renal cell carcinoma ( rcc ) is the most common cancer of the kidney , accounting for 85% of renal tumors . according to the american cancer society estimates , rcc is the seventh most common cancer and is the tenth leading cause for cancer - specific deaths . data from india regarding the incidence and mortality of rcc are lacking , but rcc does not figure in the top ten cancers - incidence and mortality wise .
up to 30% patients with rcc present with metastatic disease and recurrence develops in approximately 40% of patients treated for a localized tumor .
there has been a paradigm shift in the management of metastatic rcc ( mrcc ) with the emergence of tyrosine - kinase inhibitors ( tkis ) and monoclonal antibodies as systemic therapy . despite these advancements ,
survival has largely remained unchanged , and prognosis for stage iv disease continues to remain poor .
all patients with a histopathological diagnosis of rcc in tertiary care university hospital in south india between january 2009 and december 2013 , and a minimum follow - up of 12 months were included in this analysis .
all patients with metastatic disease received sunitinib as the first line therapy , irrespective of histology and risk score .
analysis consisted of demographic profile , sites of metastases , starting dose of sunitinib , response , toxicity profile , progression - free survival ( pfs ) , and overall survival ( os ) .
the presence of comorbidities especially smoking , obesity , and chronic renal failure ( chronic kidney disease [ ckd ] ) were noted .
patients were started on sunitinib at a dose of 37.5 mg or 50 mg once a day based on eastern cooperative oncology group performance score .
the schedules followed were 4 weeks on and 2 weeks off drug , or a 2-week on 1-week off schedule .
response evaluation was done using response evaluation criteria in solid tumors version ( recist ) criteria .
response was classified as complete response ( cr ) , partial response ( pr ) , stable disease ( sd ) , or progressive disease ( pd ) . clinical progression and cancer - related deaths
progression - free survival was calculated as the time between the start of therapy and the date of progression or death from any cause .
os was calculated as the time between start of therapy and the date of death due to any cause .
toxicity profile was calculated according to the common terminology criteria for adverse effects version 4.0 .
the median age of patients at presentation was 58 years ( range : 1580 years ) .
risk factors such as smoking , obesity , and ckd were noted in 64 ( 59.25% ) , 36 ( 33.33% ) , and 9 ( 8.33% ) , respectively .
the most common presentations were hematuria in 64 patients ( 59.25% ) followed by loin pain in 62 patients ( 57.4% ) .
the clinical triad of hematuria , loin pain , and fever was present in 23 patients ( 21% ) only [ table 1 ] .
demographic and clinical characteristics of patients with renal cell carcinoma in this study , most of the patients were included in intermediate and poor risk except 3.7% of the study group , which was depicted in table 2 .
heng risk stratification the histopathological variants and sites of metastases are mentioned in tables 3 and 4 , respectively .
clear cell carcinoma was the most common histologic variant , reported in 84.25% of patients .
of the 108 patients , 34 ( 31.48% ) had localized disease and the remaining 74 ( 68.51% ) had metastatic disease at initial presentation [ table 5 ] .
the most common sites of metastases were lung in 47 patients ( 48.45% ) , followed by bone in 23 patients ( 23.71% ) .
the 34 patients who had radical nephrectomy for localized disease , 23 ( 67.64% ) became metastatic over a median period of 13.65 months .
palliative nephrectomy was done in 26 patients with persistent hematuria or intractable pain in which 21 ( 80.76% ) patients had disease progression .
the number of patients eligible for sunitinib at first visit was 97 ( 89.98% ) .
out of them , 74 ( 76.28% ) patients had metastasis upfront and 23 ( 13.70% ) patients developed metastasis later on during the course of follow - up . of the 74 patients who had metastasis at presentation , 21 ( 28.37% )
patients did not return after the first visit and a further 28 were lost to follow - up after one cycle .
seventy - six ( 78.35% ) patients received sunitinib at a dose of 50 mg / day or 37.5 mg / day based on ps ( ps 0 - 1 - 50 mg and ps 2 - 37.5 mg ) . in these 76 patients who are eligible for sunitinib , 28 ( 36.84% ) received only one cycle and lost for follow - up
the remaining 48 ( 49.98% ) patients had received at least two cycles of sunitinib ( range : 236 ) . of the 48 patients , 40 ( 83.33% )
were started on 4 weeks on and 2 weeks off schedule and 8 were started on 2 weeks on 1 week off schedule .
the most common adverse effect noticed in our population was mucositis in 31 patients ( 18.67% ) followed by hand - foot syndrome in 25 patients ( 15.06% ) .
the treatment response is measured using recist criteria and response achieved is shown in table 7 .
after disease progression , only seven patients received second - line treatment , three received sorafenib , and four received everolimus .
cigarette smoking doubles the likelihood of renal - cell carcinoma and contributes to as many as one - third of all cases .
obesity is also a risk factor , particularly in women , in whom there is a linear relation between increasing body weight and the increased risk of renal - cell carcinoma .
