Revistas
Revista:
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
ISSN:
0306-5251
Año:
2023
Vol.:
89
N°:
2
Págs.:
727 - 736
Aims: We aimed to study the relation between pharmacokinetics (PK) and pharmacodynamics (PD) of docetaxel in early breast cancer and recommend a target exposure.
Methods: A PK/PD study was performed in 27 early breast cancer patients treated with doxorubicin and cyclophosphamide for 4 cycles followed by 4 cycles of docetaxel 75-100 mg/m2 infused every 21 days. Individual Bayesian estimates of docetaxel PK parameters were obtained using a nonparametric population PK model developed with data from patients with metastatic breast cancer who received dose-intensified docetaxel (300-350 mg/m2 ). Docetaxel area under the curve (AUC) and maximum concentration (Cmax) in each cycle and total cumulative AUC (AUCcum) were calculated and related to the incidence of adverse effects and tumour recurrence.
Results: Docetaxel clearance showed no change over the 4 treatment cycles, but a gradual increase in the volume of distribution was observed. One third of the patients had at least 1 dose reduction of docetaxel due to toxicity. The mean AUC, AUCcum and Cmax in patients showing docetaxel-associated adverse events were significantly higher than in patients free of toxicity (P < .05). Fatigue and decrease in haemoglobin and haematocrit levels were related to docetaxel AUC and Cmax and pain to AUC. AUC and Cmax >4.5 mg*h/L and 3.5 mg/L, respectively, were risk factors for docetaxel toxicity, while an AUC <4.5 mg*h/L was associated with tumour recurrence.
Conclusion: We report for the first time a relation between docetaxel exposure and toxicity and recommend specific targets of drug exposure with implications for the clinical management of early breast cancer patients.
Revista:
CANCERS
ISSN:
2072-6694
Año:
2022
Vol.:
14
N°:
12
Págs.:
2941
Simple Summary Left ventricular dysfunction (LVD) induced by anthracycline-based cancer chemotherapy (ACC) is becoming an urgent healthcare concern. Myocardial fibrosis (MF) may contribute to LVD after ACC. We show that elevated circulating levels of procollagen type I C-terminal propeptide (PICP, biomarker of MF) are associated with early subclinical LVD and predict later development of cardiotoxicity in patients treated with ACC. In addition, an association between PICP and LVD in patients with ACC-induced heart failure is observed. These results provide novel insights into MF as a mechanism underlying LVD after ACC, with PICP emerging as a promising tool to monitor cardiotoxicity in patients treated with ACC. Anthracycline-based cancer chemotherapy (ACC) causes myocardial fibrosis, a lesion contributing to left ventricular dysfunction (LVD). We investigated whether the procollagen-derived type-I C-terminal-propeptide (PICP): (1) associates with subclinical LVD (sLVD) at 3-months after ACC (3m-post-ACC); (2) predicts cardiotoxicity 1-year after ACC (12m-post-ACC) in breast cancer patients (BC-patients); and (3) associates with LVD in ACC-induced heart failure patients (ACC-HF-patients). Echocardiography, serum PICP and biomarkers of cardiomyocyte damage were assessed in two independent cohorts of BC-patients: CUN (n = 87) at baseline, post-ACC, and 3m and 12m (n = 65)-post-ACC; and HULAFE (n = 70) at baseline, 3m and 12m-post-ACC. Thirty-seven ACC-HF-patients were also studied. Global longitudinal strain (GLS)-based sLVD (3m-post-ACC) and LV ejection fraction (LVEF)-based cardiotoxicity (12m-post-ACC) were defined according to guidelines. BC-patients: all biomarkers increased at 3m-post-ACC versus baseline. PICP was particularly increased in patients with sLVD (interaction-p < 0.001) and was associated with GLS (p < 0.001). PICP increase at 3m-post-ACC predicted cardiotoxicity at 12m-post-ACC (odds-ratio >= 2.95 per doubling PICP, p <= 0.025) in both BC-cohorts, adding prognostic value to the early assessment of GLS and LVEF. ACC-HF-patients: PICP was inversely associated with LVEF (p = 0.004). In ACC-treated BC-patients, an early increase in PICP is associated with early sLVD and predicts cardiotoxicity 1 year after ACC. PICP is also associated with LVD in ACC-HF-patients.
