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1.
Clin Lung Cancer ; 25(5): 440-448, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38627155

ABSTRACT

BACKGROUND: Novel neoadjuvant chemoimmunotherapy treatments are being investigated for locally advanced non-small-cell lung cancer (NSCLC), but real-world outcomes for neoadjuvant treatments are poorly understood. This study examined neoadjuvant treatment patterns, real-world event-free survival (rwEFS) and overall survival (OS) in patients with resected, stage II-III NSCLC in the United States (US). METHODS: This retrospective study identified patients in the SEER-Medicare database (2007-2019) with newly diagnosed stage II, IIIA, and IIIB (N2) NSCLC (AJCC 8th edition) treated with neoadjuvant chemo/chemoradiotherapy and resection (index date: neoadjuvant therapy initiation). Neoadjuvant treatment regimens were described. rwEFS (time from index to first recurrence or death, whichever occurred first) and OS (time from index to death) were summarized by Kaplan-Meier analysis for overall population, by disease stage at diagnosis, and by neoadjuvant treatment modality. RESULTS: 221 patients (stage II, N=70; stage III, N=151) met eligibility criteria. The median follow-up from index was 32.7 months. All patients received neoadjuvant chemotherapy (51%) or chemoradiotherapy (49%) prior to surgery; 97% of patients received platinum-based regimens, among which carboplatin+paclitaxel was the most frequent (45%). In all patients, median rwEFS was 17.6 months and 5-year rwEFS was 20.9%; median OS was 48.5 months and 5-year OS was 44.9%. 71% of patients had disease recurrence during follow-up; among them, 28% developed locoregional recurrence as the first recurrence event. CONCLUSIONS: Patients with resected, stage II-III NSCLC who received neoadjuvant chemo/chemoradiotherapy have high rates of disease recurrence and poor survival outcomes, highlighting need for more effective treatments to improve survival rates.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Neoadjuvant Therapy , Humans , Carcinoma, Non-Small-Cell Lung/therapy , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Non-Small-Cell Lung/mortality , Lung Neoplasms/pathology , Lung Neoplasms/therapy , Lung Neoplasms/mortality , Neoadjuvant Therapy/mortality , Neoadjuvant Therapy/methods , Male , Female , Aged , Retrospective Studies , Aged, 80 and over , Survival Rate , Neoplasm Staging , United States , Pneumonectomy , Treatment Outcome , SEER Program , Follow-Up Studies , Antineoplastic Combined Chemotherapy Protocols/therapeutic use
2.
J Immunother ; 47(4): 128-138, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38112201

ABSTRACT

The therapeutic landscape for patients with advanced or metastatic non-small cell lung cancer (NSCLC) is rapidly evolving due to advances in molecular testing and the development of new targeted therapies and immunotherapies. However, the efficacy of programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors in advanced or metastatic patients with NSCLC whose tumors harbor BRAF V600E mutation, HER2/ERBB2 alteration, MET exon 14 skipping mutation, or RET rearrangement is not completely understood. A systematic literature review was performed to summarize evidence from clinical trials and observational studies on objective response rate, progression-free survival, and overall survival in patients whose tumors express these biomarkers and who were treated with PD-1/PD-L1 inhibitors. Searches of Embase, MEDLINE, conference abstracts, and a clinical trial registry identified a total of 12 unique studies: 4 studies included patients with BRAF V600E mutation, 6 studies included patients with HER2/ERBB2 alteration, 7 studies included patients with MET exon 14 skipping mutation, and 5 studies included patients with RET rearrangement. Across studies, there was heterogeneity in treatment and patient characteristics and a lack of reporting on many important predictive and prognostic factors, including treatment regimens, patients' line of therapy, and tumor PD-L1 expression, which may explain the wide variation in objective response rate, progression-free survival, and overall survival across studies. Therefore, additional studies prospectively evaluating clinical outcomes of PD-1/PD-L1 inhibitors among patients with advanced or metastatic NSCLC whose tumors harbor emerging predictive or prognostic biomarkers are needed to determine whether this class of immunotherapy can provide additional survival benefits for these patients.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Humans , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/pathology , Lung Neoplasms/drug therapy , Lung Neoplasms/genetics , Lung Neoplasms/pathology , Immune Checkpoint Inhibitors/therapeutic use , Proto-Oncogene Proteins B-raf/genetics , B7-H1 Antigen/metabolism , Programmed Cell Death 1 Receptor , Proto-Oncogene Proteins c-ret/genetics , Proto-Oncogene Proteins c-ret/therapeutic use , Receptor, ErbB-2
3.
Article in English | MEDLINE | ID: mdl-38092284

