Efficacy and safety of adjuvant systemic therapies in trial non-eligible resected stages III and IV melanoma patients.

IF 1 Q4 ONCOLOGY

Melanoma Management Pub Date : 2025-12-01 Epub Date: 2025-02-17 DOI:10.1080/20450885.2025.2461963

Sarah Alsadiq, Adi Kartolo, Elaine McWhirter, Wilma Hopman, Tara Baetz

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引用次数: 0

Abstract

Background: Adjuvant immunotherapy and targeted therapy are now the standard of care for patients with resected stage IIIA-IV melanoma. However, little is known regarding its efficacy in real-world patients who were not represented in these landmark trials.

Methods: This retrospective study included all patients with resected stage IIIA-IV melanoma who received adjuvant systemic therapy between January 1 2018 and December 31 2020, in two Canadian academic cancer. Primary outcome was the proportion of trial non-eligible patients in the real-world setting. Survival and safety analyses were also conducted.

Results: Of the total 113 patient, 99 (88%) were trial non-eligible patients. Most common reasons for trial non-eligible criteria was having no baseline CLND (72%), followed by outside of treatment window >12 weeks (30%), stage IIIA (14%), unknown primary (9%), stage IV (14%), and baseline AD on immunosuppressants (3%). There were no significant RFS (P = 0.731) or OS (P = 0.110) differences in the overall population of trial eligible vs. non-eligible. Safety profiles were similar between the trial eligible vs. non-eligible groups.

Conclusion: Our study suggested a high proportion of real-world patients would have been deemed non-eligible for clinical trials. Regardless, adjuvant systemic therapy delivered similar survival and toxicity outcomes in both groups.

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辅助全身治疗在不符合条件的III期和IV期黑色素瘤切除患者中的疗效和安全性。

背景：辅助免疫治疗和靶向治疗是目前IIIA-IV期黑色素瘤切除患者的标准治疗方法。然而，对于在这些具有里程碑意义的试验中没有代表的现实世界患者，其疗效知之甚少。方法：这项回顾性研究纳入了2018年1月1日至2020年12月31日期间接受辅助全身治疗的所有IIIA-IV期黑色素瘤切除术患者，包括两名加拿大学术癌症患者。主要结局是真实环境中试验不合格患者的比例。还进行了生存和安全性分析。结果：在113例患者中，99例（88%）为试验不合格患者。不符合试验标准的最常见原因是没有基线CLND(72%)，其次是治疗窗口外bb0 12周（30%），IIIA期（14%），未知原发期（9%），IV期（14%）和基线免疫抑制剂AD（3%）。在符合试验条件和不符合试验条件的总体人群中，RFS （P = 0.731）和OS （P = 0.110）没有显著差异。试验合格组与非试验合格组的安全性概况相似。结论：我们的研究表明，现实世界中有很大比例的患者被认为不符合临床试验的条件。无论如何，辅助全身治疗在两组中提供了相似的生存和毒性结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Melanoma Management ONCOLOGY-

CiteScore

5.10

自引率

0.00%

发文量

审稿时长

13 weeks

期刊介绍： Skin cancer is on the rise. According to the World Health Organization, 132,000 melanoma skin cancers occur globally each year. While early-stage melanoma is usually relatively easy to treat, once disease spreads prognosis worsens considerably. Therefore, research into combating advanced-stage melanoma is a high priority. New and emerging therapies, such as monoclonal antibodies, B-RAF and KIT inhibitors, antiangiogenic agents and novel chemotherapy approaches hold promise for prolonging survival, but the search for a cure is ongoing. Melanoma Management publishes high-quality peer-reviewed articles on all aspects of melanoma, from prevention to diagnosis and from treatment of early-stage disease to late-stage melanoma and metastasis. The journal presents the latest research findings in melanoma research and treatment, together with authoritative reviews, cutting-edge editorials and perspectives that highlight hot topics and controversy in the field. Independent drug evaluations assess newly approved medications and their role in clinical practice. Key topics covered include: Risk factors, prevention and sun safety education Diagnosis, staging and grading Surgical excision of melanoma lesions Sentinel lymph node biopsy Biological therapies, including immunotherapy and vaccination Novel chemotherapy options Treatment of metastasis Prevention of recurrence Patient care and quality of life.