Ariana Pelosci

Patients who were treated with cancer biosimilars and underwent extensive clinical evaluations experienced indistinguishable efficacy compared with reference products across drugs, disease types, and outcomes, according to a results from a systematic review published in 

Of the 31 biosimilar studies and 3 reference products across 7 subgroups included in the analysis, no differences in surrogacy efficacy were observed compared with the reference drugs. Investigators included 6 reference drug trials and reported that biosimilar studies often included more patients (397 vs 302), were more likely to be randomized vs single-group observational studies (100% vs 50%), and double blind than open label (84% vs 17%).

Investigators initially identified 184 studies, and 42 remained after exclusion criteria. An additional 11 studies were excluded after final review. The review included 12,310 patients.Overall, 21 studies had a low risk of bias, 2 had a high risk of bias, and 2 had bias that was unclear. Among the reference trials, 11 comparing bevacizumab (Avastin) with a biosimilar, 9 used trastuzumab (Herceptin), and 11 used rituximab (Rituxan). Of the studies examined, 12 have led to FDA approvals.

The efficacy meta-analysis investigated 3 originator drugs in 6 disease settings, including non–small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), ERBB2-positive early breast cancer, ERBB2-positive metastatic breast cancer, follicular lymphoma, and diffuse large B-cell lymphoma (DLBCL).

Among the comparing bevacizumab to a biosimilar, 6 had patients with NSCLC and 5 had a population with mCRC. NSCLC reported overall response rate (ORR) as a primary end point. Three mCRC trials reported ORR data, and 1 trial reported pharmacokinetic profile as an end point . An additional mCRC trials used disease control rate, and 2 used progression-free survival (PFS) as an end point. The meta-analysis showed the biosimilars were indistinguishable from bevacizumab in terms of ORR and PFS.

Of the trastuzumab studies, 4 had patients with ERBB2-positive metastatic breast cancer and 5 had a population with ERBB2-positive early breast cancer. All trials in the combined studies reported ORR as the primary end point, with 7 trials using pathological complete response rate as a primary end point. No difference between trastuzumab and biosimilars in terms of efficacy outcomes were reported. Those with metastatic breast cancer had no heterogeneity, although those with early breast cancer did (

 = .04). When the 2 studies were removed that did not use pathological complete response rates, investigators found identical results (

For the rituximab studies, 7 studies concerned follicular lymphoma, 3 had a group with DLBCL, and 1 focused on chronic lymphocytic leukemia (CLL). Despite including CLL in the reported sample, it was not included in the meta-analysis. ORR was the primary end point of all included studies with the exception of 1 that reported ORR with pharmacokinetics as the primary end point. The investigators did not find a difference in ORR between rituximab and the biosimilar, and none had heterogeneity.

This article originally apepared on Cancer Network.

Bloomfield D, D'Andrea E, Nagar S, Kesselheim A. Characteristics of clinical trials evaluating biosimilars in the treatment of cancer: a systematic review and meta-analysis. 

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Findings from a systematic review found little difference in outcomes between biosimilar and reference product treatment options. 


Efficacy Outcomes of Some Cancer Biosimilars Indistinguishable Vs Reference Product

Those who live in rural areas were reported to have higher levels of cancer fatalism and an overload of cancer information compared with individuals living in urban areas, according to a new study published in 

Cancer Epidemiology, Biomarkers, and Prevention

Rural residents were more inclined to believe that everything causes cancer (OR, 1.29; 95% CI, 1.17-1.43), prevention is not possible (OR, 1.34; 95% CI, 1.19-1.51), there are too many recommendations to prevent cancer (OR = 1.26; 95% CI, 1.13-1.41), and cancer is always fatal (OR = 1.21; 95% CI, 1.11-1.33) when compared with their urban counterparts. These concepts were referred to as the study’s “4 core beliefs.”

“Addressing this disparity is difficult on multiple levels, but perhaps most challenging is that rural adults often bypass cancer prevention and detection resources when they are made available. Trying to understand the reasons behind this behavior is a pressing task for cancer researchers. Our research hypothesis was that beliefs and attitudes about cancer may be the underlying cause, and that rural adults might be more prone to negative beliefs about cancer, possibly as a way to cope with limited access and resources,” lead investigator Jakob Jensen, PhD, a professor in the Department of Communication at the University of Utah, said in a press release.

Investigators collected data from 12 centers, which included 3821 patients from rural areas and 6541 from urban areas. The majority of participants were non-Hispanic White (82.7%), although centers in the South, especially in rural areas, had a higher number of non-Hispanic Black individuals vs other centers (39.4% vs 22.0%). This was the case for the University of Alabama and Virginia Commonwealth University.

It was noted that while it wasn’t pertinent to the study to evaluate actual screening practices, it was important to discuss gender and eligibility for cancer screenings. Among women who were between the ages of 21 to 65 years, 21.9% were evaluable for cervical cancer screening. Additionally, 24.5% of women over 50 years of age were eligible for a mammography and 49.3% of individuals over the age of 50 years were eligible for a colorectal screening. At initial screening, 9.6% of participants indicated that they were current smokers, but not enough data was collected to determine if they were eligible for low-dose CT lung cancer screening.

When comparing between rural and urban residents, investigators noted significant differences. Those in rural areas were older, White, and were more likely to be female, have lower income, abd be less educated. Additionally, the population was more likely to be retired, be receiving Medicare, married, a smoker, and classified as obese according to their body mass index.

When looking at the 4 core beliefs the study was investigating, rural residents were more likely to respond that they agree or strongly agree with all 4 beliefs (

As investigators accounted for other demographic or lifestyle variables, the associations remained. The multivariate analysis found that individuals who had lower educational attainments and were smokers were more likely to agree with the four cancer beliefs statements. Additional variables that remained significant were age, sex, race or ethnicity, income, trouble paying medical bills, employment, and marital status. However, these were not significant in the 4 cancer belief outcome measures.

“Our findings are in line with previous research showing that this type of thinking might be a consequence of a wider cultural setup that fosters self-reliance and coping beliefs in response to stress and lack of resources. This is known as the psychological stress and coping theory. The findings of our study are consistent with this logic as populations with fewer resources (in this case, rural adults) are more likely to reduce (fatalism) or revise (overload) the situation,” Jensen concluded.

This article originally appeared on Cancer Network.

1. Jensen JD, Shannon J, Iachan R, et al. Examining rural-urban differences in fatalism and information overload: data from 12 NCI-designated cancer centers. 

. 2022;31(2):393-403. doi:10.1158/1055-9965.EPI-21-0355

2. Rural residents tend to hold fatalistic beliefs and perceive more cancer-related information overload than urban residents. News Release. American Association for Cancer Research. January 28, 2022. Accessed on February 1, 2022. https://bit.ly/35H3SS8

Cancer misinformation may be more prevalent among residents in rural vs urban areas, study finds. 