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result(s) for
"Gálvez-Niño, Marco"
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Evaluation of a risk-sharing agreement for atezolizumab treatment in patients with non-small cell lung cancer: a strategy to improve access in low-income countries
by
Ramos-Ramírez, Maritza
,
Guzmán-Vázquez, Silvia
,
Gálvez-Niño, Marco
in
Adult
,
Aged
,
Antibodies, Monoclonal, Humanized - economics
2025
Abstract
Background
Using immune checkpoint inhibitors (IO) is a promising approach to maximize clinical benefits for patients with non-small cell lung cancer (NSCLC). PD-L1 expression serves as a predictive factor for treatment outcomes with IO. However, the high cost of this treatment creates significant barriers to access. Substantial evidence demonstrates the sustained clinical benefits experienced by patients who respond to immunotherapy. While IOs show promise in NSCLC treatment, their high cost poses access barriers.
Aim
This study focused on a prospective cost analysis conducted at a high-specialty health facility to assess the economic implications of implementing a risk-sharing agreement (RSA) for atezolizumab in NSCLC.
Methods
The study included 30 patients with advanced NSCLC, with the pharmaceutical company funding the initial cycles. If patients responded, a government program covered costs until disease progression.
Results
A median progression-free survival of 4.67 months across populations, rising to 9.4 months for responders. The 2-year overall survival rate for the response group was 64%, significantly higher than for non-response. Without an RSA, a total treatment cost of $881 859.36 ($29 395.31/patient) was reported, compared to $530 467.12 ($17 682.24/patient) with an RSA, representing a 40% cost reduction. In responders, the average cost per year of life per patient dropped by 22%. Risk-sharing, assessed through non-parametric tests, showed a statistically significant difference in pharmacological costs (P < .001).
Conclusion
Implementing RSAs can optimize resource allocation, making IO treatment more accessible, especially in low-income countries.
This study focused on a prospective cost analysis conducted at a high-specialty health facility to assess the economic implications of implementing a risk-sharing agreement for atezolizumab in non-small cell lung cancer.
Journal Article
Real‐world outcomes of anti‐EGFR therapy in advanced non–small cell lung cancer EGFR mutated in Peru
by
Galvez‐Nino, Marco
,
Valdivieso, Natalia
,
Mas, Luis
in
Biopsy
,
Brain cancer
,
Brain Neoplasms - drug therapy
2023
Background Despite the advances in the management of advanced non–small cell lung cancer (NSCLC), the access to genetic profiling and target therapies remains a challenge in Latin America, even in countries with a higher rate of targetable mutations. The aim of this study is to evaluate the clinical outcomes of anti‐epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) treatment in a Peruvian real‐world setting. Methods This is a retrospective study of recurrent or advanced NSCLC EGFR mutated patients diagnosed and treated with anti‐EGFR TKI at Instituto Nacional de Enfermedades Neoplásicas (INEN) between January 1, 2015 to December 31, 2020. The outcomes were objective response rate (ORR), progression free survival (PFS), and overall survival (OS). Results We identify 613 stage IV or recurrent NSCLC patients who were tested for EGFR mutations and found a pathogenic mutation in 39.5% of patients. Only 51.2% of them received anti‐EGFR TKI as institutional treatment. ORR was 58%, after median follow‐up of 32 months, the estimated median PFS was 13.9 months (11.1–16.7 months), and the estimated median OS was 21.7 months (18.5–24.9 months). No differences were found in PFS according to line of treatment or brain metastases at diagnosis (p = 0.46 and p = 0.07, respectively), respect to OS there were no differences line of treatment (p = 0.12), significant difference were found in presence of brain metastases (p = 0.006). Conclusion Our study demonstrates that erlotinib for advanced NSCLC harboring EGFR‐activating mutations is effective even in patients usually excluded from clinical trial, like those previously exposed to one or more lines of chemotherapy or with brain metastases. After molecular study of 613 patients with stage IV or recurrent non–small cell lung cancer, epidermal growth factor receptor (EGFR) mutation was detected in 39.5% of patients, however, only 51.2% received anti‐EGFR tyrosine kinase inhibitors as institutional treatment and 72 (0.6%) of them as first line. Despite the lack of access to target therapy and the late onset of treatment, erlotinib showed effectiveness even in patients previously exposed to one or more lines of chemotherapy or with brain metastases.
