Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort study (HOPE-001)

Tamiya, Motohiro; Tamiya, Akihiro; Hosoya, Kazumi; Taniguchi, Yoshihiko; Yokoyama, Toshihide; Fukuda, Yasushi; Hirano, Katsuya; Matsumoto, Hirotaka; Kominami, Ryota; Suzuki, Hidekazu; Hirashima, Tomonori; Uchida, Junji; Morita, Mitsunori; Kanazu, Masaki; Sawa, Nobuhiko; Kinoshita, Yoshinori; Hara, Satoshi; Kumagai, Toru; Fujimoto, Daichi

doi:10.1007/s10637-019-00843-y

Cited by 42 publications

(26 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The subgroup analysis of patients with PD-L1 TPS ≥ 50% receiving pembrolizumab (compared to standard platinum-based chemotherapy) within the Keynote-042 trial, otherwise reported an ORR of 39%, a PFS of 7.1 months and a median OS of 20.0 months (median follow-up of 12.8 months), which were slightly worse compared to our study population in terms of ORR [25]. Our efficacy results are also comparable to recent real-life studies [4][5][6]; however, to properly evaluate the comparability with clinical trials, we must consider some several key differences in the study population, beside the significant differences regarding the reported follow-up. Consistently with other recent retrospective analysis [4][5][6], also I our study patients with an ECOG-PS ≥ 2 (15.4%) were included, differently from the Keynote-024 trial [1].…”

Section: Discussionsupporting

confidence: 75%

“…Our efficacy results are also comparable to recent real-life studies [4][5][6]; however, to properly evaluate the comparability with clinical trials, we must consider some several key differences in the study population, beside the significant differences regarding the reported follow-up. Consistently with other recent retrospective analysis [4][5][6], also I our study patients with an ECOG-PS ≥ 2 (15.4%) were included, differently from the Keynote-024 trial [1]. Of note, patients with an ECOG-PS ≥ 2 are known to be not the best candidates for single agent immunotherapy [7].…”

Section: Discussionsupporting

confidence: 68%

“…However, clinical trials data often do not apply to real life populations. Recent real-world experiences with pembrolizumab monotherapy showed inferior progression free survival (PFS) and overall survival (OS), compared to the Keynote-024 experimental arm [4][5][6], as patients with poor performance status and genetic drivers are usually excluded form clinical trials. For instance, a retrospective multicenter study of pembrolizumab monotherapy in NSCLC patients, with PD-L1 TPS ≥ 50% and Eastern Cooperative Performance Status (ECOG-PS) ≥ 2, has revealed poor clinical outcomes to treatment, particularly in those patients whose poor PS was related to a high disease burden [7].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50%

Cortellini

Tiseo

Banna

et al. 2020

Cancer Immunol Immunother

View full text Add to dashboard Cite

show abstract

Section: Discussionsupporting

confidence: 75%

Section: Discussionsupporting

confidence: 68%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50%

Cortellini

Tiseo

Banna

et al. 2020

Cancer Immunol Immunother

View full text Add to dashboard Cite

show abstract

“…Aguilar et al investigated 187 patients and reported an ORR of 44.4% and median OS of NR 20 . Tamiya et al studied 213 patients and found an ORR of 51.2% and median OS of 17.8 months 21 . Cortellini et al studied 1010 patients and reported an ORR of 48.9% and median OS of 27.4 months 22 .…”

Section: Discussionmentioning

confidence: 99%

A retrospective analysis of pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for advanced or recurrent non‐small cell lung cancer

