Real-world safety of pemetrexed, carboplatin, and pembrolizumab in U.S. NSCLC patients.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 50-50
Author(s):  
Catherine Muehlenbein ◽  
Sangmi Kim ◽  
Ekaterina Ryabko ◽  
Ana Oton ◽  
Himani Agg ◽  
...  
Keyword(s):  
Real World ◽  
Safety Data ◽  
Treatment Phase ◽  
Occurrence Rate ◽  
World Population ◽  
Induction Phase ◽  
Mild Renal Impairment ◽  
Number Of Patients ◽  
Grade 3 ◽  
Nsclc Patients

50 Background: A Phase 3 KEYNOTE-189 clinical trial showed improved clinical benefit with acceptable toxicity of pemetrexed combined with pembrolizumab and platinum (Gandhi, 2018). However, the safety data with this combination has not been evaluated in a real-world setting with large number of patients with non-squamous non-small cell lung cancer (NSQ NSCLC). Methods: Flatiron Health’s electronic health record-derived data were used to identify advanced NSQ NSCLC patients (≥18 y) who received pemetrexed, pembrolizumab, and carboplatin (≤6 cycles; Pem+Pembro+Carb) as initial treatment from May 2017 to Oct 2018. Endpoints were overall occurrence of select laboratory adverse events (AEs; any Grade and Grade ≥3), which were described by treatment phase (Pem/Pembro cycles < 5 vs ≥5) and pre-specified subgroups. Results: The study included 1088 patients (median age = 68 y; male, 57%). In patients with maintenance (Pem/Pembro ≥5) cohort (N = 462), the median number of treatment cycles was 9 for Pembro and 6 for Pem. The occurrence rates of neutrophil count decrease and platelet count decrease were numerically higher in the induction phase, whereas those of chronic kidney disease (CKD) showed an opposite trend (Table). Grade ≥3 CKD occurrence rate was higher in patients with mild renal impairment (5.1% vs 2.6%) and elderly (≥75 y) patients (7.5% vs 3.3%). Conclusions: Considering the heterogeneity and vulnerability of real-world population, the laboratory AE occurrence rate with Pem+Pembro+Carb in this study was comparable with those reported in KEYNOTE-189. Various trends were observed for the respective AEs by treatment phase. [Table: see text]

scholarly journals Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review

2019 ◽  
Vol 11 ◽  
pp. 175883591985036 ◽  
Author(s):  
Elena Gabriela Chiorean ◽  
Winson Y. Cheung ◽  
Guido Giordano ◽  
George Kim ◽  
Salah-Eddin Al-Batran
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Real World ◽  
Controlled Trial ◽  
Safety Data ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Eligibility Criteria ◽  
Grade 3

Background: No clinical trial has directly compared nab-paclitaxel/gemcitabine (nab-P/G) with FOLFIRINOX (fluorouracil/leucovorin/oxaliplatin/irinotecan) in metastatic or advanced pancreatic cancer (mPC or aPC). We conducted a systematic review of real-world studies comparing these regimens in the first-line setting. Methods: Embase and MEDLINE databases through 22 January 2019, and Gastrointestinal Cancers Symposium 2019 abstracts were searched for real-world, retrospective studies comparing first-line nab-P/G versus FOLFIRINOX in mPC or aPC that met specific parameters. Studies with radiotherapy were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Results: Of 818 records initially identified, 35 were duplicates and 749 did not meet the eligibility criteria, mostly because they were either not comparative ( n = 356) or not first line ( n = 245). The remaining 34 studies (21 mPC; 13 aPC) assessed >6915 patients who received nab-P/G or FOLFIRINOX. In the studies identified, the median overall survival (OS) reached 14.4 and 15.9 months with nab-P/G and FOLFIRINOX, respectively, and median progression-free survival reached 8.5 and 11.7 months, respectively. Safety data were reported in 14 studies (2205 patients), including 8 single-institutional studies. In most single-institutional studies that reported safety data, rates were higher with FOLFIRINOX versus nab-P/G for grade 3/4 neutropenia (five of six studies) and febrile neutropenia (all three studies), while rates of grade 3/4 peripheral neuropathy were higher with nab-P/G in four of seven studies. Conclusions: Although FOLFIRINOX was associated with slightly longer median OS in more studies, the differences, when available, were not statistically significant. Therefore, a randomized, controlled trial is warranted. Toxicity profile differences represent key considerations for treatment decisions.