lung metastases are the most common sites of distant relapse , occurring in 50%60% of patients .
the median time before a relapse after nephrectomy is 1518 months , and 85% of relapses occur within 3 years .
approved agents for first - line use in clear cell rcc include pazopanib , sunitinib , and bevacizumab and interferon combination according to esmo and nccn guidelines . in nonclear cell variants ,
this study was carried out in mrcc , and the objectives were to evaluate the demographic profile , sunitinib , adverse effects , response rates , and survival .
comparison of our study with previous studies the median age of presentation in our study is 58 years .
this is lower than other studies by motzer et al . and yuasa et al .
similar to other studies the males were more than females in our study , however , the ratio of male to female was much higher ( 9.8:1 ) when compared to those studies . the percentage of patients who were eligible for sunitinib in our study ( i.e. with a performance score of 01 ) was lower when compared to other studies
. delay in diagnosis , poor follow - up after radical nephrectomy , compliance , lack of awareness , and lack of cancer care centers might be reasons for a low - performance score at presentation .
the percentage of patients who were anemic ( low hb - which is a risk stratification parameter ) at presentation was more in our study when compared to other studies ; this may be because of poor nutrition and low - socioeconomic status .
the number of patients who had calcium < 10 g / l was more in our study when compared with yuasa et al .
the percentage of patients with ldh more than 1.5 times the upper limit of normal was 64.81% .
it was less when compared with 80.95% in yuasa et al . in our study , 68.42% of patients presented earlier with metastatic disease , i.e. , < 1 year when compared to 47.61% in yuasa et al .
the most common histology seen in our population was clear cell carcinoma seen in 84.25% which was similar to other studies .
the most common site of metastasis was lung followed by bone and liver metastasis which was similar to other studies and the least common site of metastasis was the brain .
only 55.55% of our patients underwent nephrectomy when compared to 77.77% in yuasa et al . and 90.2% in kim et al .
the clinical efficacy rate ( cr + pr + sd ) was 86% in our study when it was 81% in yuasa et al . and
the median values of pfs [ figure 1 ] and os [ figure 2 ] in our patients were similar to other previous studies .
the median pfs was 10.2 months in our study , 11.4 months in krishna et al .
, 9.3 months in yuasa et al . , 8.2 months in kim et al . , and 11.0 months in motzer et al
meier estimates of progression - free survival ( pfs ) kaplan  meier estimates of overall survival ( os ) the median os in our patients was similar to previous reports .
the median os in our patients was 28.2 months when compared to 22.6 months in krishna et al .
, 32.2 months in yuasa et al . and 23.1 months in kim et al . despite our patients faring worse in nutritional parameters such as hemoglobin , body mass index , serum calcium , and ps ,
the median os and pfs are similar to other studies probably hinting toward better disease biology among our patients which needs further validation in large - scale studies
. a few limitations of this study are its retrospective nature , small sample size , and high levels of attrition .
median values of os and pfs in this study are similar to other reported studies despite the presence of poor risk factors in the patient population .
the pitfall in this study is significant attrition due to poor compliance to treatment and follow - up , which is a major factor in the clinic , limiting optimal , and standard treatment , thereby compromising outcomes .
this poor follow - up may be due to toxicity , major concern which needs tailoring the dose of therapy , adequate counseling , and careful follow - up which are essential for better outcomes .
 introduction : renal cell carcinoma ( rcc ) is the most common cancer of the kidney accounting for 85% of renal tumors . 
 metastatic rcc ( mrcc ) had a poor prognosis and with the introduction of tyrosine - kinase inhibitors , such as sunitinib , pazopanib the outcomes improved . 
 there is only one study reported from india on the use of sunitinib in mrcc . 
 we present our analysis of mrcc and use of sunitinib at our institute over 5 years.materials and methods : all patients with mrcc receiving sunitinib were analyzed with respect to patient characteristics , response , toxicity , and outcomes.results:a total of 108 patients were seen during the study period . 
 the male to female ratio was 9.8:1 . 
 the median age of patients at presentation was 58 years ( range : 1580 years ) . 
 of the 108 patients , 68.51% had metastatic disease at initial presentation . 
 the most common sites of metastases were lung followed by bone . 
 of the 97 patients eligible for sunitinib , only 76 received at least one cycle of sunitinib , out of which only 48 received further cycles ( range : 236 ) . 
 the median progression - free survival ( pfs ) and overall survival ( os ) in our patients were 10.2 and 28.2 months , respectively . the most common adverse effect noticed in our population was mucositis followed by hand - foot syndrome.conclusion:sunitinib is an option for the treatment of mrcc and shows a good pfs in indian patients . 
 median os and pfs in this study are similar to other reported studies despite the presence of poor risk factors in the patient population . 
 the pitfall in this study is significant attrition due to poor compliance to treatment and follow - up , which is a major factor in the clinic thereby compromising outcomes . 
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSION
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