Lisardo Ugidos

Hospital Universitario HM Sanchinarro

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Antonio Cubillo

Hospital Universitario HM Sanchinarro

Jesús Rodríguez-Pascual

HM Hospitales

RÁ

Rafael Álvarez-Gallego

Hospital Universitario HM Sanchinarro

Paloma Peinado

Hospital Universitario HM Sanchinarro

Yolanda Quijano

Hospital Universitario HM Sanchinarro

Manuel Hidalgo

Cornell University

César Muñoz

Catholic University of the Maule

Fernando López‐Ríos

Universidad Complutense de Madrid

Emiliano Calvo

South Texas Accelerated Research Therapeutics

José Miguel Cárdenas‐Rebollo

Universidad San Pablo CEU

Cooperative Institutions

Hospital Universitario HM Sanchinarro

HM Hospitales

Centro Oncológico de Galicia

Universidad San Pablo CEU

University Hospital HM Puerta del Sur

Universitat de Barcelona

Hospital Clínic de Barcelona

Universidad Autónoma de Madrid

Hospital Universitario 12 De Octubre

Consorci Institut D'Investigacions Biomediques August Pi I Sunyer

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Relapse-free survival (RFS) after surgical resection to predict survival after relapse (SAR) and overall survival (OS) in patients with pancreatic ductal adenocarcinoma (PDA).

Journal of Clinical Oncology (2019)

Jesús Rodríguez-Pascual Rafael Álvarez-Gallego César Muñoz Lisardo Ugidos Enrique Sanz

e15735 Background: We aimed to evaluate the clinical relevance of RFS after local PDA resection as a prognostic factor in terms of SAR and OS. Methods: Patients diagnosed with local PDA who had undergone surgical resection in 4 hospitals from Spain were identified. Disease location, demographic, pathologic, treatment during recurrence and mortality information was retrospectively collected. RFS was measured from date of surgery until recurrence and censored at death or last follow-up. SAR was measured from relapse, until death or last follow-up. We defined patients presenting an RFS value of 6 months or more, or less than 6 months as High-RFS and Low-RFS respectively. Results: Of 93 patients with resected PDA, 51 (54.8%) were male and 42 (45.2%) female. The median age was 65.2 years. 62 (66.7%) tumors were localized in the head. There were 5 (5.4%), 17 (18.3%) and 69 (74.1%) stage I, II and III respectively. 53 (57%) patients had undergone cephalic (Whipple), 20 (21.5%) distal and 20 (21,5%) total pancreatectomy. 48 (51.6%) patients received radiotherapy and 86 (92.5%) received chemotherapy in the neoadjuvant and/or adjuvant setting. Median RFS was 12.3 months. In the metastatic setting, the most frequent chemotherapy combination was gemcitabine plus nab-paclitaxel. 43(46,2%) of patients received second line chemotherapy. Median OS and median SAR were 25,9 and 10,1 months respectively. Kaplan-Meier survival analysis showed that PDA cancer patients with Low-RFS have a poorer clinical outcome than those with High-RFS (median OS 48.26 months, CI 95% 39,3-57,1 for High-RFS; 19.2 months CI 95% 15.7-22-8 for Low-RFS; p = 0.0001). On multivariate Cox regression analysis, age, initial stage I-II, adjuvant chemotherapy utilization and High-RFS were independent prognostic factors for OS and SAR rate. Conclusions: RFS was strongly correlated and discriminated PDA patients with better SAR and OS from the poorer prognosis patients in the ulterior metastatic setting. Prospective studies are needed to confirm this finding.

10.1200/jco.2019.37.15_suppl.e15735

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How to measure faculty clinical activity in a comprenhesive cancer center.