PALOMAGE, a French real-world cohort of elderly women beyond age 70 with advanced breast cancer receiving palbociclib: Baseline characteristics and safety evaluation.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1012-1012
Author(s):  
Philippe Caillet ◽  
Marina Pulido ◽  
Etienne Brain ◽  
Claire Falandry ◽  
Isabelle Desmoulins ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Real World ◽  
Older Patients ◽  
Systemic Treatment ◽  
Safety Data ◽  
Real Life ◽  
Advanced Breast ◽  
Baseline Characteristics ◽  
Grade 3

1012 Background: Advanced breast cancer (ABC) is common in older patients, resulting from the high incidence of breast cancer beyond age 70. This population is often limited in clinical trials. Endocrine therapy (ET) combined with a CDK4/6 inhibitor is the standard of care in ABC overexpressing hormonal receptors (HR+). Data specific to older patients are scarce in the literature, deserving further research. Methods: PALOMAGE is an ongoing French prospective study evaluating palbociclib (PAL) + ET in real life setting in women aged ≥70 with HR+ HER2- ABC, split in 2 cohorts: ET sensitive patients with no prior systemic treatment for ABC (cohort A), and ET resistant patients and/or with prior systemic treatment for ABC (cohort B). Data collected include clinical characteristics, quality of life (EORTC QLQ-C30 and ELD14) and geriatric description [G8 and Geriatric-COre DatasEt (G-CODE)]. This analysis reports on baseline characteristics and safety data for the whole population. Results: From 10/2018 to 10/2020, 400 and 407 patients were included in cohort A and B, respectively. The median age was 79 years (69-98), 15.1% with an age > 85. ECOG performance status (PS) was ≥2 in 17.9% patients, 68.3% had a G8 score ≤14 suggesting frailty, 32.1% had bone only metastasis, and 44% had visceral disease. 35.8% of patients in cohort B had no prior treatment for ABC. Safety data were available for 787 patients. The median follow-up was 6.7 months (IC95% = 6.1-7.6). At start of treatment, full dose of PAL (125 mg) was used in 76% of the patients: 62.6%, 68.7% and 71.6% of patients aged ≥ 80, those with ECOG PS ≥2 and those with a G8 score ≤14, respectively. In the safety population, 70% had ≥1 adverse event (AE), including 43.1% grade 3/4 AE, and 22.9% ≥ 1 serious AE. Most frequent AE reported were neutropenia (43.2%), anemia (17.5%), asthenia (16.3%) and thrombocytopenia (13.6%). Grade 3/4 neutropenia was observed in 32.3% of patients, with febrile neutropenia in 1.1%. Grade 3/4 AE PAL-related were reported in 40.1%, 31.4% of patients aged < 80, ≥80, respectively. Regarding PAL, 23.4% of patients had a dose reduction and 41.8% had a temporary or permanent discontinuation due to AE. Safety data were similar in both cohorts. Geriatric data and impact on safety will be presented. Conclusions: PALOMAGE is a unique large real-world cohort focusing on older patients treated with PAL in France. These preliminary data do not suggest any new safety signal, matching data derived from PALOMA trials. The occurrence of less grade3/4 AE related to PAL in patients aged 80 and beyond might reflect the 30% decrease of PAL dose upfront. Effectiveness analyses are eagerly awaited. Clinical trial information: EUPAS23012 .

