Gimeno-Morales, M. (Marta)

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    Long-term results of intraoperative multicatheter breast implant (IOMBI) for accelerated partial breast irradiation (APBI) on early breast cancer patients
    (Elsevier, 2024) Martinez-Monge, R. (Rafael); Blanco, J. (Javier); Martinez-Regueira, F. (Fernando); Rodriguez-Spiteri, N. (Natalia); Jablonska, P.A. (Paola Anna); Elizalde, A. (Arlette); Pina-Insausti, L. (Luis); Abengozar-Muela, M. (Marta); Cambeiro, M. (Mauricio); Olartecoechea, B. (Begoña); Gimeno-Morales, M. (Marta); Ramos, L. (Luis); Martínez-Lage, A. (Adriana)
    Background and purpose: Multicatheter breast brachytherapy is a standard technique for accelerated partial breast irradiation (APBI) in early breast cancer patients. Intraoperative multicatheter breast implant (IOMBI) followed by perioperative high-dose-rate brachytherapy (PHDRBT) offers a novel and advantageous approach. We present long-term oncological, toxicity, and cosmesis outcomes for a well-experienced single institution. Materials and methods: Eligible women aged ≥ 40 years with clinically and radiologically confirmed unifocal invasive or in situ ≤ 3 cm breast tumors underwent IOMBI during breast-conserving surgery. Patients meeting APBI criteria by definitive pathologic results received 3.4 Gy × 10fx with PHDRBT. Patients not suitable for APBI received PHDRBT-boost followed by WBRT. Results: A total of 171 patients underwent IOMBI during BCS, 120 patients (70.1 %) were suitable for APBI and 51 (29.8 %) for anticipated PHDRBT-boost. The median age was 61 years (range: 40-78), the median tumor size was 1.1 cm (range: 0.2-3.5), with a histological diagnosis of invasive ductal carcinoma in 78.9 % and ductal in situ in 21.1 %. A median of 9 catheters (range: 4-14) were used. For APBI, the median CTV and V100 were 40.8 cc (range: 8.6-99) and 35.4 cc (range: 7.2-94). The median of healthy breast tissue irradiated represents 7.2 % (range: 2.3-28 %) and the median local treatment duration was 10 days (range: 7-16). With a median follow-up of 8.8 years (range: 0.3-16.25), the 8-year local, locoregional, and distant control rates were 99 %, 98.1 %, and 100 %. G1-G2 late-toxicity rate was 53.4 %. Long-term cosmetic evaluation was excellent-good in 90.8 %. Conclusion: IOMBI&PHDRBT program reports excellent long-term oncological outcomes, with a reduction from unnecessary irradiation exposure which translates into low long-term toxicity and good cosmesis outcomes, especially on well-selected APBI patients.
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    Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease
    (Elsevier, 2020) Gil-Bazo, I. (Ignacio); Aristu-Mendioroz, J.J. (José Javier); Domínguez-Echávarri, P.D. (Pablo Daniel); Martín-Pastor, S.M. (Santiago Mariano); Arbea-Moreno, L. (Leire); Ramos, L.I. (Luis Isaac); Martín-Pastor, M. (Manuel); Jablonskaa, P.A. (Paola Anna); Serrano-Tejero, D. (Diego); Gimeno-Morales, M. (Marta); Calvo-González, A. (Alfonso); Moreno-Jimenez, M. (Marta)
    Due to improvements in systemic therapies and longer survivals, cancer patients frequently present with re- current brain metastases (BM). The optimal therapeutic strategies for limited brain relapse remain undefined. We analyzed tumor control and survival in patients treated with salvage focal radiotherapy in our center. Thirty- three patients with 112 BM received salvage stereotactic radiosurgery (SRS) or fractionated stereotactic radio- therapy (FSRT) for local or regional recurrences. Local progression was observed in 11 BM (9.8 %). After 1 year, 72 % of patients were free of distant brain failure, and the 2-year overall survival (OS) was 37.7 %. No increase in toxicity or neurologically related deaths were observed. The 2- and 3-year whole brain radiation therapy free survival (WFS) rates were 92.9 % and 77.4 %, respectively. Hence, focal radiotherapy is a feasible salvage of recurrent BM in selected group of patients with limited brain disease, achieving a maintained intracranial control and less neurological toxicity.
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    Minimally invasive tumor bed implant (MITBI) and peri-operative high-dose-rate brachytherapy (PHDRBT) for accelerated minimal breast irradiation (AMBI) or anticipated boost (A-PHDRBT-boost) in breast-conserving surgery for ductal carcinoma in situ
    (2020) Esgueva, A. (Antonio); Martinez-Monge, R. (Rafael); Martinez-Regueira, F. (Fernando); Rodriguez-Spiteri, N. (Natalia); Rubio, I. (Isabel); Sobrido-Sampedro, C. (Carolina); Elizalde, A. (Arlette); Abengozar-Muela, M. (Marta); Idoate, M.A. (Miguel Ángel); Cambeiro, M. (Mauricio); Pina, L. (Luis); Olartecoechea, B. (Begoña); Gimeno-Morales, M. (Marta); Ramos, L. (Luis); Calvo-Manuel, F.Á. (Felipe Ángel)
    Purpose: To evaluate our institutional experience of minimally invasive tumor bed implantation (MITBI) during breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS) to deliver peri-operative high-dose-rate brachytherapy (PHDRBT) as accelerated minimal breast irradiation (AMBI) or anticipated boost (A-PHDRBT-boost). Material and methods: Patients older than 40, with clinical and radiological unifocal DCIS < 3 cm were considered potential candidates for accelerated partial breast irradiation (APBI) and were implanted during BCS using MITBItechnique. Patients who in final pathology reports showed free margins and no other microscopic tumor foci, received AMBI with PHDRBT (3.4 Gy BID in 5 days). Patients with adverse features received A-PHDRBT-boost with post-operative external beam radiotherapy (EBRT). Results: Forty-one patients were implanted, and 36 were treated and analyzed. According to final pathology, 24 (67%) patients were suitable for AMBI and 12 (33%) were qualified for A-PHDRBT-boost. Reoperation rate for those with clear margins was 16.6% (6/36); this rate increased to 33% (4/12) for G3 histology, and 66% (4/6) were rescued using AMBI. Early complications were documented in 5 patients (14%). With a median follow-up of 97 (range, 42-138) months, 5-year rates of local, elsewhere, locoregional, and distant control were all 97.2%. 5-year ipsilateral breast tumor recurrence rates (IBTR) were 5.6% (2/36), 8.3% (2/24) for AMBI, and 0% (0/12) for A-PHDRBT-boost patients. Both instances of IBTR were confirmed G3 tumors in pre-operative biopsies; no IBTR was documented in G1-2 tumors. Cosmetic outcomes were excellent/good in 96% of AMBI vs. 67% in A-PHDRBT-boost (p = 0.034). Conclusions: The MITBI-PHDRBT program allows selection of patients with excellent prognoses (G1-2 DCIS with negative margins and no multifocality), for whom AMBI could be a good alternative with low recurrence rate, decrease of unnecessary radiation, treatment logistics improvement, and over-treatment reduction. Patients whose pre-operative biopsy showed G3 tumor, presents with inferior local control and more risk of reoperation due to positive margins.
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    Estudio de factibilidad, seguridad y eficacia de la irradiación ultra-acelerada de mínimo volumen empleando técnica de braquiterapia perioperatoria en cáncer precoz de mama
    (Universidad de Navarra, 2022-01-21) Gimeno-Morales, M. (Marta); Martinez-Regueira, F. (Fernando); Cambeiro, M. (Mauricio)
    Durante la última década, ha existido un continuo interés en acortar la duración de los tratamientos de irradiación adyuvante en el cáncer precoz de mama, tanto para WBRT como para APBI.En el escenario de la APBI, una nueva generación de esquemas se definen como esquemas ultracortos o ultra-acelerados y tienen como objetivo administrar 3-4 fracciones en 2 días. A este respecto, novedosas estrategias han sido investigadas bajo experiencias institucionales con con técnica de braquiterapia con balón (Mammosite® o Contura®) que administran 21 Gy y 28 Gy administrados en 3 y 4 fracciones.Un estudio con implante intersticial multicatéter perioperatorio o postoperatorio que administra una dosis de 22,35 Gy y 25 Gy en 3 y 4 fracciones y otro estudio con dosis única de 16 Gy o 18 Gy también con implante intersticial multicatéter perioperatorio o postoperatorio. En el momento del diseño del estudio, no existía ningún estudio que implemente en su diseño, no solo un esquema ultra-acelerado, con el objetivo de reducir la duración del tratamiento; sino que también reduzca los volúmenes subsidiarios de irradiación a través de una innovación técnica en el diseño de implante de braquiterapia intersticial.En base a los resultados de la experiencia institucional previa publicados por Cambeiro et al., en 2017 nuestro grupo inició un programa de hipofraccionamiento extremo con irradiación ultra-acelerada fraccionada de mínimo volumen, previa realización de un implante intraoperatorio mínimamente invasivo durante la cirugía conservadora (MITBI&4f-AMBI).El programa MITBI&4f-AMBI ofrece una triple selección de pacientes establecida a lo largo de tres etapas bien diferenciadas (preoperatoria, intervencionista y postoperatoria) selecciona a pacientes con excelente pronóstico, para las cuales un tratamiento de irradiación de mínimo volumen