Revista:
CLINICAL AND TRANSLATIONAL ONCOLOGY
ISSN:
1699-048X
Año:
2021
Vol.:
23
N°:
9
Págs.:
1934 - 1941
Background Pelvic recurrences from previously irradiated gynecological cancer lack solid evidence for recommendation on salvage. Methods A total of 58 patients were included in this clinical analysis. Salvage surgery was performed for locoregional relapse within previously irradiated pelvic area after initial surgery and adjuvant radiotherapy or radical external beam radiotherapy. The primary tumor diagnosis included cervical cancer (n = 47, 81%), uterine cancer (n = 4, 7%), and other types (n = 7, 12%). Thirty-three patients received adjuvant IOERT (1984-2000) at a median dose of 15 Gy (range 10-20 Gy) and 25 patients received adjuvant PHDRB (2001-2016) at a median dose of 32 Gy (range 24-40 Gy) in 6, 8, or 10 b.i.d. fractions. Results The median follow-up was 5.6 years (range 0.5-14.2 years). Twenty-nine (50.0%) patients had positive surgical margins. Grade >= 3 toxic events were recorded in 34 (58.6%) patients. The local control rate at 2 years was 51% and remained stable up to 14 years. Disease-free survival rates at 2, 5, and 10 years were 17.2, 15.5, and 15.5%, respectively. Overall survival rates at 2, 5, and 10 years were 58.1, 17.8, and 17.8%, respectively. Conclusions IOERT and PHDRB account for an effective salvage in oligorecurrent gynecological tumors. Patients with previous pelvic radiation suitable for salvage surgery and at risk of inadequate margins could benefit from adjuvant reirradiation in form of IOERT or PHDRB. However, the rate of severe grade >= 3 toxicity associated with the entire treatment program is relevant and needs to be closely counterbalanced against the expected therapeutic gain.
Revista:
BRITISH JOURNAL OF CANCER
ISSN:
0007-0920
Año:
2021
Vol.:
124
N°:
6
Págs.:
1138 - 1149
Background Adoptive immunotherapy with tumour-infiltrating lymphocytes (TIL) may benefit from the use of selective markers, such as PD-1, for tumour-specific T-cell enrichment, and the identification of predictive factors that help identify those patients capable of rendering tumour-reactive TILs. We have investigated this in ovarian cancer (OC) patients as candidates for TIL therapy implementation. Methods PD-1(-) and PD-1(+) CD8 TILs were isolated from ovarian tumours and expanded cells were tested against autologous tumour cells. Baseline tumour samples were examined using flow cytometry, multiplexed immunofluorescence and Nanostring technology, for gene expression analyses, as well as a next-generation sequencing gene panel, for tumour mutational burden (TMB) calculation. Results Tumour-reactive TILs were detected in half of patients and were exclusively present in cells derived from the PD-1(+) fraction. Importantly, a high TIL density in the fresh tumour, the presence of CD137(+) cells within the PD-1(+)CD8(+) TIL subset and their location in the tumour epithelium, together with a baseline T-cell-inflamed genetic signature and/or a high TMB, are features that identify patients rendering tumour-reactive TIL products. Conclusion We have demonstrated that PD-1 identifies ovarian tumour-specific CD8 TILs and has uncovered predictive factors that identify OC patients who are likely to render tumour-specific cells from PD-1(+) TILs.
Revista:
EUROPEAN JOURNAL OF GYNAECOLOGICAL ONCOLOGY
ISSN:
0392-2936
Año:
2020
Vol.:
41
N°:
6
Págs.:
906 - 912
Introduction: We aimed to analyze the outcome in a series of women with primary advanced ovarian cancer in an Intermediate Volume Hospital where new surgical and chemotherapy treatments were implemented over a period of 14 years. Material and Methods: One hundred and twenty-seven women with stage IIIB-IV disease underwent primary (76.4%) or interval debulking surgery (23.6%). Fifty-seven were operated on from 2000 to 2005 (Group 1) and 70 from 2006 to 2014 (Group 2). Results: No gross residual disease was achieved in 51.5% and 43.3% of women who underwent primary and interval surgery, respectively. For no gross and < 1cm residual disease, median overall and progression-free survival were 94.7 vs. 60.6 months (p = 0.001) and 25.3 vs. 20.0 months, respectively (p = 0.02). The rate of no gross residual (36.8 to 60.0%) and 5-yr median overall survival (56.3 to 73.7 months) increased between 2000-2005 (Group 1) and from 2006 to 2014 (Group 2). On multivariate analysis, interval surgery, multiple peritoneal implants and residual disease were predictive of overall and progression-free survival. Conclusions: Survival after primary and interval debulking surgery progressively correlates with decrease in residual disease. Increasing rates of successful primary surgery are possible through standardization and adoption of best practices without increasing morbidity.
Revista:
PUBLIC HEALTH NUTRITION
ISSN:
1368-9800
Año:
2020
Vol.:
23
N°:
17
Págs.:
3148 - 3159
Objective: Due to the growing interest in the role of dietary patterns (DPs) on chronic diseases, we assessed the association between a posteriori identified DPs in the Seguimiento Universidad de Navarra (SUN) Project - a prospective cohort study in a Mediterranean country - and breast cancer (BC) risk. Design: DPs were ascertained through a principal component analysis based on 31 predefined food groups. BC cases were initially identified through self-report or, if deceased, from death certificates or by notification by the next kin. Women reporting BC were asked to provide a copy of their medical report and diagnoses for confirmation purposes. We fitted Cox regression models to assess the association between adherence to the identified DPs and BC risk. Setting: Spanish university graduates. Participants: We included 10 713 young and middle-aged - mainly premenopausal - women. Results: After a median follow-up of 10 center dot 3 years, we identified 100 confirmed and 168 probable incident BC cases. We described two major DPs: 'Western dietary pattern' (WDP) and 'Mediterranean dietary pattern' (MDP). A higher adherence to a WDP was associated with an increased risk of overall BC (multivariable-adjusted HR for confirmed BC Q4 v. Q1 1 center dot 70; 95 % CI 0 center dot 93, 3 center dot 12; P for trend = 0 center dot 045). Contrarily, adherence to a MDP was inversely associated with premenopausal BC (multivariable-adjusted HR Q4 v. Q1 0 center dot 33; 95 % CI 0 center dot 12, 0 center dot 91). No significant associations were observed for postmenopausal BC. Conclusions: Whereas a higher adherence to the WDP may increase the risk of BC, a higher adherence to the MDP may decrease the risk of premenopausal BC.
Revista:
EUROPEAN JOURNAL OF GYNAECOLOGICAL ONCOLOGY
ISSN:
0392-2936
Año:
2020
Vol.:
41
N°:
4
Págs.:
523 - 530
Objective: Analyze the effect on survival of secondary cytoreduction surgery (SCS) in treatment of first recurrence platinum-sensitive epithelial ovarian cancer (REOC). Methods: Retrospective analysis of patients with first REOC who had platinum time-free interval (TFIp) > 6 months and were treated either with SCS followed by chemotherapy or chemotherapy only (CT). Clinical data such as patient's performance status and number of sites with metastases were specifically assessed. The primary endpoint was overall survival (OS). Results: Seventy-one patients were treated either by SCS (n = 37) or CT (n = 34). Complete resection after SCS was achieved in 89% of patients. After a median follow-up of 51.2 months, median OS, and progression-free survival (PFS) were 68.2 and 21.6 months, respectively, for the whole series of the SCS patients had better survival and disease progression survival than the CT only patients (HR: 0.33, 95% CI: 0.17-0.6; p= 0.001) and (HR: 0.28, 95% CI: 0.15-0.5; p= 0.001), respectively. TFIp < 12 months and multiple metastases were most important prognostic factors for risk of death (HR: 7.7 and 6.2, respectively) and recurrence (HR: 5.8 and 3.8, respectively). Probability to undergo successful SCS is related to oligometastatic disease and no residual disease after first surgery (OR: 30.0 and 5.9, respectively). Conclusions: In women with REOC oligometastatic disease and no residual disease at first surgery are associated with successful SCS. In these patients oligometastatic disease and long platinum TFI are associated with improved probability of survival.
