***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: We performed a prospect ively r and omised clinical trial to compare the efficacy of four subcutaneous interleukin-2-(sc-IL-2 ) and sc interferon-α2a (sc-IFN-α2a)-based outpatient regimens in 379 patients with progressive metastatic renal cell carcinoma . Patients with lung metastases , an erythrocyte sedimentation rate ⩽70 mm h−1 and neutrophil counts ⩽6000 μl−1 ( group I ) were r and omised to arm A : sc-IL-2 , sc-IFN-α2a , peroral 13-cis-retinoic acid ( po-13cRA ) ( n=78 ) , or arm B : arm A plus inhaled-IL-2 ( n=65 ) . All others ( group II ) were r and omised to arm C : arm A plus intravenous 5-fluorouracil ( iv-5-FU ) ( n=116 ) , or arm D : arm A plus po-Capecitabine ( n=120 ) . Median overall survival ( OS ) was 22 months ( arm A ; 3-year OS : 29.7 % ) and 18 months ( arm B ; 3-year OS : 29.2 % ) in group I , and 18 months ( arm C ; 3-year OS : 25.7 % ) and 16 months ( arm D ; 3-year OS : 32.6 % ) in group II . There were no statistically significant differences in OS , progression-free survival , and objective response between arms A and B , and between arms C and D , respectively . Given the known therapeutic efficacy of sc-IL-2/sc-INF-α2a/po-13cRA-based outpatient chemoimmunotherapies , our results did not establish survival advantages in favour of po-Capecitabine vs iv-5-FU , and in favour of short-term inhaled-IL-2 in patients with advanced renal cell carcinoma receiving systemic cytokines This report summarizes the U.S. Food and Drug Administration ( FDA ) 's approval of temsirolimus ( Torisel ) , on May 30 , 2007 , for the treatment of advanced renal cell carcinoma ( RCC ) . Information provided includes regulatory history , study design , study results , and literature review . A multicenter , three-arm , r and omized , open-label study was conducted in previously untreated patients with poor-prognosis , advanced RCC . The study objectives were to compare overall survival ( OS ) , progression-free survival ( PFS ) , objective response rate , and safety in patients receiving interferon (IFN)-alpha  versus those receiving temsirolimus alone or in combination with IFN-alpha . In the second planned interim analysis of the intent-to-treat population ( n = 626 ) , there was a statistically significant longer OS time in the temsirolimus ( 25 mg ) arm than in the IFN-alpha arm ( median , 10.9 months versus 7.3 months ; hazard ratio [ HR ] , 0.73 ; p = .0078 ) . The combination of temsirolimus ( 15 mg ) and IFN-alpha did not lead to a significant difference in OS compared with IFN-alpha alone . There was also a statistically significant longer PFS time for the temsirolimus ( 25 mg ) arm than for the IFN-alpha arm ( median , 5.5 months versus 3.1 months ; HR , 0.66 , p = .0001 ) . Common adverse reactions reported in patients receiving temsirolimus were rash , asthenia , and mucositis . Common laboratory abnormalities were anemia , hyperglycemia , hyperlipidemia , and hypertriglyceridemia . Serious but rare cases of interstitial lung disease , bowel perforation , and acute renal failure were observed . Temsirolimus has demonstrated superiority in terms of OS and PFS over IFN-alpha and provides an additional treatment option for patients with advanced RCC BACKGROUND The treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis . So far , no phase 3 r and omised trials comparing the effectiveness of one targeted agent against another have been reported . We did a r and omised phase 3 study comparing axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor ( VEGF ) receptors , with sorafenib , an approved VEGF receptor inhibitor , as second-line therapy in patients with metastatic renal cell cancer . METHODS We included patients coming from 175 sites ( hospitals and outpatient clinics ) in 22 countries aged 18 years or older with confirmed renal clear-cell carcinoma who progressed despite first-line therapy containing sunitinib , bevacizumab plus interferon-alfa , temsirolimus , or cytokines .  Patients were stratified according to Eastern Cooperative Oncology Group performance status and type of previous treatment and then r and omly assigned ( 1:1 ) to either axitinib ( 5 mg twice daily ) or sorafenib ( 400 mg twice daily ) . Axitinib dose increases to 7 mg and then to 10 mg , twice daily , were allowed for those patients without hypertension or adverse reactions above grade 2 . Participants were not masked to study treatment . The primary endpoint was progression-free survival ( PFS ) and was assessed by a masked , independent radiology review and analysed by intention to treat . This trial was registered on Clinical Trials.gov , number NCT00678392 . FINDINGS A total of 723 patients were enrolled and r and omly assigned to receive axitinib ( n=361 ) or sorafenib ( n=362 ) . The median PFS was 6·7 months with axitinib compared to 4·7 months with sorafenib ( hazard ratio 0·665 ; 95 % CI 0·544 - 0·812 ; one-sided p<0·0001 ) . Treatment was discontinued because of toxic effects in 14 ( 4 % ) of 359 patients treated with axitinib and 29 ( 8 % ) of 355 patients treated with sorafenib . The most common adverse events were diarrhoea , hypertension , and fatigue in the axitinib arm , and diarrhoea , palmar-plantar erythrodysaesthesia , and alopecia in the sorafenib arm . INTERPRETATION Axitinib result ed in significantly longer PFS compared with sorafenib . Axitinib is a treatment option for second-line therapy of advanced renal cell carcinoma . FUNDING Pfizer On September 27 , 2006 , the U.S. Food and Drug Administration granted approval to panitumumab ( Vectibix , Amgen , Inc. , Thous and Oaks , CA ) for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing , metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens . Panitumumab approval is based on the results of a single , open-label , r and omized , multinational study that enrolled 463 patients with EGFR-expressing ( at least 1 + membrane staining in > or = 1 % of tumor cells ) metastatic colorectal cancer . Patients were r and omized to either best supportive care ( BSC ) alone or BSC plus panitumumab  , 6 mg/kg i.v . , every other week . The primary study endpoint was progression-free survival ( PFS ) , determined by an independent review committee that was blinded as to treatment assignment . BSC patients who progressed were eligible to receive panitumumab .  