During a shortage of the generic platinum chemotherapy drugs cisplatin and carboplatin that began in early 2023, investigators found no difference in mortality rates among patients with advanced cancer compared with the previous year, according to a recent study published by Reibel et al in the Journal of the National Cancer Institute.
Background
Cisplatin and carboplatin—which have been approved for over 30 years—are widely used to treat a variety of cancers, including lung cancer, head and neck cancer, breast cancer, urothelial carcinoma, ovarian cancer, endometrial carcinoma, and testicular cancer. When the U.S. Food and Drug Administration (FDA) announced a shortage of cisplatin in February 2023 followed by a shortage of carboplatin in April 2023, it drew attention to the ongoing challenge of generic drug shortages and prompted major national oncology societies to recommend best practices for priority use and alternative medicines.
“At the time, national surveys showed that most cancer centers in the [United States] were reporting shortages of these platinum chemotherapies, but it wasn’t clear how the shortages were actually affecting patients,” stressed lead study author Jacob B. Reibel, MD, a third-year fellow in Hematology-Oncology at the University of Pennsylvania. “When we looked at the data on prescribing practices over the shortage period, compared to the previous year, we found that although reporting of the shortages was widespread, it didn't affect as many patients as we had feared,” he continued.
Study Methods and Results
In the study, the investigators analyzed the data from 11,797 adult patients across the United States with advanced solid cancers for which platinum chemotherapy was recommended as the first line of therapy and who began treatment during the 1-year period prior to or during the platinum chemotherapy shortage. Because cisplatin and carboplatin were prioritized for patients with curable cancers during the shortage, the investigators expected that patients with advanced cancers would be most affected by drug availability.
Between February 2023 and January 2024, there was a 2.7% decrease in platinum chemotherapy use compared with the previous year—translating to 137 fewer patients in the advanced cancer cohort receiving platinum chemotherapy than expected. Based on the rates observed in the study, the investigators estimated that about 1,000 patients were affected overall in the United States. At the peak of the shortage in June 2023, the decrease was 15.1% compared with the previous year. With a median follow-up time of 7.6 months following treatment initiation, there was no statistically significant difference in mortality compared with the previous year.
Conclusions
The investigators hypothesized that the limited impact on mortality was likely caused by the use of effective alternative treatments recommended by medical societies, including immune checkpoint inhibitors, targeted therapy, or other types of chemotherapies. They did not assess the potential drawbacks of alternative treatments, such as the financial burden of more expensive nongeneric alternatives and the side effects of different drugs.
“We always want to prioritize the best treatments that we have for patients, and platinum chemotherapies just happen to also be very cost-effective because they’re generic and have been around for decades,” emphasized senior study author Ronac Mamtani, MD, MSCE, Section Chief of Genitourinary Cancers at the University of Pennsylvania. “While the alternative options may be effective, we want to be able to provide the standard-of-care [treatments] to any patient in need. Even 100 patients who can’t get the preferred chemotherapy for their cancer type [because of] supply chain issues is far too many,” he underscored.
The FDA listed the cisplatin shortage as resolved at the end of June 2024, and carboplatin remains on the shortage list. However, the investigators found prescribing levels have returned to normal.
Disclosure: The research in this study was funded by the National Institutes of Health. For full disclosures of the study authors, visit academic.oup.com.
