Measures of aggressive care in advanced non-small cell lung cancer (NSCLC) patients

9063 Background: Data suggests that cancer care has become more aggressive over the last decade. Patients with advanced NSCLC have a short life expectancy and achieve only a modest survival benefit from chemotherapy. Investigating the aggressiveness of care during and at the end of life (EOL) is a key first step to better understanding quality of care in this patient population. Methods: This exploratory study uses previously defined measures of aggressive care (Earle, JCO 22(2), 2004) to evaluate a small cohort of patients with advanced NSCLC. We performed a pilot study of integrated palliative care in good performance status (PS) patients with newly diagnosed advanced NSCLC, which has been previously reported. This is a retrospective chart review of patients accrued at Massachusetts General Hospital (MGH) using the electronic medical record and case report forms for data collection. Results: 46 patients were enrolled from 10/03 to 6/05 (median age 65.5, 28 female). 43 (93%) patients had stage IV disease and the remainder had stage IIIB with effusions. 45 (98%) of patients had PS 0–1. 39 (85%) patients died at the time of chart review with a median follow up of 29.3 months. Using Earle's data as a benchmark more patients in this study received and began new chemotherapy at the EOL. Patients were also more likely to present to the emergency room (ER) and be admitted to the hospital. While more patients were admitted to hospice before death, the length of stay (LOS) in hospice was shorter and many patients still died in acute care hospitals. Conclusions: This study supports the finding that current cancer care is aggressive with many patients receiving chemotherapy at the EOL and having a short LOS in hospice. [Table: see text] No significant financial relationships to disclose.

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Cost Drivers of Lung Cancer Care: Results From A Retrospective Chart Review of Pretreated Advanced Nsclc Patients in Europe

Value in Health ◽

10.1016/j.jval.2017.08.194 ◽

2017 ◽

Vol 20 (9) ◽

pp. A431-A432

Author(s):

CT Solem ◽

JR Penrod ◽

M Lees ◽

C Macahilig ◽

L Luo ◽

...

Keyword(s):

Lung Cancer ◽

Cancer Care ◽

Chart Review ◽

Advanced Nsclc ◽

Retrospective Chart Review ◽

Cost Drivers ◽

Nsclc Patients

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Treatment of stage IV NSCLC with chemotherapy in a community setting based on ECOG PS.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.30_suppl.62 ◽

2014 ◽

Vol 32 (30_suppl) ◽

pp. 62-62

Author(s):

Rahul Singh ◽

Jillian Saucier ◽

Andrew Michael Schreiber

Keyword(s):

Chart Review ◽

Performance Status ◽

Community Setting ◽

Stage Iv ◽

Retrospective Chart Review ◽

Cytotoxic Chemotherapy ◽

Ecog Performance Status ◽

Significant Difference ◽

Ecog Ps ◽

Nsclc Patients

62 Background: ECOG Performance Status (PS) plays a pivotal role in the decision to treat patients with NSCLC Stage IV. The current ASCO guidelines for offering cytotoxic chemotherapy in stage IV NSCLC state that a PS of ≤2 can be considered for intravenous treatment. The goal of our retrospective evaluation was to evaluate treatment patterns based on ECOG PS in a community setting. Methods: An IRB-retrospective chart review of all stage IV NSCLC patients at our institution between 1/1/2008 and 1/1/2013 was conducted. A total of 150 patients with NSCLC and an ECOG of ≤2 were randomly selected and reviewed from the cancer registry (12 were excluded for undocumented ECOG PS status). 138 patients were included. The data was analyzed using X2 test of independence, Fisher’s exact, and students T-Test all run by SAS 9.1. Results: Of the 138 patients observed, 92 (66.7%) had an ECOG PS of 0, 16 (11.6%) were PS 1 and 30 (21.7%) were PS 2. There were no significant differences in ECOG PS based on race, gender or payer status. Patients with a PS of 2 received chemotherapy (N=1/30, p <0.0001) significantly less than those with PS 0-1 (N=54/108, p <0.0001). Those with PS 2 were more likely to have additional comorbidities as well (N=23/30, p<0.0001) versus patients with a PS 0 or 1. Chemotherapy was not offered to 76.7% of patients with a PS of 2 (N= 23/30, p <0.0001). Conclusions: In our community setting cytotoxic chemotherapy was offered significantly less in patients with ECOG PS of 2 compared to those with 0 and 1. While it is more likely that patients with better PS will be offered treatment, this significant difference reflects practice that differs from ASCO’s guidelines. It is suspected the disparity in offering treatment depending on the PS of 2 vs 0-1 likely was due to many cofounding variables as well as provider and patient preference. Another disparity noted was that of undocumented ECOG PS. As the system of healthcare is switching to an electronic based system one proposed theory would be to add the quality measure ECOG PS as an additional vital sign in an oncologist progress note, with a prompt to consider chemotherapy in patients with PS ≤2 and not to consider in PS 3 or 4. This could greatly benefit the medical oncologist in considering possible treatment.

