First-line osimertinib in EGFR mutation-positive non-small cell lung cancer patients with poor performance status

2021 ◽  
Author(s):  
Shigemasa Takamizawa ◽  
Yusuke Okuma ◽  
Yasuhiro Kato ◽  
Taiki Hakozaki ◽  
Shingo Kitagawa ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Kinase Inhibitors ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
First Line ◽  
Free Survival ◽  
Lung Cancer Patients ◽  
Egfr Tyrosine Kinase Inhibitors

Background: The efficacy of osimertinib as a first-line treatment for patients with poor performance status (PS) remains unclear. Patients & methods: This multicenter retrospective study evaluated patients treated with osimertinib between 2018 and 2020, with PS 2–4. Results: Among 36 patients with PS 2, the median progression-free survival (PFS), 1-year PFS, median overall survival (OS) and 1-year OS were 14.5 months, 65.4%, 18.1 months and 72.7%, respectively. Among 20 patients with PS 3–4, the median PFS, 1-year PFS, median OS and 1-year OS were 3.0 months, 27.1%, 5.0 months and 46.1%, respectively. Conclusion: Osimertinib was not as efficacious as other EGFR-tyrosine kinase inhibitors.

Attenuated regimen of biweekly gemcitabine/nab-paclitaxel in patients aged > 65 years with advanced pancreatic cancer (APC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 705-705
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  
Keyword(s):  
Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Weekly Schedule ◽  
Free Survival ◽  
Kaplan Meier ◽  
Ecog Ps ◽  
Dose Reductions

705 Background: Treatment with gemcitabine/nab-paclitaxel confers a survival benefit over gemcitabine monotherapy in APC. However, such treatment can be associated with significant toxicities especially in older patients and carries practical disadvantages related to a weekly schedule along with financial cost. We retrospectively analyzed patients > 65 years of age with APC who received a modified biweekly regimen of gemcitabine/nab-paclitaxel to evaluate efficacy and toxicity. Methods: Patients aged > 65 years with chemo-naive APC and ECOG PS < 2 were studied. Patients were treated with a modified regimen of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 every 2 weeks on days 1 and 15 of a 28-day cycle. Patients were evaluated for progression-free survival (PFS) and overall survival (OS) with analyses performed using Kaplan-Meier method. Adverse events were recorded on the day of chemotherapy. CA19-9 was measured every cycle and restaging scans were performed every two cycles. Results: Seventy-three patients (median age: 73; range: 66 - 93) were treated with biweekly gemcitabine/nab-paclitaxel as first-line treatment. The median OS and PFS were 9.1 months and 4.8 months respectively. 66% of patients received growth factor support based on ASCO guidelines and no patients developed neutropenic fever. The incidence of grade > 3 toxicity for neutropenia, anemia, thrombocytopenia, and neurotoxicity were 2%, 7%, 3%, and 5% respectively. Dose reductions of gemcitabine/nab-paclitaxel were required in 10% and 4% patients respectively. Conclusions: In patients > 65 years of age with APC, a modified regimen of biweekly gemcitabine/nab-paclitaxel was found to be effective when compared with historical control from the MPACT study. This regimen allowed for less dose reductions, reduced healthcare costs from additional appointments, travel-related cost, as well as favorable side effect profile while maintaining efficacy. Though retrospective in nature, this study underlines the need for further investigation, particularly in elderly patients with APC and poor performance status. Better tolerability may allow for combination with a third agent, such as a targeted or immunotherapy.

scholarly journals Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A retrospective multicenter study

Liver Cancer ◽  
2022 ◽  
Author(s):  
Sabrina Welland ◽  
Catherine Leyh ◽  
Fabian Finkelmeier ◽  
André Jefremow ◽  
Kateryna Shmanko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Median Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Inclusion Criteria ◽  
First Line ◽  
Ecog Performance Status ◽  
Free Survival ◽  
First Line Treatment

Background Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria. Methods A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

Rituximab Plus Bendamustin (R-B) Treatment In Patients with Aggressive Large B-Cell Lymphoma (LBCL): Response and Tolerability - a Single Institution Experience

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4900-4900
Author(s):  
Julia Horn ◽  
Martina Kleber ◽  
Ulrike Kohlweyer ◽  
Stefanie Hieke ◽  
Regina Herzog ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
B Cell Lymphoma ◽  
Poor Performance Status ◽  
First Line ◽  
Documentation System ◽  
Cd34 Cells ◽  
Grade Iii