Revista:
CLINICAL NUTRITION
ISSN:
0261-5614
Año:
2019
Vol.:
38
N°:
54
Págs.:
2259 - 2268
Background & aims: Breast cancer (BC) is the most commonly diagnosed cancer, and diet is suspected to play a role in its development. Dietary factors may mediate this process through modulation of inflammation, though findings from previous studies have not been consistent. We aimed to longitudinally assess the association between the dietary inflammatory index (DII (R)), a frequently used method to assess the inflammatory potential of the diet, and incident BC. Methods: We included 10,713 middle-aged, Spanish female university graduates from the SUN cohort. DII (R) scores were derived from a validated 136-item food-frequency questionnaire, and it was based on scientific evidence on the relationship between diet and inflammatory biomarkers. Diagnosis of BC was reported by the participant or, if deceased, by the next of kin or identified from death certificates. Self-reports of BC were confirmed by revision of medical reports by an experienced oncologist. Cox proportional hazard models were used to estimate multivariable-adjusted hazard ratios (HR) and 95% confidence intervals (CI) for the association between quartiles of DII (R) and incident BC. Results: After 10.3 years of median follow-up, we identified 100 confirmed and 168 probable incident BC cases. The multivariable-adjusted HR for participants in the 4th quartile to the 1st quartile was 1.44 (95% CI 0.76-2.72; p-trend: 0.339) when confirmed cases were analyzed, and 1.20 (95% CI 0.72-1.99; p-trend: 0.757) for the probable cases. We neither observed statistically significant differences in regard to menopausal status. Conclusions: The apparent increase in risk between DII (R) scores and BC in our cohort was not statistically significant, which could be partly explained by the small number of observed cases. (C) 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Revista:
BRITISH JOURNAL OF NUTRITION
ISSN:
0007-1145
Año:
2019
Vol.:
122
N°:
5
Págs.:
542 - 551
Polyphenols are a wide family of phytochemicals present in diverse foods. They might play a role in cancer development and progression. In vivo and in vitro studies have suggested beneficial properties and potential mechanisms. We aimed to evaluate the association between total and main classes of polyphenol intake and breast cancer (BC) risk in the Seguimiento Universidad de Navarra project - a prospective Mediterranean cohort study. We included 10 713 middle-aged, Spanish female university graduates. Polyphenol intake was derived from a semi-quantitative FFQ and matching food consumption data from the Phenol-Explorer database. Women with self-reported BC were asked to return a copy of their medical report for confirmation purposes; death certificates were used for fatal cases. Cox models were fitted to estimate multivariable-adjusted hazard ratios (HR) and 95 % CI for the association between tertiles (T) of polyphenol intake and BC. After 10 center dot 3 years of median follow-up, 168 probable incident BC cases were identified, out of which 100 were confirmed. We found no association between polyphenol intake and the overall BC risk. Nevertheless, we observed a significant inverse association between total polyphenol intake and BC risk for postmenopausal women, either for probable or only for confirmed cases (HRT3 v. T1 0 center dot 31 (95 % CI 0 center dot 13, 0 center dot 77; P-trend=0 center dot 010)). Also, phenolic acid intake was inversely associated with postmenopausal BC. In summary, we observed no significant association between total polyphenol intake and BC risk. Despite a low number of incident BC cases in our cohort, higher total polyphenol intake was associated with a lower risk of postmenopausal BC.
