Ana-María Jiménez-Gordo

Universidad Autónoma de Madrid

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Juan Moreno‐Rubio

Hospital Universitario Infanta Sofía

Enrique Casado

Madrid Institute for Advanced Studies

Sonia Alcalá

Universidad Autónoma de Madrid

Bruno Sáinz

Instituto de Investigaciones Biomédicas Sols-Morreale

Francisco Zambrana

Hospital Universitario Infanta Sofía

David Abraham Cortes Bandy

Hospital Universitario Infanta Sofía

Javier Martínez Alegre

Hospital Universitario Infanta Sofía

Miriam López-Gómez

Hospital Universitario Infanta Sofía

Gonzalo Serralta San Martín

Hospital Universitario Infanta Sofía

Marta Muñoz-Fernández de Legaria

Hospital Universitario Infanta Sofía

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Hospital Universitario La Paz

Hospital Universitario Infanta Sofía

Centro de Investigación Biomédica en Red de Cáncer

Universidad Autónoma de Madrid

Instituto de Salud Carlos III

Hospital La Paz Institute for Health Research

Institut Català d'Oncologia

Hospital Universitario Puerta de Hierro Majadahonda

Universidad Europea de Madrid

Universitat de Barcelona

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Figure 1 from Autofluorescent Cancer Stem Cells: Potential Biomarker to Predict Recurrence in Resected Colorectal Tumors

Sonia Alcalá Gonzalo Serralta San Martín Marta Muñoz-Fernández de Legaria Juan Moreno‐Rubio Silvia Salinas

Expression of AF in different tumor entities. A, Workflow followed for the detection of AF cells. Tumors were digested and single-cell suspensions incubated overnight with riboflavin (Rb) prior to flow cytometric analysis of AF using a 4-laser Attune NxT Acoustic cytometer. B, Distribution of the percentage of AF-positive cells in the indicated tumors (colorectal cancer, n = 60; kidney, n = 16; breast, n = 10; stomach, n = 9; rectum, n = 7; liver, n = 4; larynx, n = 3). C, Representative flow cytometric plots depicting the percentage of AF cells in colorectal cancer and kidney tumors. D, Representative flow cytometric plots depicting the percentage of AF cells in a kidney tumor incubated with and without 100 μmol/L Rb. E, Left, Representative images of tumor formation achieved with 103 and 102 AF-positive (+) or AF-negative (−) FACS-sorted cells, injected subcutaneously (in duplicate) in athymic nude mice. Photographs correspond to 12 weeks after injection. Right, Table summarizing the number of tumors formed/number of injections per dilution for a colorectal cancer or stomach tumor, digested and sorted for AF cells. F, To confirm that the AF detected was a result of riboflavin accumulation in ABCG2-coated vesicles, parallel samples were incubated overnight (in parallel with Rb) with 150 µM FTC, an ABCG2 inhibitor. AF diminished in FTC-treated cells, confirming that AF is ABCG2 mediated.

10.1158/2767-9764.27152148

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Pregnancy in a breast cancer patient treated with a LHRH analogue at ablative doses

The Breast (2000)

Ana-María Jiménez-Gordo Enrique Espinosa P. Zamora Jaime Feliú Nuria Rodrı́guez-Salas

A 36-year-old female diagnosed of breast cancer was treated with surgery, chemotherapy, radiotherapy and goserelin. After 17 months of uninterrupted therapy with this LHRH analogue at hormone suppressive doses, a 16-week gestation foetus was detected and the treatment was withdrawn. Although the drug was administered throughout the first 4 months of pregnancy it resulted in the term delivery of a healthy infant, and no foetal adverse effects were detected. A review of the influence of hormonal treatment for breast cancer on fertility and birth defects has been performed.

