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 outcomes with panobinostat in patients with penta- and quad-refractory multiple myeloma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19522-e19522 ◽  
Author(s):  
Noa Biran ◽  
David H. Vesole ◽  
Shijia Zhang ◽  
Joshua Ryan Richter ◽  
Yen Hong Kuo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Kidney Injury ◽  
Progression Free Survival ◽  
Median Number ◽  
Minor Response ◽  
Duration Of Response ◽  
Grade 3 ◽  
Gi Bleed ◽  
Line Of Therapy

e19522 Background: Panobinostat (pano) is a pan histone de-acetylatase inhibitor (HDAC-i) approved by the FDA for use with bortezomib (btz) and dexamethasone (dex) for patients with multiple myeloma (MM) who have had ≥2 prior lines of therapy including both btz and an immunomodulatory agent (IMiD). The goal of this retrospective study is to evaluate the efficacy and safety of pano in combination with a variety of FDA approved agents as would be utilized in a real world management in relapsed/refractory (RR) MM. Methods: Between February 2015 and July 2016, 37 consecutive patients with RRMM treated with commercial pano were identified and the electronic medical record was reviewed. Results: Median age was 62 (range 27-78), with 57% percent male. Ten (27%) had high-risk FISH as defined by t(14;16), t(4;14), del p53, and gain 1q21. Median number of prior lines was 6 (range 2-9). All patients were RR to their last line of therapy, and 20 (54%) were btz-refractory, 27 (73%) were lenalidomide-refractory, 29 (78%) were pomalidomide-refractory, and 29 (78%) were carfilzomib-refractory. Thirty-three (89%) were penta-refractory; eight (21%) were penta-refractory, and 4 (11%) were refractory to prior HDAC-i therapy. Median number of cycles with pano was 2 (range 0.25 - 10). The overall response rate (≥ partial response) was 29.4% and the clinical benefit rate (≥ minor response) was 71.4%. Median progression-free survival was 2.4 months (95% CI: [1.63 – 4.43]). Median duration of response (≥SD) was 4.1 months. Median overall survival from initiation of pano was 7.5 months (95% CI: [5.17, NA]). One patient discontinued pano due to AEs. Grade 3 and 4 non-hematologic toxicities were diarrhea (N = 1), and respiratory failure (N = 1). Grade 3 and 4 hematologic adverse events (AEs) occurred in 13 (35%) patients, with 7 (19%) anemia, 11 neutropenia (30%), and 10 (37%) thrombocytopenia. Serious AEs included acute kidney injury, GI bleed, and febrile neutropenia each occurring in 1 patient. Conclusions: Use of pano outside of the FDA indication in combination with PI and IMiD-based regimens has activity and is well tolerated in quad and penta-refractory MM patients.

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.

scholarly journals Real world analysis of high-cut-off (HCO) hemodialysis with bortezomib-based backbone therapy in patients with multiple myeloma and acute kidney injury

2020 ◽  
Author(s):  
N. Steiner ◽  
A. Abdel Hamid ◽  
A. Kronbichler ◽  
H. Neuwirt ◽  
M. Myslivecek ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Acute Kidney Injury ◽  
Real World ◽  
Kidney Injury ◽  
Median Number ◽  
Poor Survival ◽  
Real World Data ◽  
The Czech Republic ◽  
Cast Nephropathy ◽  
Serum Free Light Chains

Abstract Background In patients with multiple myeloma (MM) free light chain-induced cast nephropathy is a serious complication associated with poor survival. High-cut-off (HCO) hemodialysis can reduce the amount of serum free light chains (sFLC), but data on its impact on clinical outcome is limited and contradictory. To gain further insights we collected real world data from two major myeloma and nephrology centers in Austria and the Czech Republic. Methods Sixty-one patients with MM and acute kidney injury, who were treated between 2011 and 2019 with HCO hemodialysis and bortezomib-based MM therapy, were analyzed. Results The median number of HCO hemodialysis sessions was 11 (range 1–42). Median glomerular filtration rate at diagnosis was 7 ± 4.2 ml/min/1.73m2. sFLC after the first HCO hemodialysis decreased by 66.5% and by 89.2% at day 18. At 3 and 6 months, 26 (42.6%) and 30 (49.2%) of patients became dialysis-independent. Conclusion The widely used strategy combining HCO hemodialysis and bortezomib-based antimyeloma treatment is dissatisfactory for half of the patients undergoing it and clearly in need of improvement.