Abstract Abstract 4900 Introduction: Clinical studies have shown that Rituximab plus Bendamustin (R-B) in indolent lymphoma results in favourable responses, progression free survival (PFS) and lower toxicity as compared to R-CHOP. The aim of this analysis was to characterize response and tolerability of R-B in patients with LBCL, who were not qualifying for R-CHOP due to age, comorbidity and/or prior pretreatment (including anthracyclines). Methods: We retrospectively identified consecutive patients with LBCL receiving at least two cycles of R-B in our department between 2003 and 2010 using our electronic tumor documentation system. Patient characteristics, response to R-B, and toxicity were assessed. Results: We identified 9 caucasian patients (5 females, 4 males) with LBCL; their median age was 71 years (range; 51–82). Two presented with stage I/II, seven with stage III/IV disease at initial diagnosis and before R-B. Six patients had a low or intermediate IPI and three were high risk. Four patients received R-B as first-line therapy, and five were treated for relapsed or refractory disease. Main determinants for the R-B-selection were contraindications for anthracyclines in five patients and advanced age and/or poor performance status in four patients. A median of four R-B-cycles were applied (range; 2–6). Response with achievement of CR and PR was observed in 6/9 (CR: 2, PR: 4), two achieved SD. Only one pt showed PD after four R-B cycles. The response of R-B in first-line vs. relapsed appeared similar. Of note, one female patient with secondary LCBL, after initial Hodgkin's lymphoma and C-MOPP chemotherapy (CTx) and mediastinal irradiation - with excellent response to R-B- failed to successfully mobilize PBSC thereafter. However, she was effectively mobilized with R-Ara-C-thiotepa (peripheral blood CD34+ cells were 5.82 vs. 54/μl, obtaining no vs. 6.72 × 106 CD34+ cells/kg KG via leukapheresis, respectively). Clinical tolerance of R-B in all patients was excellent in a total of 31 R-B-cycles, only two major CTC-events occurred: one infection (CTC grade III) and one thromboembolism (grade IV). Median PFS and overall Survival (OS) were 16 (7- not reached) and 20 (11-21) months. Conclusions: If standard R-CHOP cannot be given due to age, comorbidity or CTx-contraindications (e.g. anthracyclines), R-B may represent an effective treatment in LBCL. Larger cohorts and prospective clinical trials are needed to confirm these promising results. Currently, patients with grade III/IV follicular lymphoma are additionally evaluated for response and tolerability under R-B, also being presented at the meeting. Disclosures: No relevant conflicts of interest to declare.

221 Poor performance status negatively affects survival benefit of immunotherapy in non-small cell lung cancer

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A240-A240
Author(s):  
Hameem Kawsar ◽  
Pramod Gaudel ◽  
Nahid Suleiman ◽  
Mohammed Al-Jumayli ◽  
Chao Huang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Free Survival ◽  
Good Performance Status ◽  
Ecog Ps

BackgroundImmunotherapy has shown survival benefit as both frontline and subsequent therapy in multiple cancers. However, its efficacy in patients with poor performance status is unknown since they are excluded from the clinical trials. We conducted a retrospective study to investigate the effect of poor performance status (PS) on survival in patients with non-small cell lung cancer (NSCLC) who received immunotherapy as a subsequent line of treatment.MethodsWe reviewed the medical records of 341 patients with NSCLC receiving immunotherapy as between July 2013 and June 2018. Progression-free survival and overall survival was calculated using Kaplan-Meier curve.ResultsThe average age of patients was 66 years (range: 39–90 years), with a male predominance (57%). Majority of the patients were Caucasian (87%), followed by African-American (12%), and Asian (1%). Most of the patients were former smoker (72%), followed by current smoker (19%) and never smoker (7%). Adenocarcinoma and squamous cell carcinoma was diagnosed in 206 (60%) patients and 112 (33%) patients, respectively. The ECOG-PS was 0, 1, 2 and 3 in 46 (13%), 175 (51%), 86 (25%) and 34 (10%), respectively. Four different immunotherapies were used, namely atezolizumab in 10 (3%), durvalumab in 34 (10%), nivolumab in 152 (44%) and pembrolizumab in 144 (42%) patients. Average number of cycles of atezolizumab received by the patient was 6 (range 2–22 cycles), durvalumab 15 (range 1–29 cycles), nivolumab 11 (range 1–112 cycles), and pembrolizumab 12 (range 1–52 cycles). Patients were grouped in good performance status (ECOG 0–1) and poor performance status (ECOG ≥2). The median progression free survival (PFS) was 7 months (95% CI 6.3–8.2) in patients with good PS and 3 months (95% CI 1.8–4.6) in patients with poor performance status (p<0.001). The median overall survival (OS) for patients with good performance status was 30 months (95% CI 16.6–42.3) and 4 months (95% CI 3.2–8.1) in patients with poor PS (figure 1). Adverse effects were recorded in a total of 83 (24%) patients, 18 (5%) patients had ECOG-PS 0, 50 (14%) patients had ECOG-PS 1, 18 (4%) patients had ECOG-PS 2 and 3 (1%) patients had ECOG-PS of 3. Most common adverse effects were pneumonitis (28%), diarrhea (8%) and hypothyroidism (8%).Abstract 221 Figure 1Progression free survival (PFS) and overall survival (OS) in patients with good performance status (ECOS PS 0–1) and poor performance status (ECOG ≥2) treated with immunotherapy in NSCLCConclusionsOur data suggests that while the patients with poor PS tolerated the immunotherapy. However, poor PS was associated with significantly lower PFS and OS. Further studies are required to evaluate the effect of PS on survival in frontline immunotherapy.AcknowledgementsWe thank Dr. Saqib Abbasi for helpful discussions.Trial RegistrationN/AEthics ApprovalThe study was approved by the Institution Review Board at KUMC, #CR00009003.ReferencesN/A

scholarly journals Clinical Effectiveness of Immune Checkpoint Inhibitors in Non-Small-Cell Lung Cancer with a Poor Performance Status