Journal Article
Epidemiology of thymic epithelial tumors: 22‐years experience from a single‐institution
by
Valdiviezo, Natalia
,
Cabero, Octavio
,
Amorin, Edgar
in
Chemotherapy
,
Classification
,
Confidence intervals
2021
Background To assess the correlation of WHO histological classification and Masaoka–Koga staging system of thymic epithelial tumors (TETs) with prognosis. Methods We retrospectively analyzed 83 patients with TETs in the Instituto Nacional de Enfermedades Neoplasicas between 1996 to 2018. We analyzed the clinical stages, histological types and treatment modalities and attempted to determine the impact on overall survival. The data was retrieved from clinical files and reviewed by a pathologist who reclassificated according to the 2004 WHO classification system. The staging was performed with the Masaoka–Koga staging system. Survival curves were constructed with Kaplan‐Meir method. Results There was a total of 83 patients with a median age of 55 years old included in the study. The histological type corresponded to thymoma (T) in 63.8% (n = 53) and to thymic carcinoma (TC) in 36.1%. T were type A, AB, B1, B2 and B3 in 14.4%, 18%, 12%, 3.6%, 7.4% of cases, respectively. The proportion of advanced disease (Masaoka stage III–IV) was high (65%). With a median follow‐up of 88.4 months, median overall survival (OS) was 81.6 months for T and 12.3 months for TC (P = 0.01). Univariate analysis showed that sex, histological type, clinical stage and surgery (P = 0.01) were significant independent prognostic factors. On multivariate analysis, histology type and Masaoka–Koga staging had an effect on survival. Conclusions The results indicates a clear association between the WHO histological classification and Masaoka–Koga staging system with survival. We found a higher proportion of TETs with advanced disease at diagnosis. Further research are required and collaboration is important to foster knowledge focused on classification and treatment. Key points Significant findings of the study The WHO histological classification, the Masaoka–Koga system and surgery treatment were associated with overall survival. What this study adds To determine prognosis factors in TETs. The aim of our study is prove the correlation of WHO histological classification and Masaoka–Koga staging system of thymic epithelial tumors (TETs) with prognosis.
Journal Article
Socioeconomic disparities and the genomic landscape of gastric cancer
2024
The genomic characteristics of Peruvian patients with gastric adenocarcinoma from diverse socioeconomic backgrounds were examined in consideration of the possibility that patients from different socioeconomic backgrounds may be exposed to different risk factors. We conducted a prospective pilot study in two Peruvian cities (Lima and Ica). This study enrolled 15 patients from low socioeconomic status (LSES) and 15 patients from medium/high socioeconomic status (MHSES). The genomic profiling of gastric adenocarcinoma samples was done through the FoundationOne CDx platform. We compared the genomic characteristics and the need for targeted therapy and immunotherapy between LSES and MHSES. The genes with higher rates of alterations were
TP53
(73.3% vs. 50.0%,
P
= 0.2635);
CDH1
(26.7% vs. 28.6%,
P
= 1);
CDKN2A
(20.0% vs. 28.6%, P = 1);
KRAS
(33.3% vs. 7.1%,
P
= 0.1686);
ARID1A
(20.0% vs. 14.3%,
P
= 1);
MLL2
(13.3% vs. 21.4%,
P
= 1) and
SOX9
(33.3% vs. 0.0%,
P
= 0.0421) in LSES versus HMSES, respectively. There was no significant difference in tumor mutational burden (
P
= 0.377) or microsatellite status (
P
= 1). The LSES group had a higher need for targeted therapy or immunotherapy according to gene involvement and alterations. A significant genomic difference exists among patients with gastric adenocarcinoma of different socioeconomic status, which may result in a different need for targeted therapy and immunotherapy.
Journal Article
Lung Cancer in the Young
by
Mantilla, Raul
,
Mas, Luis
,
Pinto, Joseph A.
in
Analysis
,
Lung Cancer
,
Lung cancer, Non-small cell
2020
Introduction
Median age at diagnosis of lung cancer is 70 years. Its presentation in patients 40 or younger is uncommon and it has been proposed that maybe it is a different disease due to its clinical characteristics and genetic makeup. There are a limited number of studies in this population and they report different clinic-pathological characteristics in comparison with older patients.