Ablative case

Goserelin

Hormonal Therapy

10.1054/brst.2000.0133

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Autofluorescence: A new marker for identifying cancer stem cells (CSCs) in primary tumors

Annals of Oncology (2018)

M. López Gómez Enrique Casado M. Muñoz Sonia Alcalá Juan Moreno‐Rubio

Autofluorescence

CD90

Abcg2

10.1093/annonc/mdy304.040

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Biliary tract cancers: SEOM clinical guidelines

Clinical & Translational Oncology (2015)

Manuel Benavides A. Antón Javier Gállego María Auxiliadora Gómez Ana-María Jiménez-Gordo

Biliary tract cancer (BTC) is an uncommon and highly fatal malignancy. It is composed of three main different entities; Gall bladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCC) and extrahepatic cholangiocarcinoma (eCC) sharing different genetic, risk factors and clinical presentation. Multidetector-row computed tomography (MDCT) and magnetic resonance cholangio-pancreatography (MRCP) are the more important diagnostic techniques. Surgery is the only potentially curative therapy but disease recurrence is frequent. Treatment with chemotherapy, radiotherapy or both has not demonstrated survival benefit in the adjuvant setting. Cisplatin plus gemcitabine constitutes the gold standard in metastatic disease. New ongoing studies mainly in the adjuvant and neoadjuvant setting along with molecular research will hopefully help to improve survival and quality of life of this disease.

Biliary Tract Cancer

10.1007/s12094-015-1436-2

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Data from Autofluorescent Cancer Stem Cells: Potential Biomarker to Predict Recurrence in Resected Colorectal Tumors

Sonia Alcalá Gonzalo Serralta San Martín Marta Muñoz-Fernández de Legaria Juan Moreno‐Rubio Silvia Salinas

<div>AbstractCancer stem cells (CSC) in colorectal cancer drive intratumoral heterogeneity and distant metastases. Previous research from our group showed that CSCs can be easily detected by autofluorescence (AF). The aim of the present study was to evaluate the potential role of AF CSCs as a prognostic biomarker for colorectal cancer relapse. Seventy-five freshly resected tumors were analyzed by flow cytometry. AF was categorized as high (H-AF) or low, and the results were correlated with histologic features [grade of differentiation, presence of metastases in lymph nodes (LN), perivascular and lymphovascular invasion] and clinical variables (time to relapse and overall survival). Nineteen of the 75 (25.3%) patients experienced relapse (local or distant); of these 19 patients, 13 showed positive LNs and 6 had H-AF. Of note, four of them died before 5 years. Although patients with H-AF CSC percentages in the global population experienced 1.5 times increased relapse [HR, 1.47; 95% confidence interval (0.60–3.63)], patients with H-AF CSC percentages and LN metastases had the highest risk of relapse [HR, 7.92; P < 0.004; 95% confidence interval (1.97–31.82)]. These data support AF as an accurate and feasible marker to identify CSCs in resected colorectal cancer. A strong statistical association between H-AF CSCs and the risk of relapse was observed, particularly in patients with positive LNs, suggesting that H-AF patients might benefit from adjuvant chemotherapy regimens and intensive surveillance due to their high propensity to experience disease recurrence.Significance: AF has been proven to be an accurate biomarker for CSC identification; however, to date, their role as a prognostic factor after resection of colorectal cancer tumors has not been investigated. Our results show that determining the presence of AF CSCs after tumor resection has prognostic value and represents a potentially important tool for the management of patients with colorectal cancer.</div>

10.1158/2767-9764.c.7476426

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Retrospective analysis of clinical factors associated with a greater benefit with Trifluridine and Tipiracil in metastasic colorectal cancer

Annals of Oncology (2018)

Nuria Rodrı́guez-Salas M. Soriano Segura Ana-María Jiménez-Gordo R. Molina Juan Carlos Cámara

