Familial Exudative Vitreoretinopathy or Retinopathy of Prematurity

Retinopathy of prematurity (ROP) and familial exudative vitreoretinopathy (FEVR) can have very similar clinical presentations. Both diseases have abnormal development of retinal vessels and lead to severe vitreoretinopathy which causes blindness in newborn infants. The single most important difference is prematurity. In ROP, the most important risk factors are gestational age and low birth weight. In FEVR, it is the genetic mutation. Identifying the underlying mutations in the causative gene can predict the prognosis of patients with FEVR. ROP tends to resolve naturally or with treatment, but FEVR is a lifelong disease. Even we know that the clinical characteristics and risk factors between both diseases are different; the clinical similarity makes differential diagnosis difficult, especially in FEVR patients who were born prematurely. In such a scenario, patients could exhibit features of FEVR or ROP or both and found to have a discrepancy between birth history and fundus appearance, thus ROPER/fROP was used to describe these patients under such conditions

Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)

Background: A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods: Thismulticentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2- week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged usingMRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 2.0 Gy or 28 1.8Gy in radiotherapy-naive patients, and 15 2.0Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-termoncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion: This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections