Third Line ◽  
Line Of Therapy

e13103 Background: In March 2019, atezo + nab-pac received accelerated FDA-approval for the treatment (tx) of patients (pts) with unresectable locally advanced or metastatic TNBC who express PD-L1 in immune cells (IC), based on the results from the randomized IMpassion130 clinical trial. A companion diagnostic, the Ventana SP142 PD-L1 assay, was concurrently approved. This real-world data analysis describes the uptake of both PD-L1 testing and therapy with atezo + nab-pac from the time of approval. Methods: This is a retrospective study using the Flatiron Health electronic health record (EHR) derived de-identified database, representing > 2.4 million US cancer pts from > 280 cancer clinics. Pts diagnosed with mTNBC starting any line of systemic therapy between March 9, 2019 and December 31, 2019 (to be updated in April 2020 for 12-months follow-up) were included. Two cohorts were examined: pts receiving either atezo-based tx, or tx without atezo. Demographics were described in the pt group overall and by line of therapy (LOT). Steroid tx at baseline was classified as any order/administration of a steroid within the first three administrations of a systemic therapy in a given LOT. Any record of a PD-L1 test was reported. Results: 228 pts diagnosed with mTNBC were included; 65 pts (28%) received any atezo combination, the majority in combination with nab-pac: 57% (n = 37) in first-line (1L), 25% (n = 16) in second-line (2L), and 18% (n = 12) in third-line or later (3L+). Median age at metastatic diagnosis (mDx) for atezo-treated pts was: 1L, 65 y (IQR: 49, 72); 2L, 56 y (IQR: 48, 64); 3L+, 52 y (IQR: 42, 60). Median age at mDx for non-atezo-treated patients was: 1L, 63 y (IQR: 53, 74); 2L, 59 y (IQR: 51, 65); 3L+, 61 y (IQR: 53, 71). Of 228 pts, 158 (69%) had any PD-L1 test recorded. Among atezo-treated pts, 62 (95%) had a documented PD-L1 test; of those 40 (62%) were tested using the SP142 assay. Overall, 205 tests were recorded: SP142, n = 96 (46.8%); unknown/not documented, n = 44 (21.5%); 22C3, n = 36 (17.6%); lab-developed test, n = 26 (12.7%); SP263, n = 2 (1.0%); and 28-8, n = 1, (0.5%). 37 (57%) atezo-treated pts received a steroid at baseline. Conclusions: Atezo tx and testing with SP142 is being implemented following accelerated FDA-approval. A considerable proportion of pts received steroids at baseline and had nab-pac as chemotherapy backbone in clinical practice. Clinical outcomes of atezo-treated pts in the real-world setting remain to be further explored pending longer pt follow-up times.

scholarly journals Real-World Data with the Use of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 14-16
Author(s):  
M Moraima Jimenez ◽  
Sabela Bobillo ◽  
Ana Pérez ◽  
Pamela Arenas ◽  
Alba Cabirta ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Randomized Clinical Trials ◽  
Immunosuppressive Agents ◽  
Response To Treatment ◽  
Lower Percentage ◽  
Neurological Involvement ◽  
Control Group ◽  
Real World Data

