ESTRO 37 Abstract book

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ESTRO 37

investigated as compared to care as usual (CAU). Primary endpoint was pain intensity at 12 weeks, secondary outcome was quality of life (QoL). Material and Methods In this multicentre, randomised phase 3 study, patients referred for short schedule RT, with uncontrolled pain (a score of ≥5 on a 0-10 NRS), were randomised between NLE or CAU before start of RT. The NLE consisted of a structured interview to assess pain and patients’ knowledge about pain and pain management. Based on patients’ lack of knowledge, tailored education was provided. A workbook including information on pain- related topics was given afterwards. At 1, 4, 8 & 12 weeks follow up, pain-related questions were addressed by phone. Relatives were welcome to attend the educational session. Patients in CAU received leaflets on RT, cancer pain and opioid use. Patient characteristics were assessed at baseline. Pain intensity and QoL were evaluated with the Brief Pain Inventory, EORTC QLQ-C15-PAL and EORTC QLQ-BM22 at baseline, and week 1, 4, 8 & 12. Power calculation showed that there were 89 patients per arm needed to detect a 10% difference in number of patients with a NRS<5 at 12 weeks (1-sided α=0.05; β 0.8). Results Between May 2011-April 2016, 354 patients were randomised (176 NLE, 178 CAU). At twelve weeks, 185 (NLE 95) had completed follow-up. 38 were excluded (30 NRS <5 at baseline, 7 no short schedule RT, 1 missing informed consent). At twelve weeks, 185 (NLE 95) had completed follow-up (72 stopped filling out questionnaires, 59 died prematurely). Baseline characteristics were similar in both groups; mean age 65 years, 56% men. At week 12, more patients in NLE than in CAU had controlled pain (NRS<5; respectively 70% and 47%, p=0.013). Moreover, patients in NLE reached faster a pain score <5 than patients in CAU (31 versus 54 days respectively, p=0.026). On all time points, no significant differences in QoL were found between both groups. Conclusion Controlled pain, i.e. a pain intensity <5, was reached faster and by more patients with painful bone metastases undergoing RT by the addition of nurse-led pain education. OC-0390 Clinical outcome with dose escalation using IMRT in Cervical Cancer: A phase II randomized trial S. Gudi 1 , P. Naga 1 , U. Mahantshetty 1 , S. Chopra 1 , R. Engineer 1 , L. G 1 , Y. Ghadi 2 , S.V. Jamema 2 , S. Gupta 3 , S.K. Shrivatava 1 1 TATA MEMORIAL CENTRE, Radiation Oncology, Mumbai, India 2 TATA MEMORIAL CENTRE, Medical Physics, Mumbai, India 3 TATA MEMORIAL CENTRE, Medical Oncology, Mumbai, India Purpose or Objective To evaluate loco-regional control and toxicities with dose escalation using IMRT in FIGO Stage IIB cervical cancer Material and Methods Histo-pathologically proven cervical cancer with FIGO Stage IIB who were planned for curative radio(chemo)therapy were randomly allocated to either study arm of IMRT or standard arm of Conventional/3D conformal radiotherapy. External radiation was delivered to whole pelvis using box-field (standard arm) or fixed- five field IMRT (Study arm) with concurrent cisplatin Proffered Papers: CL 8: Gynaecology

chemotherapy and high dose rate brachytherapy (HDR- BT). The standard arm was treated according to the Institutional guidelines of 40 Gy/20#/4 weeks (20Gy open fields and 20Gy with midline shielding), while the study arm received to a dose of 50 Gy/25# to pelvic planning target volume. In both the arms, all patients received HDR-BT to a prescription dose of 7 Gy to point A x 5# once weekly. Acute and late toxicities were graded according to CTCAE version 3.0 and RTOG criteria. Results Between February 2005 and June 2013, two hundred patients [median age 51years (31-65 years)] were randomized to either standard arm (n=101) or study arm (n=99). Ninety six percent of the patients in standard arm and 98% in study arm completed planned treatment. Treatment compliance, the external and BT doses radiation doses were compiled using EQD2 and a post-hoc analysis is done to compare loco-regional control, DFS and toxicities according to doses delivered. Mean (SD) Equivalent Dose at 2Gy per fraction (EQD2) doses to point A, ICRU rectal point and ICRU bladder point were 72.7Gy (+/- 8) and 98.2Gy (+/-5.5), 52.1Gy (+/-10.1) and 81.3Gy (+/-9.9), 54.3Gy (+/-14.9) and 83.2Gy (+/-16.1) in the standard arm and the study arm respectively. After a median follow-up of 62 months, there was no difference in loco-regional control (86.5% Vs 85.8%; p = 0.96) or disease-free-survival (74.3% vs 70.8%, p=0.99) between the standard arm and the study arm respectively. No significant difference was observed in acute grade 2 or more dermatitis (15.8% vs 25.3%, p=0.25), enteritis (15.8% vs 19.2%, p=0.79) and cystitis (2% vs 4%, p=0.58) between the standard arm and the study arm, respectively. Haematological toxicities (anaemia, leukopenia and thrombocytopenia) also were not significantly different between trial arms. Late rectal toxicity was significantly higher in study arm as compared to standard arm [Grade II: 14 Vs 0 (p<0.005); Grade III/IV: 15 Vs 2 (p<0.005)]. However, there was no significant difference in late bladder and bowel toxicities. Conclusion In FIGO Stage IIB cervical cancer patients, there is no significant difference in loco-regional control, disease free survival and acute toxicities with dose-escalation using IMRT. Late rectal toxicities are significantly higher in IMRT arm which is probably related to dose escalation including BT. OC-0391 Evolution of external beam radiotherapy in cervix cancer: from EMBRACE I to EMBRACE II T. Berger 1 , M. Sanggaard Assenholt 1 , Y. Seppenwoolde 2 , A. De Leeuw 3 , I. Jürgenliemk-Schultz 3 , N. Boje Kibsgaard Jensen 1 , R. Nout 4 , L.T. Tan 5 , J. Swamidas 6 , G. Lowe 7 , R. Hudej 8 , I. Dumas 9 , D. Georg 2 , C. Kirisits 2 , R. Pötter 2 , J. Lindegaard 1 , K. Tanderup 1 1 Aarhus University Hospital, Oncology, Aarhus C, Denmark 2 Medical University of Vienna / General Hospital of Vienna, Department of Radiation Oncology, Vienna, Austria 3 University Medical Centre Utrecht, Department of Radiation Oncology, Utrecht, The Netherlands 4 Leiden University Medical Center, Department of Radiation Oncology, Leiden, The Netherlands 5 Cambridge University Hospitals NHS Foundation Trust, Oncology Centre, Cambridge, United Kingdom 6 Tata Memorial Hospital, Department of Medical Physics, Mumbai, India 7 Mount Vernon Cancer Centre, Radiotherapy Physics, Northwood, United Kingdom 8 Institute of Oncology Ljubljana, Department of Radiophysics, Ljubljana, Slovenia 9 Gustave Roussy, Department of Radiotherapy, Villejuif, France