1510P Selective intra-arterial doxorubicin-eluting embolization for desmoid fibromatosis: A combined prospective and retrospective study
Eldad ElnekaveE. Ben AmiSivan ShamaiIdit PeretzJ.P. ErinjeriAmos StemmerJens RickeMax SeidenstickerM. WildgruberShifra AshAlona Zer
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Keywords:
Aggressive Fibromatosis
Aggressive Fibromatosis
Clinical endpoint
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Hepatic metastatectomy and ablation are associated with prolonged survival, but not all lesions are anatomically amenable to these therapies. We evaluated safety and initial efficacy of segmental ablative transarterial radioembolization, or radiation segmentectomy (RS), as a treatment for hepatic metastases.A single institution retrospective analysis was performed of patients with hepatic metastases, determined unamenable to resection by a multidisciplinary tumor board, treated with RS from 2015-2017. Safety parameters evaluated were pre and post procedure liver chemistry, MELD score, ALBI grade, platelet count, and adverse events using both Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 and Clavien Dindo (CD) classifications. Initial efficacy was evaluated using RECIST, mRECIST, and PERCIST criteria.Ten patients underwent between 1-3 RS treatments. There was no clinical treatment toxicity or significant post-treatment change in liver chemistry, MELD, or ALBI score. One patient had a CTCAE Grade 1/CD Grade 1 adverse event. All patients showed partial or complete imaging response at initial assessment (1-3 months). Seven patients demonstrated disease control at a mean of 7.1 months post treatment. Three patients developed out of field disease progression. One RS was technically unsuccessful.Early evaluation of segmental radioembolization suggests a safe treatment option for select patients with hepatic metastases. Initial efficacy as definitive radiotherapy with minimal toxicity is promising in anatomic locations unamenable to resection or alternative means of ablation.
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Abstract Refractory pheochromocytoma and paraganglioma (PPGL) have a poor prognosis and the treatment strategy remains to be established. This multi-institutional phase I study was performed to determine the safety, dose-limiting toxicity (DLT), and efficacy of [ 131 I]-meta-iodobenzylguanidine ( 131 I-mIBG) therapy for refractory PPGLs. Twenty patients with refractory PPGL were enrolled in this study. We administered fixed doses of 131 I-mIBG to all patients, delivering a second and third course of 131 I-mIBG to eight and three patients, respectively. During the 20 weeks after 131 I-mIBG injection, the authors surveyed the adverse events in accordance with the Common Terminology Criteria for Adverse Events. All patients experienced adverse events and adverse reactions, but none experienced a grade 4 adverse event. Twelve weeks after 131 I-mIBG injection, examinations for the evaluation of therapeutic effects was performed in accordance with the Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response rates (based on RECIST categories) were 10% (complete response), 65% (stable disease), 15% (progressive disease), and 10% (not all evaluated). The efficacy and safety of 131 I-mIBG therapy was shown in patients with refractory PPGL, and DLT was observed in neither single nor repeated 131 I-mIBG therapy, indicating a tolerability for 131 I-mIBG therapy.
Tolerability
Refractory (planetary science)
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Objective
To evaluate the short-term efficacy, safety and impact on the quality of life of anlotinib in third-line and above treatment for advanced non-small cell lung cancer (NSCLC) patients.
Methods
All the patients received alotinib 12 mg/d. One cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment until disease progression or treatment intolerance. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess tumor responses. Common Terminology Criteria for Adverse Events (CTCAE) 4.02 was used to assess the adverse events. The European Organization for Research on Treatment of Cancer (EORTC) QLQ-C30 and QLQ-LC13 were used to assess quality of life.
