Drug products: Gemcitabin Actavis, Gemcitabin Ebewe, Gemcitabin Fresenius Kabi, Gemcitabin Hospira, Gemcitabin Pfizer, Gemcitabin Sandoz, Gemcitabin SUN, Gemcitabine Accord, Gemcitabine Vianex, Gemkabi, Gemzar®, Gitrabin
ATC code: L01BC05
Substances: gemcitabine, gemcitabine hydrochloride
Women may benefit more than men of gemcitabine-based combination chemotherapies but are more likely to suffer from emesis. Use of gemcitabine during pregnancy may cause birth defects.
Pharmacokinetics and dosing
The clearance of gemcitabine is 25-48% lower in women than men, with more pronounced difference at higher age and resulting in higher concentrations . According to the product information, the clearance for women is about 25% lower than for men, but the recommended gemcitabine dose of 1000 mg per square meter of body surface area does not need to be reduced for women .
Pancreatic cancerOutcome of chemoradiotherapy for unresectable pancreatic cancer in 103 men and 77 women was analyzed retrospectively: Multivariate analysis showed that male sex , lower performance status, and higher posttreatment CA 19-9 level predicted worse overall survival . Data on Japanese patients with nonresectable pancreatic cancer receiving gemcitabine-based chemotherapy (306 men, 225 women) collected to generate a nomogram to predict survival and patient´s sex was not a significant factor .A single-arm prospective, multicenter, open-label phase II study (25 men, 21 women) evaluated the combination of erlotinib and weekly fixed dose-rate gemcitabine, in previously untreated patients with locally advanced, inoperable, or metastatic pancreatic cancer. Female sex was a predictor of longer progression free survival (HR 2.99, 05%CI 1.13-7.90), but not overall survival .
Biliary tract cancerBetween 2010 and 2016, 740 Korean patients (425 men, 315 women) with cholangiocarcinoma and gallbladder cancer were treated with first-line gemcitabine plus cisplatin. In multivariate analysis, male sex was associated with lower overall survival (HR 0.83) .
Urothelial cancerA total of 174 men and 54 women with metastatic urothelial carcinoma undergoing systemic chemotherapy were included in a multi-institutional study. The gemcitabine plus cisplatin regimen was administered as first-line chemotherapy to 131 patients. Of all patients, 119 received at least 2 different regimens and 22 underwent resection of metastases. The median overall survival (OS) time was 17 months. One of the favorable prognostic factors was female sex . Median survival was 16 months for men and 27 months for women (HR 0.48) .
Non-small cell lung cancer (NSCLC)A retrospective study included 235 men and 83 women with advanced NSCLC treated with first-line gemcitabine-based chemotherapy. No difference in terms of progression-free survival or overall survival according to sex, age, stage, chemotherapy (single-agent versus combination chemotherapy) and thrombocytosis was observed .
Female sex predicts a greater risk for acute emesis and poor antiemetic control .A total of 120 patients (74 men, 46 women) with biliary tract cancer were enrolled in a study to evaluate acid suppressants’ efficacy in prevention of chemotherapy-induced nausea and vomiting. It showed that the treatment was not associated with nausea incidence. Female sex was a predictive factor for onset of all-grade nausea in association with cisplatin and gemcitabine treatment .
Reproductive health issues
Gemcitabine may cause fetal harm. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2022-10-14
- Food and Drug Administration (FDA). Drug label - GEMZAR (gemcitabine). Drugs@FDA [www]. [updated 2005-04-20, cited 2022-10-14]. länk
- Gemcitabine Accord (gemcitabine). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2022-10-24, cited 2022-11-08]
- Zhou J, Fang CX, Shen J, Schipper MJ, Zalupski MM, Minter RM et al. Definitive Chemoradiation With Full-dose Gemcitabine for Unresectable Pancreatic Cancer: Efficacy of Involved-Field Radiotherapy. Am J Clin Oncol. 2017;40(5):517-522. PubMed
- Hamada T, Nakai Y, Yasunaga H, Isayama H, Matsui H, Takahara N et al. Prognostic nomogram for nonresectable pancreatic cancer treated with gemcitabine-based chemotherapy. Br J Cancer. 2014;110(8):1943-9. PubMed
- Vaccaro V, Bria E, Sperduti I, Gelibter A, Moscetti L, Mansueto G et al. First-line erlotinib and fixed dose-rate gemcitabine for advanced pancreatic cancer. World J Gastroenterol. 2013;19(28):4511-9. PubMed
- Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS et al. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017;80(1):209-215. PubMed
- Abe T, Ishizaki J, Kikuchi H, Minami K, Matsumoto R, Harabayashi T et al. Outcome of metastatic urothelial carcinoma treated by systemic chemotherapy: Prognostic factors based on real-world clinical practice in Japan. Urol Oncol. 2017;35(2):38e1-38e8. PubMed
- Canova S, Cicchiello F, Agustoni F, Bianchini G, Abbate MI, Bidoli P et al. Gemcitabine-induced thrombocytosis as a potential predictive factor in non-small cell lung cancer: analysis of 318 patients. Tumori. 2017;103(2):143-147. PubMed
- Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines American Society of Clinical Oncology. J Clin Oncol. 1999;17(9):2971-94. PubMed
- Saito Y, Takekuma Y, Komatsu Y, Sugawara M. Evaluation of risk factors for chemotherapy-induced nausea and vomiting in cisplatin and gemcitabine treatment for biliary tract cancer: acid suppressants do not prevent nausea. Pharmazie. 2022;77(6):196-201. PubMed
- Concise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2019-03-14.] länk
Reviewed by: Diana Rydberg, Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson