Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

Friedlaender, Alex; Metro, Giulio; Signorelli, Diego; Gili, Alessio; Economopoulou, Panagiota; Roila, Fausto; Banna, Giuseppe Luigi; Toma, Alessandro De; Camerini, Andrea; Christopoulou, Athina; Russo, Giuseppe Lo; Banini, Marco; Galetta, Domenico; Jiménez, Beatriz; Collazo-Lorduy, Ana; Calles, Antonio; Baxevanos, Panagiotis; Linardou, Helena; Kosmidis, P.; Mountzios, Giannis; Garassino, Marina Chiara; Addeo, Alfredo

doi:10.1080/0284186x.2020.1781249

Cited by 33 publications

(33 citation statements)

References 29 publications

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“…When compared to PS 0-1 patients, poor PS ones had frequently worse response and DCRs, and in many cases the difference was statistically significant (Table 5). Pooling the data, 491 and 210 PS ≥2 patients were evaluated for ORR [seven studies (28,29,40,41,45,46,51)] and DCR [five studies (29,36,37,40,41)], respectively (Figures S1,S2). Disease responses were observed in 30.9% of the cases [95% CI: 22.5-40.0%] and 41.5% of the patient achieved disease control (95% CI: 27.1-56.9%) (Figure 2).…”

Section: Response and Dcrsmentioning

confidence: 99%

“…Across studies, 1,262 ECOG PS 0-1 patients in five studies were evaluated for disease response (28,40,45,46,51) and ORR was 55.2% (95% CI: 42.8-67.2%) (Figure 2C; Figure S3). DCR data was obtained for 185 patients in four studies (36,37,40,51) and occurred in 71.5% of the cases (95% CI: 56.0-84.7%) (Figure 2D; Figure S2).…”

Section: Response and Dcrsmentioning

confidence: 99%

“…Records identified in proceedings of main international meetings (n=16) in two studies specifically reporting outcomes of PS 2 patients (43,50). Pooling data into landmark PFS rates from six studies with available information (28,29,32,39,45,46), it was estimated that 45%, 30%, 22% and 13% of the patients had not progressed at thee, six, 12 and 18 months, respectively (Table 7) (71)(72)(73).…”

Section: Progression-free Survivalmentioning

confidence: 99%

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First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis

Facchinetti¹,

Maïo²,

Perrone³

et al. 2021

Transl Lung Cancer Res

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Background: Immune checkpoint inhibitors (ICIs) have become the standard of care for the first-line treatment of advanced non-small cell lung cancer patients (NSCLC), either as single agents or combined with chemotherapy. The evidence sustaining their role for poor performance status (ECOG PS ≥2) patients is limited. Methods:We search PubMed and the proceedings of international oncology meetings to perform a systematic review to assess the outcomes poor PS NSCLC patients who received ICIs as first-line treatment.A meta-analysis included retrospective studies focusing on pembrolizumab monotherapy in PD-L1 ≥50% NSCLC. We reported the global objective response rate (ORR), disease control rate (DCR) and landmark progression-free and overall survival (PFS and OS, respectively) in ECOG PS ≥2 and 0-1 patients, respectively.Results: Forty-one studies were included in the systematic review. Thirty-two retrospective studies focused on pembrolizumab monotherapy in PD-L1 ≥50% cases. 1030 out of 5357 (19%) of patients across 30 studies presented with a PS ≥2 at pembrolizumab initiation. In 18 studies with detailed clinical information, worse outcomes in poor PS compared to good PS patients were documented. The meta-analysis revealed that ORR and DCR within the PS ≥2 patient population were 30.9% and 41.5% respectively (55.2% and 71.5% in PS 0-1 patients). The rates of PFS (at three, six, 12 and 18 months) and OS (at six, 12, 18 and 24 months) were approximately double in the good PS compared to the poor PS group of patients. In the three prospective trials where of ICIs in PS 2 populations, the diverse strictness in PS definition likely contributed to the differential outcomes observed. Six retrospective studies dealt with chemo-immunotherapy combinations.Conclusions: Still with limited prospective evidence sustaining the role of immunotherapy in previously untreated NSCLC with poor PS, 19% of patients in retrospective series dealing with pembrolizumab in PD-L1 ≥50% tumors had an ECOG PS ≥2. Clinical effort encompassing the definition of poor PS, of the factors conditioning it, and the development of dedicated treatment strategies is required to improve the outcomes in this patient population.

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Section: Response and Dcrsmentioning

confidence: 99%

Section: Response and Dcrsmentioning

confidence: 99%

Section: Progression-free Survivalmentioning

confidence: 99%

See 1 more Smart Citation

First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis

Facchinetti¹,

Maïo²,

Perrone³

et al. 2021

Transl Lung Cancer Res

View full text Add to dashboard Cite

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“…Alessi et al investigated 234 NSCLC patients with PD‐L1 TPS ≥50% treated with first‐line pembrolizumab, including 195 with ECOG PS of 0 or 1 and 39 with PS of 2, and reported that the patients with PS of 2 had significantly lower ORR and shorter median OS than those with PS of 0 or 1 (25.6% vs. 43.1% and 7.4 vs. 20.3 months, respectively) 13 . Friedlaender et al also studied 302 NSCLC patients with PD‐L1 TPS ≥50% treated with first‐line pembrolizumab, including 246 with PS of 0 or 1 and 56 with PS of 2, and reported that the patients with PS of 2 had significantly lower ORR and shorter median OS than those with PS of 0 or 1 (45% vs. 72% and 7.8 months vs. NR, respectively) 14 . AEs of grade ≥3 occurred in 9% of the patients with ECOG PS of 2 and in 7% of the patients with ECOG PS of 0 or 1, and there was no significant difference in the incidence of AEs between them.…”

Section: Discussionmentioning

confidence: 99%

“…No reports evaluated first‐line pembrolizumab plus chemotherapy for patients with ECOG PS of ≥2 and patients aged ≥75 years in the clinical setting. A few reports evaluated first‐line pembrolizumab monotherapy in NSCLC patients in the clinical setting and showed that adverse events (AEs) occurred more frequently in patients aged ≥75 years and poor clinical response in patients with poor ECOG PS 12–15 …”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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%.

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Association of Performance Status With Survival in Patients With Advanced Non–Small Cell Lung Cancer Treated With Pembrolizumab Monotherapy

et al. 2021

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Key Points Question Is Eastern Cooperative Oncology Group (ECOG) performance status at the beginning of therapy associated with survival outcomes in patients with advanced non–small cell lung cancer who are treated with palliative pembrolizumab monotherapy? Findings In this cohort study of 74 patients, those with ECOG performance status of at least 2 had significantly lower disease control, progression-free survival, and overall survival than those with performance status of 0 or 1. Survival differences remained significant after multivariable adjustment for confounding factors. Meaning These findings suggest that ECOG performance status should be considered while making shared therapeutic decisions regarding pembrolizumab monotherapy with patients.

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Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

Cited by 33 publications

References 29 publications

First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis

First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis

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

Association of Performance Status With Survival in Patients With Advanced Non–Small Cell Lung Cancer Treated With Pembrolizumab Monotherapy

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