“This has been a historic year in oncology pharmacology,” Rowena Schwartz, PharmD, BCOP, associate professor at the University of Cincinnati, told the audience during a session at the 42nd Annual Congress in Denver, CO. “There were new drugs, yes, but we’re really learning how to use the drugs that we have.”
In fact, things have been changing so rapidly, that Schwartz was updating her presentation slides even in the days leading up to her session. Researchers are finding new targets and developing new drugs, confirming additional indications for treatments that are already being marketed in other disease states, and learning which drugs are best in certain individuals. Therefore, throughout the review of the year’s biggest pharmacology news, Schwartz challenged nurses to stop thinking of new drugs as treatments for cancer, but instead to think about the target.
Venetoclax, which targets the BCL2 protein, was recently approved by the U.S. Food and Drug Administration (FDA) for patients with chronic lymphocytic leukemia whose tumor cells are missing a portion of chromosome 17, commonly referred to as a 17p deletion. The treatment causes rapid cell death.
The most toxic adverse event is tumor lysis syndrome, even in early doses, so nurse management of this oral drug requires aggressive monitoring, examination of drug−drug interactions, and risk stratification. Schwartz said healthcare practitioners may even consider hospitalization during early doses.
Venetoclax has potential for broader use. It is being studied in other cancers, ongoing trials are looking at combination therapy, and the next year or two will likely bring new indications, Schwartz said.
“[Immunotherapeutic drugs] have wide indications,” said Schwartz, “and we are just beginning to see the benefits of these drugs in clinical trials and clinical practice.”
The first new immunotherapeutic treatment she discussed was avelumab, an anti-PD-L1 monoclonal antibody. It was recently approved for Merkel cell carcinoma, a rare and aggressive skin cancer that has poor prognosis in patients with advanced disease.
The drug is well-tolerated, so it can be used in the elderly population that is most affected by Merkel cell carcinoma, but patient management is important. In the study on which the FDA approval was based, patients could stay on therapy past the 12-month mark based on investigator assessment, even beyond observation of progressive disease, so clinicians must now determine a good way to clinically assess when patients should stay on therapy.
Also approved just days before Schwartz’ presentation is durvalumab, an PD-L1 human monoclonal antibody, for patients with locally advanced or metastatic urothelial bladder cancer. The drug was well-tolerated in the study leading to its approval. Encouraging data have been published in non-small cell lung cancer (NSCLC) as well, although that indication is not yet FDA approved.
Schwartz encouraged nurse researchers in the audience to consider studying fatigue in these new immunotherapies.
Drugs With Other New Targets
Schwartz reviewed many other drugs that have new targets, have been very recently approved by the FDA, and are being studied in broader indications, including:
- Olaratumab: A monoclonal antibody whose target is platelet-derived growth factor; for the treatment of patients with soft tissue sarcoma not amenable to curative treatment with radiotherapy or surgery
- Brigatinib: For the treatment of patients with metastatic anaplastic lymphoma kinase–positive NSCLC who have progressed on or are intolerant to crizotinib
- Midostaurin: For the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation–positive
- Ribociclib: A cyclin-dependent kinase 4/6 inhibitor for the treatment of postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer
- Rucaparib: An inhibitor of poly ADP ribose polymerase (PARP) for the treatment of patients with deleterious BRCA mutation–associated advanced ovarian cancer
- Niraparib: A PARP inhibitor for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
“This talk could have been called: These Are Not Chemotherapy,” Schwartz said. “The gold standard of treatment is changing.” Her hope is that the knowledge practitioners gain from practice is shared broadly to minimize toxicities and optimize benefits for as many patients as possible.