Background: We previously presented data of this multicentric, phase II study showing that everolimus plus octreotide long-acting repeatable (LAR) for advanced neuroendocrine neoplasms (NENs), in the first line setting, is an active and safe treatment. We now present updated data at 5 years. Methods: Patients with advanced well-differentiated, previously untreated neuroendocrine tumors of the gastroenteropancreatic tract and of the lung received octreotide LAR 30 mg plus everolimus 10 mg/day. The primary endpoint was the objective response rate (ORR). We performed an analysis of “long responder” patients and of time to progression (TTP) and overall survival (OS) at 5 years. Results: Fifty patients were enrolled; the primary tumor site was: pancreas (14 patients), lung (11 patients), ileum (9 patients), jejunum/duodenum (2 patients), and unknown (14 patients). Seventeen (34%) of these patients have received treatment for more than 2 years. The median exposure to study drugs was 519.5 days (range 48-2,024). Currently 3 patients are still in treatment. The ORR (partial response + complete response) was 18% (95% confidence interval [CI] 7.4-28.6): complete response 1 patient (2%), partial response 8 patients (16%), stable disease 37 patients (74%). The median TTP was 33.6 months (95% CI 18.7-41.2) and the median OS was 61.0 months (95% CI 49.8-not reached). Conclusion: In this update of clinical outcome at 5-year follow-up, everolimus plus octreotide has been shown to be active in advanced NENs. The current analysis showed a further prolongation of TTP and a long exposure to the study drug without major side effects in the long term.
Because of the super imposable activity and the better toxicity profile, carboplatin-paclitaxel may be a suitable alternative to cisplatin-ifosfamide in the treatment of uterine CS.
Objective: To compare the surgeon's intraoperative assessment of residual tumor (RT) disease with that identified on postoperative computed tomography (CT) in patients undergoing optimal primary surgical cytoreduction (RT <1 cm) and to identify the prognostic significance of postoperative CT scan of RT. Methods: Patients with FIGO stage III-IV ovarian cancer treated at the Gynecologic Oncology Unit of the National Cancer Institute between November 2011 and March 2013, who underwent optimal primary cytoreduction and were entered in prospective controlled clinical trials requiring a baseline postoperative CT evaluation within 30 days, were enrolled. All CT scans were reviewed by a dedicated radiologist to evaluate RT. Median follow-up was 16 months. Results: 64 out of 160 patients met the eligibility criteria. RT = 0, 0.1 < RT < 0.5 cm, and 0.6 < RT < 1 cm was reported in 53 (82.8%), 9 (14.1%) and 2 (3.1%) cases, respectively. Postoperative CT disagreed with RT in 13 out of 64 (20.3%) cases. Progression-free survival (PFS) of patients with a positive and negative postoperative CT scan of RT was 5 months (95% CI 1-15 months) and 28 months (95% CI 2-46 months), respectively (p < 0.0001). Evidence of the disease using postoperative CT was an independent prognostic factor in multivariate analysis (HR = 8.87, 95% CI = 3.23-24.31, p < 0.0001). Conclusions: Evidence of the disease using postoperative CT was associated with a significant decrease in PFS in patients who underwent optimal primary cytoreduction. RT status as evaluated with early postoperative CT may have an important role in prognostic assessment.
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