Maria Carmen Álamo de la Gala

Hospital Universitario Virgen Macarena

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Nicola Maurea

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Carlo G. Tocchetti

Federico II University Hospital

Pedro Sánchez‐Rovira

GEICAM – Spanish Breast Cancer Group

C. Arra

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Carmela Coppola

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Rosario Dueñas García

Complejo Hospitalario de Jaén

Claudia De Lorenzo

University of Naples Federico II

Alejandro Falcón

Hospital Universitario Virgen del Rocío

David Fernández Garay

Spanish Society of Hematology and Hemotherapy

Giuseppe Palma

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Cooperative Institutions

Complejo Hospitalario de Jaén

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Instituto de Investigación Biomédica de Málaga

GEICAM – Spanish Breast Cancer Group

Hospital Universitario Virgen del Rocío

Hospital Clínico Universitario Virgen de la Victoria

University of Naples Federico II

Centro de Investigación Biomédica en Red de Cáncer

Hospital Clínic de Barcelona

Hospital Universitario Virgen Macarena

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Chemotherapy effectiveness in the treatment of non-medullary well-differentiated thyroid cancer: A systematic review.

Journal of Clinical Oncology (2015)

Ana Alberto Tamarit Esther MartÃÂn Alberto Torres Teresa GarcÃÂa Manrique Maria Carmen Álamo de la Gala

e17058 Background: Nowadays, the use of chemotherapy in the well-differentiated non medullary thyroid cancer, locally advanced stage and/or with radioiodine refractory metastases (Advanced CDT) is considered of scanty value. However, in the last 40 years was not published any phase III study nor a systematic review of its use in clinical setting. Methods: A systematic literature search was performed in databases such as Medline and Embase, among others. Two independent reviewers analyzed the articles selected full text, made a critical reading and extracted results using forms designed specifically. A qualitative synthesis of the results was performed and the accumulated data were calculated. Results: Of 509 references identified by searching the database, sixteen studies with 473 patients published in the last 40 years were included. Four studies included only patients with well-differentiated tumors. The overall response rate was 22.5% (between 0-57%) with a 2.5% complete responses and a clinical benefit (BC) in 51% (19-93 %) of cases. In addition, unlike modern studies a performance status > 2 was described in about 40% of patients. Five studies published individual survival data from 54 patients with advanced CDT: the median survival was estimated at 18 months (95% CI 0 to 37.5), with significant differences between patients treated before 2000 versus patients treated later (7 vs 41 months, P < 0.00) Overall survival time was unable to assess due to lack of data and the heterogeneity of the included studies. However, these data must be interpreted with caution because of the high risk of bias detected. Conclusions: Although it has not been able to find firm evidence on the effectiveness of chemotherapy, the results shown seems to have some efficacy, therefore, it could be necessary to be tested in well-designed studies versus or in combination with new therapies.

Medullary Thyroid Cancer

10.1200/jco.2015.33.15_suppl.e17058

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Real-world experience with pertuzumab and trastuzumab combined with chemotherapy in neoadjuvant treatment for patients with early-stage HER2-positive breast cancer: the NEOPERSUR study

Clinical & Translational Oncology (2024)

Alejandro Falcón Josefina Cruz Jurado E. Llabrés Valentí Rocío Urbano Cubero Maria Carmen Álamo de la Gala

HER2-targeted therapies have dramatically improved outcomes of patients with HER2-positive breast cancer (BC), as demonstrated in neoadjuvant trials. This study aims to provide real-world evidence on the use and effectiveness of combined pertuzumab, trastuzumab and chemotherapy (CT) in early-stage HER2-positive BC.

Pertuzumab

Taxane

Lapatinib

Neoadjuvant Therapy

Carboplatin

Breast-conserving surgery

Clinical endpoint

10.1007/s12094-024-03440-5

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The ErbB2-antibody 2C4 and cardiac dysfunction in mice.

