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Alternative examinations and treatments for oncology patients due to lack of radiopharmaceuticals

Recommendations of the Cyprus Oncology Society (OEK)

Import

The restrictive measures and the ban on flights to Cyprus due to the Covid-19 pandemic have unfortunately led to a shortage of radiopharmaceuticals used in diagnostic tests and treatments for cancer patients.

Nuclear Medicine diagnostic tests in Oncology concern the staging of patients mainly with breast, prostate, lung and melanoma cancer, where bone scintigraphy using Technetium-99m ( 
99 m TC-MDP) can identify or exclude bone metastases and determine the stage of the disease. In addition to staging, bone scintigraphy is used in the post-treatment monitoring of cancer patients. Technetium-99m is also used diagnostically in thyroid scintigraphy and assists in the differentiation of nodules in the gland as to their etiology.

Nuclear Medicine also contributes to the treatment of oncological patients, mainly through the use of radioactive Iodine-131 ( 
131 I), the so-called Radioactive Ablation Iodine (RAI) treatment, and the use of the radiopharmaceutical Xofigo ( 
223 Radium) in the treatment of bone metastases in prostate cancer.

In Cyprus, following the flight ban and the inability to transport radiopharmaceuticals from abroad, mainly Poland and France, only Positrons produced in a reactor at the private German Oncology Center (GOK) are available, which offers the 18 FDG-PET/CT scan or 18 F-Sodium Fluoride-PET/CT (18F-NaF) scan. The examination is also offered by the Ministry of Health under its contract with the GOK.

Bibliographic data

Taking into account the relevant literature and international guidelines, OEK submits the following comments regarding alternative diagnostic and therapeutic methods:

  • Bone metastases are common in cancer, especially breast, lung, prostate and melanoma 9 . The literature shows that approximately 7.3% of new breast cancer patients and 7.7% of those under follow-up (mean follow-up time 3.3 years) present with bone metastases. This percentage concerns up to 30% of newly diagnosed patients with non-small cell lung cancer (NSCLC). The Canadian Cancer Study estimates the rates of bone metastases in breast, lung and prostate cancers at 7.4%, 17.1% and 9.4% respectively per 100,000 cases 1 . Melanomas constitute less than 5% of all skin malignancies and have an incidence of 2.8-3.1% per 100,000 inhabitants 7, 8 . The incidence of bone metastases in melanomas is estimated to be around 4.1% at all stages and 17.2% in metastatic stages 9 .
  • Performing diagnostic imaging tests allows treatment planning and post-treatment monitoring in oncological patients. Their non-performance is not expected to be life-threatening, but it has a moderate impact on mortality and quality of life. Incorrect staging can lead to incorrect treatment planning. On the other hand, their performance has no effect on mortality 1,2 .
  • Alternative diagnostic tests to bone scintigraphy, without replacing it, are Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and 18 FDG-PET/CT and 18F-NaF scans. The first two image part of the skeleton or the third the entire skeleton. MRI and 18 FDG-PET/CT, 18F-NaF scans have high sensitivity in detecting bone metastases with a particular advantage in identifying osteolytic lesions. MRI and 18 FDG-PET/CT are advantageous in evaluating the therapeutic effect and response to treatment 2, 12, . 13, 17 .
  • The role of 99 TC-MDP bone scintigraphy in patients under surveillance is still a matter of debate. While it is generally accepted that it is indicated in symptomatic patients, it has not been proven to be cost-effective in asymptomatic patients and furthermore, it has not yet been determined which high-risk patients are indicated for screening as part of surveillance 3 .
  • Thyroid scintigraphy is now rarely used in the investigation of thyroid nodules (autonomously functioning thyroid nodules – AFTN) and this in cases with low TSH. The radiopharmaceuticals that are usually used are 99m TcO4 – and  123 Based on the 2015 guidelines of the American Thyroid Association (ATA) if scintigraphy is to be performed, 123 I is preferred over  99m TcO4 – 3 , but this preference is not justified according to the European Association for Nuclear Medicine. In the event that scintigraphy is not used in the investigation of thyroid nodules, the Y/G and the examination criteria for suspected malignancy are currently the established practice that determines the indication for fine needle aspiration cytology (FNAC) biopsy 10 .
  • Postoperative ablation of thyroid remnants with radioactive iodine (RAI – 131 I) has specific indications, mainly in papillary (differentiated) thyroid carcinoma. These are defined in international guidelines. The American Thyroid Association (ATA) has set the time point for administering the treatment postoperatively as up to 3 months from surgery, although a 3-month interval is not documented 11 .
  • Sentinel lymph node biopsy has become established in the practice of treating early breast cancer. The established method for mapping is the technique that combines the use of radioisotope and blue dye, although some Centers use only radioisotope or only blue dye. These techniques have been tested and have repeatedly achieved success rates of more than 90% in identifying the sentinel lymph node, with a false negative rate of less than 10%. They have demonstrated oncological safety in many randomized studies compared to axillary lymph node dissection. Some surgeons use only blue dye (Patent blue V, methylene blue, isosulfan blue) with a lower rate of identifying the sentinel lymph node, but acceptable in more than 90% of cases. With this technique, a lower rate of allergic reaction is observed. The same methods are also used successfully in melanoma 14, 15 .

Recommendations of the Cyprus Oncology Society (OEK)

Based on the bibliographic data, the OEK recommends the following procedures during the period when there are no radiopharmaceuticals available on the Cypriot market.