INTRODUCTION For more than two decades, the treatment of aTTPconsisted of therapeutic plasma exchange (TPE) and immunosuppressive agents. The addition of caplacizumab, a nano-antibody that binds to the A1 domain of the von Willebrand factor, inhibiting platelet aggregation, has been shown to reduce the time to resolution of thrombocytopenia, the rate of recurrence and the aTTP-related death. Real-world evidence of the effectiveness of caplacizumab is limited yet. The objective of our study was to assess the results of the introduction of caplacizumab in our internal protocol and to compare those results with the patients treated before the drug was available. METHODS A single-center retrospective observational study that evaluates the clinical characteristics and response to treatment of 18 consecutively diagnosed aTTP patients between May/14 to May/20. All patients received initial treatment with TPE and prednisone (PDN) 1 mg/Kg; the control group did not receive any other initial therapy, whereas nine patients received caplacizumab in addition to PEX and PDN once ADAMTS-13 deficiency was confirmed. Complete response (CR) was defined as the second of two consecutive days with platelets ≥150x109/L, refractoriness as the lack of platelet increase despite optimal therapy after 7 days, exacerbation as the decrease in platelet count during the first 30 days of discontinuation of TPE, and relapse as a new episode of aTTP beyond 30 days after the last TPE. All results are given as median (interquartile range). Statistical analysis was conducted using STATA/IC software. RESULTS The clinical characteristics at diagnosis of patients treated with or without caplacizumab were similar, except for a lower percentage of males and lower neurological involvement in the caplacizumab group (Table 1). Caplacizumab was started at a median of 3 days after diagnosis following ADAMTS-13 deficiency determination, and was administered during a median of 39 days (IQR 33-39). Adverse events related to caplacizumab were mild: 1 patient presented mild metrorrhagia, 1 developed pain and erythema at the puncture area and 1 suffered an urticarial dermatitis, the last case leading to the suspension of the drug since levels of ADAMTS-13 were recovered. The caplacizumab group achieved CR after a median of 4 days (IQR 3-4) vs. 6 days (IQR 5-14) in the control group (p = 0.016). Likewise, the number of TPE was lower with caplacizumab (Figure 1), with a median of 10 TPE (IQR 9-11) vs. 19 (IQR 16-23) (p = 0.001). Hospitalization time was also shorter in the caplacizumab group with a median of 12 days (IQR 12-14) vs. 26 (IQR 20-27) (p = 0.002). Finally the time of hospitalization into the intensive care unit was shorter in the caplacizumab group with a median of 3 days (IQR 2-4) vs. 4 (IQR 3-13) (p=0.1). In the caplacizumab group (median follow-up of 6.8 months), there were no refractory cases. There was 1 exacerbation before initiation of caplacizumab and 1 relapse. Both cases were treated with rituximab. In contrast, in the control group (median follow-up of 51.8 months), we observed 4 refractory cases (1 aTTP-related death), 3 exacerbations and 1 relapse; rituximab was necessary in 8 patients and a 3rd line with vincristine was administered in 4 cases. CONCLUSIONS The observed benefits of caplacizumab in our series are in line with the ones identified in randomized clinical trials. Caplacizumab can be used in combination with other therapies to attain a faster response and reduce aTTP-related complications. Disclosures Bosch: Hoffmann-La Roche: Research Funding.

scholarly journals Efficacy, safety and prognostic factors in patients with refractory metastatic colorectal cancer treated with trifluridine/tipiracil plus bevacizumab in a real-world setting

2022 ◽  
Author(s):  
Nieves Martínez-Lago ◽  
Teresa Calleja Chucla ◽  
Beatriz Alonso de Castro ◽  
Rafael Varela Ponte ◽  
Cristina Reboredo Rendo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Common Grade ◽  
Third Line ◽  
Grade 3

Abstract We evaluated the efficacy and safety of trifluridine/tipiracil (TAS-102) plus bevacizumab in treating refractory metastatic colorectal cancer (mCRC) in a retrospective, observational study. Patients refractory or intolerant to standard therapies received TAS-102 (30–35 mg/m2 twice daily on days 1–5 and days 8–12 every 28 days) plus bevacizumab 5 mg/kg on days 1 and 15. Clinical and pathological characteristics, overall response rate (ORR) and disease control rate (DCR), overall survival (OS) and progression-free survival (PFS) data were collected and analysed. Thirty-five patients were treated from July 2019 to October 2021 (median age 64 years). The majority of patients (68.6%) were receiving TAS-102 plus bevacizumab as third-line treatment. Patients received a median of 4 (range 2–15) cycles of treatment. Among 31 patients evaluable for response (88.6%), ORR and DCR were 3.2% and 51.6%, respectively. After a median 11.6 months’ follow-up, median PFS was 4.3 (95% confidence interval [CI] 3.4–5.1) months and median OS was 9.3 (95% CI 6.6–12.1) months. The most common grade 3–4 toxicities were neutropenia, asthenia and nausea/vomiting, and there were no treatment-related deaths. This real-world study confirms the efficacy and safety of TAS-102 plus bevacizumab in patients with refractory mCRC.

scholarly journals Real-life use of ramucirumab in gastric cancer in Spain: the RAMIS study

2021 ◽  
Vol 17 (14) ◽  
pp. 1777-1791
Author(s):  
Federico Longo ◽  
Mónica Jorge ◽  
Ricardo Yaya ◽  
Ana Fernández Montes ◽  
Nieves Martínez Lago ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Descriptive Analysis ◽  
Gastroesophageal Junction ◽  
Real Life ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Combination Regimen ◽  
Real World Data

Aims: To obtain real-world data on ramucirumab use and effectiveness for the treatment of advanced gastric cancer (AGC) or gastroesophageal junction adenocarcinoma (GEJ). Methods: Observational, retrospective study carried out in 20 Spanish hospitals, in patients who started ramucirumab treatment between December 2015 and December 2018. Descriptive analysis was conducted for patient characteristics, treatment patterns and effectiveness outcomes. Results: Three hundred seventeen patients were included (93.7% treated with ramucirumab-paclitaxel and 6.3% with ramucirumab); age 62.5 (11.3) years; 66.9% male. Median progression-free survival and overall survival were 3.9 months (95% CI: 3.4–4.3) and 7.4 (95% CI: 6.4–8.9) in combination regimen and 2.0 (1.1–2.8) and 4.3 (95% CI: 1.9–7.3) in monotherapy, respectively. Conclusion: The study findings were consistent with available real-world studies and randomized clinical trials.

Real-world clinical and economic burden associated with hospitalization in metastatic triple-negative (ER-/PR-/HER2-) breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19236-e19236
Author(s):  
Amie Tan ◽  
Xu Han ◽  
Aimee Near ◽  
Jenny Tse ◽  
Luciana Preger
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Economic Burden ◽  
Triple Negative ◽  
Treatment Initiation ◽  
Hospitalized Patients ◽  
Cost Driver ◽  
Real World Data ◽  
Her2 Breast Cancer

e19236 Background: Metastatic triple-negative breast cancer (mTNBC) is associated with poorer disease prognosis and higher healthcare utilization and costs compared with other breast cancer subtypes, with hospitalizations being a major cost driver. This study aimed to understand reasons for hospitalization and describe the clinical and economic burden associated with hospitalizations in mTNBC patients following 1L treatment initiation. Methods: mTNBC patients were identified in the IQVIA Real-World Data Adjudicated Claims-US database (Jan. 2012 – Jan. 2019) and indexed on the day of 1L treatment initiation. Women ≥18 years of age with mTNBC who had continuous enrollment for ≥12 months before (baseline) and ≥30 days after (follow-up) index and no evidence of other primary cancers during baseline were included. Patient baseline characteristics and all-cause hospitalizations during follow-up were described. Results: 4,617 mTNBC patients were identified (mean age 54 years; 99.7% with chemotherapy as IL); 1,595 (35%) had ≥ 1 hospitalization during follow-up (mean duration 17 months). More hospitalized patients had ≥2 metastasis sites (25% vs. 15%, p < 0.01) as well as visceral (15% vs. 7%, p < 0.01) or bone metastases (15% vs. 8%, p < 0.01) than non-hospitalized patients. The average time from index to first hospitalization was 7.4 months and hospitalized patients had a mean of 2.4 hospitalizations per patient per year (PPPY), with mean length of stay of 6 days. 25% of hospitalized patients were admitted from the ED. Reasons for hospitalization included chemotherapy-related adverse events (AEs; 76%), followed by disease progression (72%), breast-related surgeries (6%), and others (4%). Common chemotherapy-related AEs included infection or pyrexia (46%), anemia (35%), and neutropenia (17%). Total cost associated with hospitalization was $57,115 PPPY, with the annual out-of-pocket cost averaging $3,659 per patient; mean out-of-pocket cost per hospitalization was $1,840. The proportion of patients with hospitalization was similar between metropolitan and rural patients (35% vs. 37%, p = 0.51), yet metropolitan patients had slightly longer hospital stays (mean 6 vs. 5 days, p = 0.03). Conclusions: Approximately one-third of mTNBC patients were hospitalized following 1L treatment initiation and in turn, bear a high economic burden. New therapies are needed to mitigate the clinical and economic burden associated with hospitalizations in this population.

928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 928-P
Author(s):  
REEMA MODY ◽  
MARIA YU ◽  
BAL K. NEPAL ◽  
MANIGE KONIG ◽  
MICHAEL GRABNER
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Exenatide Qw

scholarly journals Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

2021 ◽  
Vol 13 ◽  
pp. 175883592098765
Author(s):  
Raffaella Palumbo ◽  
Rosalba Torrisi ◽  
Federico Sottotetti ◽  
Daniele Presti ◽  
Anna Rita Gambaro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Her2 Receptor ◽  
Treatment Line ◽  
Hormone Receptor Positive

Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials. Patients and methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B). Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47–79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6–32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively. Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2− MBC, also suggesting a better performance of the combinations in earlier treatment lines.

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