Abstract 2301
Background
The PLATO platform consists of 3 anal cancer trials (ACT) across the loco-regional disease spectrum (ACT3, 4 and 5). ACT5 tests the benefit of RT dose escalation using intensity modulated RT (IMRT) in locally advanced disease. We planned to analyse treatment compliance, acute toxicity and patient reported outcomes (PROs) on the first 60 patients (pts) prior to the phase II/III trial (final target n = 640) to evaluate the need for protocol modifications.
Methods
Pts with T2 N1-3, T3-4 N any M0 squamous cancer of the anus entered a prospective, multi-centre, open-labelled randomised 3-arm trial, and received 28 fractions (F) of IMRT at total standard dose of 53.2Gy or escalated to 58.8Gy or 61.6Gy to the gross tumour (40Gy in 28F elective nodal irradiation in all arms). All pts received concurrent mitomycin 12mg/m2 day 1 and capecitabine (CAP) 825mg/m2 twice daily (week days) or 5-fluorouracil 1000mg/m2 days 1-4 and 29-32. Compliance to RT (no delay >3 days due to toxicity) and chemotherapy, worst acute toxicity during treatment (CTCAEv4) and PROs up to 6 months (EORTC-QLQ C30 and ANL27) were analysed.
Results
60 pts were enrolled from 12 UK sites (53.2Gy n = 19; 58.8Gy n = 21; 61.6Gy n = 20). 78% female, median age 61 years (36 -77), 67% T2/3 and 28% ECOG PS1. All pts received planned RT dose with no delays >3days. Chemotherapy (5FU n = 18; CAP n = 42) modifications were: 8.3% (n = 5) overall dose reductions and 35% (n = 15) temporary CAP omissions (range 1-5 days). Pts had acceptable acute toxicity/PROs for both experimental arms not requiring protocol modification. Worst reported CTCAE toxicity grade (G) per pt: G2 51.7% (n = 31), G3 47.6% (n = 28, 19 radiation dermatitis, 7 diarrhoea), G4 1.7% (n = 1; thrombocytopenia). PRO compliance was 86.7% at 6 months. Pre-specified PRO items on quality of life, pain, and bowel toxicity were worst in final treatment week, improving by 6 weeks and returned to baseline or better by 6 months.
Conclusions
RT dose intensification appears safe with acceptable compliance, acute toxicity and PROs at 6 months. Data Monitoring Committee approved phase II with no treatment schedule changes but included a 6 month clinician toxicity assessment. Phase II will open in June 2019.
Clinical trial identification
ISRCTN88455282.
Editorial acknowledgement
Legal entity responsible for the study
University of Leeds.
Funding
Cancer Research UK.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3330 - Tumour-infiltrating lymphocytes and BRCA-like status in stage III breast cancer patients treated with intensified carboplatin-based chemotherapy
Presenter: Leonora De Boo
Session: Poster Display session 2
Resources:
Abstract
3971 - Unravelling the biological characteristics of MammaPrint extreme risk subgroups
Presenter: Rajith Bhaskaran
Session: Poster Display session 2
Resources:
Abstract
5871 - Residual Cancer burden as a prognostic factor in a large series of Neoadjuvant chemotherapy. Subgroup analysis per molecular surrogated subtypes
Presenter: Catalina Falo
Session: Poster Display session 2
Resources:
Abstract
5014 - Clinical validation of CanAssist Breast in a Spanish cohort
Presenter: Manjiri Bakre
Session: Poster Display session 2
Resources:
Abstract
2787 - Meta-analysis on association of pathological complete response with long-term survival outcomes in triple-negative breast cancer
Presenter: Peter A. Fasching
Session: Poster Display session 2
Resources:
Abstract
4301 - Immune infiltrate composition across intrinsic subtypes in hormone receptor (HR)+/HER2- early breast cancer (BC) enrolled in the prospective LETLOB trial
Presenter: Gaia Griguolo
Session: Poster Display session 2
Resources:
Abstract
3205 - Frequency of germline mutations in women's cancer susceptibility genes in a large cohort of Chinese breast cancer patients
Presenter: Ning Liao
Session: Poster Display session 2
Resources:
Abstract
4091 - Triple blinded Prospective Study assessing the Impact of Genomics & Artificial Intelligence Watson For Oncology (WFO) on MDT’s Decision of Adjuvant Systemic Therapy for Hormone Receptor Positive Early Breast Carcinoma-
Presenter: Somashekhar Sampige Prasannakumar
Session: Poster Display session 2
Resources:
Abstract
4359 - Prognostic significance of Progesterone Receptor levels in luminal-like Her2- early Breast Cancer patients. A retrospective single Cancer Center analysis.
Presenter: Anna Diana
Session: Poster Display session 2
Resources:
Abstract
1369 - PAM50 HER2-enriched subtype and pathological complete response in HER2-positive early breast cancer: a meta-analysis
Presenter: Francesco Schettini
Session: Poster Display session 2
Resources:
Abstract