A prophylactic, graded, extended infusion of carboplatin, compared with a shorter, standard infusion, is not associated with a reduced rate of hypersensitivity reactions (HSRs) in women with recurrent ovarian cancer, according to a study published in the International Journal of Gynecological Cancer.
Katherine LaVigne, MD, from the Gynecologic Medical Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center in New York City and colleagues conducted a prospective randomized clinical trial that compared an extended infusion with a standard infusion of carboplatin. The primary objective was to determine whether the prophylactic use of an extended infusion was associated with a clinically meaningful lower rate of HSRs compared with the standard 30-minute schedule.
Eligible patients included women with histologically confirmed ovarian, fallopian tube, or primary peritoneal carcinoma who had received at least 1 prior platinum-containing regimen. Participants were required to have adequate hematologic, hepatic, and renal function. Exclusion criteria included a history of platinum HSR, uncontrolled concurrent illness, a life expectancy of less than 12 weeks, pregnancy or lactation, or receipt of another investigational agent. All patients had previously received at least 6 cycles of a platinum-containing regimen.
All patients in both arms received identical chemotherapy premedications: montelukast 10 mg once daily for 3 days prior, dexamethasone 20 mg the night before and day of the carboplatin infusion, and either ranitidine 50 mg intravenously (IV) or famotidine 20 mg IV before the carboplatin infusion. An HSR was defined as any allergic or anaphylactic reaction, regardless of grade, deemed unlikely, possibly, potentially, or definitely attributed to the carboplatin.
Of the 146 patients who were enrolled between January 2011 and April 2015, 114 (78%) were evaluable for the primary study end point. The median age of the participants was 60 years (range, 35 to 79 years), and the majority were white (88%) and had a diagnosis of a high-grade serous malignancy.
Fifteen (13%) had an HSR: 11% (6/56) in the extended-infusion and 16% (9/58) in the standard-infusion groups. Planned treatment completion was achieved in 50 (89%) of 56 patients and 49 (84%) of 58 patients, respectively. Of 25 patients who received single-agent carboplatin, 8 (32%) had an HSR (53% of all patients who had an HSR [8/15]). Of 23 patients who received carboplatin with gemcitabine, 4 (17%) had an HSR (27% of all patients who had an HSR [4/15]). Of 8 patients who received carboplatin with paclitaxel, 3 (38%) had an HSR (20% of all patients who had an HSR [3/15]). There were no HSRs with pegylated liposomal doxorubicin, the most commonly given concurrent chemotherapy (46% of all patients).
“In this randomized controlled trial, a prophylactic, extended infusion of carboplatin was not associated with a decreased HSR rate in patients undergoing treatment for recurrent ovarian cancer,” the authors concluded.
LaVigne K, Hyman DM, Zhou QC, et al. A randomized trial of prophylactic extended carboplatin infusion to reduce hypersensitivity reactions in recurrent ovarian cancer [published online May 4 2018]. Int J Gynecol Cancer. doi: 10.1097/IGC.0000000000001280