Publications by authors named "Giulia Marvaso"

68 Publications

Semi-Automated Segmentation of Bone Metastases from Whole-Body MRI: Reproducibility of Apparent Diffusion Coefficient Measurements.

Diagnostics (Basel) 2021 Mar 11;11(3). Epub 2021 Mar 11.

Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.

Using semi-automated software simplifies quantitative analysis of the visible burden of disease on whole-body MRI diffusion-weighted images. To establish the intra- and inter-observer reproducibility of apparent diffusion coefficient (ADC) measures, we retrospectively analyzed data from 20 patients with bone metastases from breast (BCa; = 10; aged 62.3 ± 14.8) or prostate cancer (PCa; = 10; aged 67.4 ± 9.0) who had undergone examinations at two timepoints, before and after hormone-therapy. Four independent observers processed all images twice, first segmenting the entire skeleton on diffusion-weighted images, and then isolating bone metastases via ADC histogram thresholding (ADC: 650-1400 µm/s). Dice Similarity, Bland-Altman method, and Intraclass Correlation Coefficient were used to assess reproducibility. Inter-observer Dice similarity was moderate (0.71) for women with BCa and poor (0.40) for men with PCa. Nonetheless, the limits of agreement of the mean ADC were just ±6% for women with BCa and ±10% for men with PCa (mean ADCs: 941 and 999 µm/s, respectively). Inter-observer Intraclass Correlation Coefficients of the ADC histogram parameters were consistently greater in women with BCa than in men with PCa. While scope remains for improving consistency of the volume segmented, the observer-dependent variability measured in this study was appropriate to distinguish the clinically meaningful changes of ADC observed in patients responding to therapy, as changes of at least 25% are of interest.
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http://dx.doi.org/10.3390/diagnostics11030499DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998160PMC
March 2021

COVID-19 and radiotherapy: impact on work and personal life of Lombardy residents during first lockdown, survey endorsed by AIRO Young.

Tumori 2021 Mar 17:3008916211000826. Epub 2021 Mar 17.

Division of Radiation Oncology, IEO, European Institute of Oncology, IRCCS, Milan, Italy.

Aim: Since 20 February 2020, Lombardy has been one of the most affected areas worldwide by the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study is to evaluate work and psychological impact of COVID-19 on Lombardy radiation therapy (RT) residents in the first 3 months of the outbreak (first lockdown).

Methods: An online questionnaire (22 multiple choice questions) via Microsoft Forms was administered on 30 May 2020 to RT residents.

Results: Nineteen Lombardy RT residents responded to the survey. Nineteen percent of residents underwent a nasal swab and 11% were quarantined. Seventeen residents (89%) reported an increase in workload. Twelve residents (63%) did not find any difference in terms of work distress; worsening was highlighted in 5 cases (26%). The majority has never considered the possibility of stopping work due to excessive stress (89%). Almost all the residents experienced self- or relative-referred apprehension (95%). Ninety-five percent reported having missed extra-work social relationships. Most of the sample noted worsening sleep quality and difficulty concentrating (69%). No residents requested psychological support, even if provided by the hospital.

Conclusion: Overall, the residents adapted to the new workplace scenario, although some health risks and well-being challenges have been reported. An extension of the survey to all Italian RT residents endorsed by Italian Association of Radiotherapy and Clinical Oncology "Young AIRO" will allow an evaluation of COVID-19 impact on a national level. A second survey is planned to underline differences between the first lockdown and the current situation of the pandemic.
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http://dx.doi.org/10.1177/03008916211000826DOI Listing
March 2021

Whole-body magnetic resonance imaging: technique, guidelines and key applications.

Ecancermedicalscience 2021 7;15:1164. Epub 2021 Jan 7.

Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.

Whole-body magnetic resonance imaging (WB-MRI) is an imaging method without ionising radiation that can provide WB coverage with a core protocol of essential imaging contrasts in less than 40 minutes, and it can be complemented with sequences to evaluate specific body regions as needed. In many cases, WB-MRI surpasses bone scintigraphy and computed tomography in detecting and characterising lesions, evaluating their response to therapy and in screening of high-risk patients. Consequently, international guidelines now recommend the use of WB-MRI in the management of patients with multiple myeloma, prostate cancer, melanoma and individuals with certain cancer predisposition syndromes. The use of WB-MRI is also growing for metastatic breast cancer, ovarian cancer and lymphoma as well as for cancer screening amongst the general population. In light of the increasing interest from clinicians and patients in WB-MRI as a radiation-free technique for guiding the management of cancer and for cancer screening, we review its technical basis, current international guidelines for its use and key applications.
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http://dx.doi.org/10.3332/ecancer.2021.1164DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929776PMC
January 2021

Re: Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial.

Eur Urol 2021 Feb 22. Epub 2021 Feb 22.

Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.

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http://dx.doi.org/10.1016/j.eururo.2021.02.011DOI Listing
February 2021

Prognostic value of the , , and mutations in oral squamous cell carcinoma: literature review.

Arch Med Sci 2021 13;17(1):207-217. Epub 2020 Nov 13.

Department of Radiotherapy, European Institute of Oncology, IRCCS, Milan, Italy.

Over 260,000 (2013) new oral squamous cell carcinoma (OSCC) cases are reported annually worldwide. Despite development in OSCC management, the outcome is still unsatisfactory. Identification of new molecular markers may be of use in prevention, prognosis, and choice of an appropriate therapy. The intracellular molecular signalling pathway of phosphatidyl-inositol-3-kinase is involved in the process of cell growth, differentiation, migration, and survival. The main components of this pathway: PIK3CA (phosphatidylinositol-4,5-bisphosphate-3-kinase catalytic subunit α), PTEN (phosphatase and tensin homologue deleted on chromosome 10), and AKT (serine-threonine kinase) are potential objects of research when introducing new therapeutic agents. The aim of this paper is to evaluate the , , and gene mutations as prognostic factors in OSCC and to describe their role in aggressive disease progression. This is crucial for oral cancer biology understanding and for indicating which direction new clinical treatments should take.
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http://dx.doi.org/10.5114/aoms.2020.100780DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811327PMC
November 2020

The role of palliative radiotherapy in the management of elderly and frail patients with advanced bladder cancer: A survey by the AIRO uro-group.

