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Summary of ASCO Clinical Guidance for Drug Shortages

Summary of ASCO Clinical Guidance for Drug Shortages
The following statements provide general guidance on managing anticancer drugs in limited supply.
Provider-specific guidance
  • Decisions to use a drug in short supply should incorporate the treatment goals for each patient. Settings with a demonstrated survival benefit should be prioritized for use (both in the early and advanced disease settings).*
  • Reprioritize use of drugs that are in limited supply. If an alternative treatment strategy with similar efficacy and safety can be used, opt for that strategy.
  • If clinically appropriate, extend the time between treatment cycles and/or decrease the amount of drug used to the lowest effective dose.Δ
  • Limit the use of the agent in shortage for cancers that have recurred despite multiple therapies.
  • Decrease waste by optimizing the size of vials, rounding down on doses (if appropriate), and using multi-use vials.
  • Discuss with colleagues in hematology and oncology to identify alternative treatment options, including clinical trials.
Support services for shortage-related distress
  • Drug shortages cay cause distress both for clinicians and for patients. Clinicians may feel emotional distress if unable to provide optimal care; patients may experience distress if their care is impacted, and the therapeutic relationship with their provider may suffer.
  • Institutions should communicate to clinicians about available resources to manage distress related to drug shortages. Possible support resources include ASCO Safe Haven,[1] group forums, and peer to peer discussions.
  • Clinicians should refer patients with distress for counseling. Other appropriate support options include patient support groups.

ASCO: America Society of Clinical Oncology; SCLC: small cell lung cancer; CRT: chemoradiation; FU: fluorouracil; FOLFOX: oxaliplatin, leucovorin, and fluorouracil; RT: radiation therapy; CAPOX: capecitabine and oxaliplatin; FLOT: docetaxel, oxaliplatin, leucovorin, and fluorouracil; TCHP: docetaxel, carboplatin, trastuzumab, and pertuzumab; HER2: human epidermal growth factor 2; AUC: area under the curve; AC: doxorubicin and cyclophosphamide.

* As an example of when to prioritize use of an agent in limited supply, patients with limited-stage SCLC treated should be referred to a center where a platinum agent is available.[2]

Most locally advanced, resectable esophageal and/or gastroesophageal junction carcinomas are managed with neoadjuvant CRT, followed by surgical resection. Radiosensitizing regimens for CRT include carboplatin plus paclitaxel, FU plus cisplatin, or FOLFOX. As examples of using an alternative treatment strategy:

  • If cisplatin and carboplatin are in limited supply, neoadjuvant CRT with FOLFOX plus RT is an appropriate option.[3] If FU is also limited, CAPOX may be used concurrently with RT.
  • For gastroesophageal junction cancers, appropriate alternatives to neoadjuvant CRT may include perioperative chemotherapy. If FU is available, perioperative regimens include FOLFOX or FLOT.
  • For further details and supporting evidence, refer to UpToDate topics on treatment of resectable esophageal, gastroesophageal, and gastric cancers.

Δ For the TCHP regimen used in early HER2-positive breast cancer,[4] consider decreasing carboplatin to an AUC of 5 instead of 6 or omitting carboplatin.[5] Similarly, for the KEYNOTE-522 regimen used as neoadjuvant treatment in triple-negative breast cancer,[6] the standard dose of weekly carboplatin is an AUC of 1.5, but modifying to an AUC of 1 is acceptable given shortages of carboplatin. One could also start with AC plus pembrolizumab to be followed by paclitaxel and pembrolizumab, with or without carboplatin. ASCO recommends that providers consider prioritizing carboplatin for those whose tumors did not have a good response to AC plus pembrolizumab, but also notes that the incremental benefit of carboplatin in the KEYNOTE-522 regimen is unknown. For further details on the indications and efficacy of these regimens, refer to UpToDate topics on selecting neoadjuvant chemotherapy for HER2-negative and HER2-positive breast cancer.

◊ As an example, consider decreasing the dose or omitting use of either cisplatin or carboplatin in recurrent platinum-resistant ovarian cancer.[7]
References:
  1. ASCO Safe Haven. Available at: https://asco.safehavenhealth.org/ (Accessed on June 18, 2023).
  2. Small cell lung cancer. ASCO Clinical Guidance on Drug Shortages. Available at: https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/practice-patients/documents/2023-Final-SCLC-Updated-6-20-23.pdf.
  3. Gastrointestinal cancers. ASCO Clinical Guidance on Drug Shortages. Available at: https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2023-GI-ds-recs.pdf.
  4. Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol 2013; 24:2278.
  5. Breast cancer. ASCO Clinical Guidance on Drug Shortages. Available at: https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/practice-patients/documents/2023-ds-breast-recs.pdf.
  6. Schmid P, Cortes J, Pusztai L, et al. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med 2020; 382:810.
  7. Gynecologic cancers. SGO Statement: Carboplatin And Cisplatin Shortages. Available at: https://www.sgo.org/news/drugshortage.

Adapted from: ASCO Clinical Guidance on Drug Shortages. Available at: https://old-prod.asco.org/practice-patients/practice-support/drug-shortages/clinical-guidance (Accessed on June 18, 2023).

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