Abstract 4876: Long-term high quality survival with single agent mifepristone treatment despite advanced lung cancer and advanced renal cell carcinoma - 2 case reports

Author(s):  
Jerome H. Check ◽  
Diane Check ◽  
Jasmine Aly ◽  
Carrie Wilson
1993 ◽  
Vol 11 (7) ◽  
pp. 1368-1375 ◽  
Author(s):  
L M Minasian ◽  
R J Motzer ◽  
L Gluck ◽  
M Mazumdar ◽  
V Vlamis ◽  
...  

PURPOSE Three trials were conducted to define the efficacy and toxicity of interferon alfa-2a in the treatment of metastatic renal cell cancer. Univariate and multivariate analyses were performed to identify prognostic factors for survival. PATIENTS AND METHODS Prospectively, 159 patients were treated with interferon alfa-2a. In the first trial, 42 patients received 50 x 10(6) U/m2 intramuscularly three times per week. In the second trial, 64 patients received gradually escalating doses of interferon alfa-2a from 3 to 36 x 10(6) U subcutaneously administered daily. The third trial was randomized; 25 patients received daily interferon alfa-2a alone and 28 were treated with daily interferon alfa-2a and 0.15 mg/kg vinblastine every 3 weeks. RESULTS The overall response proportion was 10% (two complete and 14 partial responses). The median response duration was 12.2 months. The median survival duration was 11.4 months, with 3% of patients alive at 5 or more years. A univariate statistical analysis showed that a Karnofsky performance status > or = 80, prior nephrectomy, and interval from diagnosis to treatment of longer than 365 days were significant prognostic factors for survival. In a multivariate analysis, only prior nephrectomy and Karnofsky performance status > or = 80 were shown to be independent predictors of survival. CONCLUSION Interferon alfa-2a had minimal antitumor activity in patients with advanced renal cell carcinoma and long-term survival was achieved in a small proportion of patients. The need for continued investigation and the identification of more effective therapy for advanced renal cell carcinoma is evident from the poor overall survival rate observed in these 159 patients. The investigation of new agents and of interferon alfa-2a in combination with other agents remains a priority.


2014 ◽  
Vol 25 ◽  
pp. iv293
Author(s):  
S. Hariharan ◽  
W.G. Roberts ◽  
Z. Askerova ◽  
B. Escudier ◽  
J. Tarazi ◽  
...  

Cancer ◽  
2020 ◽  
Vol 126 (18) ◽  
pp. 4156-4167 ◽  
Author(s):  
Robert J. Motzer ◽  
Bernard Escudier ◽  
Saby George ◽  
Hans J. Hammers ◽  
Sandhya Srinivas ◽  
...  

Cancer ◽  
2002 ◽  
Vol 95 (5) ◽  
pp. 1045-1050 ◽  
Author(s):  
Jens Atzpodien ◽  
Reinhard Hoffmann ◽  
Marcus Franzke ◽  
Christian Stief ◽  
Thomas Wandert ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14134-14134 ◽  
Author(s):  
M. A. Lowery ◽  
D. G. Power ◽  
A. T. Behbehani ◽  
D. N. Carney ◽  
J. A. McCaffrey

