Jorge Alatorre-Alexander

Instituto Nacional de Enfermedades Respiratorias

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Jerónimo Rafael Rodríguez‐Cid

Hospital Médica Sur

Luis Manuel Martínez-Barrera

Instituto Nacional de Enfermedades Respiratorias

Carla Paola Sánchez‐Ríos

Instituto Nacional de Enfermedades Respiratorias

Patricio Santillán‐Doherty

Instituto Nacional de Enfermedades Respiratorias

Tony Mok

Chinese University of Hong Kong

Solange Peters

University Hospital of Lausanne

Niels Reinmuth

Asklepios Fachkliniken München-Gauting

Byoung Chul Cho

Yonsei University

Melissa L. Johnson

Tennessee Oncology

José Fabián Martínez‐Herrera

Centro Médico ABC

Cooperative Institutions

Instituto Nacional de Enfermedades Respiratorias

Instituto Nacional de Cancerología

Yonsei University

Asan Medical Center

Seoul National University Bundang Hospital

Samsung Medical Center

Chungbuk National University Hospital

Instituto Nacional del Cáncer

Hospital de Clínicas

Scottish Intercollegiate Guidelines Network

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Durvalumab (D) +/- tremelimumab (T) + chemotherapy (CT) in first-line (1L) metastatic (m) NSCLC: AE management in POSEIDON.

Journal of Clinical Oncology (2022)

Byoung Chul Cho Niels Reinmuth Alexander Luft Jorge Alatorre-Alexander Sarayut Lucien Geater

9035 Background: In the Phase 3 POSEIDON study in 1L mNSCLC, adding T to D+CT resulted in statistically significant improvements in PFS and OS vs CT. No new safety signals were identified and treatment discontinuations due to treatment-related AEs (TRAEs) were similar for the T+D+CT and D+CT arms (15.5% and 14.1%). Here we present details of AEs and their management. Methods: 1013 pts with EGFR/ ALK wild-type mNSCLC were randomized 1:1:1 to 1L T+D+CT, D+CT or CT. Safety was assessed in all treated pts. Results: 330, 334 and 333 pts received T+D+CT, D+CT and CT; 78%, 82% and 74% received at least 4 cycles of platinum-based CT. The most common grade 3/4 TRAEs were hematologic (anemia in 17%, 15% and 20% of pts in the T+D+CT, D+CT and CT arms and neutropenia in 16%, 13% and 12%) and most were managed using standard approaches per local practice; 22%, 18% and 16% of pts received colony stimulating factors and 22%, 21% and 26% received blood transfusions. All grade immune-mediated AEs (imAEs) occurred in 34%, 19% and 5% of pts in the T+D+CT, D+CT and CT arms; a higher incidence of diarrhea/colitis, dermatitis/rash and endocrinopathies was seen with the addition of T to D+CT (Table). Grade 3/4 imAEs occurred in 10%, 7% and 2% of pts in the T+D+CT, D+CT and CT arms, and serious imAEs in 10%, 6% and 1%; imAEs led to discontinuation of any study treatment in 6%, 4% and 0.6%, and led to death in 0.6%, 0.3% and 0%. Most imAEs were low grade and manageable with systemic corticosteroids (received by 26%, 13% and 4% of pts in the T+D+CT, D+CT and CT arms) or endocrine therapy (12%, 8% and 1%). Median time from first dose to onset of imAEs (TTO) was generally > 60 days and the majority of non-endocrine imAEs resolved (Table). Conclusions: In POSEIDON, the safety profile of all regimens was manageable per standard guidelines and in line with the known profiles of D, T+D and CT; the most common grade 3/4 TRAEs were those typically associated with CT. As expected, more imAEs occurred with T+D+CT than D+CT, but the incidence of grade 3 or 4 imAEs, imAE-related deaths and treatment discontinuations due to imAEs was generally similar in the IO arms. T+D did not compromise the ability to administer planned CT. Clinical trial information: NCT03164616. [Table: see text]

Tremelimumab

10.1200/jco.2022.40.16_suppl.9035

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Patient-Reported Outcomes (PROs) from LIBRETTO-431: First-Line Selpercatinib versus Chemotherapy With Pembrolizumab in RET Fusion-positive NSCLC

