Chemotherapy shortages did not increase short-term mortality for people with advanced cancer
Key takeaways:
- Platinum chemotherapy utilization declined by 15.1% at the height of the national shortage.
- The shortage did not translate to an increase in short-term mortality.
The shortage of generic chemotherapy drugs cisplatin and carboplatin that began in early 2023 did not increase short-term mortality rates among people with advanced cancer, according to results of a cohort study.
The analysis included data from 11,797 adults with advanced solid cancers who began first-line treatment during a 1-year interval before the shortage (Feb. 1, 2022, to Feb. 9, 2023) or a 1-year period during the shortage (Feb. 10, 2023, to Jan. 31, 2024).
Analysis of platinum chemotherapy utilization in each period showed an absolute reduction of 2.7% (95% CI, 4.4 to 0.9) during the shortage interval.
At the height of the shortage in June 2023, the study showed a wider gap of platinum utilization (57.8% in June 2023 vs. 72.9% in June 2022; absolute reduction, 15.1%).
However, results showed no statistically significant difference in mortality during the shortage compared with the preceding 1-year interval (adjusted HR = 1; 95% CI, 0.94-1.07).
“Platinum chemotherapies remain the standard of care for these cancer types, and I hope that this research provides a basis for the imperative to secure a robust supply chain of these and other essential anticancer drugs,” Jacob B. Reibel, MD, third-year fellow in hematology-oncology at University of Pennsylvania’s Perelman School of Medicine, told Healio. “Further studies are needed to quantify the full range of harms due to low-quality drugs and brittle supply chains.”
Healio spoke with Reibel about the motivation for conducting this study and how the findings may influence clinical practice.
Healio: What motivated you to study the effects of the platinum chemotherapy shortage?
Reibel: Access to curative and life-prolonging treatments is critical to our patients. We knew from a poll in 2023 that National Comprehensive Cancer Network member institutions were experiencing widespread shortages of cisplatin and carboplatin, but we did not know how that was affecting prescribing practices. Drug shortages are a recurrent problem, and I was particularly interested to evaluate the impact of limited cisplatin and carboplatin supply on patients with cancer and physician prescribing patterns.
My interest also was piqued when I read the FDA warning letter to the sole pharmaceutical company that manufactures the U.S. supply of cisplatin. It cites findings of quality control records doused in acid, shredded in plastic bags, on a truck outside of the facility. This is a cautionary tale about importing drugs at the lowest possible cost at the expense of quality. For reference, a cycle of cisplatin costs about $35. Paying slightly higher prices to ensure a robust supply chain would benefit patients. With the amount of money that is spent on oncologic care, costs for generic drugs make up the smallest fraction of the total. We need research and development of new therapies. We also need access to old drugs that are proven to work.
Healio: How did you conduct the study?
Reibel: We used data obtained from Flatiron Health to examine prescribing rates of first-line platinum combinations among a real-world cohort of patients with advanced or metastatic lung, bladder, ovarian, endometrial, or head and neck cancers.
The FDA announced the cisplatin shortage on Feb. 10, 2023, so we selected that date as the start of the shortage period. We reported unadjusted percentages of patients receiving these therapies before and after the shortage announcement. We also performed multivariable logistic regression to adjust for patient and practice factors to model the probability of receiving a platinum combination each day of the 2-year study period.
Healio: Did the findings surprise you?
Reibel: I was surprised that the decrease in platinum prescribing was relatively modest after reading that the majority of NCCN centers were affected. However, applying the rates from our results to the national cancer population, as many as 1,000 patients might have been affected, and that is no small number in real terms.
Healio: What are your thoughts on the potential impact of alternative therapies on these outcomes?
I commend the efforts of ASCO and other oncologic societies to address the shortage by providing guidance to clinicians with recommendations for alternative therapies. Although these are likely still efficacious, they may be less so than platinum, with additional side effects and increased expense.
Healio: Is there anything else you’d like to mention?
Reibel: Although there was no spike in mortality during the shortage, there has not been enough follow-up time to know the true impact of the shortage on long-term mortality. Further research is needed to understand the impact of the shortage in terms of the emotional and psychological toll on patients and providers. We do not know the financial burden on patients or the health care system. Finally, these data do not account for adverse effects that led to ED visits and hospitalizations due to use of alternative therapies during the platinum chemotherapy shortage. Access to curative and life-prolonging treatments is critical to our patients.
Reference:
For more information:
Jacob B. Reibel, MD, can be reached at jacob.reibel@pennmedicine.upenn.edu.
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