Publications by authors named "Vittorio Donato"

33 Publications

Radiotherapy with Intensity-Modulated (IMRT) Techniques in the Treatment of Anal Carcinoma (RAINSTORM): A Multicenter Study on Behalf of AIRO (Italian Association of Radiotherapy and Clinical Oncology) Gastrointestinal Study Group.

Cancers (Basel) 2021 Apr 15;13(8). Epub 2021 Apr 15.

Laboratory of Biostatistics, Department of Medical, Oral and Biotechnological Sciences, "G. D'Annunzio" University of Chieti-Pescara, 66100 Chieti, Italy.

A multi-institutional retrospective study was conducted to evaluate the pattern of care and clinical outcomes of anal cancer patients treated with intensity-modulated radiotherapy (IMRT) techniques. In a cohort of 987 patients, the clinical complete response (CR) rate (beyond 6 months) was 90.6%. The 3-year local control (LC) rate was 85.8% (95% CI: 84.4-87.2), and the 3-year colostomy-free survival (CFS) rate was 77.9% (95% CI: 76.1-79.8). Three-year progression-free survival (PFS) and overall survival (OS) rates were 80.2% and 88.1% (95% CI: 78.8-89.4) (95% CI: 78.5-81.9), respectively. Histological grade 3 and nodal involvement were associated with lower CR ( = 0.030 and = 0.004, respectively). A statistically significant association was found between advanced stage and nodal involvement, and LC, CFS, PFS, OS and event-free survival (EFS). Overall treatment time (OTT) ≥45 days showed a trend for a lower PFS ( = 0.050) and was significantly associated with lower EFS ( = 0.030) and histological grade 3 with a lower LC ( = 0.025). No statistically significant association was found between total dose, dose/fraction and/or boost modality and clinical outcomes. This analysis reports excellent clinical results and a mild toxicity profile, confirming IMRT techniques as standard of care for the curative treatment of anal cancer patients. Lymph node involvement and histological grade have been confirmed as the most important negative prognostic factors.
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http://dx.doi.org/10.3390/cancers13081902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8071256PMC
April 2021

Treatment Volume, Dose Prescription and Delivery Techniques for Dose-intensification in Rectal Cancer: A National Survey.

Anticancer Res 2021 Apr;41(4):1985-1995

Radiation Oncology Unit, "SS Annunziata" Hospital, "G. D'Annunzio" University, Chieti, Italy.

Background/aim: The aim of the study was to investigate boost volume definition, doses, and delivery techniques for rectal cancer dose intensification.

Patients And Methods: An online survey was made on 25 items (characteristics, simulation, imaging, volumes, doses, planning and treatment).

Results: Thirty-eight radiation oncologists joined the study. Twenty-one delivered long-course radiotherapy with dose intensification. Boost volume was delineated on diagnostic magnetic resonance imaging (MRI) in 18 centres (85.7%), and computed tomography (CT) and/or positron emission tomography-CT in 9 (42.8%); 16 centres (76.2%) performed co-registration with CT-simulation. Boost dose was delivered on gross tumor volume in 10 centres (47.6%) and on clinical target volume in 11 (52.4%). The most common total dose was 54-55 Gy (71.4%), with moderate hypofractionation (85.7%). Intensity-modulated radiotherapy (IMRT) was used in all centres, with simultaneous integrated boost in 17 (80.8%) and image-guidance in 18 (85.7%).

Conclusion: A high quality of treatment using dose escalation can be inferred by widespread multidisciplinary discussion, MRI-based treatment volume delineation, and radiation delivery relying on IMRT with accurate image-guided radiation therapy protocols.
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http://dx.doi.org/10.21873/anticanres.14966DOI Listing
April 2021

Outcomes and toxicities of re-irradiation for prostate cancer: A systematic review on behalf of the Re-Irradiation Working Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Cancer Treat Rev 2021 Apr 8;95:102176. Epub 2021 Mar 8.

Department of Radiological, Radiotherapy and Hematology Sciences, Fondazione Policlinico Universitario "A. Gemelli", Catholic University of Sacred Heart, Via della Pineta Sacchetti, 217, 00168 Rome, Italy.

Aims: The best therapeutic approach for local relapses of previously irradiated prostate cancer (PC) is still not defined. Re-irradiation (Re-I) could offer a chance of cure for highly selected patients, although high quality evidences are lacking. The aim of our study is to provide a literature review on efficacy and safety of Re-I.

Methods: Only studies where Re-I field overlaps with previous radiotherapy were considered. To determine 2 and 4 years overall mortality (OM), 2 and 4 years biochemical failure (BF) and pooled acute and late G ≥ 3 toxicities rate, a meta-analysis over single arm study was performed.

Results: Thirty-eight studies with 1194 patients were included. Median follow-up from Re-I was 30 months (10-94 months). Brachytherapy (BRT) was the most used Re-I technique (27 studies), followed by Stereotactic Body Radiotherapy (SBRT) (9) and External Beam Radiation Therapy (EBRT) (2). Re-I prescription doses ranged from 19 Gy in single HDR fraction to 145 Gy (interstitial BRT). The pooled 2 and 4 years OM rates were 2.1% (95%CI:1.1-3.7%, P < 0.001) and 12.5% (95%CI:8.1-19.5%; P < 0.001). The pooled 2 years BF rate was 24% (95% CI: 19.1-30.2%, P < 0.001). The pooled 4 years BF was 35.6% (95% CI: 28.7-44.3%, P < 0.001). The pooled result of G ≥ 3 acute toxicity was 1.4% (95%CI: 0.7-3%, P < 0.001). One hundred and three G ≥ 3 late adverse events were reported, with a pooled result of G ≥ 3 late toxicity of 8.7% (95%CI: 5.8-13%, P < 0.001).

Conclusions: Re-I of local failures from PC showed promising OM and biochemical control rates with a safe toxicity profile.
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http://dx.doi.org/10.1016/j.ctrv.2021.102176DOI Listing
April 2021

Radiation treatment for adult rare cancers: Oldest and newest indication.

