Abstract
AbstractThe complexity of neoplasia and its treatment are a challenge to the formulation of general criteria that are applicable across solid cancers. Determining the number of prior lines of therapy (LoT) is critically important for optimising future treatment, conducting medication audits, and assessing eligibility for clinical trial enrolment. Currently, however, no accepted set of criteria or definitions exists to enumerate LoT. In this article, we seek to open a dialogue to address this challenge by proposing a systematic and comprehensive framework to determine LoT uniformly across solid malignancies. First, key terms, including LoT and ‘clinical progression of disease’ are defined. Next, we clarify which therapies should be assigned a LoT, and why. Finally, we propose reporting LoT in a novel and standardised format as LoT N (CLoT + PLoT), where CLoT is the number of systemic anti-cancer therapies (SACT) administered with curative intent and/or in the early setting, PLoT is the number of SACT given with palliative intent and/or in the advanced setting, and N is the sum of CLoT and PLoT. As a next step, the cancer research community should develop and adopt standardised guidelines for enumerating LoT in a uniform manner.
Publisher
Springer Science and Business Media LLC
Reference56 articles.
1. Baker, K., Dunwoodie, E., Jones, R. G., Newsham, A., Johnson, O., Price, C. P. et al. Process mining routinely collected electronic health records to define real-life clinical pathways during chemotherapy. Int. J. Med. Inform. 103, 32–41 (2017).
2. Cardoso, F., Paluch-Shimon, S., Senkus, E., Curigliano, G., Aapro, M. S., André, F. et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann. Oncol. S0923-7534, 42460–42463 (2020).
3. Bright, C. J., Lawton, S., Benson, S., Bomb, M., Dodwell, D., Henson, K. E. et al. Data Resource Profile: The Systemic Anti-Cancer Therapy (SACT) dataset. Int. J. Epidemiol. 49, 15–15l (2020). [published correction appears in Int. J. Epidemiol. 49, 354 (2020)].
4. FDA. FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-fourth-line-treatment-advanced-gastrointestinal-stromal-tumors (2020).
5. Powles, T., Plimack, E. R., Soulières, D., Waddell, T., Stus, V., Gafanov, R. et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 21, 1563–1573 (2020). [published correction appears in Lancet Oncol. 21, e553 (2020)].