First-line osimertinib for poor performance status patients with EGFR mutation-positive non-small cell lung cancer: A prospective observational study

Igawa, Satoshi; Fukui, Tomoya; Kasajima, Masashi; Ono, Taihei; Ozawa, Tetsuya; Kakegawa, Mikiko; Kusuhara, Seiichiro; Sato, Takashi; Nakahara, Yoshiro; Mitsufuji, Hisashi; Sasaki, Jiichiro; Naoki, Katsuhiko

doi:10.1007/s10637-021-01195-2

Cited by 15 publications

(8 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Therefore, multigene testing should be performed more frequently in patients without adenocarcinoma. In addition, some targeted therapies, such as osimertinib mesylate 21 , 22 and alectinib hydrochloride, 23 have been safely administered to patients with poor ECOG-PS. In vulnerable patients, treatment options are limited.…”

Section: Discussionmentioning

confidence: 99%

Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer

Sakamoto,

Matsubara,

Takahama

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

ImportanceBiomarker testing for driver mutations is essential for selecting appropriate non–small cell lung cancer (NSCLC) treatment but is insufficient.ObjectiveTo investigate the status of biomarker testing and drug therapy for NSCLC in Japan for identifying problems in treatment.Design, Setting, and ParticipantsThe REVEAL cohort study included retrospective data collection and prospective follow-up from 29 institutions across Japan. Of 1500 patients diagnosed with advanced or recurrent NSCLC between January 1 and March 18, 2021, 1479 were eligible. Cases recognized at the wrong clinical stage (n = 12), diagnosed outside the study period (n = 6), not treated according to eligibility criteria before recurrence (n = 2), and with deficient consent acquisition procedure (n = 1) were excluded.Main Outcomes and MeasuresThe primary end point was the biomarker testing status. Treatment-related factors were examined.ResultsAmong the 1479 patients included in the analysis, the median age was 72 (range, 30-95) years; 1013 (68.5%) were men; 1161 (78.5%) had an Eastern Cooperative Oncology Group performance status 0 or 1; 1097 (74.2%) were current or past smokers; and 947 (64.0%) had adenocarcinoma. Biomarker status was confirmed in 1273 patients (86.1%). Multigene testing was performed in 705 cases (47.7%); single-gene testing, in 847 (57.3%); and both, in 279 (18.9%). Biomarker testing was performed for EGFR in 1245 cases (84.2%); ALK, in 1165 (78.8%); ROS1, in 1077 (72.8%); BRAF, in 803 (54.3%); and MET, in 805 (54.4%). Positivity rates among 898 adenocarcinoma cases included 305 (34.0%) for EGFR, 29 (3.2%) for ALK, 19 (2.1%) for ROS1, 11 (1.2%) for BRAF, and 14 (1.6%) for MET. Positivity rates among 375 nonadenocarcinoma cases were 14 (3.7%) for EGFR, 6 (1.6%) for ALK, 1 (0.3%) for ROS1, 3 (0.8%) for BRAF, and 8 (2.1%) for MET. Poor physical status, squamous cell carcinoma, and other comorbidities were associated with hampered multigene testing. Targeted therapy was received as first-line treatment by 263 of 278 cases (94.6%) positive for EGFR, 25 of 32 (78.1%) positive for ALK, 15 of 24 (62.5%) positive for ROS1, 9 of 12 (75.0%) positive for BRAF, and 12 of 19 (63.2%) positive for MET. Median overall survival of patients with positive findings for driver gene alteration and who received targeted therapy was 24.3 (95% CI, not reported) months; with positive findings for driver gene alteration and who did not receive targeted therapy, 15.2 (95% CI, 7.7 to not reported) months; and with negative findings for driver gene alteration, 11.0 (95% CI, 10.0-12.5) months. Multigene testing for nonadenocarcinomas and adenocarcinomas accounted for 705 (47.7%) of all NSCLC cases.Conclusions and RelevanceThese findings suggest that multigene testing has not been sufficiently implemented in Japan and should be considered prospectively, even in nonadenocarcinomas, to avoid missing rare driver gene alterations.

show abstract

Section: Discussionmentioning

confidence: 99%

Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer

Sakamoto,

Matsubara,

Takahama

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

show abstract

“…Therefore, it can also be delivered to patients with a deteriorated PS, elderly patients, and patients with co-morbidities. However, the PFS is shorter in patients with a poor PS, when they are treated with osimertinib ( 19 - 21 ).…”

Section: Discussionmentioning

confidence: 99%

Osimertinib as first-line treatment for recurrent lung cancer patients with EGFR mutation