Med Oncol 2021 Jan 23;38(2):14. Epub 2021 Jan 23.

UOC Radioterapia ASST Monza, Università di Milano, Bicocca, Italy.

Radiotherapy (RT) is rarely used in the palliative management of muscle-invasive bladder cancer (MIBC). This survey aims to explore current care patterns within the Italian Radiation Oncologist community on this topic. In 2020, the uro-oncological study group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) conducted a survey evaluating the RT role in advanced MIBC. An electronic questionnaire was administered online to the society members asking for: general considerations, patients' selection, and aim of the treatment, RT schedule and practical consideration, past and future perspective. Sixty-one questionnaires were returned (33% response rate). Most responders (62.30%) declared to work in a Center with a multidisciplinary uro-oncological team, and 8.20% to evaluate more than 20 patients with MIBC/year for palliative RT. Elderly patients were the most frequently evaluated (46.7%) and life expectancy was the most common selection criteria (44.60%). Thirty Gy in 10 fractions (58.9%), whole bladder as GTV (62.5%), PTV isotropic margins of 1.5-2 cm (44.6%) and IMRT/VMAT technique (58.14%) were the most common treatment choices. Patients amenable for bladder palliative RT were most commonly referred by the urologist (43.86%) or the multidisciplinary team (38%). The reported main reasons for the low involvement of radiation oncologist in the management of MIBC patients were low attention to the palliative setting in bladder cancer (37.5%); radiation oncologist not involved in the management of these patients (32.1%); cases not discussed in the multidisciplinary board (26.8%). This survey illustrated the current use of palliative RT for patients with advanced MIBC in Italy and suggested the need for a greater involvement of radiation oncologists in their management.
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http://dx.doi.org/10.1007/s12032-021-01455-4DOI Listing
January 2021

COVID-19 impact in radiotherapy practice in an oncology hub: a screenshot from Lombardy, Italy.

Tumori 2020 Dec 16:300891620980065. Epub 2020 Dec 16.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Objective: During 2020, medical clinical activities were dramatically modified by the coronavirus disease 2019 (COVID-19) emergency. We aim to evaluate the impact of COVID-19 on radiotherapy (RT) practice in a hub cancer center.

Methods: Retrospective data collection of patients with suspected COVID-19 infection, identified by pathognomonic symptoms feedback at triage realized at the entrance to RT division. Inclusion criteria were diagnosis of oncologic disease, COVID-19-related symptoms, and signed written informed consent.

Results: Between 1 March and 30 June 2020, 1,006 patients accessed our RT division for RT simulation or treatment. Forty-four patients matched inclusion criteria (4.4% of all patients): 29 women and 15 men. Seventeen patients had metastatic disease. Twenty-one patients reported fever, 6 presented dyspnea, 4 complained of ageusia and anosmia, and 3 developed conjunctivitis. Thirty-six patients underwent nasal swab, with 7 positive results. From our cohort, 4 cases of pneumonia were diagnosed with computed tomography scan imaging: 3 were related to COVID-19 infection, while the fourth was evaluated as an RT adverse event. From the entire series, 4 patients died: 3 during hospitalization in intensive care unit of complications of COVID-19 and 1 of other causes neither COVID-19 nor cancer-related.

Conclusions: Cancer hub allows for safe RT practice continuation while minimizing the spread of contagion in this frail patient population. A challenge for the future will be to understand pandemic consequences in cancer natural history and manage its clinical impact.
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http://dx.doi.org/10.1177/0300891620980065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746951PMC
December 2020

Any Role of PIK3CA and PTEN Biomarkers in the Prognosis in Oral Squamous Cell Carcinoma?

Life (Basel) 2020 Dec 3;10(12). Epub 2020 Dec 3.

Division of Radiotherapy, IEO European Institute of Oncology, IRCCS, 435 Ripamonti Street, 20-141 Milan, Italy.

Oral squamous cell carcinoma (OSCC) accounts for 95% of the lesions in the oral cavity. Despite development in OSCC management, the outcome is still unsatisfactory. Identification of new therapies in OSCC is urgently needed. One objective of such treatment may be a signaling pathway of phosphatidylinositol 3-kinase. The study group included 92 patients treated for OSCC at the University Clinical Centre in Gdańsk, Poland. Study was performed on formalin-fixed paraffin-embedded samples from primary OSCC. Phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA) and phosphatase and tensin homolog encoded on chromosome 10 (PTEN) protein expression was assessed by immunohistochemistry (IHC). gene copy number was analyzed using chromogenic and silver in situ hybridization where molecular probes are marked by chromogens and silver ions. PIK3CA IHC H-score ≥ 70 was found in 51.65% patients, and loss of PTEN protein was noticed in 31.46% cases. PIK3CA amplification was detected in 5 tumors. In the case of PTEN protein expression, there was an inverse correlation with the T stage of the primary tumor ( -0.243) and positive correlation with a 5-year survival ( 0.235). The number of copies of the gene was associated with the tumor grading ( 0.208). The present study shows that loss of PTEN protein and the grading ( 0.040), distant metastases ( 0.033), smoking ( 0.016), and alcohol abuse ( 0.042) were prognostic factors for the survival of patients with OSCC. In contrast, the presence of amplification and OSCC on the floor of the mouth resulted in a nearly six-fold increase in the risk of shortening survival ( 0.037). Our finding suggests a potential prognostic significance of PTEN loss and PIK3CA amplification in OSCC. Future studies are needed to confirm our results.
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http://dx.doi.org/10.3390/life10120325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761816PMC
December 2020

Back to (new) normality-A CODRAL/AIRO-L survey on cancer radiotherapy in Lombardy during Italian COVID-19 phase 2.

