Weekly Vinorelbine in Elderly Patients with Non-Small-Cell Lung Cancer

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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Metronomic Chemotherapy with Vinorelbine Produces Clinical Benefit and Low Toxicity in Frail Elderly Patients Affected by Advanced Non-Small Cell Lung Cancer

BioMed Research International ◽

10.1155/2018/6278403 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Michela D’Ascanio ◽

Aldo Pezzuto ◽

Chiara Fiorentino ◽

Bruno Sposato ◽

Pierdonato Bruno ◽

...

Keyword(s):

Lung Cancer ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Safety Profile ◽

Small Cell ◽

Small Cell Lung ◽

Significant Difference ◽

Ecog Ps ◽

Metronomic Vinorelbine

Background. Lung cancer is the leading cause of death worldwide. The treatment choice for advanced stage of lung cancer may depend on histotype, performance status (PS), age, and comorbidities. In the present study, we focused on the effect of metronomic vinorelbine treatment in elderly patients with advanced unresectable non-small cell lung cancer (NSCLC).Methods. From January 2016 to December 2016, 44 patients affected by non-small cell lung cancer referred to our oncology day hospital were progressively analyzed. The patients were treated with oral vinorelbine 30 mg x 3/wk or 40 mg x 3/wk meaning one day on and one day off. The patients were older than 60, stage IIIB or IV, ECOG PS ≥ 1, and have at least one important comorbidity (renal, hepatic, or cardiovascular disease). The schedule was based on ECOG-PS and comorbidities. The primary endpoint was progression-free survival (PFS). PFS was used to compare patients based on different scheduled dosage (30 or 40 mg x3/weekly) and age (more or less than 75 years old) as exploratory analysis. We also evaluated as secondary endpoint toxicity according to Common Toxicity Criteria Version 2.0.Results. Vinorelbine showed a good safety profile at different doses taken orally and was effective in controlling cancer progression. The median overall survival (OS) was 12 months. The disease control rate (DCR) achieved 63%. The median PFS was 9 months. A significant difference in PFS was detected comparing patients aged below with those over 75, and the HR value was 0.72 (p<0.05). Not significant was the difference between groups with different schedules.Conclusions.This study confirmed the safety profile of metronomic vinorelbine and its applicability for patients unfit for standard chemotherapies and adds the possibility of considering this type of schedule not only for very elderly patients.

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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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Pemetrexed versus gefitinib versus erlotinib in previously treated non-small cell lung cancer by retrospective analysis

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e19103 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e19103-e19103

Author(s):

E. Cho ◽

J. Hong ◽

S. Kyung ◽

Y. Kim ◽

S. Shim ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Retrospective Analysis ◽

Cell Lung Cancer ◽

Performance Status ◽

Small Cell ◽

Small Cell Lung ◽

Folate Supplementation ◽

Significant Difference ◽

Previously Treated

e19103 Background: The standards in 2nd-line therapy with advanced non-small cell lung cancer (NSCLC) were erlotinib or pemetrexed as well as docetaxel. To evaluate the efficacies and safeties of pemetrexed, gefitinib, and erlotinib in previously treated NSCLC we analyzed the datas retrospectively. Methods: Eligible patents were 1) histologically confirmed pretreated advanced (stage IIIB or IV) NSCLC, 2) with at least one measurable lesion, 3) age over 18 years, 4) performance status (PS) 0–2, and 5) should never experience other two drugs as previous therapy. Patients of pemetrexed group received IV infusion of 500mg/m2 pemetrexed mixed with normal saline every 3 weeks with vitamin B12 and folate supplementation. Patients of gefitinib group received gefitinib 250mg PO daily and of erlotinib took erlotinib 150mg PO daily. Cycles of IV pemetrexed or taking PO drugs were continued until disease progression or unacceptable toxicity. Results: we analyzed 57 patients (pemetrexed; 20, gefitnib; 20, and erlotinib; 17). The response rates were 5.3%, 25.0%, and 12.5% (P=0.22), and the disease control rate were 5.3%, 40.0%, and 50.0% respectively (P<0.01). Median progression-free survival (PFS) of pemetrexed, gefitinib, and erlotinib were 1.7, 3.5 and 4.4 months (P<0.01) and median overall survival (OS) were 5.6, 21.8 and 21.5 months respectively (P=0.04). In subgroup analysis, patients with non-squamous carcinoma, smokers and good PS (0 or 1) showed longer PFS and OS in gefitinib and erlotinib compared with in pemetrexed. All of these agents showed mild and tolerable toxicity. Conclusions: In retrospective analysis, the patients with gefitinib or erlotinib had longer PFS and OS than pemetrexed, eventhough there was no significant difference for response rate in three group. These results have to confirm by large randomized prospective study because the sample size was small and it was not randomized. No significant financial relationships to disclose.

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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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Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non–Small-Cell Lung Cancer and Poor Performance Status

Journal of Clinical Oncology ◽

10.1200/jco.2008.18.4408 ◽

2009 ◽

Vol 27 (13) ◽

pp. 2253-2260 ◽

Cited By ~ 82

Author(s):

Glenwood Goss ◽

David Ferry ◽

Rafal Wierzbicki ◽

Scott A. Laurie ◽

Joyce Thompson ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Performance Status ◽

Poor Performance ◽

Small Cell ◽

Gene Copy ◽

Poor Performance Status ◽

Small Cell Lung ◽

Significant Difference

Purpose To compare gefitinib with placebo in chemotherapy naïve patients with advanced non–small-cell lung cancer (NSCLC) and poor performance status. Patients and Methods NSCLC patients (chemotherapy naïve, WHO performance status 2 or 3; unfit for chemotherapy; stage IIIB/IV) were randomly assigned to gefitinib (250 mg/d) plus best supportive care (BSC; n = 100) or placebo plus BSC (n = 101). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and safety. Correlation of gefitinib efficacy with EGFR gene copy number (fluorescent in situ hybridization [FISH]) was explored. Results Hazard ratios (HRs; gefitinib:placebo) were 0.82 (95% CI, 0.60 to 1.12; P = .217) for PFS and 0.84 (95% CI, 0.62 to 1.15; P = .272) for OS. As expected for this patient population, OS for both arms was poor, at about 3 months. ORRs were 6.0% (gefitinib) and 1.0% (placebo). QOL and PSI rates were 21.1% and 28.3% (gefitinib) and 20.0% and 28.3% (placebo), respectively. In EGFR FISH-positive patients (n = 32), HRs were 0.29 (95% CI, 0.11 to 0.73) for PFS and 0.44 (95% CI, 0.17 to 1.12) for OS. No unexpected adverse events occurred. Conclusion There was no statistically significant difference in PFS, OS, and ORRs after treatment with gefitinib or placebo, in the overall population; improvements in QOL and symptoms were similar in both groups. Tolerability profile of gefitinib was consistent with previous studies. PFS was statistically significantly improved for gefitinib-treated patients with EGFR FISH-positive tumors.

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