Crit Rev Oncol Hematol 2021 Mar 27;159:103228. Epub 2021 Jan 27.

Radiation Oncology Department, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy.

Aim: Aim of this analysis is to review the role of RT in the management of several rare tumors for adult patients.

Methods: Collection data regarding RT and rare tumors was made by Pubmed.

Results: For mucosal melanomas, RT is prescribed, being associated with lower local recurrence rate. For trachea tumors, RT was used as adjuvant or salvage treatment for unresectable disease. For pNET, RT can be a suitable option for post-surgical or unresectable/borderline. For bronchopulmonary neuroendocrine tumors the role of adjuvant treatments is uncertain. For hepatobiliary and ovarian malignancy, stereotactic body RT (SBRT) is a promising approach. For soft tissue sarcoma, perioperative treatments are indicated, and a growing role of SBRT in oligometastatic disease is recognized. For endocrine tumors, adjuvant RT has demonstrated benefits through reducing recurrence risk.

Conclusion: The radiotherapy is a frequent indication in adult rare cancers; thus the role of Radiation Oncologist must not be neglected.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103228DOI Listing
March 2021

INTERACTS (INTErventional Radiotherapy ACtive Teaching School) consensus conference on sarcoma interventional radiotherapy (brachytherapy) endorsed by AIRO (Italian Association of Radiotherapy and Clinical Oncology).

J Contemp Brachytherapy 2020 Aug 21;12(4):397-404. Epub 2020 Aug 21.

Radiotherapy Department, University of Florence, Florence, Italy.

Purpose: To report the results of INTERACTS (INTErventional Radiotherapy ACtive Teaching School) consensus conference on sarcoma interventional radiotherapy (brachytherapy).

Material And Methods: An international board of multidisciplinary experts was invited to a consensus conference on the state-of-the-art of sarcoma interventional oncology during the 9 Rome INTER-MEETING (INTERventional Radiotherapy Multidisciplinary Meeting), proposing 3 statements for each one speech. At the end of each lecture, the entire group of experts was invited to vote with an electronic device. The preliminary results were presented and discussed at the end of the meeting, during a dedicated session. After the meeting, a survey was distributed within the consensus conference board to share and definitively vote the statements.

Results: All the invited authors of the consensus conference board completed the final survey. All the 38 statements received more than 70% of agreement, 31 statements (82%) obtained an agreement of level higher or equal to 90%, 6 statements (15.8%) received an agreement level between 80% and 90%, and 1 statement (2.6%) had less than 80% of agreement.

Conclusions: The consensus conference demonstrated that interventional radiotherapy must be considered by a multidisciplinary management of patients affected by sarcoma.
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http://dx.doi.org/10.5114/jcb.2020.98120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690224PMC
August 2020

A snapshot on radiotherapy for head and neck cancer patients during the COVID-19 pandemic: a survey of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) head and neck working group.

Radiol Med 2021 Feb 6;126(2):343-347. Epub 2020 Oct 6.

National Center of Oncological Hadrontherapy (Fondazione CNAO), Strada Campeggi, 53, 27100, Pavia, Italy.

Objectives: The objective of the paper was to assess real-life experience in the management of head and neck cancer (HNC) patients during the COVID-19 pandemic in radiotherapy departments and to evaluate the variability in terms of adherence to American Society of Radiation Oncology (ASTRO) and European Society for Radiotherapy and Oncology (ESTRO) recommendations.

Materials And Methods: In May 2020, an anonymous 30-question online survey, comparing acute phase of outbreak and pre-COVID-19 period, was conducted. Two sections exploited changes in general management of HNC patients and different HNC primary tumors, addressing specific statements from ASTRO ESTRO consensus statement as well.

Results: Eighty-eight questionnaires were included in the demographic/clinical workflow analysis, and 64 were analyzed for treatment management. Forty-eight percent of radiotherapy departments became part of oncologic hubs. First consultations reduced, and patients were addressed to other centers in 33.8 and 18.3% of cases, respectively. Telematic consultations were used in 50% of follow-up visits and 73.9% of multidisciplinary tumor board discussions. There were no practical changes in the management of patients affected by different primitive HNCs. Hypofractionation was not favored over conventional schedules.

Conclusions: Compared to pre-COVID era, the clinical workflow was highly re-organized, whereas there were no consistent changes in RT indications and schedules.
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http://dx.doi.org/10.1007/s11547-020-01296-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538045PMC
February 2021

Italian consensus conference on management of uterine sarcomas on behalf of S.I.G.O. (Societa' italiana di Ginecologia E Ostetricia).

Eur J Cancer 2020 11 29;139:149-168. Epub 2020 Sep 29.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology Unit, Roma, Italy; Universita' Cattolica Del Sacro Cuore, Roma, Italy.

Background: Uterine sarcomas are very rare tumours with different histotypes, molecular features and clinical outcomes; therefore, it is difficult to carry out prospective clinical trials, and this often results in heterogeneous management of patients in the clinical practice.

Aim: We planned to set up an Italian consensus conference on these diseases in order to provide recommendations on treatments and quality of care in our country.

Results: Early-stage uterine sarcomas are managed by hysterectomy + bilateral salpingo-oophorectomy according to menopausal status and histology; lymphadenectomy is not indicated in patients without bulky nodes, and morcellation must be avoided. The postoperative management is represented by observation, even though chemotherapy can be considered in some high-risk patients. In early-stage low-grade endometrial stromal sarcoma and adenosarcomas without sarcomatous overgrowth, hormonal adjuvant treatment can be offered based on hormone receptor expression. In selected cases, external beam radiotherapy ± brachytherapy can be considered to increase local control only. Patients with advanced disease involving the abdomen can be offered primary chemotherapy (or hormonal therapy in the case of low-grade endometrial stromal sarcoma and adenosarcoma without sarcomatous overgrowth), even if potentially resectable in the absence of residual disease in order to test the chemosensitivity (or hormonosensitivity); debulking surgery can be considered in patients with clinical and radiological response. Chemotherapy is based on anthracyclines ± ifosfamide or dacarbazine. Palliative radiotherapy can be offered for symptom control, and stereotactic radiotherapy can be used for up to five isolated metastatic lesions.