Introduction: Colorectal cancer (CRC) is the most incident in Spain, according to Spanish Network of Cancer Registries (REDECAN) and is the second cause of death by cancer in Spain. Although the OS in metastatic setting has increased to 24-30 months, the 5-year OS continues to be less than 12%. The first and second line of treatment are well defined; however, there are few therapeutic options for those patients who have progressed to these standard therapies. After progression to the second line of treatment, the only therapeutic options with approved specific indication are Regorafenib and Trifluridine and Tipiracil. Trifluridine and Tipiracil has shown its efficacy in two randomized clinical trials comparing Trifluridine and Tipiracil versus placebo: a Phase II and a Phase III study (RECOURSE). In the previous Phase II study, the mOS was 9.0 months in the group treated with Trifluridine and Tipiracil, compared to 6.6 months in the placebo group. In the RECOURSE study, among patients treated with Trifluridine and Tipiracil mPFS was 2 months versus 1.7 months among those treated with placebo, and mOS was 10,5 with Trifluridine and Tipiracil vs 7,6 with placebo. We described the clinical characteristic of patients treated with Trifluridine and Tipiracil in seven hospitals from Madrid; identifying and analyzing clinical factors associated with long-term response. Methods: We collected retrospectively the clinical data of 98 patients who had received treatment with Trifluridine and Tipiracil until January 2018 in seven different hospitals in Madrid. Results: The mean age at first use of Trifluridine and Tipiracil was 66± 9.45 years, 57.5% were men and 42.3% were women, most of them in good performance status (ECOG 0-1: 71.2%), 27.8% had ECOG ≥2 when started Trifluridine and Tipiracil. All of the patients were diagnosed of metastatic colorectal cancer (73.2% had liver metastases, 58.2% lung metastases and 30.9% peritoneal metastases). Tumor localization was: 73.2% left colon, 24.8% right colon, and only 2% small intestine or 1% two synchronous colonic tumors. KRAS mutations were found in 62.9%, NRAS mutations in 17.4% and BRAF mutations were found in 5.4% patients. The median of prior lines of chemotherapy was three. The median progression free survival was 3 months (95% CI 2.65 – 3.36). The median overall survival was 5 months (95% CI 4.23-5.78). The median duration of treatment was 3 cycles. 23.7% patients had an adverse event that led to treatment withdrawal. The requirement of dose-reduction was associated with longer PFS (4 months vs 3 months, p = 0.002) and OS (14 months vs 5 months, p = 0.017). The existence of BRAF mutation was also associated with shorter PFS (1 month vs 3 months, p = 0.002) and OS (1 month vs 5 months, p = 0.000). There was no statistically significant difference of PFS and OS according to primary tumor location. Conclusion: Trifluridine and Tipiracil is effective in metastatic colorectal cancer (in patients with ≥2 lines of treatment). The OS (5 months) and PFS (3 months) reached in our study in real clinical practice are consistent with findings from previous studies. Mutational status of BRAF was statistically significant associated with shortened PFS and OS. Dose reduction during treatment is associated with Trifluridine and Tipiracil efficacy in terms of prolonged OS and PFS.

10.1093/annonc/mdy151.265

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Table 3 from Autofluorescent Cancer Stem Cells: Potential Biomarker to Predict Recurrence in Resected Colorectal Tumors

Sonia Alcalá Gonzalo Serralta San Martín Marta Muñoz-Fernández de Legaria Juan Moreno‐Rubio Silvia Salinas

HR for relapse

10.1158/2767-9764.27152124

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Safety and efficacy of encorafenib–cetuximab combination in BRAF-mutated metastatic colorectal cancer: real-world evidence from the CONFIDENCE Spanish multicenter study

ESMO Real World Data and Digital Oncology (2024)

Ana Fernández Montés Javier Ros Pilar García‐Alfonso Ana Fernández Montés Elena Brozos-Vázquez