Med Oncol 2020 Nov 4;37(11):108. Epub 2020 Nov 4.

Radiotherapy Unit, ASST Ospedale Niguarda, Milano, Italy.

Background: Italy experienced one of the world's severest COVID-19 outbreak, with Lombardy being the most afflicted region. However, the imposed safety measures allowed to flatten the epidemic curve and hence to ease the restrictions and inaugurate, on the 4th of May 2020, the Italian phase (P) 2 of the pandemic. The present survey study, endorsed by CODRAL and AIRO-L, aimed to assess how radiotherapy (RT) departments in Lombardy have dealt with the recovery.

Materials And Methods: A questionnaire dealing with the management of pandemic was developed online and sent to all CODRAL Directors on the 10th of June 2020. Answers were collected in full anonymity one week after.

Results: All the 33 contacted RT facilities (100%) responded to the survey. Despite the scale of the pandemic, during P1 14 (42.4%) centres managed to safely continue the activity (≤ 10% reduction). During P2, 10 (30.3%) centres fully recovered and 14 (42.4%) reported an increase. Nonetheless, 6 (18.2%) declared no changes and, interestingly, 3 (9.1%) reduced activities. Overall, 21 centres (63.6%) reported suspected or positive cases within healthcare workforce since the beginning of the pandemic. Staff units were quarantined in 19 (57.6%) and 6 (18.2%) centres throughout P1 and P2, respectively. In the two phases, about two thirds centres registered positive or suspected cases amongst patients.

Conclusion: The study revealed a particular attention to anti-contagion measures and a return to normal or even higher clinical workload in most RT centres in Lombardy, necessary to carry out current and previously deferred treatments.
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http://dx.doi.org/10.1007/s12032-020-01434-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641253PMC
November 2020

MRI-targeted or systematic random biopsies for prostate cancer diagnosis in biopsy naïve patients: follow-up of a PRECISION trial-like retrospective cohort.

Prostate Cancer Prostatic Dis 2020 Sep 28. Epub 2020 Sep 28.

Department of Urology, IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.

Background: To test clinically significant prostate cancer (csPCa) rates during follow-up in biopsy naïve patients that underwent two different diagnostic pathways: (1) SB GROUP (n = 354): systematic random biopsies (SB) vs. (2) TB GROUP (n = 264): multiparametric magnetic resonance imaging (mpMRI) and only targeted biopsies (TB) of PI-RADS ≥ 3 lesions. Patients with PI-RADS ≤ 2 score avoided prostate biopsies.

Methods: Retrospective single centre study of 618 biopsy naive patients (2015-2018). Two different definitions of csPCa were used: (1) csPCa ISUP GG ≥ 2 (ISUP grade group [GG] ≥ 2) and (2) csPCa ISUP GG ≥ 3. Kaplan-Meier plots and univariable Cox regression models tested rates over time of csPCa ISUP GG ≥ 2 and caPCa ISUP GG ≥ 3 in SB GROUP vs. TB GROUP.

Results: At initial biopsy, TB achieved higher rates of csPCa ISUP GG ≥ 2 (35.3 vs. 18.9%; p < 0.001) and csPCa ISUP GG ≥ 3 (12.6 vs. 6.2%; p = 0.04), relative to SB. After a median time follow-up of 36 months, the rates of csPCa ISUP GG ≥ 2 (6.1 vs. 4.4%; p = 0.6) and csPCa ISUP GG ≥ 3 (3.3 vs. 1.1%; p = 0.2) were similar in SB GROUP vs. TB GROUP. Moreover, in TB GROUP patients that avoided prostate biopsies because of negative baseline mpMRI (n = 145), only 4.1% exhibited csPCa ISUP GG ≥ 2 during follow-up. Moreover, none of these patients (PI-RADS ≤ 2) had csPCa ISUP GG ≥ 3.

Conclusions: In biopsy naïve setting, a diagnostic pathway including pre-biopsy mpMRI and TB of only PCa suspicious lesions is not associated with higher rates of csPCa during follow-up, relative to a diagnostic pathway of SB. Moreover, patients with negative baseline mpMRI could safely avoid prostate biopsies and could be followed with repeated PSA testing, since only a small proportion of them would harbor csPCa.
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http://dx.doi.org/10.1038/s41391-020-00290-4DOI Listing
September 2020

Adjuvant radiotherapy in node positive prostate cancer patients: a debate still on. when, for whom?

BJU Int 2021 Apr 25;127(4):454-462. Epub 2020 Sep 25.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Objective: To evaluate the impact of adjuvant radiotherapy (aRT) in patients with prostate cancer (PCa) found to have pathological positive lymph nodes (pN1s) after radical prostatectomy (RP) and extended pelvic lymph node dissection (ePLND) with regard to distant recurrence-free survival (RFS), according to both main tumour pathological characteristics and number of positive lymph nodes. Biochemical RFS, local RFS, overall survival (OS) and acute and late toxicity were assessed as secondary endpoints.

Patients And Methods: A retrospective cohort of 187 consecutive patients with pN1 PCa were treated with aRT at the IEO, European Institute of Oncology IRCCS, Milan, Italy. aRT on the tumour bed and pelvis was administered within 6 months of RP. Androgen deprivation therapy was administered according to the guidelines. Univariate and multivariate Cox regression analyses predicting biochemical RFS, local RFS, distant RFS and OS rates were performed to assess whether the number of pN1s represented an independent prognostic factor. The Youden index was computed to find the optimal threshold for the number of pN1s able to discriminate between patients with or without biochemical and clinical relapse.

