Uma Naidoo, MD, recently spoke with Oncology Nursing News

to explain the connection between the gut and brain, and how the food individuals eat can affect emotional health.

Naidoo, a nutritional psychiatrist and director of nutritional & lifestyle psychiatry at Massachusetts General Hospital, is the author of the acclaimed book 

Naidoo explained that “the gut and brain emerge from the same exact cells in the embryo. They then form the organs and develop apart in the body. They then remain connect throughout life by the tenth cranial nerve or vagus nerve, which I like to call a two-way superhighway, which allows for chemical messaging back and forth, between brain and gut and gut and brain. In addition, more than 90% of serotonin receptors and serotonin is made in the gut.” 

Through this connection, she added, “food actually can impact our emotional health.”

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“More than 90% of serotonin receptors and serotonin is made in the gut.”

The Food-Mood Connection: Diet Directly Impacts Emotional Health

, suggested that the combination of brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine (AVD) with and without consolidative radiotherapy induced significant clinical responses in patients with early-stage, unfavorable-risk Hodgkin lymphoma, and that the treatment was generally tolerable for patients.

Overall, PET negativity rates were 87% at PET-2, 88% at PET-4, and 85% at the end of therapy. Moreover, the complete response (CR) rates at the end of therapy in cohorts 1 though 4 were 93%, 100%, 93%, and 97%, respectively, meeting the primary efficacy end points for cohorts 2 to 4.

At a median follow-up of 3.8 years (cohorts 1-4: 5,9, 4.5, 2.5, and 2.2, respectively), the overall 2-year progression-free survival (PFS) rate was 94% (95% CI, 89.7%-98.3%), and the overall survival (OS) rate at this time point was 99.1% (95% CI, 97.3%-1.0%).

When broken down by cohort, the 2-year PFS rates in cohorts 1 through 4 were 93.1% (95% CI, 83.9%-1.0%), 96.6% (95% CI, 89.9%-1.0%), 89.7% (95% CI, 78.5%-1.0%), and 96.6% (95% CI, 89.9%-1.0%), respectively. Moreover, the 4-year PFS rates in both cohorts 1 and 2 was 93.1%.

“This study represents among the best-reported outcomes to date for patients with bulky early-stage Hodgkin lymphoma,” Anita Kumar, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, wrote. “Given the limited number of patients per cohort and the nonrandomized design, the current pilot study was note designed to definitively compare the 4 treatment arms; however, the outcomes establish brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine [AVD] x 4 cycles as a highly active and well-tolerated regimen.”

The multicenter study comprised 4 cohorts. To be eligible for participation, patients needed to be aged 18 years to 60 years and have treatment-naïve, stage I/II, biopsy-proven, CD30-positive classical Hodgkin lymphoma.

In cohort 1, eligible candidates had to having unfavorable-risk factors like bulky mediastinal mass, an erythrocyte sedimentation rate of at least 50 mm/h or a rate of at least 30 mm/h in patients with B symptoms, extranodal involvement, over 2 lymph node sites, or infradiaphragmatic disease. In cohort 2, patients needed to meet the same disease bulk criteria; however, the definition was updated to reflect the Memorial Sloan Kettering (MSK) definition of maximal transverse or coronal diameter of the largest lymph node mass at any site greater than 7 cm on CT imaging. In cohorts 3 and 4, patients with early-stage Hodgkin lymphoma needed to have disease bulk per MSK criteria.

Across the cohorts, patients needed to have stage IIB disease with disease bulk and/or extranodal involvement.

Study participants were given brentuximab vedotin at 1.2 mg/kg, doxorubicin at 25 mg/m2, vinblastine at 6 mg/m2, and dacarbazine at 375 mg/m2 on days 1 and 15 of each 28-day cycle for 4 cycles.

Patients who had a PET-negative response following 4 cycles of brentuximab vedotin plus AVD and those with a PET-positive response with subsequent biopsy that was negative for disease were given 30-Gy involved-site radiotherapy (ISRT) in cohort 1, 20-Gy ISRT in cohort 2, 30-Gy consolidation-volume radiotherapy in cohort 3, and no radiotherapy in cohort 4.

Notably, in cohorts 2 and 3, either dose or field was reduced. In cohort 2, the dose was reduced to 20 Gy. In cohort 3, the field was reduced with consolidation-volume radiotherapy and the standard dose of 30 Gy was maintained.

