한빛사논문
- 조회143
Sandip P. Patel1, Megan Othus2, Young Kwang Chae3, Tridu Huynh4, Benjamin Tan5, Timothy Kuzel6, Christine McLeod7, Gabby Lopez8, Helen X Chen9, Elad Sharon10, Howard Streicher11, Christopher W Ryan12, Charles Blanke12 and Razelle Kurzrock13
1Moores Cancer Center, University of California San Diego, La Jolla, California, USA
2Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
3Northwestern University, Chicago, Illinois, USA
4UC San Diego Moores Cancer Center, La Jolla, California, USA
5Washington University in St Louis School of Medicine, St Louis, Missouri, USA
6Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
7SWOG, San Antonio, Texas, USA
8SWOG Statistical and Data Management Center/Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington, USA
9CTEP, National Cancer Institute, Bethesda, UK
10DFCI, Boston, Massachusetts, USA
11Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, Maryland, USA
12OHSU, Portland, Oregon, USA
13Medical College of Wisconsin, Milwaukee, Wisconsin, USA
SPP and YKC contributed equally.
Correspondence to Dr Sandip P Patel, Dr Young Kwang Chae, Razelle Kurzrock
Abstract
Objectives Multiple common cancers benefit from immunotherapy; however, less is known about efficacy in rare tumors. We report the results of the adrenocortical carcinoma cohort of NCI/SWOG S1609 Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors.
Design/setting A prospective, phase 2 clinical trial of ipilimumab plus nivolumab was conducted by the SWOG Early Therapeutics and Rare Cancers Committee for multiple rare tumor cohorts across >1,000 National Clinical Trial Network sites.
Participants 21 eligible patients were registered. Median age was 53 years (range 26–69); 16 (76%) were women.
Interventions Ipilimumab 1 mg/kg intravenously every 6 weeks with nivolumab 240 mg intravenously every 2 weeks was administered until disease progression, symptomatic deterioration, treatment delay for any reason >56 days, unacceptable or immune-related toxicity with inability to decrease prednisone to <10 mg daily, or per patient request.
Main outcome measures The primary endpoint was the overall response rate (ORR) (RECIST V.1.1). Secondary endpoints include clinical benefit rate (CBR) (includes stable disease (SD)>6 months), progression-free survival (PFS), overall survival (OS), and toxicity. Immune-related outcomes included immune ORR (iORR), immune CBR (iCBR), and immune PFS (iPFS). A two-stage design was used assuming: null=5% alternative=30%, n=6 in the first stage, 16 max, one-sided alpha=13%.
Results The median number of prior therapy lines was 2 (range: 1–9). 3 of 21 patients attained confirmed partial response (PR) (ORR=14%). In addition, one patient had an unconfirmed PR; one, stable disease (SD)>6 months; one, immune-related RECIST (iRECIST) PR (iPR); and one patient attained iSD>6 months: clinical benefit rate (response or SD>6 months)=5/21 (24%), iORR=4/21 (19%), iCBR=7/21 (33%). The 6-month PFS was 24%; 6-month iPFS, 33%. The PFS for patients (N=7) with iRECIST clinical benefit were 57, 52, 18, 15, 13, 7, and 7 months. The 6-month OS was 76%; the median OS, was 15.8 months. The most common toxicities were fatigue (62%) and rash (38%), and the most common grade 3/4 immune-related adverse events were hepatic dysfunction (9.5%) and adrenal insufficiency (9.5%). Treatment-related adverse events leading to discontinuation of therapy in four patients (21%). There were no grade 5 adverse events.
Conclusions Ipilimumab plus nivolumab is active in refractory metastatic adrenocortical cancer meeting the primary endpoint of the study, with a 19% iORR and 33% iCBR (includes SD/iSD>6 months) and with the longest PFS/iPFS of 52 and 57 months.
논문정보
- Research article
- 2024년 07월 (BRIC 등록일 2024-07-31)
- 국외 연구진
- 의약학 > 종양의학
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