Gabriella Macchia1, Calogero Casà2, Martina Ferioli3, Valentina Lancellotta4, Donato Pezzulla1, Brigida Pappalardi5, Concetta Laliscia6, Edy Ippolito7, Jacopo Di Muzio8, Alessandra Huscher9, Francesca Tortoreto10, Mariangela Boccardi1, Roberta Lazzari11, Pierandrea De Iaco12, Francesco Raspagliesi13, Angiolo Gadducci14, Giorgia Garganese15, Gabriella Ferrandina16, Alessio Giuseppe Morganti3, Luca Tagliaferri2. 1. Radiation Oncology Unit, Gemelli Molise Hospital - Università Cattolica del Sacro Cuore, Campobasso, Italy. 2. Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 3. Radiation Oncology, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, IRCCS Azienda Ospedaliero, Universitaria di Bologna - Alma Mater Studiorum University of Bologna, Bologna, Italy. 4. Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. valentina.lancellotta@policlinicogemelli.it. 5. Radiotherapy Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 6. Department of New Technologies and Translational Research, Division of Radiation Oncology, University of Pisa, Pisa, Italy. 7. Radiation Oncology, Università Campus Bio-Medico, Rome, Italy. 8. Dipartimento di Oncologia P.O. S. Anna - SS Radioterapia, A.O.U "Città della Salute e della Scienza", Turin, Italy. 9. Fondazione Poliambulanza, U.O. di Radioterapia Oncologica "Guido Berlucchi", Brescia, Italy. 10. U.O.C. Radiotherapy, S. Giovanni Calibita Fatebenefratelli Hospital - Amethyst Radioterapia Italia, Rome, Italy. 11. Division of Radiotherapy, IEO European Institute of Oncology IRCCS, Milan, Italy. 12. Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero, Universitaria di Bologna - Alma Mater Studiorum University of Bologna, Bologna, Italy. 13. Gynecologic Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 14. Department of Clinical and Experimental Medicine, Division of Gynecology and Obstetrics, University of Pisa, Pisa, Italy. 15. Gynecology and Breast Care Center, Mater Olbia Hospital, Olbia, Italy. 16. Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.
Abstract
BACKGROUND: Adjuvant radiotherapy (aRT) has been shown to reduce the risk of local relapse in vulvar cancer (VC). In this multicentre study (OLDLADY-1.2), several Institutions have combined their retrospective data on VC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of aRT. METHODS: The primary study end-point was the 2-year-local control, secondary end-points were the 2-year-metastasis free-survival, the 2-year-overall survival and the rate and severity of acute and late toxicities. Participating centres were required to fill data sets including age, stage, tumor diameter, type of surgery, margin status, depth of invasion, histology, grading as well technical/dosimetric details of radiotherapy. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected. RESULTS: One hundred eighty-one patients with invasive VC from 9 Institutions were retrospectively identified. The majority of patients were stage III (63%), grade 2 (62.4%) squamous carcinoma (97.2%). Positive nodes were observed in 117 patients (64.6%), moreover tumor diameter > 4 cm, positive/close margins and depth of invasion deeper than 5 mm were found in 59.1%, 38.6%, 58% of patients, respectively. Sixty-one patients (33.7%) received adjuvant chemoradiation, and 120 (66.3%) received radiotherapy alone. aRT was started 3 months after surgery in 50.8% of patients. Prescribed volumes and doses heterogeneity was recorded according to margin status and nodal disease. Overall, 42.5% locoregional recurrences were recorded. With a median follow-up of 27 months (range 1-179), the 2-year actuarial local control rate, metastasis free and overall survival were 68.7%, 84.5%, and 67.5%, respectively. In term of safety, aRT leads to a prevalence of acute skin toxicity with a low incidence of severe toxicities. CONCLUSIONS: In the context of aRT for VC the present study reports a broad spectrum of approaches which would deserve greater standardization in terms of doses, volumes and drugs used.
BACKGROUND: Adjuvant radiotherapy (aRT) has been shown to reduce the risk of local relapse in vulvar cancer (VC). In this multicentre study (OLDLADY-1.2), several Institutions have combined their retrospective data on VC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of aRT. METHODS: The primary study end-point was the 2-year-local control, secondary end-points were the 2-year-metastasis free-survival, the 2-year-overall survival and the rate and severity of acute and late toxicities. Participating centres were required to fill data sets including age, stage, tumor diameter, type of surgery, margin status, depth of invasion, histology, grading as well technical/dosimetric details of radiotherapy. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected. RESULTS: One hundred eighty-one patients with invasive VC from 9 Institutions were retrospectively identified. The majority of patients were stage III (63%), grade 2 (62.4%) squamous carcinoma (97.2%). Positive nodes were observed in 117 patients (64.6%), moreover tumor diameter > 4 cm, positive/close margins and depth of invasion deeper than 5 mm were found in 59.1%, 38.6%, 58% of patients, respectively. Sixty-one patients (33.7%) received adjuvant chemoradiation, and 120 (66.3%) received radiotherapy alone. aRT was started 3 months after surgery in 50.8% of patients. Prescribed volumes and doses heterogeneity was recorded according to margin status and nodal disease. Overall, 42.5% locoregional recurrences were recorded. With a median follow-up of 27 months (range 1-179), the 2-year actuarial local control rate, metastasis free and overall survival were 68.7%, 84.5%, and 67.5%, respectively. In term of safety, aRT leads to a prevalence of acute skin toxicity with a low incidence of severe toxicities. CONCLUSIONS: In the context of aRT for VC the present study reports a broad spectrum of approaches which would deserve greater standardization in terms of doses, volumes and drugs used.
Authors: Anand Parthasarathy; Michael K Cheung; Kathryn Osann; Amreen Husain; Nelson N Teng; Jonathan S Berek; Daniel S Kapp; John K Chan Journal: Gynecol Oncol Date: 2006-08-04 Impact factor: 5.482