According to results of a subgroup analysis from the phase 3 CheckMate 9ER trial (NCT03141177) presented at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium, combination treatment with nivolumab and cabozantinib demonstrated improved efficacy and prolonged survival when compared with sunitinib (Sutent) among patients with previously treated advanced renal cell carcinoma (aRCC), regardless of sarcomatoid status.

In this open-label trial, adults with confirmed aRCC with a clear cell component, including those with sarcomatoid features (sRCC), were randomized 1:1 to receive either nivolumab plus cabozantinib or sunitinib. The primary end point was RECIST v1.1-defined progression-free survival by blinded independent central review (BICR) in all randomized patients. Key secondary end points included overall survival, objective response rate by BICR, and safety.

Overall, 75 patients (11.5%) had sRCC and 557 (85.6%) did not; sRCC status was not reported in 19 patients (2.9%). In total, 34 patients with sRCC received nivolumab and cabozantinib and 41 received sunitinib.

, Robert J. Motzer, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, explained the results of the sarcomatoid subgroup analysis with regard to the overall study population.

What we find is that for the most part, the outcomes for the [immuno-oncologic; IO] therapy plus the [a tyrosine kinase inhibitor] are similar [in all treated patients]. It may be a bit inferior with sarcomatoid features compared to [non-sarcomatoid RCC], but it’s really the difference that we see when we compare it with the sunitinib group. Because the sarcomatoid-feature tumors are very resistant to sunitinib, we see that that resistance is released, or it’s overcome, by the IO therapy. So, it’s really more relative to how they did before.

I think it’s very clear that [for] patients who have tumors that contain these sarcomatoid features, a requirement of their therapy is one of these [immuno-oncologic] checkpoint inhibitors in combination [with a VEGF inhibitor].

Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER.

. 2021;39(suppl 6):308. doi: 10.1200/JCO.2021.39.6_suppl.308

Videos

The medical oncologist at Memorial Sloan Kettering Cancer Center discussed the significance of the phase 3 CheckMate 9ER study results.

Robert J. Motzer, MD, on Outcomes of the Phase 3 CheckMate 9ER Trial in Advanced RCC

Older patients with locoregional esophageal or esophagogastric junction (EGJ) cancer need to be evaluated for optimal curative therapy, including neoadjuvant chemoradiotherapy and surgical resection, according to data published in the 

Journal of the American College of Surgeons.

Although the data found that preoperative risk scoring and postoperative atrial arrythmias were higher for patients aged 70 years or older versus younger patients, both short- and long-term outcomes were noninferior for the group of older patients.

“We found that surgical resection after [neoadjuvant chemoradiotherapy] can be performed safely in well-selected older patients with esophageal and EGJ cancer with short- and long-term outcomes that are comparable with those obtained in patients younger than 70 years,” wrote the investigators. “In addition, use rates for triple modality therapy including surgical resection are increasing over time at our institution.”

Over the span of 16 years—between January 1, 2004 and December 31, 2019—405 consecutive patients with esophageal or EGJ cancer underwent primary treatment at a single institution. The team collected data on demographic information, tumor stage, preoperative Charlson Comorbidity Index scores, treatment variables, and short- and long-term outcomes, with patients 70 years or older classified in the “older” group and those under the age of 70 years classified in the “younger” group.

Of that initial cohort of patients, 188 patients in the younger group (median age, 59 years) and 94 patients in the older group (median age, 74 years) received neoadjuvant chemoradiotherapy and surgical resection for disease stage 2 or higher.

When investigating preoperative characteristics, patients in the older group had significantly worse Charlson Comorbidity Index scores than patients in the younger group. More, the older group saw postoperative atrial fibrillation and urinary retention develop more frequently than in the younger cohort.

“Our data show that, in this age group, significantly fewer patients underwent optimal triple modality therapy including surgical resection,” wrote the investigators. “This included a significantly lower percentage of surgically resected patients 70 years or older who underwent neoadjuvant chemoradiation therapy and a significantly lower percentage of all patients 70 years or older with stage II and III cancer who underwent neoadjuvant chemoradiation and surgical resection, compared with the age group 70 years or younger.”

