News | Radiation Oncology | November 02, 2020

Effectiveness of Gemcitabine and Daily RT for Bladder Preservation in Muscle-invasive Bladder Cancer

Updated results of NRG Oncology trial display effectiveness of gemcitabine and daily radiation for bladder preservation in muscle-invasive bladder cancer patients

Updated results of NRG Oncology trial display effectiveness of gemcitabine and daily radiation for bladder preservation in muscle-invasive bladder cancer patients

November 2, 2020 — Bladder preservation with trimodality therapy can be a safe and effective alternative to cystectomy for selected patients with muscle-invasive bladder cancer. The phase II NRG Oncology NRG-RTOG 0712 trial evaluated two regimens. One was the prior RTOG standard using 5-flourouracil and cisplatin with twice daily radiation (FCT), and the other a regimen of gemcitabine and daily radiation (GD) which had demonstrated efficacy in single institution clinical trials. This trial sought to determine if either or both of these regimens demonstrated sufficient efficacy to be included in future larger studies. The previously published results demonstrated high efficacy rates and low rates of distant metastasis in both arms. The updated results were presented at the virtual edition of the American Society for Radiation Oncology's (ASTRO) Annual Meeting in October 2020.

NRG-RTOG 0712 accrued 66 eligible patients with muscle invasive bladder cancer for analysis and randomly assigned them to either receive the FCT or (GD) regimen. The trial was designed to determine if either or both treatments exceed a 3-year distant metastasis free (DMF3) rate of 75% defined as the benchmark for efficacy. Researchers on the trial also assessed 5-year distant metastasis free rates (DMF5), toxicity, complete response, and bladder intact distant free survival for each treatment arm. This trial was not statistically powered to compare the two treatment regimens.

With a median follow up of 7.3 years, the FCT treatment arm yielded a 79% DMF3 rate and the GD treatment arm had a DMF3 rate of 85%. Secondary objectives and efficiency endpoints data demonstrated that: DMF5 was 70% in the FCT arm and 77% in the GD arm; 3-year bladder-intact distant metastasis free (BI-DMF3) rates were 67% for the FCT treatment and 72.5% for GD and 5-year rates (BI-DMF5) were 65.1% for FCT and 72.5% for GD; and, post-induction complete response rates were 88% for FCT treatment and 76% for GD treatment. 58% of patients in the FCT treatment arm had treatment related-grade 3 or 4 hematologic, gastrointestinal, or genitourinary toxicities and 52% of patients in the GD arm exhibited these toxicities. Both regimens demonstrated a DMF3 greater than 75%, thus confirming gemcitabine and daily radiation is an acceptable alternative treatment option.

"Not only did this trial conclude that gemcitabine and daily radiation is an acceptable regimen with favorable distant metastasis free rates at 3 years, the results also indicate that both treatments maintain their high rates of distant metastasis free at 5 years and both treatments had low cystectomy rates with high overall survival rates. The efficacy of the GD regimen may facilitate wider adoption of bladder preservation as many patients have comorbidities that preclude the use of cisplatin. The daily radiation schedule is also easier for patients and treatment centers to administer than twice daily treatment which will also likely increase interest in this strategy. These findings are important to future trials that may assess a systemic therapy for this muscle-invasive bladder cancer," stated John J. Coen, M.D., of GenesisCare ( formerly 21st Century Oncology) and the Principal Investigator of the NRG-RTOG 0712 study.

For more information: www.nrgoncology.org

Related Content

News | Radiation Therapy | May 06, 2021
May 6, 2021 — Individuals living with severe...
Research finds that a commonly used risk-prediction model for lung cancer does not accurately identify high-risk Black patients who could benefit from early screening

Getty Images

News | Lung Imaging | May 05, 2021
May 5, 2021 — Lung cancer is the third most common cance
After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by

After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by N. Galldiks et al., Research Center Juelich, Juelich, Germany.

News | PET Imaging | May 05, 2021
May 5, 2021 — For patients with brain metastases, amino acid ...
The emergence of #therapeutic #radiopharmaceuticals and its adoption in #cancer care provide one more weapon in combating cancer

Getty Images

Feature | Radiation Oncology | May 04, 2021 | By Vinay Shivaprasad
The term nuclear medicine is associated with the diag
Despite receiving high radiation doses to their tumors, lung cancer patients treated with technique that spares a large part of the esophagus did not develop severe inflammation of the esophagus

Getty Images

News | Lung Imaging | April 30, 2021
April 30, 2021 — For many patients with localized lung cance...
#prostatecancer During the first wave of the corona pandemic, 36 percent fewer men were diagnosed with prostate cancer in Sweden than in previous years.

Getty Images

News | Prostate Cancer | April 30, 2021
April 30, 2021 — During the first wave of the corona pandemic, 36 percent fewer men were diagnosed with prostate canc
Using ultra-high field magnetic resonance imaging (MRI) to map the brains of people with #Down_syndrome (#DS), #researchers from #CaseWesternReserveUniversity, #ClevelandClinic, University Hospitals and other institutions detected subtle differences in the structure and function of the #hippocampus—a region of the #brain tied to memory and learning.

Using ultra-high field magnetic resonance imaging (MRI) to map the brains of people with Down syndrome (DS), researchers from Case Western Reserve University, Cleveland Clinic, University Hospitals and other institutions detected subtle differences in the structure and function of the hippocampus—a region of the brain tied to memory and learning.

News | Magnetic Resonance Imaging (MRI) | April 29, 2021
April 29, 2021 — Using...
A 63-year-old multiple #myeloma patient, with skeletal pain. New #FDG avid axillary #lymphadenopathy 62 days (9 weeks) after second #mRNA #vaccination dose. Image used with permission of the Radiological Society of North America (#RSNA)

A 63-year-old multiple myeloma patient, with skeletal pain. New FDG avid axillary lymphadenopathy 62 days (9 weeks) after second mRNA vaccination dose. Image used with permission of the Radiological Society of North America (RSNA)

Feature | Coronavirus (COVID-19) | April 29, 2021 | By Melinda Taschetta-Millane