human
***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 We conducted a phase III , non-inferiority trial comparing upfront primary debulking surgery ( PDS ) and interval debulking surgery ( IDS ) following neoadjuvant chemotherapy ( NAC ) for stage III/IV ovarian , tubal , and peritoneal cancers ( JCOG0602 ) . Two earlier studies , EORTC55971 and CHORUS , demonstrated non-inferior survival of patients treated with NAC .  However , they could not evaluate true treatment invasiveness because of adding diagnostic laparotomy or laparoscopy before treatment in over 30 % of both arms of EORTC55971 and in 16 % of NAC arm of CHORUS . METHODS Patients were r and omised into the st and ard arm ( PDS  followed by eight cycles of paclitaxel and carboplatin [ TC ] ) and NAC arm ( four cycles of TC , IDS , and four cycles of TC ) . In the st and ard arm , IDS was optional for patients who had undergone suboptimal or incomplete PDS . Treatment invasiveness was compared between arms ( UMIN000000523 ) . RESULTS Between November 2006 and October 2011 , 301 patients were r and omised . In the st and ard arm , 147/149 underwent PDS and 49 underwent IDS . In the NAC arm , 130/152 underwent IDS . The NAC arm required fewer surgeries ( mean 0.86 versus 1.32 , p < 0.001 ) and shorter total operation time ( median 273 min versus 341 min , p < 0.001 ) than the st and ard arm and required a lower frequency of abdominal organ resection ( 23.7 % versus 37.6 % , p = 0.012 ) or distant metastases resection ( 3.9 % versus 10.7 % , p = 0.027 ) . In the NAC arm IDS , blood/ascites loss was smaller ( median 787 ml versus 3235 ml , p < 0.001 ) and albumin transfusion and G3/4 adverse events after surgery in total were less frequent ( 26.2 % versus 58.5 % , p < 0.001 ; 4.6 % versus 15.0 % , p = 0.005 , respectively ) . CONCLUSION Our findings demonstrated that NAC treatment is less invasive than st and ard treatment . NAC treatment may become the new st and ard treatment for advanced ovarian cancer when non-inferior survival is confirmed in the planned primary analysis in 2017 PURPOSE We sought to determine the level of concordance among surgeons ' assessment of residual disease ( RD ) and pre-treatment computed tomography ( CT ) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer . METHODS This is a post-trial ad hoc analysis of a phase 3 r and omized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction . All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy . Information collected on trial was utilized to compare surgeon 's operative assessment of RD , to pre-treatment imaging . RESULTS Of 1873 enrolled patients , surgical outcome was described as optimal ( RD≤1 cm ) in 639 subjects . Twelve patients were excluded as they did not have a baseline , pretreatment imaging , leaving 627 participants for analysis .  The average interval from surgery to baseline scan was 26days ( range : 1 - 109 ) . In 251 cases ( 40 % ) , the post-operative scan was discordant with surgeon assessment , demonstrating RD>1 cm in size . RD>1 cm was most commonly identified in the right upper quadrant ( 28.4 % ) , retroperitoneal para-aortic lymph nodes ( RD>1.5 cm ; 28.2 % ) and the left upper quadrant ( 10.7 % ) . Patients with RD>1 cm on pre-treatment CT ( discordant ) exhibited a significantly greater risk of disease progression ( HR 1.30 ; 95 % CI 1.08 - 1.56 ; p=0.0059 ) . CONCLUSIONS Among patients reported to have undergone optimal cytoreduction , 40 % were found to have lesions > 1 cm on postoperative , pretreatment imaging . Although inflammatory changes and /or rapid tumor regrowth could account for the discordance , the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon BACKGROUND The international st and ard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy . We aim ed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen . METHODS In this phase 3 , non-inferiority , r and omised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zeal and , we enrolled women with suspected stage III or IV ovarian cancer . We r and omly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy . Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m(2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy . We did the r and om assignment by use of a minimisation method with a r and om element , and stratified participants according to the r and omising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen . Patients and investigators were not masked to group assignment . The primary outcome measure was overall survival . Primary analyses were done in the intention-to-treat population . To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 . This trial is registered , number IS RCT N74802813 , and is closed to new participants . FINDINGS Between March 1 , 2004 , and Aug 30 , 2010 , we r and omly assigned 552 women to treatment . Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy . All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per- protocol analysis . As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary -surgery group versus 220 in the primary -chemotherapy group . Median overall survival was 22.6 months in the primary -surgery group versus 24.1 months in primary chemotherapy . The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72 - 1.05 ) . Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary -surgery group than in the primary -chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p=0.0007 , and 14 women [ 6 % ] vs 1 woman [ < 1 % ] , p=0.001 ) . The most common grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary -surgery group vs 14 [ 6 % ] in the primary -chemotherapy group ) . 