Regardless of the worse prognoses for patients in the older cohort, complication severity scores of 3 or higher via postoperative Clavien-Dindo classification, perioperative mortality rates, and lengths of stay were all similar between the 2 groups.

Finally, long-term, age-adjusted survival rates examined at 5 years were 44.8% in the older group and 39% for the younger group of patients.

The research team noted that all patients in the older group were treated with optimal triple modality therapy. More, patients with “unstable or severe chronic heart disease, moderate to severe chronic liver disease, and severe chronic pulmonary disease” were excluded from consideration for undergoing surgical resection.

“In view of increasing lifespans in the US and worldwide, and the increasing incidence rate of esophageal and esophagogastric cancer, it can be expected that increasing numbers of elderly patients will present with stage II and III esophageal and EGJ cancer in the future,” wrote the investigators. “The development of comprehensive prehabilitation programs might expand the proportion of elderly patients who can undergo optimal triple modality therapy, and this is a current focus of our group for these patients.”

Sawyer WP, Luo X, Welch AM, et al. 15-Year Experience with Multimodality Therapy Including Esophagectomy for Elderly Patients with Locoregional Esophageal Cancer. 

 Published online February 4, 2021. doi:10.1016/j.jamcollsurg.2020.11.027

Articles

Data from the Journal of the American College of Surgeons suggest patients 70 years or older with esophageal or esophagogastric junction cancers should be evaluated for optimal curative therapy.

Patients Aged 70 or Older With Esophageal or EGJ Cancers Should Be Evaluated for Optimal Curative Therapy

The first single-dose COVID-19 vaccine was granted Emergency Use Authorization (EUA) by the FDA, according to its developer Janssen Pharmaceutical Companies of Johnson & Johnson, and is the third to become available for use in patients within the United States.1

Shipping of vaccines is set to start immediately, with estimates reporting around 20 million doses being delivered in March and 100 million to become available in the first half of 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world–all of whom shared a goal of bringing a single-shot vaccine to the public,” Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson, said in a press release. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

Data from the phase 3 ENSEMBLE trial (NCT04505722) served to support the FDA’s decision showing that the vaccine had 85% efficacy in preventing severe disease across all regions studied. In addition, protection against COVID-19–related hospitalization and death beginning 28 days after vaccination was demonstrated.

This decision by the agency occurred 1 day after a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, where there was a unanimous vote in favor of the EUA.2

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said in a press release. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Although the EUA will make the vaccine available while more research is done, the company plans to submit a biologics license application later in the year. They have also submitted a European Conditional Marketing Authorisation Application to the European Medicines Agency, an Emergency Use Listing (EUL) with the World Health Organization, and rolling submissions to various agencies worldwide.

1. Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use. News release. Johnson & Johnson. February 27, 2021. Accessed February 27, 2021. https://prnmedia.prnewswire.com/news-releases/johnson--johnson-covid-19-vaccine-authorized-by-us-fda-for-emergency-use-301236878.html

2. Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. News release. Johnson & Johnson. February 26, 2021. Accessed February 27, 2021. https://prnmedia.prnewswire.com/news-releases/johnson--johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-us-fda-advisory-committee-301236740.html

The first single shot COVID-19 vaccine, and the third overall, to receive Emergency Use Authorization will start shipping to all parts of the United States immediately following a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Third COVID-19 Vaccine Earns Emergency Use Authorization Following Favorable Advisory Committee Meeting

In a comparison of systemic treatments as add-ons to androgen-deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), abiraterone acetate (Zytiga) and apalutamide (Erleada) are likeliest to provide patients with enhanced overall survival (OS) benefit with low risks of serious adverse events.

, also found that enzalutamide (Xtandi) would improve radiographic progression-free survival (PFS) the most, but further follow-up data is necessary to investigate the OS benefit.

“We identified 7 eligible trials constructing a scarce network in which most treatments have not been compared in head-to-head trials, which highlights the importance of the study,” wrote the investigators. “Three drugs were associated with significantly improved OS when added to ADT. Among them, abiraterone acetate was associated with significantly larger OS benefit than docetaxel, and similar OS benefit to apalutamide.”