Osoegawa,

Karashima,

Takumi

et al. 2023

J Thorac Dis

View full text Add to dashboard Cite

Background Although osimertinib was approved as adjuvant therapy for lung cancer patients with EGFR mutation in various countries, there is still some ongoing debate as osimertinib has been approved based on disease-free survival (DFS) rather than overall survival (OS). We curated a case series in which we documented patterns of recurrence and efficacy and safety of osimertinib after recurrence. Methods Patients who received osimertinib as first-line treatment for postoperative recurrence between September 2018 and January 2023 were included. Clinicopathological factors, duration of osimertinib treatment (DoT), and adverse events were collected and analyzed. Results Twenty patients received osimertinib [male, n=6; median age, 75 years (range, 55–85 years)]. The EGFR mutation type was L858R in 11 patients and exon 19 deletion in eight patients. The performance status (PS) was 0 or 1 in all but two patients, who had symptomatic brain metastasis and were therefore PS 3. The first site of postoperative recurrence was locoregional in five patients and distant in 15 patients, including seven with brain metastasis. As of February 2023, 10 patients were still on osimertinib, including three with brain metastasis. Patients with brain metastasis or poor PS had a considerably shorter DoT than their counterparts. Three patients with symptomatic brain metastasis or leptomeningeal metastasis initially responded to osimertinib, but all died of disease progression. Five patients discontinued osimertinib due to serious adverse effects (pneumonitis, drug eruption, and heart failure). Conclusions Although osimertinib exerts great disease control, even in patients with brain metastasis or poor PS, their presence was associated with a poor prognosis, even with osimertinib treatment. Therefore, adjuvant osimertinib is recommended unless contraindicated.

show abstract

“…Notably, it was previously reported that the GPS had a greater prognostic value than that of the ECOG PS score [ 34 , 35 ]. Whereas EGFR-TKIs are key therapies for patients with EGFR -mutated NSCLC, data regarding their effectiveness in patients with a poor PS are scarce [ 36 – 38 ]. In the current study, we found that patients with a poor PS had worse PFS and OS if their GPS values were 2; this might help determine the most suitable TKI for this subgroup.…”

Section: Discussionmentioning

confidence: 99%

The Glasgow Prognostic Score Predicts Survival in Patients with Advanced Non-Small Cell Lung Cancer Harboring Sensitive Epidermal Growth Factor Receptor Mutations Who Are Treated with Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Akazawa¹,

Igawa²,

Yamada³

et al. 2023

Oncology

Self Cite

View full text Add to dashboard Cite

Introduction: Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) are the standard first-line treatment for advanced non-small cell lung cancer (NSCLC) with sensitive EGFR mutations. The Glasgow prognostic score (GPS) is an inflammation-assessing score based on C-reactive protein and albumin concentrations. Information regarding the association between the GPS and EGFR-TKI treatment effectiveness is limited; hence, we investigated whether the GPS can predict the response of NSCLC to EGFR-TKIs. Methods: We evaluated 340 patients with NSCLC harboring sensitive EGFR mutations who received EGFR-TKI monotherapy between March 2009 and July 2021. The Kaplan–Meier method and Cox proportional hazards models were used to assess progression-free survival (PFS) and overall survival (OS). Results: After a median follow-up of 26.6 months, patients with a GPS of 0, 1, and 2 had PFS of 15.7, 10.0, and 6.3 months, respectively, and OS of 40.1, 25.8, and 14.4 months, respectively; patients with a GPS of 0 had significantly better PFS and OS than those with a GPS of 1 (P=0.03, P=0.001, respectively) or 2 (P<0.001, P<0.001, respectively). Multivariate analysis identified poor performance status, stage IV at diagnosis, type of EGFR-TKI (gefitinib/erlotinib vs. afatinib), and GPS=2 as predictors of a short PFS. Meanwhile, poor performance status, gefitinib/erlotinib administration, and GPS=2 were predictive of a short OS. Conclusion: The GPS predicted the survival of NSCLC patients harboring sensitive EGFR mutations who were undergoing EGFR-TKI treatment. The GPS might be ideal for routine use in clinical practice, given that it is an easily calculated parameter.

show abstract

First-line osimertinib for poor performance status patients with EGFR mutation-positive non-small cell lung cancer: A prospective observational study

Cited by 15 publications

References 25 publications

Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer

Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer

Osimertinib as first-line treatment for recurrent lung cancer patients with EGFR mutation

The Glasgow Prognostic Score Predicts Survival in Patients with Advanced Non-Small Cell Lung Cancer Harboring Sensitive Epidermal Growth Factor Receptor Mutations Who Are Treated with Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Contact Info

Product

Resources

About