Chemoimmunotherapy combination: Potential option for metastatic NSCLC patients with EGFR mutation resistant to osimertinib.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20618-e20618
Author(s):  
Bo Yang ◽  
Yaping Long ◽  
Yi Hu
Keyword(s):  
Egfr Mutation ◽  
Acquired Resistance ◽  
Progression Free Survival ◽  
Egfr Mutations ◽  
Combination Group ◽  
Metastatic Nsclc ◽  
Number Of Patients ◽  
Grade 3 ◽  
Egfr Mutant ◽  
Nsclc Patients

e20618 Background: Osimertinib has been emerged as the standard selection in EGFR T790M-positive NSCLC patients who failed prior treatment with EGFR TKIs. However, acquired resistance to osimertinib is a growing clinical challenge. Despite the significant antitumor activity of Chemoimmunotherapy (CIT) combinations in NSCLC, clinical benefit in patients with EGFR mutations has not been shown obviously. Our objective was to assess the effectiveness and tolerability of CIT for metastatic EGFR-mutant NSCLC patients with acquired resistance to Osimertinib. Methods: We conducted a retrospective study in patients with sensitizing EGFR-mutant NSCLC who were resistant to Osimertinib and received anti-PD1 immunotherapy combined with chemotherapy at Chinese PLA General Hospital. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and toxicities were examined. Results: Between Oct 2015 and Nov 2018, 11 patients were available for analysis, 45.5% male, 45.5% ECOG PS 0-1, median age 54 years, all pts who failed treatment with Osimertinib had received previously targeted therapies. In this CIT combination group, 6 [54.5%] of 11 pts received pembrolizumab and 5[54.5%] of 11 pts received Nivolumab anti-PD1 therapy, 8 [72.7%] of 11 pts received mono-chemotherapy and 3 [27.3%] of 11 pts received platinum-based doublet chemotherapy. The median PFS was 7.47 months (95% CI 3.04 to 11.89). Despite Median OS was not reached, the OS rate at one year was 6 [54.5%] of 11. The ORR was 5 [45.5%] of 11. Treatment-related adverse events (TRAE) of grade 3 or higher were reported in 6 [54.5%] of 11 patients. The most common grade 3 or worse TRAEs were fatigue (3 [27.3%] of 11) and anemia (3 [27.3%] of 11); The following ≥Grade 3 TRAEs occurred once: decreased neutrophil count, acute kidney injury, gastrointestinal bleeding. One patient discontinued treatment because of immune-associated gastroenteritis. Conclusions: In metastatic NSCLC patients with activating EGFR mutation resistant to Osimertinib, our single institution real-world experience in Chemoimmunotherapy combination shows promising activity and acceptable toxicity profile. Given the small number of patients studied, further clinical trials are warranted.

Safety results of a phase III randomized trial of adjuvant treatment with 5- fluorouracil and folinic acid with or without irinotecan, in Dukes B2 and C colon cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4053-4053 ◽  
Author(s):  
P. Papakostas ◽  
H. P. Kalofonos ◽  
G. Pentheroudakis ◽  
E. Timotheadou ◽  
C. Papadimitriou ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Folinic Acid ◽  
Adjuvant Treatment ◽  
Safety Data ◽  
Phase Iii ◽  
Severe Neutropenia ◽  
Severe Diarrhea ◽  
Number Of Patients ◽  
Group A ◽  
Grade 3

4053 Background: The aim of our phase III study was to compare the effectiveness and the toxicity profile of 5-Fluorouracil (5- FU) + folinic acid (FA) + irinotecan (CPT-11) as adjuvant chemotherapy for resectable colon cancer (Dukes B2 and C) to that of 5-FU + FA which was considered the standard treatment. Since patients are still on follow-up regarding the primary endpoint, only safety results will be presented. Methods: Eligible patients received either 5-FU (450 mg/m2 bolus) + FA (200 mg/m2, 120 min infusion) + CPT- 11 (80 mg/m2, 90 min infusion) given 4 weeks on, two weeks off for a total of 6 treatment cycles (Arm A) or 5-FU (500 mg/m2 bolus) + FA (200 mg/m2, 120 min infusion) given 6 weeks on, two weeks off for a total of 4 treatment cycles (Arm B). Results: From January 1999 to September 2004, 910 patients (pts) were enrolled in this multi-center phase III trial. Safety data are available for 826 of the 910 pts, (415 in arm A and 411 in arm B). The total number of chemotherapy courses delivered was 8,906 (92%) in arm A and 8,775 (91%) in arm B, with median courses per patient 24 in both groups. Among patients who received treatment as randomized (403 in arm A and 398 in arm B), treatment was completed in 342 pts (82%) in arm A and in 341 pts (83%) in arm B. The number of patients who discontinued the treatment was 61 (15%) in arm A and 57 (14%) in arm B. Hospitalizations because of toxic effects happened in 37 pts (9%) in arm A and in 45 pts (11%) in arm B. Three deaths occurred in both arms. Use of G-CSF was more common in arm A (94 pts, 23%) than in arm B (38 pts, 9.5%) (p< 0.001). Significantly higher grade 3/4 neutropenia was observed in group A (11% in arm A and 3% in arm B, p< 0.001). Severe diarrhea was also frequently reported in both groups. Conclusions: These data show that both regimens have comparable and manageable toxicity profiles as adjuvant treatment in colon cancer. Severe neutropenia was more often seen in arm A. No significant financial relationships to disclose.