Conclusions: Treatment of uterine sarcoma should be centralised at referral centres and managed in a multidisciplinary setting.
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http://dx.doi.org/10.1016/j.ejca.2020.08.016DOI Listing
November 2020

Head and neck radiotherapy amid the COVID-19 pandemic: practice recommendations of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Med Oncol 2020 Aug 17;37(10):85. Epub 2020 Aug 17.

Department of Radiotherapy, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Management of patients with head and neck cancers (HNCs) is challenging for the Radiation Oncologist, especially in the COVID-19 era. The Italian Society of Radiotherapy and Clinical Oncology (AIRO) identified the need of practice recommendations on logistic issues, treatment delivery and healthcare personnel's protection in a time of limited resources. A panel of 15 national experts on HNCs completed a modified Delphi process. A five-point Likert scale was used; the chosen cut-offs for strong agreement and agreement were 75% and 66%, respectively. Items were organized into two sections: (1) general recommendations (10 items) and (2) special recommendations (45 items), detailing a set of procedures to be applied to all specific phases of the Radiation Oncology workflow. The distribution of facilities across the country was as follows: 47% Northern, 33% Central and 20% Southern regions. There was agreement or strong agreement across the majority (93%) of proposed items including treatment strategies, use of personal protection devices, set-up modifications and follow-up re-scheduling. Guaranteeing treatment delivery for HNC patients is well-recognized in Radiation Oncology. Our recommendations provide a flexible tool for management both in the pandemic and post-pandemic phase of the COVID-19 outbreak.
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http://dx.doi.org/10.1007/s12032-020-01409-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430932PMC
August 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

Re-irradiation with curative intent in patients with squamous cell carcinoma of the head and neck: a national survey of usual practice on behalf of the Italian Association of Radiation Oncology (AIRO).

Eur Arch Otorhinolaryngol 2018 Feb 26;275(2):561-567. Epub 2017 Dec 26.

Radiation Oncology Department, Azienda Ospedaliera Sant'Andrea, Roma, Italy.

Objective: To report the results of a national survey investigating the pattern of practice of curative re-irradiation (ReRT) for recurrent squamous cell carcinoma of the head and neck.

Methods: In March 2016, a 22-item, 4-section questionnaire was sent to all Italian Radiation Oncology centers. Sections were focused on assessing the expertise level of each center and collecting specific information on reRT prescription modalities in the adjuvant and definitive settings.

Results: Overall, 77 centers completed the survey. The majority (50/77, 64.9%) of participating radiation oncologists were senior consultants (> 10 years of experience). Of the responding centers, 63 (81.8%) performed curative ReRT, while 14 (18.1%) did not, mainly (5/14, 35.7%) due to the avoidance of severe toxicity. The use of adjuvant ReRT was reported by less than half of the interviewed radiation oncologists (36/77, 46.7%). In case of unresectable local recurrence, definitive ReRT was claimed to be adopted in 55/77 (71.4%) for non-nasopharyngeal and 47/77 (61%) for nasopharyngeal cancer. The preferred treatment technique was Intensity Modulated Radiation Therapy (IMRT) followed by Stereotactic Body Radiation Therapy (SBRT). When IMRT was applied, the most common (19/55 responders, 34.5%) selection of treatment volume consisted of the Gross Tumor Volume (GTV) + 0.5 cm margin to account for microscopic disease.

Conclusion: Despite the absence of definitive evidence-based recommendations, a possible consideration for ReRT in case of unresectable recurrent head and neck cancer was reported by over 80% of radiation oncologists taking part in the national survey.
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http://dx.doi.org/10.1007/s00405-017-4853-8DOI Listing
February 2018

Policies for reirradiation of recurrent high-grade gliomas: a survey among Italian radiation oncologists.

Tumori 2018 Dec 8;104(6):466-470. Epub 2018 May 8.

29 Radiation Therapy, Azienda Ospedaliera Sant'Andrea, Rome - Italy.

Purpose: To assess the contribution of Italian radiation oncologists in the current management of recurrent high-grade gliomas (HGG), focusing on a reirradiation (reRT) approach.

Methods: In 2015, the Reirradiation and the Central Nervous System Study Groups on behalf of the Italian Association of Radiation Oncology (AIRO) proposed a survey. All Italian radiation oncologists were individually invited to complete an online questionnaire regarding their clinical management of recurrent HGG, focusing on a reRT approach.

Results: A total of 37 of 210 questionnaires were returned (18% of all centers): 16 (43%) from nonacademic hospitals, 14 (38%) from academic hospitals, 5 (13%) from private institutions, and 2 (6%) from hadron therapy centers. The majority of responding centers (59%) treated ≤5 cases per year. Performance status at the time of recurrence, along with a target diameter <5 cm and an interval from primary radiation ≥6 months, were the prevalent predictive factors considered for reRT. Sixty percent of reirradiated patients had already received a salvage therapy, either chemotherapy (40%) or reoperation (20%). The most common approach for reRT was fractionated stereotactic radiotherapy to a mean (photon) dose of 41.6 Gy.

Conclusions: Although there were wide variations in the clinical practice of reRT across the 37 centers, the core activities were reasonably consistent. These findings provide a basis for encouraging a national collaborative study to develop, implement, and monitor the use of reRT in this challenging clinical setting.
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http://dx.doi.org/10.5301/tj.5000615DOI Listing
December 2018

Treatment outcomes and patterns of radiologic appearance after hypofractionated image-guided radiotherapy delivered with helical tomotherapy (HHT) for lung tumours.

Br J Radiol 2017 Mar;90(1071):20160853

1 Department of Radiation Oncology, San Camillo-Forlanini Hospitals, Rome, Italy.

Objective: To evaluate treatment outcomes and patterns of CT lung injury after hypofractionated image-guided radiotherapy delivered with helical tomotherapy (HHT) in a series of inoperable lung lesions.

