PhaseII study of durvalumab and tremelimumab in pulmonary sarcomatoid carcinoma:KCSG‐LU16 ‐07
| Autor: | Dae Seog Heo, Joo Hang Kim, Jong Seok Lee, Mi Sun Ahn, Yu Jung Kim, Eun Joo Kang, Bhumsuk Keam, Seong Hoon Shin, Se Hyun Kim, Jong Il Kim, Dong Wan Kim, Jin-Soo Kim, Miso Kim, Sook Hee Hong, Tae Min Kim, Sun Min Lim, Sun Wha Im, Chan Young Ock |
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| Rok vydání: | 2020 |
| Předmět: |
non‐small cell lung cancer
Adult Male 0301 basic medicine Pulmonary and Respiratory Medicine medicine.medical_specialty Lung Neoplasms Durvalumab Phases of clinical research Antibodies Monoclonal Humanized Gastroenterology 03 medical and health sciences tremelimumab 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Adverse effect Sarcomatoid carcinoma Aged Pneumonitis business.industry Antibodies Monoclonal Original Articles General Medicine Middle Aged medicine.disease Rash 030104 developmental biology Oncology 030220 oncology & carcinogenesis Original Article pulmonary sarcomatoid carcinoma Female Immunotherapy medicine.symptom business Tremelimumab medicine.drug |
| Zdroj: | Thoracic Cancer |
| ISSN: | 1759-7714 1759-7706 |
| Popis: | Background Pulmonary sarcomatoid carcinoma (PSC) is rare with a poor outcome and is resistant to conventional cytotoxic chemotherapy. The efficacy and safety of durvalumab and tremelimumab for treating recurrent or metastatic PSCs were assessed by a nonrandomized, open‐label, phase II study. Methods A total of 18 patients with recurrent or metastatic PSC received 1500 mg of durvalumab and 75 mg of tremelimumab every four weeks, followed by 750 mg of durvalumab every two weeks until the disease progressed, or an unacceptable toxicity level was reached. The primary endpoint was the objective response rate (ORR). The secondary endpoints were progression‐free survival (PFS), overall survival (OS), and toxicity. Genomic profiling of PSC by next‐generation sequencing (NGS) and determination of peripheral blood lymphocyte subsets using flow cytometry were performed for exploratory analysis. Results A total of 15 out of 18 patients were evaluated for the analysis of the primary endpoint. At the data cutoff point, the ORR of 26.7% (95% confidence interval [CI]: 7.8–55.1) was achieved with the median follow‐up duration of 12.0 months (range, 8.4–16.1). Median PFS and OS were 5.9 months (95% CI: 1.1–11.9) and 15.4 months (95% CI: 11.1‐not reached), respectively. Treatment‐related adverse events (AEs) of any grade were reported in 16 patients; the most common AEs were pruritus (n = 5), pneumonitis (n = 4), and rash (n = 4). Treatment was discontinued in two patients due to AEs of grade ≥ 3. Conclusions Durvalumab and tremelimumab demonstrated clinical benefit with a prolonged survival and manageable toxicity profile in patients with recurrent or metastatic PSC. This first prospective phase II trial for recurrent or metastatic pulmonary sarcomatoid carcinomas demonstrated that durvalumab and tremelimumab was effective with a confirmed ORR of 26.7%. The combination of durvalumab and tremelimumab was well‐tolerated with favorable toxicity profiles. |
| Databáze: | OpenAIRE |
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