es una alternativa que optimiza la logística y reduce el sobretratamiento.El implante MITBI asegura una discriminación topográfica de alta precisión en el reconocimiento intraoperatorio del lecho tumoral subsidiario a implante y reduce la invasividad frente al implante postoperatorio.La innovación técnica en el diseño de implante presenta una tasa de complicaciones perioperatorias del 11% similar a la reportada en el programa institucional previo FHIOMBI&PHDRBT.Tras implantar, tratar y analizar a 60 pacientes con cáncer precoz de mama, candidatas a irradiación parcial, el esquema ultra-acelerado aplicado en el programa MITBI&4f-AMBI acorta en un 60%, el número de fracciones y los días de tratamiento de irradiación, y en un 27% la duración de permanencia de implante y de tratamiento local con respecto al programa previo con esquema en 10 fracciones.El volumen de irradiación (V100) resultante se limita a 27,6cc, que representa el 5% del tejido mamario remanente, lo que implica una reducción de dosis recibida a los OAR en relación a otras modalidades de APBI y define el concepto de irradiación de mínimo volumen.La tasa de toxicidad RTOG aguda G1 se limita a 11%, sin documentar toxicidad G2 o superior.Crónicamente, la tada de txicidad G1 reportada asciende al 36%, siendo no superior a las documentadas con fraccionamiento clásico.Con una mediana de seguimiento de 25 meses, los resultados de control oncológico no ofrecen un exceso de recurrencias respecto al estudio institucional con fraccionamiento convencional, ni al resto de estudios de referencia.La tasa de control en cualquier parte de la mama a tres años es del 97%.La irradiación de mínimo volumen con un esquema ultra-acelerado (4f-AMBI) ofrece un resultado estético bueno o excelente en un 94,5% de las pacientes, sin ser inferior a la experiencia institucional previa, ni a los estudios de referencia.El programa MITBI&4f-AMBI instaura una estrategia de eficiencia y desescalada en términos logísticos, técnicos y dosimétricos, así como adecúa el tratamiento óptimo de irradiación adyuvante al riesgo individual de las pacientes.
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    Intraoperative electron beam radiotherapy and perioperative high‑dose‑rate brachytherapy in previously irradiated oligorecurrent gynecological cancer: clinical outcome analysis
    (Springer, 2021) Jablonska, P.A. (Paola Anna); Cambeiro, M. (Mauricio); Gimeno-Morales, M. (Marta); Aramendia, J.M. (José Manuel); NO USAR Mínguez-Milio, J. (José Ángel); Alcazar, J.L. (Juan Luis); Aristu-Mendioroz, J.J. (José Javier); Calvo, F.A. (Felipe A.); Martinez-Monge, R. (Rafael)
    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 efective salvage in oligorecurrent gynecological tumors. Patients with previous pelvic radiation suitable for salvage surgery and at risk of inadequate margins could beneft 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.
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    Post- versus intra-operative implant for breast cancer interstitial brachytherapy: How to choose?
    (Polskie Towarzystwo Brachyterapii, 2024) Gimeno-Morales, M. (Marta); Motisi, L. (Laura); Rodriguez-Spiteri, N. (Natalia); Martínez-Regueira, F. (Fernando); Worthington, T. (Tucker); Strnad, V. (Vratislav); Hannoun-Levi, J.M. (Jean-Michel); Gutierrez, C. (Cristina)
    Purpose: Breast brachytherapy (BB) represents an important radiation therapy modality in modern breast cancer treatments. Currently, BB is mainly used for accelerated partial breast irradiation (APBI), local boost after whole breast radiation therapy (WBRT), and as salvage re-irradiation after second lumpectomy (APBrl). Two multi-catheter interstitial brachytherapy (MIB) techniques can be offered: intra-operative (IOB) and post-operative (POB) brachytherapy. The aim of this article was to summarize current available data on these two different brachytherapy approaches for breast cancer. Material and methods: A literature search was performed, and different experiences published by BB expert teams were analyzed and compared. These two different brachytherapy approaches for breast cancer have also been presented and discussed during meetings of the GEC-ESTRO BCWG. In addition, expert recommendations were defined. Results: A comprehensive description and practical comparison of both the techniques, i.e., IOB and POB, considering the latest available published data were presented. Different technical, logistic, and clinical aspects of both the methods were thoroughly examined and analyzed. This detailed comparison of the two breast brachytherapy techniques was supported by scientific data from extensive experience of experts, facilitating an objective analysis that, to our knowledge, has not been previously published. Conclusions: Based on the comprehensive analysis of both the brachytherapy techniques available, this article serves as a valuable resource to guide breast teams in selecting the optimal BB technique (POB or IOB), considering hospital environment, multi-disciplinary collaboration, and patient logistics.
