Real-world outcomes of immunotherapy with or without chemotherapy in first-line treatment of advanced non-small cell lung cancer

Abstract

BackgroundImmunotherapy alone (mono-IT) or combined with chemotherapy (chemo-IT) has recently become the cornerstone of first-line treatment for advanced non-small cell lung cancer (NSCLC) patients. Here, real-world outcomes of first-line mono-IT and chemo-IT of advanced NSCLC treated within routine clinical practice at a single academic center in the Central Eastern European (CEE) region are presented.Materials and methodsA total of 176 consecutive patients with advanced NSCLC treated with mono-IT (118 patients) or chemo-IT (58 patients) were included. At the participating institution, all medical data relevant for providing oncology care are collected prospectively and in a standardized manner using purposely created pro-forms. Adverse events (AEs) were recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE). The Kaplan−Meier method was used to estimate median overall survival (mOS) and median duration of treatment (mDOT).ResultsThe 118 patients in the mono-IT cohort had a median age of 64 years, most were male (59%), 20% had ECOG PS ≥2, and 14% had controlled CNS metastases at baseline. With a median follow-up time (mFU) of 24.1 months, the mOS was 19.4 months (95% CI, 11.1-27.6), and the mDOT was 5.0 months (95% CI, 3.5-6.5). The 1-year OS was 62%. The 58 patients in the chemo-IT cohort had a median age of 64 years, most were male (64%), 9% had ECOG PS ≥2, and 7% had controlled CNS metastases at baseline. With a mFU of 15.5 months, the mOS was 21.3 months (95% CI, 15.9-26.7), and the mDOT was 12.0 months (95% CI, 8.3-15.6). The 1-year OS was 75%. Adverse events of severe grade were recorded in 18% and 26% of patients, and immunotherapy discontinuation due to AEs occurred in 19% and 9% in the mono-IT and chemo-IT groups, respectively. No treatment-related deaths were recorded.ConclusionThe results from the present real-world observational study from a CEE country suggest similar effectiveness and safety of first-line mono-IT and chemo-IT in patients with advanced NSCLC to those observed in randomized clinical trials. However, continuous follow-up will offer better insight into the magnitude of long-term benefits in routine clinical practice.

Comparison of treatment outcome between first‐line combination immunotherapy (anti‐PD‐L1 or anti‐PD1) with or without chemotherapy and chemotherapy alone in advanced non‐small cell lung cancer patients in tertiary care hospital

“…In many real-world studies, [20][21][22][23][24] outcomes comparable to RCTs have been observed, despite including patients with poor prognostic factors such as high tumor burden, unstable or untreated CNS metastasis, and ECOS-PS greater than 2 19 who are typically excluded from RCTs. In immunotherapy-based group, 15% of patients had ECOG-PS greater than 2, and 24% had CNS metastasis at baseline.…”

“…Caucasian patients, 63% have PD-L1 positive tumors, 33% of Chinese patients exhibit PD-L1 positivity, smoking is a share risk factor that increases likelihood of PD-L1 high expression. 16,17 Hence, researchers recognize the significance of realworld data [18][19][20][21][22][23][24] in elucidating the efficacy of immunotherapy. In Asian countries such as China, Japan, and Korea, there are real-world data [25][26][27][28][29] comprising 1390 treated patients with immunotherapy, either with or without chemotherapy demonstrate survival benefits consistent with clinical studies.…”