Adjuvant paclitaxel followed by oral fluoropyrimidines for gastric cancer: Safety data of the factorial phase III SAMIT trial.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 72-72
Author(s):  
Michiya Kobayashi ◽  
Akira Tsuburaya ◽  
Kazuhiro Yoshida ◽  
Shigefumi Yoshino ◽  
Yumi Miyashita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Safety Data ◽  
Data Monitoring Committee ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Number Of Patients ◽  
Grade 3 ◽  
Lavage Cytology ◽  
Disease Free

72 Background: Adjuvant chemotherapy with fluoropyrimidine (FP) with or without platinum for gastric cancer (GC) has become standard almost worldwide; however, there has been no comparison among concurrent, sequential, and monotherapy. Paclitaxel (PTX) is one of key drugs in GC widely used as 2nd-line chemotherapy in Japan. Methods: SAMIT is a randomized, multicenter phase III study of FP (S1 or UFT) vs. PTX followed by FP in patients (pts) with gastric adenocarcinoma. Eligibility includes T3/T4, N0-2, M0 except for positive lavage cytology, chemotherapy- and radiotherapy- naive, being able to start chemotherapy 14 and 56 days after D2 gastrectomy. Pts received either UFT 267 mg/m2/day for 4w, q4w x 6 cycles (arm A); S1 80 mg/m2/day for 2w, q3w x 8 cycles (arm B); PTX 80 mg/m2 Day 1, 8 for the first 3w x 1 cycle, Day 1, 8, 15 q4w x 2 cycles, followed by UFT 267 mg/m2/day for 4w, q4w x 3 cycles (arm C); or PTX as in C, followed by S1 80 mg/m2/day for 2w, q3w x 4 cycles (arm D). The FP cycles was prolonged by 24w after ACTS-GC publication in 2007. Primary endpoint is disease-free survival and total number of patients was calculated to be1480 where 90% power for superiority of C+D group vs. A+B. The Independent Data Monitoring Committee undertook a review of the 1417 pts at the 2nd interim analysis in 2011. Results: Arm A (n=353), arm B (n=359), arm C (n=352), arm D (n=353) were well balanced for baseline factors. The compliance with UFT in arm A and S1 in B was 74% and 76% in the first 12 weeks, and 89% and 90% between week 37 and 48; that in arm C and D was 83% and 80% in the second 12 weeks, and 94% and 84% between week 37 and 48. Numbers of grade 3/4 hematological and non-hematological adverse events (AEs) were 3 and 46, 0 and 64, 5 and 35, and 16 and 67 for arm A, B, C, and D, respectively. Anorexia was the most common AE observed in 5.8%, 6.8%, 1.7%, and 5.1% for arm A, B, C, and D, respectively. There were 363/1323 (27%) deaths and 762/1323 (58%) of pts survived disease free. Conclusions: Adjuvant chemotherapy with sequential PTX and FP for GC was safe and the compliance of the FP part could be better than that of FP monotherapy. The final efficacy results will be formally assessed in 2012.