ABSTRACT

OBJECTIVES: Event-free survival has replaced overall survival as a primary end point in many recent and ongoing clinical trials. This study aims to examine the correlation between real-world event-free survival and overall survival and to assess the clinical and economic burden associated with disease recurrence among patients with resected stage II to III non-small cell lung cancer who received neoadjuvant therapy in the United States. METHODS: This retrospective study used the Surveillance, Epidemiology, and End Results Medicare database (2007-2019) to identify patients with newly diagnosed, resected, stage II to IIIB (N2) non-small cell lung cancer who received neoadjuvant therapy. The correlation between real-world event-free survival and overall survival was assessed using the normal scores rank correlation and landmark analysis. Overall survival, all-cause health care resource use and costs, and non-small cell lung cancer-related health care resource use and costs were compared between patients with and without recurrence. RESULTS: A total of 221 patients met the eligibility criteria (median follow-up time from neoadjuvant treatment initiation: 32.7 months). The mean age was 72.1 years, and 57.0% of patients were male. Real-world, event-free survival and overall survival are positively and significantly correlated (0.68; 95% CI, 0.52-0.79). Patients with recurrence had significantly shorter median overall survival (19.3 vs 116.9 months), 4.59 times increased risk of death (95% CI, 2.56-8.26), and significantly higher all-cause and non-small cell lung cancer-related health care resource use and costs (adjusted mean monthly costs per patient difference: $5758 and $3187, respectively [all P < .001]). CONCLUSIONS: These findings help validate event-free survival as a clinically meaningful end point and strong predictor for overall survival and highlight the need for additional novel therapies that may delay or prevent recurrence in resectable stage II and III non-small cell lung cancer.

4.
Immunotherapy ; 15(16): 1375-1387, 2023 11.
Article in English | MEDLINE | ID: mdl-37694560

ABSTRACT

Aim: This study examined real-world treatment patterns for extensive-stage small-cell lung cancer (ES-SCLC) after immune checkpoint inhibitors (ICIs) became available for frontline use. Methods: Adult patients with ES-SCLC initiating 1L systemic treatment were identified from electronic health records. Results: Among patients with recurrent/progressive ES-SCLC, the most common treatment classes were platinum-based chemotherapy (81.1% of 228) and ICI monotherapy (35.1% of 191) in 1L and 2L, respectively. Among patients with de novo ES-SCLC, the most common treatment classes were ICI + platinum-based chemotherapy (64.4% of 1268) and other chemotherapy (44.9% of 512) in 1L and 2L, respectively. Among patients who received no ICI in 1L, 62.6%-70.3% received it in 2L and 62.6-68.5% in 3L. Some who received 1L ICI were re-treated with ICI in subsequent lines (14.5-18.8% in 2L, 18.2-50.0% in 3L). Conclusion: Real-world ICI utilization in ES-SCLC, particularly ICI re-challenge, demonstrates high unmet needs in this patient population.


Small-cell lung cancer (SCLC) is a type of lung cancer that is highly lethal. About 70% of patients have advanced SCLC when they first get their diagnosis and most die within 5 years. This study focused on immune checkpoint inhibitors (ICIs), a type of treatments that can help the immune system to fight cancer and has only been approved to treat SCLC in the past 4­5 years. We studied 1496 patients with advanced SCLC treated at community cancer practices in USA between October 2018 and February 2020. Patients averaged about 68 years old when they started treatment. By looking at the types and sequences of treatments, we found that although ICI are often used to treat SCLC, patients with this aggressive cancer still need other effective treatment choices.