Results: At 5 years, local RFS, distant RFS, biochemical RFS and OS were 68%, 71%, 56% and 94%, respectively. The median follow-up was 49 months. The number of pN1s was significantly associated with biochemical RFS, local RFS and distant RFS. The best threshold for discriminating between patients with or without biochemical and clinical relapse was five pN1s. In multivariate analyses, the number of pN1s was confirmed to be an independent predictor of biochemical RFS, local RFS and distant RFS, but not of OS. Multivariate analyses also showed an increased risk of biochemical relapse for increasing values of initial prostate-specific antigen and for patients with tumour vascular invasion. Local and distant RFS were also inversely correlated with significantly reduced risk for International Society of Urological Pathology grade group <3 (group 1 or 2 compared to group 3).

Conclusions: Our data confirmed the encouraging outcomes of patients with pN1 PCa treated with adjuvant treatments and the key role represented by the number of pN1s in predicting biochemical RFS, clinical RFS and distant RFS. Large prospective cohort studies and randomized clinical trials are needed to confirm these results and to identify the subgroup of patients with pN1 PCa who would most benefit from aRT.
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http://dx.doi.org/10.1111/bju.15228DOI Listing
April 2021

Carotid blowout syndrome after reirradiation for head and neck malignancies: a comprehensive systematic review for a pragmatic multidisciplinary approach.

Crit Rev Oncol Hematol 2020 Nov 25;155:103088. Epub 2020 Aug 25.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.

Aim: To provide a literature review on risk factors and strategies to prevent acute carotid blowout (CBO) syndrome in patients who underwent reirradiation (reRT) for recurrent head and neck (HN) malignancies.

Patients And Methods: Inclusion criteria were: 1) CBO following reRT in the HN region, 2) description on patient-, tumor- or treatment-related risk factors, 3) clinical or radiological signs of threatened or impending CBO, and 4) CBO prevention strategies.

Results: Thirty-five studies were selected for the analysis from five hundred seventy-seven records. Results provided indications on clinical, radiological and dosimetric parameters possibly associated with higher risk of CBO. Endovascular procedures (artery occlusion and stenting) to prevent acute massive hemorrhage in high risk patients were discussed.

Conclusion: Literature data are still scarce with a low level of evidence. Nevertheless, the present work provides a comprehensive review useful for clinicians as a multidisciplinary pragmatic tool in their clinical practice.
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http://dx.doi.org/10.1016/j.critrevonc.2020.103088DOI Listing
November 2020

MRI-based radiomics signature for localized prostate cancer: a new clinical tool for cancer aggressiveness prediction? Sub-study of prospective phase II trial on ultra-hypofractionated radiotherapy (AIRC IG-13218).

Eur Radiol 2021 Feb 27;31(2):716-728. Epub 2020 Aug 27.

Division of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.

Objectives: Radiomic involves testing the associations of a large number of quantitative imaging features with clinical characteristics. Our aim was to extract a radiomic signature from axial T2-weighted (T2-W) magnetic resonance imaging (MRI) of the whole prostate able to predict oncological and radiological scores in prostate cancer (PCa).

Methods: This study included 65 patients with localized PCa treated with radiotherapy (RT) between 2014 and 2018. For each patient, the T2-W MRI images were normalized with the histogram intensity scale standardization method. Features were extracted with the IBEX software. The association of each radiomic feature with risk class, T-stage, Gleason score (GS), extracapsular extension (ECE) score, and Prostate Imaging Reporting and Data System (PI-RADS v2) score was assessed by univariate and multivariate analysis.

Results: Forty-nine out of 65 patients were eligible. Among the 1702 features extracted, 3 to 6 features with the highest predictive power were selected for each outcome. This analysis showed that texture features were the most predictive for GS, PI-RADS v2 score, and risk class; intensity features were highly associated with T-stage, ECE score, and risk class, with areas under the receiver operating characteristic curve (ROC AUC) ranging from 0.74 to 0.94.

Conclusions: MRI-based radiomics is a promising tool for prediction of PCa characteristics. Although a significant association was found between the selected features and all the mentioned clinical/radiological scores, further validations on larger cohorts are needed before these findings can be applied in the clinical practice.

Key Points: • A radiomic model was used to classify PCa aggressiveness. • Radiomic analysis was performed on T2-W magnetic resonance images of the whole prostate gland. • The most predictive features belong to the texture (57%) and intensity (43%) domains.
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http://dx.doi.org/10.1007/s00330-020-07105-zDOI Listing
February 2021

IMRT versus 2D/3D conformal RT in oropharyngeal cancer: A review of the literature and meta-analysis.

Oral Dis 2020 Aug 18. Epub 2020 Aug 18.

Division of Radiotherapy, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Based on literature, intensity-modulated radiation therapy (IMRT) provides less related toxicity compared with conventional 2D/3D-RT with no impact on oncological outcomes for oropharyngeal cancer. The aim of this systematic review and meta-analysis is to assess whether IMRT might provide similar clinical outcomes with reduced related toxicity in comparison with conventional 2D/3D RT in patients treated for clinically advanced oropharyngeal cancer (OPC). Inclusion criteria for paper selection included: squamous OPC patients, treatment performed by concomitant CRT or RT alone, four treatment performed for curative intent, and presence of clinical outcome of interest, namely, overall survival (OS) and disease-free survival (DFS) and full paper available in English. Acute and late toxicities were retrieved together with OS and DFS. Crude relative risk estimates of relapse and death comparing 2D/3D-RT versus IMRT were calculated from tabular data, extracting events at 2-3 years of follow-up. Eight studies were selected. Six of them were included in the meta-analysis considering summary relative risk. Considering both acute and late toxicities, the considered studies evidenced advantages for IMRT populations, with the 2D/3D-RT population showing higher frequencies than the IMRT one. No statistical difference between IMRT and 2D/3D-RT in terms of death (SRR = 0.93, 95% CI: 0.83-1.04 with no heterogeneity I  = 0%) and relapse (SRR = 0.92, 95% CI: 0.83-1.03, with no heterogeneity I  = 0%) was found. Results of our study suggest the improvement in the therapeutic index with IMRT with evidenced reduced toxicity without any worsening in clinical outcome when compared to 2D/3DCRT.
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http://dx.doi.org/10.1111/odi.13599DOI Listing
August 2020

Mixed-beam approach for high-risk prostate cancer: Carbon-ion boost followed by photon intensity-modulated radiotherapy. Dosimetric and geometric evaluations (AIRC IG-14300).