Methods: 68 patients who were medically inoperable (69 lesions) without evidence of viable extrathoracic disease were included. Dose prescription was driven by tumour location (hilar/pericentral vs peripheral) and/or target volume. 52% of the lesions received a biological equivalent dose (BED) ≥100 Gy. Assessment of tumour response was based on the Response Evaluation Criteria in Solid Tumours 1.1 criteria coupled with fluorine-18 fludeoxyglucose/positron emission tomography-CT. Toxicity monitoring was focused on treatment-related pulmonary adverse events according to the Common Terminology Criteria for Adverse Events v. 4.0. Acute and late events were classified as radiation pneumonitis (RP) and radiation fibrosis (RF), respectively. Survival curves were calculated using the Kaplan-Meier method. Univariate and multivariate analyses of survival were performed using the Cox proportional hazards model.

Results: After a median follow-up of 12 months (range, 3-31 months), no instances of ≥Grade 4 RP was documented, and clinically severe (Grade 3) RP occurred in 5.8% of the patients. 2 (3%) patients developed a late severe (≥Grade 3) symptomatic RF. No specific pattern of CT lung injury was demonstrated, in both acute and late settings. Median overall survival (OS) and progression-free survival (PFS) for the entire population were 30.8 and 14.1 months, respectively. At multivariate analysis (MVA), BED ≥ 100 Gy and KPS ≥ 90 emerged as significant prognostic factors for OS (p = 0.01 and p = 0.001, respectively), and BED ≥ 100 Gy for PFS (p = 0.02).

Conclusion: Our findings show that HHT adjusted for tumour location and/or target volume is an effective treatment with an acceptable toxicity profile in patients who are medically inoperable with lung tumours and is not associated with a specific pattern of lung injury. Therefore, it can represent a viable option when conventional stereotactic ablative radiotherapy facilities are not available. Advances in knowledge: The present study is among the largest series addressing the role of HHT for inoperable lung tumours. This technique is safe and effective and is not associated with a specific pattern of lung injury, at least at early and average time points.
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http://dx.doi.org/10.1259/bjr.20160853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5601537PMC
March 2017

A Voxel-Based Approach to Explore Local Dose Differences Associated With Radiation-Induced Lung Damage.

Int J Radiat Oncol Biol Phys 2016 09 7;96(1):127-33. Epub 2016 May 7.

Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy. Electronic address:

Purpose: To apply a voxel-based (VB) approach aimed at exploring local dose differences associated with late radiation-induced lung damage (RILD).

Methods And Materials: An interinstitutional database of 98 patients who were Hodgkin lymphoma (HL) survivors treated with postchemotherapy supradiaphragmatic radiation therapy was analyzed in the study. Eighteen patients experienced late RILD, classified according to the Radiation Therapy Oncology Group scoring system. Each patient's computed tomographic (CT) scan was normalized to a single reference case anatomy (common coordinate system, CCS) through a log-diffeomorphic approach. The obtained deformation fields were used to map the dose of each patient into the CCS. The coregistration robustness and the dose mapping accuracy were evaluated by geometric and dose scores. Two different statistical mapping schemes for nonparametric multiple permutation inference on dose maps were applied, and the corresponding P<.05 significance lung subregions were generated. A receiver operating characteristic (ROC)-based test was performed on the mean dose extracted from each subregion.

Results: The coregistration process resulted in a geometrically robust and accurate dose warping. A significantly higher dose was consistently delivered to RILD patients in voxel clusters near the peripheral medial-basal portion of the lungs. The area under the ROC curves (AUC) from the mean dose of the voxel clusters was higher than the corresponding AUC derived from the total lung mean dose.

Conclusions: We implemented a framework including a robust registration process and a VB approach accounting for the multiple comparison problem in dose-response modeling, and applied it to a cohort of HL survivors to explore a local dose-RILD relationship in the lungs. Patients with RILD received a significantly greater dose in parenchymal regions where low doses (∼6 Gy) were delivered. Interestingly, the relation between differences in the high-dose range and RILD seems to lack a clear spatial signature.
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http://dx.doi.org/10.1016/j.ijrobp.2016.04.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533285PMC
September 2016

Retreatment for prostate cancer with stereotactic body radiation therapy (SBRT): Feasible or foolhardy?

Rep Pract Oncol Radiother 2015 Nov-Dec;20(6):425-9. Epub 2014 Sep 10.

Department of Radiotherapy, Azienda Ospedaliera S. Camillo-Forlanini, Rome, Italy.

The most popular therapeutic option in the management of radio-recurrent prostatic carcinoma is represented by the androgen deprivation therapy, that however should be considered only palliative and hampered by potential adverse effects of testosterone suppression. Local therapies such as surgery, cryoablation or brachytherapy might be curative choices for patients in good conditions and with a long-life expectancy, but at cost of significant risk of failure and severe toxicity. The administration of stereotactic body radiation therapy (SBRT) in this setting have come about because of tremendous technologic advances in image guidance and treatment delivery techniques that enable the delivery of large doses to tumor with reduced margins and high gradients outside the target, thereby reducing the volume of rectum which already received significant doses from primary radiotherapy. So far, very modest data are available to support its employment. Rationale, clinical experience, and challenges are herein reviewed and discussed.
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http://dx.doi.org/10.1016/j.rpor.2014.08.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4661353PMC
December 2015

Modeling the risk of radiation-induced lung fibrosis: Irradiated heart tissue is as important as irradiated lung.

Radiother Oncol 2015 Oct 12;117(1):36-43. Epub 2015 Aug 12.

Institute of Biostructure and Bioimaging, National Research Council (CNR), Naples, Italy; Department of Advanced Biomedical Sciences, Federico II University School of Medicine, Naples, Italy.

Purpose: We used normal tissue complication probability (NTCP) modeling to explore the impact of heart irradiation on radiation-induced lung fibrosis (RILF).