Subject(s)
Lung Neoplasms , Small Cell Lung Carcinoma , Adult , Humans , Immune Checkpoint Inhibitors/therapeutic use , Small Cell Lung Carcinoma/drug therapy , Lung Neoplasms/drug therapy
5.
JTO Clin Res Rep ; 4(10): 100568, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37744307

ABSTRACT

Introduction: Data on utilization and clinical outcomes of programmed cell death protein or programmed death-ligand 1 (PD-[L]1) inhibitors in NSCLC with uncommon oncogenic alterations is limited. Methods: This retrospective study used a deidentified U.S. nationwide clinicogenomic database to select patients with advanced nonsquamous NSCLC without EGFR, ALK, or ROS1 alterations, diagnosed from January 1, 2016 to September 30, 2020, who initiated first-line therapy. Our objectives were to summarize characteristics and treatment patterns for patients with four little-studied genomic alterations or driver-negative NSCLC. We estimated Kaplan-Meier real-world time on treatment (rwTOT) and time to next treatment for patients receiving PD-(L)1 inhibitors. The data cutoff was September 30, 2021. Results: Of the 3971 eligible patients, 84 (2%) had NSCLC with BRAF V600E mutation, 117 (3%) had MET exon 14 skipping mutation, 130 (3%) had MET amplification, 91 (2%) had ERBB2 activation mutation, and 691 patients (17%) had driver-negative NSCLC. Patient characteristics differed among cohorts as expected. The most common first-line regimen in each cohort was a PD-(L)1 inhibitor as monotherapy or in combination with chemotherapy. The median rwTOT with anti-PD-(L)1 monotherapy was 4.6 months in the driver-negative cohort and ranged from 2.9 months (ERBB2 mutation) to 7.6 months (BRAF V600E mutation). The median rwTOT with anti-PD-(L)1-chemotherapy combination was 5.2 months in the driver-negative cohort and 6 months in all but the BRAF V600E cohort (17.5 mo). The patterns of real-world time to next treatment results were similar. Conclusions: Substantial use of anti-PD-(L)1 therapy and associated clinical outcomes are consistent with previous real-world findings and suggest no detriment from PD-(L)1 inhibitors for advanced nonsquamous NSCLC harboring one of these four genomic alterations relative to driver-negative NSCLC.

6.
Lung Cancer ; 176: 132-139, 2023 02.
Article in English | MEDLINE | ID: mdl-36638588

ABSTRACT

Thymic carcinoma (TC) is a rare cancer and patients failing initial chemotherapy (relapse/refractory) face limited therapeutic options given no approved options or consensus standard of care. This study aimed to identify and summarize clinical outcomes of all regimens evaluated in clinical trials of relapsed or refractory patients. Interventional trials enrolling advanced TC patients who failed first-line chemotherapy and reported outcomes in this group were eligible for inclusion in our systemic literature review (SLR). Between-study heterogeneity was assessed to determine the feasibility of pooling specific studies and treatments. Objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR) endpoints were of interest for meta-analysis. Nineteen trials were identified in the SLR. Three trials with one or two TC patients were removed from our assessment to reduce publication bias. Response rates among studies with at least ten TC patients varied from 9 % to 38 %. Pooled ORRs in patients receiving S-1 (46 patients), sunitinib (46 patients), or pembrolizumab (66 patients) were 28 %, 24 %, and 21 %, respectively. Prolonged duration of response with pembrolizumab was observed with a pooled median of 23.8 months (95 % confidence interval [CI]: 12, not reached). Median PFS of five months or greater was reported in patients treated with sunitinib, lenvatinib, pembrolizumab, capecitabine + gemcitabine, everolimus, or S-1. Median OS of 20 months or greater was reported in trials evaluating S-1 or pembrolizumab; this endpoint was not reached in trials evaluating lenvatinib, regorafenib, or sunitinib. Generalizability of treatment effects is challenging in the research of rare diseases and meta-analysis of clinical outcomes may help to increase precision and relevance of results to the larger TC population. Our study found limited treatment options upon relapse, demonstrating a need for further investigations into novel therapeutics and well-powered clinical trials to better inform on optimal treatments.