Safety and Efficacy of the Combination of Bortezomib with the Deacetylase Inhibitor Romidepsin in Patients with Relapsed or Refractory Multiple Myeloma: Preliminary Results of a Phase I Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1167-1167 ◽  
Author(s):  
Miles Prince ◽  
Hang Quach ◽  
Paul Neeson ◽  
Mitch Keegan ◽  
Michael Copeman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Peripheral Neuropathy ◽  
Phase I ◽  
Dose Escalation ◽  
Proteasome Inhibitor ◽  
Response Rate ◽  
Median Number ◽  
Synergistic Activity ◽  
Minor Response ◽  
Grade 3

Abstract INTRODUCTION. There is substantial pre-clinical data demonstrating single agent and synergistic activity of the proteasome inhibitor (PI) bortezomib and deacetylase inhibitors (DACi) in multiple myeloma (MM). This is the first clinical trial combining these two classes of drugs. METHODS. This is an ongoing open label single-centre single-arm phase I/II dose escalation trial of bortezomib, dexamethasone and romidepsin (depsipeptide) in patients with relapsed or refractory MM. All patients received bortezomib (1.3 mg/m2; d1,4,8,11) with dexamethasone (20mg d1,2,4,5,8,9,11,12). The dose escalation of romidepsin commenced at a dose of 8 mg/m2 IV d1, 8, 15 every 28d and involved an initial accelerated dose escalation phase, with intra-patient dose escalation of romidepsin. Response rates were assessed according to M-protein response criteria, with complete responses documented by EMBT criteria. RESULTS. To date, 8 patients have entered the study with 7 evaluable for response and toxicity. Median number of prior therapies = 2 (range: 2–5). Most patients had previously taken potential neurotoxic medications; vincristine-containing (3), thalidomide (4), bortezomib (1). No dose-limiting toxicities (NCI-CTC v3: defined as platelets <25 × 109/L; Grade 4 neutropenia despite G-CSF support; Grade 3 or 4 nausea, emesis or diarrhoea despite treatment; any other Grade 3 or 4 non-haematological toxicity; > 4 week suspension of treatment due to toxicity) were demonstrated at romidepsin doses of 8mg (n=1) or 10mg (n=3). At doses of 12mg, 3 episodes of Grade 4 thrombocytopenia occurred and one episode of febrile neutropenia. Of note, 2 of the patients with Grade 4 thrombocytopaenia had platelets below 100 × 109/L prior to commencing the combination (at inclusion, patients must have had a platelet count >50 × 109/L). Other drug-related toxicities observed include: Grade 3: fatigue (n=1), neutropaenia (n=1), sepsis (n=1); Grade 2: fatigue (n=1), peripheral neuropathy (n=2), nausea (n=1), diarrhoea (n=1). Two patients required dose reduction of bortezomib due to peripheral neuropathy (these patients were co-administered 12 mg/m2 romidepsin). As of August 2007, the median number of cycles delivered was 3; 3 patients have progressed (after Cycle 1 (n=2), and Cycle 4 (n=1). There has been 1 immunofixation negative Complete Response, 3 Partial Responses and 1 Minor Response with an overall response rate of 5/7 (71%). Most patients remain on the combination therapy (n=5/8). The trial continues accruing patients at the doses of romidepsin (10 mg/m2) with bortezomib (1.3 mg/m2). CONCLUSION. These early results demonstrate efficacy with a promising response rate and some durable responses with acceptable toxicity of a proteasome inhibitor-DACi combination. There are planned regimen scheduling modifications to address the current dose limiting toxicity of transient thrombocytopenia.

scholarly journals Study of Gemcitabine Plus Nab-Paclitaxel-Based Chemotherapy Regimen as First-Line Treatment in Metastatic Pancreatic Carcinoma

2021 ◽  
Author(s):  
Kshitij Domadia ◽  
Varun Goel ◽  
Venkata Pradeep Babu Koyyala ◽  
Nivedita Patnaik ◽  
Krushna Chaudhari ◽  
...  
Keyword(s):  
Pancreatic Carcinoma ◽  
Chemotherapy Regimen ◽  
Objective Response ◽  
Safety Data ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
First Line ◽  
Significant Difference ◽  
Grade 3

Background The purpose of this study was to study the effectiveness of gemcitabine and nab-paclitaxel combination as first-line chemotherapy regimen for the treatment of metastatic pancreatic cancer. There is scarcity of data regarding efficacy and toxicity profile of this combination in Indian population. Aims and Objectives The primary aim of this study was to assess efficacy of this regimen, for which evaluation done in terms of the objective response rate, progression-free survival (PFS), and overall survival. Safety data were also evaluated. Materials and Methods In this prospective study, gemcitabine plus nab-paclitaxel combination chemotherapy was given as first line in metastatic pancreatic carcinoma patients till progression or appearance of grade 3/4 toxicities with treatment. Results The study was performed in 30 patients comprising 18 (60%) males and 12 (40%) females. The median age was 60 years. Median number of cycles administered were six cycles per patient. Seventeen patients (56.67%) had a partial response and 0% had complete response. A total of seven (23.3%) patients progressed on chemotherapy and six (20%) had stable disease (SD). The disease control rate (responses and SD) was 76.7%. The median PFS was 5.75 months. There was no statistically significant difference in terms of response rates and baseline CA 19-9 levels. Most common toxicities were hematological toxicities with rates of grade 3/4 anemia and neutropenia of 20%. Among nonhematological toxicities, nausea (46.67%) and fatigue (30%) were the commonest. Conclusion Combination of gemcitabine and nab-paclitaxel is active and well tolerated in advanced pancreatic carcinoma. To the best of our knowledge, this is the first such study conducted in India.

Factors associated with efficacy of TAS-102 in patients with refractory metastatic colorectal cancer (mCRC).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 858-858
Author(s):  
Peter Grell ◽  
Josef Dvorak ◽  
Michal Vocka ◽  
Stanislav John ◽  
Helena Tuskova ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Real World ◽  
Progression Free Survival ◽  
Median Number ◽  
Tumor Location ◽  
Factors Associated ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Practice Methods ◽  
Ecog Ps