14134 Introduction: Vascular endothelial growth factor (VEGF) is upregulated in many tumours. Bevacizumab (BV) is a recombinant, humanised monoclonal antibody against the VEGF receptor and has shown promising results in phase II / III trials in colorectal cancer, non-small cell lung cancer, renal cell carcinoma, and breast cancer. Hypertension (HT) has been reported in all studies involving BV and management of this is not well established. Methods: The records of patients treated with BV in our institution were analyzed from January to August 2006. Indications for BV therapy, incidence and management of HT, and resulting outcomes were assessed. Results: 71 patients (45 male, 28–84 years) were treated with BV, at a dose of 5mg/kg every two weeks. 87% (n=60) had colon cancer. Lung cancer, renal cell carcinoma, melanoma, and pancreatic cancer accounted for the rest. 20% (n=14) had pre-existing HT. In all of these cases HT was well controlled with medication. 10 patients developed new-onset HT, and 7 patients experienced exacerbation of existing HT. Using the CTCAE(v3.0) guidelines for grading of HT, 5 had grade II and 10 had grade III. HT developed after a median of 15 weeks of BV (range 6–36 weeks), and a median cumulative BV dose of 20mg/kg (range 10 - 85 mg/kg). In the new onset HT cases 8 patients were controlled (BP= 140/90) with a single anti-HT, and one patient needed two or more agents (BP<160/100). In the pre-existing HT cases who needed an adjustment of anti-hypertensives, 3 were controlled (BP=160/100) with two or more agents and 4 patients required dose escalation of a single agent. In 2 patients BV was permanently discontinued. Anti-HT agents used included beta-blockers, ACE-inhibitors and Ca++- channel blockers. Conclusions: HT may develop at any point during treatment with BV. BP should be measured regularly. In this study 14% of patients developed HT de novo, and 50% experienced exacerbation of pre-existing HT. Median time to BV-induced HT was 15 weeks. There is currently no data to define which anti-HT is the best to use. BV is now becoming widely used, and as with all new targeted therapies, it is important that oncologists recognise relatively unusual side effects, and develop appropriate practice guidelines. No significant financial relationships to disclose.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5080-5080
Author(s):  
Michael B. Atkins ◽  
Igor Puzanov ◽  
Elizabeth R. Plimack ◽  
Mayer N. Fishman ◽  
David F. McDermott ◽  
...  

5080 Background: Axitinib (AXI) plus pembrolizumab (pembro) showed superior overall survival (OS), progression-free survival (PFS) and response rate compared with sunitinib in a randomized Phase 3 trial in advanced renal cell carcinoma (RCC). Here, we report long-term efficacy and safety data of the combination AXI/pembro from the Phase 1 trial, with almost 5 years of follow-up. Methods: 52 treatment-naïve patients with advanced RCC were enrolled between 23 September 2014 and 13 October 2015, and were treated with oral AXI 5 mg twice daily and intravenous pembro 2 mg/kg every 3 weeks. Planned treatment duration was 2 years for pembro and not limited for AXI. Based on International Metastatic Database Consortium (IMDC) criteria, 46.2%, 44.2% and 5.8% of patients were reported as having favourable, intermediate and poor risk. Results: At data cut-off date (July 3, 2019), median OS was not reached; 38 (73.1%) patients were alive. 14 (26.9%) patients had died, none were related to treatment. The probability of being alive was 96.1% (95% CI 85.2–99.0) at 1 year, 88.2% (95% CI 75.7– 94.5) at 2 years, 82.2 % (95% CI 68.5– 90.3) at 3 years, and 66.8 % (95% CI 49.1–79.5) at 4 years. Median PFS was 23.5 (95% CI 15.4–30.4) months. Median duration of response was 22.1 (95% CI 15.1–not evaluable) months. Median time on treatment with the combination AXI/pembro was 14.5 months (n=52), median time on pembro after AXI discontinuation was 9.0 months (n=10), and median time on AXI after pembro discontinuation was 7.5 months (n=11). After stopping study treatment, 22 patients received subsequent systemic therapy, including nivolumab and cabozantinib (n=6 each). Grade 3/4 AEs were reported in 38 (73.1%) patients. 20 (38.5%) patients discontinued either drug due to AEs: 17 (32.7%) patients discontinued AXI, and 13 (25.0%) patients discontinued pembro with 10 (19.2%) discontinuing both drugs. Dose reduction of AXI due to AEs was reported in 16 (30.8%) patients. The most common AEs reported were diarrhea (84.6%), fatigue (80.8%), hypertension (53.8%), cough (48.1%), and dysphonia (48.1%). Increased alanine aminotransferase and aspartate aminotransferase occurred in 44.2% and 36.5% of patients, respectively. With this longer follow-up, there were no cumulative AEs or new AEs. OS by IMDC risk group will be presented. Conclusions: In patients with advanced RCC with almost 5 years of follow-up, the combination of AXI/pembro continues to demonstrate clinical benefit with no new safety signals. Clinical trial information: NCT02133742 .


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