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The quantification of the catalytic subunit of telomerase in plasma is a prognostic factor in advanced non-small cell lung cancer (NSCLC) patients

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.7052 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 7052-7052

Author(s):

R. Sirera ◽

C. Camps ◽

L. Llobat ◽

A. Berrocal ◽

R. M. Bremnes ◽

...

Keyword(s):

Advanced Nsclc ◽

Performance Status ◽

Stage Iv ◽

Large Cell ◽

Complete Response ◽

Response To Therapy ◽

Catalytic Subunit ◽

Stage Iiib ◽

Circulating Dna ◽

Nsclc Patients

7052 Background: Qualitative and quantitative analysis of circulating DNA in blood is a promising non-invasive diagnostic and prognostic tool. Our aim was to study the association between the free amount in plasma of the catalytic subunit of telomerase (hTERT) and several clinical variables in advanced NSCLC patients. Methods: We examined 451 NSCLC patients in stage IIIB and IV, treated with cisplatin and docetaxel. Blood samples were collected before chemotherapy, and circulating DNA was extracted from the serum using commercial adsorption columns. The amount of free hTERT in plasma was quantified by using RT-PCR. Results: Median age was 61 years [35–82] and 84% were males. 99% had performance status 0–1. 84% were in stage IV and 16% in stage IIIB. The histological subtypes were: 32% squamous cell carcinoma, 50% adenocarcinoma, 14% anaplastic large cell, and 4% undifferentiated. 41% of the patients received second line chemotherapy. 1% achieved complete response (CR), 36% partial response (PR), 35% had stable disease (SD) and 28% progressive disease (PD). Median hTERT value was 4856 ng/ml; for patients in IIIB was 4847 ng/ml [263–964826] and 4886 ng/ml [67–4373520] in stage IV (p = 0.75). There was not association between hTERT values and response to therapy, 20588 ng/ml [122–317251] in the CR+PR group vs 50204 ng/ml [67–4373520] in the SD+PD group (p = 0.09). hTERT values were not related with the localization of the metastasis. Dividing the cohort in two sets according to hTERT median we found two significantly different groups in terms of Overall Survival (OS) and Time To Progression (TTP). Patients with hTERT <4856 ng/ml had a median TTP of 5.3 months (m) [4.4–6.1] while for hTERT >4856 ng/ml was 4.1 m [3.5–4.6], (p = 0.0009). OS when hTERT <4856 ng/ml was 10.1m [4.9–11.3] and for hTERT >4856 ng/ml was 8.4 m [7.2–9.5], (p = 0.01). In the multivariate analysis, hTERT was an independent predictive variable for TTP (HR 1.39, CI 95% 1.1–1.7, p = 0.002) and OS (HR 1.27, CI 95% 1.1–1.6, p = 0.04). Conclusions: In advanced NSCLC patients, the quantification of free circulating hTERT in plasma is an affordable and valuable prognostic marker. High plasma hTERT levels are a poor prognostic indicator for TTP and OS. No significant financial relationships to disclose.

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Randomized phase III trial of gemcitabine and cisplatin versus gemcitabine alone in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) 2: CAPPA-2 study.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.8066 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 8066-8066

Author(s):

Alessandro Morabito ◽

Vittorio Gebbia ◽

Saverio Cinieri ◽

Maria Grazia Viganò ◽

Roberto Bianco ◽

...

Keyword(s):

Advanced Nsclc ◽

Performance Status ◽

Single Agent ◽

Stage Iv ◽

Phase Iii ◽

Line Treatment ◽

First Line ◽

Platinum Based Chemotherapy ◽

Nsclc Patients ◽

First Line Treatment

8066 Background: Platinum-based chemotherapy (CT) is the standard treatment for patients (pts) with advanced NSCLC, but the evidence of its efficacy among ECOG PS2 pts is weak, because these pts are usually excluded from clinical trials; concern exists about tolerability and feasibility of standard CT in these pts. No prospective randomized trial has tested the addition of cisplatin to single-agent CT in pts with advanced NSCLC and PS2. Methods: CAPPA-2 was a multicentre, randomized phase III study for first-line treatment of PS2 pts with advanced NSCLC. Patients, aged 18-70, were eligible if they had stage IV or IIIB with malignant pleural effusion or metastatic supraclavicular nodes (TNM VI ed.) and adequate organ function. Patients in standard arm received gemcitabine 1,200 mg/m2 dd1 and 8.Patients in experimental arm received cispaltin 60 mg/m2 d1 plus gemcitabine 1,000 mg/m2 dd1 and 8. All treatments were repeated q3w, up to 4 cycles, unless disease progression or unacceptable toxicity. Primary endpoint was overall survival (OS). To have 80% power of detecting hazard ratio (HR) 0.71, corresponding to an increase in median OS from 4.8 to 6.8 months, 285 deaths were required. Results: The study was stopped in June 2012 after the enrolment of 57 pts, due to the slow accrual and the report of positive results from a similar study. Median OS was 3.0 months with single-agent gemcitabine and 5.9 months with cisplatin + gemcitabine (HR 0.52, 95% CI 0.28-0.98, p=0.039). Combination CT produced longer PFS (median 1.7 vs. 3.3 months, HR 0.49, 95% CI 0.27-0.89, p=0.017) and higher response rate (4% vs. 18%, p=0.19), without substantial increase in toxicity. Conclusions: Addition of cisplatin to single-agent gemcitabine improves survival as first-line treatment of PS2 patients with advanced NSCLC. Clinical trial information: NCT00526643.

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Interim analysis of the data of non-interventional study to determine the prevalence of EGFR mutations in advanced NSCLC Russian patients (ORTUS).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e13109 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e13109-e13109

Author(s):

Konstantin K. Laktionov ◽

Irina Demidova ◽

Aleksandr Ageev ◽

Valeriy Vladimirovich Breder ◽

Pavel Grigoriev ◽

...

Keyword(s):

Interim Analysis ◽

Advanced Nsclc ◽

Gene Mutations ◽

Stage Iv ◽

Tumor Burden ◽

Egfr Mutations ◽

Plasma Samples ◽

Stage Iv Disease ◽

Treatment Naïve ◽

Nsclc Patients

e13109 Background: There is a little information of correlation between EGFRm rate in cytology and plasma samples in Russian NSCLC population. The interim analysis of the study aimed to evaluate the prevalence and types of EGFR mutations in paired cytology and plasma samples in treatment-naive patients with advanced NSCLC. Methods: ORTUS is a multicenter, non-interventional, prospective study to determine EGFR mutations rate in treatmentnaive Russian patients with advanced NSCLC. ClinicalTrials.gov identifier: NCT02321046. The study enrolled 426 patients in stage IIIB / IV of NSCLC. Interim analysis covered the data of 214 cytology verified patients (mean age - 62.6 (range 32-86) years, 58,4% of men) with EGFRm test results in paired cytology and ctDNA samples. 99.5% cases were adenocarcinoma. The proportion of non-smokers/smokers/exsmokers was 46.3%/36%/17.8% respectively. Stage IV disease was in 81% of cases; 84.1% of patients had symptoms. DNA isolation performed using QIAamp DNA FFPE Tissue Kit for cytology and Qiagen Circulating Nucleic Acid Kit for ctDNA according to the manufacturer’s instructions. EGFR gene mutations were analyzed using THerascreen RGQ EGFR PCR Kit in cytology samples and RGQ Plasma EGFR PCR kit in plasma (Qiagen). Results: EGFRm was identified in 17,8% cytology samples (38/214) that is close to 20,2% (1759/8716) in Russian tissue EGFRm study (Imyanitov et al., 2016). 10,3% of paired ctDNA samples were EGFRm positive. Sensitivity and specificity for ctDNA were 42.1%, and 97.1% respectively. The EGFRm rate was 3,9% and 2,6% in smokers, 5,3% and 0% in ex-smokers and 33,3% and 21,2% in nonsmokers in cytology and plasma samples respectively. EGFRm rate and concordance between cytology and ctDNA are presented in a table. EGFRm in ctDNA were detected more frequently in M1a/b groups (p = 0,028). Conclusions: Cytology samples are appropriate for EGFRm testing in NSCLC patients in comparison with tumor tissue ones. High tumor burden (positive metastatic status) is an important factor for successful mutation analysis in ctDNA. [Table: see text]