The study enrolled 117 patients; 30 patients were enrolled to cohort 1 and cohort 2 through 4 comprised 29 patients each. Eighty-six percent of patients had MSK-defined disease bulk, 27% had traditionally-defined bulk, and 23% had advanced-stage disease per German Hodgkin Study Group criteria.

With the change in eligibility criteria, a greater proportion of patients had disease bulk per MSK criteria in cohorts 3 and 4, but more patients had traditional disease bulk in cohort 1 vs cohorts 2 through 4. Across the cohorts, 99% of patients had been given the 4 cycles of chemotherapy as planned and 94% of patients in cohorts 1 through 3 were administered planned consolidative radiation therapy.

Additional data demonstrated that 2 patients in cohort 1 had a positive PET-4 following brentuximab vedotin plus AVD for 4 cycles and biopsy-proven primary refractory disease. One patient in cohort 2 relapsed 34 months following the start of chemotherapy. Two patients in cohort 3 had a positive PET scan at end of therapy following completion of 30-Gy CVRT and biopsy-proven primary refractory disease; 1 patient relapsed 9 months following the start of treatment. Three patients in cohort 3 reported early treatment failures following CVRT. One patient in cohort 4 had a positive PET-4 and/or end-of-therapy PET, as well as biopsy-confirmed primary refractory disease.

Regarding safety, dose modifications like delays holds, or reductions were reported at a low rate. The most common reason for dose modification was because of the development of peripheral neuropathy, which resulted in a dose reduction of brentuximab vedotin, mostly from 1.2 mg/kg to 0.9 mg/kg.

Forty-four percent of patients experienced any-grade neutropenia and 8% had febrile neutropenia with the regimen. All participants received mandatory growth factor support. Fifty-four percent of patients experienced peripheral sensory neuropathy; however, most were low grade (95%) and resolved (76%) or improved to grade 1 (24%) by the last follow-up visit. Notably, no treatment-associated pulmonary toxicity was reported.

Forty-one serious adverse effects were reported in 21 patients and required hospitalization and these included fever and neutropenia, abdominal pain, and infection.

“The results of this pilot study of brentuximab vedotin plus AVD with and without consolidative radiotherapy for early-stage, unfavorable-risk Hodgkin lymphoma, including patients with disease bulk, demonstrate excellent efficacy across all 4 cohorts with an overall 2-year PFS of 94%,” the study authors concluded. “To our knowledge, this is the largest published study reporting outcomes associated with frontline brentuximab vedotin plus AVD in patients with bulky stage I or II classical Hodgkin lymphoma.”

Kumar A, Casulo C, Advani RH, et al. Brentuximab vedotin combined with chemotherapy in patients with newly diagnosed early-stage unfavorable-risk Hodgkin lymphoma. 

. 2021;39(20):2257-2265. doi:10.1200/JCO.21.00108

This article was originally published on OncLive as 

“Brentuximab Vedotin Plus Chemo Shows Strong Activity in Early-Stage Hodgkin Lymphoma”

Articles

Treating patients with brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine with and without consolidative radiotherapy resulted in strong efficacy and encouraging tolerability in early-stage, unfavorable-risk Hodgkin lymphoma.

Brentuximab Vedotin Plus Chemo Is Effective and Tolerable in Patients with Early-Stage Hodgkin Lymphoma

Single infusions of ciltacabtagene autoleucel (cilta-cel)were associated with early, deep, and durable responses in patients with relapsed or refractory multiple myeloma who were heavily pretreated, according to study results published in 

The single arm, open label, phase 1b CARTITUDE-1 study, evaluated 97 patients who were treated with single cilta-cel infusions at the recommended phase 2 dose (0

75 x 106 CAR-positive viable T cells per kg). There were 113 participants, of which 97 received cilta-cel infusion treatments.

The overall response rate was 97% (95% CI, 91.2–99.4), including 65 patients (67%) who achieved stringent complete response. The 12-month progression-free survival (PFS) rate was 77% (95% CI, 66.0–84.3) and overall survival (OS) rate was 89% (95% CI, 80.2–93.5). Median PFS and OS had not yet been reached as of the September 1, 2020, clinical cutoff. While the time to first response was 1 month, responses reportedly deepened over time.