110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p=0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) . One fatal toxic effect , neutropenic sepsis , occurred in the primary -chemotherapy group . INTERPRETATION In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery . In this study population , giving primary chemotherapy before surgery is an acceptable st and ard of care for women with advanced ovarian cancer . FUNDING Cancer Research UK and the Royal College of Obstetricians and Gynaecologists BACKGROUND Although open resection using a sphincter-saving operation ( SSO ) remains the st and ard of care for rectal cancer , few studies have compared open and robot-assisted ( RA ) SSOs . This study aim ed to compare the operative features , functional outcomes , and oncological validity of open and RA SSO for rectal cancer . METHODS A total of 200 rectal cancer patients undergoing curative SSO were enrolled prospect ively . The open and RA groups ( n = 100 , respectively ) were matched for clinical stage and operation type . RESULTS The mean operation time was significantly longer in the RA group than in the open group ( 188 vs. 103 min , P < 0.001 ) , but it was significantly reduced in the latter half of the RA patients compared with that in the first half ( 164 vs. 214 min , P < 0.001 ) . The mean distal resection margin was significantly longer in the RA than in the open group ( 2.7 vs. 1.9 cm ; P = 0.001 ) , but only one patient in either group had positive circumferential resection margin . Bowel peristalsis returned one day earlier in the RA than in the open group ( P < 0.001 ) . Postoperative complication rates and anorectal functional outcomes were comparable between the two groups . The operator 's physical discomfort , assessed on a visual analog scale , was significantly lower in the RA than in the open group ( P < 0.001 ) . CONCLUSIONS According to this short-term study , the RA SSO showed equivalent oncological safety , functional outcome , and morbidities to open SSO . Although the operation takes longer , the robotic system enables a technically versatile SSO with fine dissection in a limited surgical field OBJECTIVE To further investigate the role of MIS comparing patients su bmi tted to MI-IDS  with a balanced population treated by st and ard laparotomy . METHODS The investigational arm ( Cases ) includes 30 AEOC patients treated with MI-IDS . The Control arm included a consecutive series of 65 AEOC patients su bmi tted to laparotomic IDS . Inclusion criteria were : age>18years , histologically proven EOC , clinical complete/partial response after NACT , and ECOG PS < 2 . Preoperative clinical data , perioperative and oncological outcomes were analyzed . General Well-Being Schedule ( GWBS ) was administered to evaluate quality of life before and after surgery . RESULTS Both groups were well-balanced . A higher percentage of women among Cases received bevacizumab-containing NACT compared with Controls . No statistical differences were registered in terms of surgical procedures and residual tumor . A significantly longer median OT in Cases was counterbalanced by more favorable EBL and median length of stay and TTC . No statistically significant differences were registered in terms of postoperative complications . Cases showed a 6months longer PFS compared to Controls . However , in multivariate analysis only the administration of Bevacizumab and a shorter TTC were independently associated with a longer PFS . Regarding QoL , no statistically significant differences were registered in Cases between pre- and postoperative GWBS score . Differently from Controls where this difference was statistically significant and a more intense distress were recorded . CONCLUSIONS Minimally invasive approach could represent an advantageous alternative surgical way to perform interval debulking surgery in this specific subset of patients , with no impact on PFS . Based on these findings a r and omized clinical trial is now under evaluation in our Institution Background : Presently , the use of laparoscopy in advanced ovarian cancer ( AOC ) is extremely controversial . In the era of neoadjuvant chemotherapy ( NACT ) , endoscopic debulking surgery could be a reasonable alternative for selected patients with primarily unresectable disease . Objectives : To evaluate the feasibility as well as the operative and oncologic safety of laparoscopic debulking surgery in patients with AOC su bmi tted to NACT . Methods : This is a pilot observational study on initially unresectable , high- grade serous ovarian cancer treated with a sequence of 6 cycles of carboplatin and paclitaxel followed by debulking surgery performed by laparoscopy ( group 1 ) or laparotomy ( group 2 ) . The inclusion criteria were clinical complete response , CA-125 normalization , imaging without disease in critical areas , and optimal cytoreduction . Results : From January 2011 to March 2014 , 21 patients were included . Ten women underwent laparoscopy and 11 laparotomy . No epidemiological or oncologic differences were observed between the groups . No surgery-related casualties , intraoperative complications , conversion to laparotomy , or excessive blood loss or transfusion was detected in the laparoscopic procedures . The mean time of operation was 292 min . The length of hospital stay averaged 3.6 days . Two women in group 1 developed relevant complications . 
    Output:
    
agent
***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 We conducted a phase III , non-inferiority trial comparing upfront primary debulking surgery ( PDS ) and interval debulking surgery ( IDS ) following neoadjuvant chemotherapy ( NAC ) for stage III/IV ovarian , tubal , and peritoneal cancers ( JCOG0602 ) . Two earlier studies , EORTC55971 and CHORUS , demonstrated non-inferior survival of patients treated with NAC .  However , they could not evaluate true treatment invasiveness because of adding diagnostic laparotomy or laparoscopy before treatment in over 30 % of both arms of EORTC55971 and in 16 % of NAC arm of CHORUS . METHODS Patients were r and omised into the st and ard arm ( PDS  followed by eight cycles of paclitaxel and carboplatin [ TC ] ) and NAC arm ( four cycles of TC , IDS , and four cycles of TC ) . In the st and ard arm , IDS was optional for patients who had undergone suboptimal or incomplete PDS . Treatment invasiveness was compared between arms ( UMIN000000523 ) . RESULTS Between November 2006 and October 2011 , 301 patients were r and omised . In the st and ard arm , 147/149 underwent PDS and 49 underwent IDS . In the NAC arm , 130/152 underwent IDS . The NAC arm required fewer surgeries ( mean 0.86 versus 1.32 , p < 0.001 ) and shorter total operation time ( median 273 min versus 341 min , p < 0.001 ) than the st and ard arm and required a lower frequency of abdominal organ resection ( 23.7 % versus 37.6 % , p = 0.012 ) or distant metastases resection ( 3.9 % versus 10.7 % , p = 0.027 ) . In the NAC arm IDS , blood/ascites loss was smaller ( median 787 ml versus 3235 ml , p < 0.001 ) and albumin transfusion and G3/4 adverse events after surgery in total were less frequent ( 26.2 % versus 58.5 % , p < 0.001 ; 4.6 % versus 15.0 % , p = 0.005 , respectively ) . CONCLUSION Our findings demonstrated that NAC treatment is less invasive than st and ard treatment . NAC treatment may become the new st and ard treatment for advanced ovarian cancer when non-inferior survival is confirmed in the planned primary analysis in 2017 PURPOSE We sought to determine the level of concordance among surgeons ' assessment of residual disease ( RD ) and pre-treatment computed tomography ( CT ) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer . METHODS This is a post-trial ad hoc analysis of a phase 3 r and omized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction . All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy . Information collected on trial was utilized to compare surgeon 's operative assessment of RD , to pre-treatment imaging . RESULTS Of 1873 enrolled patients , surgical outcome was described as optimal ( RD≤1 cm ) in 639 subjects . Twelve patients were excluded as they did not have a baseline , pretreatment imaging , leaving 627 participants for analysis .  The average interval from surgery to baseline scan was 26days ( range : 1 - 109 ) . In 251 cases ( 40 % ) , the post-operative scan was discordant with surgeon assessment , demonstrating RD>1 cm in size . RD>1 cm was most commonly identified in the right upper quadrant ( 28.4 % ) , retroperitoneal para-aortic lymph nodes ( RD>1.5 cm ; 28.2 % ) and the left upper quadrant ( 10.7 % ) . Patients with RD>1 cm on pre-treatment CT ( discordant ) exhibited a significantly greater risk of disease progression ( HR 1.30 ; 95 % CI 1.08 - 1.56 ; p=0.0059 ) . CONCLUSIONS Among patients reported to have undergone optimal cytoreduction , 40 % were found to have lesions > 1 cm on postoperative , pretreatment imaging . Although inflammatory changes and /or rapid tumor regrowth could account for the discordance , the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon BACKGROUND The international st and ard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy . We aim ed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen . METHODS In this phase 3 , non-inferiority , r and omised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zeal and , we enrolled women with suspected stage III or IV ovarian cancer . We r and omly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy . Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m(2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy . We did the r and om assignment by use of a minimisation method with a r and om element , and stratified participants according to the r and omising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen . Patients and investigators were not masked to group assignment . The primary outcome measure was overall survival . Primary analyses were done in the intention-to-treat population . To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 . This trial is registered , number IS RCT N74802813 , and is closed to new participants . FINDINGS Between March 1 , 2004 , and Aug 30 , 2010 , we r and omly assigned 552 women to treatment . Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy . All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per- protocol analysis . As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary -surgery group versus 220 in the primary -chemotherapy group . Median overall survival was 22.6 months in the primary -surgery group versus 24.1 months in primary chemotherapy . The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72 - 1.05 ) . Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary -surgery group than in the primary -chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p=0.0007 , and 14 women [ 6 % ] vs 1 woman [ < 1 % ] , p=0.001 ) . The most common grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary -surgery group vs 14 [ 6 % ] in the primary -chemotherapy group ) . 