Oral vinorelbine to treat women with ectopic pregnancy: a phase 1 clinical safety and tolerability study

Vinorelbine is a chemotherapy medication used as an oral alternative to other agents ( 1 Hastie R. Lim E. Sluka P. Campbell L. Horne A.W. Ellett L. et al. Vinorelbine potently induces placental cell death, does not harm fertility and is a potential treatment for ectopic pregnancy. EBioMedicine. 2018; 29: 166-176 Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar ). Methotrexate is the only medical option available to treat ectopic pregnancy via intramuscular injection ( 2 Farquhar C.M. Ectopic pregnancy. Lancet. 2005; 366: 583-591 Abstract Full Text Full Text PDF PubMed Scopus (379) Google Scholar , 3 Cohen A. Zakar L. Gil Y. Amer-Alshiek J. Bibi G. Almog B. et al. Methotrexate success rates in progressing ectopic pregnancies: a reappraisal. Am J Obstet Gynecol. 2014; 211: 128.e1-128.e5 Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar ). It is less invasive than surgery but incurs approximately a 29% risk of requiring rescue surgery ( 4 Centers for Disease Control and Prevention, Current trends - ectopic. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00014677.htm. Google Scholar ). An oral therapy to treat ectopic pregnancy does not exist ( 5 Åhman E. Dolea C. Shah I. The global burden of unsafe abortion in the year 2000. World Health Organization, Geneva2005 Google Scholar ). Preclinical studies have identified the potential of vinorelbine as a novel tablet-only treatment for ectopic pregnancies ( 1 Hastie R. Lim E. Sluka P. Campbell L. Horne A.W. Ellett L. et al. Vinorelbine potently induces placental cell death, does not harm fertility and is a potential treatment for ectopic pregnancy. EBioMedicine. 2018; 29: 166-176 Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar ). Here, we assessed the safety, toxicity, and tolerability profiles of vinorelbine when administered to women with stable ectopic pregnancies. Magic bullet or simply nice to have: safety and tolerability of oral vinorelbine for ectopic pregnancyFertility and SterilityVol. 120Issue 3PreviewAn ectopic pregnancy occurs in 1% of pregnancies and is a common indication for hospitalization and treatment, as well as a significant cause of morbidity in gynecological patients (1). Patients with ruptured ectopic pregnancies who are hemodynamically unstable, patients with positive embryonic cardiac activity, and patients with ß-human chorionic gonadotropin (hCG) levels above 5,000–10,000 IU/mL are usually treated surgically, whereas hemodynamically stable patients are usually followed up or treated medically (1). Full-Text PDF