The research team identified 7 trials investigating 6 treatment options—abiraterone acetate, apalutamide, docetaxel, enzalutamide, standard nonsteroidal antiandrogen, and placebo/no treatment—for 7287 total patients.

When added to ADT, treatment options that improved OS for patients with mCSPC included abiraterone acetate (HR, 0.61; 95% CI, 0.54-0.70), apalutamide (HR, 0.67; 95% CI, 0.51-0.89), and docetaxel (HR, 0.79; 95% CI, 0.71-0.89).

More, treatment options that improved radiographic PFS included enzalutamide (HR, 0.39; 95% CI, 0.30-0.50), apalutamide (HR, 0.48; 95% CI, 0.39-0.60), abiraterone acetate (HR, 0.51; 95% CI, 0.45-0.58), and docetaxel (HR, 0.67; 95% CI 0.60-0.74).

While docetaxel (odds ratio, 23.72; 95% CI, 13.37-45.15) and abiraterone acetate (odds ratio, 1.42; 95% CI, 1.10-1.83) were associated with significantly increased and slightly increased odds of serious adverse events versus placebo/no treatment, respectively, all other treatments were not associated with significant differences.

“Our results are consistent with those of a previous review that compared abiraterone acetate, docetaxel, zoledronic acid, and celecoxib [Celebrex] for mCSPC and suggested that abiraterone acetate may be the most effective treatment followed by docetaxel,” wrote the investigators. “Our findings are different from those of a review that suggested enzalutamide to be the most effective treatment; relative rankings of other drugs were similar to our estimates.”

The research team utilized bibliographic databases such as MEDLINE, Embase, and Cochrane Central, regulatory documents from the FDA and European Medicines Agency, and trial registries like ClinicalTrials.gov and the European Union clinical trials register to collect their data. The team worked to compare the effectiveness and safety of adding certain systemic treatment options to ADT.

Two limitations of the research included inconsistencies among outcome measures across each trial, which “precluded treatment comparison for many outcomes.” Because of different cutoff levels across each trial, subgroup analyses were not available.

“This study is important for patients, clinicians, and payers given the uncertainty about the optimal treatment for mCSPC, which causes significant morbidity and mortality among older men,” wrote the investigators. “The findings of this study may be applicable to patients with mCSPC in different countries because most included trials were multinational, recruiting patients from America, Europe, Asia, and Oceania.”

Wang L, Paller CJ, Hong H, et al. Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer. 

A study published in JAMA Oncology found that, of 6 tested systemic treatment options, abiraterone acetate and apalutamide were the likeliest to improve overall survival when combined with ADT for patients with metastatic castration-sensitive prostate cancer.

Abiraterone Acetate, Apalutamide Likeliest to Improve Survival for Patients with Castration-Sensitive Prostate Cancer

A cross-sectional study of digital breast tomosynthesis (DBT) screening published in 

indicated that women of minority race/ethnicity and lower socioeconomic status experienced lower DBT access during the early adoption period and consistently lower use when available over time.

Given these findings, the investigators suggested that future efforts should address racial/ethnic, educational, financial, and geographic barriers to receiving DBT screening at the facility level.

“This study was about whether adoption of this technology is equitable. We’re showing that it has not been, even though it has been FDA-approved for a decade now,” lead author Christoph Lee, MD, MS, MBA, professor of radiology at the University of Washington School of Medicine, said in a press release.

 “Black and Hispanic women, and less-educated and lower-income women have not been able to obtain 3D mammography as easily as white, well-educated, and higher-income women.”

In this study, 92 geographically diverse imaging facilities were evaluated across 5 states in the United States. Investigators assessed whether the facilities offered DBT onsite at the time of a screening exam and compared the use of DBT and digital mammography across patient populations at those facilities.

Overall, 2,313,118 screening examinations had been performed among women aged 40 to 89 years from January 1, 2011 to December 31, 2017. Of the total screening examinations, the proportion of women who had access to DBT at the time of their screening appointment increased from 11,558 of 354,107 (3.3%) in 2011 to 194,842 of 235,972 (82.6%) in 2017.