•RW effectiveness and safety of EC align with data from clinical trials.•Better survival outcomes may be potentially derived from early EC administration.•Factors of poor prognosis need to be further investigated to reach consensus. BackgroundDual blockade therapy encorafenib–cetuximab (EC) was recently established as the standard of care for second- or third-line treatment for BRAFV600E-mutated metastatic colorectal cancer (mCRC) patients based on BEACON phase III study results. The CONFIDENCE study aims to provide insight about the real-world (RW) safety and effectiveness of EC in a Spanish cohort.Materials and methodsThis retrospective study included BRAFV600E-mutated mCRC patients treated in second line with EC in the RW setting. The primary endpoint (EC effectiveness) was measured by progression-free survival (PFS) and overall survival (OS). Key secondary endpoints were overall response rate (ORR), disease control rate (DCR), duration of response (DoR), potential factors affecting PFS and OS and safety.ResultsEighty-one patients were included after at least 5 months of follow-up before study onset, 50.6% female with a median age of 66.1 years. Overall, 65% of patients debuted with synchronous metastatic disease. Patients received a median of six EC cycles. The median OS and PFS after 9.7 months of follow-up were 12.6 and 5.0 months, respectively. The median DoR was 5.8 months. ORR was 33.8% and DCR was 68.8%. Alkaline phosphatase, neutrophil/lymphocyte ratio and three or more metastatic lesions were accurate prognostic factors for OS. Additionally, the presence of liver metastases has prognostic value for PFS. The most reported adverse events (AEs) were skin-related toxicities (43.2%). Grade ≥3 AEs occurred in 13.5% of patients.ConclusionsOur results align with the BEACON trial results, confirming the safety and efficacy of EC in the RW setting and additionally provide insight about survival prognostic factors. Dual blockade therapy encorafenib–cetuximab (EC) was recently established as the standard of care for second- or third-line treatment for BRAFV600E-mutated metastatic colorectal cancer (mCRC) patients based on BEACON phase III study results. The CONFIDENCE study aims to provide insight about the real-world (RW) safety and effectiveness of EC in a Spanish cohort. This retrospective study included BRAFV600E-mutated mCRC patients treated in second line with EC in the RW setting. The primary endpoint (EC effectiveness) was measured by progression-free survival (PFS) and overall survival (OS). Key secondary endpoints were overall response rate (ORR), disease control rate (DCR), duration of response (DoR), potential factors affecting PFS and OS and safety. Eighty-one patients were included after at least 5 months of follow-up before study onset, 50.6% female with a median age of 66.1 years. Overall, 65% of patients debuted with synchronous metastatic disease. Patients received a median of six EC cycles. The median OS and PFS after 9.7 months of follow-up were 12.6 and 5.0 months, respectively. The median DoR was 5.8 months. ORR was 33.8% and DCR was 68.8%. Alkaline phosphatase, neutrophil/lymphocyte ratio and three or more metastatic lesions were accurate prognostic factors for OS. Additionally, the presence of liver metastases has prognostic value for PFS. The most reported adverse events (AEs) were skin-related toxicities (43.2%). Grade ≥3 AEs occurred in 13.5% of patients. Our results align with the BEACON trial results, confirming the safety and efficacy of EC in the RW setting and additionally provide insight about survival prognostic factors.

10.1016/j.esmorw.2024.100055

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Table 2 from Autofluorescent Cancer Stem Cells: Potential Biomarker to Predict Recurrence in Resected Colorectal Tumors

Sonia Alcalá Gonzalo Serralta San Martín Marta Muñoz-Fernández de Legaria Juan Moreno‐Rubio Silvia Salinas

Cumulative incidence and incidence rate for relapse

10.1158/2767-9764.27152127

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Figure 2 from Autofluorescent Cancer Stem Cells: Potential Biomarker to Predict Recurrence in Resected Colorectal Tumors

Sonia Alcalá Gonzalo Serralta San Martín Marta Muñoz-Fernández de Legaria Juan Moreno‐Rubio Silvia Salinas

Expression of AF and CSC markers in different tumor entities. A, Representative flow cytometric plots depicting the percentage of CD133 cells in one colorectal cancer tumor and two kidney tumors. B, Representative flow cytometric plots depicting the percentage of CD90, CD133, SSEA1, and/or SSEA4 cells in colorectal cancer and stomach tumors. C, Representative flow cytometric plots depicting the percentage of CD90, EpCAM, and EpCAM/AF cells in colorectal cancer and kidney tumors.

10.1158/2767-9764.27152145

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