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Efficacy and Safety of Gemcitabine as First-Line Therapy in Patients Aged 65 and Older with Advanced Pancreatic Cancer
Annals of Oncology 25 (Supplement 5): v44–v74, 2014 doi:10.1093/annonc/mdu435.120
Oral Session (Oral presentations categorized by each organ) O3
13
3
Yosuke Kito1, Akiko Todaka1, Akira Fukutomi1, Kenji Kunieda1, Takahiro Tsushima1, Tomoya Yokota1, Nozomu Machida1, Kentaro Yamazaki1, Yusuke Onozawa2, Hirofumi Yasui1 1 Divisiont of Gastrointestinal Oncology, Shizuoka Cancer Center 2 Division of Medical Oncology, Shizuoka Cancer Center
abstracts
Background: We have previously reported the efficacy and safety of gemcitabine (GEM) therapy in patients aged 75 years and older with advanced pancreatic cancer (APC): (1) 98% of the patients had good PS, and initial dose reductions were performed in 40%; (2) the efficacy was inferior to that of previous reports, which was assumed to result from low relative dose intensity (RDI) and proportion of patients
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v73/2240228 by guest on 24 October 2019
EFFICACY AND SAFETY OF GEMCITABINE AS FIRST-LINE THERAPY IN PATIENTS AGED 65 AND OLDER WITH ADVANCED PANCREATIC CANCER
who received second-line therapy. We assessed the efficacy and safety in patients aged 65-74 years. Methods: We retrospectively reviewed 187 consecutive patients aged 65-74 years with APC who received GEM as first-line therapy at our institution between September 2002 and March 2013. Inclusion criteria were as follows: PS0-2, adequate organ function, no massive fluid collection, no critical complication, adequate oral intake, and no active concomitant malignancy. Results: This analysis identified 137 patients. Patients characteristics were as follows: median age 70 years (range, 65-74), male/female 75/62, PS0/1/2 59/62/16, unresectable/recurrence 124/13, and metastasis +/- 116/21. Median number of administration was 10 times (1-110). Initial dose reductions were required in 5 (3.6%) patients. The median RDI was 79.8% (31.5-99.9). Out of the 135 patients with measurable lesion, the response rate was 7.4%, and disease control rate was 64.4%. The median progression free survival and median overall survival were 3.7 months and 9.4 months, respectively. Grade 3/4 adverse events were neutropenia (46.0%), anemia (12.4%), thrombocytopenia (12.4%), blood bilirubin increased (10.4%), and biliary tract infection (13.1%). Second-line therapy was administered in 91 (67.9%) patients. Conclusions: 11.7% of the patients aged 65-74 years had PS2, but the efficacy and treatment exposure of GEM therapy were comparable to those of previous reports, and toxicity was tolerable.
Oral Session (Oral presentations categorized by each organ) O3
13
3
Yosuke Kito1, Akiko Todaka1, Akira Fukutomi1, Kenji Kunieda1, Takahiro Tsushima1, Tomoya Yokota1, Nozomu Machida1, Kentaro Yamazaki1, Yusuke Onozawa2, Hirofumi Yasui1 1 Divisiont of Gastrointestinal Oncology, Shizuoka Cancer Center 2 Division of Medical Oncology, Shizuoka Cancer Center
abstracts
Background: We have previously reported the efficacy and safety of gemcitabine (GEM) therapy in patients aged 75 years and older with advanced pancreatic cancer (APC): (1) 98% of the patients had good PS, and initial dose reductions were performed in 40%; (2) the efficacy was inferior to that of previous reports, which was assumed to result from low relative dose intensity (RDI) and proportion of patients
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v73/2240228 by guest on 24 October 2019
EFFICACY AND SAFETY OF GEMCITABINE AS FIRST-LINE THERAPY IN PATIENTS AGED 65 AND OLDER WITH ADVANCED PANCREATIC CANCER
who received second-line therapy. We assessed the efficacy and safety in patients aged 65-74 years. Methods: We retrospectively reviewed 187 consecutive patients aged 65-74 years with APC who received GEM as first-line therapy at our institution between September 2002 and March 2013. Inclusion criteria were as follows: PS0-2, adequate organ function, no massive fluid collection, no critical complication, adequate oral intake, and no active concomitant malignancy. Results: This analysis identified 137 patients. Patients characteristics were as follows: median age 70 years (range, 65-74), male/female 75/62, PS0/1/2 59/62/16, unresectable/recurrence 124/13, and metastasis +/- 116/21. Median number of administration was 10 times (1-110). Initial dose reductions were required in 5 (3.6%) patients. The median RDI was 79.8% (31.5-99.9). Out of the 135 patients with measurable lesion, the response rate was 7.4%, and disease control rate was 64.4%. The median progression free survival and median overall survival were 3.7 months and 9.4 months, respectively. Grade 3/4 adverse events were neutropenia (46.0%), anemia (12.4%), thrombocytopenia (12.4%), blood bilirubin increased (10.4%), and biliary tract infection (13.1%). Second-line therapy was administered in 91 (67.9%) patients. Conclusions: 11.7% of the patients aged 65-74 years had PS2, but the efficacy and treatment exposure of GEM therapy were comparable to those of previous reports, and toxicity was tolerable.