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Nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for advanced non-small cell lung cancer (NSCLC): 4-year update from CheckMate 227.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.9016 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 9016-9016

Author(s):

Luis G. Paz-Ares ◽

Tudor-Eliade Ciuleanu ◽

Jong-Seok Lee ◽

Laszlo Urban ◽

Reyes Bernabe Caro ◽

...

Keyword(s):

Advanced Nsclc ◽

Performance Status ◽

Stage Iv ◽

Ecog Performance Status ◽

Programmed Death ◽

Long Term Follow Up ◽

To Receive ◽

Clinical Trial Information

9016 Background: 1L NIVO + IPI was shown to provide durable long-term overall survival (OS) benefit vs chemo regardless of tumor programmed death ligand 1 (PD-L1) expression in patients (pts) with advanced NSCLC in CheckMate 227 Part 1 (NCT02477826); 3-year OS rates were 33% vs 22% in pts with PD-L1 ≥ 1% (HR, 0.79 [95% CI, 0.67–0.93]) and 34% vs 15% in pts with PD-L1 < 1% (HR, 0.64 [95% CI, 0.51–0.81]). Here we report updated results from the study with 4 years’ minimum follow-up. Methods: Adults with previously untreated stage IV / recurrent NSCLC, no known EGFR/ ALK alterations , and ECOG performance status ≤ 1 were enrolled; pts were stratified by squamous (SQ) and non-squamous (NSQ) histology. Pts with PD-L1 ≥ 1% (n = 1189) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), NIVO alone (240 mg Q2W), or chemo. Pts with PD-L1 < 1% (n = 550) were randomized 1:1:1 to receive NIVO + IPI, NIVO (360 mg Q3W) + chemo, or chemo. OS with NIVO + IPI vs chemo in pts with PD-L1 ≥ 1% was the primary endpoint. Results: With minimum follow-up of 49.4 months (database lock, Feb 18, 2021), pts were at least 2 years beyond the protocol-specified end of immunotherapy treatment. Pts with PD-L1 ≥ 1% continued to show durable benefit with NIVO + IPI vs chemo (HR, 0.76 [95% CI, 0.65–0.90]); 4-year OS rates were 29% (NIVO + IPI), 21% (NIVO), and 18% (chemo). At 4 years, 14% (NIVO + IPI), 10% (NIVO), and 4% (chemo) remained progression free. Among responders, 34%, 30%, and 7% remained in response, respectively. In an exploratory analysis in pts with PD-L1 ≥ 50%, 4-year OS rates were 37% (NIVO + IPI), 26% (NIVO), and 20% (chemo). In pts with PD-L1 < 1%, OS HR for NIVO + IPI vs chemo was 0.64 (95% CI, 0.51–0.81); 4-year OS rates were 24% (NIVO + IPI), 13% (NIVO + chemo) and 10% (chemo). At 4 years, 12% (NIVO + IPI), 7% (NIVO + chemo), and 0% (chemo) remained progression free. Among responders, 31%, 13%, and 0% remained in response, respectively. Among pts who progressed on NIVO + IPI vs chemo, 7% vs 40% (PD-L1 ≥ 1%), and 9% vs 33% (PD-L1 < 1%), received subsequent immunotherapy. Benefit with NIVO + IPI vs chemo was observed for both SQ and NSQ histology (Table). With long-term follow-up, no new safety signals were identified. Conclusions: With 4 years’ minimum follow-up, 1L NIVO + IPI continued to provide durable, long-term OS benefit vs chemo in pts with advanced NSCLC regardless of PD-L1 expression or histology. Clinical trial information: NCT02477826. [Table: see text]

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T-cell lymphomas: immunologic, histologic, clinical, and therapeutic analysis of 63 cases.

