Background: Patients with platinum-resistant ovarian cancer have a poor prognosis. Effective treatment options for these patients are limited. In this study (ANNIE), we evaluate the activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian carcinoma. Methods:The ANNIE trial (NCT04376073) was a multicentre, single-arm, phase II study that evaluated the safety and activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer cancer, and with measurable disease according to the Response Evaluation Criteria in Solid Tumors. Patients received oral niraparib 300mg/ 200mg once daily continuously and anlotinib 12mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary objective was to assess objective response rate according to RECIST version 1.1. 40 cases are planned to be enrolled.Results: Between May 22, 2020 and April 22, 2021, we enrolled 40 patients. Patients had received a median of four (range, 2-9) previous lines of therapy, only 3 patients had a deleterious germline BRCA1/2 mutation. The cut-off date of analysis was May 1, 2021, the median follow-up was 7.6 months (range, 0.2e11.1). At data cutoff, all but ten (2 voluntarily withdrew, 8 with progressive disease) of the patients were still on treatment. Twenty-six patients underwent imaging evaluation. The confirmed best overall response assessment showed 13 with partial responses, yielding the ORR of 50.0% (95% CI, 29.4%w70.6%). The median duration of response and the median PFS were not reached. Drug-related grade 3 or worse treatment-emergent adverse events were occurred in 32.5% patients. The most common treatment emergent adverse events was hand-foot skin reaction (47.5%). No treatment-related death was recorded.Conclusions: Niraparib in combination with anlotinib showed promising antitumor activity and tolerable toxicity in patients with platinum resistant recurrent ovarian cancer.Clinical trial identification: NCT04376073.
Background: Breast cancer (BC) is one of the most prevalent malignancies. BC survivors have higher risk of second primary cancers than the general population. There is an increased interest in BC survivor management, including the prevention of these second cancers. The aim of this study was to assess the risk of gynaecological malignancy (GM) as second neoplasm among BC patients in our population. Methods: Patients with invasive BC diagnosed from 1980 to 2014 included in the Girona Cancer Registry were included. The incidence of second GM in these patients was compared to those in the general population. Second primary cancer was stated as a tumour diagnosed after 2 months from the BC diagnosis. Standardized incidence ratios (SIR) and absolute excess of risk (AER) were calculated. Results: 9,717 patients were diagnosed with invasive BC during this period, with a median age at diagnosis of 61 years, and a median follow-up of 7.9 years. 117 of them developed a second GM. By tumour type, the only statistically signifi cant higher SIR was observed for corpus uteri cancer (SIR:2.28 95% CI 1.82-2.83; AER:6.43 95% CI 4.13-9.14). After reviewing the histology of the corpus uteri cancer cases, we found that 71.4% were type I (endometrioid adenocarcinoma), 15.5% type II (serous adenocarcinomas and clear cell carcinomas), 10.7% carcinosarcomas, 2.4% sarcomas and there were no unspecifi ed malignant neoplasms. Conclusion: BC survivors have an increased risk of corpus uteri cancer, with an increase in unfavourable histologies compared to the general population. Lifelong primary and secondary prevention interventions should be recommended for these patients.
Methodology All women with non-endometrioid EC, defined as serous, clearcell, carcinosarcoma and undifferentiated, were identified through the Swedish Quality Registry for Gynecological Cancer in the western Sweden health care region (1.9 million inhabitants) between 2010-2017 where the NGEC were implemented in 2013. Recurrences were identified including location and relative survival (RS), overall survival (OS) and disease-free survival (DFS) were analysed .The cohort was divided according to treatment protocol before and after NGEC implementation and compared. Result(s)* In total 401 patients were identified and after exclusion for neoadjuvant chemotherapy, palliative treatment and preoperative stage IV, the final study cohort consisted of 261 patients who underwent primary surgical treatment with no evidence of disease at start of follow-up. The cohort before NGEC implementation was 103 patients and 158 patients after. The total recurrence rate was 26% and 6% were localized only to vagina. The RS rate for all patients diagnosed with a recurrence was 14.1% (95%CI 7.7-26.0) compared to 92.8% (95%CI 85.7-100.5) with no recurrence. Both the RS and OS rates were significantly improved after implementation of the NGEC. The 5-year RS was 58.8% (95%CI 48.6-71.0) for treatment in the first period and 79.8% (95%CI 71.0-89.8) for the second period (p=0.005). The 5-year OS was 54.3% (95%CI 45.5-64.9) and 68.7% (95%CI 61.3-77.0) respectively (p=0.011). Conclusion* In this populationbased study of a complete cohort of non-endometrioid ECs we conclude that adequate lymphnode staging followed by adjuvant chemotherapy to all patients and radiotherapy only to those with postive nodes is associated with superior survival compared to chemo-and radiotherapy to all regardless of lymphnode status.
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