86: The impact of age, performance status and co-morbidities in determining treatment options in elderly patients with non-small cell lung cancer (NSCLC) in Newcastle upon Tyne NHS trust (NUTH)

Aims and background Many lung cancers are diagnosed in patients over 65 years of age, but limited data are available on the tolerance and activity in elderly patients of chemotherapy protocols designed for adults. Methods We therefore activated a phase II study in patients aged 65 years or older affected by stage IIIB-IV non-small-cell lung cancer in order to assess the tolerance and activity of vinorelbine administered weekly at a dose of 25 mg/m2. Results Since June 1992, 25 patients (20 males, 5 females; performance status ECOG, 0-2) have been included in the study and are evaluable for response and side effects. Two-hundred and twenty-eight cycles of therapy have been delivered (median/patient, 9 cycles). Four partial remissions (16%; 95% confidence interval 5–36%), 9 disease stabilizations, and 12 progressions have been observed. Median time to disease progression was 3 months, and median survival was 5 months (range, 2–25+). Mild or moderate side effects included leukopenia (6 cases), neutropenia (4 cases), anemia (4 cases), nausea (4 cases), infection (3 cases) and thoracic pain (2 cases). Grade III/IV toxicity consisted mainly of leukopenia and neutropenia observed respectively in 5 and in 7 patients. No significant difference in terms of tolerability has been observed for patients aged 65 to 70 with respect to patients aged 70 years or older. Conclusions The administration of vinorelbine in elderly patients does not seem to differ significantly in terms of response and tolerability from that recorded for adults. Selected elderly patients with good performance status and adequate organ function can be safely treated with systemic chemotherapy.

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A Phase II Study of S-1 for Previously Untreated Elderly Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy ◽

10.1159/000441486 ◽

2015 ◽

Vol 61 (2) ◽

pp. 93-98 ◽

Cited By ~ 7

Author(s):

Takashi Kasai ◽

Yoichi Nakamura ◽

Minoru Fukuda ◽

Takeshi Kitazaki ◽

Seiji Nagashima ◽

...

Keyword(s):

Lung Cancer ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Response Rate ◽

Performance Status ◽

Small Cell ◽

Small Cell Lung ◽

Eligibility Criteria ◽

Grade 3

Background: S-1, a novel oral fluoropyrimidine, is active in the treatment of non-small cell lung cancer (NSCLC). However, data on S-1 for elderly patients with NSCLC are insufficient. Methods: Eligibility criteria were no prior chemotherapy, stage IIIB or IV NSCLC, performance status 0-1, age >70 years, and adequate hematological, hepatic, and renal functions. Patients received S-1 (40 mg/m2 twice a day) for 28 consecutive days. This schedule was repeated every 6 weeks. The primary end point was the tumor response rate. Results: Thirty-two patients were enrolled and 31 patients were evaluable for response. The patients' median age was 80 years (range: 71-88). The response rate was 22.6% (95% CI: 11-38). Neutropenia, anemia, thrombocytopenia, febrile neutropenia, and diarrhea of grade ≥3 occurred in 6, 6, 10, 3, and 3%, respectively. Conclusions: In elderly patients with previously untreated advanced NSCLC, S-1 appears to be well tolerated and demonstrates encouraging activity.

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Open-label, multicenter, randomized phase III trial of pemetrexed/carboplatin doublet vs pemetrexed singlet in chemotherapy-naïve elderly patients aged 70 or more with advanced non-squamous non-small cell lung cancer and good performance status.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.15_suppl.9081 ◽

2016 ◽

Vol 34 (15_suppl) ◽

pp. 9081-9081

Author(s):

Dae Ho Lee ◽

Eun Kyung Cho ◽

Jin Seok Ahn ◽

Dong-Wan Kim ◽

Byoung Chul Cho ◽

...

Keyword(s):

Lung Cancer ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Performance Status ◽

Small Cell ◽

Phase Iii ◽

Small Cell Lung ◽

Open Label ◽

Phase Iii Trial

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Do Elderly Lung Cancer Patients Aged ≥75 Years Benefit from Immune Checkpoint Inhibitors?

Cancers ◽

10.3390/cancers12071995 ◽

2020 ◽

Vol 12 (7) ◽

pp. 1995

Author(s):

Nagio Takigawa ◽

Nobuaki Ochi ◽

Nozomu Nakagawa ◽

Yasunari Nagasaki ◽

Masataka Taoka ◽

...

Keyword(s):

Lung Cancer ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cancer Patients ◽

Cell Lung Cancer ◽

Performance Status ◽

Small Cell ◽

Poor Performance Status ◽

Small Cell Lung ◽

Lung Cancer Patients

Lung cancer patients ≥75 years represent nearly 40% of all lung cancer patients and continue to increase. If elderly patients have a good performance status and adequate organ function, they can be treated the same as non-elderly patients. However, few comparative studies limited to elderly patients (≥75 years) have been conducted. We review the evidence on using immune check inhibitors for the treatment of elderly patients (≥75 years old) with advanced non-small cell lung cancer. Prospective randomized or non-randomized, retrospective, registrational, insurance-based, and community-based studies have shown that elderly (≥75 years) and non-elderly patients are similarly treated with immune check inhibitors effectively and safely. However, such analyses have not shown that immune check inhibitors are significantly more effective than chemotherapy alone. In addition, patient selection might be critically performed to administer immune check inhibitors in the elderly because they are more likely to have a poor performance status with comorbidities, which lead to little benefit, even in non-elderly patients. There is a need for more evidence showing the benefit of immune check inhibitors in non-small cell lung cancer patients ≥75 years.

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Docetaxel compared with vinorelbine in elderly patients with advanced non-small cell lung cancer (NSCLC): A randomized phase II Hellenic Oncology Research Group trial

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.7615 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 7615-7615 ◽

Cited By ~ 3

Author(s):

A. Karampeazis ◽

L. Vamvakas ◽

A. Agelidou ◽

V. Chandrinos ◽

X. Tsiafaki ◽

...

Keyword(s):

Lung Cancer ◽

Overall Survival ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Statistical Difference ◽

Median Overall Survival ◽

Performance Status ◽

Small Cell ◽

Small Cell Lung

7615 Background: To compare docetaxel versus vinorelbine as front-line treatment of elderly patients with advanced non-small-cell lung cancer (NSCLC). Methods: Chemotherapy-naive patients >65 years, with stage histologically or cytologically documented IIIB/IV NSCLC and performance status (PS) 0–3 were randomly assigned to receive docetaxel 38 mg/m2 (days 1 and 8) or vinorelbine 25 mg/m2 (days 1 and 8) every 21 days. Treatment was continued for a maximum of six cycles and was interrupted in case of disease progression or unacceptable toxicity. Results: A total of 112 patients with median age of 76 years (range, 66–87) were enrolled onto the study. PS 2–3 had 39 (35%) patients. The two treatment groups were well balanced. There was no statistical difference between the 2 arms in median overall survival (6.27 months vs 3.97 months; p=0.129), in median time to progression (2.2 months vs 2 months; p=0.863.) and in overall response rate (5.3% vs 11.3%; p=0.247). Docetaxel conferred a statistically significant survival benefit compared to vinorelbine only in patients with PS 0–1 (11.4 months vs 4.3 months; p=0.009). Among patients treated with docetaxel there was a significant difference in median overall survival for patients with PS 0–1 compared with patients with PS 2–3 (11.4 months vs 2.5 months; p=0.004) while there was no statistical difference in the vinorelbine arm (4.3 months vs 2.8 months; p=0.970).The most common grade 3 and 4 toxicity was neutropenia (3.4% for docetaxel; 27.8% for vinorelbine; p=0.0001). Other toxicities were mild, well tolerated and similar for both groups with the exception of asthenia grade 2 (8.6% for docetaxel; 24.1% for vinorelbine; p=0.026). Conclusions: Docetaxel improves survival compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer and good performance status without increasing toxicity. No significant financial relationships to disclose.

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Evaluation of elderly patients with extended disease small-cell lung cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e18515 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e18515-e18515 ◽

Cited By ~ 2

Author(s):

Tatiane Caldas Montella ◽

Marina Mendes Vasco ◽

Ana Licia Maia Silva ◽

Morgana Stelzer Rossi ◽

Carla Valéria Santos Sena ◽

...

Keyword(s):

Lung Cancer ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Performance Status ◽