Phys Med 2020 Aug 2;76:327-336. Epub 2020 Aug 2.

Scientific Directorate, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141 Milan, Italy.

Background And Purpose: The aim was to evaluate dosimetric uncertainties of a mixed beam approach for patients with high-risk prostate cancer (PCa). The treatment consists of a carbon ion radiotherapy (CIRT) boost followed by whole-pelvis intensity-modulated RT (IMRT).

Materials And Methods: Patients were treated with a CIRT boost of 16.6 Gy/4 fractions followed by whole-pelvis IMRT of 50 Gy/25 fractions, with consequent long term androgen deprivation therapy. Deformable computed tomography image registration (DIR) was performed and corresponding doses were used for plan sum. A comparative IMRT photon plan was obtained as whole-pelvis IMRT of 50 Gy/25 fractions followed by a boost of 28 Gy/14 fractions. DIR performances were evaluated through structure-related and image characteristics parameters.

Results: Until now, five patients out of ten total enrolled ended the treatment. Dosimetric parameters were lower in CIRT + IMRT than IMRT-only plans for all organs at risk (OARs) except femoral heads. Regarding DIR evaluation, femoral heads were the less deformed OAR. Penile bulb, bladder and anal canal showed intermediate deformation. Rectum was the most deformed. DIR algorithms were patient (P)-dependent, as performances were the highest for P3 and P4, intermediate for P2 and P5, and the lowest for P1.

Conclusions: CIRT allows better OARs sparing while increasing the efficacy due to the higher radio-biological effect of carbon ions. However, a mixed beam approach could introduce DIR problems in multi-centric treatments with different operative protocols. The development of this prospective trial will lead to more mature data concerning the clinical impact of implementing DIR procedures in dose accumulation applications for high-risk PCa treatments.
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http://dx.doi.org/10.1016/j.ejmp.2020.07.012DOI Listing
August 2020

Phase II prospective trial "Give Me Five" short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218).

Med Oncol 2020 Jul 28;37(8):74. Epub 2020 Jul 28.

Division of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.

As part of the AIRC IG-13218 (NCT01913717), we analyzed data from patients with low- and intermediate-risk prostate cancer treated with extreme hypofractionated radiotherapy (RT) and simultaneous boost to the intraprostatic lesion. The aim of the study is to identify clinically meaningful information through the analysis of validated questionnaires testing gastrointestinal (GI) and genitourinary (GU) RT-related toxicity and their impact on quality of life (QoL). At the end of RT treatment, clinical assessment and prostate-specific antigen (PSA) measurements were performed every 3 months for at least 2 years and GI and GU toxicities were evaluated contextually. QoL of enrolled patients was assessed by International Prostate Symptoms score (IPSS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), EORTC QLQ prostate specific (QLQ-PR25), and sexual activity by International Index of Erectile Function (IIEF-5). Patients' score changes were calculated at the end of RT, at one month after RT and at 12 and 24 months. Sixty-five prospectively enrolled patients were analyzed. Extensive analysis of different QoL assessments showed that patients' tolerance was satisfactory across all the considered time points, with no statistically significant change of QoL from baseline compared to that before RT. Overall survival and biochemical progression-free survival at 2-years were of 98% and 97%, respectively. Despite the toxicity of extreme hypofractionation was low and tumor control was encouraging, a longer follow-up is necessary to confirm our findings. The increasing dose to the dominant intraprostatic lesion does not worsen the RT toxicity and consequently does not affect patients' QoL, thus questioning the possibility of an even more escalated treatment.
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http://dx.doi.org/10.1007/s12032-020-01397-3DOI Listing
July 2020

PROLAPSE: survey about local prostate cancer relapse salvage treatment with external beam re-irradiation: results of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

J Cancer Res Clin Oncol 2020 Sep 24;146(9):2311-2317. Epub 2020 Jun 24.

Advanced Radiation Oncology Department, Cancer Care Center, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Italy.

Purpose: We herein present the results of the first Italian Association of Radiotherapy and Clinical Oncology (AIRO) survey regarding salvage external beam re-irradiation of local prostate cancer relapse named PROLAPSE.

Methods: A questionnaire with 12 items was administered to the 775 Italian radiation oncologist members of the AIRO.

Results: One hundred of the members completed the survey. The survey highlighted that 59% of the participants are currently performing prostate re-EBRT, while nearly two-thirds (65%) affirmed that they are taking into consideration the procedure in case of intraprostatic relapse. Regarding the clinical target volume (CTV), only a minority (16%) declared to always prefer the partial prostate re-irradiation, while a consistent portion (nearly two-thirds) relied on clinical considerations of the choice towards partial or whole gland irradiation. The main techniques used for re-irradiation resulted to be intensity-modulated RT (IMRT)/volumetric modulated arc therapy (VMAT) and SBRT, having received approximately 40% of responses each. Regarding the criteria for patients' selection, more than 75% of responders agreed on the use of positron emission tomography (PET)/computed tomography (CT)-choline to exclude distant metastases and of multiparametric magnetic resonance imaging (mp-MRI) to detect intraprostatic recurrence. A sufficient timeframe (> 3 years) between primary RT and reirradiation was indicated by more than half of participants as an important driver in decision-making, while histological confirmation of the relapse was considered not essential by more than two-thirds. For the use of concomitant androgen deprivation therapy (ADT), most AIRO members (79%) agreed that the prescription should be based on a case-by-case analysis. Extreme hypofractionation (> 5 Gy/fraction) was preferred by the majority (52%) of the AIRO members. In most centers (more than 74%), the planning dose-volume constraints were generally extrapolated from the published data. In half of the cases, the interviewed responders affirmed that no major gastrointestinal (GI) and genitourinary (GU) toxicities were registered in the follow-up of their re-EBRT patients. Bladder complications represented the most commonly observed form of toxicity, with an incidence of 67%.