“The rapidity and depth of response further suggest the potential of CAR T-cell therapies for changing the multiple myeloma disease course,” said lead authors, Jesus G Berdeja, MD, Sarah Cannon Research Insitute, and Deepu Madduri

MD, Mount Sinai Medical Center. They expressed that “Cilta-cel is a structurally differentiated CAR T-cell therapy featuring two BCMA-targeting single-domain antibodies designed to confer avidity. Cilta-cel showed unprecedented clinical activity compared with other novel anti-myeloma treatments in comparable study populations.”

The trial included patients with multiple myeloma who were 18 years and older. All participants had received 3 or more lines of therapy or were double refractory to a proteasome inhibitor and an immunomodulatory drug, and had received a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, prior to the initiation of the trial.

Single cilta-cel infusions began 5 to 7 days after the start of lymphodepletion and were administered at the target dose 0.75 × 106 CAR-positive viable T cells per kg.

The authors noted that the previous frequent use of lenalidomide and autologous stem-cell transplantation (ASCT) may have resulted in myelodysplastic syndrome or acute myelogenous leukemia in the study.In addition, a total of 6 adverse event (AE)-related deaths occurred during the study. The authors argued that both the incidence of myelodysplastic syndrome or acute myelogenous leukemia, as well as the number of fatal events, were comparable to total incidences reported in other populations of heavily pretreated patients with multiple myeloma.

The findings also showed that cytokine release syndrome occurred in 92 patients. Most cases were grades 1 or 2 and almost all cases were resolved through treatment with tocilizumab, corticosteroids, and anakinra. In comparison to another anti-BCMA Car T-cell therapy, the median time to onset of cytokine release syndrome was much longer (2 vs 7 days, respectively). The study authors explained that the low-weight-based dose of infused CAR T cells might be responsible for the cilta-cel safety profile.

Twenty-one percent of patients experienced neurotoxicity; out of which immune effector cell-associated neurotoxicity syndrome (ICANS) accounted for 17%. While the incidence, type, and grade differ from other investigational CAR T-cell therapies, the number of AEs was comparable to those reported with those therapies.

Further studies (CARTITUDE-2 and CATITUDE-4) assessing cilta-cel will address outpatient dosing in order to reduce AEs.

“To minimize risk for patients in the ongoing cilta-cel clinical development program, monitoring and mitigation strategies were implemented, including enhanced bridging therapy to reduce baseline tumor burden, early aggressive treatment of cytokine release syndrome and ICANS, handwriting assessments for early detection of neurotoxicity symptoms, and extended monitoring and reporting time for neurotoxicity up to 1 year after cilta-cel infusion,” the authors concluded. “Overall, cilta-cel has a manageable safety profile at the recommended phase 2 dose that is generally consistent with the current understanding of CAR T-cell therapy.”

Berdeja JG, Madduri D, Usmani SZ, et, al. Ciltacabtagene autoleucel, a B-cell maturation antigen- directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. 

https://doi.org/10.1016/S0140-6736(21)00933-8

At 12 months, 97% patients treated with single infusions of cilta-cel had responded to the therapy. 

Cilta-Cel Induces Deep and Durable Responses in Patients with Multiple Myeloma

Multicancer early detection (MCED) tests demonstrated a strong capacity for delivering accurate and specific cancer signal origin (CSO) predictions across various tumor types. These results suggest that MCED tests should be included as a complement to existing single-cancer screening tests.

Specifically, data from The Circulating Cell-Free Genome Atlas Study (CCGA; NCT02889978), published in 

 showed that cancer signals were detected across more than 50 tumor types and that the MCED tests demonstrated a specificity for cancer signal detection of 99.5% (95% CI, 99.0%-99.8%). The overall sensitivity for cancer signal detection was 51.5% (n = 1453/2823; 95% CI, 49.6%-53.3%) and the sensitivity of the tests increased with disease stage; sensitivity for stage I disease was 16.8% (95% CI, 14.5%-19.5%), 40.4% (95% CI, 36.8%-44.1%) for stage II, 77.0% (95% CI, 73.4%-80.3%) for stage III, and 90.1% (95% CI, 87.5%-92.2%) for stage IV.

Overall, the accuracy of CSO prediction in true positives was 88.7% (95% CI, 87.0%-90.2%).

Investigators also reported that the MCED test demonstrated a cancer signal detection sensitivity of 40.7% (95% CI, 38.7%-42.9%) in an analysis was conducted in a cohort of patients with 12 prespecified cancers which account for approximately 66% of annual cancer deaths annually in the United States. Specifically, this cohort included patients with either anal, esophageal, lung, pancreatic, bladder, head and neck, stomach, ovarian, liver/bile duct, and colorectal cancers, as well as lymphoma and plasma cell neoplasms.

