phase ii study
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ESMO Open ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 100314
M.M. Javle ◽  
D.-Y. Oh ◽  
M. Ikeda ◽  
W.-P. Yong ◽  
K. Hsu ◽  

2022 ◽  
Vol 226 (1) ◽  
pp. S751-S752
Ana Collins ◽  
Shanelle Mason ◽  
Andrew Smith ◽  
Adi Davidov ◽  
Gary Fruhman

2021 ◽  
Steven F Powell ◽  
Miroslaw Mazurczak ◽  
Elie G Dib ◽  
Jonathon S Bleeker ◽  
Louis H Geeraerts ◽  

Abstract Background: Chemoradiotherapy (CRT) for locally-advanced head and neck squamous cell carcinoma (LA-HSNCC) yields 5-year survival rates near 50% despite causing significant toxicity. Dichloroacetate (DCA), a pyruvate dehydrogenase kinase metabolic inhibitor, reduces tumor lactate production and has been used in cancer therapy previously. The safety of adding this agent to CRT is unknown. Methods: Our randomized, placebo-controlled, double-blind phase II study added DCA to cisplatin-based CRT in patients with LA-HNSCC. The primary endpoint was safety by adverse events (AEs). Secondary endpoints compared efficacy via 3-month end-of-treatment response, 5-year progression-free and overall survival. Translational research evaluated pharmacodynamics of serum metabolite response. Results: 45 participants (21 DCA, 24 Placebo) were enrolled from May 2011-April 2014. Higher rates of all-grade drug related fevers (43% vs 8%, p = 0.01) and decreased platelet count (67% vs 33%, p = 0.02) were seen in DCA versus placebo. However, there were no significant differences in grade 3/4 AE rates. Treatment compliance to DCA/placebo, radiation therapy, and cisplatin showed no significant difference between groups. While end-of-treatment complete response rates were significantly higher in the DCA group compared to placebo (71.4% vs 37.5%, p = 0.0362), survival outcomes were not significantly different between groups. Treatment to baseline metabolites demonstrated a significant drop in pyruvate (0.47, p <0.005) and lactate (0.61, p <0.005) in the DCA group. Conclusions: Adding DCA to cisplatin-based CRT appears safe with no detrimental effect on survival and expected metabolite changes compared to placebo. This supports further investigation into combining metabolic agents to CRT.Trial registration number: NCT01386632, Date of Registration: July 1, 2011.

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261994
Manish A. Shah ◽  
Zev A. Wainberg ◽  
Daniel V. T. Catenacci ◽  
Howard S. Hochster ◽  
James Ford ◽  

2021 ◽  
Vol 29 (1) ◽  
pp. 27-37
Darren M. C. Poon ◽  
Daisy Lam ◽  
Kenneth Wong ◽  
Cheuk Man Chu ◽  
Michael Cheung ◽  

Background: Stereotactic body radiotherapy (SBRT) has potential radiobiologic and economic advantages over conventional fractionated radiotherapy (CFRT) in localized prostate cancer (PC). This study aimed to compare the effects of these two distinct fractionations on patient-reported quality of life (PRQOL) and tolerability. Methods: In this prospective phase II study, patients with low- and intermediate-risk localized PC patients were randomly assigned in a 1:1 ratio to the SBRT (36.25 Gy/5 fractions/2 weeks) or CFRT (76 Gy/38 fractions/7.5 weeks) treatment groups. The primary endpoint of variation in PRQOL at 1 year was assessed by changes in the Expanded Prostate Cancer Index Composite (EPIC) questionnaire scores and analysed by z-tests and t-tests. Results: Sixty-four eligible Chinese men were treated (SBRT, n = 31; CFRT, n = 33) with a median follow-up of 2.3 years. At 1 year, 40.0%/46.9% of SBRT/CFRT patients had a >5-point decrease in bowel score (p = 0.08/0.28), respectively, and 53.3%/46.9% had a >2-point decrease in urinary score (p = 0.21/0.07). There were no significant differences in EPIC score changes between the arms at 3, 6, 9 and 12 months, but SBRT was associated with significantly fewer grade ≥ 1 acute and 1-year late gastrointestinal toxicities (acute: 35% vs. 87%, p < 0.0001; 1-year late: 64% vs. 84%, p = 0.03), and grade ≥ 2 acute genitourinary toxicities (3% vs. 24%, p = 0.04) compared with CFRT. Conclusion: SBRT offered similar PRQOL and less toxicity compared with CFRT in Chinese men with localized PC.

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