This is a plain language summary of an article originally published in The New England Journal of Medicine. It is about initial results (collected in October 2019) from the JAVELIN Bladder 100 study (a clinical trial), which looked at avelumab maintenance treatment in people with advanced urothelial cancer. Urothelial cancer is the most common type of bladder cancer. People with advanced urothelial cancer often receive chemotherapy. If this is the first treatment people with advanced disease are given, it is called first-line treatment. If the cancer stops growing or shrinks with first-line chemotherapy, people can be given different treatment to try to prevent the cancer from growing again. This is called maintenance treatment. It may help people live longer.
In the JAVELIN Bladder 100 study, researchers wanted to find out if maintenance treatment with avelumab would help people with advanced urothelial cancer live longer. Avelumab is a type of medicine called immunotherapy. Immunotherapy helps the body's immune system fight cancer. 700 people took part in the study. To take part, they must have already been treated with first-line chemotherapy. Also, their cancer must have shrunk or not grown with this treatment. They were then treated with either avelumab maintenance treatment plus best supportive care or best supportive care alone. Best supportive care means treatments that help improve symptoms and quality of life. These treatments do not affect the cancer directly and can include medicines to relieve pain.
Researchers found that people treated with avelumab maintenance treatment plus best supportive care lived, on average, 7 months longer than people who received best supportive care alone. People treated with avelumab had more side effects than those not treated with avelumab, but most were not severe. Common side effects with avelumab included persistent tiredness, itchy skin, urinary tract infection, and diarrhea.
Results from the JAVELIN Bladder 100 study support the use of avelumab as maintenance treatment for people with advanced urothelial cancer whose cancer has shrunk or not grown with first-line chemotherapy. ClinicalTrials.gov NCT number: NCT02603432.
Future oncology (London, England). 2022 Apr 13 [Epub ahead of print]
Thomas Powles, Se Hoon Park, Eric Voog, Claudia Caserta, Begoña P Valderrama, Howard Gurney, Haralabos Kalofonos, Sinisa Radulovic, Wim Demey, Anders Ullén, Yohann Loriot, Srikala S Sridhar, Norihiko Tsuchiya, Evgeny Kopyltsov, Cora N Sternberg, Joaquim Bellmunt, Jeanny B Aragon-Ching, Daniel P Petrylak, Robert J Laliberte, Bo Huang, Nuno Costa, John A Blake-Haskins, Petros Grivas
Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Sungkyunkwan University Samsung Medical Center, Seoul, Korea., Centre Jean Bernard Clinique Victor Hugo, Le Mans, France., Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni, Italy., Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Department of Clinical Medicine, Macquarie University, Sydney, New South Wales, Australia., Medical Oncology, University General Hospital of Patras, Patras, Greece., Institute for Oncology and Radiology of Serbia, Belgrade, Serbia., Department of Medical Oncology, AZ KLINA, Brasschaat, Belgium., Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden., Gustave Roussy, INSERMU981, Université Paris-Saclay Villejuif, France., Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia., Hematology/Oncology, Weill Cornell Medicine, Englander Institute for Precision Medicine, Sandra and Edward Meyer Cancer Center, New York, New York, USA., Department of Medical Oncology, Beth Israel Deaconess Medical Center; Harvard Medical School, Boston, Massachusetts, USA., Inova Schar Cancer Institute, Fairfax, Virginia, USA., Yale Cancer Center, New Haven, Connecticut, USA., Pfizer, Cambridge, Massachusetts, USA., Pfizer, Groton, Connecticut, USA., Pfizer, Porto Salvo, Portugal., Pfizer, La Jolla, California, USA., Department of Medicine, Division of Medical Oncology, University of Washington; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.