Bartomeu Massutí

Hospital General Universitario de Alicante Doctor Balmis

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Co-Authors

Mariano Provencio

Hospital Universitario Puerta de Hierro Majadahonda

108

Carlos Camps

Hospital General Universitario De Valencia

100

Manuel Cobo

Instituto de Investigación Biomédica de Málaga

Margarita Majem

Hospital de Sant Pau

Manuel Dómine

Hospital Universitario Fundación Jiménez Díaz

Teresa Morán

Institut Català d'Oncologia

Enric Carcereny

Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol

Miquel Tarón

Hospital Universitario Virgen del Rocío

Rafael Rosell

Instituto Oncológico Dr. Rosell

Delvys Rodríguez‐Abreu

Hospital Universitario Insular de Gran Canaria

Cooperative Institutions

Institut Català d'Oncologia

228

Centro de Investigación Biomédica en Red de Cáncer

146

Instituto de Salud Carlos III

127

Hospital Universitario Puerta de Hierro Majadahonda

123

Universitat Autònoma de Barcelona

104

Hospital Universitari Germans Trias i Pujol

100

Hospital General Universitario de Alicante Doctor Balmis

Universidad Autónoma de Madrid

Hospital Clínico San Carlos

Universitat de Barcelona

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Erlotinib as single agent in patients (p) with advanced or metastatic NSCLC: A multivariate analysis in a prospective study

Journal of Clinical Oncology (2006)

Cinta Pallarés Luís Paz-Ares José M. López-Picazo R. Pérez-Carrión A. Montes

7180 Background: Erlotinib is the first orally available selective EGFR tyrosine-kinase inhibitor that improves survival in 2nd and 3rd line therapy for NSCLC. This non-randomised, phase II trial evaluated the efficacy and safety of erlotinib in patients with advanced or metastatic NSCLC. Methods: Patients with previously treated advanced or metastatic NSCLC or patients that were not suitable for first line conventional chemotherapy, stage IIIB/IV, PS 0–2 were enrolled to receive erlotinib 150 mg/day until disease progression or withdrawal. The primary endpoint of the study was time to progression (TTP) in the intent to treat (ITT) population. A multivariate analysis (Cox-model) was performed. Results: 416 patients were enrolled from June 04 to March 05. Demographics: M 78%/F 22%; median age 64 y [range 28–100]; stage IV 91.6%; PS 0/1/≥2: 65 (16%)/227 (55%)/105 (25%); adeno histology 178p (43%), SCC 121p (29%), BAC 3p (0.7%), LLC 2p (20%), other 29p (7%); smoking status: yes 349 p (84%) no 62 p (15%). 1st line: 60p (14.4%); 2nd line 181p (43.5%) and ≥ 3 rd line 175p (42%). 230 patients had measurable disease and were evaluable for response: 1CR, 30 PR (ORR: 13.4%), 98 SD, and 101 PD. Toxicity was predictable (mainly rash, and diarrhoea). In the ITT population the median TTP was 3.2 m [95% CI 2.8–3.6]. For evaluable population median TTP was 4.6 m in 1st line, 3.23 m in 2nd line, and 2.8 m in 3rd line. Exploratory analysis showed that ORR was associated with gender, smoking history, previous treatment and histology. The multivariate analysis for TTP showed that no smoking history (p < 0.005), adeno histology (p < 0.0001), and erlotinib as 1st line treatment (p < 0.02) correlated with better TTP. Conclusions: Erlotinib is an active and very well tolerated treatment in patients with advanced NSCLC untreated or that have previously failed to conventional chemotherapy. Our data suggest that non smoking history, adeno histology and erlotinib as 1st line treatment are associated with better TTP. The study is ongoing. [Table: see text]

Clinical endpoint

Erlotinib Hydrochloride

Performance status

Progression-free survival

10.1200/jco.2006.24.18_suppl.7180

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Citations (1)

Perioperative Nivolumab and Chemotherapy in Non–Small-Cell Lung Cancer

New England Journal of Medicine (2023)

Mariano Provencio Bartomeu Massutí Atocha Romero

10.1056/nejmc2310641

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Citations (3)

Capmatinib plus nivolumab in pretreated patients with EGFR wild-type advanced non–small cell lung cancer

Lung Cancer (2024)

Enriqueta Felip Giulio Metro Daniel Shao-Weng Tan Juergen Wolf Michael Mark

Clinical endpoint

Progression-free survival

10.1016/j.lungcan.2024.107820

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Citations (2)

Development of a Multicriteria Decision Analysis Framework for Evaluating and Positioning Oncologic Treatments in Clinical Practice

JCO Oncology Practice (2020)

Carlos Camps Xavier Badía Rosario García‐Campelo Jesús García‐Foncillas Rafael López‐López

PURPOSE: Several frameworks have been developed to define and quantify the value of oncologic therapies and to support decision making; however, they define treatment value mainly in terms of clinical benefit. As part of its mission to improve oncologic care, the ECO Foundation (Excellence and Quality in Oncology) directed this pilot study aimed at developing a reflective multicriteria decision analysis (MCDA)–based framework for evaluating and positioning oncologic drugs in the clinical setting. METHODS: The framework was developed following Evidence and Value: Impact on Decision-Making methodology, and literature was reviewed to identify relevant criteria. The selected criteria were then presented to a group of experts composed of 9 clinical oncologists who assessed each criterion for inclusion in the framework and suggested modifications in their definition and/or response scale. The framework was tested in 2 case studies (abemaciclib for advanced or metastatic hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer and TAS-102 for metastatic colorectal cancer) to validate the proposed framework; this was followed by a discussion of the results. RESULTS: Eight of the 15 criteria presented to the experts were included in the framework: disease severity, unmet needs, comparative efficacy, comparative safety/tolerability, treatment intent, comparative treatment cost, comparative other medical costs, and quality of evidence. Framework validation in 2 drug cases resulted in similar value scores, although they were based on different contributing criteria and resulted in different clinical recommendations. CONCLUSION: We developed and validated a reflective MCDA framework for the assessment and positioning of oncologic therapies in Spain. Additional work is needed to create a manual for practical decision making in the clinical setting.

Tolerability

Excellence

10.1200/jop.19.00487

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Citations (10)

Predicting Response to Chemotherapy With Early-Stage Lung Cancer

The Cancer Journal (2011)

Rafael Rosell Miquel Tarón Bartomeu Massutí Nuria Mederos Ignacio Magrí

A recent meta-analysis of 11,107 patients with non-small cell lung cancer who had undergone surgical resection showed that the 5-year survival benefit of adjuvant chemotherapy was 4%, and that of adjuvant chemoradiotherapy was 5%. Two trials have shown a trend toward improved survival with adjuvant paclitaxel plus carboplatin. However, the benefit of adjuvant treatment remains suboptimal. We must distinguish between patients who will not relapse-and who can thus be spared adjuvant treatment-and those who will-for whom adjuvant treatment must be personalized. Several gene expression signatures, generally containing nonoverlapping genes, provide similar predictive information on clinical outcome, and a model combining several signatures did not perform better than did each of the signatures separately. The invasiveness gene signature, containing 186 genes, includes genes involved in the nuclear factor κB pathway, the RAS-mitogen-activated protein kinase pathway, and epigenetic control of gene expression. A 15-gene signature has identified JBR.10 patients who are more sensitive to adjuvant chemotherapy.

Carboplatin

Gene signature

Adjuvant Chemotherapy

10.1097/ppo.0b013e3182091fa3

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Citations (12)

Comparison of three different molecular methods to detect mutations in KRAS, NRAS, BRAF and PIK3CA in metastatic colorectal cancer samples (mCRC): Interim analysis of a Spanish cohort.

Journal of Clinical Oncology (2015)

Cristina Santos Valentín Navarro-Perez Maria Elena Elez Fernandez Bartomeu Massutí Manuel Valladares Ayerbes

e14613 Background: Mutational analysis of RAS in mCRC has demonstrated an improvement in patient selection for anti-EGFR drugs. The techniques for the detection of point mutations have an analytical sensitivity of 1-5%. Even more sensitive techniques can detect 0.05-0.1% mutated alleles, although it is not clear the impact on anti-EGFR treatment benefit. Objective: The aim of our study was to compare the sensitivity to detect point mutations in KRAS, NRAS, BRAF and PIK3CAby cobas, therascreen assays and Digital PCR (Fluidigm), and their predictive value to anti-EGFR and bevacizumab (bev) treatments in terms of progression free survival. 600 patient level datasets treated with chemotherapy and anti-EGFR or bev were pooled from several mCRC trials and retrospective series from the TTD/RTICC Spanish network. Methods: Interim analysis of mutational studies of tumor samples from 249 (out of 600) mCRC mostly treated in clinical trials with bev (37.4%), cetuximab (12.6%) or panitumumab (49.9%) is reported. Invalid rates and turnaround time (TAT) were assessed for each platform. Concordance and predictive capability were evaluated using kappa and Harrel’s C index. Results: There were no invalid results for Digital PCR and only one for cobas and therascreen each. The average time for DNA extraction per 24 samples was 21.5 hrs for cobas Kit and 23 hrs for QIAamp DNA mini Kit. The average time for testing all genes per 24 samples was 14 hrs for cobas, 35 hrs for therascreen and 65 hrs for Digital PCR. There was a very good concordance between cobas and therascreen in the KRAS mutation analysis (kappa index: 0.87 (95% CI, 0.8-0.94)). The best platforms in terms of Harrel’s C index for all patients were KRAScriteria by cobas and Digital PCR (both with 0.53). Conclusions: Concordance in the KRAS mutation analysis between platforms is good with a TAT favoring cobas assay. Mutations (n,% & kappa) Cobas Kappa Therascreen Kappa Digital PCR Kappa Digital PCR/Cobas KRAS (exon2/3) 64(25.70%) 0.87 60(24.1%) 0.6 88(35.34%) 0.7 RAS extended (exon2/3/4) 90(36.14%) 0.78 81(32.53%) 0.58 111(44.58%) 0.64 Any mutation 120(48.2%) 0.70 106(46.57%) 0.52 124(49.8 %) 0.60

Panitumumab

Concordance

10.1200/jco.2015.33.15_suppl.e14613

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Citations (0)

P2.10-02 Smoking Habit in Lung Cancer in Spain

Journal of Thoracic Oncology (2019)

Enric Carcereny F. Franco Delvys Rodríguez‐Abreu Rafael López Castro R. de las Peñas

Habit

10.1016/j.jtho.2019.08.1686

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Citations (0)

Nondisruptive p53 Mutations Are Associated with Shorter Survival in Patients with Advanced Non–Small Cell Lung Cancer

Clinical Cancer Research (2014)

Miguel Ángel Molina‐Vila Jordi Bertrán-Alamillo Amaya Gascó Clara Mayo‐de‐las‐Casas María Sánchez-Ronco

TP53 mutations in early-stage non-small cell lung cancer (NSCLC) may be associated with worse survival but their prognostic role in advanced NSCLC is controversial. In addition, it remains unclear whether mutated patients represent a clinically homogeneous group.We retrospectively examined TP53 mutations and outcome in a training cohort of 318 patients with stage IIIB-IV NSCLC: 125 epidermal growth factor receptor (EGFR) wild-type (wt) and 193 EGFR mutated (mut). An independent validation cohort of 64 EGFR-mut patients was subsequently analyzed. Mutations were classified as "disruptive" and "nondisruptive" according to their predicted degree of disturbance of the p53 protein structure and function.In the training cohort, TP53 mutations were found in 43 of the 125 EGFR-wt patients (34.4%). Of these, 28 had nondisruptive TP53 mutations and a median overall survival (OS) of 8.5 months, compared with 15.6 months for the remaining 97 patients (P=0.003). In the EGFR-mut group, TP53 mutations were found in 50 of the 193 patients (25.9%). The OS for the 26 patients with TP53 nondisruptive mutations was 17.8 months versus 28.4 months for the remaining 167 patients (P=0.04). In the validation cohort, the 11 patients with nondisruptive TP53 mutations had a median OS of 18.1 months compared with 37.8 months for the 53 remaining patients (P=0.006). In multivariate analyses, nondisruptive TP53 mutations had an independent, significant association with a shorter OS.Nondisruptive mutations in the TP53 gene are an independent prognostic factor of shorter survival in advanced NSCLC.

10.1158/1078-0432.ccr-13-2391

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Citations (144)

Treatment of advanced non-small cell lung cancer in the elderly: Spanish Lung Cancer Group (SLCG) experience

Journal of Clinical Oncology (2007)

Mariano Provencio Carlos Camps Vicente Alberola Manuel Dómine D. Isla

18012 Background: The number of elderly patients (p) with cancer continues to increase. Approximately two-thirds of p diagnosed with non-small cel lung cancer are > 65 years (y), and nearly 50% are > 70 y. The aim of our study was to discern whether clinical characteristics, toxicity, response rate, treatment and survival are different in p < 70 y vs p = 70 y. Methods: We reviewed the database of 6 SLCG clinical trials with different doublet combinations from 2000 to 2005 Results: Of 1653 p included, only 280 p (17% ) were = 70 y. No significant differences were found between the two groups with respect to gender, stage, response rate or histology. However, a higher frequency of squamous cell carcinoma was found in p = 70y. No differences were found in median number of cycles administered. The only significant difference was found in the higher frequency of grade 3–4 neutropenia among p = 70 y. (Table) Conclusions: p = 70 y were a small percentage of all p included in these clinical trials. However, outcome and toxicities were similar in p = 70y vs <70 y, and “fit” elderly p can be treated with standard doublets. Further research is warranted on genetic differences for customizing treatment in this population. [Table: see text] No significant financial relationships to disclose.

10.1200/jco.2007.25.18_suppl.18012

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P1.09-09 Evaluation of a Novel ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in NSCLC Patients

Journal of Thoracic Oncology (2018)

Esther Conde Susana Hernández Roberto Martínez Javier de Castro Ana Collazo-Lorduy

clone (Java method)

Guideline

10.1016/j.jtho.2018.08.785

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