858 Background: TAS-102 significantly improved progression free survival (PFS) and overall survival (OS) versus placebo in patients with treatment refractory mCRC. We analyzed potential predictive and prognostic factors in patients treated with TAS-102 in real-world practice. Methods: We retrospectively evaluated the clinical data of 129 patients who received TAS-102. Different factors associated with PFS and OS were analyzed. Results: Baseline characteristics were: median age 67 (range 37-83), male 63.6%, ECOG PS 0 in 40.3% and 1 in 59.7%. Primary tumor location: right 20.2%, left 79.2%, wt RAS 45%. Median number of TAS-102 treatment line 3 (range 2-8). Prior treatment: anti-EGFR 45%, anti-VEGF 83%, and regorafenib 20.9%. Median follow-up was 9.4 months. The median number of cycles of TAS-102 was 3 (range 1-14). Best achieved response was SD in 23%. Median PFS was 3.3 months and OS was 11.1 months. Any ≥ grade 3 AE was in 45%, the most common ≥ grade 3 AEs were neutropenia (40.2%), anemia (6.2%), thrombocytopenia (4.7%), febrile neutropenia (2.3%), diarrhea (1.6%), nausea (1.6%), and asthenia (1.6%). Dose reduction was needed in 29.5% and cycle delay in 53.5%. Factors significantly associated with longer PFS were: initiation of TAS-102 treatment more than 3 months from last fluoropyrimidine therapy (p = 0.022, HR 0.633), normal baseline CRP level (p = 0.004, HR 0.479), baseline WBC < 8 × 109/L (p = 0.025, HR 0.641), monocytes < 0.5 × 109/L (p = 0.016, HR 0.522), neutropenia ≥ grade 2 during treatment (p < 0.0001, HR 0.349), TAS-102 dose reduction during treatment (p < 0.0001, HR 0.397), and TAS-102 cycle delay (p < 0.0001, HR 0.402). Factors associated with longer OS were normal CRP (p = 0.001, HR 0.295), normal LDH (p = 0.006, HR 0.422), WBC < 8 × 109/L (p = 0.0001, HR 0.357), monocytes < 0.5 × 109/L (p = 0.016, HR 0.373), neutropenia ≥ G2 during treatment (p = 0.0002, HR 0.343), TAS-102 cycle delay (p = 0.002, HR 0.421), wt RAS (p = 0.05, HR 0.578). Conclusions: This analysis confirms that TAS-102 is effective in patients with refractory mCRC treated in a real-world setting. Factors associated with better outcomes were baseline CRP, WBC, monocytes, and neutropenia, dose reduction and cycle delays during the treatment.

scholarly journals Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

2021 ◽  
Vol 10 (7) ◽  
pp. 1509
Author(s):  
Evangelos Terpos ◽  
Panagiotis Repousis ◽  
Chrysavgi Lalayanni ◽  
Evdoxia Hatjiharissi ◽  
Theodora Assimakopoulou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Low Dose ◽  
Safety Data ◽  
Progression Free Survival ◽  
Routine Care ◽  
Refractory Multiple Myeloma ◽  
Kaplan Meier ◽  
Line Of Therapy

The “POWERFUL” multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3–47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan–Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4–14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade  ≥  3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging.

Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma

Blood ◽  
2009 ◽  
Vol 114 (4) ◽  
pp. 772-778 ◽  
Author(s):  
Paul Richardson ◽  
Sundar Jagannath ◽  
Mohamad Hussein ◽  
James Berenson ◽  
Seema Singhal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Single Agent ◽  
Progression Free Survival ◽  
Prior Treatment ◽  
Once Daily ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Treatment Regimens ◽  
Common Grade ◽  
Grade 3

Abstract Lenalidomide plus dexamethasone is effective for the treatment of relapsed and refractory multiple myeloma (MM); however, toxicities from dexamethasone can be dose limiting. We evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed and refractory MM. Patients (N = 222) received lenalidomide 30 mg/day once daily (days 1-21 every 28 days) until disease progression or intolerance. Response, progression-free survival (PFS), overall survival (OS), time to progression (TTP), and safety were assessed. Overall, 67% of patients had received 3 or more prior treatment regimens. Partial response or better was reported in 26% of patients, with minimal response 18%. There was no difference between patients who had received 2 or fewer versus 3 or more prior treatment regimens (45% vs 44%, respectively). Median values for TTP, PFS, and OS were 5.2, 4.9, and 23.2 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (60%), thrombocytopenia (39%), and anemia (20%), which proved manageable with dose reduction. Grade 3 or 4 febrile neutropenia occurred in 4% of patients. Lenalidomide monotherapy is active in relapsed and refractory MM with acceptable toxicities. These data support treatment with single-agent lenalidomide, as well as its use in steroid-sparing combination approaches. The study is registered at http://www.clinicaltrials.gov as NCT00065351.

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.

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 .

Sign in / Sign up

Export Citation Format

Share Document