Materials And Methods: We retrospectively reviewed for RILF 148 consecutive Hodgkin lymphoma (HL) patients treated with sequential chemo-radiotherapy (CHT-RT). Left, right, total lung and heart dose-volume and dose-mass parameters along with clinical, disease and treatment-related characteristics were analyzed. NTCP modeling by multivariate logistic regression analysis using bootstrapping was performed. Models were evaluated by Spearman Rs coefficient and ROC area.

Results: At a median time of 13months, 18 out of 115 analyzable patients (15.6%) developed RILF after treatment. A three-variable predictive model resulted to be optimal for RILF. The two models most frequently selected by bootstrap included increasing age and mass of heart receiving >30Gy as common predictors, in combination with left lung V5 (Rs=0.35, AUC=0.78), or alternatively, the lungs near maximum dose D2% (Rs=0.38, AUC=0.80).

Conclusion: CHT-RT may cause lung injury in a small, but significant fraction of HL patients. Our results suggest that aging along with both heart and lung irradiation plays a fundamental role in the risk of developing RILF.
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http://dx.doi.org/10.1016/j.radonc.2015.07.051DOI Listing
October 2015

Stereotactic body radiation therapy salvage reirradiation of radiorecurrent prostatic carcinoma relapsed in the prostatic bed.

Tumori 2015 Apr 28;101(2):e57-9. Epub 2015 Apr 28.

Department of Radiotherapy, Azienda Ospedaliera S. Camillo-Forlanini, Rome - Italy.

A 67-year-old man presented with a slow increase of prostate-specific antigen value after radical prostatectomy and postoperative radiotherapy for prostate cancer. The patient had received 3D conformal radiotherapy to a total dose of 66 Gy in 33 fractions of 2 Gy each on the prostatic bed. Three years later, a macroscopic local failure was diagnosed at the apical region. The patient could not receive androgenic deprivation therapy or other types of treatment owing to comorbid conditions. Thus, stereotactic body radiation therapy with helical image-guided tomotherapy was administered. The total dose was 30 Gy in 5 consecutive fractions of 6 Gy each to the site of the local failure. The treatment was preceded by a transperineal-guided injection of a self-absorbable hydrogel into the prostatic bed, between rectum and bladder, in order to preserve the rectal wall, which already had received significant doses from the first radiation course. Radiation therapy was well-tolerated. After a follow-up period of 6 months, the patient remains healthy, and there has been no further evidence of metastatic spread or recurrence.
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http://dx.doi.org/10.5301/tj.5000251DOI Listing
April 2015

Moderately Escalated Hypofractionated (Chemo) Radiotherapy Delivered with Helical Intensity-Modulated Technique in Stage III Unresectable Non-Small Cell Lung Cancer.

Front Oncol 2013 18;3:286. Epub 2013 Nov 18.

Department of Radiotherapy, Azienda Ospedaliera S.Camillo-Forlanini , Rome , Italy.

Purpose: To assess clinical outcomes and toxicities in patients with stage III unresectable non-small cell lung cancer (NSCLC) treated with a moderately escalated hypofractionated radiotherapy delivered with Helical Intensity-Modulated Technique in combination with sequential or concurrent chemotherapy.

Materials And Methods: Sixty-one consecutive patients considered non-progressive after two cycles of induction chemotherapy were treated with a moderately escalated hypofractionated radiation course of 30 daily fractions of 2.25-2.28 Gy each administered in 6 weeks up to a total dose of 67.5-68.4 Gy (range, 64.5-71.3 Gy). Thirty-two received sequential RT after two more cycles (total = 4 cycles) of chemotherapy, while 29 were treated with concurrent chemo-radiation. The target was considered the gross tumor volume and the clinically proven nodal regions, without elective nodal irradiation.

Results: With a median follow up of 27 months (range 6-40), 1-year and 2-year OS rate for all patients was 77 and 53%, respectively, with a median survival duration of 18.6 months in the sequential group and 24.1 months in the concomitant group. No Grade ≥4 acute and late toxicity was reported. Acute Grade 3 treatment-related pneumonitis was detected in 10% of patients. Two patients, both receiving the concurrent schedule, developed a Grade 3 acute esophagitis. The overall incidence of late Grade 3 lung toxicity was 5%. No patients experienced a Grade 3 late esophageal toxicity.

Conclusion: A moderately hypofractionated radiation course delivered with a Helical Intensity-Modulated Technique is a feasible treatment option for patients with unresectable locally advanced NSCLC receiving chemotherapy (sequentially or concurrently). Hypofractionated radiotherapy with a dedicated technique allows safely dose escalation, minimizing the effect of tumor repopulation that may occur with prolonged treatment time.
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http://dx.doi.org/10.3389/fonc.2013.00286DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3831267PMC
December 2013

Helical tomotherapy: an innovative radiotherapy technique for the treatment of locally advanced oropharynx and inoperable oral cavity carcinoma.

Radiat Oncol 2013 Sep 10;8:210. Epub 2013 Sep 10.

Department of Radiation Oncology, San Camillo-Forlanini Hospital, Rome, Italy.

Background: To report our initial clinical experience of helical tomotherapy (HT) in the treatment of locally advanced oropharynx and inoperable oral cavity cancer.

Methods: Between February 2008 and January 2011, 24 consecutive patients, 15 with oropharyngeal cancer and 9 with oral cavity cancer were treated with exclusive radiotherapy or concomitant chemoradiotherapy. Simultaneous integrated boost (SIB) in 30 fractions scheme was prescribed to all patients, using Helical Tomotherapy. Doses administered to primary tumor, oropharynx/oral cavity and positive lymph-nodes and negative lymph-nodes were 66-67.5 Gy, 60-63 Gy and 54 Gy, respectively.

Results: Complete response rate for the oropharynx and the oral cavity group was 86.7% and 77.8%, respectively. The 1 and 2-year Overall Survival (OS) and Disease Free Survival (DFS) rate for the oropharynx group was 92.9%, 85.1%, 92.9% and 77.4% respectively. For the oral cavity group, 1 and 2-year OS and DFS rates were 55.6%, 55.6%, 75% and 75%, respectively. No patient developed grade ≥3 mucositis, dysphagia or dermatitis. The maximum late-toxicity grade observed was 2, for all the variables examined.

Conclusions: HT appears to achieve encouraging clinical outcomes in terms of response, survival and toxicity rates.
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http://dx.doi.org/10.1186/1748-717X-8-210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3852307PMC
September 2013

Radiation therapy in the treatment of HIV-related Kaposi's sarcoma.

Anticancer Res 2013 May;33(5):2153-7

Radiotherapy Department Bld.busi San Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00151 Rome, Italy.

Background: Kaposi's sarcoma (KS) is the most frequent neoplasm occurring in patients with HIV-related AIDS and very often exhibits multifocal distribution so that a systemic approach is needed. KS is considered a radiosensitive tumor and (RT) has always played an important role in the therapeutic strategy of its various forms. RT is a valuable means of pain relief, bleeding control and edema palliation, but it is also an effective treatment modality for local control of skin and mucosal lesions in KS. The purpose of the present article is to report the results obtained by the Radiotherapy Unit of S. Camillo-Forlanini Hospital in Rome in the management of 38 AIDS-associated KS lesions and to assess the efficacy of RT in the treatment and local control of KS.

Patients And Methods: Eighteen patients histologically-diagnosed with HIV-related KS underwent RT in the period between January 2002 and January 2012 at the Radiotherapy Unit of S. Camillo-Forlanini Hospital in Rome. In all cases, the lesions caused pain or discomfort and a thorough careful clinical evaluation had indicated a radiation treatment. A total of 38 lesions were treated with radiotherapy. Fifteen patients received systemic chemotherapy. Eight patients with multiple cutaneous lesions on their legs and arms were treated with a radiation schedule prescribing extended cutaneous irradiation using 6-18 MeV electron beam energy, 200 cGy per fraction and a total dose between 24-30 Gy, according to the depth of lesions. One of these patients had also a cutaneous lesion on an eyelid that was treated with a radiation schedule using 6 MeV electron beam energy and bolus of 1 cm, 200 cGy per fraction and a total dose of 30 Gy. Seven patients with single cutaneous lesions on the legs and arms were treated using a photon regimen of 6 Mv energy, 200 cGy per fraction and a total dose between 20 and 36 Gy. Two patients had oral mucosa lesions and they were treated with a radiation schedule prescribing irradiation using 6 Mev photon regimen and personal mask, 200 cGy per fraction and a total dose of 24 and 30 Gy, respectively. A patient with a single bone lesion on the spinal column was treated with irradiation using 6 Mev photon regimen, 300 cGy per fraction and a total dose of 30 Gy.

Results: At the time of reporting, 14 patients were alive and four patients had died. One patient died due to complications from HIV infection. The follow-up from the end of the treatment ranged from four to 124 months (mean=51.17 months). The overall survival for the group was 88.8% at one year. The mean overall survival was 57.4 months. A complete response was achieved for 31 lesions (83.8 %); a partial response with a tumor regression was observed for six lesions (16.2 %). No relapses were observed during the period of follow-up, but we observed new lesions in one patient. According to the Radiation Therapy Oncology Group scale we observed erythematic and dry desquamation (grade 1) in eight sites (21%); in only one patient (2.6%) did stomatitis occur (grade 1). Good cosmetic results were described for 25 (65.7%) out of 31 lesions. Effective palliative action was obtained for all lesions except for two (5.2%) located in a vertebra and hard palate.

Conclusion: RT will be a mainstay of cure for this group of patients especially when of young age and the will to preserve the cosmetic appearance is a primary need.
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May 2013

Hodgkin's lymphoma emerging radiation treatment techniques: trade-offs between late radio-induced toxicities and secondary malignant neoplasms.

Radiat Oncol 2013 Jan 30;8:22. Epub 2013 Jan 30.

Institute of Biostructures and Bioimaging, National Council of Research, Napoli, Italy.

Background: Purpose of this study is to explore the trade-offs between radio-induced toxicities and second malignant neoplasm (SMN) induction risk of different emerging radiotherapy techniques for Hodgkin's lymphoma (HL) through a comprehensive dosimetric analysis on a representative clinical model.

Methods: Three different planning target volume (PTVi) scenarios of a female patient with supradiaphragmatic HL were used as models for the purpose of this study. Five treatment radiation techniques were simulated: an anterior-posterior parallel-opposed (AP-PA), a forward intensity modulated (FIMRT), an inverse intensity modulated (IMRT), a Tomotherapy (TOMO), a proton (PRO) technique. A radiation dose of 30 Gy or CGE was prescribed. Dose-volume histograms of PTVs and organs-at-risk (OARs) were calculated and related to available dose-volume constraints. SMN risk for breasts, thyroid, and lungs was estimated through the Organ Equivalent Dose model considering cell repopulation and inhomogeneous organ doses.

Results: With similar level of PTVi coverage, IMRT, TOMO and PRO plans generally reduced the OARs' dose and accordingly the related radio-induced toxicities. However, only TOMO and PRO plans were compliant with all constraints in all scenarios. For the IMRT and TOMO plans an increased risk of development of breast, and lung SMN compared with AP-PA and FIMRT techniques was estimated. Only PRO plans seemed to reduce the risk of predicted SMN compared with AP-PA technique.

Conclusions: Our model-based study supports the use of advanced RT techniques to successfully spare OARs and to reduce the risk of radio-induced toxicities in HL patients. However, the estimated increase of SMNs' risk inherent to TOMO and IMRT techniques should be carefully considered in the evaluation of a risk-adapted therapeutic strategy.
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http://dx.doi.org/10.1186/1748-717X-8-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3641014PMC
January 2013

Evaluation of helical tomotherapy in the treatment of high-grade gliomas near critical structures.

Tumori 2012 Sep-Oct;98(5):636-42

Department of Radiation Oncology, S Camillo-Forlanini Hospital, Rome, Italy.

Background: Our purpose was to investigate the role of helical tomotherapy using a simultaneous integrated boost technique for the treatment of high-grade gliomas near intracranial critical structures.

