ASCO has issued new clinical guidance for treating patients with gastrointestinal cancers amid a nationwide shortage of carboplatin and cisplatin.
The two chemotherapy agents, in extremely short supply, are essential to treating an array of gastrointestinal cancers—such as esophageal cancer, pancreatic cancer, and colorectal cancer.
New ASCO Guidance
The new clinical guidance provides five general principles outlining reasonable drug substitutes and how to prioritize patient needs, including a focus on:
- Upper gastrointestinal malignancies
- Pancreatobiliary malignancies
- Small intestine malignancies
- Colorectal cancer
- Anal cancer.
ASCO will also issue guidance for treating breast cancer, genitourinary cancer, and lung cancers and endorsed guidance from the Society of Gynecologic Oncology for treating gynecologic cancers like cervical cancer and ovarian cancer. Further, ASCO published overarching guidance for all cancer types that may be affected by the shortage, and clinicians waiting for additional disease-specific guidance can consult the full complement of published treatment guidelines on ASCO’s website in the interim at old-prod.asco.org.
“This shortage is among the most severe we have seen in a long time, and its ripple effects are being felt across the country,” stressed Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer and Executive Vice President of ASCO. “The clinical guidelines are essential to helping clinicians deliver the best possible care for the best patient outcomes despite these dire shortages,” she said.
Next Steps
The Association of Clinical Oncology, an affiliated professional organization of ASCO, is actively working with policymakers to help mitigate the shortages as well as prevent similar situations from occurring in the future. Clinicians are encouraged to report shortages to the U.S. Food and Drug Administration (FDA) and to contact their representatives in Congress to make clear the urgent need for action.
Among the short-term policies ASCO is supporting is for the FDA to continue importing drugs from other countries as necessary and require manufacturers to notify the FDA if they notice an increased demand for any of their products.
In the long-term, U.S. regulators should create a comprehensive list of critical drugs needed for emergency responses and saving lives—and every drug on the list should be evaluated for availability, quality, manufacturer reliability, and potential weaknesses in the supply chain. Additionally, legislators need to develop incentives for drug manufacturers to make sure critical products stay available.
Conclusions
“There is no single solution to this serious problem, but doing nothing is not an option,” Dr. Gralow underscored. “We need government and manufacturers to come together to do the hard work necessary to prevent these crises,” she concluded.
Oncology professionals were encouraged to monitor ASCO’s drug shortage web page for the latest updates at old-prod.asco.org.
