Browsing by Author "Gómez, HL"

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Adaptation of international coronavirus disease 2019 and breast cancer guidelines to local context
(Baishideng Publishing Group, 2021) Valencia, GA; Neciosup, S; Gómez, HL; Benites, MDP; Falcón, S; Moron Dveliz, K; Maldonado, M; Auqui, R
Background: The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (a novel coronavirus), which was first identified amid an outbreak of respiratory illness cases in Wuhan, China and declared a global health emergency, is currently considered an additional challenge in the management of patients with breast cancer (BC). Cancer patients are more vulnerable to becoming infected with severe acute respiratory syndrome coronavirus 2 and are more likely to suffer additional complications that can increase mortality. Identifying those BC patients who require more urgent therapy than others in the current situation is essential. These recommendations are based on and have been adapted from those similarly published by international scientific societies for BC management. They are divided mainly by clinical stage (early, advanced), subtype [luminal, human epidermal growth factor receptor 2 (HER2), triple-negative], or type of medical treatment and setting (neoadjuvant, adjuvant, metastatic). Recommendations for HER2 and triple-negative subtypes are similar, whereas in luminal subtype there are various options of management. The objective is to adapt guidelines to local context through relevant decision-makers, avoiding duplication of efforts and optimizing use or resources. We hope that these recommendations will help medical oncologists provide the best quality care to BC patients during the COVID-19 pandemic with information tailored to our healthcare system. Aim: To establish and adapt recommendations from those published by international scientific societies for BC management. Methods: The Peruvian Society of Medical Oncology developed a consensus and propose here a manuscript with recommendations for oncological medical treatment of BC during the COVID-19 pandemic. The Peruvian Society of Medical Oncology invited a panel of experts and opinion leaders on BC working in major health care systems around Peru. Panel experts selected three international clinical practice guidelines (National Comprehensive Cancer Network, European Society for Medical Oncology, Spanish Foundation Research Group in Breast Cancer), considering that these are more representative in COVID-19 management. Also, the panel agreed to include at least one European and American clinical practice guideline. Results: Recommendations about BC management during the COVID-19 pandemic were divided mainly by clinical stage (early, advanced), subtype (luminal, HER2, triple-negative), or type of medical treatment and setting (neoadjuvant, adjuvant, metastatic). Recommendations for HER2 and triple-negative subtypes were similar between clinical practice guidelines, whereas in luminal subtype there were various options of management. One hundred twelve recommendations were reviewed, adapted, and voted. A consensus was made in order to provide best decisions of management, avoid duplication of efforts, and optimize medical resources, considering health care system reality. These recommendations are not intended to replace clinical judgment.Conclusion: Most of recommendations are similar, mainly in high-risk subtypes (HER2, triple-negative). Certain societies adapt them to deal with different situations involving the best decision in the management of BC patients.
Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology)
(American Society of Clinical Oncology, 2017) Blum, JL; Flynn, PJ; Yothers, G; Asmar, L; Geyer, CE Jr; Jacobs, SA; Robert, NJ; Hopkins, JO; O'Shaughnessy, JA; Dang, CT; Gómez, HL; Fehrenbacher, L; Vukelja, SJ; Lyss, AP; Paul, D; Brufsky, AM; Jeong, JH; Colangelo, LH; Swain, SM; Mamounas, EP; Jones, SE; Wolmark, N
Purpose Docetaxel and cyclophosphamide (TC) was superior to doxorubicin and cyclophosphamide (AC) in a trial in early breast cancer. However, activity of TC relative to AC regimens with a taxane (TaxAC) is unknown. Methods In a series of three adjuvant trials, women were randomly assigned to TC for six cycles (TC6) or to a standard TaxAC regimen. US Oncology Research (USOR) 06-090 compared TC6 with docetaxel, doxorubicin, and cyclophosphamide (TAC6). National Surgical Adjuvant Breast and Bowel Project (NSABP) B-46-I/USOR 07132 compared TC6, TAC6, or TC6 plus bevacizumab. NSABP B-49 compared TC6 with several standard AC and taxane combination regimens. Before any analysis of individual trials, a joint efficacy analysis of TC versus the TaxAC regimens was planned, with invasive disease-free survival (IDFS) as the primary end point. Patients who received TC6 plus bevacizumab on NSABP B-46-I/USOR 07132 were not included. A hazard ratio (HR) from a stratified Cox model that exceeded 1.18 for TC6 versus TaxAC was predefined as inferiority for TC6. The prespecified interim monitoring plan was to report for futility if the HR was > 1.18 when 334 IDFS events were observed (50% of 668 events required for definitive analysis). Results A total of 2,125 patients were randomly assigned to receive TC6 regimens and 2,117 patients were randomly assigned to receive TaxAC regimens. The median follow-up time was 3.3 years. There were 334 IDFS events, and the HR for TC6 versus TaxAC was 1.202 (95% CI, 0.97 to 1.49), which triggered early reporting for futility. The 4-year IDFS was 88.2% for TC6 and was 90.7% for TaxAC ( P = .04). Tests for treatment interaction by protocol, hormone receptor status, and nodal status were negative. Conclusion The TaxAC regimens improved IDFS in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer compared with the TC6 regimen.
Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT
(Elsevier Ltd., 2017) Regan, MM; Walley, BA; Francis, PA; Fleming, GF; Láng, I; Gómez, HL; Colleoni, M; Tondini, C; Pinotti, G; Salim, M; Spazzapan, S; Parmar, V; Ruhstaller, T; Abdi, EA; Gelber, RD; Coates, AS; Goldhirsch, A; Pagani, O
Background: Recent breast cancer treatment guidelines recommend that higher-risk premenopausal patients should receive ovarian function suppression (OFS) as part of adjuvant endocrine therapy. If chemotherapy is also given, it is uncertain whether to select concurrent or sequential OFS initiation. Design and methods: We analyzed 1872 patients enrolled in the randomized phase III TEXT and SOFT trials who received adjuvant chemotherapy for hormone receptor-positive, HER2-negative breast cancer and upon randomization to an OFS-containing adjuvant endocrine therapy, initiated gonadotropin-releasing-hormone-agonist triptorelin. Breast cancer-free interval (BCFI) was compared between patients who received OFS concurrently with chemotherapy in TEXT (n = 1242) versus sequentially post-chemotherapy in SOFT (n = 630). Because timing of trial enrollment relative to adjuvant chemotherapy differed, we implemented landmark analysis re-defining BCFI beginning 1 year after final dose of chemotherapy (median, 15.5 and 8.1 months from enrollment to landmark in TEXT and SOFT, respectively). As a non-randomized treatment comparison, we implemented comparative-effectiveness propensity score methodology with weighted Cox modeling. Results: Distributions of several clinico-pathologic characteristics differed between groups. Patients who were premenopausal post-chemotherapy in SOFT were younger on average. The median duration of adjuvant chemotherapy was 18 weeks in both groups. There were 231 (12%) BC events after post-landmark median follow-up of about 5 years. Concurrent use of triptorelin with chemotherapy was not associated with a significant difference in post-landmark BCFI compared with sequential triptorelin post-chemotherapy, either in the overall population (HR = 1.11, 95% CI 0.72-1.72; P = 0.72; 4-year BCFI 89% in both groups), or in the subgroup of 692 women <40 years at diagnosis (HR = 1.13, 95% CI 0.69-1.84) who are less likely to develop chemotherapy-induced amenorrhea. Conclusion: Based on comparative-effectiveness modeling of TEXT and SOFT after about 5 years median follow-up, with limited statistical power especially for the subgroup <40 years, neither detrimental nor beneficial effect of concurrent administration of OFS with chemotherapy on the efficacy of adjuvant therapy that includes chemotherapy was detected.
