During shortages of generic platinum chemotherapy drugs cisplatin and carboplatin that began in early 2023, there was no difference in mortality rates amongst patients with advanced cancer in comparison with the previous yr, and prescription rates for these two drugs declined overall by lower than three percent – and at its peak 15.1 percent – in keeping with an evaluation published this week in The Times by researchers on the Perelman School of Medicine on the University of Pennsylvania and the Abramson Cancer Center at Penn Medicine.
Cisplatin and carboplatin – approved for over 30 years – are widely used to treat a spread of cancers, including lung, head and neck, breast, bladder, ovary, uterine and testicular cancer. When the FDA announced a cisplatin shortage in February 2023, followed by a carboplatin shortage in April 2023, it highlighted the continuing challenge of generic drug shortages and prompted major national cancer societies to recommend best practices for priority use and alternative drugs .
“At that time, national surveys showed that most U.S. cancer centers were reporting shortages of platinum chemotherapy, but it was unclear how these shortages were actually affecting patients,” said lead writer Jacob B. Reibel, M.D., a third-year fellow in hematology- oncology. “When we looked at data on prescribing practices during the period of shortages, compared to the previous year, we found that although reporting of shortages was common, it did not affect as many patients as we had feared.”
Reibel, senior writer Ronac Mamtani, MD, chief of the section of genitourinary cancers, and colleagues analyzed data from 11,797 adults across the United States with advanced solid cancers for whom platinum-based chemotherapy is advisable as the primary line of treatment and who initiated treatment inside one yr the yr before or in the course of the shortage of platinum-containing chemotherapy. Because cisplatin and carboplatin were prioritized for patients with curable cancers in the course of the period of shortages, scientists expected that patients with advanced cancers can be most affected by the supply of the drugs.
From February 2023 to January 2024, there was a 2.7% decrease in the use of platinum-based chemotherapy in comparison with the previous yr. This implies that in this cohort of patients with advanced cancer, there have been 137 fewer patients receiving platinum-containing chemotherapy than expected, and based on the rates observed in the study, researchers estimate that there are roughly 1,000 patients overall in the U.S. affected by this disease. At the height of the shortage in June 2023, the decline was 15.1%. in comparison with the previous yr. With a median follow-up of 7.6 months from the beginning of treatment, there was no difference in mortality in comparison with the previous yr.
Alternative therapies help alleviate the crisis, but they’re not the primary selection
The researchers hypothesized that the limited effect on mortality was likely on account of the use of effective alternative drugs advisable by medical societies, comparable to immune checkpoint inhibitors, targeted therapy, or other forms of chemotherapy. The study did not evaluate the potential disadvantages of alternative medicines, including the financial burden of dearer, non-generic alternative medicines or the uncomfortable side effects of different medicines.
“We always want to prioritize the best treatments we have for patients, and platinum chemotherapies are also very cost-effective because they are generic and have been used for decades,” Mamtani said. “While alternative options may be effective, we want to be able to provide ‘standard’ medicines to every patient in need. Even a hundred patients who cannot receive their preferred chemotherapy for their cancer type due to the supply of chain problems is far too many.”
The FDA deemed the cisplatin shortage resolved in late June 2024, and carboplatin stays on the shortage list, although the research team concluded that cisplatin prescription levels have returned to normal.
The study was funded by the National Institutes of Health (T32CA009679).