Journal of Clinical Oncology (2011)

Nicola Maurea Carlo G. Tocchetti Carmela Coppola Gianluca Ragone Andréa Barbieri

e11040 Background: Anti-ErbB2 therapies are associated with increased risk of left ventricular (LV) dysfunction. Trastuzumab increases the frequency of asymptomatic decrease in LV ejection fraction (LVEF) by 3-18%, and the risk of heart failure (HF) by 2-4%. The newer ErbB2 antibody rhuMAb 2C4 (pertuzumab) seems to affect ligand induced ErbB signaling in a more direct fashion, affecting EGFR/ErbB2 dimerization; yet, its cardiac side effects are only beginning to emerge. Here, we test whether the murine 2C4 induces cardiac dysfunction in normal mice. Methods: In vivo cardiac function was measured with LV fractional shortening (FS) by M-mode echocardiography in sedated C57BL/6 mice (2-4 mo. old) at day 0, and after 2 and 6 days of daily i.p. administration of 2C4 (2.25 μg/g/day) or doxorubicin (Doxo, 2.17 μg/g/day) as a positive control, and in sham animals. With Speckle Tracking echocardiography (ST) we also evaluated radial myocardial strain (%), a very sensitive parameter which can predict LV dysfunction. Results: After 2 days, FS was reduced with 2C4: 58±1%, p=.01 vs sham (60±0.4%). The reduction in FS obtained with Doxo was even larger: 52±0.2%, p=.0000001 vs sham, p=.00004 vs 2C4. Myocardial strain was similarly reduced in both 2C4 (40±8%) and Doxo-treated mice (43±3%) compared to sham (66±0.6%; p=.02 vs 2C4, and p=.0005 vs Doxo). After 6 days, LV dysfunction was exacerbated, with FS further reduced to similar values by 2C4 (39±5%) and Doxo (46±2%, p=NS vs 2C4; both p<.05 vs sham and vs 2 days), and strain decreased to 31±7% (2C4) and 40±7% (Doxo, p=NS vs 2C4; both p=.01 vs sham and p=NS vs 2 days). Conclusions: The murine ErbB2 antibody 2C4 is cardiotoxic in mice. The reduction in FS is milder than Doxo early at 2 days, but comparable to Doxo after 6 days. The clear mechanisms of anti ErbB2-induced cardiotoxicity are to be elucidated. Further studies will be crucial to establish the cardiotoxic mechanisms of ErbB2-antagonists, and to influence the design of future anticancer therapies in an attempt to retain anticancer effects, while minimizing cardiac toxicity. We also plan to apply speckle tracking echocardiography to clinical studies, in order to evaluate the impact of early identification of ErbB2-blockers cardiotoxicity in the treatment of women with breast cancer.

Pertuzumab

10.1200/jco.2011.29.15_suppl.e11040

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Observational cross-sectional study evaluating the sociodemographic and clinical characteristics of patients with metastatic melanoma harboring a BRAF V600 mutation, treated with cobimetinib and vemurafenib based on routine clinical practice.

Journal of Clinical Oncology (2020)

Maria Carmen Álamo de la Gala Sebastián Ochenduszko Guillermo Crespo Mónica Corral J.M. Oramas Rodriguez

e22028 Background: The drug combination of BRAF inhibitors with MEK inhibitors delays the onset of resistance and enhances apoptosis. Objectives: The main objective was to evaluate the percentage of long responders to the combination therapy. Methods: Participants were patients with advanced melanoma harboring a BRAF V600 mutation, who received Cobimetinib + Vemurafenib as first line, and who started treatment at least 12 months before inclusion. Patients were classified as long responders (patients who have reached at least 12 months of objective response -complete response CR/ partial response PR- to the treatment) or non-responders. Sociodemographic, anthropometric, clinical characteristics, baseline tumor characteristics and treatment dose modification were compared between long responders and non-responders. HADS scale, WPAI-GH and SMAQ questionnaires were used to evaluate the anxiety and depression, productivity and treatment compliance respectively, in patients under active treatment at the moment of the study visit. Results: 41 patients were evaluated. Mean (±SD) age was 57.8 (14.0) years. 56.1% were male. Almost one third of the population (29,3%) was classified as long responder. There were no statistically significant differences in the baseline tumor characteristics, demographic data nor in the clinical characteristics neither in treatment dose modification. CR was the best response achieved by 29.3% of patients, 46.3% achieved PR and 12.2% SD (stable disease). Mean of time to response was 6.9 months for CR patient, and 3.3 and 2.2 months for PR and SD patients respectively. Mean of duration of response was 9.4 months for CR patients, and 10.1 and 9.5 months for PR and SD patients respectively. 42.5% of Adverse Events (AEs) were related with the combination treatment. In the 68.5% of AEs the severity was mild, and in 19.4% moderate. In most cases no action was taken (74.9%) and the outcome was recovered (83.4%). Conclusions: Vemurafenib and Cobimetinib have an important impact in long term survival, leading to a steady complete response in one third of the patients.

