***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 In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine  ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine  ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P<0.001 ) . The survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group , as compared with 3.7 months in the gemcitabine group ( hazard ratio for disease progression or death , 0.69 ; 95 % CI , 0.58 to 0.82 ; P<0.001 ) ; the response rate according to independent review was 23 % versus 7 % in the two groups ( P<0.001 ) . The most common adverse events of grade 3 or higher were neutropenia ( 38 % in the nab-paclitaxel-gemcitabine group vs. 27 % in the gemcitabine group ) , fatigue ( 17 % vs. 7 % ) , and neuropathy ( 17 % vs. 1 % ) . Febrile neutropenia occurred in 3 % versus 1 % of the patients in the two groups . In the nab-paclitaxel-gemcitabine group , neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days . CONCLUSIONS In patients with metastatic pancreatic adenocarcinoma , nab-paclitaxel plus gemcitabine significantly improved overall survival , progression-free survival , and response rate , but rates of peripheral neuropathy and myelosuppression were increased . ( Funded by Celgene ; Clinical Trials.gov number , NCT00844649 . ) Purpose FOLFIRINOX ( FFN ) , nab-paclitaxel plus gemcitabine ( GN ) , and gemcitabine are three systemic therapies that provide clinical ly meaningful benefit to patients with unresectable pancreatic cancer ( UPC ) . There are no clinical trials that directly compare the efficacy of all three regimens . In this study , we aim to examine and compare the real-world effectiveness of these treatments . Methods Patients diagnosed with UPC who initiated palliative chemotherapy from August 2014 to January 2016 at any one of six cancer centers in British Columbia were identified from the provincial pharmacy . Clinical , pathological , treatment , and outcome characteristics were compared . Results Two hundred twenty-five patients were included : 55 % men , 68 % Eastern Cooperative Oncology Group 0/1 , 58 % metastatic disease . Patients who received FFN were younger ( p < 0.001 ) and in better performance status ( p < 0.001 ) . Patients treated with FFN or GN experienced significantly longer median overall survival ( OS ) when compared to those treated with gemcitabine ( 14.1 vs 10.5 vs 4.2 months , respectively , p < 0.001 ) . Progression-free survival ( PFS ) was also longer among patients on FFN or GN in comparison to gemcitabine ( FFN , HR 0.44 , 95 % CI 0.24 to 0.814 , p = 0.008 ; GN , HR 0.30 , 95 % CI 0.19 to 0.47 , p < 0.001 ) . A significantly higher proportion of patients require two or more dose modifications on FFN ( 40 % ) compared to GN ( 14 % ) or gemcitabine ( 9 % ) ( p < 0.001 ) . Conclusions Receipt of modified FFN and GN portends a better prognosis than gemcitabine alone . In the absence of a r and omized comparison of all three regimens , our population -based study reveals that the introduction of modified FFN and GN confers real-world effectiveness for UPC patients PURPOSE Gemcitabine plus nanoparticle albumin-bound ( NAB ) paclitaxel ( GA ) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma ( PDAC ) and a Karnofsky performance status ( PS ) of 70 % or greater . Because of the low number of patients with reduced PS , the efficacy of this regimen in fragile patients remains unclear . This study aim ed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS . PATIENTS AND METHODS In the phase I part of this study , patients were r and omly assigned to one of the following four parallel GA treatment arms ( six patients per arm ) : a biweekly schedule of NAB-paclitaxel ( 150 mg/m2 [ arm A ] or 125 mg/m2 [ arm C ] ) plus gemcitabine 1,000 mg/m2 or a st and ard schedule of 3 weeks on and 1 week off of NAB-paclitaxel ( 100 mg/m2 [ arm B ] or 125 mg/m2 [ arm D ] ) plus gemcitabine 1,000 mg/m2 . The two regimens with the better tolerability profile on the basis of predefined criteria were evaluated in the phase II part of the study , the primary end point of which was 6-month actuarial survival . RESULTS Arms B and D were selected for the phase II part of the study . A total of 221 patients ( 111 patients in arm B and 110 patients in arm D ) were enrolled . Baseline characteristics including median age ( 71 and 68 years in arms B and D , respectively ) , sex ( 51 % and 55 % men in arms B and D , respectively ) , and metastatic disease ( 88 % and 84 % in arms B and D , respectively ) were comparable between arms . The most frequent grade 3 or 4 toxicities in arms B and D were anemia ( 12 % and 7 % , respectively ) , neutropenia ( 32 % and 30 % , respectively ) , thrombocytopenia ( 7 % and 11 % , respectively ) , asthenia ( 14 % and 16 % , respectively ) , and neurotoxicity ( 11 % and 16 % , respectively ) . In arms B and D , there were no significant differences in response rate ( 24 % and 28 % , respectively ) , median progression-free survival ( 5.7 and 6.7 months , respectively ) , and 6-month overall survival ( 63 % and 69 % , respectively ) . CONCLUSION NAB-paclitaxel administered at either 100 and 125 mg/m2 in combination with gemcitabine on days 1 , 8 , and 15 every 28 days is well tolerated and results in acceptable safety and efficacy in patients with metastatic pancreatic ductal adenocarcinoma and a poor PS BACKGROUND Among patients with metastatic pancreatic cancer , combination chemotherapy with fluorouracil , leucovorin , irinotecan , and oxaliplatin ( FOLFIRINOX ) leads to longer overall survival than gemcitabine therapy . We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer . METHODS We r and omly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen ( oxaliplatin [ 85 mg per square meter of body‐surface area ] , irinotecan [ 180 mg per square meter , reduced to 150 mg per square meter after a protocol ‐specified safety analysis ] , leucovorin [ 400 mg per square meter ] , and fluorouracil [ 2400 mg per square meter ] every 2 weeks ) or gemcitabine ( 1000 mg per square meter on days 1 , 8 , and 15 every 4 weeks ) for 24 weeks . The primary end point was disease‐free survival . Secondary end points included overall survival and safety . RESULTS At a median follow‐up of 33.6 months , the median disease‐free survival was 21.6 months in the modified‐FOLFIRINOX group and 12.8 months in the gemcitabine group ( stratified hazard ratio for cancer‐related event , second cancer , or death , 0.58 ; 95 % confidence interval [ CI ] , 0.46 to 0.73 ; P<0.001 ) . The disease‐free survival rate at 3 years was 39.7 % in the modified‐FOLFIRINOX group and 21.4 % in the gemcitabine group . The median overall survival was 54.4 months in the modified‐FOLFIRINOX group and 35.0 months in the gemcitabine group ( stratified hazard ratio for death , 0.64 ; 95 % CI , 0.48 to 0.86 ; P=0.003 ) . The overall survival rate at 3 years was 63.4 % in the modified‐FOLFIRINOX group and 48.6 % in the gemcitabine group . Adverse events of grade 3 or 4 occurred in 75.9 % of the patients in the modified‐FOLFIRINOX group and in 52.9 % of those in the gemcitabine group . One patient in the gemcitabine group died from toxic effects ( interstitial pneumonitis ) . CONCLUSIONS Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer , at the expense of a higher incidence of toxic effects . ( Funded by R&D Unicancer and others ; Clinical Trials.gov number , NCT01526135 ; EudraCT number , 2011‐002026‐52 . 
    Output:
    
Conclusions : Although FOLFIRINOX was associated with slightly longer median OS in more studies , the differences , when available , were not statistically significant .