The study patients ' median age was 62 years , with 40 % aged > or = 65 ; 63 % were male , 99 % were white , 86 % had a baseline Eastern Cooperative Oncology Group performance status score of 0 or 1 , and 67 % had colon cancer . The median time from diagnosis of metastases was approximately 19 months and the median number of prior therapies was 2.4 . The PFS duration was significantly longer among patients r and omized to receive panitumumab in addition to BSC ( n = 231 ) compared with BSC alone ( n = 232 ) . The median and mean PFS times were 56 and 96.4 days , respectively , for patients receiving panitumumab and 51 and 59.7 days , respectively , for patients receiving BSC alone . Nineteen partial responses ( 8 % , 95 % confidence interval [ CI ] , 5.3%-12.5 % ) were observed in panitumumab treated patients . The median duration of response was 17 weeks ( 95 % CI , 16 - 25 weeks ) . Approximately 75 % of patients in the BSC alone arm crossed over to receive panitumumab after disease progression . There was no difference in overall survival between the two study arms . The most common adverse events were skin rash , hypomagnesemia , paronychia , fatigue , abdominal pain , nausea , and diarrhea . The most serious adverse events were pulmonary fibrosis , severe dermatologic toxicity complicated by infectious sequelae and septic death , infusion reactions , abdominal pain , hypomagnesemia , nausea , vomiting , diarrhea , and constipation The relative efficacies of cytotoxic chemotherapy regimens in the treatment of advanced breast cancer are generally assessed by comparing response rates in r and omised trials . Treatment attempts to prolong survival but trials rarely demonstrate a statistically significant survival advantage : it has been argued that chemotherapy does not prolong survival . The correlation between response rates and survival has been examined by review ing 79 comparisons between arms with unequal response rates in 50 published trials of chemotherapy in advanced breast cancer . In 73 % of comparisons the group with the higher response rate also demonstrated the longer median survival ( P less than 0.001 ) . Weighted linear regression showed a statistically significant relationship between relative response rates and survival ( P less than 0.001 ) . The number of patients in a comparison did not influence this relationship Purpose : Angiogenesis is a characteristic of renal cell carcinoma .  ABT-510 is an angiogenesis inhibitor that mimics the antiangiogenic properties of thrombospondin-1 . This study was design ed to assess the safety and efficacy of ABT-510 in patients with advanced renal cell carcinoma . Experimental Design : Patients with previously untreated metastatic or unresectable renal cell carcinoma were r and omized to treatment with one of two doses of ABT-510 , self-administered s.c . twice daily in 28-day treatment periods without intervening rest periods . End points were progression-free survival ( PFS ) , objective response rate , overall survival , and toxicity . Results : The objective response rate was 4 % in the 10 mg twice daily group , and there were two unconfirmed PRs in the 100 mg twice daily group . Respective median PFS was 4.2 and 3.3 months , with a 6-month PFS of 39 % and 32 % . Median overall survival was 27.8 months ( 10 mg twice daily ) and 26.1 months ( 100 mg twice daily ) . The most frequent adverse events were injection site reactions ( 84 % ) , fatigue ( 50 % ) , headache ( 20 % ) , and nausea ( 19 % ) . The incidence of treatment-related , grade 3/4 adverse events was low and included three bleeding episodes ( gastrointestinal hemorrhage , intracranial hemorrhage , and hemoptysis ) and one thrombotic event ( deep vein thrombosis ) . No deaths were attributed to ABT-510 . Conclusions : There was little evidence of clinical activity for ABT-510 , and further evaluation as a single agent for treating advanced renal cell carcinoma is not warranted . The evidence of a favorable safety profile may justify further evaluation in combination therapy PURPOSE Mature survival data and evaluation of vascular endothelial growth factor ( VEGF ) as a prognostic biomarker from the Treatment Approaches in Renal Cancer Global Evaluation Trial ( TARGET ) study in patients with renal cell carcinoma ( RCC ) are reported . PATIENTS AND METHODS Nine hundred three previously treated patients were r and omly assigned to receive sorafenib versus placebo . On demonstration of progression-free survival ( PFS ) benefit with sorafenib , patients assigned to placebo were offered sorafenib .  Overall survival ( OS ) was determined at two planned interim analyses and one final analysis , with a secondary OS analysis conducted by censoring placebo patients who crossed over to sorafenib . The relationships between baseline VEGF level and prognosis and efficacy were evaluated . RESULTS The final OS of patients receiving sorafenib was comparable with that of patients receiving placebo ( 17.8 v 15.2 months , respectively ; hazard ratio [ HR ] = 0.88 ; P = .146 ) ; however , when post-cross-over placebo survival data were censored , the difference became significant ( 17.8 v 14.3 months , respectively ; HR = 0.78 ; P = .029 ) . Adverse events at 16 months after cross over were similar to those previously reported . Baseline VEGF levels correlated with Eastern Cooperative Oncology Group performance status ( P < .0001 ) , Memorial Sloan-Kettering Cancer Center score ( P < .0001 ) , and PFS and OS in univariate ( PFS , P = .0013 ; OS , P = .000 
    Output:
    
The all-trials and immunotherapy-only trials analysis failed to demonstrate a STE .
A new targeted therapy trial showing a PFS difference of 3.9 months can cl aim an OS benefit in mRCC .