Chemotherapy patients at the Christiana Care Helen F. Graham Cancer Center & Research Institute helped test a drug called olanzapine (Zyprexa) that proved highly effective in controlling symptoms of nausea and vomiting during treatment for ovarian, breast, lung and head and neck cancers.

Medical Oncology Section Chief David Biggs, M.D., was the top local enroller in the study and a co-author of the report published in the July 14, 2016, issue of the New England Journal of Medicine (NEJM).

This double-blind, randomized study evaluated 380 patients at multiple centers across the country that participate in the National Cancer Institute’s National Community Oncology Research Program (NCORP). Neither the patients nor their doctors knew if they were getting olanzapine or a placebo.

“Nausea and vomiting are two things patients fear most about chemotherapy,” said Dr. Biggs. “We have made great strides in our ability to control chemotherapy-induced nausea and vomiting, but the results from the olanzapine study have already changed our routine practices here and no doubt will similarly benefit patients around the country.”

The NCORP sponsored study demonstrated that olanzapine given in combination with a standard triple-drug, anti-nausea, anti-vomiting regimen was significantly more effective than the placebo in preventing both nausea and vomiting in patients undergoing chemotherapy for the first time. Patients on the study received similar doses of either cisplatin or cyclophosphamide (Cytoxan)-doxorubicin (Adriamycin), notorious for producing chemotherapy-induced nausea and vomiting.

“A strong commitment to clinical research shared by Dr. Biggs and our colleagues continues to distinguish us among the most successful NCORP programs,” said Nicholas J. Petrelli, M.D., Bank of America-endowed medical director at the Helen F Graham Cancer Center & Research Institute. “Leadership in the olanzapine study is one more step on the pathway to converting best practices into better ones for the benefit of patients seeking treatment here and at centers throughout the country.”

Teresa Dessin of Middletown was one of 20 patients who participated in the study at the Graham Cancer Center. Like the others, she was asked to complete daily records of vomiting and use of any rescue therapy during the first five days of chemotherapy. Patients were also asked to rate their feelings of nausea on a scale of 0 (none) to 10 (worst it can be).

After being diagnosed with triple-negative breast cancer, Dessin had experienced violent bouts of nausea and vomiting well before starting chemotherapy.  “I was not looking forward to having those symptoms again,” she said,  “While on the study, I actually felt good, other than being a little tired.”

Most of the patients on the study drug had a similar experience. The overall response rate among patients who had no nausea or vomiting was 63.6 percent for the olanzapine group, and 40.6 percent for the placebo group. The olanzapine group (86 percent) also experienced no vomiting and needed no rescue medication, compared with the placebo group (65 percent), with no significant side effects. A small number of patients (5 percent) on olanzapine experienced feelings of sedation (tiredness) on day 2, which resolved on subsequent days as they continued on the drug.

Olanzapine is a relatively well-known antipsychotic drug that works by blocking receptors in the brain that actually trigger nausea and vomiting. “Although olanzapine has been available for some time, it was never considered a standard anti-nausea drug until this clinical trial,” Dr. Biggs said.

“The beauty of this study,” he added, “is that olanzapine is a readily available, highly effective oral anti-emetic that costs a lot less than some of the expensive IV treatments we use now to control chemotherapy induced nausea and vomiting. Further studies would tell us whether olanzapine could replace some of these IV drugs.”