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Introduction/Background*Vulvar cancer (VC) is a rare gynaecologic malignancy. The study aims to evaluate in a retrospective, multicentred, real-world dataset of patients affected by VC efficacy and safety of adjuvant (chemo)radiotherapy (aRT), focusing especially to the treatment prescription among participant centers joining the Observational itaLian stuDy on vuLvar cAncer adjuvant raDiotherapY (OLDLADY) project endorsed by the GYN study group of the AIRO (Italian Association of Radiotherapy and Clinical Oncology).MethodologyPatients affected by VC and treated by eRT from January 2010 to December 2018 in Nine Italian radiotherapy centers were retrospectively included and clinical data were collected, analysing tumour staging, treatment prescription, clinical and toxicity outcomes.Result(s)*The multicentred retrospective cohort was composed by 181 patients (patient populations shown in table 1), with a median age of 71.5 years (range 17-90). A considerable heterogeneity was found in the treatment prescription, radiotherapy doses and concomitant chemotherapy schedules. The most relevant acute toxicity revealed for the patient cohort was skin toxicity (22.1%); instead, the rate of severe chronic lymphoedema was 1.1%. After a median follow-up of 30 months (range 1-185), the 2-year actuarial local control rate (LC), the 2-year disease free survival rate (DFS) and the overall survival rate (OS) were 57.2%, 49.4%, and 55.1%, respectively. Kaplan-Meier curves were computed and reported in figure 1.Abstract 1103 Table 1Study populationAge Median 71.5 (range 17-90) Surgery- Radical vulvectomy- Partial vulvectomy- Vulvectomy- Local Excision- Plastic surgery 104 (57.5%)69 (38.1%)3 (1.66%)4 (2.2%)1 (0.6%) Staging- pT1a- pT1b- pT2- pT3 - pNx- pN0- pN+ 15 (8.3%)137 (75.7%)27 (14.9%)2 (1.1%) 19 (10.5%)45 (24.9%)117 (64.6%) Maximal tumor diameter- >4cm- <4cm 107 (59.1%)74 (40.9%) Grading- G1- G2- G3- NA 17 (9.4%)113 (62.4%)47 (26.0%)4 (2.2%) Histology- Squamous cell carcinoma- Other 176 (97.2%)5 (2.8%) Radiotherapy prescription:- Dose on the surgical bed- Dose on the residual tumor (if any)- Dose on the lymph nodes (if prescribed) 45-70 Gy (1.8-2 Gy/die)50-70 Gy (1.8-2 Gy/die)45-70.4 Gy (1.8-2 Gy/die) Concomitant chemotherapy- Yes- No 61 (33.7%)120 (66.3%) Toxicity G3-4- Acute skin- Chronic skin- Acute lymphoedema- Chronic lymphoedema- Vaginal stenosis 40 (22.1%)4 (2.2%)0 (0%)2 (1.1%)1 (0.6%) NA: not availableAbstract 1103 Figure 1Kaplan meier curves for LC, DFS and OSConclusion*A diverse spectrum of radiotherapy options to exclusively treat patients affected by VC was reported. To achieve higher treatment standardisation, in terms of prescribed doses and volumes, this study suggest further cooperative prospective studies.

