scholarly journals Immunotherapy with nivolumab in metastatic renal cell carcinoma patients in India: Bringing a change in clinical practice

2019 ◽  
Vol 30 ◽  
pp. ix72 ◽  
Author(s):  
A. Rauthan ◽  
P. Patil ◽  
S. Sampige Prasannakumar ◽  
S. Zaveri
2019 ◽  
pp. 1-10 ◽  
Author(s):  
Marwan Ghosn ◽  
Roland Eid ◽  
Emad Hamada ◽  
Hamdy Abdel Azim ◽  
Jamal Zekri ◽  
...  

PURPOSE Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies.


2017 ◽  
Vol 17 (3) ◽  
pp. 227-233 ◽  
Author(s):  
Sergio Bracarda ◽  
Sylvie Negrier ◽  
Jochen Casper ◽  
Camillo Porta ◽  
Manuela Schmidinger ◽  
...  

2019 ◽  
Vol 20 (17) ◽  
pp. 4263 ◽  
Author(s):  
Alessandra Raimondi ◽  
Giovanni Randon ◽  
Pierangela Sepe ◽  
Melanie Claps ◽  
Elena Verzoni ◽  
...  

Immunotherapy has changed the therapeutic scenario of metastatic renal cell carcinoma (mRCC), however the evaluation of disease response to immune-checkpoint inhibitors is still an open challenge. Response evaluation criteria in solid tumors (RECIST) 1.1 criteria are the cornerstone of response assessment to anti-neoplastic treatments, but the use of anti-programmed death receptor 1 (PD1) and other immunotherapeutic agents has shown atypical patterns of response such as pseudoprogression. Therefore, immune-modified criteria have been developed in order to more accurately categorize the disease response, even though their use in the everyday clinical practice is still limited. In this review we summarize the available evidence on this topic, with particular focus on the application of immune-modified criteria in the setting of mRCC.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 416-416
Author(s):  
Gregory P. Hess ◽  
Rohit Borker ◽  
Eileen Fonseca

416 Background: Limited information about real-world treatment patterns of targeted agents for metastatic renal cell carcinoma (mRCC) is available to inform their use in clinical practice. Methods: This retrospective, observational study employed US claims data (January 2007-November 2010) to identify treatment patterns, including treatment duration and dosing, for targeted agents (sunitinib, sorafenib, pazopanib, bevacizumab, and temsirolimus) indicated in 1st line management of advanced/mRCC. The study included adult mRCC patients who were observed for ≥3 months after initiation of their 1st line therapy with a targeted agent. Descriptive analyses were conducted for the observed treatment patterns. Results: A total of 273 patients on 1st line therapy were identified and included in the study sample out of which 235 patients were treated with sunitinib, 16 patients with sorafenib, and 15 patients with temsirolimus. Pazopanib and bevacizumab were excluded from further analysis due to their small samples; n<10. The median observed treatment durations were: sunitinib 3.3 months, sorafenib 4.0 months, and temsirolimus 2.6 months. Patients initiating therapy on sorafenib (n=16) and temsirolimus (n=15) in the study sample were insufficient for meaningful dosing analyses. In sum, of the n=235 sunitinib patients, 178 (approximately 76%) initiated therapy at the indicated dose of 50 mg. Sixty-five percent of these patients were not observed filling a 4th script (the average number observed), while 26% maintained their starting dose and 9% experienced a dose reduction at their fourth fill. (See table). Conclusions: This study suggests that opportunities exist to improve treatment duration in real-world clinical practice and to better understand possible influences, other than disease progression, on treatment and dose changes. [Table: see text]


Oncology ◽  
2019 ◽  
Vol 98 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Andrey Soares ◽  
Manuel C. Maia ◽  
Fernando Vidigal ◽  
Fernando Sabino Marques Monteiro

2010 ◽  
Vol 28 (8) ◽  
pp. 856-864 ◽  
Author(s):  
Manuela Schmidinger ◽  
Dirk Arnold ◽  
Cezary Szczylik ◽  
John Wagstaff ◽  
Alain Ravaud

2014 ◽  
Vol 37 (3) ◽  
pp. 136-141 ◽  
Author(s):  
Lothar Bergmann ◽  
Jochaim Beck ◽  
Kathrin Bothe ◽  
Olaf A. Brinkmann ◽  
Stephan Buse ◽  
...  

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