Revista:
BRACHYTHERAPY
ISSN:
1538-4721
Año:
2018
Vol.:
17
N°:
5
Págs.:
734 - 741
PURPOSE: To determine the long-term results of a Phase II trial of perioperative high-dose-rate brachytherapy (PHDRB) in primary advanced or recurrent gynecological cancer. METHODS AND MATERIALS: Fifty patients with locally advanced and recurrent gynecological cancer suitable for salvage surgery were included. Unirradiated patients (n = 25) received preoperative chemoradiation followed by surgery and PHDRB (16-24 Gy). Previously irradiated patients (n = 25) received surgery and PHDRB alone (32-40 Gy). RESULTS: Median followup was 11.5 years. Eight unirradiated patients (32%) developed Grade >= 3 toxic events including two fatal events. Local and locoregional control rates at 16 years were 87.3% and 78.9%, respectively. Sixteen-year disease-free and overall survival rates were 42.9% and 46.4%, respectively. Ten previously irradiated patients (40.0%) developed Grade >= 3 adverse events, including four fatal events. Local and locoregional control rates at 14 years were 59.6% and 42.6%, respectively. Fourteen-year disease-free and overall survival rates were 16.0% and 19.2%, respectively. CONCLUSIONS: PHDRB allows effective salvage of a subset of unfavorable gynecological tumors with high-risk surgical margins. Toxicity was unacceptable at the initial dose levels but deescalation resulted in the absence of severe toxicity without a negative impact on locoregional control. A substantial percentage of patients remain alive and controlled at >10 years including a few previously irradiated cases with positive margins. (C) 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
Revista:
BRACHYTHERAPY
ISSN:
1538-4721
Año:
2018
Vol.:
17
N°:
6
Págs.:
1045
Autores:
Isabel Martinez-Fernandez, Maria; Legaspi Folgueira, Jairo; Valtuena Peydro, German; et al.
Revista:
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
ISSN:
1525-1438
Año:
2016
Vol.:
26
N°:
6
Págs.:
1162-1168
Revista:
BRACHYTHERAPY
ISSN:
1538-4721
Año:
2016
Vol.:
15
N°:
4
Págs.:
485 - 494
Purpose: To assess the safety, feasibility, and efficacy of free-hand intraoperative multicatheter breast implant (FHIOMBI) and perioperative high-dose-rate brachytherapy (PHDRBT) in early breast cancer. Methods and Materials: Patients with early breast cancer candidates for breast conservative surgery (BCS) were prospectively enrolled. Patients suitable for accelerated partial breast irradiation (APBI) (low or intermediate risk according GEC-ESTRO criteria) received PHDRBT (3.4 Gy BID × 10 in 5 days). Patients not suitable for APBI (high risk patients according GEC-ESTRO criteria) received PHDRBT boost (3.4 Gy BID × 4 in 2 days) followed by whole breast irradiation. Results: From June 2007 to November 2014, 119 patients were treated and 122 FHIOMBI procedures were performed. Median duration of FHIOMBI was 25 minutes. A median of eight catheters (range, 4-14) were used. No severe intraoperative complications were observed. Severe early postoperative complications (bleeding) were documented in 2 patients (1.6%), wound healing complications in 3 (2.4%), and infection (mastitis or abscess) in 2 (1.6%). PHDRBT was delivered as APBI in 88 cases (72.1%) and as a boost in 34 (27.8%). The median clinical target volume T was 40.8 cc (range, 12.3-160.5); median D90 was 3.32 Gy (range, 3.11-3.85); median dose homogeneity index was 0.72 (range, 0.48-0.82). With a median followup of 38.4 months (range, 8.7-98.7) no local, elsewhere, or regional relapses were observed; there was only one distant failure in PHDRBT boost. No major (acute or late) RTOG grade 3 or higher were documented in any of the 119 patients treated with PHDRBT. Cosmetic outcome in APBI patients was excellent or good in (87.0%) and fair or poor in (11.9%) while in boost patients was excellent or good in (76.4%) and fair in (23.5%). Conclusion: The FHIOMBI-PHDRBT program does not add complications to conservative surgery. It allows precise selection of APBI patients and offers excellent results in disease control and cosmetics. It also offers logistic advantages because it dramatically shortens the time of local treatment and avoids further invasive procedures.