Introduction/Background*Vulvar cancer (VC) is a rare gynaecologic cancer with poor outcomes in locally advanced disease. This study aims to evaluate in a retrospective, multicentred, real-world dataset of patients affected by VC efficacy and safety of exclusive (chemo)radiotherapy (eRT), focusing especially to the treatment prescription among participant centers joining the Observational itaLian stuDy on vuLvar cAncer radical raDiotherapY (OLDLADY) project endorsed by the GYN study group of the AIRO (Italian Association of Radiotherapy and Clinical Oncology).MethodologyPatients affected by VC and treated by eRT from January 2010 to December 2018 in Seven Italian radiotherapy centers were retrospectively included and clinical data were collected, analysing tumour staging, treatment prescription, clinical and toxicity outcomes.Result(s)*The multicentred retrospective cohort was composed by 90 patients (patient populations shown in table 1), with a median age of 76 years (range 32-92). A considerable heterogeneity was found in the treatment prescription, radiotherapy doses and concomitant chemotherapy schedules. The most relevant acute toxicity revealed for the patient cohort was skin toxicity (26%); instead, the rate of severe skin fibrosis was 4.4%. After a median follow-up of 10 months (range 1-199), the 2-year actuarial local control rate (LC), the 2-year disease free survival rate (DFS) and the overall survival rate (OS) were 42.2%, 40%, and 36.7%, respectively. Kaplan-Meier curves were computed and reported in figure 1.Abstract 1112 Figure 1Kaplan Meier curves for LC, DFS and OSAbstract 1112 Table 1Study populationAge Median 76 (range 32-92) Status- Primary disease- Relapse 61 (76.7%)29 (23.3%) Staging- T1a- T1b- T2- T3 - Nx- N0- N+- NA 3 (3.3%)28 (31.1%)44 (48.9%)15 (16.7%) 4 (4.4%)34 (37.8%)51 (56.7%)1 (1.1%) Maximal tumor diameter- >4cm- <4cm 54 (60%)36 (40%) Grading- G1- G2- G3- NA 19 (21.1%)52 (57.8%)3 (8.9%)11 (12.1%) Histology- Squamous cell carcinoma- Other 88 (97.8%)2 (2.2%) Radiotherapy prescription:- Dose on the vulva- Dose on the tumour- Dose on the lymph nodes (if prescribed) Dose (dose per fraction)45-70.4 Gy (1.8-2 Gy/die)55-70.4 Gy (1.8-2 Gy/die)45-70.4 Gy (1.8-2 Gy/die) Concomitant chemotherapy- Yes- No 52 (57.8%)38 (42.2%) Toxicity G3-4- Acute skin- Chronic skin- Acute lymphoedema- Chronic lymphoedema- Vaginal stenosis 24 (26%)4 (4.4%)1 (1.1%)0 (0%)1 (1.1%) NA: not availableConclusion*A diverse spectrum of radiotherapy options to exclusively treat patients affected by VC was reported. Clinical outcomes are still confirmed to be poor. The results suggest the clinical evaluation of the impact of treatment standardisation, in terms of doses and volumes, in a further perspective study.

Introduction/Background*Data supporting stereotactic body radiotherapy (SBRT) for oligometastatic gynecological cancer patients are increasing, but stereotactic treatments have not yet been fully explored. The aim of this retrospective, multicenter study (MITO RT-02) was to define efficacy and safety of SBRT in a very large, real life dataset of metastatic/persistent/recurrent cervical cancer (MPR-CC) patients.MethodologyClinical and SBRT parameters have been collected in order to fulfill primary endpoints, i.e. the rate of complete response (CR) to SBRT, and the 24-month actuarial local control (LC) rate on ‘per lesion’ basis. The secondary end-points were acute and late toxicities. Objective response rate (ORR) included CR and partial response (PR). Clinical benefit (CB) included ORR and stable disease (SD). Toxicity was evaluated by RTOG/EORTC and CTC-AE scales, according to center policy.Result(s)*Fifteen centers participated to the study; after evaluation of inclusion/exclusion criteria, 84 CC patients, carrying a total of 126 lesions treated by SBRT between March 2006 and February 2021, were selected for the analysis. Patient characteristics and treatment data are summarized in table 1. Complete and partial response, as well as stable disease were observed in 73 (57.9%), 30 (23.8%), and 16 (12.7%) lesions, respectively, reaching about 94% CB rate. With a median follow-up of 14 months (range: 3-130), the 24-month actuarial LC, DFS and OS rate were 61.8%, 22.3%, 52.9%, respectively. Mild acute toxicity was experienced in 14 (16.6%) patients; late toxicity was documented in 4 patients (4.7%).Abstract 933 Table 1Patients and treatments characteristics N. (%) Patients 84 Lesions 126 Age, yrs Median (range) 58 (30-92) ECOG Performance Status 0-12-3 79 (94.1)5 (5.9) Histotype SquamousAdenocarcinomaAdenosquamousClear cellOther 77 (61.1)36 (28.6)5 (4.0)3 (2.4)5 (4.0) N. lesions per patients 12 >3 61 (72.6)13 (15.4)10 (12.0) Type of lesion (%) Lymph nodeParenchymaBone 70 (55.5)46 (36.5)10 (8.0) Anatomic Site NeckThoraxAbdomenPelvisBone 7 (5.5)34 (27.0)32 (25.4)46 (36.6)7 (5.5) Metachronous lesions NoYes 99 (78.6)27 (21.4) N. patients undergoing previous radiotherapy in site NoYes 53 (63.1)31 (36.9) Equipments INACCyberknifeTomotherapyMRI LINAC 108 (85.7)10 (7.9)1 (0.8)7 (5.6) Type of treatment SRS, stereotactic radiosurgery (single fraction)SBRT, stereotactic radiotherapy (more fractions) 26 (20.6)100 (79.4) PTV Median, range (cc) 16.8 (1.8-223.3) Total dose, Gy Median (range) 35 (5-60) Dose/fraction, Gy Median (range) 7 (2.5-26) Dose prescription Specific isodoseIsocenterTarget mean 48 (38.1)32 (25.4)46 (36.5) Conclusion*This study confirms the efficacy and safety of SBRT in MPR-CC patients. The low toxicity profile suggests a wider use of this treatment in this setting, however combinations with new drugs are needed to improve outcomes.

Introduction/BackgroundRe-irradiation of local recurrences of gynaecological cancer pose a difficult challenge to Oncologist. For their biological and physical characteristics particle therapy (PT) could be an interesting treatment.MethodologyThe aim of the study was to evaluate the feasibility and early clinical outcome in patients (pts) with gynaecological pelvic sidewall recurrence (PSWr). Between May 2014 to December 2018, 10 patients (median age 56) with PSWr within or at the edge of the previously irradiated field were treated using PT. They had recurrence of: cervical (5), endometrial (3), uterine (1) and ovarian (1) cancer. Previous radiotherapy prescription dose ranged from 46 to 59.4 Gy and 5 patients underwent brachytherapy (range: 7–28 Gy).Two patients, with marginal lymph node recurrence, were irradiated with protons with up to a total dose of 25 GyRBE and 51 GyRBE, respectively. The remaining women underwent carbon-ion radiotherapy (median total dose 50.4 GyRBE; range: 36–57) administered in a median number of 12 fractions. Six patients with PSWr received surgical spacer placement by open surgery to keep intestinal tracts apart from the tumour as the distance between tumour and nearest intestinal tracts was not sufficient. No pts received concurrent chemotherapy. Preliminary local control (LC) and toxicity profile (according to CTCAE V4.03 scale) were evaluated.ResultsAll patients completed the planned treatment and no acute toxicities G>2 were observed. For the evaluable patients, 1 case of intermediate G≥3 toxicity was reported in women received sequential Bevacizumab (BV). For pts with a follow-up ≥3 months, median LC was 7 months (range: 3–14), median MFS was 4.5 months (range: 3–14,5) and median OS was 7 months (range: 3–14,5). 1 pt experienced local progression and 4 pts died for systemic progression. Data are still ongoing.ConclusionFor pts with PSWr a PT approach seems to be feasible and our results showed a promising short-term outcome and limited radiation-related side effects. Longer follow-up and large patient accrual are required.DisclosureNothing to disclose.

Introduction/BackgroundWe analyzed early clinical outcomes of carbon ion radiotherapy (CIRT) in the first patients with gynecological malignant mucosal melanoma(g-MMM) treated at CNAO.MethodologyBetween 2016 and 2018, 9 patients(pts) with g-MMM were treated with CIRT after surgery or in exclusive settings (table 1) . They had 7 vaginal(VaM),1 cervical(CM) and 1 vulvar(VuM)MMM. One pt with VaM had been previously irradiated with photons;8 pts are considered inoperable and 1 pt underwent adjuvant CIRT on the small pelvic space after radical surgery without lymphadenectomy. Two pts underwent neoadjuvant and sequential anti-PD-1 immunotherapy. Because of the large volume of macroscopic disease,CM and VuM patients were irradiated with up to a total dose of 28 GyRBE(3 fractions) and 68.8 GyRBE(16 fractions), respectively, to the Clinical Target Volume (CTV) defined as the Gross Tumor Volume (GTV)+uterine cervix and corpus for the CM and GTV+vulva for the VuM. For inoperable VaM, small pelvic space including GTV was irradiated with up to a total dose of 38.7-43 GyRBE followed by a GTV boost of up to a total dose of 68.8 GyRBE in 16 fractions (figure 1). All patients were treated with synchrotron-based scanning carbon ion beams. Early clinical and toxicity profile(according to CTCAE V4.03) were evaluated.ResultsTreatment was well tolerated and no interruption was needed. For the evaluable pts, toxicity profile was favorable and no G≥2 acute/late toxicities were observed. Overall,for pts with a follow-up≥3 months,median LC ranged from 3 to 13 months(

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