A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma

2021 ◽  
pp. 1-6
Author(s):  
Peter C. Petersen ◽  
Lone N. Petersen ◽  
Ivan Vogelius ◽  
Jon K. Bjerregaard ◽  
Lene Baeksgaard
Keyword(s):  
Phase 2 ◽  
First Line ◽  
Phase 2 Trial ◽  
Randomized Phase 2 ◽  
Esophagogastric Adenocarcinoma

scholarly journals Paclitaxel/carboplatin with or without belinostat as empiric first-line treatment for patients with carcinoma of unknown primary site: A randomized, phase 2 trial

Cancer ◽  
2015 ◽  
Vol 121 (10) ◽  
pp. 1654-1661 ◽  
Author(s):  
John D. Hainsworth ◽  
Gedske Daugaard ◽  
Thierry Lesimple ◽  
Gerdt Hübner ◽  
F. Anthony Greco ◽  
...  
Keyword(s):  
Primary Site ◽  
Unknown Primary ◽  
Line Treatment ◽  
Phase 2 ◽  
Unknown Primary Site ◽  
First Line ◽  
Carcinoma Of Unknown Primary ◽  
Phase 2 Trial ◽  
Randomized Phase 2 ◽  
First Line Treatment

Randomized phase 2 study of maintenance pemetrexed (Pem) versus observation (Obs) for patients (pts) with malignant pleural mesothelioma (MPM) without progression after first-line chemotherapy: Cancer and Leukemia Group B (CALGB) 30901 (Alliance).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8517-8517 ◽  
Author(s):  
Arkadiusz Z. Dudek ◽  
Xiaofei F. Wang ◽  
Lin Gu ◽  
Tom Stinchcombe ◽  
Robert Arthur Kratzke ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Phase 2 ◽  
First Line ◽  
Efficacy Analysis ◽  
Phase 2 Trial ◽  
Group B ◽  
Line Chemotherapy ◽  
Randomized Phase 2

8517 Background: Standard front-line chemotherapy for advanced MPM is (Pem and a platinum; optimal treatment duration is unknown. We performed a randomized phase 2 trial (NCT01085630) to determine if continuation of single-agent Pem after 4-6 cycles of Pem-platinum would improve progression-free survival (PFS). Methods: Eligible pts had histologically confirmed unresectable MPM, and performance status (PS) 0-1. Pts with at least stable disease following 4-6 cycles of Pem-platinum were stratified by first-line regimen (cis- or carboplatin) and histology (epithelioid versus other) and randomized 1:1 to Obs or continuation of Pem until progression. The primary endpoint was PFS. We assumed that Obs produced a median (m) PFS of 3 months (mo) and Pem would yield a 100% improvement in mPFS to 6 mo; 60 eligible pts (30 per arm) were to be randomized. Results: 72 pts from 30 sites registered 12/10-6/16. The study closed early due to slow accrual once 53 pts were randomized; 49 eligible pts (22 Obs, 27 Pem) are included in the efficacy analysis. Pt characteristics (Obs/Pem): age: median (range) 70 (39-85)/70 (52-87); male 68%/78%; PS 0 27%/33%; epithelioid histology 77%/70%; first-line cisplatin 27%/26%. A median of 4 cycles of Pem (range 1-33) was delivered; 22% of pts required dose modification. mPFS was 3 mo on Obs and 3.4 mo on Pem (hazard ratio (HR) 0.99; 95% CI: 0.51-1.90; p=0.9733). Median overall survival (mOS) was 11.8 mo for Obs, and 16.3 mo for Pem (HR 0.86; 95% CI 0.44-1.71; p=0.6737). Toxicities ≥ grade 3 on Pem included anemia 8%, lymphopenia 8%, neutropenia 4%, and fatigue 4%; there were no grade 5 toxicities. A higher baseline level of serum mesothelin related peptide (SMRP) was associated with worse PFS (HR 1.861, p=0.049). Baseline osteopontin did not significantly affect PFS (p=0.3630). Conclusions: Although it was well tolerated, maintenance Pem following initial Pem/platinum doublet chemotherapy does not improve PFS in MPM patients. High baseline SMRP was associated with shorter PFS. Support: U10CA180821, U10CA180882; https://acknowledgments.alliancefound.org . Clinical trial information: NCT01085630.

scholarly journals A Randomized Phase 2 Trial of Azacitidine ± Durvalumab as First-line Therapy for Higher-Risk Myelodysplastic Syndromes

2021 ◽  
Author(s):  
Amer M. Zeidan ◽  
Isaac Wayne Boss ◽  
CL Beach ◽  
Wilbert B. Copeland ◽  
Ethan Greene Thompson ◽  
...  
Keyword(s):  
Myelodysplastic Syndromes ◽  
Surface Expression ◽  
Immune Recognition ◽  
Phase 2 ◽  
First Line ◽  
First Line Therapy ◽  
Phase 2 Trial ◽  
Phase 2 Study ◽  
Grade 3 ◽  
Randomized Phase 2

Azacitidine-mediated hypomethylation promotes tumor cell immune recognition but may increase inhibitory immune checkpoint (ICP) molecule expression. We conducted the first randomized phase 2 study of azacitidine plus the ICP inhibitor durvalumab versus azacitidine monotherapy as first-line treatment of higher-risk myelodysplastic syndromes (HR-MDS). Patients (N=84) received azacitidine 75 mg/m2 subcutaneously (days 1-7) with (Arm A) or without (Arm B) durvalumab 1500 mg intravenously on day 1 every 4 weeks. After a median follow-up of 15.25 months, 8 patients in Arm A and 6 in Arm B remained on treatment. Patients in Arms A and B received a median of 7.9 and 7.0 treatment cycles, respectively, with 73.7% and 65.9% completing ≥4 cycles. The overall response rate (primary endpoint) was 61.9% in Arm A (26/42) and 47.6% in Arm B (20/42; P=0.18), and median overall survival was 11.6 months (95% CI: 9.5, nonevaluable) versus 16.7 months (95% CI: 9.8, 23.5) (P=0.74). Durvalumab-related adverse events (AEs) were reported by 71.1% of patients; azacitidine-related AEs were reported by 82% (A) and 81% (B). Grade 3 or 4 hematologic AEs were reported in (Arm A vs B) 89.5% vs 68.3% of patients. Patients with TP53 mutations tended to have a worse response than patients without these mutations. Azacitidine increased PD-L1 (CD274) surface expression on bone marrow granulocytes and monocytes, but not blasts, in both arms. In summary, combining durvalumab and azacitidine in patients with HR-MDS was feasible, but with more toxicities and without significant improvement in clinical outcomes over azacitidine alone. ClinicalTrials.gov: NCT02775903

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