110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p=0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) . One fatal toxic effect , neutropenic sepsis , occurred in the primary -chemotherapy group . INTERPRETATION In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery . In this study population , giving primary chemotherapy before surgery is an acceptable st and ard of care for women with advanced ovarian cancer . FUNDING Cancer Research UK and the Royal College of Obstetricians and Gynaecologists BACKGROUND Although open resection using a sphincter-saving operation ( SSO ) remains the st and ard of care for rectal cancer , few studies have compared open and robot-assisted ( RA ) SSOs . This study aim ed to compare the operative features , functional outcomes , and oncological validity of open and RA SSO for rectal cancer . METHODS A total of 200 rectal cancer patients undergoing curative SSO were enrolled prospect ively . The open and RA groups ( n = 100 , respectively ) were matched for clinical stage and operation type . RESULTS The mean operation time was significantly longer in the RA group than in the open group ( 188 vs. 103 min , P < 0.001 ) , but it was significantly reduced in the latter half of the RA patients compared with that in the first half ( 164 vs. 214 min , P < 0.001 ) . The mean distal resection margin was significantly longer in the RA than in the open group ( 2.7 vs. 1.9 cm ; P = 0.001 ) , but only one patient in either group had positive circumferential resection margin . Bowel peristalsis returned one day earlier in the RA than in the open group ( P < 0.001 ) . Postoperative complication rates and anorectal functional outcomes were comparable between the two groups . The operator 's physical discomfort , assessed on a visual analog scale , was significantly lower in the RA than in the open group ( P < 0.001 ) . CONCLUSIONS According to this short-term study , the RA SSO showed equivalent oncological safety , functional outcome , and morbidities to open SSO . Although the operation takes longer , the robotic system enables a technically versatile SSO with fine dissection in a limited surgical field OBJECTIVE To further investigate the role of MIS comparing patients su bmi tted to MI-IDS  with a balanced population treated by st and ard laparotomy . METHODS The investigational arm ( Cases ) includes 30 AEOC patients treated with MI-IDS . The Control arm included a consecutive series of 65 AEOC patients su bmi tted to laparotomic IDS . Inclusion criteria were : age>18years , histologically proven EOC , clinical complete/partial response after NACT , and ECOG PS < 2 . Preoperative clinical data , perioperative and oncological outcomes were analyzed . General Well-Being Schedule ( GWBS ) was administered to evaluate quality of life before and after surgery . RESULTS Both groups were well-balanced . A higher percentage of women among Cases received bevacizumab-containing NACT compared with Controls . No statistical differences were registered in terms of surgical procedures and residual tumor . A significantly longer median OT in Cases was counterbalanced by more favorable EBL and median length of stay and TTC . No statistically significant differences were registered in terms of postoperative complications . Cases showed a 6months longer PFS compared to Controls . However , in multivariate analysis only the administration of Bevacizumab and a shorter TTC were independently associated with a longer PFS . Regarding QoL , no statistically significant differences were registered in Cases between pre- and postoperative GWBS score . Differently from Controls where this difference was statistically significant and a more intense distress were recorded . CONCLUSIONS Minimally invasive approach could represent an advantageous alternative surgical way to perform interval debulking surgery in this specific subset of patients , with no impact on PFS . Based on these findings a r and omized clinical trial is now under evaluation in our Institution Background : Presently , the use of laparoscopy in advanced ovarian cancer ( AOC ) is extremely controversial . In the era of neoadjuvant chemotherapy ( NACT ) , endoscopic debulking surgery could be a reasonable alternative for selected patients with primarily unresectable disease . Objectives : To evaluate the feasibility as well as the operative and oncologic safety of laparoscopic debulking surgery in patients with AOC su bmi tted to NACT . Methods : This is a pilot observational study on initially unresectable , high- grade serous ovarian cancer treated with a sequence of 6 cycles of carboplatin and paclitaxel followed by debulking surgery performed by laparoscopy ( group 1 ) or laparotomy ( group 2 ) . The inclusion criteria were clinical complete response , CA-125 normalization , imaging without disease in critical areas , and optimal cytoreduction . Results : From January 2011 to March 2014 , 21 patients were included . Ten women underwent laparoscopy and 11 laparotomy . No epidemiological or oncologic differences were observed between the groups . No surgery-related casualties , intraoperative complications , conversion to laparotomy , or excessive blood loss or transfusion was detected in the laparoscopic procedures . The mean time of operation was 292 min . The length of hospital stay averaged 3.6 days . Two women in group 1 developed relevant complications . 
    Output:
    