Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .
Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study.
PURPOSE Single-agent gemcitabine became st and ard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil . The Gruppo Italiano Pancreas 1 r and omized phase III trial aim ed to compare gemcitabine plus cisplatin versus gemcitabine alone ( Clinical Trials.gov ID NCT00813696 ) . PATIENTS AND METHODS Patients with locally advanced or metastatic pancreatic cancer , age 18 to 75 years , and Karnofsky performance status ( KPS ) > or = 50 , were r and omly assigned to receive gemcitabine ( arm A ) or gemcitabine plus cisplatin ( arm B ) . Arm A : gemcitabine 1,000 mg/m(2 ) weekly for 7 weeks , and , after a 1-week rest , on days 1 , 8 , and 15 every 4 weeks . Arm B : cisplatin 25 mg/m(2 ) added weekly to gemcitabine , except cycle 1 day 22 . Primary end point was overall survival . To have 8 % power of detecting a 0.74 hazard ratio ( HR ) of death , with bilateral alpha .05 , 355 events were needed and 400 patients planned . RESULTS Four hundred patients were enrolled ( arm A : 199 ; arm B : 201 ) . Median age was 63 , 59 % were male , 84 % had stage IV , and 83 % had KPS > or = 80 .  Median overall survival was 8.3 months versus 7.2 months in arm A and B , respectively ( HR , 1.10 ; 95 % CI , 0.89 to 1.35 ; P = .38 ) . Median progression-free survival was 3.9 months versus 3.8 months in arm A and B , respectively ( HR , 0.97 ; 95 % CI , 0.80 to 1.19 ; P = .80 ) . The objective response rate was 10.1 % in A and 12.9 % in B ( P = .37 ) . Clinical benefit was experienced by 23.0 % in A and 15.1 % in B ( P = .057 ) . Combination therapy produced more hematologic toxicity , without relevant differences in nonhematologic toxicity . CONCLUSION The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer
Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .