A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers
| العنوان: | A Phase |
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| المؤلفون: | Elizabeth H. Cull, Julie C. Martin, Wesley M. Smith, William Jeffery Edenfield, Ki Y. Chung, Mark Allen O'Rourke, William Larry Gluck, Heather Bowers |
| المصدر: | Oncologist |
| بيانات النشر: | Oxford University Press (OUP), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Cancer Research, medicine.medical_specialty, Durvalumab, Population, Phases of clinical research, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, 0302 clinical medicine, Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, education, Pneumonitis, education.field_of_study, business.industry, Clinical Trial Results, Standard treatment, Antibodies, Monoclonal, Unevaluable, medicine.disease, Clinical trial, Oncology, 030220 oncology & carcinogenesis, business, Tremelimumab, medicine.drug |
| الوصف: | Lessons Learned Disease control with signals of response were demonstrated, which should lead to future validating clinical trials using checkpoint inhibitors in this underserved rare malignancy population. Although the study of single types of rare cancers is practically challenging, clinical trial designs that aggregate such patients into cohorts treated similarly are feasible, even in the community setting. Background Patients with rare cancers are an underserved population with limited access to clinical trials aside from phase I trials in the refractory setting. Treatment of these patients is often based on collections of anecdotes and small denominator review articles. Despite broad evidence of efficacy of combined immune checkpoint blockade across multiple tumor types, patients with rare tumors have not been afforded the opportunity for these therapies. Methods A phase II, investigator-initiated, single institution trial using durvalumab (1,500 mg every [Q]4 weeks × 13) and tremelimumab (75 mg Q4 weeks × 7, then Q12 weeks × 2) is reported. The population included 50 patients with advanced rare solid tumors (incidence Results A complete response was demonstrated in one patient with anal cancer. Striking partial responses were seen in four patients. Prolonged disease stability was noted in 18 patients. Thirteen patients experienced disease progression. Patients were considered unevaluable if unable to initiate therapy (n = 6) or unable to complete two cycles of therapy (n = 8). In all cases, patients were unevaluable because of clinical deterioration. The toxicity profile paralleled prior published studies. Toxicities were manageable and without new signals. There were two events of grade 4 immune-mediated hepatitis and one death from pneumonitis. Conclusion This single-cohort basket trial demonstrated clinical activity from combined checkpoint blockade in 23 of the 36 evaluable patients. Patients with rare cancers, not eligible for immunotherapy via conventional clinical trial mechanisms, should be considered for this therapy through compassionate use, further clinical trials, and national registry programs. |
| تدمد: | 1549-490X 1083-7159 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a9767f651b82c62292b4207d32046ecTest https://doi.org/10.1002/onco.13798Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4a9767f651b82c62292b4207d32046ec |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1549490X 10837159 |
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