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SGO, FWC, GOG-F* Communique: Considerations When Treating Patients with Gynecologic Cancers on Clinical Trials in the Setting of Chemotherapy Shortages

Joint StatementNews Article
May 15, 2023
A platinum drug shortage in the U.S. was first reported to the FDA on February 10th, 2023[1]. Please refer to the SGO Rapid Communique dated April 21st, 2023 for details and guidance regarding platinum dosing and sparing strategies[2]. Within the context of continued limited drug availability, this joint communication provides guidance for treating patients with gynecologic cancers enrolled in clinical trials.
Hospital systems or similar organizations are encouraged to facilitate open and frequent communication among multi-specialty teams, including gynecologic, medical, and radiation oncologists, pharmacists, infusion managers, advanced practitioners, and patient advocates. In doing so, the goal is to create institution- and population-specific strategies to overcome anticipated treatment challenges.
Importantly, cancer care disparities may emerge or worsen in times of resource scarcity. As treatment recommendations are adjusted during this shortage, identifying patients at risk for experiencing structural barriers to care – and having a plan to mitigate those barriers – must be considered as part of each institution’s strategic plan. Therefore, the allocation of limited-supply drugs must be prioritized in a transparent and data-driven fashion to ensure thoughtful and equitable distribution. This may include formation of institutional drug shortage task forces, conduction of daily cancer center calls to assess drug supply and anticipated drug delivery dates, adoption of institutional guidelines for utilization of select chemotherapy agents based on curative and palliative intent, and clinical trials leadership review of chemotherapy regimens and patient consent modifications required for studies that include carboplatin/cisplatin etc. Additionally, considerable operational workflow resources must be facilitated by hospital leadership, administrators, pharmacists, and payors to ensure adequate and equitable patient care.
On 4/27/23, NRG Oncology broadcast a statement to member institutions regarding management of platinum-based therapies on clinical trials during chemotherapy drug shortages:
The approach for delays and/or modifications in therapy for patients already enrolled in the research without prior IRB approval is permissible under the Department of Health and Human Services (HHS) regulations 45 CFR 46.103(b)(4)(iii) since the modifications are being made to eliminate immediate apparent hazards to study participants. In the instance of drug shortage, appropriate delays and/or modifications in study treatment may be made when the commercial agent is not available. The participant must be informed of delays or modifications in therapy due to supply shortage and potential risks. The discussion must also be documented in the participant’s medical record and reported as an unanticipated problem to the IRB.
The SGO, FWC, and GOG-F endorse the NRG Oncology statement and recommend the following general principles for institutions who participate in cooperative group or investigator-initiated trials:
  1. Whether a patient is treated on a clinical trial or is receiving standard-of-care therapy, cisplatin and carboplatin should be prioritized for patients receiving treatment for curative intent or when prolonged clinical benefit is anticipated.
  2. Patients receiving platinum-based regimens as either standard-of-care or on clinical trial should be given equal prioritization during the drug shortage.
  3. For institutions anticipating a prolonged platinum drug shortage, consider discussion with oncology colleagues at institutions without similar chemotherapy drug shortages regarding potential new patient trial referrals.
  4. For platinum-based investigator-initiated trials or cooperative group studies in which referral to another institution is not feasible, avoid enrollment of new study participants until confirmation of an adequate and sustainable institutional drug supply. Investigators should communicate with their local IRBs and with the study chairs/principal investigators if a pause in enrollment is anticipated.
  5. In settings in which an institutional drug shortage develops when patients are already enrolled on a platinum-based clinical trial, the respective study chairs/principal investigators should be contacted to discuss each situation on a case-by-case basis.
    1. Although drug shortages are known to lead to protocol deviation in clinical trials and may impact data interpretation, patient safety and outcomes must be prioritized[3]. Additionally, based on upon the Department of Health and Human Services (HHS) regulations 45 CFR 46.103(b)(4)(iii), which provide robust protections for human research study subjects, it is reasonable to consider modifications to trials in the setting of commercial drug shortages[4]. Modifications to consider for patients enrolled on platinum-based trials include:
      1. Utilizing the lowest effective dose of platinum (i.e., carboplatin AUC 4-5 IV or cisplatin 50-75 mg/m2 IV every 21 days)
      2. Substituting cisplatin for carboplatin or carboplatin for cisplatin at institutions in which these drug shortages do not overlap.
      3. Delaying the next chemotherapy cycle briefly if drug supply is anticipated soon.
      4. Omitting the platinum-based therapy but continuing with other study treatment if receiving a multi-drug regimen.
  6. When a drug shortage exists, patients enrolled on clinical trials must be informed of any treatment delays or modifications, as well as potential associated risks[4]. Any treatment modifications and associated patient counseling should also be documented in the patient’s medical record and reported to the institutional IRB.
  7. The following NRG trials currently utilize a platinum regimen either as a primary regimen or drug substitution[5]:
    1. Cisplatin
      1. NRG-GY019
      2. NRG-GY024
    2. Carboplatin
      1. NRG-GY018
      2. NRG-GY019
      3. NRG-GY022
      4. NRG-GY026
      5. NRG-GY027
  8. The following GOG-F trials currently utilize a platinum regimen either as a primary regimen or drug substitution[6]:
    1. Cisplatin
      1. GOG 3053 (KEYNOTE B51)
      2. GOG 3064 (KEYNOTE C93)
      3. GOG 3068 (HOTT)
    2. Carboplatin
      1. GOG 3025 (DUO-O)
      2. GOG 3031 (RUBY)
      3. GOG 3035 (FLORA 5)
      4. GOG 3036 (KEYLYNK 001)
      5. GOG 3053 (KEYNOTE B51)
      6. GOG 3064 (KEYNOTE C93)
      7. GOG-3076 (On Prime)
  9. The SGO, FWC, and GOG-F continue to monitor the supply shortage closely. This document is subject to an update as more information is learned.


*Organizations involved in production of this communique include the Society of Gynecologic Oncology, the Foundation for Women’s Cancer, and The GOG Foundation, Inc.

The SGO, FWC, and GOG-F wish to acknowledge the following members and professionals for their contributions to this communique: Amanda Fader, MD; Leslie Randall, MD; Thomas Herzog, MD; Bhavana Pothuri, MD, MS; David O’Malley, MD; Angeles Alvarez Secord, MD, MHSc; Roisin O’Cearbhaill, MD; Peter Rose, MD; Deborah Armstrong; MD; Paul DiSilvestro, MD; Eloise Chapman-Davis, MD; Ginger Gardner, MD; Navya Nair, MD, MPH; Ms. Katherine Campbell; Ms. Jenna Cummins; Ms. Elizabeth Kix; Ms. Katie Martino; Ms. Kayla Nixon; Ms. Jessica Oldham; Ms. Traci Schwendner

For questions or further guidance, please email sgo@sgo.org.