Real-world study of disease-free survival &amp; patient characteristics associated with disease-free survival in early-stage non-small cell lung cancer: A retrospective observational study

Shah, Anne; Apple, Jon; Belli, Andrew J.; Barcellos, Anna; Hansen, Eric; Fernandes, Laura L.; Zettler, C.; Wang, Ching-Kun

doi:10.1016/j.ctarc.2023.100742

Cited by 4 publications

(5 citation statements)

References 24 publications

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“…This is, to our knowledge, the first study to focus on DFS dynamics and treatment in a large unselected early-stage NSCLC patient population [9,20,21]. In this cohort study of 1341 early-stage NSCLC patients in Denmark, we found that over one-third (42%) of patients were EGFR-tested, and 10% of these were EGFRm + .…”

Section: Discussionmentioning

confidence: 76%

Diagnostic Workup, Treatment Patterns, and Clinical Outcomes in Early-Stage IB–IIIA Non-Small-Cell Lung Cancer Patients in Denmark

Uldbjerg,

Ringgaard,

Andersen

et al. 2023

Cancers

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Despite recent improvements in early-stage non-small-cell lung cancer (NSCLC), disease relapse remains challenging. Moreover, real-world evidence on long-term follow-up of disease-free survival (DFS) and recurrence patterns in a large, unselected cohort of early-stage NSCLC patients is lacking. This cohort study aimed to assess clinical characteristics, diagnostic workup, treatment, survival, and risk of disease relapse among early-stage NSCLC patients. Adult patients with stage IB, II, or IIIA NSCLC diagnosed and/or treated at Aarhus University Hospital in Denmark from January 2010 to December 2020 were included and followed-up until May 2021. Comprehensive clinical data were collected from electronic medical records of eligible patients and linked to Danish register data. The study population comprised 1341 early-stage NSCLC patients: 22%, 40%, and 38% were diagnosed with stage IB, II, and IIIA disease, respectively. In total, 42% of patients were tested for epidermal growth factor receptor (EGFR), of whom 10% were EGFR-mutation-positive (EGFRm+). Half of all patients received surgery, and nine percent of patients received stereotactic body radiation therapy (SBRT). Disease-free survival 5 years post-diagnosis was 49%, 42%, and 22% for stage IB, II, and stage IIIA patients, respectively. DFS improved over time both for patients treated with surgery and SBRT. However, disease relapse remained a challenge, with approximately 40% of stage IIIA having relapsed 3 years post-diagnosis. This study contributes important knowledge that puts clinical trials on new perioperative treatment modalities for early-stage NSCLC patients into perspective. Our findings cover an essential evidence gap on real-world DFS and recurrence dynamics, confirming that despite an improvement in DFS over time and across different treatment modalities, disease relapse remains a monumental challenge. Therefore, better treatment strategies are needed.

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Section: Discussionmentioning

confidence: 76%

Diagnostic Workup, Treatment Patterns, and Clinical Outcomes in Early-Stage IB–IIIA Non-Small-Cell Lung Cancer Patients in Denmark

Uldbjerg,

Ringgaard,

Andersen

et al. 2023

Cancers

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“…The significance of EGFR mutations associated with prognosis of early-stage NSCLC has been reported, along with various factors such as age, histologic pattern, pathologic stage, and presence of lymphovascular invasion [29][30][31][32][33]. Saw et al reported an association between EGFR mutations and recurrence in resected NSCLC for stage IA to IIIA disease.…”

Section: Discussionmentioning

confidence: 99%

Genetic Alterations and Risk Factors for Recurrence in Patients with Non-Small Cell Lung Cancer Who Underwent Complete Surgical Resection

Park,

Choi,

Yun

et al. 2023

Preprint

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Definitive surgical resection is the preferred treatment for early-stage non-small-cell lung cancer (NSCLC). Research into genetic alterations, including epidermal growth factor receptor (EGFR) mutation, in early stage NSCLC remains insufficient. Here, we investigated the prevalence of genetic alterations in early-stage NSCLC and the association between EGFR mutation and recurrence after complete resection. Between January 2019 and December 2021, 659 patients with NSCLC who underwent curative surgical resection at a single regional cancer center were recruited. We compared the clinical and pathological data between the recurrence and non-recurrence groups. Multivariate logistic regression was used to predict the risk factors for recurrence. Among the 659 enrolled cases, the most common histology was adenocarcinoma (74.5%), followed by squamous cell carcinoma (21.7%). The prevalence of EGFR mutation was 43% (194/451). Among them, L858R point mutation and exon 19 deletion was 52.3% and 42%, respectively. ALK rearrangement was found at 5.7% (26/453), and ROS1 fusion was found at 1.6% (7/441). The recurrence rate of the entire population was 19.7%. In multivariate analysis, the presence of EGFR mutation, stage II or III (vs. stage I), and pathologic subtype (presence of solid type) were associated with recurrence. Among the recurred group, 86.5% of the patients with EGFR mutation experienced distant recurrence compared to only 66.7% of wild-type (p = 0.016), with no significant difference in median disease-free survival (p = 0.983). In conclusion, the prevalence of EGFR mutation, ALK rearrangement, and ROS1 fusion was 43.0%, 5.7%, and 1.6%, respectively in patients with early-stage NSCLC who underwent curative resection. Along with stage II/III and solid pathologic subtype, EGFR mutation was an independent risk factor for recurrence. In the recurrence group, the rate of distant metastasis was higher in patients with EGFR mutation than in those with wild-type.