Methods
We described the incidence of lung cancer patients diagnosed at age 40 or younger at the Instituto Nacional de Enfermedades Neoplasicas (INEN), Lima-Peru; from 2009 to 2017 and evaluated the characteristic of NSCLC. Epidemiologic and clinic-pathological data was collected from clinical files. Analysis was carried out using SPSSvs19 software.
Results
We identified 3823 patients with lung cancer seen at INEN during the study period. Among these, 166 (4.3%) patients were 40 years or younger, and 137/166 (82.5%) were NSCLC. Median age at diagnosis was 36 years (range 14–40 years) and 59.1% of patients were female. A smoking history was present in 14.4% of patients. Frequent symptoms at diagnosis were cough (62.0%), chest pain (51.8%) and dyspnea (40.9%). Adenocarcinoma was the most common histological type (63.3%). Most patients had advanced disease at diagnosis (84.7%). The median overall survival was 8.2 months.
Conclusions
The proportion of young patients with lung cancer in our population is higher than that reported in the most recent literature. Lung cancer in the young is mostly sporadic, more frequent in women, usually adenocarcinoma type and it presents with advanced disease, resulting in a very poor survival.
Journal Article
Comparison of Erlotinib vs. Osimertinib for Advanced or Metastatic EGFR Mutation-Positive Non-Small-Cell Lung Cancer Without Prior Treatment: A Network Meta-Analysis
2025
Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer cases globally and most patients receive their diagnosis at advanced or metastatic disease stages. The use of tyrosine kinase inhibitors (TKIs) such as erlotinib (first-generation) and osimertinib (third-generation) to treat NSCLC is possible because of activating mutations in the epidermal growth factor receptor (EGFR). Although osimertinib has shown better results in recent trials, direct and updated comparisons with erlotinib, especially in combination regimens, are still limited. Background/Objectives: This study aimed to compare the efficacy and safety of osimertinib versus erlotinib, both as monotherapies and in combination, in treatment-naïve patients with advanced or metastatic EGFR-mutated NSCLC. Methods: A systematic review and network meta-analysis were conducted following PRISMA-NMA guidelines and registered in PROSPERO (CRD42025649761). PubMed, EMBASE, and Scopus were searched up to February 2025 for randomized controlled trials (RCTs) that compared erlotinib- or osimertinib-based regimens in previously untreated EGFR-mutated advanced NSCLC. Outcomes included overall survival (OS), progression-free survival (PFS), and grade ≥ 3 adverse events. A frequentist random-effects model was used, and treatments were ranked using p-scores. Results: Eleven RCTs (2341 patients) were included. Osimertinib, alone or with chemotherapy, resulted in significantly longer OS compared to erlotinib-based regimens (HR for OS vs. erlotinib: 1.59, 95% CI 1.09–2.31). All osimertinib and erlotinib regimens outperformed chemotherapy for PFS, but no statistically significant differences were observed between osimertinib and erlotinib. Severe adverse events were comparable, though osimertinib ranked highest for safety. The combination of osimertinib with chemotherapy achieved the highest p-scores for both OS and PFS. Conclusions: Osimertinib is associated with superior overall survival and comparable safety versus erlotinib-based strategies in first-line treatment of advanced EGFR-mutated NSCLC. These findings reinforce osimertinib as the preferred first-line option in this setting.
Journal Article
Level of tumor-infiltrating lymphocytes and density of infiltrating immune cells in different malignancies
by
Castillo, Miluska
,
Villa, Maria R
,
Landa-Baella, Maria P
in
Antigens
,
biomarker
,
Brain cancer
2019
To correlate levels of tumor-infiltrating lymphocytes (TIL) evaluated using the International Immuno-Oncology Biomarker Working Group methodology, and both density of tumor-infiltrating immune cell and clinicopathological features in different malignancies.
209 pathological samples from gastric cancer, cervical cancer (CC), non-small-lung cancer, cutaneous melanoma (CM) and glioblastoma were tested for TIL in hematoxylin eosin, and density of CD3
, CD4
, CD8
, CD20
, CD68
and CD163
cells by digital analysis.
TIL levels were higher in invasive margin compartments (IMC). TIL in IMC, intratumoral and stromal compartments predicted survival. CC and gastric cancer had higher TIL in intratumoral; CC and CM had higher TIL in stromal compartment and IMC. CM had the highest density of lymphocyte and macrophage populations. CD20 density was associated with survival in the whole series.
Standardized evaluation of TIL levels may provide valuable prognostic information in a spectrum of different malignancies.
Journal Article