Small Cell ◽

Small Cell Lung ◽

Optimal Care ◽

Cycle Number ◽

Dismal Prognosis

e18515 Background: At diagnosis approximately 25-40% of patients with small cell lung cancer (SCLC) are over age 65 and more than 60% of them have extended disease (ED). There is a scarcity of data on this subpopulation. The aim of this study was to report clinical characteristics of this subpopulation, highlighting some challenges in their clinical management. Methods: In this retrospective cohort, data from 96 patients aged >65 years with SCLC diagnosed between 1997 and 2007 at a single institution were analyzed. Results: At diagnosis median age at presentation was 71, and most patients (n=65; 67.7%) had ED_SCLC and became the focus of our analysis. In this particular population the median survival time was 5 compared to 9 months for limited disease patients. Further, 63% of these patients had performance status (PS)≥2 and that was correlated with worse survival (PS0-1=9 months, PS2=4 months and PS3-4=3months; p=0.05). Additionally, 70% of this group with ED had at least one comorbidity and 30% had more than one. Of note, chemotherapy (CT) or radiotherapy (RT) were not administered in 23% of those patients, due to the lack of clinical conditions. CT was administered in 49 patients (75%), being carboplatin and etoposide the preferred regimen in contrast to cisplatin and etoposide (71 vs 28%). However, 44% of patients received less than 4 cycles of CT and 34% received only one cycle. Number of CT cycles were correlated with survival (1 cycle 1.5 months and 2-4cycles 8.7 months). Conclusions: Our data show that elderly patients with ED-SCLC constitutes a frail subpopulation, with poor PS and associated comorbidities, leading to suboptimal treatment and a dismal prognosis. Moreover, most of those patients were considered unfit for current treatment. These results highlight the urgent need for an individualized approach and clinical trials focused on elderly patients, in order to provide them an optimal care and improve their outcomes.

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Efficacy and safety of immunotherapy in non-small cell lung cancer patients with poor performance status.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e21601 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e21601-e21601

Author(s):

Riccardo Lobefaro ◽

Giuseppe Viscardi ◽

Raimondo Di Liello ◽

Giacomo Massa ◽

Maria Lucia Iacovino ◽

...

Keyword(s):

Lung Cancer ◽

Liver Metastasis ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Performance Status ◽

Univariate Analysis ◽

Small Cell ◽

Small Cell Lung ◽

Metastatic Sites ◽

The Impact

e21601 Background: The introduction of Immunotherapy (IO) has dramatically improved the prognosis of patients (pts) with advanced Non-Small Cell Lung Cancer (NSCLC). However, data regarding the role of IO in ECOG Performance Status (PS) 2 pts are generally limited in randomized trials, and real-world evidences could support clinical decision-making. Methods: We retrospectively analyzed data about pts with stage IV NSCLC treated with IO between April 2013 and December 2019 in two Italian Centers. The aim of our study was to assess the impact of PS status (0-1 vs 2) on disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). Response was classified according to RECIST v1.1 criteria. PFS and OS were estimated by the Kaplan-Meier method. Chi-square test was used to compare clinical-pathological variables: gender, age ( < 70, 70-79, ≥80 years-old), smoking status, histology (squamous, non-squamous), PDL1 expression ( < 1%, ≥1%), IO line (1°, ≥2°), number (N) of metastatic sites (1, ≥2), presence of liver and/or brain metastasis. Their impact on survival was evaluated through Cox proportional hazard models. Results: Four-hundred-one pts (35.7% female) with median age of 65.4 years (range 27-88) were studied. Baseline PS was 0 in 134 pts (33.4%), 1 in 209 pts (52.1%) and 2 in 58 pts (14.5%). 312 pts had non-squamous NSCLC, 89 squamous NSCLC. Clinical-pathological variables were uniformly distributed across PS groups except for a higher rate of liver metastasis in PS2 pts ( p= 0.046). Response evaluation was available for 386 pts. DCR was 49.7% in PS0-1 pts and 25.9% in PS2 pts ( p= 0.006). At a median follow-up of 29 months (mos), median PFS was 3.0 mos (95% CI 2.63-4.00) and 2.04 mos (95% CI 1.84-3.00) in pts with PS0-1 and 2 ( p< 0.0001). Median OS was 13.2 mos (95% CI 11.18-15.78) and 4.0 mos (95% CI 2.66-5.62) in pts with PS 0-1 and 2 respectively ( p< 0.0001). Univariate analysis showed significant correlation of PS2 status, negative PDL1, IO line ≥2, N of metastatic sites ≥2 and liver metastasis, for both PFS and OS. Multivariate analysis confirmed an independent association of PS ( p= 0.0013 for PFS, p< 0.0001 for OS), PDL1 ( p= 0.0002 for PFS, p= 0.02 for OS) and liver metastasis ( p= 0.017 for PFS, p= 0.02 for OS). The incidence of Grade 3/4 adverse events was 10.5% in PS 0-1 pts and 13.7% in PS 2 pts ( p= 0.41). Conclusions: Our data confirm reduced efficacy of IO in pts with poor PS, regardless of the N of prior therapy lines or PDL1 expression. Despite IO appears to be safe and tolerable its role remains uncertain in PS2 pts based on worse survival outcomes.

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