Subject(s)
Lung Neoplasms , Thymoma , Thymus Neoplasms , Humans , Sunitinib , Platinum , Neoplasm Recurrence, Local , Thymus Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/adverse effects
7.
Immunotherapy ; 13(10): 851-861, 2021 07.
Article in English | MEDLINE | ID: mdl-34034511

ABSTRACT

Aim: We describe PD-L1 testing patterns and first-line treatment for patients with metastatic non-small-cell lung cancer in a 2.3 million-member state-mandated health service in Israel. Materials & methods: Newly diagnosed stage IV non-small-cell lung cancer patients initiating systemic anticancer treatment from 1 January 2017 until 31 December 2018 were identified from the national cancer registry and Maccabi Healthcare Service database and followed until 30 June 2019. Results: The cohort consisted of 410 patients; 58% males, median age 68 years, 70% current/former smokers, 81% adenocarcinoma, 14% had brain metastases, and Eastern Cooperative Oncology Group performance status was 46/17/37% for 0-1/2-4/unknown, respectively. A total of 80% tested for PD-L1 expression, of which 47% had tumor proportion score (TPS) ≥ 50%. A total of 95% with TPS ≥ 50% and no known tumor aberrations (including EGFR mutations, and translocations in ALK and ROS1) received first-line PD-1/PD-L1-inhibitor monotherapy, and 80% of untested/TPS < 50% received platinum doublets. Conclusion: Fast uptake of testing was observed, and treatment patterns showed high adherence to guidelines.


Lay abstract We describe PD-L1 testing patterns in a cohort of 410 patients with stage IV non-small-cell lung cancer. All patients were newly diagnosed and newly treated in the years 2017 and 2018. In this cohort, 58% were males, average age was 68 years and 70% were current or former smokers. In this, 80% were tested for PD-L1 expression and 95% of those with a tumor score of >50% and no other tumor receptor mutations received first-line PD-1/PD-L1-inhibitor monotherapy (most receiving pembrolizumab). Moreover, 80% of those untested for PD-L1 or with a low tumor proportion score (<50%) received chemotherapy. After introduction in 2017, a fast uptake of PD-L1 testing was observed, and treatment patterns showed high adherence to guidelines.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/immunology , Immune Checkpoint Inhibitors/therapeutic use , Lung Neoplasms/drug therapy , Lung Neoplasms/immunology , Aged , Carcinoma, Non-Small-Cell Lung/pathology , Cohort Studies , Female , Humans , Israel , Lung Neoplasms/pathology , Male , Middle Aged , Registries , Retrospective Studies
8.
Immunotherapy ; 11(5): 407-428, 2019 04.
Article in English | MEDLINE | ID: mdl-30712477

ABSTRACT

AIM: A systematic review and network meta-analysis were conducted to evaluate the efficacy of pembrolizumab + pemetrexed + platinum relative to other regimens in metastatic nonsquamous non-small-cell lung cancer (NSq-NSCLC). PATIENTS & METHODS: Eligible studies evaluated first-line regimens in NSq-NSCLC patients without known targetable mutations. Relative treatment effects were synthesized with random effects proportional hazards Bayesian network meta-analyses. RESULTS: The hazard ratio (HR) for overall survival (OS) for pembrolizumab + pemetrexed + platinum was statistically significant over all platinum-doublet (HR range: 0.42-0.61), platinum-doublet + bevacizumab (HR range: 0.44-0.53) and platinum-doublet + atezolizumab regimens (HR range: 0.56-0.62). Additionally, pembrolizumab + pemetrexed + platinum numerically improved OS over atezolizumab + paclitaxel + carboplatin + bevacizumab (HR: 0.65; 95% credible interval: 0.43, 1.01). Pembrolizumab + pemetrexed + platinum had 95.6% probability of being the best treatment regimen for OS. CONCLUSION: Pembrolizumab + pemetrexed + platinum is likely the most efficacious first-line regimen for metastatic NSq-NSCLC.


Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Antibodies, Monoclonal, Humanized/adverse effects , Bevacizumab/administration & dosage , Bevacizumab/adverse effects , Carboplatin/administration & dosage , Carboplatin/adverse effects , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/pathology , Disease-Free Survival , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Neoplasm Metastasis , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Pemetrexed/administration & dosage , Pemetrexed/adverse effects , Survival Rate
9.
PLoS One ; 13(8): e0202865, 2018.
Article in English | MEDLINE | ID: mdl-30148862

ABSTRACT

BACKGROUND: The goals of this multinational retrospective study were to describe treatment patterns and survival outcomes by receipt of molecular testing and molecular status of patients with advanced non-small cell lung cancer (NSCLC). METHODS: This chart review study, conducted in Italy, Spain, Germany, Australia, Japan, Korea, Taiwan, and Brazil, included 1440 patients with newly diagnosed advanced (stage IIIB/IV) NSCLC initiating systemic therapy from January 2011 through June 2013, with follow-up until July 2016. We evaluated treatment patterns and survival by histology, line of therapy, molecular testing, and test results for epidermal growth factor receptor (EGFR) mutation and/or anaplastic lymphoma kinase (ALK) rearrangement. Country-specific data were analyzed descriptively and presented as ranges (lowest to highest country). Overall survival (OS) was estimated using Kaplan-Meier method. RESULTS: Patients with ≥1 molecular test varied from 43% (Brazil) to 85% (Taiwan). Numerically greater proportions of patients who were female, Asian, or never/former-smokers, and those with nonsquamous histology or stage-IV NSCLC, received a test. Testing was common for nonsquamous NSCLC (54%, Brazil, to 91%, Taiwan), with positive EGFR and ALK tests from 17% (Brazil and Spain) to 67% (Taiwan) and from 0% (Brazil) to 60% (Taiwan), respectively. First-line treatment regimens for nonsquamous NSCLC with positive EGFR/ALK tests included targeted therapy for 30% (Germany) to 89% (Japan); with negative/inconclusive test results, platinum-based combinations for 88% (Japan) to 98% (Brazil); and if not tested, platinum-based combinations for 80% (Australia) to 95% (Japan), except in Taiwan, where 44% received single agents. Median OS from first-line therapy initiation was 10.0 (Japan) to 26.7 (Taiwan) months for those tested and 7.6 (Australia/Brazil) to 19.3 (Taiwan) months for those not tested. CONCLUSIONS: We observed substantial variation among countries in testing percentages, treatment patterns, and survival outcomes. Efforts to optimize molecular testing rates should be implemented in the context of each country's health care scenario.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biomarkers, Tumor/genetics , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Squamous Cell/pathology , Lung Neoplasms/pathology , Adult , Aged , Aged, 80 and over , Asia , Australia , Brazil , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Squamous Cell/drug therapy , Europe , Female , Genetic Testing , Humans , Lung Neoplasms/drug therapy , Male , Middle Aged , Mutation , Practice Patterns, Physicians' , Prognosis , Retrospective Studies , Survival Rate
10.
Clin Lung Cancer ; 19(5): e783-e799, 2018 09.
Article in English | MEDLINE | ID: mdl-29983370