10.1200/jco.2020.38.15_suppl.e22028

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A metabolomic signature for predicting chemosensitivity in gastric cancer.

Journal of Clinical Oncology (2017)

Francisco José García Verdejo A.L. Ortega Granados Caridad Díaz Natalia Luque David Fernández Garay

e15504 Background: Perioperative chemotherapy (QT) with platinum and fluoropyrimidines with or without anthracyclines is recommended option in patients with resectable gastric cancer (GC) at least cT2 or nodal involvement. Another option is surgery followed by QT with radiotherapy (QT/RT) or QT without RT in patients with D2 lymphadenectomy. Unfortunately, a considerable percentage of patients progress during neoadjuvant-QT (neo-QT) and some cases become inoperable cancer. These patients could benefit from curative surgery after diagnosis without neo-QT. Currently, histological/molecular markers have not been established to predict which patients can benefit from neo-QT. As potent analysis method, study of blood metabolites of resectable GC patients to establish a profile to differentiate responder patients (R-P) or not-responder (NR-P) to neoadjuvant-QT is promising. To establish a metabolomic profile or metabolomic signature and correlate with chemosensitivity, defined as pathological and clinical response is our endpoint. Methods: To this end we performend an untargeted metabolomic analysis by LC-HRMS of serum samples from resectable GC patients before neo-QT (n = 20 vs n = 10 healthy controls). Chemosensitive tumors were defined as those with good pathological response (Mandard 1 or 2) and partial response by TAC and chemoresistance tumors, defined as those with poor pathological response (Mandard 5) or/and progression by TAC. Reverse phase and HILIC chromatographic modes were applied to deal with highly polar as well as hydrophobic as required for untargeted metabolomics. For identification of potential biomarkers, we used in combination 2 independent variable selection techniques: principal component analysis and Student t test. Results: 11 patients were R-P and 9 patients were NR-P. We observed differences in metabolic profile between patients with GC & healthy controls and R-P & NR-P to neo-QT. Seven identified metabolites contributed most to the differentiating between R-P and NR-P. Conclusions: There are different metabolomic phenotypes among patients R-P and NR-P to neo-QT. It is necessary to validate a metabolomic signature to allow effective chemosensitivity prediction in patients with resectable GC.

10.1200/jco.2017.35.15_suppl.e15504

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Different pCR rates according PAM50 defined subtypes in HER2 positive early breast cancer treated with neoadjuvant pertuzumab and trastuzumab.

Journal of Clinical Oncology (2018)

Tamara Díaz-Redondo Rocío Lavado-Valenzuela Begoña Jiménez Rodríguez TomÃ¡s Pascual Fernando Gálvez Montosa