Methods And Materials: Of 27 patients treated with helical tomotherapy, 11 were eligible. Only patients whose tumors were within 0.5 cm of the optic chiasm, the optic nerve or the brainstem were included. The therapeutic approach was a simultaneous integrated boost, prescribing 66 and 60 Gy to the PTV1 and PTV2, respectively, in 30 fractions. All patients received concomitant temozolomide at a dose of 75 mg/m2 daily during radiation therapy.

Results: Of the 11 patients considered, 3 patients (27%) died after 4 months from the completion of the combined treatment. Three patients (27%) presented local progression, and the median time to disease progression was 6 months (range, 1-12). Five patients (45%), at the time of this evaluation, did not have signs or symptoms of recurrence or progression of the disease. Acute toxicity, evaluated during radiochemotherapy, was minimal, with all patients experiencing RTOG grade 0 and grade 1 toxicity.

Conclusions: . Helical tomotherapy proved to be an effective and safe treatment modality, with an improvement of accuracy in delivery of high-dose radiotherapy despite the presence of nearby critical structures.
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http://dx.doi.org/10.1700/1190.13206DOI Listing
February 2013

Radiotherapy for inoperable non-small cell lung cancer using helical tomotherapy.

Tumori 2012 Jan-Feb;98(1):86-9

Department of Radiotherapy, S. Camillo-Forlanini Hospital, Rome, Italy.

Aim: To investigate the impact of tomotherapy on the dose delivered to the lungs and other normal tissues.

Material And Methods: From February 2008 to May 2009, 35 patients with stage IIIA/IIIB non-small cell lung cancer were treated with helical tomotherapy at the S. Camillo-Forlanini Hospital. For our study we selected 20 patients who underwent chemotherapy followed by sequential radiotherapy. The planning target volume was delineated using planning CT scan and FDG-PET. The mean prescribed radiation dose was 67.5 Gy delivered in 30 fractions at a dose of 2.25 Gy per fraction.

Results: Median follow-up was 12.3 months. All patients developed acute esophageal toxicity, 15 of RTOG grade 1 and 5 of RTOG grade 2. At first follow-up 15 patients presented stable disease or partial response, 4 patients presented complete response, and 1 patient presented disease progression.

Conclusions: Helical tomotherapy is useful to achieve dose-per-fraction escalation without increasing the treatment-related morbidity. Our results applying dose escalation were encouraging considering that we delivered doses that may be difficult to achieve with 3-dimensional treatments with no excessive complication rates.
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http://dx.doi.org/10.1700/1053.11504DOI Listing
July 2012

Single-nucleotide polymorphisms in BER and HRR genes, XRCC1 haplotypes and breast cancer risk in Caucasian women.

J Cancer Res Clin Oncol 2010 Apr 6;136(4):631-6. Epub 2010 Feb 6.

Department of Biology, Rome Tre University, Rome, Italy.

Purpose: This study aimed to assess whether haplotypes in XRCC1 and SNPs in OGG1 and XRCC3 were associated with an increased risk of developing breast cancer (BC) and early adverse reactions after radiotherapy.

Methods: 43 Italian breast cancer patients and 31 healthy controls were genotyped for XRCC1(-77T-->C,194,399), OGG1-326 and XRCC3-241 by RFLP-PCR.

Results: XRCC1-77T-->C, XRCC1-194, OGG1 and XRCC3 were not associated with BC. On the contrary, we found a significant association (p or=3 SNPs [OR = 2.72 (0.99-7.39), p = 0.04].

Conclusion: In our study, the 399-Gln allele of XRCC1 increased significantly the risk of BC and it may act as a dominant allele [Arg/Arg vs. (Gln/Gln + Arg/Gln), OR = 4.67 (95% CI 1.65-13.23), p = 0.005]. The combination of variant alleles at codon 399 and in position -77 could affect XRCC1 protein activity, impairing genome integrity and promoting cancer occurrence. Also, the number of SNPs in several genes involved in BER and HRR mechanisms made higher the risk of sporadic BC. We can conclude that genetic variants in multiple repair pathways may have a joint or additive effect in cancer risk.
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http://dx.doi.org/10.1007/s00432-010-0791-1DOI Listing
April 2010

DNA repair capacity and acute radiotherapy adverse effects in Italian breast cancer patients.

Mutat Res 2010 Feb 3;684(1-2):43-8. Epub 2009 Dec 3.

Department of Biology, University of Roma TRE, V.le G. Marconi 446, Rome 00146, Italy.

Therapeutic exposure to ionising radiation can induce normal tissue side effects which consistently differ among individuals suggesting a possible genetic control. One approach to elucidate the underlying mechanisms is to analyse the relation between genetic traits, biomarkers of in vitro DNA damage and side toxicity in vivo. 43 breast cancer (BC) patients receiving radiotherapy after a breast-conserving surgery were recruited together with 34 age- and sex-matched healthy controls. Adverse tissue reactions were recorded as indicators of radiotherapy susceptibility. All blood samples from both patients (35) and controls (34) were irradiated in vitro and DNA primary damage and repair kinetic were measured through Comet assay. All study subjects were genotyped for XRCC1, OGG1 and XRCC3 gene polymorphisms. In our small groups we found a positive association between XRCC1 variant allele (399Gln) and the occurrence of breast cancer [p=0.01; OR=2.41, 95%CI (1.24-4.66)]. BC patients showed a higher degree of basal (p<0.001) and X-ray induced DNA damage (p<0.01) when compared to healthy controls. A reduced repair ability was found in BC patients showing high degrees of tissue side effects as classified by Radiation Morbidity Scoring Scheme. BC patients showed an impairment of their DNA repair capacity associated with the development of radiation sensitivity but not with polymorphisms in any of the considered genes.
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http://dx.doi.org/10.1016/j.mrfmmm.2009.11.009DOI Listing
February 2010

Prognostic implication of clinical and pathologic features in patients with glioblastoma multiforme treated with concomitant radiation plus temozolomide.