Revista:
MINERVA CHIRURGICA
ISSN:
1827-1626
Año:
2015
Vol.:
70
N°:
6
Págs.:
495 - 498
Revista:
ANNALS OF ALLERGY ASTHMA AND IMMUNOLOGY
ISSN:
1081-1206
Año:
2015
Vol.:
114
N°:
6
Págs.:
534-5
Revista:
JOURNAL OF NEURO-ONCOLOGY
ISSN:
1573-7373
Año:
2013
Vol.:
115
N°:
3
Págs.:
429 - 435
Interesting neurological and cytological response rates after intrathecal (i.t) liposomal cytarabine have been observed in patients with leptomeningeal carcinomatosis (LMC) from solid tumors. However, the potential use of those responses as early predictors of time-to-progression (TTP) and overall survival (OS) is unexplored. 27 consecutive patients with LMC treated with 50 mg i.t liposomal cytarabine under compassionate drug use were retrospectively studied. All patients received i.t treatment every 2 weeks during induction and every 4 weeks during maintenance periods. Neurological and cytological responses were assessed before every liposomal cytarabine cycle. Most of the patients were female (17/27) diagnosed with breast cancer (15/27). A complete neurological response was seen among 11 % of the patients; partial response in 22 % of the patients; stable disease in 30 % of the patients and progressive disease in 37 % of them. Cytological assessment was available in 11/27 patients showing a 26 % complete response rate. The median time to neurological and cytological response was 15 days and 14 days, respectively. Patients showing a combined neurological and cytological response showed a significantly longer median TTP (122 vs. 3 days; p = 0.001) and OS (141 vs. 3 days; p = 0.002) compared to those showing both neurological and cytological progression. No grade 4 toxicities were recorded. According to these preliminary results, early neurological and cytological responses may be further studied as early predictors of TTP and OS in patients receiving i.t liposomal cytarabine for LMC.
Revista:
ONCOLOGY LETTERS
ISSN:
1792-1074
Año:
2011
Vol.:
2
N°:
5
Págs.:
807-9
We report a novel BRCA1 germline 4156delAA mutation detected in a 41-year-old woman with breast and ovarian cancer. Genomic DNA was obtained from peripheral blood. Standard polymerase chain reactions and direct sequencing were performed.
Revista:
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
ISSN:
1048-891X
Año:
2010
Vol.:
20
N°:
1
Págs.:
133 - 140
Objectives: This study was undertaken to determine the tolerability of a 7-week schedule of external beam radiation therapy, high-dose-rate brachytherapy, and weekly cisplatin and paclitaxel in patients with locally advanced carcinoma of the cervix. Methods: Twenty-nine patients with International Federation of Gynecology and Obstetrics stages IB2 to IVa cervical cancer were treated with 40 mg/m2 per week of intravenous (i.v.) cisplatin and 50 mg/m2 per week of i.v. paclitaxel combined with 45 Gy of pelvic external beam radiation therapy and 30 Gy of high-dose-rate brachytherapy. Results: Eleven patients (37.9%) were able to complete the 6 scheduled cycles of chemotherapy. The median number of weekly chemotherapy cycles administered was 5 (range, 2-7). Thirty-five (20.1%) of 174 cycles of chemotherapy were not given because of toxicity. The median dose intensity of cisplatin was 31 mg/m2 per week (95% confidence interval [CI], 25.2-36.8); that of paclitaxel was 44 mg/m2 per week (95% CI, 39.9-48.3). Twenty-two patients (78.6%) were able to complete the planned radiation course in less than 7 weeks. Median radiation treatment length was 45 days (95% CI, 43.4-46.6). After a median follow-up of 48 months, 7 patients (24.1%) experienced severe (Radiation Therapy Oncology Group grade 3 or higher) late toxicity. No fatal events were observed. Seven patients have failed, 1 locally and 6 at distant sites. The 8-year local/pelvic control rate was 95.7%, and the 8-year freedom from systemic failure rate was 76.1%. Eight-year actuarial disease-free survival and overall survival were 63.1% and 75.9%, respectively. Conclusions: This study demonstrated unacceptable toxicity of combining the stated doses of concurrent cisplatin and paclitaxel chemotherapy with definitive radiotherapy for patients with advanced cervical cancer. Additional phase I/II trials are recommended to clearly establish the recommended phase II dose for these drugs.
Revista:
CANCER CHEMOTHERAPY AND PHARMACOLOGY
ISSN:
0344-5704
Año:
2010
Vol.:
65
N°:
3
Págs.:
457 - 465
Purpose
Capecitabine is effective against metastatic breast cancer (MBC). We hypothesized that sequential treatment with dose-dense epirubicin/cyclophosphamide (EC) and docetaxel/capecitabine would be active and tolerable in the adjuvant/neoadjuvant setting.
Methods
In this prospective phase II clinical trial patients with HER2-negative and node-positive or locally advanced tumors were eligible to receive four cycles of EC (100/600 mg/m2) every 2 weeks with G-CSF on days 3¿10, followed by four cycles of docetaxel/capecitabine (75/1,000 mg/m2 b.i.d., days 1¿14) every 3 weeks.