e12634 Background: We aim to compare the benefit of adding pertuzumab (P) to the standard neoadjuvant treatment with trastuzumab (T) in patients (pt) with early immunohistochemically (IHC) defined HER2+ breast cancer (BC) in the different intrinsic molecular subtypes defined by PAM50 gene expression analysis. Methods: 219 pt. with IHC HER2+ BC, stage I-IIIC, diagnosed in 8 Spanish hospitals were consecutively treated with neoadjuvant chemotherapy (NAC) + antitargeted HER2 therapy. Cohort A (n128) received NAC+T and Cohort B (n91) received NAC+T+P. Patients were classified into intrinsic molecular subtypes based on the PAM50 signature. Rate of pathologic complete response in breast and axilla (pCR) in the different subtypes was compared by ChiSquared test. A multivariate logistic regression model was used to analyze the potential effects of the covariates over the pCR rates. Results: Characteristics of the patients and intrinsic molecular subtypes are shown in Table 1. The overall pCR rate was significantly higher in cohort B vs A (66%vs39%, p = 0,0002). The pCR rate in the HER2E was 50% for T and 77% for T+P (p = 0,002) and 11% for T and 54% for T+P (p = 0.0007) in Luminals. In the multivariate analysis, the improvement pCR rates was highly associated with cohort (p = 0.00015, OR:3.22) and was not related to clinicopathologic covariates (p > 0.05). These results were confirmed for the HER2E subtype (p = 0.00168, OR:3.11) and more strongly for Luminals (p = 0.0045, OR:23.35). Conclusions: The highest pCR was reached by the PAM50 HER2E patients treated with T+P. In Luminal subtype the improvement of pCR is strongly associated with the used of pertuzumab and this association is independent of clinical covariates. Table 1. Clinicopathologic characteristics of pt T+NCT (n128) T+P+NCT (n91) Median age (range) 52 (29-83) 51 (30-77) n (%) n (%) Ki67 < 14% 11 (9) 4 (4) 15-50% 58 (45) 61(67) > 50% 24(19) 22 (24) Unk 35(27) 4 (4) HR + 89 (70) 56 (62) - 39 (30) 35 (38) PAM50 Sub HER2E 88 (69) 53 (58) Lum B 19 (15) 15 (17) Lum A 16 (12) 13 (14) Basal like 2 (2) 10 (11) Normal like 3 (2) 0 T T1 23 (18) 12 (13) T2 75 (59) 50 (55) T3 12 (9) 19 (21) T4 10 (8) 10 (11) Tx 8 (6) Node - 54 (42) 31 (34) + 74 (58) 60 (66)

Pertuzumab

10.1200/jco.2018.36.15_suppl.e12634

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The anticancer mTOR-inhibitor temsirolimus induces cardiac dysfunction in mice

Carlo G. Tocchetti Carmela Coppola Cristina Quintavalle Anna Barbieri Daniel Rea

Temsirolimus

Cardiac Dysfunction

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P114 The anti-neoplastic ErbB2-antibody 2C4 produces left ventricular dysfunction in murine hearts

The Breast (2011)

Carlo G. Tocchetti Carmela Coppola Gianluca Ragone Andréa Barbieri Daniel Rea

10.1016/s0960-9776(11)70058-3

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Differences in survival between usual practice and clinical trial participants in advanced NSCLC by age.

Journal of Clinical Oncology (2017)

A.L. Ortega Granados Nuria Cárdenas Quesada Capilla de la Torre Cabrera Mónica Fernández Navarro María Ruiz Sanjuan

e20515 Background: It is known that outcome of patients included in clinical trials have a better outcome than patients treated with standard therapy. This is a retrospective case-control study of outcome of patients with stage III and IV non-small cell lung cáncer (NSCLC) recruited in clinical trials vs advanced NSCLC patients in usual clinical practice in our institution. Methods: We performed a case-control study matching all patients participating in trials with chemotherapy and/or TKis (immunotherapy was not included) in a 5 year period (January 2010-November 2014) in 1 st line setting, matching them in a ratio 1:2 with individuals in usual clinical practice. There were 36 patients in trials and 72 patients treated by our protocol. Cases were matched by age ( < 65 and > 65), histology (adenocarcinoma and squamous), EGFR status (mutated and wild-type). All patients were WHO performance status 0-1. Results: Patients in each group were matched for stage, histological subtype, previous surgery and systemic therapy. Median follow up for patients treated on a trial was 3.3 years, compared with 2.9 years for matched patients who received standard 1 st line therapy. Median overall survival for patients included a trial was 19.6 months, and 15.7 months for control group. The difference between groups was not significant (Log rank test, HR 0.81, 95% CI: 0.42 to 1.30, p = 0.53). Median overall survival in younger patients in trials ( < 65) was 19.3 months, and in elderly patients was 19.8 months. The median progression-free survival in the two groups was 6.8 and 5.5 months respectively (HR 0.72, 95% CI 0.30 to 1.43, p = 0.21). Conclusions: In our institution, we didn’t found significant differences for overall survival or progression-free survival, but there is a trend for a better outcome for those items. Benefit seems to be similar in younger patients than in older patients, so this encourages recruiting of selected elderly patients.

Performance status

10.1200/jco.2017.35.15_suppl.e20515

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