Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study

Abstract

We determined RDs for gemcitabine and S-1 adjuvant chemotherapy after major hepatectomy with a DLT that does not exceed 10%.

Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer

“…Interestingly, the present study showed similar results regarding dose intensity and toxicity, even though the profile of the surgical procedures differed between the studies, as half of the patients here underwent major hepatectomy. Although the optimal dose modification of gemcitabine in patients who have undergone hepatectomy has rarely been addressed 23 , the present findings suggest that patients who underwent extended hepatectomy were able to tolerate gemcitabine therapy alone and support the previous observation that the pharmacokinetics of gemcitabine in patients were comparable after major hepatectomy versus pancreatoduodenectomy 24 . In this context, toxicity-associated low dose intensity is unlikely to affect the present survival results.…”

Population Pharmacodynamic Model for Bayesian Prediction of Myelosuppression Profiles Based on Routine Clinical Data after Gemcitabine and Carboplatin Treatment

“…Accordingly, neutrophil reduction times are known to be around 15 days after the start of treatments with most anticancer drugs [24,25] . However, this period varies between patients as observed in the present study (days [13][14][15][16][17][18][19][20][21][22], and this suggests the necessity of frequent individual monitoring of cell counts. Therefore, predictions of nadir values and T nadir in individual patients after starting chemotherapy will be of great value.…”

“…GEM is commonly used to treat several cancers, including bladder, non-smallcell lung, pancreatic, biliary, ovarian, breast cancers, urothelial cancer, renal pelvis cancer and malignant lymphomas [10,11] . Hematotoxicity is considered a major toxicity [12] and is defined as a dose-limiting factor for GEM [13] . Although hematotoxicity of GEM reportedly occurs between 10 and 20 days after the start of chemotherapy [9][10][11] , nadir values vary widely among patients [14] .…”

Adjuvant gemcitabine monotherapy for resectable perihilar cholangiocarcinoma with lymph node involvement: a propensity score matching analysis

“…This result was consistent with the previous studies. Recently, a Japanese multicenter study group conducted a phase I trial [42] and pharmacokinetic study [43] on gemcitabine in patients with biliary tract cancers undergoing major hepatectomy, and have reported that the dose of gemcitabine should be reduced to 1000 mg/m 2 biweekly. A modification of the dose of gemcitabine would, therefore, be required for biliary malignancy patients after resection depending on the procedure that was performed.…”