Journal of Clinical Oncology (2017)

Rafael Álvarez-Gallego Jesús Rodríguez-Pascual Lisardo Ugidos Eduardo García‐Rico Cesar Munoz

e18202 Background: The faculty clinical activity in a comprehensive Cancer Center is difficult to measure. Time clinical units is the most common procedure worldwide. In our group we have developed a new system based on the daily real activity of each medical oncologist of our team. Methods: We collected the daily activity from january to december 2016 of each doctor considering different values( from 1 to 4)depending on the complexity of the activity. Follow up visit of a patient (1), treatment visit (2). Clinical trial visit or Inpatient visit (3) and New Patient First visit (4). Then we added all the daily values of each medical oncologist. Results: 2016 Clinical activity growth measured by traditional time methods was consider 31,5%. When we applicated our new method it was 33,4%. The clinical activity of each Oncology Unit changed clearly when we applied our method. For example , breast cancer unit change from 25% to 20 % of the global activity, GI Unit from 47% to 50%, Lung Unit from 13% to 15% . In Genitourinary and Gynecological cancer and Prostate tumor units there are no change. This changes draw the different complexity of each Oncology Unit. It was clearly usefull to get a better information of the real clinical activity of each team and cancer center. Conclusions: This tool can be useful to unifique and compare the different complexity in the clinical activity of Medical Oncology Teams, units and hospitals allocating resources based on this new system.

Clinical Oncology

10.1200/jco.2017.35.15_suppl.e18202

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Dynamic Angiogenic Switch as Predictor of Response to Chemotherapy-Bevacizumab in Patients With Metastatic Colorectal Cancer

American Journal of Clinical Oncology (2018)

Antonio Cubillo Rafael Álvarez-Gallego Manuel Muñoz Gregory R. Pond Sofía Perea

Previous studies have shown that metastatic colorectal carcinoma (mCRC) patients treated with bevacizumab, experience variation in the plasma levels of angiogenesis growth factors and related cytokines, called angiogenic switch (AS). The aim of the present study was to analyze the relationship between AS and the clinical response during standard chemotherapy-bevacizumab treatment.Patients with Eastern Cooperative Oncology Group 0-1 mCRC were eligible. Patients received treatment with standard dose capecitabine plus either oxaliplatin or irinotecan and bevacizumab for 6 cycles. Initial treatment was followed by maintenance therapy with bevacizumab plus capecitabine until progression. Plasma levels of angiogenic-related cytokines (hepatocyte growth factor, placental growth factor, macrophage chemoattractant protein-3, MM-9, eotaxin, basic fibroblast growth factor, and interleukin 18) were prospectively analyzed at baseline and every 8 weeks. Progression-free survival (PFS) was calculated using the Kaplan-Meier method.A total of 71 patients were enrolled. AS was observed in 45 patients (63.4%), 28 of whom experienced AS at the first evaluation after treatment start. Disease control, which includes partial/complete response and stable disease, was seen in 96% of AS patients (43/45), but only in 15/26 (58%) for the remaining patients without evidence of AS (P<0.001). The median PFS of AS patients was 11.4 months (95% confidence interval, 8.6-15.8) versus 8.3 months for patients without AS (95% confidence interval, 5.6-16.4; P=0.04).Chemotherapy plus Bevacizumab combination in mCRC patients results in dynamic changes in plasma cytokines, which is associated with better disease control and longer PFS. These new findings support continuing studying AS as a potential marker of angiogenesis inhibitor effectiveness.

Progression-free survival

10.1097/coc.0000000000000474

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Clinical Case: Patient with Locally Rectal Cancer in Watch and Wait Program with Perianal Tumor Fistula

Clinics in Oncology (2021)

César Muñoz Rafael Álvarez-Gallego Paloma Peinado V. Pérez Dueñas E. Sánchez Saugar

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Durvalumab (DUR) effectiveness in advanced biliary tract cancer (aBTC) patients based on real-world data evidence.

Journal of Clinical Oncology (2025)

Jesús Rodríguez-Pascual Gema Hernández Lisardo Ugidos Alejandro Parralejo Juan Diego Rodriguez-Castaño

598 Background: Based on TOPAZ-1 trial, Durvalumab (DUR) plus gemcitabine and cisplatin significantly improved overall survival (OS) in advanced biliary tract cancer (aBTC) patients. Real-World data evidence can evaluate the benefit of this combination outside controlled studies comparing patients treated with standard chemotherapy with or without DUR. Methods: Using the TriNetX Global Collaborative Network, a platform that operates globally based on anonymized and aggregated clinical data, a sample of aBTC patients from 128 healthcare organizations (HCOs) who met the initial criteria was selected. 5-year overall survival (OS) was analyzed between these cohorts using a Kaplan-Meier analysis. Hazard Ratio (HR) and its 95% confidence interval (95%CI) were calculated to evaluate the difference between cohorts. Propensity Score Matching (PSM) was used to balance the cohorts based on age, gender, and race mitigating possible cofounding variables. All statistical analyses were conducted utilizing the TriNetX Analytics function in the online research. Results: A total of 1099 patients met the study criteria and were included in our study. 399 received DUR plus chemotherapy and 700 received only chemotherapy. Patients treated with DUR showed a significant better OS compared to patients treated with only chemotherapy, both previous to PSM and before PSM (post-PMS median OS 418 days vs 359 days, HR 0.862, 95%CI 0.759-0.979, p=0.022). Conclusions: This is the largest World-Real Data study exploring the effectiveness of Durvalumab in aBTC patients outside clinical trials, confirming a similar benefit than TOPAZ-1 study.

Durvalumab

Biliary Tract Cancer

10.1200/jco.2025.43.4_suppl.598

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Durvalumab plus tremelimumab for the treatment of patients (pts) with refractory and progressive advanced thyroid carcinoma: A phase II multicohort trial (DUTHY / GETNE T1812)

Annals of Oncology (2019)

Jorge Hernando Cubero M. Taberna Sanz Alberto Carmona‐Bayonas L. Iglesias Enrique Grande

Durvalumab

Tremelimumab

Refractory (planetary science)

10.1093/annonc/mdz267.009

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Long-Term Survival in Hepatocellular Carcinoma following Second-Line Tumor Treating Fields Therapy and Sorafenib: A Case Report

Case Reports in Oncology (2024)

Marisa Torres Velasco Rafael Álvarez-Gallego Paloma Peinado Cesar Muñoz Gregorio Lisardo Ugidos

Hepatocellular carcinoma (HCC) is an aggressive solid tumor associated with high mortality. Surgery is the main treatment consideration for early disease, but patients who present with locally advanced or metastatic HCC at diagnosis have limited treatment options. There has been great progress in locoregional, immunotherapy, and targeted treatments for advanced HCC. Standard of care for HCC has changed due to results demonstrating safety and efficacy in phase 3 studies, namely, for atezolizumab concomitant with bevacizumab. Nonetheless, additional therapeutic approaches are still warranted to further increase overall survival in HCC. A first-in-class treatment option investigated in patients with HCC is Tumor Treating Fields (TTFields) therapy, which is delivered locoregionally to the tumor site from a portable medical device. TTFields are electric fields that interfere with critical cancer cell processes, hindering tumor progression.

Atezolizumab

Concomitant

10.1159/000539719

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Abstract P2-06-17: Biological Study of the Effects of GW572016 (Lapatinib) in Ras/Raf/MAK and PI3K/Akt Signaling Pathways in HER2 Positive Ductal Breast Carcinoma in Situ (DCIS)

Cancer Research (2010)

LG Estévez Amileth Suárez Isabel Calvo Lisardo Ugidos Cristina Martínez Miró

Abstract Background: DCIS is a heterogeneous disease, with increasing incidence. Up to 37% of DCIS overexpress HER2. Lapatinib is a tyrosine kinase inhibitor that directly inhibits HER2 receptor signaling by blocking the receptor's kinase activity. This work tested the hypothesis that Lapatinib inhibits Ras/Raf/MAK and PI3K/AKT signaling in HER2 positive DCIS. Patients and Methods: Patients with HER2 positive (FISH rate >2.2) DCIS diagnosed by core needle biopsy with low risk of having a hidden invasive component were eligible. Neoadjuvant Lapatinib 1500mg daily was administered for 4 weeks prior to surgical resection. EGFR was analyzed by FISH in the biopsy specimen. Ki67, PTEN, AKT, pAKT and pERK were evaluated by IHQ. PI3KCA mutations were screened at exons 9 and 20 by PCR. Apoptosis was analyzed by TUNEL assay. All biological markers were measured before and after Lapatinib treatment. Results: Eleven pts with HER2 positive DCIS have been included to date. Median FISH amplification was 7 (range 2, 70-14). Evaluation pre-Lapatinib showed that: none of the pts had EGFR amplification; six pts (54%) had a Ki67 >25%; pAKT was overexpressed in 3 pts (27%) and pERK in 2 pts (18%); PTEN was deleted in 3 pts (27%). PI3KCA mutations were detected in only 1 pt (9%). After Lapatinib treatment, 9 pts were evaluable. We observed a trend for inactivation of the Ras/Raf/MAK signaling pathway in 7 pts (70%) patients. Interestingly, 3 of these pts had paradoxical activation of PI3K/Akt suggesting a compensatory feed back loop. One out of these 3 pts has PTEN deleted. In addition, 3 pts (33%) showed an increase in the apoptotic index. Conclusions: In our study, four weeks of Lapatinib against HER2 positive DCIS resulted in inactivation of Ras/Raf/MAK pathway; however an activation of the PI3K/Akt was seen as the same time in 3 pts. Nevertheless this trend needs to be confirmed with the inclusion of more pts. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-06-17.

Lapatinib

10.1158/0008-5472.sabcs10-p2-06-17

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Primary systemic therapy in breast cancer

CRC Press eBooks (2013)

Lisardo Ugidos Andreas Makris Jenny C. Chang

The most recent meta-analysis by the Oxford group (published in 2011), examined the outcomes among more than 10,000 women in 17 randomized trials of breast conservation therapy and yielded the following conclusions:● Radiotherapy provides highly effective local control, preventing local recurrence in more than 80% of those treated.

Systemic therapy

Primary (astronomy)

10.1201/b13937-47

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Cell-free circulating tumour DNA as a tool for monitoring response to anti-EGFR therapies of mCCR.

Journal of Clinical Oncology (2016)

Estela Vega Antonio Cubillo Rodrigo A. Toledo Elena Garralda Rafael Álvarez-Gallego

e23059 Background: RAS/RAF/PIK3CA mutations are frequent drivers of secondary drug resistance to cetuximab in mCCR, which typically occurs within 3-12months from the start of therapy. The emergence ofmutant clones can be detected non-invasively months prior to radiographic progression through liquid biopsy We aimed to analyze the plasma genetic status and relate this with clinical outcome Methods: Patients with no prior chemotherapy for KRAS wt mCRC received FOLFIRI-Cetuximab until progression or unacceptable toxicity. Objective tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (RECIST) every 2months. Blood samples for liquid biopsy were collected before treatment and with each tumor assessment. KRAS(G12S/R/C/V/A/D, G13D, Q61H, A146T); NRAS(Q61K/R/L/H); BRAF(V600E); PIK3CA(E542K, E545K/G, Q546K, M1043I, H1047Y/R/L) hotspot mutations were assessed in the tumor samples using Ion Torrent NGS or Cobas kits, and in the plasma cell-free DNA by BEAMing technique Results: 25 patients were included, from which 1 was considered non evaluable (second synchronous primary lung carcinoma). 3 patients harbored BRAF/PIK3CA somatic mutations before treatment; all of which presented a quick clinical progression with median PFS 2.1 months(0.8-3.3). Continuous wt liquid biopsy results were observed in patients with prolonged response to cetuximab. 18 cases(75%) presented disease control(CR/PR/SD), 13 with partial/complete response. 6 underwent surgery after response, and 11 maintained prolonged response to the treatment(median follow up 19.3 months; median time to response duration is not reached). Emerged KRAS/PIK3CA mutations were found in three patients, two of whom initial responder that subsequently developed imminent progression; with median PFS 2.5 months Conclusions: Our results showed that patients with prolonged response maintained wt circulating status throughout the period of anti-EGFR therapy while circulating mutation levels upsurges are associated with imminent clinical deterioration and metastasis spread. It suggests that wt circulating status during treatment with anti-EGFR is a potential biomarker of prolonged good response in mCRC patients Clinical trial information: NCT01943786.

Liquid biopsy

FOLFIRI

Cell-free fetal DNA

10.1200/jco.2016.34.15_suppl.e23059

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