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    Long-term results of Perioperative High Dose Rate Brachytherapy (PHDRB) and external beam radiation in adult patients with soft tissue sarcomas of the extremities and the superficial trunk: Final results of a prospective controlled study
    (Elsevier, 2019) Gimeno-Morales, M. (Marta); San-Julian, M. (Mikel); Cambeiro, M. (Mauricio); NO USAR Arbea, L. (Leire); Jablonska, P.A. (Paola Anna); Moreno-Jimenez, M. (Marta); Amillo, S. (Santiago); Aristu, J. (Javier); Lecanda, F. (Fernando); Martinez-Monge, R. (Rafael)
    Background: To analyze toxicity, patterns of failure, and survival in 106 adult patients with soft tissue sarcomas of the extremity and the superficial trunk treated in a prospective controlled trial of combined Perioperative High Dose Rate Brachytherapy (PHDRB) and external beam radiotherapy (EBRT). Methods: Patients were treated with surgical resection and 16 Gy or 24 Gy of PHDRB for negative or close/positive margins, respectively. EBRT (45 Gy) was added postoperatively. Adjuvant chemotherapy was given to selected patients with high-grade tumors. Results: The median follow-up was 7.1 years (range, 0.6–16.0). Grade 3 adverse events were observed in 22 patients (20.8%), and grade 4 events in 14 patients (13.2%). No grade 5 events were noted. Multivariate analysis (p = 0.003) found that Grade 3 toxic events increased with increasing implant volume (TV100). Local control, locoregional control, and distant control rates at 5 and 10 years were 89% and 87%, 82% and 80% and 75% and 69%, respectively. Multivariate analysis (p = 0.024) found that positive margins correlated with decreased local control. Disease-free survival and overall survival rates at 5 and 10 years were 64% and 59% and 73% and 62%, respectively. In multivariate analysis, disease-free survival rates decreased with increasing tumor size (p = 0.0001) and inadequate margins (p = 0.024), and overall survival decreased with increasing tumor size (p = 0.001) and male gender (p = 0.039). Conclusions: The combination of conservative surgery, high-dose PHDRB, and EBRT produces adequate function and local control in the majority of patients with soft tissue sarcomas of the extremities and the superficial trunk, including a substantial percentage of cases with positive margins. Patients with larger tumors are at a higher risk of complications, treatment failure, and cancer-related death and require an individualized treatment approach.
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    Perioperative high-dose-rate brachytherapy in locally advanced and recurrent gynecological cancer: Final results of a Phase II trial
    (Elsevier, 2018) Martinez-Monge, R. (Rafael); Valtueña-Peydró, G. (Germán); Cambeiro, M. (Mauricio); Aramendia, J.M. (José Manuel); Gimeno-Morales, M. (Marta); Santisteban, M. (Marta); Lecanda, F. (Fernando); Minguez, J.A. (José Ángel); Alcazar, J.L. (Juan Luis); Jurado, M. (Matías)
    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 5 25) received preoperative chemoradiation followed by surgery and PHDRB (16e24 Gy). Previously irradiated patients (n 5 25) received surgery and PHDRB alone (32e40 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 O10 years including a few previously irradiated cases with positive margins.