Real-world safety data and differentiation of second-line (2L) 5-fluorouracil (5-FU) based regimens among patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 390-390
Author(s):  
George P. Kim ◽  
Paul Cockrum ◽  
Aleksander Chudnovsky ◽  
Andy Surinach ◽  
Zev A. Wainberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Safety Data ◽  
Ductal Adenocarcinoma ◽  
Icd 10 ◽  
Health Database ◽  
Liposomal Irinotecan ◽  
Grade 3 ◽  
Cost Implications

390 Background: Chemotherapy related adverse events (AEs) can impact the treatment of patients, reducing quality of life and leading to dose delays and treatment discontinuation. This study examined the proportion of patients (pts) with mPDAC treated with 5-FU-based regimens in the 2L setting who experienced AEs during treatment. Methods: Data were extracted for pts diagnosed with mPDAC who initiated 2L treatment between January 2016 and July 2020 from the Flatiron Health electronic health database. Pts included in the study were treated with FOLFIRINOX (FFX), FOLFOX, FOLFIRI, or a regimen containing liposomal irinotecan. The occurrence of grade 3 (G3) and grade 4 (G4) neutropenia, G3/G4 elevated alanine transaminase (ALT) and anemia where transfusion was indicated were determined using lab results and the grading criteria from the Common Terminology Criteria for Adverse Events v4.03. The occurrence of diarrhea, fatigue, nausea and vomiting (N/V), and neuropathy were identified from structured diagnosis records through ICD-10-CM codes. Duration of therapy (DOT) was assessed for each regimen. Descriptive statistics for AEs and DOT were reported. Results: Of the 804 pts included in the study, 28.4% (n=228) received FFX, 39.8% (n=320) received regimens containing liposomal irinotecan, 24.8% (n=199) received FOLFOX, and 7.1% (n=57) received FOLFIRI. The median DOT (IQR) was 86 days (d) (43 – 206), 79d (41 – 169), 72d (43 – 166), and 84d (46 – 148) for pts who received FFX, liposomal irinotecan, FOLFOX, and FOLFIRI, respectively. G3/G4 neutropenia (<1000/mm3) presented in 28.1% (n=64) of pts treated with FFX, 11.9% (n=38) of pts treated with liposomal irinotecan, 17.1% (n=34) of pts treated with FOLFOX, and 36.8% (n=21) of pts treated with FOLFIRI. NV occurred in 14.9% (n=34), 13.1% (n=42), 12.6% (n=25), and 10.5% (n=6), respectively. The full AE results are summarized in the table. Conclusions: In this assessment of often dose-limiting AEs among pts with mPDAC treated in 2L, pts who received liposomal irinotecan had the lowest proportion of neutropenia. No clear pattern was noted for N/V, neuropathy, fatigue, anemia, and elevated ALT. Further research is necessary to determine the real-world cost implications of AEs in this patient population. [Table: see text]

scholarly journals Real World Outcomes of Ipilimumab and Nivolumab in Patients with Metastatic Melanoma

Cancers ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2329
Author(s):  
Nethanel Asher ◽  
Guy Ben-Betzalel ◽  
Shaked Lev-Ari ◽  
Ronnie Shapira-Frommer ◽  
Yael Steinberg-Silman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Metastatic Melanoma ◽  
Real World ◽  
Real Life ◽  
Response Rates ◽  
Immune Checkpoints ◽  
World Population ◽  
Induction Phase ◽  
Treatment Naïve ◽  
Melanoma Patients