Results
Fifty-five patients were enrolled with median age of 49, and 80% had hormone receptor-positive disease. The median tumor size was 2.5 cm, with a median of two axillary nodes involved. Seventy-five percent of the first 20 patients had grade 2/3 hand-foot syndrome (HFS). Dose reduction of capecitabine to 800 mg/m2 reduced the grade 2/3 HFS incidence to 31% in the remaining patients. No grade 4/5 toxicities were observed. All 20 patients treated preoperatively responded, with 5 (25%) pathologic complete responses and 3 additional pT0N1 tumors. At a median follow-up of 48 (range 28¿60) months, the event-free and overall survival rates are 91 and 98%, respectively.
Conclusions
Sequential treatment with dose-dense EC followed by docetaxel/capecitabine, using a lower capecitabine dose than that approved for MBC, has an acceptable toxicity profile and encouraging activity when used as neoadjuvant or adjuvant treatment of breast cancer.
Nacionales y Regionales
Título:
Utilización de datos genómicos para generar una vacuna contra el cáncer (BLANCA: Breast Long non coding ANti-Cancer Antigens)
Código de expediente:
0011-1411-2021-000103
Investigador principal:
Marta Santisteban Eslava
Financiador:
GOBIERNO DE NAVARRA
Convocatoria:
2021 GN PROYECTOS ESTRATEGICOS DE I+D 2021-2024
Fecha de inicio:
15/04/2021
Fecha fin:
31/12/2023
Importe concedido:
85.358,50€
Otros fondos:
-
Título:
Aplicaciones del estudio multi-ómico de la microbiota al desarrollo de soluciones biotecnológicas innovadoras en el área de la salud (microBiomics)
Código de expediente:
0011-1411-2021-000106
Investigador principal:
María Teresa Herráiz Bayod
Financiador:
GOBIERNO DE NAVARRA
Convocatoria:
2021 GN PROYECTOS ESTRATEGICOS DE I+D 2021-2024
Fecha de inicio:
15/04/2021
Fecha fin:
31/12/2023
Importe concedido:
366.577,17€
Otros fondos:
-
Título:
Plataforma para la Identificación de TCR Específicos de Antígenos Tumorales para la Inmunoterapia de Tumores Sólidos (PITAGORAS)
Código de expediente:
0011-1411-2023-000107
Investigador principal:
Ascensión López Díaz de Cerio
Financiador:
GOBIERNO DE NAVARRA
Convocatoria:
2023 GN PROYECTOS ESTRATEGICOS DE I+D 2023-2026
Fecha de inicio:
01/07/2023
Fecha fin:
31/12/2025
Importe concedido:
474.228,40€
Otros fondos:
-
Título:
Expanded LifeBreast trial: long-term lifestyle changes may improve the prognosis of breast cancer
Código de expediente:
PI22/00828
Investigador principal:
Estefanía Ainhoa Toledo Atucha
Financiador:
INSTITUTO DE SALUD CARLOS III
Convocatoria:
2022 AES Proyectos de investigación
Fecha de inicio:
01/01/2023
Fecha fin:
31/12/2025
Importe concedido:
136.004,00€
Otros fondos:
-
Título:
Explotación de la vía adenosinérica con la radioinmunoterapia en el cáncer de mama triple negativo.
Código de expediente:
PI22/01506
Investigador principal:
Rafael Martínez Monge
Financiador:
INSTITUTO DE SALUD CARLOS III
Convocatoria:
2022 AES Proyectos de investigación
Fecha de inicio:
01/01/2023
Fecha fin:
31/12/2025
Importe concedido:
147.620,00€
Otros fondos:
-
Título:
Estilos de vida y cáncer de mama - Ensayo LifeBreast
Código de expediente:
PI18/00631
Investigador principal:
Estefanía Ainhoa Toledo Atucha
Financiador:
INSTITUTO DE SALUD CARLOS III
Convocatoria:
AES2018 PI
Fecha de inicio:
01/01/2019
Fecha fin:
30/06/2023
Importe concedido:
140.360,00€
Otros fondos:
Fondos FEDER