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    Four-fraction ultra-accelerated minimal breast irradiation in early breast cancer: The initial feasibility results of an institutional experience
    (Elsevier, 2022) Gimeno-Morales, M. (Marta); Martinez-Monge, R. (Rafael); Martínez-Regueira, F. (Fernando); Rodriguez-Spiteri, N. (Natalia); Olartecoechea, B. (Begoña); Ramos, L. (Luis); Ayestaran, A. (Adriana); Pina-Insausti, L. (Luis); Elizalde, A. (Arlette); Abengozar-Muela, M. (Marta); Rubio, I. (Isabel); Esgueva, A. (Antonio); Sobrido, C. (Carolina); Cambeiro, M. (Mauricio)
    PURPOSE: To evaluate the feasibility, early toxicity, and clinical outcomes of early-breast cancer patients in a single-arm, phase I/II study of an ultra-accelerated, four-fraction schedule of minimal breast irradiation (4f-AMBI) using a multicatheter, minimally-invasive, intraoperative tumor bed implant (MITBI) during breast-conserving surgery (BCS). METHODS AND MATERIALS: Eligible women aged >40 years with clinically and radiologically confirmed, unifocal invasive or in situ ≤3 cm tumors were considered as potential candidates for MITBI during BCS. After the pathology report, patients who met APBI criteria received ultra-accelerated four-fractions irradiation (6.2 Gy BID x 4fx over 2 days) with perioperative HDR-brachytherapy (PHDRBT). Early complications, toxicity, clinical outcomes, and cosmetic results were analyzed. RESULTS: Of 89 patients initially implanted, 60(67.4%) were definitively included in the 4fAMBI-protocol. The median age was 64.4 years; the median CTV was 32.1 cc (6.9–75.4 cc), and the external-V100 was 43.1 cc (12.87–107 cc), representing 5% of the breast tissue irradiated with a median CTV D90 of 6.2 Gy (5.6–6.28 Gy). The entire local treatment (BCS&MITBI-4fAMBI) was completed at a median of 8 days (4–10 days). The rate of early complications was 11%. There were no major complications. Acute skin-subcutaneous G1 toxicity was reported in 11.7%, and late G1 toxicity on 36.7%. After a median follow-up of 27 months (11–51 months), the local, elsewhere, locoregional and distant-control rates were 100%, 98.3%, 100%, and 100% respectively. The early-cosmetic evaluation was excellent-good in 94.5% of patients evaluated. CONCLUSIONS: Ultra-accelerated, four-fraction, minimal breast irradiation (4f-AMBI) using a minimally-invasive tumor bed implant procedure is safe, dosimetrically feasible, and shows small irradiated volumes. This program provides low toxicity rates and excellent short-term clinical and cosmesis outcomes.
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    Very accelerated partial breast irradiation in 1 or 2 days: Late toxicity and early oncological outcome of the GEC-ESTRO VAPBI cohort
    (Elsevier, 2024) Hannoun-Levi, J.M. (Jean-Michel); Gimeno-Morales, M. (Marta); Gal, J. (Jocelyn); Anchuelo, J. (Javier); Guinot, J.L. (Jose Luis); Gaztañaga, M. (Miren); Meszaros, N. (Norbert); Polgar, C. (Csaba); Strnad, V. (Vratislav); Schiappa, R. (Renaud); Gutierrez, C. (Cristina)
    Purpose: To analyze late toxicity after very accelerated partial breast irradiation (VAPBI) for low-risk breast cancer. Materials: Methods: In this retrospective, observational, international multicenter study (HDH F20220713143949), patients with low-risk breast cancer underwent lumpectomy + vAPBI (high-dose rate multicatheter interstitial brachytherapy-MIBT). VAPBI was performed with 4(4x6.2 Gy/2d), 3(3x7.45 Gy/2d) or 1 fraction (1x16Gy or 1x18Gy/1d). Primary endpoint was late toxicity. Secondary endpoints were cumulative incidence of breast cancer local relapse (LR) and distant metastatic relapse (DMR) and specific (SS) and overall (OS) survivals. Prognostic factors for late toxicity were analyzed. Results: From 01/2012 to 06/2022, 516 pts with early breast cancer were enrolled. Median follow-up was 44 months [95 %CI 39–46]. Median age was 71 years [40–100]. Median tumor size was 12 mm [1–35]. VAPBI delivered 1, 3 and 4 fractions for 205pts (39.7 %), 167pts (32.4 %) and 144pts (28 %) respectively. 221 late toxicity events were observed in 168pts (32.6 %) (Fibrosis, dyschromia, pain and telangiectasia). Grade 2 and 3 late toxicities were observed in 7.2 and 0.6 % respectively (no G4) with no difference between 1 and ≥ 2 treatment days. CTV > 50 cc (p = 0.007) and V150 > 40 % (p = 0.027) were prognostic factors for G ≥ 2 late toxicity. Four-year cumulative incidence rates of LR and DMR were 2 % [95 %CI 0–3] and 1 % [95 %CI 0–2] respectively. Conclusions: VAPBI based on 1 or ≥ 2 days of MIBT represents an attractive de-escalation of irradiation approach for low-risk breast cancer. Late toxicity profile appears acceptable while early oncological outcome shows encouraging local control. Longer follow-up is warranted in order to confirm these preliminary results