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 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.

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 EVALUATION OF THE EFFICIENCY AND TOLERABILITY OF MONO THERAPY WITH ORAL ETOPOSIDE IN ELDERLY PATIENTS (70+ YEARS OF AGE) WITH ADVANCED NON SMALL CELL LUNG CANCER AND POOR PERFORMANCE STATUS

2013 ◽  
Vol 6 ◽  
pp. 1
Author(s):  
Zoran Andrić ◽  
Vladimir Kovčin ◽  
Slobodanka Crevar ◽  
Zafir Murtezani ◽  
Sanja Kostić
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Poor Performance ◽  
Small Cell ◽  
Poor Performance Status ◽  
Oral Etoposide ◽  
Small Cell Lung

Motivation Until recently it was considered that 65 years is cutoff for defining patients as elderly, but newer reports indicate that this age limit shift to 70 years of age. Elderly patients with advanced non small cell lung cancer, associated comorbidities and poor performance status represent a specific population and a challenge for use of chemotherapy. Primary aim was to evaluate the impact of mono therapy with oral etoposide on overall survival in elderly patients (≥ 70 years of age) with advanced non small cell lung cancer and poor performance status (PS) ≥ 2 (clinical stage IIIb and IV ), and as well to evaluate tolerability of this therapy. Secondary aim was to evaluate response rate.Methods Retrospectively, medical records of 79 female and male patients with advanced non small cell lung cancer and poor performance status treated with oral etoposide (2x25 mg 20 days/10 days pause) in period from 2007 till 2010 were checked for relevant data. Data regarding demographics, performance status, overall survival, response rates and drug toxicity were collected. For statistical analysis we used Pearson chi-square test, T-test, Kaplan-Meier product limited method and Cox regression.Results Median overall survival (OS) was 31 weeks, in patients with PS 2 overall survival was 34 weeks, and in group with PS 3 was only 24 weeks. Partial response was registered in 20.2% of patients, stable disease in 41.85 % and disease progression in 38% of patients. Treatment was well tolerated, febrile neutropenia and toxic deaths were not registered. Toxic effects didn't have statistically significant influence on OS.Conclusion Oral etoposide used as mono therapy has been shown as moderate effective and very safe in treating elderly patients with advanced non small cell lung cancer and poor performance status so it represents a good therapy option for treating this specific population. 

Metronomic weekly paclitaxel in metastatic or recurrent non-small cell lung cancers.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19095-e19095 ◽  
Author(s):  
Nidhi Tandon ◽  
Vanita Noronha ◽  
Kumar Prabhash
Keyword(s):  
Performance Status ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Weekly Paclitaxel ◽  
Poor Performance Status ◽  
Motor Neuropathy ◽  
Small Cell Lung ◽  
Lung Cancers

e19095 Background: Metastatic non small cell lung cancer (NSCLC) has a median survival of 4 months in absence of therapy. We present our experience with metronomic weekly paclitaxel in patients with metastatic or recurrent NSCLC and those with poor performance status. Methods: This is a retrospective analysis of prospectively collected data of patients with metastatic or recurrent NSCLC without significant neuropathy who were heavily pretreated or platinum ineligible from Feb 2010 to Oct 2012 at our centre. Patients were treated with paclitaxel at 80 mg/m2 over 1 hour weekly and underwent regular follow up. Chemotherapy was discontinued on disease progression or intolerable side -effects or patients choice. Patients who received at least 4 cycles of chemotherapy were included in the analysis. Toxicity was graded according to CTCAEv4.03. Statistics were calculated using SPSSv18.0. The progression-free survival was calculated from date of start of paclitaxel till date of symptomatic deterioration, radiological progression or start of next line of therapy or death due to any cause. Overall survival was calculated from date of start of paclitaxel to the date of death due to any cause. Results: Of the 100 patients studied (median age = 57 y, range 29–77 y), 74% were males, 51% were smokers, 45% had comorbidities, 35% had PS>2 and 74% had adenocarcinoma. About 53% received >2 prior lines of chemotherapy. Patients received a mean of 16.9 cycles of paclitaxel (range 4-72) after which it was withheld in 63% due to PD (53% radiological, 10% clinical) and in 12% due to toxicity. The response rates were 37% (CR-3% and PR-34%) while 35% had SD. 9% required dose reduction while 32% had delay in dose administration. G.3 adverse events observed were 12%-anaemia, 10%-neutropenia, 2%-febrile neutropenia, 15%- sensory neuropathy and 4%-motor neuropathy. The median OS was 12 months while median PFS was 5 months. Conclusions: Weekly paclitaxel is a promising and well tolerated therapy for advanced NSCLC.