In 2012, it was revealed that Black (relative risk [RR], 0.05; 95% CI, 0.03-0.11), Asian American (RR, 0.28; 95% CI, 0.11-0.75), and Hispanic (RR, 0.38; 95% CI, 0.18-0.80) women had significantly lowered access to DBT compared with White women. Moreover, when compared with college graduates, women with less than a high school education had lower DBT access (RR, 0.18; 95% CI, 0.10-0.32).

“These subpopulations of women with poorer access to 3D [imaging] are already traditionally underserved and more at risk for greater morbidity and mortality from breast cancer,” added Lee.

Among women attending facilities with both digital mammography (DM) and DBT available at the time of their screening, Black women experienced lower DBT use compared with White women attending the same facility (RRs, 0.83 [95% CI, 0.82-0.85] and 0.98 [95% CI, 0.97-0.99], respectively). Women with lower educational level, such as those with and without a high school diploma, also experienced lower DBT use than those with a college degree (RRs, 0.79 [95% CI, 0.74-0.84] and 0.88 [95% CI, 0.85-0.91], respectively). Regardless of the number of years after facility-level DBT adoption, women within the lowest income quartile experienced lower DBT use as compared to women in the highest income quartile (RRs, 0.89 [95% CI, 0.87-0.91] to 0.99 [95% CI, 0.98-1.00]).

“Given the large research sample and our longitudinal data collection, we were able to evaluate use by minority and traditionally underserved populations,” senior author Diana Miglioretti, PhD, professor and division chief of biostatistics at the University of California Davis, said in the release. “Unfortunately, we were not surprised to find that these traditionally underserved populations were less likely to attend facilities that offered 3D mammography, and even when they did, they were less likely to receive a 3D mammogram.”

Importantly, the current study did not evaluate whether structural racism in health care environments or out-of-pocket costs could have contributed to the lower access and use of new technologies among women of minority race/ethnicity. However, given that these may be real barriers, investigators recommended radiology practices and policy makers be cognizant of these screening access issues and consider disparities going forward.

1. Lee CI, Zhu W, Onega T, et al. Comparative access to and use of digital breast tomosynthesis screening by women’s race/ethnicity and socioeconomic status. 

. 2021;4(2)e2037546. doi: 10.1001/jamanetworkopen.2020.37546

2. Race, income, education affect access to 3D mammography. News release. University of Washington School of Medicine. Published February 19, 2021. Accessed February 22, 2021. https://www.eurekalert.org/pub_releases/2021-02/uowh-rie021721.php

Given these study findings, investigators suggested that future efforts should address racial/ethnic, educational, financial, and geographic barriers to receiving digital breast tomosynthesis screening at the facility level.

Women of Minority Race/Ethnicity, Lower Socioeconomic Status Experience Lower Digital Breast Tomosynthesis Access

Results of an analysis of tivozanib (Fotivda) versus sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC) included in the phase 3 TIVO-3 study (NCT02627963), which were presented at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium, suggest Q-TWiST may be considered an alternative patient-centered measure of benefit in these settings.

The analysis revealed that as a third- or fourth-line treatment for RCC, tivozanib significantly increased Q-TWiST compared with sorafenib, primarily through an increase in TWiST.

, Michael Szarek, PhD, of the SUNY Downstate Medical Center, explained this observed outcome and why it is so significant for patients with advanced RCC.

You take a patient’s survival time, and you divide it into 3 mutually exclusive states. [Toxicity] time, which is the time that patients experience toxicity prior to progression; in our case, we defined that as grade 3 or 4 adverse events. Then there’s TWiST time, which is the time prior to progression where the patient is not experiencing that toxicity. Then there’s time after progression [or relapse], which is called REL time. And what we found is that by splitting every patient’s survival into those 3 states, tivozanib increased TWiST time; there was really no difference in [toxicity] time. And because of the similar survival between the 2 treatment groups, REL time was longer for sorafenib than for tivozanib. However, part of the Q-TWiST analysis is that you apply weight to each state, and the idea is that TWiST time is more valuable to a patient than REL time or [toxicity] time, which makes sense because that’s the ideal situation where prior to progression, you’re not experiencing any toxicity. And so, when you apply weight to those 3 states, we found a significant benefit of tivozanib relative to sorafenib on Q-TWiST. It’s, in a sense, confirmed the progression-free survival results of the trial in extending it by showing that if you weigh the patient survival by different quality states you also see a benefit.