Conclusion: This first AIRO survey about salvage prostate re-EBRT provides an interesting snapshot and suggests increasing interest in re-EBRT patients in Italy. Consensus about some aspects of patients' selection, the necessity of biopsy, fractionation, and highly selective techniques seems feasible, but other key points such as irradiated volume, dosimetry parameters, and hormonal treatment association need to be clarified.
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http://dx.doi.org/10.1007/s00432-020-03297-5DOI Listing
September 2020

Machine Learning-Based Models for Prediction of Toxicity Outcomes in Radiotherapy.

Front Oncol 2020 5;10:790. Epub 2020 Jun 5.

Division of Radiotherapy, IEO European Institute of Oncology IRCCS, Milan, Italy.

In order to limit radiotherapy (RT)-related side effects, effective toxicity prediction and assessment schemes are essential. In recent years, the growing interest toward artificial intelligence and machine learning (ML) within the science community has led to the implementation of innovative tools in RT. Several researchers have demonstrated the high performance of ML-based models in predicting toxicity, but the application of these approaches in clinics is still lagging, partly due to their low interpretability. Therefore, an overview of contemporary research is needed in order to familiarize practitioners with common methods and strategies. Here, we present a review of ML-based models for predicting and classifying RT-induced complications from both a methodological and a clinical standpoint, focusing on the type of features considered, the ML methods used, and the main results achieved. Our work overviews published research in multiple cancer sites, including brain, breast, esophagus, gynecological, head and neck, liver, lung, and prostate cancers. The aim is to define the current state of the art and main achievements within the field for both researchers and clinicians.
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http://dx.doi.org/10.3389/fonc.2020.00790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289968PMC
June 2020

Head and neck cancer radiotherapy amid COVID-19 pandemic: Report from Milan, Italy.

Head Neck 2020 Jul 18;42(7):1482-1490. Epub 2020 Jun 18.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Background: Management of head and neck cancers (HNC) in radiation oncology in the coronavirus disease 2019 (COVID-19) era is challenging. Aim of our work is to report organization strategies at a radiation therapy (RT) department in the first European area experiencing the COVID-19 pandemic.

Methods: We focused on (a) dedicated procedures for HNC, (b) RT scheduling, and (c) health care professionals' protection applied during the COVID-19 breakdown (from March 1, 2020 to April 30, 2020).

Results: Applied procedures are reported and discussed. Forty-three patients were treated. Image-guided, intensity modulated RT was performed in all cases. Median overall treatment time was 50 (interquartile range: 47-54.25) days. RT was interrupted/delayed in seven patients (16%) for suspected COVID-19 infection. Two health professionals managing HNC patients were proven as COVID-19 positive.

Conclusion: Adequate and well-timed organization allowed for the optimization of HNC patients balancing at the best of our possibilities patients' care and personnel's safety.
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http://dx.doi.org/10.1002/hed.26319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323327PMC
July 2020

Influence of different urinary bladder filling levels and controlling regions of interest selection on deformable image registration algorithms.

Phys Med 2020 May 27;75:19-25. Epub 2020 May 27.

Unit of Medical Physics, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, I 20132 Milan, Italy.

Purpose: Evaluation of Raystation ANAtomically CONstrained Deformation Algorithm (ANACONDA) performance to different urinary bladder filling levels in male pelvis anatomic site varying the controlling Regions Of Interest (ROIs).

Methods: Different image datasets were obtained with ImSimQA (Oncology System Limited, Shrewsbury, UK) to evaluate ANACONDA performances (RaySearch Laboratories, Stockholm, Sweden). Deformation vector fields were applied to a synthetic man pelvis and a real patient computed tomography (CT) dataset (reference CTs) resulting in deformed CTs (target CTs) with various bladder filling levels. Different deformable image registrations (DIRs) were generated between each target CTs and reference CTs varying the controlling ROIs subset. Deformed ROIs were mapped from target CT to reference CT and then compared to reference ROIs. Evaluation was performed by Dice Similarity Coefficient (DSC), Correlation Coefficient (CC), Mean Distance to Agreement (MDA), maximum Distance to Agreement (maxDA) and with the introduction of global DSC (global_DSC) and global CC (global_CC) parameters.

Results: In both synthetic and real patient CT cases, DSC scored less than 0.75 and MDA greater than 3 mm when no ROIs or only bladder were exploited as controlling ROI. DSC and CC increased by increasing the number of controlling ROIs selected whereas, an opposite behavior was observed for MDA and maxDA.

Conclusions: ANACONDA performances can be influenced by bladder filling fluctuation if no controlling ROIs are selected. Global_DSC and global_CC are useful parameters to quantitatively compare DIR algorithms. DIR performances improve by increasing the number of controlling ROIs selected, reaching a saturation level after a defined ROIs subset selection.
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http://dx.doi.org/10.1016/j.ejmp.2020.05.016DOI Listing
May 2020

COVID-19 outbreak and cancer radiotherapy disruption in Italy: Survey endorsed by the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Radiother Oncol 2020 08 12;149:89-93. Epub 2020 May 12.

Radiation Oncology Division, Oncology and Speciality Medicine Department, San Camillo-Forlanini Hospital, Roma, Italy; President of AIRO (Italian Association of Radiotherapy and Clinical Oncology), Italy.