First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial

2020 ◽  
Vol 56 (2) ◽  
pp. 1902066 ◽  
Author(s):  
Armelle Lavole ◽  
Laurent Greillier ◽  
Julien Mazières ◽  
Isabelle Monnet ◽  
Lize Kiakouama-Maleka ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Cd4 Lymphocyte

HIV infection is an exclusion criterion in lung cancer trials. This multicentre phase II trial aimed to assess feasibility, efficacy and safety of first-line carboplatin plus pemetrexed (CaP) followed by pemetrexed (P) maintenance in people living with HIV (PLHIV) with advanced non-squamous non-small cell lung cancer (NS-NSCLC).Four cycles of CaP were followed by P-maintenance therapy in patients with Eastern Cooperative Oncology Group performance status ≤2. The primary objective was a disease control rate (DCR) ≥30% after 12 weeks.Of the 61 PLHIV enrolled, 49 (80%) had a performance status of 0–1, and 19 (31%) had brain metastases. Median CD4 lymphocyte count was 418 cells·µL−1 (range 18–1230), median CD4 lymphocyte nadir was 169.5 cells·µL−1 (1–822); 48 (80%) patients were virologically controlled. Four-cycle inductions were achieved by 38 (62%) patients, and 31 (51%) started P-maintenance (median of 4.1 cycles (range 1–19)). The 12-week DCR was 50.8% (95% CI 38.3–63.4) and partial response rate 21.3%. Median progression-free survival and overall survival were 3.5 (95% CI 2.7–4.4) and 7.6 months (5.7–12.8), respectively. Patients with a performance status of 0–1 had the longest median progression-free survival (4.3 months, 95% CI 3.1–5.2) and overall survival (11.9 months, 95% CI 6.4–14.3). During induction, CaP doublet was well tolerated apart from grade 3–4 haematological toxicities (neutropenia 53.8%; thrombocytopenia 35.0%; anaemia 30.0%). Two fatal treatment-related sepses were reported. No opportunistic infections were experienced.In PLHIV with advanced NS-NSCLC, first-line four-cycle CaP induction followed by P-maintenance was effective and reasonably well-tolerated. Further studies should evaluate combination strategies of CaP with immunotherapy in PLHIV.

scholarly journals EPSILoN: A Prognostic Score for Immunotherapy in Advanced Non-Small-Cell Lung Cancer: A Validation Cohort

Cancers ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 1954 ◽  
Author(s):  
Arsela Prelaj ◽  
Roberto Ferrara ◽  
Sara Elena Rebuzzi ◽  
Claudia Proto ◽  
Diego Signorelli ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Liver Metastases ◽  
Prognostic Score ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Prognostic Groups ◽  
Ecog Ps