ABSTRACT

INTRODUCTION: Real-world data on current treatment practices for non-small-cell lung cancer (NSCLC) are needed to understand the place in therapy and potential economic impact of newer therapies. PATIENTS AND METHODS: This retrospective cohort study identified patients ≥ 65 years old in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database with first-time diagnosis of stage IIIB/IV NSCLC from 2007-2011 who received second-line therapy after first-line platinum-based chemotherapy from 2007 through mid-2013. Second-line regimens, health care resource use, adverse events (AEs), and associated costs were analyzed descriptively. Overall survival was determined by Kaplan-Meier test. Costs were adjusted to 2013 US dollars. RESULTS: We identified 4033 patients with advanced NSCLC who received second-line therapy (47% of those who received first-line platinum-based chemotherapy). Mean (SD) age was 73 (5) years, 2246 (56%) were male; 1134 (28%) and 2899 (72%) had squamous and nonsquamous NSCLC, respectively. The 4 most common second-line regimens were pemetrexed (22%), docetaxel (12%), carboplatin/paclitaxel (11%), and gemcitabine (7%). Median overall survival from second-line therapy initiation was 7.3 months (95% confidence interval, 7.0-7.7). Dyspnea and anemia were the most common AEs of interest, affecting 29% and 26% of patients, respectively; atypical pneumonia was associated with the highest AE-related costs (mean, $5339). The mean total per-patient-per-month cost was $10,885; AE-related per-patient-per-month costs totaled $1036 (10%). Costs were highest for pemetrexed-treated patients. CONCLUSION: These real-world data illustrate the variety of second-line regimens, poor prognosis, and high cost of second-line chemotherapy for patients with advanced NSCLC treated before the approval of immunotherapies for these patients.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/economics , Carcinoma, Non-Small-Cell Lung/economics , Carcinoma, Non-Small-Cell Lung/mortality , Drug-Related Side Effects and Adverse Reactions/economics , Lung Neoplasms/economics , Lung Neoplasms/mortality , Salvage Therapy/economics , Adenocarcinoma/drug therapy , Adenocarcinoma/economics , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Large Cell/drug therapy , Carcinoma, Large Cell/economics , Carcinoma, Large Cell/mortality , Carcinoma, Large Cell/pathology , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/secondary , Carcinoma, Squamous Cell/drug therapy , Carcinoma, Squamous Cell/economics , Carcinoma, Squamous Cell/mortality , Carcinoma, Squamous Cell/pathology , Cost-Benefit Analysis , Female , Follow-Up Studies , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Lymphatic Metastasis , Male , Medicare , Prognosis , Retrospective Studies , SEER Program , Survival Rate , United States
11.
Clin Lung Cancer ; 19(5): e629-e645, 2018 09.
Article in English | MEDLINE | ID: mdl-29885945

ABSTRACT

PURPOSE: This study sought to better understand real-world treatment patterns, overall and non-small-cell lung cancer (NSCLC)-specific survival, adverse event (AE) occurrence, and economic impact of first-line cancer therapies in Medicare patients. PATIENTS AND METHODS: This retrospective cohort study identified patients ≥ 65 years in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database who received a first-time advanced (stage IV) NSCLC diagnosis from 2007 to 2011, and who received first-line platinum-based chemotherapy from 2007 through mid-2013. First-line regimens, healthcare resource use, occurrence of AEs, and associated costs (2013 US dollars) were analyzed. Median survival was determined using the Kaplan-Meier method. RESULTS: Surprisingly, only 46% of patients (n = 13,472) with stage IIIB/IV NSCLC received systemic therapy, and 5931 received platinum-based therapy. The mean age was 73 years, with 3354 (57%) males; 1489 (25%) had squamous and 4442 (75%) nonsquamous histology. The most common regimens were carboplatin doublets (70%), including carboplatin/paclitaxel (38%), carboplatin/pemetrexed (12%), carboplatin/gemcitabine (11%), and carboplatin/docetaxel (7%). The median overall survival from first-line therapy initiation was 7.2 months (95% confidence interval, 7.0-7.5 months). Dyspnea and anemia were the most common AEs of interest, whereas atypical pneumonia was associated with the greatest AE-related costs (mean, $5044). The mean total per-patient-per-month cost was $11,909, with AE-related costs comprising 9% of total costs. The highest costs and survival were observed for patients treated with carboplatin/pemetrexed and bevacizumab/carboplatin/paclitaxel. CONCLUSIONS: These real-world data illustrate the most common first-line regimens by histology, overall survival, AEs, and some of the high AE-related costs of therapy for advanced NSCLC, and provides extremely useful information for clinicians.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/economics , Carcinoma, Non-Small-Cell Lung/economics , Carcinoma, Non-Small-Cell Lung/mortality , Drug-Related Side Effects and Adverse Reactions/economics , Lung Neoplasms/economics , Lung Neoplasms/mortality , Medicare/statistics & numerical data , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/secondary , Cost-Benefit Analysis , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Follow-Up Studies , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Male , Neoplasm Metastasis , Prognosis , Retrospective Studies , SEER Program , Survival Rate , United States
12.
BMC Health Serv Res ; 18(1): 147, 2018 03 01.
Article in English | MEDLINE | ID: mdl-29490654

