Arthritis Research UK and Pfizer.

PURPOSE Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent. METHODS Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy–General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246. RESULTS Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 ( P = .028) and 12 ( P = .039) weeks and no difference at 18 weeks (primary end point) ( P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks ( P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy ( P = .007) and better health on EQ5D-VAS ( P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks. CONCLUSION Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.

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BackgroundPsoriatic Arthritis (PsA) is estimated to occur in 10-15% of people with psoriasis and accounts for 13% of people attending early arthritis clinics. With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective, but costly, treatments, there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether, in treatment naive early PsA patients, “tight control” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to standard care alone.Methods/designTICOPA is a UK multicentre, open-label, randomised controlled, parallel group trial of 206 patients with early PsA. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or intensive management (4 weekly review) for a period of 48 weeks. Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity (MDA) criteria. Patients assigned to the standard care group will have treatment prescribed as felt appropriate by the treating clinician, with no set protocol. The primary objective of the trial is to compare intensive management with standard care in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy. Key secondary outcomes include ACR 50 and 70, PASI 75 and X-ray Van der Heijde score at 48 weeks post-randomisation along with cost-effectiveness at 12, 24 and 28 weeks.DiscussionThe TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients’ disease activity and a reduction in radiological joint damage.Trial registrationISRCTN30147736, NCT01106079

Purpose/Objective(s): Liver transplant, the gold standard treatment for most Hepatocellular carcinomas (HCC), was till recently not being considered as an option in patients having portal vein tumor thrombus (PVTT). These patients were offered only palliative treatments like Radio frequency ablation (RFA), Trans-arterial chemo-embolization (TACE) and conventional external beam radiation therapy (EBRT). With advent of SBRT, precise targeting and motion management has improved local control, making it possible to offer curative liver transplant post SBRT (Stereotactic Body Radiation therapy) to these cases where transplant was ruled out in the past. Materials/Methods: We present 48 of our cases, initially considered unfit for transplant and referred for SBRT to PVTT alone or with HCC lesion from April 2011 till November 2015. Adequate respiratory motion management with either deep inspiratory breath hold (DIBH) or synchrony respiratory tracking was used in all cases. Post SBRT, cases were assessed at 4, 8 and 12 weeks for transplant feasibility. Plan details and follow up data was analyzed with primary end point as amenability to liver transplant. Results: Intent of treatment was curative in 32 (66.6%) cases with limited disease and palliative in remaining 16 (33.3%) cases. Of all the cases, 38 (79%) had multi centric disease and 34 cases (70.8%) had received alternative multimodality treatment in past, before SBRT. Based on Japan cancer group classification 12.5% (n Z 6), 25% (n Z 12), 22.9% (n Z 11) and 39.5% (n Z 19) cases had Vp1, Vp2, Vp3 and Vp4 type PVTT, respectively. Twenty cases (42%) were treated on robotic radiosurgery and 28 cases (58%) on Linac with DIBH. Most frequent dose fractionation used was 60 Gy (range 25 -60 Gy) in 5 fractions (range 3-20 fr). Treatment was well tolerated with mild nausea and fatigue being the most common side effect with no RTOG grade 3 or more toxicity reported. At the time of analyses, amongst 32 curative cases, 23 (71.9%) were alive while 6 (18.8%) had expired and 3 (9.3%) were lost to follow up. Eleven (34.3% of 32 curative) cases underwent successful transplant, 2-3 months post SBRT while 5 (15.6%) are awaiting response assessment. Remaining 2 (6.2%) cases are living with stable disease and 5 (15.6%) with systemic progression. Amongst 16 palliative cases, 7 (43.75%) were still alive, 4 cases (25%) lost to follow up and 5 (31.25%) had expired. Median survival was 13 months in all 48 cases and 26 months (range 8-46 months) for transplant cases. Conclusion: Presence of PVTT is no longer considered a contraindication to liver transplant. Adequately selected cases can be offered SBRT as single modality or as a part of multimodality regime. With growing data from well-designed future studies, PVTT-SBRT promises to improve outcomes in selected HCC cases by making them amenable to liver transplant. SBRT-PVTT therefore merits attention for its potential as an integral part of multidisciplinary treatment approach towards inoperable HCC, realizing the unmet need of adequate local c...