Impact of the Delayed Initiation of Adjuvant Chemotherapy in the Outcome of Triple Negative Breast Cancer
(Elsevir, 2021) Morante, ZRJ; Ruiz, RJ; Araujo, JMJ; Pinto, JAJ; Cruz-Ku, GJ; Urrunaga-Pastor, DJ; Namuche, FJ; Flores, CJ; Mantilla, RJ; Luján, MGJ; Fuentes, HJ; Schwarz, LJ; Aguilar, AJ; Neciosup, SJ; Gómez, HL
Background: Adjuvant chemotherapy decreases the recurrence risk and improves survival rates; however, it is unclear whether a delayed initiation is associated with adverse outcomes, especially in triple negative breast cancer (TNBC). In this study, we evaluated the influence of the time to start adjuvant chemotherapy (TTC) in the outcomes of TNBC. Patients and methods: We retrospectively analyzed 15 years of data from patients with TNBC who received adjuvant chemotherapy at the Instituto Nacional de Enfermedades Neoplasicas (Lima, Peru). TTC was categorized into 4 groups: ≤ 30, 31 to 60, 61 to 90, and ≥ 91 days. We evaluated overall survival (OS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were used to identify prognostic factors. Results: In total, 687 patients were included. The mean age at diagnosis was 49.1 years (SD, 11.8 years), and most (62.6%) patients had pathologic stage T2. The median TTC was 48.1 days (SD, 27.4 days); 189 (27.5%) received chemotherapy ≤ 30 days; 329 (47.9%), between 31 and 60 days; 115 (16.7%), between 61 and 90 days; and 54 (7.9%) in ≥ 90 days. In the multivariate analysis, a TTC between 31 and 60 days (hazard ratio [HR], 1.78; 95% confidence interval [CI], 1.17-2.72), 61 and 90 days (HR, 2.38; 95%CI, 1.43-3.97), and ≥ 91 days (HR, 2.45; 95% CI, 1.32-4.55) was associated with an increased mortality in contrast with a TTC < 30 days. Although a TTC between 31 and 60 days, 61 and 90 days, and ≥ 91 days was associated with an increased risk of DRFS (HR, 1.86; 95% CI, 1.24-2.79; HR, 2.34, 95% CI, 1.42-3.867; and HR, 3.16; 95% CI, 1.78-5.61, respectively). Conclusion: A delaying in TTC ≥ 30 days was associated with poorer outcomes. Our data suggest that several efforts should be conducted to avoid a delayed TTC in patients with TNBC.
Impact on Survival with Immunotherapy and Evaluation of Biomarkers in Peruvian Patients with Advanced Melanoma
(Dove Medical Press Ltd, 2024) Valencia, G; Roque, K; Rioja, P; Huamán, JA; Colomo, V; Sánchez, J; Calle, C; Mantilla, R; Morante, Z; Fuentes, H; Vidaurre, T; Neciosup, S; De, Mello, RA; Gómez, HL; Fernández-Díaz, AB; Berrocal, A; Castaneda, C
Introduction: Advanced malignant melanoma is a very aggressive disease, historically with poor prognosis before the new advances with immunotherapy and targeted therapies that have changed the standard of care, especially in cutaneous melanoma. Peru has aggressive features such as higher rates of acral lentiginous melanoma (ALM) subtype with historically shorter survival. Methods: This study describes Peruvian patients with advanced melanoma treated with immunotherapy (nivolumab) in two oncological institutions (public and private), including the discussion of the impact on overall survival (OS) divided by subtype (with incidence in ALM histology) and potential biomarkers that could be related to prognosis. Results: We found that immunotherapy is safe, and improves progression-free survival (PFS), OS and objective response rate (ORR) in our patients, with lower benefit in ALM histology. No prognostic blood inflammatory biomarkers were detected. Discussion: There is very limited data of Peruvian patients with metastatic melanoma treated with immunotherapy, especially the outcomes in ALM histology. Our goal is to share an example of the impact of immunotherapy in a Latin American (LATAM) population considered as an unsatisfied group with an enormous need of novel treatments and biomarkers.
Pathological Response and Survival in Triple-Negative Breast Cancer Following Neoadjuvant Carboplatin plus Docetaxel
(American Association for Cancer Research Inc., 2018) Sharma, P; López-Tarruella, S; García-Saenz, JA; Khan, QJ; Gómez, HL; Prat, A; Moreno, F; Jerez-Gilarranz, Y; Barnadas, A; Picornell, AC; Monte-Millán MD; González-Rivera, M; Massarrah, T; Pelaez-Lorenzo, B; Palomero, MI; González Del Val, R; Cortés, J; Fuentes-Rivera H; Morales, DB; Márquez-Rodas, I; Perou, CM; Lehn, C; Wang, YY; Klemp, JR; Mammen, JV; Wagner, JL; Amin, AL; O'Dea, AP; Heldstab, J; Jensen, RA; Kimler, BF; Godwin, AK; Martín, M
Purpose: Prognostic value of pathologic complete response (pCR) and extent of pathologic response attained with anthracycline-free platinum plus taxane neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) is unknown. We report recurrence-free survival (RFS) and overall survival (OS) according to degree of pathologic response in patients treated with carboplatin plus docetaxel NAC. Patients and methods: One-hundred and ninety patients with stage I-III TNBC were treated with neoadjuvant carboplatin (AUC6) plus docetaxel (75 mg/m2) every 21 days × 6 cycles. pCR (no evidence of invasive tumor in breast and axilla) and Residual cancer burden (RCB) were evaluated. Patients were followed for recurrence and survival. Extent of pathologic response was associated with RFS and OS using the Kaplan-Meier method. Results: Median age was 51 years, and 52% were node-positive. pCR and RCB I rates were 55% and 13%, respectively. Five percent of pCR patients, 0% of RCB I patients, and 58% of RCB II/III patients received adjuvant anthracyclines. Three-year RFS and OS were 79% and 87%, respectively. Three-year RFS was 90% in patients with pCR and 66% in those without pCR [HR = 0.30; 95% confidence interval (CI), 0.14-0.62; P = 0.0001]. Three-year OS was 94% in patients with pCR and 79% in those without pCR (HR = 0.25; 95% CI, 0.10-0.63; P = 0.001). Patients with RCB I demonstrated 3-year RFS (93%) and OS (100%) similar to those with pCR. On multivariable analysis, higher tumor stage, node positivity, and RCB II/III were associated with worse RFS. Conclusions: Neoadjuvant carboplatin plus docetaxel yields encouraging efficacy in TNBC. Patients achieving pCR or RCB I with this regimen demonstrate excellent 3-year RFS and OS without adjuvant anthracycline.
Sex, immunity, and cancer
(Elsevier B.V., 2022) Pinto, JA; Araujo, JM; Gómez, HL
The composition of the tumor microenvironment is the complex result of the interaction between tumoral and host factors. Since there are several differences in the regulation of gene circuits between sexes, mainly influenced by sex hormones, the tumor-host interaction presents some differences, leading tumors to evolve under different conditions. Nowadays, it is well known the existence of sexual dimorphism in the regulation of the immune system, where women present an improved immunity to various infectious agents and, on the other hand, a higher incidence of autoimmune diseases than men. In oncology, differences in cancer susceptibility, response to treatment, and clinical outcomes between men and women patients are well known. Recently, sex-specific differences have also been reported in mutations in driver genes and the prognostic value of several biomarkers. Sex has been a widely forgotten biomarker in cancer therapy, but it has recently acquired great relevance due to the different results seen in immunotherapy treatment. © 2021 Elsevier B.V.
Somatic Mutations in Latin American Breast Cancer Patients: A Systematic Review and Meta-Analysis
(Multidisciplinary Digital Publishing Institute (MDPI), 2024) Martínez-Nava, GA; Urbina-Jara, LK; Lira-Albarrán, S; Gómez, HL; Ruiz-García, E; Nieto-Coronel, MT; Ortiz-Lopez, R; Martínez, Villalba, KN; Muñoz-Sánchez, M; Aguilar, D; Gómez-Flores-Ramos, L; Cabrera-Nieto, SA; Mohar, A; Cruz-Ramos, M
(1) Background: Somatic mutations may be connected to the exposome, potentially playing a role in breast cancer’s development and clinical outcomes. There needs to be information regarding Latin American women specifically, as they are underrepresented in clinical trials and have limited access to somatic analysis in their countries. This study aims to systematically investigate somatic mutations in breast cancer patients from Latin America to gain a better understanding of tumor biology in the region. (2) Methods: We realize a systematic review of studies on breast cancer in 21 Latin American countries using various databases such as PubMed, Google Scholar, Web of Science, RedAlyc, Dianlet, and Biblioteca Virtual en Salud. Of 392 articles that fit the criteria, 10 studies have clinical data which can be used to create a database containing clinical and genetic information. We compared mutation frequencies across different breast cancer subtypes using statistical analyses and meta-analyses of proportions. Furthermore, we identified overexpressed biological processes and canonical pathways through functional enrichment analysis. (3) Results: 342 mutations were found in six Latin American countries, with the TP53 and PIK3CA genes being the most studied mutations. The most common PIK3CA mutation was H1047R. Functional analysis provided insights into tumor biology and potential therapies. (4) Conclusion: evaluating specific somatic mutations in the Latin American population is crucial for understanding tumor biology and determining appropriate treatment options. Combining targeted therapies may improve clinical outcomes in breast cancer. Moreover, implementing healthy lifestyle strategies in Latin America could enhance therapy effectiveness and clinical outcomes.
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
(N Engl J Med. 2018 Jul 12;379(2):122-137., 2018) Francis, PA; Pagani, O; Fleming, GF; Walley, BA; Colleoni, M; Láng, I; Gómez, HL; Tondini, C; Ciruelos, E; Burstein, HJ; Bonnefoi, HR; Bellet, M; Martino, S; Geyer, CE; Goetz, MP; Stearns, V; Pinotti, G; Puglisi, F; Spazzapan, S; Climent, MA; Pavesi, L; Ruhstaller, T; Davidson, NE; Coleman, R; Debled, M; Buchholz, S; Ingle, JN; Winer, EP; Maibach, R; Rabaglio-Poretti, M; Ruepp, B; Di Leo, A; Coates, AS; Gelber, RD; Goldhirsch, A; Regan, MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group.
Background: In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials. Methods: Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy. Results: In SOFT, the 8-year disease-free survival rate was 78.9% with tamoxifen alone, 83.2% with tamoxifen plus ovarian suppression, and 85.9% with exemestane plus ovarian suppression (P=0.009 for tamoxifen alone vs. tamoxifen plus ovarian suppression). The 8-year rate of overall survival was 91.5% with tamoxifen alone, 93.3% with tamoxifen plus ovarian suppression, and 92.1% with exemestane plus ovarian suppression (P=0.01 for tamoxifen alone vs. tamoxifen plus ovarian suppression); among the women who remained premenopausal after chemotherapy, the rates were 85.1%, 89.4%, and 87.2%, respectively. Among the women with cancers that were negative for HER2 who received chemotherapy, the 8-year rate of distant recurrence with exemestane plus ovarian suppression was lower than the rate with tamoxifen plus ovarian suppression (by 7.0 percentage points in SOFT and by 5.0 percentage points in TEXT). Grade 3 or higher adverse events were reported in 24.6% of the tamoxifen-alone group, 31.0% of the tamoxifen-ovarian suppression group, and 32.3% of the exemestane-ovarian suppression group. Conclusions: Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8-year rates of both disease-free and overall survival than tamoxifen alone. The use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence. The frequency of adverse events was higher in the two groups that received ovarian suppression than in the tamoxifen-alone group. (Funded by Pfizer and others; SOFT and TEXT ClinicalTrials.gov numbers, NCT00066690 and NCT00066703 , respectively.).
The current situation regarding the availability and accessibility of anticancer drugs for breast cancer in the Peruvian public health systems
(Cancer Intellilgence, 2021) Valencia-Mesías, G; Rioja-Viera, P; Morante-Cruz, Z; Toledo-Morote, Y; Neciosup-Delgado, S; Gómez, HL
The availability of effective, accessible, safe and high-quality anticancer drugs for the medical treatment of cancer is fundamental in ensuring optimal healthcare in the public health system in Peru. The main objective is to assess the current situation regarding anticancer drugs (termed 'high-cost') for breast cancer, as well as an analysis of the possible factors which negatively impact access to the Peruvian public health systems.There are similarities in the availability of anticancer drugs, since most treatments are covered by the Peruvian Ministry of Health. EsSalud offers an extra monoclonal antibody (pertuzumab) in the metastatic treatment stage. Meanwhile, the National Institute of Neoplastic Diseases (INEN), mainly for metastatic disease, has relied on more tested treatments over the last year. An agreement has been reached with the armed forces, which will enable patients to receive oncology care at the INEN and, thereby, benefit from the use of high-cost drugs.
Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials
(American Society of Clinical Oncology, 2017) Saha, P; Regan, MM; Pagani, O; Francis, PA; Walley, BA; Ribi, K; Bernhard, J; Luo, W; Gómez, HL; Burstein, HJ; Parmar, V; Torres, R; Stewart, J; Bellet, M; Perelló, A; Dane, F; Moreira, A; Vorobiof, D; Nottage, M; Price, KN; Coates, AS; Goldhirsch, A; Gelber, RD; Colleoni, M; Fleming, GF; SOFT TEXT Investigators; International Breast Cancer Study Group
Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.