  • In asymptomatic oncology patients under follow-up (cold cases), bone scintigraphy may be postponed.
  • In patients under follow-up with clinical symptoms suggestive of possible bone disease, imaging of the clinically suspicious area with A.T and/or M.T is recommended. In case of doubt about the existence of bone metastasis or in case of indication of localization of the extent of bone disease, an 18 FDG-PET/CT scan is recommended.
  • In patients with breast cancer requiring staging and who have negative whole-body A.T and regional lymph node metastasis, bone scintigraphy may be omitted. In cancers of higher local stage or with increased blood alkaline phosphatase (AP) and/or hypercalcemia (approximately 8.8-13%), 18 FDG-PET/CT or 18F-NaF scans are recommended since the accuracy of these tests is similar to bone scintigraphy 2, 5, 9 .
  • In patients with lung cancer under staging, who based on the whole-body CT are candidates for radical treatment (surgery, simultaneous ATR/CMT), bone scintigraphy can be omitted since the 18 FDG-PET/CT scan is anyway necessary to exclude distant metastases 16 .
  • In patients with staged prostate cancer at low risk for metastatic disease (PSA Level <10ng/mL * , Gleason score <6 * and without clinical signs of metastatic disease e.g. bone pain), bone scintigraphy is not recommended and can be omitted 5, 12 . In patients with higher percent positive core, as defined in the EAU and AUA guidelines, PET/CT scan is recommended 4 ( * there is a literature report for PSA Level <20ng/mL and Gleason score <8) 12 .
  • In patients with malignant melanoma stage I-II, bone scintigraphy can be omitted. In stages III-IV, 18 FDG-PET/CT scan is recommended 6 . 18 FDG-PET/CT scan is also recommended in patients with elevated alkaline phosphatase (AP) and/or hypercalcemia (approximately 22.5%) regardless of stage, as long as bone metastases are not detected in A.T. or M.T. 9 .
  • In patients with breast cancer and melanoma, where identification, removal and biopsy of the sentinel lymph node is indicated, the use of the blue dye method (Patent blue V, methylene blue, isosulfan blue) is recommended 14, 15 .
  • In the investigation of thyroid nodules, with regard to the presence of malignancy, the use of ultrasound is recommended, based on the malignancy criteria of which the indication for biopsy (FNA) is also determined 10 .
  • Postoperative ablation of thyroid remnants with radioactive iodine ( 131I ), where indicated based on international guidelines, can be performed within 3 months of surgery, without this being considered a final time period 3 .
  • For the treatment of painful bone metastases, the use of external beam CT is recommended, after their localization with A.T or M.T.

Epilogue

The unprecedented emergency situation that the country is experiencing is forcing the medical community to make temporary revisions to diagnosis and treatment protocols, adopting recommendations based on international literature, and aimed at providing proper medical care under the circumstances of the emergency.

The above recommendations have been approved by the Nuclear Medicine Society and can be used for the medical care of oncology patients.

From the Board of Directors of OEK April 20, 2020

Bibliography

1.     Optimizing Health System Use of Medical Isotopes and Other Imaging Modalities. APPENDIX 2.6Imaging Bone Metastases in Breast, Prostate, and Lung Cancers. https://www.ncbi.nlm.nih.gov/books/NBK174854/

2.     Imaging Bone Metastases in Breast, Prostate, and Lung Cancers. May 16, 2012.  https://www.cadth.ca/imaging-bone-metastases-breast-prostate-and-lung-cancers

3.     The EANM practice guidelines for bone scintigraphy, T. Van den Wyngaert, K. Strobel, […], and On behalf of the EANM Bone & Joint Committee and the Oncology Committee. European Journal of Nuclear Medicine and Molecular Imaging.. Eur J Nucl Med Mol Imaging.2016; 43: 1723-1738 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932135/#!po=1.25000

4.     Ari Chong, MD, Insang Hwang, MD, […], and Kwangsung Park, MD Application of bone scans for prostate cancer staging: Which guideline shows better result?. Canadian Urological Association Journal. Can Urol Assoc J. 2014 Jul-Aug; 8(7-8): E515-E519. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4137016/

13.  Frederic E Lecouvet, JN Talbot, Christina Messiou, Patric Bourquet. Monitoring the response of bone metastases to treatment with magnetic resonance imaging and nuclear medicine techniques: a review and position statement by the HER2ean Organisation for Research and Treatment of Cancer Imaging Group. European Journal of Cancer 50(15) October 2014. https://www.researchgate.net/publication/264827174_Monitoring_the_response_of_bone_metastases_to_treatment_with_magnetic_resonance_imaging_and_nuclear_medicine_techniques_a_review_and_position_statement_by_the_HER2ean_Organisation_for_Research_and_Tre

  • Amit Goyal. New Technologies for Sentinel Lymph Node Detection. Review Article. Breast Care 2018; 12:349-353.
  • Kelly J Rosso, J David Nathanson, Techniques that accurately identify the sentinel lymph node in cancer. Word J Surg Proced. Mar 28, 2015; 5(1): 14-26. https://www.wjgnet.com/2219-2832/full/v5/i1/14.htm
  • NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Non Small Cell Lung Cancer. Version 2020
  • Gary J.R. Cook, Gurdip K. Azad, and Vicky Goh. Imaging Bone Metastasis in Breast Cancer. J Nucl Med 2016; 57:27S-33S
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