BACKGROUND: The efficacy and toxicity of gemcitabine (GEM) and irinotecan (CPT-11) is evaluated in previously untreated patients with inoperable or metastatic pancreatic cancer. PATIENTS AND METHODS: From January 1999 to July 2001, 60 patients with pancreatic cancer (85% stage IV) were enrolled in a two-step extended phase II trial. Patients were treated with gemcitabine (1,000 mg/m2 on days 1 and 8) and CPT-11 (300 mg/m2 on day 8) in cycles of 3 weeks. No prophylactic use of recombinant human granulocyte colony-stimulating factor (rhG-CSF) was initially planned. RESULTS: In an intention-to-treat analysis one (1.7%) complete and 14 (23.3%) partial responses were achieved [objective response rate (ORR) 24.7%; 95% confidence interval 14.04% to 35.96%]. Twenty-two (36.7%) and 23 (38.3%) patients had stable and progressive disease, respectively. The median duration of response was 5 months, the median time to tumor progression (TTP) was 7 months and the median overall survival 7 months. One-year survival was 22.5%. Pain improvement and asthenia during treatment were observed in 45% and 43% of patients, respectively; weight gain occurred in 19.5% of patients. Grade 3 anemia occurred in three (5%) patients who required transfusion of six packed red blood cell (RBC) units. Ten (16.7%) additional patients with grade 2 anemia were treated with recombinant erythropoietin. Grade 3 thrombocytopenia occurred in seven (11.7%) patients and grades 3 and 4 neutropenia in 27 (45%). Ten patients developed febrile neutropenia, two of whom died due to sepsis. Prophylactic use of rhG-CSF was eventually required in 93 (28.3%) of 329 administered cycles. Other toxicities were mild. CONCLUSIONS: The combination of gemcitabine and irinotecan is an active chemotherapy regimen against pancreatic cancer with a 25% ORR. Toxicity was acceptable for the great majority of patients but with a high percentage of hematopoietic growth factor administration.
BACKGROUND: The efficacy and toxicity of gemcitabine (GEM) and irinotecan (CPT-11) is evaluated in previously untreated patients with inoperable or metastatic pancreatic cancer. PATIENTS AND METHODS: From January 1999 to July 2001, 60 patients with pancreatic cancer (85% stage IV) were enrolled in a two-step extended phase II trial. Patients were treated with gemcitabine (1,000 mg/m2 on days 1 and 8) and CPT-11 (300 mg/m2 on day 8) in cycles of 3 weeks. No prophylactic use of recombinant humangranulocyte colony-stimulating factor (rhG-CSF) was initially planned. RESULTS: In an intention-to-treat analysis one (1.7%) complete and 14 (23.3%) partial responses were achieved [objective response rate (ORR) 24.7%; 95% confidence interval 14.04% to 35.96%]. Twenty-two (36.7%) and 23 (38.3%) patients had stable and progressive disease, respectively. The median duration of response was 5 months, the median time to tumor progression (TTP) was 7 months and the median overall survival 7 months. One-year survival was 22.5%. Pain improvement and asthenia during treatment were observed in 45% and 43% of patients, respectively; weight gain occurred in 19.5% of patients. Grade 3 anemia occurred in three (5%) patients who required transfusion of six packed red blood cell (RBC) units. Ten (16.7%) additional patients with grade 2 anemia were treated with recombinant erythropoietin. Grade 3 thrombocytopenia occurred in seven (11.7%) patients and grades 3 and 4 neutropenia in 27 (45%). Ten patients developed febrile neutropenia, two of whom died due to sepsis. Prophylactic use of rhG-CSF was eventually required in 93 (28.3%) of 329 administered cycles. Other toxicities were mild. CONCLUSIONS: The combination of gemcitabine and irinotecan is an active chemotherapy regimen against pancreatic cancer with a 25% ORR. Toxicity was acceptable for the great majority of patients but with a high percentage of hematopoietic growth factor administration.
Authors: Leo Christopher DeRosier; Zhi-Qiang Huang; Jeffrey C Sellers; Donald J Buchsbaum; Selwyn M Vickers Journal: J Gastrointest Surg Date: 2006-11 Impact factor: 3.452
Authors: Leo Christopher DeRosier; Donald J Buchsbaum; Patsy G Oliver; Zhi-Qiang Huang; Jeffrey C Sellers; William E Grizzle; Wenquan Wang; Tong Zhou; Kurt R Zinn; Joshua W Long; Selwyn M Vickers Journal: Clin Cancer Res Date: 2007-09-15 Impact factor: 12.531
Authors: Elizabeth Dugan; Roxanne Truax; Kellen L Meadows; Gerald C Blobe; Michael A Morse; Nishan H Fernando; Jon P Gockerman; William P Petros; Herbert I Hurwitz Journal: Anticancer Res Date: 2009-12 Impact factor: 2.480
Authors: G P Stathopoulos; K Syrigos; G Aravantinos; A Polyzos; P Papakotoulas; G Fountzilas; A Potamianou; N Ziras; J Boukovinas; J Varthalitis; N Androulakis; A Kotsakis; G Samonis; V Georgoulias Journal: Br J Cancer Date: 2006-08-08 Impact factor: 7.640
Authors: G P Stathopoulos; J Dimitroulis; D Antoniou; C Katis; D Tsavdaridis; O Armenaki; C Marosis; P Michalopoulou; T Grigoratou; J Stathopoulos Journal: Br J Cancer Date: 2005-11-14 Impact factor: 7.640