BACKGROUND: Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer. OBJECTIVE: The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study. METHODS: In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m. RESULTS: Between December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized. CONCLUSION: Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.
BACKGROUND: Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer. OBJECTIVE: The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study. METHODS: In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m. RESULTS: Between December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized. CONCLUSION: Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.
Authors: Margaret A Tempero; J Pablo Arnoletti; Stephen Behrman; Edgar Ben-Josef; Al B Benson; Jordan D Berlin; John L Cameron; Ephraim S Casper; Steven J Cohen; Michelle Duff; Joshua D I Ellenhorn; William G Hawkins; John P Hoffman; Boris W Kuvshinoff; Mokenge P Malafa; Peter Muscarella; Eric K Nakakura; Aaron R Sasson; Sarah P Thayer; Douglas S Tyler; Robert S Warren; Samuel Whiting; Christopher Willett; Robert A Wolff Journal: J Natl Compr Canc Netw Date: 2010-09 Impact factor: 11.908
Authors: Jens Werner; Stephanie E Combs; Christoph Springfeld; Werner Hartwig; Thilo Hackert; Markus W Büchler Journal: Nat Rev Clin Oncol Date: 2013-04-30 Impact factor: 66.675
Authors: S E Combs; D Habermehl; K Kessel; F Bergmann; J Werner; I Brecht; P Schirmacher; D Jäger; M W Büchler; J Debus Journal: Strahlenther Onkol Date: 2013-07-31 Impact factor: 3.621
Authors: Stephanie E Combs; Daniel Habermehl; Meinhard Kieser; Constantin Dreher; Jens Werner; Renate Haselmann; Oliver Jäkel; Dirk Jäger; Markus W Büchler; Jürgen Debus Journal: BMC Cancer Date: 2013-09-14 Impact factor: 4.430