Run-in-phase results from a multicenter phase II trial to evaluate pembrolizumab (P) and gemcitabine (Gem) in patients (pts) with HER2-negative advanced breast cancer (ABC): GEICAM/2015-04 PANGEA-Breast

Quiroga, Vanesa; Holgado, Esther; Alonsó, José Luis; Andrés, Raquel; Antón, Fernando Moreno; Gala, María del Carmen Álamo de la; Henao, Fernando; Cirauqui, Beatriz; Margelı́, Mireia; Castán, J. Cortés; Cortes, M. Gion; Soto, Alberto; Benito, Sara; Escudero, M.J.; Chiesa, Massimo; Caballero, Rosalía; Montes, S. Bezares; Carrasco, Eduardo; Cruz‐Merino, Luis de la

doi:10.1093/annonc/mdy487.019

Cited by 2 publications

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“…There was an initial exploratory run-in-phase, in which the Recommended Phase II Dose (RP2D) was defined [19] Eligible patients were enrolled and treated with pembrolizumab plus gemcitabine. The primary objective was to evaluate the efficacy of the combination in terms of objective response rate (ORR) defined as complete response (CR) plus partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.…”

Section: Methodsmentioning

confidence: 99%

Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Cruz‐Merino

Gión

Cruz-Jurado

et al. 2021

Cancers

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The PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The primary objective was the objective response rate (ORR). The tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumor, and the myeloid-derived suppressor cells (MDSCs) level in peripheral blood, were analyzed to explore associations with treatment efficacy. Considering a two-stage Simon’s design, the study recruitment was stopped after its first stage as statistical assumptions were not met. A subset of 21 triple-negative breast cancer (TNBC) patients was enrolled. Their median age was 49 years; 15 patients had visceral involvement, and 16 had ≤3 metastatic locations. Treatment discontinuation due to progressive disease (PD) was reported in 16 patients. ORR was 15% (95% CI 3.2–37.9). Four patients were on treatment >6 months before PD. Grade ≥3 treatment-related adverse events were observed in 8 patients, where neutropenia was the most common. No association was found between TILs density, PD-L1 expression or MDSCs levels and treatment efficacy. ORR in TNBC patients also did not meet the assumptions, but 20% were on treatment >6 months.

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Section: Methodsmentioning

confidence: 99%

Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Cruz‐Merino

Gión

Cruz-Jurado

et al. 2021

Cancers

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“…Of the 27 studies, 16 were full-text articles, whereas 11 studies were abstracts. Sixteen studies used PD-1 antibody, 7,8,12,[19][20][21][22][23][24][25][26][27][28][29][30][31] eight studies used PD-L1 antibody, 6,[9][10][11][32][33][34][35] two studies used CTLA-4 antibody 36,37 and one study used both PD-1 and CTLA-4 antibody. 38 Patients with triple-negative breast cancer (TNBC), human epidermal growth factor receptor 2 (HER2) overexpression, and breast cancer with any subtypes were enrolled in 16, two, and nine studies, respectively.…”

Section: Baseline Characteristics Of Included Studiesmentioning

confidence: 99%

Efficacy and predictive factors of immune checkpoint inhibitors in metastatic breast cancer: a systematic review and meta-analysis

Zou

Zheng

et al. 2020

Ther Adv Med Oncol

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Background: Immune checkpoint inhibitors (ICIs) have shown encouraging treatment efficacy for metastatic breast cancer in several clinical trials. However, response only occurred in a small population. Evidence predicting response and survival of patients with metastatic breast cancer following ICI treatment with existing biomarkers has not been well summarized. This review aimed to summarize the efficacy and predictive factors of immune checkpoint therapy in metastatic breast cancer, which is critical for clinical practice. Methods: PubMed, Embase, Cochrane Library, Web of Science, www.clinicaltrials.gov , and meeting abstracts were comprehensively searched to identify clinical trials. The outcomes were objective response rate (ORR), treatment-related adverse events (trAEs), immune-related adverse events (irAEs), progression-free survival (PFS), and overall survival (OS). Results: In this review, 27 studies with 1746 patients were included for quantitative synthesis. The pooled ORR was 19% [95% confidence interval (CI) = 12–27%]. Programmed death-ligand 1 (PD-L1)-positive patients had a higher response rate [odds ratio (OR) = 1.44, p = 0.01]. First-line immunotherapy had a better ORR than second-line immunotherapy (OR = 2.00, p = 0.02). Tumor-infiltrating lymphocytes (TILs) ⩾5% (OR = 2.53, p = 0.002) and high infiltrated CD8+ T-cell level (OR = 4.33, p = 0.006) were ideal predictors of immune checkpoint therapy response. Liver metastasis indicated poor response (OR = 0.19, p = 0.009). However, the difference was non-significant in ORR based on age, performance status score, lymph node metastasis, and lactate dehydrogenase (LDH) level. In addition, the PD-L1-positive subgroup had a better 1-year PFS (OR = 1.55, p = 0.04) and 2-year OS (OR = 2.28, p = 0.02) following ICI treatment. The pooled incidence during ICI therapy of grade 3–4 trAEs was 25% (95% CI = 16–34%), whereas for grade 3–4 irAEs it was 15% (95% CI = 11–19%). Conclusions: Metastatic breast cancer had modest response to ICI therapy. PD-L1-positive, first-line immunotherapy, non-liver metastasis, and high TIL and CD8+ T-cell infiltrating levels could predict better response to ICI treatment. Patients with PD-L1-positive tumor could gain more survival benefits from immune checkpoint therapy.

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Run-in-phase results from a multicenter phase II trial to evaluate pembrolizumab (P) and gemcitabine (Gem) in patients (pts) with HER2-negative advanced breast cancer (ABC): GEICAM/2015-04 PANGEA-Breast

Cited by 2 publications

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Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Efficacy and predictive factors of immune checkpoint inhibitors in metastatic breast cancer: a systematic review and meta-analysis

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