ABSTRACT

BACKGROUND: Data are scarce regarding real-world health care resource use (HCRU) for non-small cell lung cancer (NSCLC). An understanding of current clinical practices and HCRU is needed to provide a benchmark for rapidly evolving NSCLC management recommendations and therapeutic options. The objective of this study was to describe real-world HCRU for patients with advanced NSCLC. METHODS: This multinational, retrospective chart review study was conducted at academic and community oncology sites in Italy, Spain, Germany, Australia, Japan, South Korea, Taiwan, and Brazil. Deidentified data were drawn from medical records of 1440 adults (≥18 years old) who initiated systemic therapy (2011 to mid-2013) for a new, confirmed diagnosis of advanced or metastatic (stage IIIB or IV) NSCLC. We summarized HCRU associated with first and subsequent lines of systemic therapy for advanced/metastatic NSCLC. RESULTS: The proportion of patients who were hospitalized at least once varied by country from 24% in Italy to 81% in Japan during first-line therapy and from 22% in Italy to 84% in Japan during second-line therapy; overall hospitalization frequency was 2.5-11.1 per 100 patient-weeks, depending on country. Emergency visit frequency also varied among countries (overall from 0.3-5.9 per 100 patient-weeks), increasing consistently from first- through third-line therapy in each country. The outpatient setting was the most common setting of resource use. Most patients in the study had multiple outpatient visits in association with each line of therapy (overall from 21.1 to 59.0 outpatient visits per 100 patient-weeks, depending on country). The use of health care resources showed no regular pattern associated with results of tests for activating mutations of the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangements. CONCLUSIONS: HCRU varied across countries. These findings suggest differing approaches to the clinical management of advanced NSCLC among the eight countries. Comparative findings and an understanding of country-specific clinical practices can help to identify areas of need and guide future resource allocation for patients with advanced NSCLC. Further studies evaluating the costs associated with resource use are warranted.


Subject(s)
Ambulatory Care/statistics & numerical data , Carcinoma, Non-Small-Cell Lung/therapy , Emergency Medical Services/statistics & numerical data , Hospitalization/statistics & numerical data , Lung Neoplasms/therapy , Aged , Australia , Brazil , Carcinoma, Non-Small-Cell Lung/pathology , Female , Germany , Health Services Research , Humans , Italy , Japan , Length of Stay/statistics & numerical data , Lung Neoplasms/pathology , Male , Middle Aged , Neoplasm Staging , Republic of Korea , Retrospective Studies , Spain , Taiwan
13.
Lung Cancer (Auckl) ; 8: 191-206, 2017.
Article in English | MEDLINE | ID: mdl-29123433