Medicina ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 1273
Author(s):  
Kyoichi Kaira ◽  
Hisao Imai ◽  
Atsuto Mouri ◽  
Ou Yamaguchi ◽  
Hiroshi Kagamu
Keyword(s):  
Lung Cancer ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
First Line ◽  
Lung Cancer Patients

Immune checkpoint inhibitors (ICIs) are standard treatments for patients with lung cancer. PD-1/PD-L1 or CTLA4 antibodies are chosen as the first-line therapy, contributing to the long-term survival and tolerability. Unlike molecular targeting agents, such as gefitinib, lung cancer patients with a poor performance status (PS) display unsatisfactory clinical improvements after ICI treatment. Several previous reports also demonstrated that the PS is identified as one of the most probable prognostic factors for predicting poor outcomes after ICI treatment. However, first-line pembrolizumab seemed to be effective for lung cancer patients with a PS of 2 if PD-L1 expression was greater than 50%. Currently, the induction of ICIs in patients with lung cancer with a poor PS is controversial. These problems are discussed in this review.

scholarly journals Phase II Clinical Trial of Gefitinib for the Treatment of Chemonaïve Patients with Advanced Non-small Cell Lung Cancer with Poor Performance Status

2014 ◽  
Vol 8 ◽  
pp. CMO.S15172 ◽  
Author(s):  
Nagla Abdel Karim ◽  
Salma Musaad ◽  
Ahmad Zarzour ◽  
Sadanand Patil ◽  
Abdul Rahman Jazieh
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Free Survival

Background Patients with advanced non-small cell lung cancer (NSCLC) have no curative treatment options; therefore, improving their quality of life (QOL) is an important goal. Gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, is a safe oral agent that may be of benefit to a specific population of NSCLC. Patients and Methods A Phase II clinical trial included chemonaïve patients with advanced NSCLC and poor performance status (PS). Response rate, progression-free survival, overall survival, QOL using the Functional Assessment of Cancer Therapy – Lung (FACT-L) questionnaire, and Trial Outcome Index (TOI) were evaluated. Results Twelve out of 19 enrolled patients were evaluable. The median age for the evaluable patients was 68.8 years (59.7–74.6). Out of all the patients, 7 (58.3%) had adenocarcinoma and 5 (41.7%) had squamous cell carcinoma. The median duration of treatment was 62.5 days (26.5–115.0) in the evaluable patients. Grade 3/4 toxicities included fatigue, rash, diarrhea, and nausea. One patient had partial response, eight patients had stable disease (SD), and three patients progressed. The median overall survival for the evaluable population was 4.9 months (2.3–16). The median progression-free survival was 3.7 months (1.9–6.6). TOI was marginally associated with the overall survival, with a hazard ratio of 0.92 (95% confidence interval: 0.84, 1.0) ( P = 0.061). FACT-L score and the TOI were highly correlated ( r = 0.96, P < 0.0001). TOI scores were higher in African Americans compared to Caucasians and increased with age. Conclusion Our results suggest that gefitinib use in patients with NSCLC and poor PS may improve the QOL of older patients and African American patients.

Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma

Blood ◽  
2009 ◽  
Vol 113 (15) ◽  
pp. 3435-3442 ◽  
Author(s):  
Heinz Ludwig ◽  
Roman Hajek ◽  
Elena Tóthová ◽  
Johannes Drach ◽  
Zdenek Adam ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Elderly Patients ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Interferon Α ◽  
Poor Performance Status ◽  
Time To Progression ◽  
Free Survival ◽  
Odd Cycles

AbstractWe compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM). Patients received either thalidomide 200 mg plus dexamethasone 40 mg, days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles, during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle. Patients achieving stable disease or better were randomly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon α-2b thrice weekly or to 3 MU interferon α-2b thrice weekly only. TD resulted in a higher proportion of complete and very good remissions (26% vs 13%; P = .006) and overall responses (68% vs 50%; P = .002) compared with MP. Time to progression (21.2 vs 29.1 months; P = .2), and progression-free survival was similar (16.7 vs 20.7 months; P = .1), but overall survival was significantly shorter in the TD group (41.5 vs 49.4 months; P = .024). Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status. The study was registered at ClinicalTrials.gov as NCT00205751.

Sign in / Sign up

Export Citation Format

Share Document