Italy experienced one of the world's deadliest COVID-19 outbreaks and healthcare systems had to instantly reorganise activity. The Italian Radiation Oncology Departments adapted numerous solutions to minimize the disruptions. Information technologies, treatment prioritization and implementation of hypofractionation and protection procedures allowed balancing between cancer patient care and patient/healthcare workers safety.
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http://dx.doi.org/10.1016/j.radonc.2020.04.061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7215158PMC
August 2020

Prognostic significance of neutrophil-to-lymphocyte ratio in HPV status era for oropharyngeal cancer.

Oral Dis 2020 Oct 13;26(7):1384-1392. Epub 2020 May 13.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Aim: To evaluate the role of baseline neutrophil-to-lymphocyte ratio (NLR) as prognostic marker in squamous cell carcinoma of the oropharynx (OPC) treated with definitive chemoradiotherapy (CRT) in the era of HPV status.

Patients And Methods: A retrospective analysis of 125 patients (pts) affected with locally advanced OPC was performed. Inclusion criteria were age >18 years, stage III or IV (TNM 7th ed.) and definitive CRT. Haematological marker for their independent role as prognostic biomarkers for progression-free survival (PFS) and overall survival (OS). Logistic models were used to assess the association with downstage in TNM 8th ed.

Results: Seventy-seven (61.6%) pts had HPV/p16 + related OPC. Therapeutic choice consisted in sequential and concurrent CRT. Median follow-up was 50 months. A value of NLR ≥3 was associated with poorer OS. Two-year OS was 91% and 81% in pts with NLR <3 and ≥3, respectively.

Conclusion: A baseline NLR ≥ 3 at treatment initiation represented a negative prognostic marker for OPC treated with definitive CRT. These results are in line with literature data, and prognostic value of NLR has been confirmed restaging our cohort with new TNM staging (8th ed.). Therefore, NLR could be considered a valuable biomarker for risk stratification in pts with OPC.
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http://dx.doi.org/10.1111/odi.13366DOI Listing
October 2020

A novel nomogram to identify candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings.

BJU Int 2020 07 1;126(1):104-113. Epub 2020 Apr 1.

Department of Urology, IEO European Institute of Oncology, IRCCS, Milan, Italy.

Objectives: To develop a novel nomogram to identify candidates for active surveillance (AS) that combines clinical, biopsy and multiparametric magnetic resonance imaging (mpMRI) findings; and to compare its predictive accuracy to, respectively: (i) Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, (ii) Johns Hopkins (JH) criteria, (iii) European Association of Urology (EAU) low-risk classification, and (iv) EAU low-risk or low-volume with International Society of Urological Pathology (ISUP) Grade Group (GG) 2 classification.

Patients And Methods: We selected 1837 patients with ISUP GG1 or GG2 prostate cancer (PCa), treated with radical prostatectomy (RP) between 2012 and 2018. The outcome of interest was the presence of unfavourable disease (i.e., clinically significant PCa [csPCa]) at RP, defined as: ISUP GG 3 and/or pathological T stage (pT) ≥3a and/or pathological N stage (pN) 1. First, logistic regression models including PRIAS, JH, EAU low-risk, and EAU low-risk or low-volume ISUP GG2 binary classifications (not eligible vs eligible) were used. Second, a multivariable logistic regression model including age, prostate-specific antigen density (PSA-D), ISUP GG, and the percentage of positive cores (Model 1) was fitted. Third, Prostate Imaging-Reporting and Data System (PI-RADS) score (Model 2), extracapsular extension (ECE) score (Model 3) and PI-RADS + ECE score (Model 4) were added to Model 1. Only variables associated with higher csPCa rates in Model 4 were retained in the final simplified Model 5. The area under the receiver operating characteristic curve (AUC), calibration plots and decision curve analyses were used.

Results: Of the 1837 patients, 775 (42.2%) had csPCa at RP. Overall, 837 (47.5%), 986 (53.7%), 348 (18.9%), and 209 (11.4%) patients were eligible for AS according to, respectively, the EAU low-risk, EAU low-risk or low-volume ISUP GG2, PRIAS, and JH criteria. The proportion of csPCa amongst the EAU low-risk, EAU low-risk or low-volume ISUP GG2, PRIAS and JH candidates was, respectively 28.5%, 29.3%, 25.6% and 17.2%. Model 4 and Model 5 (in which only PSA-D, ISUP GG, PI-RADS and ECE score were retained) had a greater AUC (0.84), compared to the four proposed AS criteria (all P < 0.001). The adoption of a 25% nomogram threshold increased the proportion of AS-eligible patients from 18.9% (PRIAS) and 11.4% (JH) to 44.4%. Moreover, the same 25% nomogram threshold resulted in significantly lower estimated risks of csPCa (11.3%), compared to PRIAS (Δ: -14.3%), JH (Δ: -5.9%), EAU low-risk (Δ: -17.2%), and EAU low-risk or low-volume ISUP GG2 classifications (Δ: -18.0%).

Conclusion: The novel nomogram combining clinical, biopsy and mpMRI findings was able to increase by ~25% and 35% the absolute frequency of patients suitable for AS, compared to, respectively, the PRIAS or JH criteria. Moreover, this nomogram significantly reduced the estimated frequency of csPCa that would be recommended for AS compared to, respectively, the PRIAS, JH, EAU low-risk, and EAU low-risk or low-volume ISUP GG2 classifications.
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http://dx.doi.org/10.1111/bju.15048DOI Listing
July 2020

Stereotatic radiotherapy in metastatic non-small cell lung cancer: Combining immunotherapy and radiotherapy with a focus on liver metastases.

Lung Cancer 2020 04 25;142:70-79. Epub 2020 Feb 25.

Division of Radiation Oncology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy.