Journal of Clinical Oncology ◽

10.1200/jco.1988.6.10.1584 ◽

1988 ◽

Vol 6 (10) ◽

pp. 1584-1589 ◽

Cited By ~ 49

Author(s):

B Coiffier ◽

F Berger ◽

P A Bryon ◽

J P Magaud

Keyword(s):

T Cell ◽

Clinical Presentation ◽

Performance Status ◽

Stage Iv ◽

Poor Performance ◽

Large Cell ◽

Response To Therapy ◽

Poor Performance Status ◽

T Cell Lymphomas ◽

Stage Iv Disease

Sixty-three patients with T-cell lymphoma (TCL) were analyzed to correlate morphological and immunological features with clinical presentation, response to therapy, and survival. Clinical presentation was severe, with 59% of patients having stage IV disease, 60% B symptoms, 35% poor performance status, 44% large tumoral mass, and 40% a high number of extranodal localizations. Morphological subtypes were small-cell in four cases, diffuse-mixed in 29 cases, monomorphic medium-sized in two cases, immunoblastic in 21 cases, anaplastic large-cell in four cases, and unclassified in three cases. Immunological phenotypes were immature T in 11 cases, CD4 in 26 cases, CD8 in 13 cases, and undefined (CD4 + CD8) in ten cases. Response to therapy was poor except for the 39 patients treated by an intensive and sequential regimen (non-Hodgkin's lymphoma [LNH]-80 or LNH-84) that gave a 77% complete remission (CR) rate with a 23% relapse rate. Median survival was 35 months. No correlation was found between morphological subtypes and other variables. Helper (CD4) phenotype seemed to have a better prognosis than other phenotypes. Variables associated with long survival for all the patients were localized disease and absence of large tumoral mass and for the subgroup of patients treated by the LNH regimens CD4 phenotype, absence of B symptoms, absence of a large tumoral mass, and less than two extranodal sites of disease.

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Impact of standard care on elderly glioblastoma patients

Neuro-Oncology Practice ◽

10.1093/nop/npw011 ◽

2016 ◽

Vol 4 (1) ◽

pp. 4-14

Author(s):

Sarah Lapointe ◽

Marie Florescu ◽

David Simonyan ◽

Karine Michaud

Keyword(s):

Chart Review ◽

Median Overall Survival ◽

Performance Status ◽

Retrospective Chart Review ◽

Treatment Modalities ◽

Significant Prognostic Factor ◽

Resection Status ◽

Newly Diagnosed Glioblastoma ◽

Similar Survival ◽

Stupp Protocol

Abstract Background. Uncertainty persists about the survival advantage of concomitant and adjuvant temozolomide (TMZ) plus radiotherapy (RT) in elderly patients with newly diagnosed glioblastoma (GBM). We compared the clinical outcome of unselected elderly GBM patients treated with 4 adjuvant treatment modalities, including the Stupp protocol. Methods. From 2010 to 2014, retrospective chart review was performed on 171 GBM patients aged ≥55 who received either concurrent chemoradiation therapy (CCRT) with standard 60 Gy/30 (SRT); CCRT with hypofractionated 40 Gy/15 (HRT); HRT alone; or TMZ alone. Stratification is by age (55–69, ≥70), KPS (<70, ≥70), and resection status (biopsy, resection). Results. Out of 171 patients identified, 128(75%) had surgical resection, median age was 66(55–83), and median overall survival (mOS) 11.4mo. Majority (109/171) were treated according to the Stupp protocol (CCRT-SRT), and 106/171 received post-CCRT adjuvant TMZ (median of 3 cycles). In our population, age <70yo was a significant prognostic factor (mOS of patients aged 55–69 vs ≥70 yo = 13.3 vs 6.6 mo; P = .001). However, among the population receiving the Stupp regimen, there was no difference in survival between patients aged 55–69 and those ≥70 (respectively, 14.4 vs 13.2 mo; P = .798). Patients ≥70 yo had similar survival when treated with CCRT-HRT and CCRT-SRT (P = .248), although numbers were small. Conclusions. Our data suggests that, despite having a worse global prognostic than their younger counterparts, GBM patients ≥70yo with a good performance status could be treated according to the Stupp protocol with similar survival. Theses results need prospective confirmation.

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