Background: Beyond programmed death ligand 1 (PD-L1), no other biomarkers for immunotherapy are used in daily practice. We previously created EPSILoN (Eastern Cooperative Oncology Group performance status (ECOG PS), smoking, liver metastases, lactate dehydrogenase (LDH), neutrophil-to-lymphocyte ratio (NLR)) score, a clinical/biochemical prognostic score, in 154 patients treated with second/further-line immunotherapy. This study’s aim was to validate EPSILoN score in a different population group. Methods: 193 patients were included at National Cancer Institute of Milan (second-line immunotherapy, 61%; further-line immunotherapy, 39%). Clinical/laboratory parameters such as neutrophil-to-lymphocyte ratio and lactate dehydrogenase levels were collected. Kaplan–Meier and Cox hazard methods were used for survival analysis. Results: Overall median progression-free survival and median overall survival were 2.3 and 7.6 months, respectively. Multivariate analyses for Progression-Free Survival (PFS) identified heavy smokers (hazard ratio (HR) 0.71, p = 0.036) and baseline LDH < 400 mg/dL (HR 0.66, p = 0.026) as independent positive factors and liver metastases (HR 1.48, p = 0.04) and NLR ≥ 4 (HR 1.49, p = 0.029) as negative prognostic factors. These five factors were included in the EPSILoN score which was able to stratify patients in three different prognostic groups, high, intermediate and low, with PFS of 6.0, 3.8 and 1.9 months, respectively (HR 1.94, p < 0.001); high, intermediate and low prognostic groups had overall survival (OS) of 24.5, 8.9 and 3.4 months, respectively (HR 2.40, p < 0.001). Conclusions: EPSILoN, combining five baseline clinical/blood parameters (ECOG PS, smoking, liver metastases, LDH, NLR), may help to identify advanced non-small-cell lung cancer (aNSCLC) patients who most likely benefit from immune checkpoint inhibitors (ICIs).

scholarly journals nab-Paclitaxel/Carboplatin in Vulnerable Populations With Advanced Non-Small Cell Lung Cancer: Pooled Analysis

2021 ◽  
Vol 10 ◽  
Author(s):  
Corey J. Langer ◽  
Ajeet Gajra ◽  
Cesare Gridelli ◽  
Kartik Konduri ◽  
Daniel Morgensztern ◽  
...  
Keyword(s):  
Renal Impairment ◽  
Elderly Patients ◽  
Performance Status ◽  
Poor Performance ◽  
Pooled Analysis ◽  
Small Cell ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Patients With Diabetes ◽  
Ecog Ps

IntroductionDespite improvements in the treatment of advanced non-small cell lung cancer (NSCLC), certain patient populations remain underrepresented in clinical trials. Many patients have benefited from platinum doublets, including nab-paclitaxel–based regimens, but there are patients with comorbidities who particularly require careful balancing of efficacy and safety. Clinical trial data are limited for patients who are elderly or have renal impairment, diabetes, or impaired performance status.MethodsTo better understand outcomes in these patient populations, we performed a pooled analysis using data from the ABOUND clinical trial program (ABOUND.SQM, ABOUND.PS2, ABOUND.70+) and the key phase III trial of nab-paclitaxel/carboplatin in advanced NSCLC. The populations included in this pooled analysis consisted of elderly patients (≥ 70 years) and patients with renal impairment (eGFR &lt; 60 ml/min/1.73 m2), diabetes, or poor performance status (ECOG PS 2).ResultsMedian progression-free survival (PFS) ranged from 4.1 months in patients with ECOG PS 2 (95% CI, 2.04–5.09 months) to 7.7 months in patients with diabetes (95% CI, 5.88–10.12 months). PFS for elderly patients and patients with renal impairment was 6.9 months each (95% CI, 6.01–7.98 months and 4.47–9.79 months, respectively). Median overall survival (OS) was 18.2 months (95% CI, 10.94–28.22 months), 17.4 months (95% CI, 14.59–20.14 months), and 16.1 months (95% CI, 14.09–18.50 months) in patients with renal impairment, patients with diabetes, and elderly patients, respectively. Patients with ECOG PS 2 exhibited the shortest median OS: 5.6 months (95% CI, 3.98–11.37 months). Overall response rates were 56.9%, 54.6%, 45.9%, and 29.4% in patients with diabetes, elderly patients, patients with renal impairment, and patients with ECOG PS 2, respectively. Most treatment-related adverse events were hematologic. The most common grade 3/4 hematologic adverse events in patients with renal impairment, elderly patients, patients with diabetes, and patients with poor performance status included neutropenia, anemia, and thrombocytopenia.ConclusionsAlthough survival data in patients with ECOG PS 2 were notably inferior to the other cohorts, our findings are consistent with those previously reported in the population-specific studies of the ABOUND trials and lend additional support for the use of nab-paclitaxel–based regimens in historically understudied and vulnerable populations.

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