Tumori 2007 May-Jun;93(3):248-56

Department of Radiotherapy, University of Rome La Sapienza, Rome, Italy.

Aims And Background: Glioblastoma multiforme is the most common and most malignant primary brain tumor in adults. The current standard of care for glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy plus temozolomide, given concomitantly with and after radiotherapy. This report is a prospective observational study of 43 cases treated in the Department of Radiotherapy, University of Rome La Sapienza, Italy. We examine the relationship between pathologic features and objective response rate in adult patients treated with concomitant radiation plus temozolomide to identify clinical, neuroradiologic, pathologic, and molecular factors with prognostic significance.

Methods: Forty-three consecutive patients (24 males and 19 females), ages 15-77 years (median, 57) with newly diagnosed glioblastoma multiforme, were included in this trial between 2002 and 2004 at our department. All patients were treated with surgery (complete resection in 81%, incomplete in 19%) followed by concurrent temozolomide (75 mg/m2/day) and radiotherapy (median tumor dose, 60 Gy), followed by temozolomide, 200 mg/m2/day for 5 consecutive days every 28 days. Neurologic evaluations were performed monthly and cranial magnetic resonance bimonthly. We analyzed age, clinical manifestations at diagnosis, seizures, Karnofsky performance score, tumor location, extent of resection, proliferation index (Ki-67 expression), p53, platelet-derived growth factor and epidermal growth factor receptor immunohistochemical expression as prognostic factors in the patients. The Kaplan-Meier statistical method and logrank test were used to assess correlation with survival.

Results: Fourteen patients (32%) manifested clinical and neuroradiographic evidence of tumor progression within 6 months of surgery. In contrast, 5 patients (12%) showed no disease progression for 18 months from the beginning of treatment. Median overall survival was 19 months. Multivariate analysis revealed that an age of 60 years or older (P <0.03), a postoperative performance score < or =70 (P = 0.04), the nontotal tumor resection (P= 0.03), tumor size >4 cm (P = 0.01) and proliferation index overexpression (P = 0.001) were associated with the worst prognosis. p53, PDGF and EGFR overexpression were not significant prognostic factors associated with survival.

Conclusions: The results suggest that analysis of prognostic markers in glioblastoma multiforme is complex. In addition to previously recognized prognostic variables such as age and Karnofsky performance score, tumor size, total resection and proliferation index overexpression were identified as predictors of survival in a series of patients with glioblastoma multiforme.
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September 2007

Induction therapy with paclitaxel and carboplatin followed by hyperfractionated radiotherapy plus weekly concurrent chemotherapy and subsequent consolidation therapy in unresectable locally advanced non-small-cell lung cancer.

Tumori 2007 Mar-Apr;93(2):133-7

Medical Oncology B, Policlinico Umberto I Hospital, "La Sapienza" University, Rome, Italy.

Aims And Background: The purpose of this pilot study was to determine the safety and feasibility of a complete integrated approach, including induction chemotherapy with carboplatin/paclitaxel followed by accelerated hyperfractionated radiotherapy with concurrent chemotherapy, and then by consolidation chemotherapy for locally advanced stage III non-small cell lung carcinoma.

Methods: Systemic doses of carboplatin AUC 6 and paclitaxel (200 mg/m2), 3 weeks out of 4, were planned as induction and consolidation chemotherapy. Weekly carboplatin AUC of 2 plus paclitaxel (50 mg/m2) were given during thoracic radiotherapy.

Results: Eighteen patients were enrolled: 10 were evaluated at the end of chemoradiation and 8 received consolidation chemotherapy. On an intent-to-treat basis, 55% of patients achieved a response after induction therapy, whereas chemoradiation and consolidation therapy increased the response rate by 33% and 16%, respectively. No patient experienced grade > 3 acute hematologic toxicity during systemic-dose chemotherapy. With the exception of one episode of a severe cardiac adverse event, non-hematologic toxicity was similarly tolerable. Severe acute adverse events observed during concurrent chemoradiation were mainly represented by esophagitis, resulting in interruption of the radiotherapy in 25% of patients. More notably, only one patient experienced serious non-hematologic late toxicity.

Conclusions: Although the present approach seemed feasible, our data did not support any possible advantage in favor of this three-phase integrated treatment, and therefore the design will not be investigated in a subsequent phase II study.
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July 2007

Feasibility and results of a multimodality approach in elderly patients with localized intermediate to high-grade non-Hodgkin's lymphomas.

Tumori 2004 May-Jun;90(3):289-93

Radioterapia Oncologica, Dipartimento di Radiologia, University of Rome La Sapienza, Italy.

Aims And Background: A prospective clinical study to determine efficacy and feasibility of a brief course or standard course of anthracycline-based chemotherapy and consolidation radiation therapy in non-Hodgkin's lymphoma patients over 60 years of age.

Methods: Twenty-five consecutive patients with stage I-IE intermediate to high-grade non-Hodgkin's lymphoma aged 60 and older were treated in an outpatient setting in the Radiotherapy Oncology and Hematology units. All patients had a performance status of 0-1 according to WHO criteria. The survival end points, ie, overall survival, disease-free survival and event-free survival, were considered. Lactate dehydrogenase value, nodal versus extranodal localization and dose intensity were assessed as risk factors for disease-free and overall survival. A comparison using logrank analysis with a well-matched group of stage I-IE non-Hodgkin's lymphoma patients aged less than 60 years was performed.

Results: The 5-year overall and disease-free survival rates were 90% and 86%, respectively. There was no statistical difference with respect to the younger population regarding these survival end points. Finally, the 5-year event-free survival was 85% and 86% for elderly and younger patients, respectively, without statistical difference (P = 0.41). Neither acute nor late toxicity (G3-G4) was observed during chemotherapy and radiotherapy treatment and the follow-up in the elderly group.

Conclusions: We confirm the efficacy and feasibility of a full-dose combined chemoradiotherapy in elderly patients with a good performance status with localized I-IE intermediate to high-grade non-Hodgkin's lymphoma.
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August 2004