Vinflunine in Metastatic Urothelial Carcinoma of the Bladder in Progression after a Platinum-Containing Regimen.

BACKGROUND: Vinflunine is a microtubule inhibitor of the vinca alkaloid class approved for the treatment of urothelial bladder carcinoma after a platinum-containing regimen. METHODS: To evaluate the effectiveness of vinflunine, we enrolled 80 subjects with a histologically confirmed diagnosis of metastatic urothelial bladder carcinoma that had previously undergone chemotherapy with a platinum-containing regimen and had measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST). The patients (n = 80) received vinflunine (Javlor®) every 3 weeks at 320 mg/m2 via 20-min intravenous infusion. The endpoints were progression-free survival (PFS), objective response rate, overall survival (OS), and tolerability. The cumulative survival of the patients was analyzed using the Kaplan-Meier method. RESULTS: In this retrospective study, vinflunine treatment was well tolerated and resulted in a good level of disease control (complete response + partial response + stable disease >50%), with a manageable toxicity profile. The median PFS and OS were 3.2 and 6.8 months, respectively. A significant correlation between pain and PFS was also noted. The major hematologic adverse event was neutropenia, observed in 47% of the patients. The most common nonhematologic adverse events were constipation in 48% of the patients and fatigue in 26%. DISCUSSION: In this real-word non-randomized clinical trial setting, the data showed that vinflunine is an efficacious and safe therapeutic option for second-line treatment of patients with metastatic urothelial carcinoma of the bladder after a platinum-containing regimen.

Clinical and Functional Outcome After Abdominal Wall Incisional Hernia Repair: Evaluation of Quality-of-Life Improvement and Comparison of Assessment Scales.

BACKGROUND: Hernias severely impact patient quality of life (QoL), and 80% of patients need surgical operation. The primary outcome of the study is to assess improvements in balance, posture and deambulation after abdominal hernia repair. Moreover, the study investigated the improvement in the postoperative QoL. METHODS: Patients operated at the Policlinico "Paolo Giaccone" at Palermo University Hospital between June 2015 and June 2017 were identified in a prospective database. The functional outcome measures and QoL assessment scales used were numeric rating scale for pain, performance-oriented mobility assessment (POMA) scale, Quebec back pain disability scale, center of gravity (barycenter) variation evaluation, Short-Form (36) Health Survey (SF-36 test), sit-up test and Activities Assessment Scale (AAS). The timepoints at which the parameters listed were assessed for the study were 1 week before the surgical operation and 6 months later. RESULTS: The POMA scale showed a significant improvement, with an overall preoperative score of (mean; SD) 18.80 ± 2.17 and a postoperative score of 23.56 ± 2.24 with a p < 0.003. The improvement of the barycenter was significant with p = 0.03 and 0.01 for the right and left inferior limbs, respectively. Finally, common daily activities reported by the SF-36 test and by the AAS were significantly improved with a reported p of ≤0.04 for 5 of eight items and ≤0.002 for all items, respectively. CONCLUSIONS: The improvement in such physical measures proves the importance of abdominal wall restoration to recover functional activity in the muscle-skeletal complex balance, gait and movement performance.

Nab-paclitaxel in pretreated metastatic breast cancer: evaluation of activity, safety, and quality of life.

OBJECTIVE: Metastatic breast cancer (MBC) is an incurable disease; the treatment of this disease prolongs survival, improving the quality of life (QoL) with a balance between efficacy and toxicity of the treatment. In recent years, treatment with nab-paclitaxel has improved the already known antitumor activity of conventional paclitaxel, in terms of increased efficacy and better tolerability. The aim of this study was to evaluate nab-paclitaxel in Italian patients with MBC. METHODS: We conducted a retrospective analysis of 90 patients with histologically confirmed diagnosis of MBC. To evaluate the efficacy of nab-paclitaxel, overall survival (OS), progression-free survival (PFS), and overall response rate were the primary endpoints, whereas carbohydrate antigen 15.3 (Ca15.3) reduction, QoL, and tolerability were secondary endpoints. RESULTS: The median OS was 10.4 months, the median PFS was 6.8 months. A considerable difference Ca15.3 before and after treatment was observed. Descriptive and regression analyses were done to examine the associations between Ca15.3 response and OS, demonstrating good correlation, revealing that Ca15.3 reduction is an important predictor of OS. CONCLUSION: Nab-paclitaxel is an effective and well-tolerated treatment of patients affected by MBC. The drug showed an improved tolerability profile. With all the limitations of the observational nature of our results, nab-paclitaxel has proven to be an effective and safe therapeutic option in patients with MBC.