Genomic-Matched Therapy in Advanced Solid Tumors: ROME Trial Results

Okay, here’s a breakdown of the key information from the provided text, organized for clarity.This summarizes the study’s methods:

1. Treatments:

* ⁤ Targeted Therapy (TT): Treatment was selected based on specific ‍pathway, signature, or⁣ gene alteration identified in the patient’s tumor (details in Extended Data Table 4). Generally preferred if ⁣safety data was available.
* Standard of Care (SoC): The standard treatment for the⁢ patient’s cancer⁣ type.

2. Study Endpoints (What they where measuring):

* Primary Endpoint: Overall Response Rate (ORR) -⁤ the percentage of patients⁤ who had a complete or partial response ‍to treatment.
* Secondary Endpoints:

* Progression-Free Survival (PFS) – time until disease gets worse or the patient dies.
* Time to Treatment Failure (TTF) – time until the patient stops treatment for any reason.
* Time to⁣ Next Therapy (TTNT) – time until the patient starts their next line‍ of treatment.
* Overall Survival (OS) – time until death from any cause.
* additional (Not Reported in this Paper):

* Correlation⁤ between tumor tissue and circulating tumor DNA (ctDNA) molecular profiles.
‍ * ⁣⁢ quality of life measurements.
* ‍ Immune fitness in both treatment groups.
⁤ * Association‍ between ⁢molecular evaluation and gene expression profiling.

3. How Outcomes Were Assessed:

* Tumor Response: Evaluated using RECIST v1.1 and irRC criteria.Assessments continued even⁤ after treatment stopped (unless due ⁢to lack of ⁢consent) until disease progression ⁤was documented.
* ⁢ Survival: Monitored until death, loss to follow-up, consent withdrawal, or ⁤study end.
* Adverse Events (AEs): Graded using CTCAE v5.0, and their frequency and severity were recorded.

4. Data Handling & Oversight:

* ‍ ⁢ Data Collection: Collected at clinical sites and entered into an electronic case report form (eCRF).
* ⁣ Autonomous Monitoring: An independent Data Monitoring Committee (DMC) oversaw the trial, reviewing safety and‍ efficacy.
* ⁤ Interim Analysis: A pre-planned analysis was conducted when 20% of patients (n=76) reached a specific time point. The DMC ‍recommended continuing the trial based on a conditional power calculation (CPt) showing strong evidence of benefit with TT.
* Compliance: The trial was conducted according ⁣to the protocol, amendments, and Good Clinical ‍practice guidelines.

5. Sample Size:

* Hypothesis: TT was expected to ⁣have ⁢a 20% ORR, ‍while SoC⁣ was expected to have a 5% ORR.
* Cohorts: Patients were divided into four groups based on cancer type:
* Breast Cancer
* Non-Colorectal Gastrointestinal Cancers
* Non-Small Cell⁤ Lung Cancer (NSCLC)
⁤ * ‍ Othre Malignancies
* Total Sample Size: 86 patients (43⁢ in each arm, across the four cohorts) were needed to detect a 15% ⁣difference in ORR‍ with 80% power.

let me know if you’d like me to ⁣elaborate on any specific aspect of these methods!