Presence of liver metastases correlates with worse survival and response to any treatments. This may be due to the microenvironment of liver which leads tumor to escape from Immune System. Stereotactic Body Radiation Therapy may help to sensitize Immune System and to improve the immunotherapy effect. Interest is being directed toward combining Immune-Checkpoint Inhibitors with radiotherapy to improve response to immunotherapy. However, the mechanisms by which radiation induces anti-tumor T-cells remain unclear. Preclinical studies founded radiotherapy enhances antitumor immune responses, increasing tumor antigen release, and inducing T-cell infiltration. Radiotherapy is under investigation for its ability to enhance responses to immunotherapy. Nevertheless, how to optimally deliver combination therapy regarding dose-fractionation and timing of radiotherapy is unknown. The aim of this review is to explore the role of Stereotactic Body Radiation Therapy in metastatic non-small cell lung cancer, focusing on patients with liver metastases, and the possible immunological implications combining immunotherapy and radiotherapy.
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http://dx.doi.org/10.1016/j.lungcan.2020.02.017DOI Listing
April 2020

Effects of MRI image normalization techniques in prostate cancer radiomics.

Phys Med 2020 Mar 18;71:7-13. Epub 2020 Feb 18.

Division of Radiotherapy, European Institute of Oncology IRCCS, via Ripamonti 435, Milan, Italy; Department of Oncology and Hemato-oncology, University of Milan, via Ripamonti 435, Milan, Italy.

The variance in intensities of MRI scans is a fundamental impediment for quantitative MRI analysis. Intensity values are not only highly dependent on acquisition parameters, but also on the subject and body region being scanned. This warrants the need for image normalization techniques to ensure that intensity values are consistent within tissues across different subjects and visits. Many intensity normalization methods have been developed and proven successful for the analysis of brain pathologies, but evaluation of these methods for images of the prostate region is lagging. In this paper, we compare four different normalization methods on 49 T2-w scans of prostate cancer patients: 1) the well-established histogram normalization, 2) the generalized scale normalization, 3) an extension of generalized scale normalization called generalized ball-scale normalization, and 4) a custom normalization based on healthy prostate tissue intensities. The methods are compared qualitatively and quantitatively in terms of behaviors of intensity distributions as well as impact on radiomic features. Our findings suggest that normalization based on prior knowledge of the healthy prostate tissue intensities may be the most effective way of acquiring the desired properties of normalized images. In addition, the histogram normalization method outperform the generalized scale and generalized ball-scale methods which have proven superior for other body regions.
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http://dx.doi.org/10.1016/j.ejmp.2020.02.007DOI Listing
March 2020

Soft tissue necrosis in patients treated with transoral robotic surgery and postoperative radiotherapy: preliminary results.

Tumori 2020 Dec 30;106(6):471-479. Epub 2020 Jan 30.

Department of Radiotherapy, IEO, European Institute of Oncology, IRCCS, Milan, Italy.

Objective: Postoperative radiotherapy (PORT) is indicated in almost two-thirds of patients treated with transoral robotic surgery (TORS) for head and neck tumors. The aim of this study was to quantify the toxicity profile of patients treated with PORT after TORS in oropharyngeal and supraglottic laryngeal cancer focusing on soft tissue necrosis (STN).

Methods: We retrospectively reviewed 28 patients. Acute and late toxicity were examined. Incidence and severity of STN were recorded.

Results: No patient experienced acute grade 3 skin or mucosal toxicity; 1 patient had grade 3 dysphagia. At 12 months, no evaluated patient required enteral nutrition and 2 patients had tracheostomy. STN occurred in 4 (14%) patients: 3 out of 4 (75%) patients with STN had diabetes, whereas 6 out of 13 (25%) patients without STN had diabetes ( = 0.05).

Conclusion: We found an acceptable toxicity profile of PORT performed after a TORS procedure. Diabetes mellitus might be a risk factor for STN.
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http://dx.doi.org/10.1177/0300891619900920DOI Listing
December 2020

Long-Term Results and Reconstruction Failure in Patients Receiving Postmastectomy Radiation Therapy with a Temporary Expander or Permanent Implant in Place.

Plast Reconstr Surg 2020 Feb;145(2):317-327

From the Division of Radiation Oncology, Division of Epidemiology and Biostatistics, Unit of Medical Physics, Division of Plastic and Reconstructive Surgery, Division of Breast Surgery, and the Scientific Directorate, IEO, European Institute of Oncology IRCCS; and the Department of Oncology and Hemato-oncology, University of Milan.

Background: This study investigated the risk of reconstruction failure after mastectomy, immediate breast reconstruction, and radiotherapy to either a temporary tissue expander or permanent implant.

Methods: Records of women treated at a single institution between June of 1997 and December of 2011 were reviewed. Two patient groups were identified based on type of immediate breast reconstruction: tissue expander followed by exchange with a permanent implant and permanent implant. The study endpoint was rate of reconstruction failure, defined as a replacement, loss of the implant, or conversion to flap.

Results: The tissue expander/permanent implant and the permanent implant groups consisted of 63 and 75 patients, respectively. The groups were well balanced for clinical and treatment characteristics. With a median follow-up of 116 months, eight implant losses, 50 implant replacements, and four flap conversions were recorded. Reconstruction failure occurred in 22 of 63 patients in the expander/implant group and in 40 of 75 patients in the permanent implant group. A traditional proportional hazards model showed a higher risk of reconstruction failure for the expander/implant group (hazard ratio, 2.01) and a significantly shorter time to reconstruction failure compared with the permanent implant group (109.2 months versus 157.7 months; p = 0.03); however, according to a competing risk model, the between-groups cumulative incidences were not significantly different (hazard ratio, 1.09).

Conclusions: Radiotherapy to either a tissue expander or a permanent implant presented a fairly large risk of reconstruction failure over time. The expander/implant group was not more likely to develop reconstruction failure compared to permanent implant group, but the timing of onset was shorter. More complex techniques should be investigated to lower the risk of reconstruction failure.

Clinical Question/level Of Evidence: Therapeutic, III.
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http://dx.doi.org/10.1097/PRS.0000000000006441DOI Listing
February 2020