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Long-term data from the trial put quite a damper on the idea of intensified locoregional radiotherapy (RT) in patients with stage III non-small cell lung cancer (NSCLC) as that group had significantly worse survival with dose-escalated RT -- perhaps related to increased toxicity from higher irradiation of the heart and lung, explained Mitchell Machtay, MD, of Penn State University and Cancer Institute-Milton S. Hershey Medical Center in Hershey, Pennsylvania, and colleagues.

The group then pivoted to the notion of individualized/adaptive dose-intensified RT in patients with local tumor progression and/or recurrence. Hence the stage II NRG-RTOG1106/ECOG-ACRIN 6697 (1106/6697) came about, testing if mid-treatment FDG-PET/CT could guide individualized/adaptive dose-intensified RT with the aim of improving and predicting outcomes.

The team reported in the (JCO) that the adaptive approach -- stratified by substage, primary tumor size, and histology, leading to a mean RT dose of 71 Gy in 30 fractions and a mean lung dose 17.9 Gy versus a standard RT dose of 60 Gy in 30 fractions -- "was feasible and safe in a multicenter cooperative group setting." Grade ≥3 adverse events (AEs) were similar between adaptive and standard RT even though the former patients received a much higher RT dose.

But the authors could not show a significant difference in centrally reviewed freedom from locoregional progression, leading them to hypothesize that "radiation dose selection needs even greater individualization, on the basis of intrinsic radiosensitivity defined in each patient, and that RT planning should consider the risks of cumulative irradiation of circulating lymphocytes. Greater attention to radiation dose to the heart and great vessels is needed in future studies," the team wrote.

In an accompanying comment about the context of the study, JCO associate editor Jonathan P.S. Knisely, MD, a radiation oncologist at Weill Cornell Medicine in New York City, suggested that the findings provide "promise for patients so treated to further benefit from post-treatment immunotherapy with durvalumab [Imfinzi]."

One element of 1106/6697 that was certainly a win was the relatively high percentage of Black enrollees, at about 12% for the total study population (n=138). That's key for two reasons:

• Black patients generally make up only 5-7% of clinical trial participants, according to the .

• Black patients with NSCLC were less likely to get RT versus white patients, according to a 2021 study, not to mention an underreporting by physicians of AEs in Black patients receiving RT compared with white patients, per a 2022 study.

In a 2024 , Melissa Ana Liriano Vyfhuis, MD, PhD, of the University of Maryland School of Medicine (UMSOM) in Baltimore, and colleagues, looked at psychosocial factors that impact the decision-making process of Black female breast cancer patients. The team found that these patients were less likely to trust their cancer team; were more likely to believe that research harms minorities; and that God determines health, not research.

The group built on that research with another cross-sectional survey-based study among Black cancer patients, including those with thoracic cancer. Patients were 6 months to 5 years post-treatment. Co-author Charlyn Gomez, an MD candidate at UMSOM, discussed the study at a press conference at the 2024 (ASTRO) meeting, while Chika Madu, MD, of Northwell Health in Staten Island, New York, offered an expert perspective.

What was the impetus for the study, "Centering Black voices: Factors influencing a cancer patient's decision to join a clinical trial?"

Gomez: It's been a long-standing issue, the underrepresentation of minoritized populations in the United States in clinical trials. This impacts all scopes of medicine and, in oncology, we have seen that there is a severe underrepresentation of Black patients in clinical trials. This is especially concerning because Black cancer patients tend to fare worse in terms of clinical outcomes due to several factors.

What were some of the study details?

Gomez: Our study had 45 items on a survey that was distributed to our patients at their follow-up visits. The survey also was given at two hospital sites in Baltimore. The questions were analyzed for factors that could influence the decision-making process of patients, such as spiritual beliefs, but also logistical factors like transportation, access to different resources, and potentially different roles patients would have to balance if they were to join a clinical trial.

What were some of the main findings?

Gomez: There were some clear differences between our Black and non-Black participants. For instance, the Black participants were more likely to be female and less likely to be married. They had a lower median household income and were more likely to live with family members. They also had higher Charlson Comorbidity Indexes, and this measure predicts 10-year mortality.

We asked our participants some statements and how much they agreed with them. For our first statement -- "God determines wellness, not results of research" -- our Black participants agreed with this statement at over 27%, whereas only 8% of our non-Black participants did.

For our second statement -- "Illness and death are God's will and not necessarily affected by research" -- here a third of our Black participants agreed with this statement and over a third of our non-Black participants disagreed.

The third statement was "Research is part of a conspiracy to negatively impact the health of minority groups." Twenty percent of our Black participants agreed with this, which is very important to consider, compared with only 0% of our non-Black participants who agreed.

What are some of the main take-home messages?

Gomez: Overall, our findings show that there are clear differences in the decision-making processes by these groups, and these factors do have some influence in spirituality. It's really important for clinicians and research teams to be prepared to addresses these spiritual themes, because they are impacting whether a patient wants to join a clinical trial or not.

When it comes to clinical care, we can take it there too, because we have to be better equipped to handle taking the spiritual history, for instance, if we want to advance the patient into a clinical research setting.

Also, we see that there is a difference between a patient's trust in their cancer care team versus clinical research. Our Black and non-Black patients both reported that they did trust their care team at similar rates -- but clearly that did not translate into the clinical research realm.

Madu: One may ask why it's important to have a diversity of patients in clinical trials. When you look at the U.S. demographics, you have about 14% of the population that is Black, but when you look at the demographics of trials across the board, you are probably having about 5-7% Black patients in clinical trials. So there is a disconnect there.

We should eliminate implicit bias, so give every single patient the opportunity to say yes or no to a clinical trial and not make assumptions for the patient. The other thing is: listen. Listen to the patients, talk to them, and understand the reasons for trial participation hesitancy, and when you understand the reasons why, then you can try to find strategies to get through them.

So if I have a patient who is more willing to listen to another patient who has gone through the same thing in a clinical trial, that's a win. They don't necessarily have to take that advice [to participate in a trial] from me, but they can take that advice from a patient advocate. So try to make sure that, within your clinical trial team, you have patient advocates, and in clinical trial design, when we are at the inception of any clinical trial, whether there is a DEI [diversity, equity, inclusion] lens on the clinical trial.

Read the study here.