The aim of this work was to clarify and extend the existing clinical guidelines on organ-sparing treatment of muscleinvasive bladder cancer. The standard protocol of radical conservative treatment for muscle-invasive bladder cancer includes transurethral resection of the bladder, external beam radiotherapy with simultaneous chemotherapy (radiosensitization), which is usually referred to as trimodal therapy. The implementation of trimodal therapy into routine practice in Russia is limited due to the lack of distinct criteria for each of the stages. The involvement of surgeons, radiation oncologists, and chemotherapists, on the one hand, provides the required multidisciplinary approach to cancer treatment; on the other hand, it might impede the entire algorithm. To address this problem, specialists from the Department of Radiology (project moderators), Department of Cancer Urology, and Department of Chemotherapy of N.N. Petrov National Medical Research Center of Oncology under the auspices of Saint Petersburg Oncological Research Society formed a group of experts, including radiation oncologists, urologists, and chemotherapists from federal and local cancer (educational) institutions of Saint Petersburg who had an experience of treating muscle-invasive bladder cancer. The guideline was developed with the consideration of available guidelines published by leading professional associations of radiotherapy and oncology (urological), research articles, and own experience.
One of clinical and anatomical types of melanoblastoma is melanoma of the glans penis appearing on the skin or mucosa of the penis (external opening of the urethra or ureter, internal or external layer of the foreskin). It's a rare disease, and most of specialists are unfamiliar with it, including oncologists and urologists. Thus, the conducted research has practical importance as it may improve diagnostics and treatment of patients with this oncological pathology.
Background: Therapy with immune checkpoints changed the paradigm of treatment in many solid tumors including NSCLC. Recently several drugs of this group were approved in second and first line. Still the data on their use in NSCLC is quite limited. The aim of this study was to evaluate benefits/risks of Nivo treatment within the expanded access program in refractory NSCLC patients both from physician's and patient's perspective. We report interim analysis on response rates, safety and QoL. Methods: Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w in accordance with expanded access program. Tumor response was assessed using RECIST v. 1.1. Adverse events (AEs) were evaluated by NCI CTCAE v3.0. QoL was assessed by RAND SF-36, symptom severity – by ESAS-R. Group comparisons were made using Mann-Whitney test. Results: From July of 2015 to December of 2016 with the median follow-up time of 11 weeks 141 pts were enrolled in 7 centers in RF. Clinical characteristics: 64.5% – males; median age – 60.5 (29 − 79); ECOG PS 0-1/2-3 – 78.3%/21.3%; former or current smokers – 71%; non squamous NSCLC – 65.2%; ≥2 lines of previous systemic treatment – 54%. At baseline pts had poor QoL comparing with healthy controls – 0.283 vs 0.505 (p < 0.001); 68.8% had moderate-to-severe symptoms. The most dramatic QoL worsening was observed for physical functioning and role functioning, p < 0.001. During 4 weeks of treatment Integral QoL index increased by 50% in 53% of pts. Efficacy was evaluated in 51 pts (median first evaluation – 9 weeks), PR – 6/51, SD – 30/51, PD – 15/51. Early deaths from cancer occurred in 7 pts; early deaths not related to cancer – 2 pts. 15 pts discontinued Nivo prematurely (<2 mos) because of rapid clinical worsening. 66 pts were not evaluated for response on cut-off. AEs were registered in 35 pts (median of Nivo treatment – 7 weeks); among them 8 with grade 3-4 AEs. Conclusions: QoL is dramatically compromised in advanced refractory NSCLC pts. Early data from this study supports that Nivo is effective and well tolerated by this patient population. Legal entity responsible for the study: Multinational Center for QoL Research Funding: The study was supported by the grant of BMS Disclosure: K.K. Laktionov, L.V. Bolotina, V.V. Breder, A.S. Danilova, F.V. Moiseenko, T.P. Nikitina, R.V. Orlova, E.A. Filippova, S.A. Protsenko, T.I. Ionova: Study supported by the grant of BMS