Further, an analysis of patients with stage I-III disease showed that the sensitivity of cancer signal detection with the MCED tests was 67.6% (95% CI, 64.4%-70.6%).

“Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer,” Eric Klein, MD, the chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic, said in a press release from ESMO.

 “These data suggest that, if used alongside existing screening tests, the multicancer detection test could have a profound impact on how cancer is detected and, ultimately, on public health.”

Widespread detection of cancer prior to stage IV disease could reduce cancer-related deaths by more than 15% within 5 years. Five single-cancer screening tests available for use in the United States for detection of breast, colorectal, cervical, lung, and prostate cancers, which account for 42% of annual cancer incidence rates. The use of cancer screening tests have contributed to the reduction of cancer-specific mortality, however, they are associated with high rates of false positives, over-diagnosis, and over treatment.

MCED tests represent a potential new approach to detecting signals for multiple cancer types by utilizing cell-free DNA (cfDNA) or other circulating analytes in the blood shed by tumors. As such, CCGA study investigators sought to develop and utilize a MCED test to detect cancer signals across multiple cancer types, as well as predict CSO with just a single blood draw.

From August 2016 and February 2019, this prospective, multi-center, case-control, observational study with longitudinal follow-up, enrolled 15,254 patients from 142 sites in North America. The study was then divided into 3 prespecified sub-studies that included a discovery cohort, a cohort that examined training and validation with the selected and updated assay and classifiers, and clinical validation cohort, reported here.

Patients eligible to enroll on the study were those 20 years and older, who received a diagnosis of cancer and/or were scheduled to undergo biopsy or surgical resection for a confirmed or highly suspected malignancy. Those who had previously undergone chemotherapy, radiotherapy, or definitive local therapy were not eligible to enroll.

The primary end point of the sub-study was to evaluate MCED test performance for cancer signal detection, CSO prediction, and the rates of both combined. Key secondary end points included test performance by age group, test performance for cancer signal detection by method of cancer diagnosis, and test performance for cancer signal detection in a prespecified group of 12 cancer classes.

In total, 5309 patients were enrolled on the third sub-study, 4077 of whom were included in the analysis. Of the evaluable patients, 2823 had a confirmed cancer diagnosis, and 1254 did not have a cancer diagnosis. The most common reasons for exclusion from the analysis were incomplete 1-year follow-up for noncancer participants (n = 324), presence of nonmalignant conditions at enrollment (n = 283), and unconfirmed cancer or treatment status at blood draw (n = 171).

Patients had a mean age of 60.6 years, and a majority were female (55.4%) and White (81.2%). Among patients with a confirmed cancer diagnosis, most presented with stage I or stage II disease (54.9%).

“These data add to a growing body of literature that supports the use of next-generation sequencing for the detection of cell-free DNA in blood samples as a tool for earlier detection of common cancers that account for a significant number of deaths and other health problems worldwide,” Klein said. “In addition, a screening test that requires only a simple blood draw could provide an option for communities that have poor access to medical facilities.”

Klein E, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. 

. Published online ahead of print June 23, 2021. doi:10.1016/j.annonc.2021.05.806

Blood test for early detection of cancer: final study results support screening use. News release. European Society for Medical Oncology. June 25, 2021. Accessed June 25, 2021. 

“Blood-based Test Shows Promising Accuracy in Detecting Cancer-Signal Across Multiple Tumor Types”

Multicancer early detection tests provided specified and accurate cancer signal origin detection across more than 50 tumor types. 

Blood-Based Tests Should Be Included in Single-Cancer Screenings

Cancer Treatment Centers of America’s pilot program, Oncology Clinic at Home, allows qualifying patients to receive their chemotherapy treatments in their own home.

Chevon Rariy, MD, medical director of Endocrinology at Cancer Treatment Centers of America (CTCA) Chicago, and the Telehealth Program director for the CTCA, recently spoke to Targeted Oncology

, sister publication of Oncology Nursing News

, about the effect of the pandemic on telehealth programs and the benefits that telehealth provides for patients with cancer.