Szarek M, Needle MN, Rini BI, et al. Q-TWiST analysis of tivozanib (T) versus sorafenib (S) in patients with advanced renal cell carcinoma (RCC) in the TIVO-3 study. 

. 2021;39(suppl 6):298. doi: 10.1200/JCO.2021.39.6_suppl.298

An analysis revealed that as a third- or fourth-line treatment for RCC, tivozanib significantly increased Q-TWiST compared with sorafenib, primarily through an increase in TWiST.

Michael Szarek, PhD, on the Outcomes of a Q-TWiST Analysis From the Phase 3 TIVO-3 Study

With over 5 years of follow-up, pembrolizumab (Keytruda) continued to demonstrate clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) versus docetaxel among patients with previously treated, advanced non–small cell lung cancer with a PD-L1 tumor proportion score (TPS) of at least 1%, according to updated results from the KEYNOTE-010 study (NCT01905657) presented at the IASLC 2020 World Conference on Lung Cancer.

, Roy S. Herbst, MD, PhD, of the Yale Cancer Center and Smilow Cancer Hospital, explained what multidisciplinary care teams can take away from this research.

Lung cancer is treated in a multidisciplinary setting; and certainly, if someone is treated in a metastatic setting, we should think about therapy as early as possible. But also, these drugs can now be used in the adjuvant setting. We already know from the PACIFIC trial (NCT02125461) that durvalumab improves survival after chemoradiation. And I’m confident that we’ll see some interesting results soon from some of the Agilent trials in stage I to III disease.

Herbst R, Garon E, Kim D, et al. 5-year survival update from KEYNOTE-010: pembrolizumab versus docetaxel in previously treated, PD-L1–positive advanced NSCLC. Presented at the IASLC 2020 World Conference on Lung Cancer. Abstract FP13.01.

The KEYNOTE-010 study evaluated the use of either pembrolizumab or docetaxel in patients with previously treated, PD-L1–positive advanced non–small cell lung cancer.

Roy S. Herbst, MD, PhD, on What Multidisciplinary Providers Should Know About KEYNOTE-010

Updated survival data from the randomized phase 2 MERECA trial (NCT02432846) evaluating the off-the-shelf immunotherapy ilixadencel in combination with sunitinib (Sutent) versus sunitinib alone for the first-line treatment of newly diagnosed patients with metastatic renal cell carcinoma (mRCC) demonstrated a separation in Kaplan-Meier survival curves in favor of the combination, according to the agent’s developer, Immunicum AB.

“These updated results from the phase 2 MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for [patients with kidney cancer],” Sven Rohmann, MD, PhD, CEO at Immunicum, said in a press release. “With today’s longer follow-up data, the encouraging signal observed has matured and builds our conviction to bring ilixadencel to patients in need. With our ongoing evaluation of ilixadencel, we are working to provide further clinical evidence supporting our conviction.”

In the exploratory, international, randomized, controlled, open-label trial, a total of 88 patients with newly diagnosed, intermediate- or poor-risk mRCC were enrolled. Participants were randomized 2:1 to receive either 2 intratumoral doses of ilixadencel before nephrectomy and subsequent treatment with sunitinib or sunitinib therapy alone following nephrectomy.

The study’s dual primary end points are median overall survival (OS) and 18-months survival rates. Key secondary end points include safety and tolerability, tumor response, and immunological profiling, including T-cell infiltration.

In August 2020, the co-primary end point of median OS was reached at 25.3 months in the sunitinib control group, while the median OS in the ilixadencel treatment group had not been reached. Updated data as of February 2021 revealed that the median OS for the ilixandencel combination group has now been reached and was 35.6 months.

Overall, 23 out of 56 patients (41%) in the ilixadencel combination treatment group were still alive, compared with 9 out of 30 patients (30%) in the control group. Moreover, all 5 patients with complete tumor response as best response in the ilixadencel combination treatment group are still alive in this follow-up; this compares favorably with only 1 complete response observed in the control group in a patient who has since died during the first follow-up period.

Moving forward, investigators indicated that survival updates for patients in the MERECA study will be announced for each consecutive 12-month follow-up period.

“The observed difference of 10 months in median OS for the ilixadencel combination group versus the control group is substantial and clinically meaningful,” Peter Suenaert, MD, PhD, chief medical officer at Immunicum, said in the release. “Although the randomized, controlled study was not statistically powered for the OS end point, the data announced today suggests that ilixadencel has the potential to become a promising treatment option for these patients by improving survival outcomes when combined with standard-of-care cancer therapies.”

To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). Additionally, the immunotherapy has been evaluated in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors sunitinib and regorafenib (Stivarga) as well as the checkpoint inhibitor pembrolizumab (Keytruda).

Immunicum announces encouraging signs of survival benefit in phase II MERECA trial of ilixadencel in kidney cancer. News release. Immunicum. Published February 22, 2021. Accessed February 23, 2021. https://www.globenewswire.com/news-release/2021/02/22/2179199/0/en/Immunicum-Announces-Encouraging-Signs-of-Survival-Benefit-in-Phase-II-MERECA-Trial-of-Ilixadencel-in-Kidney-Cancer.html

“These updated results from the phase 2 MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for [patients with kidney cancer],” said Sven Rohmann, MD, PhD.

Phase 2 MERECA Trial Continues to Show Promise for Ilixadencel-Sunitinib Combination for mRCC

 showed that the use of mobile health (mHealth) had a positive effect on the regularity of systemic therapy intake in children, adolescent, and young adult patients with acute lymphoblastic leukemia (ALL), representing a potential method for promoting patient adherence.

Historically, patients being treated with oral 6-mercaptopurine (6-MP) have poor drug adherence, which may lead to an increased risk of disease relapse, representing an unmet clinical need.

“Our study contributes to the existing literature on medication adherence in pediatric ALL by reporting on the potential role of mHealth interventions to optimize adherence behavior in this population,” the study investigators, who were led by Mallorie B. Heneghan, MD, MSc, wrote in the paper. “Using a cross-sectional survey design, parents and patients with ALL self-reported on their access to technology as well as preferences for mHealth intervention features.”

In order to combat these effects, investigators on the trial sought to diminish poor therapy adherence in this set with the use of mobile technology by way of mHealth, which utilizes a combination of mobile and wireless applications for the delivery of health-related services. The platform is intended to implement behavior change techniques through its accessibility on mobile devices.

Both patients and caregivers were assessed for use of mHealth and surveyed about its use. Of the 57 families who consented to participate, both parents (n = 49) and patients (n = 15) owned and electric tablet (84% and 67%, respectively), a smartphone (96% and 100%), or both. In addition, most parents and patients had unlimited text messaging (98% and 93%, respectively) and access to high-speed internet at home (92% and 93%).

All 8 proposed features of mHealth were endorsed by more than half of those surveyed, and the median number of features endorsed was 7 (interquartile range, 6-8). For most parents (98%), the most favored quality was the ability to view lab results, followed by information about ALL medication (96%) and information about ALL (92%). For patients, the most favored attributes were daily medication reminders (93%), medication tracking (93%), and education about ALL (93%).

When the data were specifically related to medication adherence aspects of mHealth, parents and patients supported a median of 13 and 11 features, respectively. Both groups favored adherence-promoting app features. Parents indicated liking information provided about what 6-MP does (71%), reminders to refill 6-MP (71%), reminders to take 6-MP (71%), and a list of medications (71%). Patients conveyed positive feedback about reminders to refill 6-MP (73%), reminders to take 6-MP (73%), and a way to track 6-MP (73%).

“Our study adds to existing literature by demonstrating ubiquitous technology access and interest in mHealth among both parents of children with leukemia and AYAs with leukemia,” the investigators wrote. “Our findings suggest previously reported low rates of mHealth use by adolescents and parents of children with cancer are not due to a lack of interest in mHealth and represents the first step in user-centered design.”