Results
Among 27 patients in study, no complete response (CR) was found, 2 patients (7.4%) achieved partial response (PR), 16 patients (59.3%) achieved stable disease (SD), 9 patients (33.3%) achieved progressive disease (PD), objective response rate (ORR) was 7.4%, and disease control rate (DCR) was 66.7%. The scores of physical functioning (76.00±10.55 vs. 64.44±11.59), emotional functioning (81.67±8.71 vs. 76.11±6.71) and global health status (48.87±7.97 vs. 40.56±12.49) of the QLQ-C30 scale after treatment were higher than those before treatment, with statistically significant differences (t=-4.516, P<0.001; t=-2.646, P=0.019; t=-3.872, P=0.002). Fatigue (50.37±8.95 vs. 40.74±13.86), nausea and vomiting (26.54±16.18 vs. 14.20±11.97), loss of appetite [M(QR): 33.33(33.33) vs. 33(33.33)] were better than before (t=-2.476, P=0.027; t=-5.036, P<0.001; Z=-2.923, P=0.003); pain (28.88±14.23 vs. 33.33±13.60) and dyspnea [33.33(33.33) vs. 33.33(66.67)] scores were lower than before (t=3.674, P=0.003; Z=-3.266, P=0.001). The scores of cough (24.44±19.12 vs. 45.24±20.34), shortness of breath [11.11(22.22) vs. 33.33(22.22)] and chest pain [0.00(33.33) vs. 33.33(33.33)] in the QLQ-LC13 scale after treatment were lower than those before treatment, with statistically significant differences (t=4.000, P=0.001; Z=-4.125, P<0.001; Z=-1.890, P=0.034); the scores of sore mouth or tongue [0.00(33.33) vs. 0.00(0.00)] and hands and feet tingling [33.33(33.33) vs. 0.00(0.00)] were higher than before (Z=-2.000, P=0.046; Z=-2.264, P=0.024). Common adverse reactions included hypertension, fatigue, elevated thyroid stimulating hormone, proteinuria, hand-foot syndrome, oral mucositis, hemoptysis, etc, mainly grade 1-2, and they were all improved after the treatments.
Conclusion
Anlotinib as a third-line and further therapy is positive effected and well tolerated. It can alleviate the clinical symptoms and significantly improve the quality of life of NSCLC patients.
Key words:
Carcinoma, non-small-cell lung; Receptors, vascular endothelial growth factor; Quality of life; Anlotinib
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Objective To investigate the clinical efficacy and adverse events (AEs) of apatinib salvage treatment for diffuse malignant peritoneal mesothelioma (DMPM) that has failed to respond to the recommended treatments. Methods 27 patients with refractory DMPM were treated with apatinib at our center from April 2014 to October 2020, at the initial dose of 250 mg/d. The dose was reduced to 125 mg/d when serious adverse events (SAEs) occurred. 28-day was set as a treatment cycle. The frequency of follow up was once every 28 days. The efficacy evaluation was conducted according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and the serum tumor markers before and after apatinib treatment. The safety assessment was performed with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The primary endpoints were objective response rate (ORR) and disease control rate (DCR), and the secondary endpoints were AEs. Results The 27 patients completed a median treatment-cycle of 15.0, ranging from 5.1 to 39.4 cycles. At the median follow-up of 14.3 (4.8-51.8) months, median overall survival (OS) was 59.4 months, median apatinib-treatment-related survival (ATRS) was 14.0 (4.8-36.8) months. Complete response (CR) was observed in 0 case (0.0%), partial response (PR) in 4 cases (14.8%), stable disease (SD) in 12 cases (44.4%), and progression disease (PD) in 11 cases (40.7%). The ORR was 14.8%, and DCR was 59.3%. The median serum CA125 values before and after apatinib treatment were 32.9 (7.0-4592.4) U/mL and 29.7 (6.1-4327.4) U/mL, respectively ( P =0.009). The common AEs were hypertension (6/27; 22.2%), hand-foot syndrome (5/27; 18.5%), albuminuria (4/27; 14.8%), anemia (4/27; 14.8%), leukopenia (4/27; 14.8%), rash (2/27; 7.4%), fatigue (2/27; 7.4%), oral ulcers (2/27; 7.4%), hoarseness (2/27; 7.4%), nausea/vomiting (2/27; 7.4%), diarrhea (2/27; 7.4%), headache (1/27; 3.7%), and fever (1/27; 3.7%). The incidence rate of grade III/IV AEs was 16.2%. Conclusions Apatinib is effective in treating refractory DMPM, with promising efficacy and acceptable safety.