JTO Clinical and Research Reports (2025)

Caicun Zhou Silvia Novello Pilar Garrido Christophe Dooms Jorge Alatorre-Alexander

10.1016/j.jtocrr.2025.100814

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Epirubicin, cisplatin plus ifosfamide versus standard chemotherapeutic regimens for advanced/unresectable primary thoracic sarcomas

Journal of Cancer Research and Clinical Oncology (2022)

Jerónimo Rafael Rodríguez‐Cid Juan José Juárez‐Vignon Whaley Gisela Sánchez-Domínguez Guzmán-Casta Jordi Sonia Carrasco-CaraChards

Regimen

Epirubicin

Univariate analysis

10.1007/s00432-022-04454-8

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Mutation profile in liquid biopsy tested by next generation sequencing in Mexican patients with non-small cell lung carcinoma and its impact on survival

Journal of Thoracic Disease (2024)

José Fabián Martínez‐Herrera Gisela Sánchez Domínguez Juan José Juárez‐Vignon Whaley Sonia Carrasco-Cara Chards Claudia López Vrátný

Background: Lung cancer represents a significant global health concern, often diagnosed in its advanced stages. The advent of massive DNA sequencing has revolutionized the landscape of cancer treatment by enabling the identification of target mutations and the development of tailored therapeutic approaches. Unfortunately, access to DNA sequencing technology remains limited in many developing countries. In this context, we emphasize the critical importance of integrating this advanced technology into healthcare systems in developing nations to improve treatment outcomes. Methods: We conducted an analysis of electronic clinical records of patients with confirmed advanced non-small cell lung cancer (NSCLC) and a verified negative status for the epidermal growth factor receptor (EGFR) mutation. These patients underwent next-generation sequencing (NGS) for molecular analysis. We performed descriptive statistical analyses for each variable and conducted both univariate and multivariate statistical analyses to assess their impact on progression-free survival (PFS) and overall survival (OS). Additionally, we classified genetic mutations as actionable or non-actionable based on the European Society for Medical Oncology Scale of Clinical Actionability of Molecular Targets (ESCAT) guidelines. Results: Our study included a total of 127 patients, revealing the presence of twenty-one distinct mutations. The most prevalent mutations were EGFR (18.9%) and Kirsten rat sarcoma viral oncogene homolog (KRAS) (15.7%). Notably, anaplastic lymphoma kinase (ALK) [hazard ratio (HR): 0.258, P<0.001], tumor mutation burden (TMB) (HR: 2.073, P=0.042) and brain magnetic resonance imaging (MRI) (HR: 0.470, P=0.032) demonstrated statistical significance in both the univariate and multivariate analyses with respect to PFS. In terms of OS, ALK (HR: 0.285, P<0.001) and EGFR (HR: 0.482, P=0.024) exhibited statistical significance in both analyses. Applying the ESCAT classification system, we identified actionable genomic variations (ESCAT level-1), including EGFR, ALK, breast cancer (BRAF) gene, c-ros oncogene 1 (ROS1), and rearranged during transfection (RET) gene, in 32.3% of the patients. Conclusions: Our findings from massive DNA sequencing underscore that 32.3% of patients who test negative for the EGFR mutation possess other targetable mutations, enabling them to receive personalized, targeted therapies at an earlier stage of their disease. Implementing massive DNA sequencing in developing countries is crucial to enhance survival rates among NSCLC patients and guide more effective treatment strategies.

Univariate analysis

10.21037/jtd-23-1029

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Real-World Evidence: Multicenter Efficacy and Toxicity Analysis of Nintedanib With Docetaxel as Second-Line Treatment in Mexican Patients With Advanced Lung Adenocarcinoma

JCO Global Oncology (2020)

Jerónimo Rafael Rodríguez‐Cid Saul Campos‐Gómez Vanessa García-Montes Manuel Magallanes-Maciel Rodrigo Rafael Flores‐Mariñelarena

The LUME-Lung 1 study has brought consistent evidence of the effective use of nintedanib in lung adenocarcinoma as a second line of treatment; however, differences among ethnicities have been found in some studies.This was a retrospective review among 21 medical centers of 150 patients with a confirmed diagnosis of lung adenocarcinoma, included in a compassionate use program of nintedanib from March 2014 to September 2015. The current study aimed to analyze the effectiveness of nintedanib in combination with docetaxel in the Mexican population, using progression-free survival rate and the best objective response to treatment by RECIST 1.1 as a surrogate of effectiveness. In addition, we examined the toxicity profile of our study population as a secondary end point.After exclusion criteria, only 99 patients met the criteria for enrollment in the current study. From the total study population, 53 patients (53.5%) were male and 46 (46.5%) were female, with an average age of 60 years and stage IV as the most prevalent clinical stage at the beginning of the compassionate use program. A total of 48 patients (48.5%) had partial response; 26 (26.3%), stable disease; 4 (4%), complete response; and 16 (16.2%), progression; and 5 (5%) were nonevaluable. We found a median progression-free survival of 5 months (95% CI, 4.3 to 5.7 months). The most common grade 3 or 4 adverse reactions were fatigue (14%) and diarrhea (13%).Nintedanib, as part of a chemotherapy regimen, is an effective option with an acceptable toxicity profile for advanced lung adenocarcinoma after first-line treatment progression.

Nintedanib

Regimen

Tolerability

10.1200/jgo.19.00330

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Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC

New England Journal of Medicine (2024)

Byoung Chul Cho Shun Lu Enriqueta Felip Alexander I. Spira Nicolas Girard

BackgroundAmivantamab plus lazertinib (amivantamab–lazertinib) has shown clinically meaningful and durable antitumor activity in patients with previously untreated or osimertinib-pretreated EGFR (epidermal growth factor receptor)–mutated advanced non–small-cell lung cancer (NSCLC).MethodsIn a phase 3, international, randomized trial, we assigned, in a 2:2:1 ratio, patients with previously untreated EGFR-mutated (exon 19 deletion or L858R), locally advanced or metastatic NSCLC to receive amivantamab–lazertinib (in an open-label fashion), osimertinib (in a blinded fashion), or lazertinib (in a blinded fashion, to assess the contribution of treatment components). The primary end point was progression-free survival in the amivantamab–lazertinib group as compared with the osimertinib group, as assessed by blinded independent central review.ResultsOverall, 1074 patients underwent randomization (429 to amivantamab–lazertinib, 429 to osimertinib, and 216 to lazertinib). The median progression-free survival was significantly longer in the amivantamab–lazertinib group than in the osimertinib group (23.7 vs. 16.6 months; hazard ratio for disease progression or death, 0.70; 95% confidence interval [CI], 0.58 to 0.85; P<0.001). An objective response was observed in 86% of the patients (95% CI, 83 to 89) in the amivantamab–lazertinib group and in 85% of those (95% CI, 81 to 88) in the osimertinib group; among patients with a confirmed response (336 in the amivantamab–lazertinib group and 314 in the osimertinib group), the median response duration was 25.8 months (95% CI, 20.1 to could not be estimated) and 16.8 months (95% CI, 14.8 to 18.5), respectively. In a planned interim overall survival analysis of amivantamab–lazertinib as compared with osimertinib, the hazard ratio for death was 0.80 (95% CI, 0.61 to 1.05). Predominant adverse events were EGFR-related toxic effects. The incidence of discontinuation of all agents due to treatment-related adverse events was 10% with amivantamab–lazertinib and 3% with osimertinib.ConclusionsAmivantamab–lazertinib showed superior efficacy to osimertinib as first-line treatment in EGFR-mutated advanced NSCLC. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.)

Osimertinib

Clinical endpoint

Progression-free survival

10.1056/nejmoa2403614

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COVID-19: recomendaciones generales y especificaciones para el paciente con cáncer de pulmón avanzado. Revisión de la literatura

NCT Neumología y Cirugía de Tórax (2020)

Carla Paola Sánchez‐Ríos Miguel Ángel Ramírez-Candelas Sergio Alejandro Menchaca-Dávila Luis Manuel Martínez-Barrera Jerónimo Rafael Rodríguez‐Cid

coronavirus 2019 (COVID-19) se ha convertido en una amenaza para la salud mundial.Sabemos que el riesgo de enfermedad grave y muerte en los casos de COVID-19 aumenta con la edad y la presencia de condiciones de salud comórbidas como obesidad, hipertensión arterial sistémica, diabetes mellitus, enfermedad pulmonar obstructiva crónica y estados de inmunosupresión como el cáncer.

10.35366/94636

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OA15.04 Association Between KRAS/STK11/KEAP1 Mutations and Outcomes in POSEIDON: Durvalumab ± Tremelimumab + Chemotherapy in mNSCLC

Journal of Thoracic Oncology (2022)

Solange Peters B.C. Cho A. Luft Jorge Alatorre-Alexander S.L. Geater

Tremelimumab

Durvalumab

10.1016/j.jtho.2022.07.073

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The role and impact of immunotherapy in multiple malignancies in the Mexican population.

Journal of Clinical Oncology (2022)

Juan Jose Juarez - Vignon Whaley Gisela Sanchez Dominguez Iván Romarico Gonzalez Espinoza Lizbett Vanessa Garcia Montes Jorge Alatorre-Alexander

e14570 Background: Cancer in Mexico represents the third cause of death nationally. Immunotherapy agents have changed management and prognosis of cancer patients. Immune-checkpoint agents are now being used as both first- and second-line treatment improving cancer patient prognosis, nevertheless it is not always accessible. Methods: Retrospective review of patients diagnosed with any type of cancer that received immunotherapy during their disease course from the last 5-years. We present the most common malignancies, immunotherapeutic regimens received, population characteristics and survival analysis. Results: 130 records of patients ≥18 years that received immunotherapy were included. 52.3% female with mean age of 59 years (range, 22-89 years), 48.5% former smokers (average pack/year of 22.5) and 31.5% asbestos exposure. 53.1% were ECOG 0 and 82.3% clinical stage IV. 62.3% of cases were lung adenocarcinoma, followed by lung epidermoid carcinoma (13.1%) and 10% small-cell lung carcinoma. Immunotherapeutic agents used included nivolumab in 63.1%, pembrolizumab 12.3%, nivolumab + ipilimumab 8.5%, durvalumab 6.2%, pembrolizumab + ipilimumab 4.6%. 36.2% of patients received immunotherapy as second line treatment, 30.0% as third and 23.8% as first line treatment. The best Response Evaluation Criteria in Solid Tumors (RECIST) was RECIST 3 in 46.2% followed by RECIST 0 with 25.4%. Median progression-free survival (PFS) was 5 months (95% CI; 3.883-6.117) and median OS of 13 months (95% CI; 10.210-15.790). Analysis per immunotherapy on PFS (p = 0.0414) and OS (p = 0.0046) demonstrated pembrolizumab had the longest median PFS with 19-months and OS with 22-months. Analysis between tumor types was significant for both PFS (p = 0.0018) and OS (p = 0.0090) with melanoma having the longest median PFS (42-months) and OS (46-months). Conclusions: Immunotherapy has changed cancer management; however, its use depends on specific biomarkers and adequate patient selection. Not all patients benefit from immunotherapy, in a country like ours where resources are limited, it is of vital importance to properly select candidates for immunotherapy. Even though, all patients had an FDA-approved indication at the time of receiving immunotherapy, PFS and OS are not as significant as Phase 3 studies demonstrate, this may be due to late stages, advanced ECOG, correct biomarkers availability and adequate patient selection. It is important to mention that about 40-60% of patients with immunotherapy do not respond adequately. In our study, because there is more evidence with pembrolizumab, the patients who received it were better chosen and therefore there was an impact in PFS and OS. Immunotherapy selection also depends on physician experience to the different immunotherapy regimens.

Durvalumab

Atezolizumab

10.1200/jco.2022.40.16_suppl.e14570

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EPH81 Clinical Characteristics and Treatment Patterns of Patients With Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Value in Health (2023)

Miguel Caballero G. Lugo-Martínez Jerónimo Rafael Rodríguez‐Cid Juan J. Juarez-Vignon Whaley Mayte Cruz-Zermeño

10.1016/j.jval.2023.09.1123

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