et al. 2021

View full text Add to dashboard Cite

Background Although clinical trials have investigated the addition of pembrolizumab to chemotherapy for non‐small cell lung cancer, none have investigated the addition of chemotherapy to pembrolizumab. Methods We conducted a retrospective study of 71 NSCLC patients including 33 treated with pembrolizumab plus chemotherapy (combination therapy group) and 38 treated with pembrolizumab monotherapy (monotherapy group) from 1 May 2016 to 31 August 2020. Results Eleven of 33 (33.3%) patients in the combination therapy group and 37 of 38 (97.4%) patients in the monotherapy group had programmed cell death ligand‐1 (PD‐L1) tumor proportion score (TPS) ≥50%. Objective response rate (ORR) and median overall survival (OS) were not significantly different between the combination therapy group and monotherapy group (54.5% vs. 47.4, p = 0.637 and 16.6 vs. 27.0 months, p = 0.463). In patients with PD‐L1 TPS ≥50%, ORR and median OS were not different between the combination therapy group and the monotherapy group (63.6% vs. 48.6%, p = 0.499 and not reached vs. 27.0 months, p = 0.976). Thirty‐three (100%) patients experienced adverse events (AEs) in the combination therapy group and 32 (84.2%) in the monotherapy group. Treatment discontinuation at 1 year due to AEs occurred more frequently in the combination therapy group (45.2%) than in the monotherapy group (21.1%). Conclusion There was no significant difference in ORR and OS between the two groups, and treatment discontinuation was more frequent in the combination group. A randomized controlled trial is needed to evaluate the addition of chemotherapy to pembrolizumab for first‐line treatment in patients with PD‐L1 TPS ≥50%.

show abstract

“…10 Therefore, several inflammatory markers, such as the Glasgow prognostic score (GPS), the neutrophil-tolymphocyte ratio (NLR), and the C-reactive protein-toalbumin ratio (CRP/ALB ratio, CAR), are expected to be valuable prognostic and predictive biomarkers in immunotherapy. [11][12][13] Cachexia in cancer patients is the result of the chronic systemic inflammatory response and often indicates a poor outcome for cancer patients. 14 Sarcopenia, which has been reported to correlate with BMI, is an important nutritional component of cancer cachexia syndrome.…”

Section: Introductionmentioning

confidence: 99%

The Predictive Significance of the Advanced Lung Cancer Inflammation Index (ALI) in Patients with Melanoma Treated with Immunotherapy as Second-Line Therapy

Cheng¹,

Dong²,

Lou³

2021

CMAR

View full text Add to dashboard Cite

The advanced lung cancer inflammation index (ALI) is a useful tool to predict the clinical outcome in several malignancies. The ALI not only contains indices related to inflammation but also the body mass index (BMI), which was reported to correlate with the sarcopenic status. However, to date, its predictive significance in metastatic melanoma patients treated with second-line immunotherapy has not been evaluated. Methods: We retrospectively analyzed data from patients who were diagnosed with metastatic melanoma and treated with immunotherapy as second-line therapy between 2016 and 2019. Weight, height, neutrophil, lymphocyte and serum albumin were collected at baseline prior to receiving immunotherapy. The BMI was calculated by dividing the weight by height squared. The neutrophil-to-lymphocyte ratio (NLR) was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The ALI was defined as follows: ALI=BMI×serum albumin/NLR. The receiver operator curve (ROC) was used to determine the best cutoff value for ALI in predicting disease control (consisting of complete response, partial response and stable disease). The aim of this study was to investigate whether the ALI is a predictive indicator for progression-free survival in melanoma patients. Results: Forty-three patients were included in this retrospective cohort study. By ROC, ALI>50.98 before immunotherapy was predictive of disease control. Baseline continuous variables, such as BMI, NLR, C-reactive protein and C-reactive protein-to-albumin ratio, had significantly worse scores in patients of the low-ALI group (n=24) than high-ALI group (n=19). The median progression-free survival was significantly worse in the patients with ALI<50.98 than the patients with ALI>50.98 (2.60 months vs 11.17 months, P = 0.023, hazard ratio: 2.241, 95% confidence interval: 1.167-5.097). Conclusion:The advanced lung cancer inflammation index (ALI) >50.98 before immunotherapy is a strong predictor for disease control. The ALI also provides great predictive value for metastatic melanoma patients treated with immunotherapy as second-line therapy.

show abstract

Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort study (HOPE-001)

Cited by 42 publications

References 33 publications

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50%

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50%

A retrospective analysis of pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for advanced or recurrent non‐small cell lung cancer

The Predictive Significance of the Advanced Lung Cancer Inflammation Index (ALI) in Patients with Melanoma Treated with Immunotherapy as Second-Line Therapy

Contact Info

Product

Resources

About