Strengths of the study include the high enrollment and completion rates in a patient sample that both racially/ethnically diverse. However, the investigators did acknowledge that there is limited generalizability of the data given the relatively small sample size and its origin from a single center.

The investigators concluded by saying the results support further development of user-centered mHealth intervention, by way of mobile apps, to promote medication adherence in this patient population with ALL. They indicated that 2 versions of the app, one each for patients and parents, may be necessary to meet the needs of each group.

Heneghan MB, Hussain T, Barrera L, et al. Access to technology and preferences for an mHealth intervention to promote medication adherence in pediatric acute lymphoblastic leukemia: approach leveraging behavior change techniques. 

Study results from the Journal of Medical Internet Research indicated that medication adherence by way of reminders on mobile devices for patients with acute lymphoblastic leukemia and their caregivers may have validity. 

Using Mobile Apps May Be Feasible for Promoting Drug Adherence in ALL

Utilizing extrapleural pneumonectomy after radiotherapy is possible and can produce positive early- and long-term effects for patients with previously untreated malignant pleural mesothelioma, according to data published in 

However, even if surgery for mesothelioma after radiotherapy (SMART) is possible, the research team warned that it is technically demanding to minimize grade 4 adverse events on the protocol and has the potential to impact survival beyond the post-operative period.

“SMART has achieved the best results in a large prospective surgical trial for malignant pleural mesothelioma in terms of overall survival,” wrote the investigators. “However, SMART requires surgical and radiation expertise to achieve optimal results and should not be adopted outside of expert centres with substantial surgical experience.”

The studied population included 96 eligible patients treated with SMART on protocol between November 1, 2008, and October 31, 2019. After completion of intensity modulated radiotherapy, extrapleural pneumonectomy was conducted at a median of 5 days (range 2-12 days).

Looking at the adverse events profile, 47 (49%) patients had 30-day perioperative grade 3/4 events, with 1 patient dying within 30 days of a grade 5 pneumonia.

The 5-year cumulative incidence of local and distant recurrence was 17 (20.1%; 95% CI, 11.4-28.8) and 62 (63.3%; 95% CI, 52.3-74.4), respectively, after a median follow-up of 46.8 months (interquartile range, 13.4-61.2). Specifically, the contralateral chest (46%) and the peritoneal cavity (44%) were recorded as the most common first sites of recurrences in 72 patients.

“The results emphasise the importance of patient selection. [Thirty]­day grade 4 complications are an independent factor affecting long­term survival after extrapleural pneumonectomy, even though most patients survived their complications,” wrote the investigators. “Although careful patient evaluation and selection for extrapleural pneumonectomy is obvious, the detrimental effects of grade 4 complications on overall survival had not been reported previously, and might explain the variable outcomes between surgical series.”

This single-center, phase 2 trial (NCT00797719) recruited patients 18 years or older with an ECOG performance status of 2 or less and resectable cT1–3N0M0 disease with previously untreated malignant pleural mesothelioma.

The primary end point of the study was feasibility defined as the “number of patients with 30-day perioperative treatment-related death (grade 5 events) or morbidity (grade 3 or 4 events).” The main secondary end point of the study was the cumulative incidence of distant recurrence.

A main limitation of this research included the lack of quality-of-life data collected. More, the research team admits that their analysis of grade 4 toxicities from randomization is better suited as a landmark analysis 30 days after.

“Despite these results, extrapleural pneumonectomy has not been widely adopted,” wrote the investigators. “SMART remains an outlier; other studies have not consistently shown a similar survival advantage with extrapleural pneumonectomy.”

Cho BCJ, Donahoe L, Bradbury PA, et al. Surgery for malignant pleural mesothelioma after radiotherapy (SMART): final results from a single-centre, phase 2 trial. 

 2021;22(2):190-197. doi:10.1016/ S1470-2045(20)30606-9

Data published in The Lancet Oncology investigating patients with malignant pleural mesothelioma determined that surgery for mesothelioma after radiotherapy, or SMART, can produce positive early- and long-term effects.