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“…Using arm C as a fulcrum, an indirect comparison between arm A and arm B was conducted using frequentist methods with the following formula: log HR AB = log HR AC − log HR BC , and its SE for the log HR was SE (log HR AB ) = [SE (log HR AC ) + SE (log HR BC )] 1/2 . Relative risk was analogously computed.…”

Section: Methodsmentioning

confidence: 99%

“…Approximately 20% to 30% of patients with non-small cell lung cancer (NSCLC) initially present with resectable disease 1 ; however, 30% to 55% develop recurrence and die of the disease despite surgical excision. 2 Given the high risk of relapse, multidisciplinary research has been the academic focus for decades. Despite use of platinum-based neoadjuvant or adjuvant chemotherapy, both approaches showed comparable yet marginal improvement in overall survival (OS).…”

Section: Introductionmentioning

confidence: 99%

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Neoadjuvant-Adjuvant vs Neoadjuvant-Only PD-1 and PD-L1 Inhibitors for Patients With Resectable NSCLC

Zhou,

Li,

et al. 2024

JAMA Netw Open

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ImportanceNeoadjuvant therapy combining programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) inhibitors with platinum-based chemotherapy has demonstrated significant improvement in pathologic response and survival rates among patients with resectable non–small cell lung cancer (NSCLC). However, it remains controversial whether PD-1 blockade therapy given before and after surgery (neoadjuvant-adjuvant treatment) is associated with better outcomes than when given only before surgery (neoadjuvant-only treatment).ObjectiveTo compare the efficacy and safety associated with neoadjuvant-adjuvant anti–PD-1 and anti–PD-L1 therapy with neoadjuvant-only anti–PD-1 and anti–PD-L1 therapy for patients with resectable NSCLC.Data SourcesA systematic search was conducted across databases including PubMed, Embase, and the Cochrane Library, as well as major oncology conferences, through July 31, 2023.Study SelectionRandomized clinical trials comparing neoadjuvant-adjuvant or neoadjuvant-only PD-1 and PD-L1 inhibitor therapy vs chemotherapy alone for patients with resectable NSCLC were selected.Data Extraction and SynthesisFollowing the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline, 2 authors independently extracted data. Hazard ratios (HRs) and 95% CIs for event-free survival (EFS) and overall survival (OS) were extracted and then pooled through the generic inverse-variance methods. Relative risks (RRs) for treatment-related adverse events (TRAEs) were derived via the Mantel-Haenszel method. Using chemotherapy as a common comparator, indirect comparisons between neoadjuvant-adjuvant immunotherapy and neoadjuvant-only immunotherapy were conducted using frequentist methods. A random or fixed model was used based on intertrial heterogeneity identified through the Cochran Q test.Main Outcomes and MeasuresThe primary outcome was EFS, with secondary outcomes including OS and TRAEs.ResultsThe study encompassed 4 trials of neoadjuvant-adjuvant immunotherapy and 1 trial of neoadjuvant-only immunotherapy, involving 2385 patients. Direct meta-analysis revealed significant improvements in EFS for both neoadjuvant-adjuvant and neoadjuvant-only immunotherapy compared with chemotherapy alone. In indirect meta-analysis, the addition of adjuvant immunotherapy to neoadjuvant immunotherapy was not associated with improved EFS (HR, 0.90; 95% CI, 0.63-1.30; P = .59) or OS (HR, 1.18; 95% CI, 0.73-1.90; P = .51) compared with neoadjuvant-only immunotherapy. Moreover, the incidence of any grade of TRAEs significantly increased with the addition of adjuvant immunotherapy (RR, 1.08; 95% CI, 1.00-1.17; P = .04).Conclusions and RelevanceThis meta-analysis suggests that adding PD-1 or PD-L1 inhibitors in the adjuvant phase to neoadjuvant treatment with PD-1 or PD-L1 inhibitors and chemotherapy may not improve survival outcomes for patients with resectable NSCLC and may be associated with increased adverse events. Future validation of these findings is warranted through head-to-head randomized clinical trials.

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Real-world study of disease-free survival & patient characteristics associated with disease-free survival in early-stage non-small cell lung cancer: A retrospective observational study

Cited by 4 publications

References 24 publications

Diagnostic Workup, Treatment Patterns, and Clinical Outcomes in Early-Stage IB–IIIA Non-Small-Cell Lung Cancer Patients in Denmark

Diagnostic Workup, Treatment Patterns, and Clinical Outcomes in Early-Stage IB–IIIA Non-Small-Cell Lung Cancer Patients in Denmark

Genetic Alterations and Risk Factors for Recurrence in Patients with Non-Small Cell Lung Cancer Who Underwent Complete Surgical Resection

Neoadjuvant-Adjuvant vs Neoadjuvant-Only PD-1 and PD-L1 Inhibitors for Patients With Resectable NSCLC

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