ABSTRACT

BACKGROUND: Recommended therapies for advanced/metastatic non-small cell lung cancer (NSCLC) have changed with the advent of targeted therapies. The objectives of this retrospective chart review study were to describe treatment patterns, biomarker testing practices, and health care resource use for advanced NSCLC at 5 sites in Japan. PATIENTS AND METHODS: We studied anonymized medical record data of patients aged ≥18 years who initiated systemic therapy for newly diagnosed stage IIIB or IV NSCLC from January 2011 through June 2013. Data were analyzed descriptively by histology and mutation status. Overall survival was estimated using the Kaplan-Meier method. RESULTS: We studied 175 patients, including 43 (25%), 129 (74%), and 3 (2%) with squamous, nonsquamous, and unknown NSCLC histology, respectively; 83% had stage IV NSCLC. Overall, 123 patients (70%) were male; the median age was 70 years (range, 47-86); and 33 (19%) were never-smokers. In the nonsquamous cohort, 105 (81%) and 25 (19%) of patients were tested for epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement, respectively; 44 (42%) had EGFR-positive NSCLC and 2 (8%) had ALK-positive NSCLC, including 26/46 (57%) women and 21/46 (46%) never-smokers. In the squamous cohort, 17 (40%) and 4 (9%), respectively, were tested; 1 EGFR-positive tumor was detected. After first-line therapy, 105 (60%) patients received second-line, and 54/105 (51%; or 31% overall) received third-line therapy. EGFR tyrosine kinase inhibitors were most commonly prescribed for EGFR-positive NSCLC across all lines. In the nonsquamous EGFR/ALK-negative/unknown cohort, most received first-line platinum combinations, particularly younger patients (78% ≥75 years vs 93% <75 years old). The average hospitalization was 21 days/admission. The median (95% CI) overall survival from start of first-line therapy was 9.9 months (7.6-11.7) for all patients and 17.9 months (9.9-24.4) for patients with EGFR/ALK-positive status. CONCLUSION: Biomarker testing is common for nonsquamous NSCLC at the 5 Japanese study sites. Treatment is personalized by mutation status and age, per guideline recommendations.

14.
PLoS One ; 12(6): e0178420, 2017.
Article in English | MEDLINE | ID: mdl-28644837

ABSTRACT

PURPOSE: To establish a baseline for care and overall survival (OS) based upon contemporary first-line treatments prescribed in the era before the introduction of immune checkpoint inhibitors, for people with metastatic non-small cell lung cancer (NSCLC) without common actionable mutations. METHODS: Using a nationally representative electronic health record data from the Flatiron dataset which included 162 practices from different regions in US, we identified patients (≥18 years old) newly diagnosed with stage IV NSCLC initiating first-line anticancer therapy (November 2012- January 2015, with follow-up through July 2015). Patients with documented epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) translocation were excluded. Anti-cancer drug therapy and overall survival were described overall, and by histology. RESULTS: A total of 2,014 patients with stage IV NSCLC without known EGFR or ALK genomic tumor aberrations initiated systemic anticancer therapy, 22% with squamous and 78% with nonsquamous histology. Their mean (SD) age was 67 (10) years, 55% were male, and 87% had a smoking history. In nonsquamous NSCLC, carboplatin plus pemetrexed either without (25.7%) or with bevacizumab (16%) were the most common regimens; 26.6% of nonsquamous patients receiving induction therapy also received continuation maintenance therapy. In squamous NSCLC, carboplatin plus paclitaxel (37.6%) or nab-paclitaxel (21.1%) were the most commonly used regimens. Overall median OS was 9.7 months (95% CI: 9.1, 10.3), 8.5 months (95% CI: 7.4, 10.0) for squamous, and 10.0 months (95% CI: 9.4, 10.8) for nonsquamous NSCLC. CONCLUSION: The results provide context for evaluating the effect of shifting treatment patterns of NSCLC treatments on patient outcomes, and for community oncology benchmarking initiatives.


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/mortality , Lung Neoplasms/drug therapy , Lung Neoplasms/mortality , Adult , Aftercare , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/pathology , Databases, Factual , Electronic Health Records , Female , Humans , Lung Neoplasms/pathology , Male , Middle Aged , Neoplasm Staging , Retrospective Studies , Survival Analysis , Treatment Outcome , United States/epidemiology
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