Abstract
BackgroundAlthough adjuvant gemcitabine (GEM) chemotherapy for pancreatic cancer is standard, the quality of life (QOL) in those patients is still impaired by the standard regimen of GEM. Therefore, we studied whether mild dose-intensity adjuvant chemotherapy with bi-weekly GEM administration could provide a survival benefit with acceptable QOL to the patients with pancreatic cancer.MethodsAfter a phase I trial, an adjuvant bi-weekly 1,000 mg/m2 of GEM chemotherapy was performed in 58 patients with pancreatic cancer for at least 12 courses (Group A). In contrast, 36 patients who declined the adjuvant bi-weekly GEM chemotherapy underwent traditional adjuvant 5FU-based chemotherapy (Group B). Careful periodical follow-ups for side effects of GEM and disease recurrence, and assessment of patients’ QOL using the EORTC QOL questionnaire (QLQ-C30) and pancreatic cancer-specific supplemental module (QLQ-PAN26) were performed. Retrospectively, the degree of side effects, patients’ QOL, compliance rate, disease-free survival (DFS), and overall survival (OS) in Group A were compared with those in Group B.ResultsNo severe side effects (higher than Grade 2 according to the common toxicity criteria of ECOG) were observed, except for patients in Group B, who were switched to the standard GEM chemotherapy. Patients’ QOL was better in Group A than B (fatigue: 48.9 ± 32.1 versus 68.1 ± 36.3, nausea and vomiting: 26.8 ± 20.4 versus 53.7 ± 32.6, diarrhea: 21.0 ± 22.6 versus 53.9 ± 38.5, difficulty gaining weight: 49.5 ± 34.4 versus 67.7 ± 40.5, P < 0.05). Compliance rates in Groups A and B were 93% and 47%. There was a significant difference in the median DFS between both groups (Group A : B =12.5 : 6.6 months, P < 0.001). The median OS of Group A was prolonged markedly compared with Group B (20.2 versus 11.9 months, P < 0.005). For OS between both groups, univariate analysis revealed no statistical difference in 69-year-old or under females, and T1–2 factors, moreover, multivariate analysis indicated three factors, such as bi-weekly adjuvant GEM chemotherapy, T2 or less, and R0.ConclusionsAdjuvant chemotherapy with bi-weekly GEM offered not only the advantage of survival benefits but the excellent compliance with acceptable QOL for postoperative pancreatic cancer patients.
Highlights
Adjuvant gemcitabine (GEM) chemotherapy for pancreatic cancer is standard, the quality of life (QOL) in those patients is still impaired by the standard regimen of GEM
From the bitter experience of the low compliance rate in our institution, we hypothesized that the dose intensity of adjuvant GEM chemotherapy with the standard regimen was too heavy and harmful for people of Asian descent, and a milder dose-intensity of adjuvant GEM chemotherapy with bi-weekly administration might be more suitable and lead to prolongation of disease-free survival (DFS) and/or overall survival (OS) without impairing patients’ QOL
Thereby, after a phase I study, we studied whether mild dose-intensity adjuvant chemotherapy with biweekly GEM administration could provide prolonged disease-free survival (DFS) and/or overall survival (OS) without impairing patients’ quality of life (QOL)
Summary
Adjuvant gemcitabine (GEM) chemotherapy for pancreatic cancer is standard, the quality of life (QOL) in those patients is still impaired by the standard regimen of GEM. Methods: After a phase I trial, an adjuvant bi-weekly 1,000 mg/m2 of GEM chemotherapy was performed in 58 patients with pancreatic cancer for at least 12 courses (Group A). Thereafter, in our institution, adjuvant GEM chemotherapy with the standard regimen for patients with resectable pancreatic cancer had been used from 2001 to 2003. From the bitter experience of the low compliance rate in our institution, we hypothesized that the dose intensity of adjuvant GEM chemotherapy with the standard regimen was too heavy and harmful for people of Asian descent, and a milder dose-intensity of adjuvant GEM chemotherapy with bi-weekly administration might be more suitable and lead to prolongation of DFS and/or OS without impairing patients’ QOL
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