NIMBUS
During his presentation “NIMBUS trial – follow up”, speaker Prof. Dr. Marc-Oliver Grimm (DE) provided the trial’s findings. He stated that in high-grade non-muscle-invasive bladder cancer (NMIBC), a reduced frequency of Bacillus Calmette-Guerin (BCG) instillations during induction and maintenance is inferior to the standard BCG schedule regarding time-to-first-recurrence. Particularly, more early recurrences occurred in the experimental arm suggesting inferior efficacy of the reduced-frequency BCG induction schedule.

According to Prof. Grimm, fewer patients were affected with fewer adverse events (AEs) in the reduced frequency arm. He added that NIMBUS is the first prospective trial using routine repeat transurethral resection (reTUR) prior to BCG induction, which was performed in 90% of the patients. The low recurrence and progression rate in the standard frequency arm in a high-grade NMIBC population with an estimated recurrence rate of 21% after three years, and a progression rate of 3.8% at first recurrence may be attributed to the routine use of reTUR.

Further exploring the topic, Prof. Dr. Axel Merseburger (DE) shared points of discussion such as how to identify early recurrent patients; he mentioned biomarkers, which had been discussed during the congress yesterday. If alterations are there, he stated to opt for IO/fibroblast growth factor receptor (FGFR) treatment. In addition, Prof. Merseburger inquired if fewer AEs in the reduced frequency arm are clinically meaningful.

He concluded, “My biggest take-home message from the NIMBUS trial is to use routine reTUR prior to BCG induction and ask a pathologist to see the muscle in the specimen.”

FLAME
Launching the presentations on the FLAME trial, oncologist Dr. Linda Kerkmeijer (NL) stated, “The FLAME trial is the first randomised trial to show that isotoxic focal radiotherapy boosting works. A five-year biochemical disease-free survival (bDFS) of 92% was achieved in mainly high-risk prostate cancer population. The focal boost had no impact on toxicity or quality of life. In addition, the radiotherapy was performed with conventional techniques and at no additional costs.”

In a complementary lecture, discussant radiotherapist Dr. Bradley Pieters (NL) focused on androgen deprivation therapy (ADT), which was used in the study, and on the duration of treatment. He stated, “There will still be discussions with regard to the need for and duration of ADT in very-high-dose-escalated radiotherapy. It’s something to explore further in the future. Another topic that will be investigated is the possibility of safely reducing treatment time and still provide very high doses through Stereotactic body radiation therapy (SBRT), brachytherapy or both.”

IMvigor130
Speaker oncologist Prof. Dr. Aristotelis Bamias (GR) shared some of the key points of the IMvigor130 trial. He stated, “The trial produces valuable information on the role of checkpoint inhibitors (CPIs) in the modern treatment paradigm in advanced urothelial cancer (aUC). Progression-free survival (PFS) is significantly prolonged by the addition of atezolizumab to first-line, platinum-based chemotherapy.”

He added that the current label of atezolizumab monotherapy in first-line treatment is justified and that the role of platinum compound in the context of immunotherapy needs to be further studied. “The evolving results of IMvigor 130 need to be viewed in the context of rapid changes in the treatment paradigm of aUC,” Prof. Bamias concluded.

Discover what oncologist Prof. Dr. Thomas Powles (GB) shared about the IMvigor130 trial, as well as, the full presentations today on the NIMBUS, FLAME, and IMvigor130 trials in the Resource Centre.  You can also access vital updates from the CLEAR and Extended vs limited Pelvic Lymph node dissection in prostate cancer trials in the Resource Centre.

The post Trial updates: NIMBUS, FLAME and IMvigor130 appeared first on EMUC25.

In his lecture “Early hormonal manipulation in M0 CRPC”, Prof. Dr. Karim Fizazi (FR) defined non-metastatic castration-resistant prostate cancer (M0 CRPC) as a male patient with prostate cancer who previously had local treatment often, and had prostate-specific antigen (PSA) relapse and then received androgen-deprivation therapy (ADT) or ADT with primary local treatment. He is progressing by PSA while on ADT, and his testosterone is at castrated levels. There are no detectable metastases using conventional imaging such as bone scan or CT scan.

“M0 CRPC is a rare situation,” said Prof. Fizazi. “If next-generation imaging is used, M0 CRPC becomes even rarer.”

He stated that two agents, Enzalutamide and Apalutamide, contributed to the “clear and meaningful improvement of metastasis-free survival (MFS).” The toxicity is acceptable; however, there are some issues such as cognitive impairment,  cardiovascular toxicity, and fractures. “We need more information to know which agent is better in terms of overall survival (OS). Also, cost is a factor to be considered.”

According to Prof. Fizazi, data on darolutamide is coming soon. He cited a press release published on 24 October 2018 that Orion and Bayer have completed the ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) Phase III trial of darolutamide in patients with M0 CRPC which stated that the primary endpoint of metastasis-free survival was met.

CARMENA trial
“Cytoreductive nephrectomy (CN) should no longer be considered as the standard of care in metastatic renal cell carcinoma (mRCC), at least when medical treatment is required,” stated Prof. Arnaud Méjean (FR) during his presentation on the Clinical Trial to Assess the Importance of Nephrectomy (CARMENA) trial.

The findings of the CARMENA trial concluded that sunitinib alone was not inferior to cytoreductive nephrectomy followed by sunitinib in patients with metastatic mRCC who were classified as having intermediate- or poor-risk patients.

Following Prof. Méjean’s presentation, discussant Prof. Axel Bex (NL) shared that poor-risk patients should not undergo CN if symptomatic, and mentioned that both CARMENA and SURTIME studies demonstrate that intermediate-risk patients, who require systemic therapy, benefit from immediate medical therapy. “However, the question is still out there,” said Prof. Bex. “Should CN be performed at a later stage in all patients except those who progress (SURTIME) or only when necessary (CARMENA)?”

POUT trial
Dr. Alison Birtle (GB) announced the successor trial to PeriOperative chemotherapy or sUrveillance in upper Tract urothelial cancer, also known as POUT (CRUK/11/027; NCT01993979, NIHR portfolio) which is POUT 2: Chemotherapy with or without immunotherapy following nephron-ureterectomy for upper tract urothelial cancer.

The rationale for POUT 2 is that high incidence of microsatellite instability in Upper Urinary Tract Urothelial Carcinoma (UTUC) may predispose to immunotherapy sensitivity; and that it has proven feasible to combine immunotherapy with chemotherapy.

The primary endpoint is disease-free survival and secondary endpoints include overall survival, safety and tolerability, and patient-reported outcomes.

Discussant Dr. Evanguelos Xylinas (FR) stated, “The opportunity to address clinical trials in the selected UTUC population is rationale/feasible (thanks to POUT), supported by different underlying biology in UTUC compared to urothelial carcinoma of the bladder (UCB).

About POUT
The POUT study won the first prize for Best Abstract in Oncology at the 33rd Annual EAU Congress held in Denmark early this year. The study concluded that adjuvant platinum-based chemotherapy should be considered as a new standard of care; it is tolerable for patients and improved MFS in UTUC. Recruitment to the POUT trial was terminated early because of efficacy was met in favour of chemotherapy. Read more about POUT here.

For more information and to access webcasts and abstracts, check out the EMUC18 Resource Centre.

The post Progress updates of notable trials at EMUC18: What you need to know appeared first on EMUC25.