Apatinib
Refractory (planetary science)
Clinical endpoint
Salvage therapy
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Purpose Desmoid tumors (aggressive fibromatosis) arise from connective tissue cells or fibroblasts. In general, they are slow growing and do not metastasize; however, locally aggressive desmoid tumors can cause severe morbidity and loss of function. Disease recurrence after surgery and/or radiation and diagnosis of multifocal desmoid tumors highlight the need to develop effective systemic treatments for this disease. In this study, we evaluate objective response rate after therapy with the γ-secretase inhibitor PF-03084014 in patients with recurrent, refractory, progressive desmoid tumors. Patients and Methods Seventeen patients with desmoid tumors received PF-03084014 150 mg orally twice a day in 3-week cycles. Response to treatment was evaluated at cycle 1 and every six cycles, that is, 18 weeks, by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Patient-reported outcomes were measured at baseline and at every restaging visit by using the MD Anderson Symptoms Inventory. Archival tumor and blood samples were genotyped for somatic and germline mutations in APC and CTNNB1. Results Of 17 patients accrued to the study, 15 had mutations in APC or CTNNB1 genes. Sixteen patients (94%) were evaluable for response; five (29%) experienced a confirmed partial response and have been on study for more than 2 years. Another five patients with prolonged stable disease as their best response remain on study. Patient-reported outcomes confirmed clinician reporting that the investigational agent was well tolerated and, in subgroup analyses, participants who demonstrated partial response also experienced clinically meaningful and statistically significant improvements in symptom burden. Conclusion PF-03084014 was well tolerated and demonstrated promising clinical benefit in patients with refractory, progressive desmoid tumors who receive long-term treatment.
Aggressive Fibromatosis
C1-inhibitor
Refractory (planetary science)
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Abstract Background Niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD). We present real-world experience from a single center of China. Methods Patients treated with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx®) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity. Results Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI = 0.060–0.759) and disease control rate (DCR) of 50% (95%CI = 0.140–0.861) in the exploratory multi-line monotherapy group. The most common AEs were nausea, thrombocytopenia, and anemia. Grade 3–4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event. Conclusion It is feasible that patients receiving a bolus of 200 mg/d in patients from Chinese population can acquire promising efficacy and tolerance. This is the first real-world data about niraparib in ovarian cancer patients with available HRD status from China.
Single Center
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Cyberknife
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To investigate the effectiveness and adverse effects of Cyberknife stereotactic body radiotherapy (SBRT) on liver metastases from PCa.From June 2009 to September 2016, we treated 20 cases of PCa liver metastases by Cyberknife SBRT, at a total dose of 36 (30－50) Gy, on 1－3 liver metastatic lesions, for 3－5 times, with a prescription isodose line of 70－92%. We assessed the therapeutic effect according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), calculated the survival and disease-control rates using the Kaplan-Meier method, and analyzed the adverse events based on the National Cancer Institute Common Terminology Criteria for Adverse Events－Version 4.0 (CTCAE 4.0).Of all the cases treated, complete response (CR) was found in 8 (40.0%), partial response (PR) in 9 (45.0%), stable disease (SD) in 2 (10.0%), and progressive disease (PD) in 1 (5.0%), with a local control rate (CR+PR) of 85.0% and a disease-control rate (CR+PR+SD) of 95.0%. Among the 14 patients with elevated PSA, 10 (71.4%) showed a significant decrease after treatment. The median follow-up time was 17 months, the 1- and 2-year survival rates were 85.0% and 15.0%, respectively, and the median survival time of the 20 patients was 16.5 months (95% CI: 12.12－22.88). Cyberknife SBRT was well tolerated in all the patients, with only a few mild adverse events (mainly grades 1 and 2 but no 4 and 5) during the whole course of treatment.Cyberknife SBRT is safe and effective in the treatment of PCa liver metastases, with a high local control rate, and capable of reducing the PSA level and raising the long-term survival rate of the patients.
Cyberknife
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Although 177 Lu-octreotate is an effective treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), some patients will fail or develop disease progression necessitating further treatment. We examined whether the safety and efficacy of everolimus after prior treatment with 177 Lu-octreotate is different from the published safety profile of everolimus in GEP-NETs. In this multicenter study, 24 GEP-NET patients were included. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Tumor response was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. Major clinical adverse events (grade 3 or 4) during treatment with everolimus were hyperglycemia (20.8%), fatigue (8.3%), thrombocytopenia (8.3%), and elevated alanine transaminase levels (8.3%). By radiological review, there were four partial responses (16.7%), five patients (62.5%) with stable disease, and three patients (12.5%) with progressive disease. For two patients (8.3%), no data on tumor response were available. Median progression-free survival (PFS) was 13.1 months (95% CI, 11.5–21.2). Median PFS of the current study was longer when compared with the RADIANT-3 trial (13.1 vs 11.4 months) and shorter when compared with the RADIANT-1 trial (13.1 vs 16.7 months). In conclusion, the safety profile of everolimus is not influenced by previous treatment with peptide receptor radiotherapy.
Everolimus
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