Background: Immunotherapy has drastically changed the outlook for melanoma patients over the past decade. Specifically, the dual blockade of immune checkpoints using ipilimumab and nivolumab has shown unprecedented response rates and survival outcomes. This immense achievement, though, is at the cost of toxicity, with 60% of the patients experiencing high-grade adverse events (AEs). Our study aims to report the efficacy and toxicity outcomes of an out-of-trial, real-life population. Methods: Data on metastatic melanoma patients treated with ipilimumab and nivolumab were retrieved from our melanoma database—a single-center prospectively updated, medical-records based oncologic registry. Data included demographics, clinical and pathological information, as well as tumor responses and survival. Associations between patient or treatment characteristics and outcomes were also evaluated. Results: We identified 172 metastatic melanoma patients, of whom 64% were treatment-naïve. The median follow-up was 12 months. The response rates for treatment-naïve and previously-treated patients were 61% and 25%, respectively; median progression-free survival (PFS) were 12.2 and 2.6 months, and median overall survival (OS) were not-reached (NR) and 6.1 months, respectively. The estimated three-year OS for treatment-naïve patients was 58% (95% CI 42–65). At data cutoff, 22% were still on-treatment. Grade 3–4 adverse events (AEs) were reported in 60% of the patients, almost all of whom were exposed to steroid treatments (59%); AEs were fatal in 4 patients, and led to permanent treatment discontinuation in 31%. Factors significantly associated with outcome were cutaneous histology, low lactate dehydrogenase (LDH), low number of metastatic sites, performance status, first line of treatment and number of combinations administered during the induction phase. Conclusions: Despite the profoundly different baseline patient characteristics, the combination of ipilimumab and nivolumab is as effective in the real-world population as it was in clinical trials, including long-term outcomes. In addition to confirming the significance of baseline prognostic factors, our study reveals that the number of combinations effectively administered may also be correlated with good outcome.

Oral Anticoagulation Treatment and Persistence After Venous Thromboembolism In a Real World Population: The Q-VTE Study Cohort

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2386-2386
Author(s):  
Vicky Tagalakis ◽  
Valerie Patenaude ◽  
Susan R. Kahn ◽  
Samy Suissa
Keyword(s):  
Venous Thromboembolism ◽  
Real World ◽  
Oral Anticoagulation ◽  
Clinical Guidelines ◽  
Conflicts Of Interest ◽  
Vitamin K Antagonists ◽  
Study Cohort ◽  
World Population ◽  
Treatment Persistence ◽  
Number Of Patients

Abstract Background For patients who are diagnosed with venous thromboembolism (VTE) provoked by transient risk factors, clinical guidelines typically recommend 3 months of oral anticoagulation, with longer treatment considered for unprovoked VTE. Describing treatment patterns of VTE in a real world population may identify remedial gaps in patient care. Aim We aimed to characterize oral anticoagulant treatment with vitamin K antagonists (VKA) following incident VTE and assess persistence of VKA therapy in patients with provoked vs. unprovoked VTE in a real world setting. Methods We used the linked administrative healthcare databases of the province of Québec, Canada, including the hospitalization, universal healthcare services, and out-patient prescription databases. We identified all beneficiaries with an incident DVT or PE between 2000 and 2009, which we classified as definite or probable VTE using a priori determined diagnostic algorithms based on ICD-9-CM or ICD-10-CA diagnosis codes. We formed two patient cohorts, one with definite and the other including definite or probable first-time VTE, that were followed until death or end of study (December 31, 2009). Anticoagulant out-patient prescription patterns were analyzed for both patient cohorts. Results From 245,452 Québec residents between 2000 and 2009 with at least 1 VTE diagnosis in RAMQ or MED-ÉCHO, we formed the definite VTE cohort including 40,776 definite cases and the any VTE cohort consisting of 54,803 definite or probable cases. From the 40,776 patients with a first definite VTE, there were 24,860 patients with DVT alone (61%) and 15,916 with PE with or without DVT (39%). Furthermore, there were 78% of patients over the age of 60 and 58.3% of patients were women. In all, 8,998 (22.1%) patients had an unprovoked VTE event while 19,010 (46.6%) patients had a provoked non-cancer event. Similar findings were found in the any VTE cohort. Among definite VTE cohort patients with a provoked non-cancer VTE, 68.6% of patients received anticoagulation after the VTE event. Most were dispensed VKA (64.9%) and 23.9% received a prescription for low molecular weight heparin (LMWH). Among patients with an unprovoked VTE, 86.3% of patients were prescribed anticoagulation (84.5% used VKA and 39.9% used LMWH). Overall, a greater number of patients received anticoagulation following PE (85.2%) than DVT alone (66.2%). Results were similar in the any VTE cohort. Persistence with VKA therapy among patients with provoked VTE was 86.9% at 90 days, 59.5% at 180 days and 19.9% at 365 days. Treatment persistence for patients with unprovoked non-cancer VTE was 88.8%, 66.8% and 22.9% for 90, 180 and 365 days, respectively. Similar findings were found in the any VTE cohort. Conclusions Our study provides useful information on VTE management in a real world population. Treatment persistence was similar for patients with provoked and unprovoked VTE. VKA therapy duration after provoked VTE was longer than the recommended 3 months, whereas treatment was shorter than suggested in patients with unprovoked VTE. Further investigation is needed to determine reasons for non-adherence to clinical guidelines. Disclosures: No relevant conflicts of interest to declare.

Real-World Outcomes with Panobinostat in Patients with Relapsed/Refractory Multiple Myeloma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5685-5685
Author(s):  
Noa Biran ◽  
David H. Vesole ◽  
Shijia Zhang ◽  
Joshua R. Richter ◽  
Yen-Hong Kuo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Safety Data ◽  
Kidney Injury ◽  
Progression Free Survival ◽  
Median Number ◽  
Cancer Center ◽  
Serious Adverse Events ◽  
Minor Response ◽  
Grade 3

Abstract Background: Histone acetylation plays a key role in regulating gene expression and in control of cellular activities in multiple pathways involved in normal and cancer cell growth.Panobinostat (pano) is a pan histone de-acetylase inhibitor (HDAC-i) approved by the FDA on February 23, 2015 for use withbortezomib (btz) and dexamethasone (dex) for patients with multiple myeloma (MM) who have had at least 2 prior lines of therapy including bothbtz and an immunomodulatory agent (IMiD). The combination ofpano withIMiDs and proteasome inhibitors (PIs) has been found to demonstrate enhanced anti-myeloma activity in clinical trials (Berdeja JG et al, 2015,Haematologica;Mateos M et al, 2010, ASCO Abstract 8030, JCO 28:15s). The goal of this retrospective study is to evaluate the real world experience on efficacy and safety ofpano in combination with a variety of FDA approved agents including a PI, anIMiD or a monoclonal antibody-based regimen in patients with relapsed/refractory MM. Methods: Between February 23, 2015 and July 1, 2016, 34 consecutive patients with relapsed/refractory MM who were treated with commercialpano were identified from the JohnTheurer Cancer Center. Charts were analyzed for response and safety data. The study was approved by the institutional review board. Results: Median age was 63 (range 27-78), with 58% percent men. Thirty-one patients (91.2%) wereDurie-Salmon stage II or III. Ten (30%) had high-risk FISH as defined byt(14;16), t(4;14), del p53, and gain 1q21. Median number of prior lines was 5 (range 2-9). All patients were relapsed/refractory to their last line of therapy, and 18 (53%) werebtz-refractory, 25 (74%) werelenalidomide-refractory, 27 (79%) werepomalidomide-refractory, and 29 (85%) were carfilzomib-refractory. Twenty-five (74%) were refractory to the combination of carfilzomib with anIMiD. Five patients (14.7%) had priordaratumumab, and 4 (12%) had prior HDAC-i therapy. Median number of cycles withpano was 1 (range 1-5). The overall response rate (≥ partial response (PR)) was 23.5% and the clinical benefit rate (≥ minor response (MR)) was 67.6%. The median duration of response (≥ stable disease (SD)) was 3 months. The median progression-free survival (PFS) for all patients was 2.3 months (95% CI: [1.27 - 4.07]). See Figure 1. Median overall survival (OS) from initiation ofpano through 7/27/16 was 5.5 months (95% CI: [3.93, NA]). See Figure 2. Of the 4 patients who were refractory to a prior HDAC-i, 1 achieved PR (4 cycles), 1 achieved MR (5 cycles) and 2 had disease progression. Only 1 patient discontinuedpano due to toxicities. Grade 3 and 4 non-hematologic toxicities were diarrhea (N=1), and hypoxia/respiratory failure (N=1). Grade 3 and 4 hematologic toxicities occurred in 11 (32%) patients, with 5 (15%) anemia, 9 neutropenia (26%), and 8 (24%) thrombocytopenia. Serious adverse events included acute kidney injury, GI bleed, and febrile neutropenia in 3 patients, respectively. Conclusions: These observations demonstrate that real-world use ofpano outside of the FDA indication in combination with PI andIMiD-based regimens has activity and is well tolerated in heavily pretreated patients with relapsed/refractory MM, even those who have exhausted conventional treatments. Further assessment in a larger prospective study is warranted. Figure 1 PFS of all patients receivingpanobinostat-based regimens Figure 1. PFS of all patients receivingpanobinostat-based regimens Figure 2 OS of all patients receivingpanobinostat-based regimens from time of initiatingpanobinostat Figure 2. OS of all patients receivingpanobinostat-based regimens from time of initiatingpanobinostat Disclosures Biran: Takeda: Speakers Bureau; Celgene: Speakers Bureau; Novartis: Speakers Bureau; Amgen: Speakers Bureau. Vesole:Janssen: Speakers Bureau; Novartis: Speakers Bureau; Takeda: Speakers Bureau; Celgene: Speakers Bureau; Amgen: Speakers Bureau. Richter:Celgene: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Jannsen: Speakers Bureau. Siegel:Celgene: Honoraria, Speakers Bureau; Merck: Honoraria; Takeda: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; BMS: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau.

Real-world safety and efficacy data of patients with synchronous metastatic renal cell carcinoma (mRCC) treated with nivolumab and ipilimumab (N+I) and the primary tumour (PT) in place.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17083-e17083
Author(s):  
Aafke Meerveld-Eggink ◽  
Niels Graafland ◽  
Sofie Wilgenhof ◽  
Johannes V. Van Thienen ◽  
Michael Grant ◽  
...  
Keyword(s):  
Real World ◽  
Tumour Size ◽  
Primary Tumour ◽  
Standard Of Care ◽  
Complete Response ◽  
World Population ◽  
Safety And Efficacy ◽  
Poor Risk ◽  
Grade 3 ◽  
Metastatic Sites

e17083 Background: Following CARMENA and SURTIME, upfront cytoreductive nephrectomy (CN) is no longer standard of care. Intermediate and poor risk patients (pts) receive systemic therapy with the PT in place with the option to perform deferred CN in responding pts. This practice has been adopted after the recent shift to immune checkpoint inhibitor combination in frontline for mRCC. We assessed the safety and efficacy of this approach in a real-world population. Methods: A retrospective analysis of a clinical audit from 3 institutional datasets of pts treated with first-line N+I and the PT in place. Pts and tumour characteristics, International Metastatic RCC Database Consortium (IMDC) risk, overall response rate (ORR) in the PT and metastatic sites, time to response (TTR) of the PT, PT- and immune related- (ir) adverse events (AE), deferred CN rate, progression free- (PFS) and overall survival (OS) were assessed. Results: Of 41 pts treated with N+I and the PT in place, 46.3% were IMDC poor risk and 51.2% had > 3 metastatic sites. After a median follow-up of 5.9 (2-10.3) months, 29 had at least 1 CT scan from baseline. Of those, 7 (24.3% [95% confidence interval [CI] 0.10-0.43]) had a partial response (PR) of the PT with a median TTR of 5.3 (2.5-8.6) months. Mean and median PT reduction were 16.9% (+7.6 to -70.3%) and 10% from a baseline mean tumour size of 9.5 (3.8-16.1) cm. Pts with a PT reduction > median (n = 14) had a PR at metastatic sites in 86% (CI 0.57-0.98) and no progressive disease (PD). Pts with PT reduction < median (n = 14) had PR in only 21% and PD at metastatic sites in 57% (CI 0.28-0.82). None of the PT progressed. There was no complete response (CR) at metastatic sites . No CN was performed; 5 pts (12%) developed hematuria grade 1-3, requiring embolisation in 2 (4.9%). Grade 3-4 irAE were observed in 22% of pts. Median PFS and OS are 8.6 months and not reached. Conclusions: N+I with the PT in place is safe and PT reduction is associated with response at metastatic sites. Most PT responded by 6 months. No CR at metastatic sites were observed (compared to a 9% CR rate in the pivotal trial) in this real-world population with a relatively high percentage of poor-risk pts. Furthermore, no deferred CN has been performed, neither for near-CR at metastatic sites nor for PT symptoms.

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