Browsing by Author "Valdivieso, N"

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Beneficios de la quimioterapia adyuvante en los resultados de supervivencia en cáncer de mama triple negativo PT1N0M0
(Universidad Ricardo Palma, Instituto de Investigaciones en Ciencias Biomedicas, Facultad de Medicina Humana, 2024) Morante, Z; Ferreyra, Y; Valdivieso, N; Castañeda, C; Vidaurre, T; Valencia, G; Otoya, I; Fuentes, H; Neciosup, S; Gomez, HL
Introduction: Triple-negative breast cancer (TNBC) is notably an aggressive breast cancer (BC) subtype, leading to early relapse and poor prognosis. Effects of adjuvant chemotherapy among early-stage TNBC (pT1N0M0) patients remain unclear in different populations. Objectives: Our study aimed to determine the impact of adjuvant chemotherapy on overall survival (OS) and progression-free survival (PFS) within the specific subset of Peruvian pT1N0M0 TNBC patients (pT1a/b vs. pT1c). Methods: We retrospectively analyzed 2007 TNBC cases diagnosed between 2000-2014 at the Instituto Nacional de Enfermedades Neoplásicas (Lima, Peru). We included only non-metastatic TNBC cases and classified them as pT1N0M0 after surgery. TNBC patients who underwent neoadjuvant chemotherapy were excluded. We describe our population according to the tumor size from the residue disease (pT1a/b vs. pT1c). We used the Kaplan-Meier method test to determine differences in survival curves for OS and PFS. A Univariate Cox proportional hazards model was used to identify risk factors for PFS. Results: Our study cohort included 124 TNBC patients. Around 65.3% (n=81) were undergoing adjuvant chemotherapy. Notably, among pT1c patients, this treatment was more prevalent compared to pT1a/b (72.1% vs. 50.0%). Survival analysis showed no significant OS benefit from chemotherapy (HR:2.46,95%CI:0.74-8.13,p=0.13). However, a marked improvement in PFS was noted exclusively in the pT1c subgroup, with patients not treated with chemotherapy offering a prognostic risk (HR:20.10,95% CI:5.54-73.10,p<0.0001). pT1a/b patients demonstrated no benefit from chemotherapy regarding progression (HR:3.07,95% CI:0.27-34.50,p=0.34). Conclusion: Our study highlights that adjuvant chemotherapy significantly improves PFS in pT1cN0M0 TNBC patients but shows no clear benefit for smaller tumors (pT1a/bN0M0). Future research should focus on personalized chemotherapy strategies in early-stage TNBC to identify predictive markers for survival.
Real-world outcomes of anti-EGFR therapy in advanced non–small cell lung cancer EGFR mutated in Peru
(John Wiley and Sons Inc, 2023) Galvez-Nino, M; Ruiz, R; Roque, K; Coanqui, O; Valdivieso, N; Olivera, M; Ganti, A; Kmas, L
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.
Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective
(Elsevier Ltd, 2022) Teran, E; Gomez-Moreno, HL; Damian, H; Lema, M; Mantilla, W; Rico-Restrepo, M; McElwee, E; Castro Sanchez, N; Valdivieso, N; Espinoza, MA
In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures
Subpopulation treatment effect pattern plot analysis: a prognostic model for distant recurrence-free survival to estimate delayed adjuvant chemotherapy initiation effect in triple-negative breast cancer
(Frontiers Media SA, 2023) Morante, Z; Ferreyra, Y; Pinto, JA; Valdivieso, N; Castañeda, C; Vidaurre, T; Valencia, G; Rioja, P; Fuentes, H; Cotrina, JM; Neciosup, S; Gomez, HL
Introduction: Triple-negative breast cancer (TNBC) is a heterogeneous disease associated with a poor prognosis. Delaying in time to start adjuvant chemotherapy (TTC) has been related to an increased risk of distant recurrence-free survival (DRFS). We aimed to develop a prognostic model to estimate the effects of delayed TTC among TNBC risk subgroups. Materials and methods: We analyzed 687 TNBC patients who received adjuvant chemotherapy at the Instituto Nacional de Enfermedades Neoplasicas (Lima, Peru). Database was randomly divided to create a discovery set (n=344) and a validation set (n=343). Univariate and multivariate Cox regression models were performed to identify prognostic factors for DRFS. Risk stratification was implemented through two models developed based on proportional hazard ratios from significant clinicopathological characteristics. Subpopulation treatment effect pattern plot (STEPP) analysis was performed to determine the best prognostic cut-off points for stratifying TNBC subgroups according to risk scores and estimate Kaplan-Meier differences in 10-year DRFS comparing TTC (≤30 vs.>30 days). Results: In univariate analysis, patients aged ≥70 years (HR=4.65; 95% CI: 2.32-9.34; p=<0.001), those at stages pT3-T4 (HR=3.28; 95% CI: 1.57-6.83; p=0.002), and pN2-N3 (HR=3.00; 95% CI: 1.90-4.76; p=<0.001) were notably associated with higher risk. STEPP analysis defined three risk subgroups for each model. Model N°01 categorized patients into low (score: 0–31), intermediate (score:32–64), and high-risk (score: 65–100) cohorts; meanwhile, Model N°02: low (score: 0–26), intermediate (score: 27–55), and high (score: 56–100). Kaplan-Meier plots showed that in the discovery set, patients with TTC>30 days experienced a 17.5% decrease in 10-year DRFS rate (95%CI=6.7-28.3), and the impact was more remarkable in patients who belong to the high-risk subgroup (53.3% decrease in 10 years-DRFS rate). Similar results were found in the validation set. Conclusions: We developed two prognostic models based on age, pT, and pN to select the best one to classify TNBC. For Model N°02, delayed adjuvant chemotherapy conferred a higher risk of relapse in patients ≥70 years and who were characterized by pT3/T4 and pN2/N3. Thus, more efforts should be considered to avoid delayed TTC in TNBC patients, especially those in high-risk subgroups.