Yelena Shames on Pausing Immunotherapy for Laboratory Abnormalities

For patients receiving immune checkpoint inhibitors (ICIs), the number of blood draws used to determine laboratory abnormality evaluations prior to each treatment cycle after induction may not be necessary, according to Yelena Shames, MSA, ACNP-BC, CNRN.

Shames, who is a nurse practitioner at Memorial Sloan Kettering Cancer Center, recently presented on abnormal laboratory values for patients undergoing treatment with immune checkpoint inhibitors during the 48th Annual Oncology Nursing Society Congress. As she explains in an interview with Oncology Nursing News® following her presentation, in a sample 183 patients receiving ICIs at her institution, most laboratory abnormalities necessitating dose delays were evident via chemistry evaluation and hematologic abnormalities only necessitated dose delays in 2 cases.

“I think the implications are large, because as nurses or advanced practice nurses we always advocate for our patients,” she said. “To know that patients may not necessarily have to undergo all the blood draws is probably one of the largest points of nursing advocacy.”

For patients undergoing treatment with ICIs, laboratory abnormalities represent a source for treatment delays or discontinuations. Although diagnostics are important to ensure that treatment-related risk is minimal, the specific treatment parameters and the appropriate frequency of blood draws are not as clear, according to Shames. Her team hypothesized that dose delays may not always be necessary because laboratory abnormalities alone are typically not clinically significant. She noted that for patients with uncomplicated ICI induction, treatment modifications related to laboratory abnormalities are rare, and that obtaining chemistry, hematology, pancreatic markers, and thyroid functions tests prior to each cycle of therapy may not be necessary.

Shames and her co-investigators conducted an IRB-approved retrospective analysis of patients treated with pembrolizumab (Keytruda). They collected the pharmacy records, data line reports, and the charts of 183 patients treated with commercial pembrolizumab.

Ultimately, treatment was either delayed or discontinued in 78 patients. Of these, only 15 patients had a documented laboratory abnormality. Further, only 15 out of 778 doses were delayed because of a laboratory abnormality. The median number of delayed pembrolizumab doses because of a laboratory abnormality was 4 (range, 1-7).

Among the patients who did experience a treatment delay inducing–laboratory abnormality, 8 cases were grade 3 or 4, in accordance with the CTCAE scale.

Several patients experience hyponatremia grade 3 or less. In most instances, this did not contribute to dose delay. However, 4 patients did experience grade 3/4 hyponatremia-associated hypophysitis and adrenal insufficiency, following approximately 2 to 7 doses of pembrolizumab. Although thyroid function tests were not collected consistently, 4 patients were reported to have abnormal thyroid-stimulating hormone levels. These did not contribute to dose delays.

Shames emphasized that most patients who needed to delay their dose had concurrent toxicities in addition to abnormal laboratory values. For those who experienced abnormal values, steroids were initiated for 6 patients, and the duration of therapy ranged from 5 to 30 days. Six patients out of 15 needed to permanently discontinue treatment, and only 1 out of 15 patients received secondary immunosuppression with infliximab (Remicade).

Reference

Shames Y, Errante M, Prempeh-Keteku N. To treat or not to treat? Evaluating abnormal laboratory values in patients receiving immune checkpoint inhibitors. Poster presented at: 48th Annual Oncology Nursing Society Congress; April 26-30, 2023; San Antonio, Texas. Accessed May 23, 2023. https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/12360