The Oncology Clinic at Home program, which is currently based in Atlanta, Georgia, delivers oncology care to patients so long as they are in good enough health to not require a hospital visit, can tolerate their medication in an in-patient setting, have reliable internet service, own a mobile device such as a laptop or mobile, and have insurance policies which cover the treatments. The program currently treats breast, lung, prostate, head and neck, colorectal and some genitourinary cancers.

“When the pandemic hit, telehealth was well positioned to be a powerful tool. It really was the silver lining in the entire shift in care.”

Chemotherapy Available at Home with Launch of CTCA Program

Several cancer organizations signed a group statement calling for health care employers to mandate COVID-19 vaccinations for their employees.  

Cancer Organizations Implore Health Care Employers to Mandate COVID-19 Vaccines 

The FDA has determined that more data are necessary to certify the clinical benefit of retifanlimab for the treatment of squamous cell carcinoma of the anal canal. 

FDA Delivers Complete Response Letter for Retifanlimab for SCC Subgroup 


The FDA has approved the first immunotherapy, pembrolizumab (Keytruda), to treat patients with high-risk early-stage triple-negative breast cancer.


FDA Approves Pembrolizumab for High-Risk Early-Stage TNBC

Bristol Myers Squibb has chosen to withdraw the indication for single-agent nivolumab for patients with hepatocellular carcinoma with previous sorafenib treatment following a confirmatory phase 3 trial. 

Bristol Myers Squibb Chooses to Withdraw Nivolumab Indication for Treatment of Liver Cancer in the United States 

New data emphasizes need for routine brain imaging in patients with advanced or metastatic renal cell carcinoma with prior treatment and high metastatic burden. 

Brain Imaging Guidelines Needed for Patients with Metastatic Kidney Cancer

Nomogram May Have the Power to Predict Treatment Outcomes in Patients with Prostate Cancer Subtype 


Patients with multiple myeloma are potentially at greater risk of developing severe COVID-19 after the SARS-COv-2 vaccination induced suboptimal antibody response. 


COVID-19 Vaccine May Not Be Effective in Patients With Multiple Myeloma 

A recent study showed that belumosudil induced clinically meaningful, durable responses among a varied cohort of patients with chronic graft-versus-host-disease. 

Newly-Approved Belumosudil Yields High Overall Response Rate in Patients with Chronic Graft-Versus-Host-Disease


Study results have posited plinabulin as a potentially effective preventative and active therapy due to its unique mechanism of action.


Distinct Mechanism of Action Makes Plinabulin a Potentially Powerful Therapy in Treating Breast Cancer

A diagnosis of COVID-19 was associated with an increased risk of respiratory problems and mortality in patients with urological cancer undergoing elective procedures for their disease. 

 COVID-19 Heightens Mortality Risk in Patients with Urological Cancer Undergoing Elective Procedures

The International Association for the Study of Lung Cancer (IASLC) has published an updated consensus on the use of liquid biopsy in screening non-small cell lung cancer (NSCLC).

Updated IASLC Report Calls Liquid Biopsy Preferred Method of Molecular Testing

Novel research at University of Washington aims to improve the rate of colorectal cancer screenings in rural America. 

New Strategies Aim to Expand Preventative CRC Screenings in Rural America

The FDA has granted a breakthrough therapy designation for venetoclax following interim results from the ongoing M15-531 trial. 

Venetoclax Receives Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome (MDS)

 is the leading national organization providing free, professional support services and information to help people manage the emotional, practical and financial challenges of cancer. Our comprehensive services include counseling and support groups over the phone, online and in-person, educational workshops, publications and financial and co-payment assistance. All Cancer

 services are provided by oncology social workers and world-leading cancer experts.

In order to meet the multifaceted needs of cancer patients, the role of case management in cancer care has recently grown.

The Role of Case Management:  Improving Outcomes and Addressing Health Disparities in Cancer Care

Lisa Cusaac never planned on being an oncology nurse. However, 25 years later she has spent her entire career providing care for patients with cancer and being an Oncology Nurse Champion. 

Top Medical News

The Food-Mood Connection: Diet Directly Impacts Emotional Health

Brentuximab Vedotin Plus Chemo Is Effective and Tolerable in Patients with Early-Stage Hodgkin Lymphoma

Cilta-Cel Induces Deep and Durable Responses in Patients with Multiple Myeloma

Blood-Based Tests Should Be Included in Single-Cancer Screenings

Chemotherapy Available at Home with Launch of CTCA Program

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