Long-term follow-up in the KEYNOTE-010 study of pembrolizumab (pembro) for advanced NSCLC, including in patients (pts) who completed 2 years of pembro and pts who received a second course of pembro

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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Modern Treatment of Non-Small Cell Lung Cancer with Intracerebral Metastases and Extracranial Metastatic Affection of Liver, Mediastinal Lymph Nodes, Skeletal Bones. Clinical Observation

Medical Radiology and radiation safety ◽

10.12737/1024-6177-2021-66-3-82-87 ◽

2021 ◽

Vol 66 (3) ◽

pp. 82-87

Author(s):

Yu. Udalov ◽

A. Samoylov ◽

L. Danilova ◽

E. Slobina ◽

E. Stepanyuchenko ◽

...

Keyword(s):

Lymph Nodes ◽

Advanced Nsclc ◽

Small Cell ◽

Mediastinal Lymph Nodes ◽

Small Cell Lung ◽

Antitumor Therapy ◽

Modern Methods ◽

Long Term Follow Up

Introduction: The article covers issues related to modern methods of treatment of non-small cell lung cancer (NSCLC) with multiple synchronous metastases in brain, liver, mediastinal lymph nodes, skeletal bones and describes a clinical case of modern effective treatment and long-term follow-up of a patient with advanced NSCLC and extra- and intracranial metastatic spread. Purpose: Evaluation of modern methods of special antitumor treatment and their application in clinical practice for the treatment of metastatic NSCLC. Material and methods: Modern methods of proton and photon radiation therapy, targeted therapy are considered. Results: The use of modern methods of special antitumor therapy has increased the overall and relapse-free survival rate of patients with multiple metastases of NSCLC in brain, liver, mediastinal lymph nodes, skeletal bones reducing the need for additional interventions. This is confirmed by a long-term follow-up after modern effective antitumor treatment of a patient with advanced NSCLC and synchronous progression in the form of extra- and intracranial metastatic spread. The patient has been alive for more than 2 years from the moment of progression with an estimated life expectancy of 4–5 months. Conclusion: Modern methods of special antitumor therapy can increase the survival rate of patients with multiple synchronous NSCLC metastases in brain, liver, mediastinal lymph nodes, skeletal bones without significant deterioration in their quality of life.

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Randomized trial of thoracic radiotherapy with or without concurrent daily low-dose carboplatin in elderly patients with locally advanced non-small cell lung cancer (NSCLC): Long-term follow-up of Japan Clinical Oncology Group (JCOG) Study JCOG0301.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.8532 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 8532-8532 ◽

Cited By ~ 1

Author(s):

Shinji Atagi ◽

Junki Mizusawa ◽

Satoshi Ishikura ◽

Toshiaki Takahashi ◽

Hiroaki Okamoto ◽

...

Keyword(s):

Elderly Patients ◽

Advanced Nsclc ◽

Locally Advanced ◽

Late Toxicity ◽

Initial Report ◽

Locally Advanced Nsclc ◽

Long Term Follow Up ◽

Grade 3

8532 Background: In the phase III JCOG0301 trial, concurrent chemoradiotherapy (CRT) was compared with radiotherapy (RT), demonstrating clinically significant survival benefits in elderly patients with locally advanced NSCLC after a median follow-up of 19.4 months. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT are poorly understood for elderly patients. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. Methods: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT alone (RT arm: irradiation with 60 Gy in 30 fractions) or CRT (CRT arm: the same RT with additional concurrent use of carboplatin 30 mg/m2 per fraction up to the first 20 fractions). The primary endpoint was overall survival (OS). Prognosis and adverse events data were collected beyond those in the initial report of this trial. Kaplan-Meier survival curves and 3- and 5-year survival proportions were calculated. Late toxicities were defined as occurring later than 90 days after RT initiation. Results: From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better OS than the RT arm (HR = 0.743, 95% CI = 0.552 – 0.998, one-sided p = 0.0239 by stratified log-rank test). In the RT and CRT arms, median OS was 16.5 and 21.7 months, 3-year survival was 16.3% and 34.3%, and 5-year survival was 9.2% and 15.2%, respectively. %Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) were seen since the initial report. There were 7 treatment-related deaths, all of which were recorded in the initial report: 4 (4.0%) in the RT arm and 3 (3.0%) in the CRT arm. Conclusions: Long-term follow-up confirms the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT, as compared with RT alone. Clinical trial information: 00132665.

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Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2019.06.010 ◽

2019 ◽

Vol 14 (10) ◽

pp. 1794-1806 ◽

Cited By ~ 24

Author(s):

Scott J. Antonia ◽

Ani Balmanoukian ◽

Julie Brahmer ◽

Sai-Hong I. Ou ◽

Matthew D. Hellmann ◽

...

Keyword(s):

Advanced Nsclc ◽

Clinical Activity ◽

Long Term Follow Up

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Therapy and prevention for mental health: What if mental diseases are mostly not brain disorders?

Behavioral and Brain Sciences ◽

10.1017/s0140525x1800105x ◽

2019 ◽

Vol 42 ◽

Cited By ~ 2

Author(s):

John P. A. Ioannidis

Keyword(s):

Mental Health ◽

Mental Disease ◽

Brain Disorders ◽

Social Stressors ◽

Labor Education ◽

Mental Diseases ◽

Long Term Follow Up ◽

Political Decisions

AbstractNeurobiology-based interventions for mental diseases and searches for useful biomarkers of treatment response have largely failed. Clinical trials should assess interventions related to environmental and social stressors, with long-term follow-up; social rather than biological endpoints; personalized outcomes; and suitable cluster, adaptive, and n-of-1 designs. Labor, education, financial, and other social/political decisions should be evaluated for their impacts on mental disease.

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