***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: BACKGROUND High dose interleukin-2 therapy , administered in bolus , is considered to be a reasonable treatment option in a selected group of patients with metastatic malignant melanoma . OBJECTIVES To present our experience using this mode of therapy in 21 patients with metastatic melanoma . MATERIAL S AND METHODS The 21 patients in our study group comprised 13 men and 8 women with a mean age of 46 years ( range 29 - 63 ) . Their metastatic disease was present in all extracranial sites , dermal and sub-dermal metastases being the most common ( 15 patients had at least one site , in addition to other locations of metastases ) . Patients with intracranial disease were excluded due to the poor effectivity of IL-2 at this site . Treatment comprised a course of 2 weeks of therapy with a 1 week rest interval between .  Radiological and physical evaluation was performed 6 - 8 weeks after the first course . If a response was achieved a second course of therapy was given . Patients received up to 14 planned doses of IL-2 in each week , 720,000 IU/kg of IL-2 per dose i.v . in 15 minutes . All treatments were given in the surgical ward , and only one patient was hospitalized in the intensive care unit . RESULTS Of the 21 patients , one had a complete response that has lasted for 17 months and 5 patients had a partial response ( range 3 months to 3 years ) . One patient died during treatment , and one patient who refused further treatment because of no response died a few days after completion of treatment . Prior to therapy three of the responders had received autologous vaccines with good immunological response ( P = 0.115 ) . Toxic side effects were significant , but they were treated successfully with no residual damage . CONCLUSIONS High dose IL-2 can be administered safely in a surgical department . The response rates achieved in this series justify the use of high dose IL-2 in a selected group of patients . To improve response rates , a combination of autologous vaccines prior to high dose IL-2 may be recommended PURPOSE To compare the response rate , survival , and toxicity of treatment with high-dose intravenous ( IV ) bolus interleukin-2 ( IL-2 ) plus interferon alfa-2a ( IFN-alpha ) with high-dose IL-2 alone in patients with advanced melanoma in a r and omized phase III trial design . PATIENTS AND METHODS Eighty-five patients with advanced melanoma were r and omly assigned to receive IL-2 6 X 10(6 ) U/m2 per dose every 8 hours as tolerated for a maximum of 14 doses on days 1 through 5 and 15 through 19 , or IL-2 4.5 X 10(6 ) U/m2 per dose , plus IFN-alpha 3 X 10(6 ) U/m2 using an identical schedule . A planned interim analysis was performed after 85 patients were entered , which forms the basis for this report . RESULTS Partial response ( PR ) occurred in two of 44 patients ( 5 % ; 95 % confidence interval , 1 % to 15 % ) receiving IL-2 alone , compared with four of 41 patients ( 10 % ; 95 % confidence interval , 3 % to 23 % ) receiving IL-2/IFN-alpha ( P = .30 ) . There were no complete responses ( CRs ) . The median duration of response was 11.5 months ( range , 2.0 to 15.7 + ) . There was no significant difference in the median survival duration for patients receiving IL-2 alone ( 10.2 months ) compared with patients receiving IL-2/IFN-alpha ( 9.7 months ) . The median and mean number of doses of IL-2 were equivalent in both groups , as was toxicity . There were three treatment-related deaths , two in the IL-2-alone arm and one in the IL-2/IFN-alpha arm . The trial was terminated after the first interim analysis based on predefined early-stopping rules , which included termination if the response rate in the IL-2/IFN-alpha arm was less than 25 % . CONCLUSION Using the preparation , dose , and schedule of IL-2 in our trial , IFN-alpha failed to enhance significantly the response rate to high-dose IL-2 in the treatment of patients with advanced melanoma BACKGROUND Treatment using interleukin-2 ( IL-2 ) alone or in conjunction with lymphokine-activated killer ( LAK ) cells has been shown to mediate disease regression in selected patients with advanced cancer . PURPOSE This prospect i ve r and omized trial was design ed to determine whether the administration of LAK cells in conjunction with high-dose IL-2 alters response and survival rates , compared with those for IL-2 alone , in patients with advanced cancer . METHODS The 181 patients who had metastatic cancer that had failed to respond to st and ard therapy or who had disease for which no effective therapy existed received treatment with  high-dose IL-2 alone or with LAK cells plus IL-2 . Both treatment groups were to receive the same dose of IL-2 administered according to the same schedule . IL-2 doses were omitted depending on the tolerance of the patient . Of the 181 patients , 97 had renal cell cancer and 54 had melanoma . RESULTS Median potential follow-up was 63.2 months . There were 10 complete responses among the 85 assessable patients who received IL-2 plus LAK cells , compared with four among the 79 who received IL-2 alone . There were 14 and 12 partial responses , respectively . Complete response continues in seven patients at 50 - 66 months . The 36-month actuarial survival with IL-2 plus LAK cells was 31 % , compared with 17 % with IL-2 alone ( two-sided P value [ P2 ] = .089 ) . A trend toward improved survival was seen for patients with melanoma who received IL-2 plus LAK cells , compared with those who received IL-2 alone ( 24-month survival : 32 % versus 15 % ; 48-month survival : 18 % versus 4 % ; P2 = .064 [ corrected ] ) . None of 26 patients with melanoma who received IL-2 alone are alive ; five of 28 who received IL-2 plus LAK cells are alive , and three continue in complete response . No difference in survival was seen in patients with renal cell cancer in the two treatment groups . There were six treatment-related deaths ( 3.3 % ) ; three were due to myocardial infa rct ion . Other toxic effects resolved by discontinuation of IL-2 . Many toxic effects were related to increased vascular permeability induced by IL-2 . CONCLUSIONS Some patients with metastatic cancer have prolonged remission when they are treated with high-dose IL-2 alone or in conjunction with LAK cells . Our results suggest a trend toward increased survival when IL-2 is given with LAK cells in patients with melanoma , but no trend was observed for patients with renal cell cancer . IMPLICATION S As these studies continue , efforts are underway to develop improved immunotherapies using tumor-infiltrating lymphocytes ( TIL ) and gene-modified TIL BACKGROUND Previously we described the immunological and clinical effects of prolonged continuous infusion of low dose rIL-2 . In this phase II study we explored the therapeutic efficacy of intermittent continuous infusion of low dose rIL-2 . PATIENTS AND METHODS We selected 15 patients with advanced melanoma and 8 patients with renal cell cancer in good clinical condition , with low tumour burden and no previous systemic treatment . A treatment cycle consisted of infusion of 1.8 x 10(6 ) IU/m2/24 hrs rIL-2 for 3 weeks on an out-patient basis followed by a 3-week rest . A maximum of four cycles were given . RESULTS A total of 35 cycles were given . Treatment was well tolerated . Transient hyperthyroidism occurred in 8 patients . No objective responses were noted . We noted a high incidence of central nervous system involvement occurring shortly after treatment . CONCLUSIONS Intermittent continuous infusion of low dose rIL-2 in advanced melanoma and renal cell cancer is well tolerated but the initial therapeutic results are not promising 
    Output:
    
In this select group of patients , il-2 treatment can produce durable complete remissions .
QUALIFYING STATEMENTS High-dose il-2 has response rates that are similar to those seen with st and ard chemotherapy .
However , unlike chemotherapy , il-2 demonstrates low but durable complete response rates that may lead to years of benefit for patients with metastatic melanoma .
Based on the available data assessing prognostic factors and patient selection , patients with non-visceral metastases and fewer metastatic sites have a much higher response rate .
In these select patients , high dose il-2 may be considered for first-line therapy .