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The September issue of ONCOLOGY features a rare case study on glioblastoma, discussions on end-of-life care, and insights into the field of pediatric oncology. 

September ONCOLOGY Publication

Bioimpedance Spectroscopy is Allowing for Lymphedema Reduction in Breast Cancer

The use of bioimpedance spectroscopy allows clinicians to diagnose lymphedema prior to symptoms being present. This new technology, which the VCU Massey Comprehensive Cancer Center is utilizing, has been integrated into the check-in routine alongside the normal vitals. This tool will be especially useful for patients with breast cancer, as lymphedema is typically present after lymph node removal or radiation.

Patients are able to place their hands and feet on the machine, and in under 2 minutes, the results show if there is an increase of fluid in a specific limb. Prior to surgery, baseline fluid levels are collected so clinicians can determine if there has been an increase.

Kandance P. McGuire, MD, FACS, spoke with CancerNetwork® about this new technology. The results from the report will go into a patient’s electronic medical records, and clinicians will be notified about any changes and if referrals to rehabilitation services are needed.

McGuire is interim senior vice president of the Cancer Service Line and chief of breast surgery at VCU Massey Comprehensive Cancer Center.

Bioimpedance spectroscopy is the use of a small electrical signal that measures “bioimpedance”. What that means is looking at the impedance of tissue to the transit of that electrical signal from one place to another. In the early years, it was done with old school EKG leads, where the impedance was measured between the leads. Now, with new technology, it’s similar to those body composition scales you see that people use, where you are putting your bare feet on one part of the unit, and your ungloved hands on one part of the unit, and then it’s measuring the transit of that signal from your hands to your feet, vice versa. The longer it takes the signal to get from one point to the other, the more fluid there is in the body, and the more likely it is that a patient’s going to experience lymphedema.

VCU Massey now offers new technology for early detection of lymphedema. News release. December 8, 2025. Accessed December 23, 2025. https://tinyurl.com/2ktfzf5k

Videos

The use of bioimpedance spectroscopy takes under 2 minutes and can help detect lymphedema before symptoms appear. 

The mobile coaching cohort experienced significantly reduced dyspnea throughout the study period, decreased eating restriction at 6 months, and lower perceived body image by 3 months postoperatively compared with the conventional counseling group.

The implementation of early interactive human coaching via a mobile app was associated with fewer symptoms in health-related quality of life (HRQOL) scales compared with conventional counseling in patients with gastric cancer postgastrectomy, according to findings from a prospective randomized controlled trial (NCT04394585) published inthe 

Journal of Medical Internet Research (JMIR).

Of patients assigned to the mobile coaching group (n = 76), 66% were deemed active users for 8 weeks or more. No significant differences in characteristics emerged between inactive and active users except for the complication rate, which was 12% vs 0%, respectively (

= .04). Additionally, the most performed activities after 3 months in both groups included meal input (285.6 vs 26.8), messaging (79.5 vs 12.8), and body weight input (45.5 vs 5.6). A median number of total activities was 487.5 (IQR, 234.5-629.3) vs 16.0 (IQR, 2.8-82.5) in the active and inactive groups, respectively, after 3 months.

Additionally, in both groups, activity generally decreased with time. In the active user group, a median of at least 40 logs per week was recorded, and at least 30 logs were maintained until week 12. In the inactive group, fewer than 20 logs were recorded in the first week, and no records were logged after week 7.

“The applicability of the mobile app in patients postgastrectomy with gastric cancer was an important finding of this study. In previous studies, app activity was evaluated using various parameters, including the mean number of log-ins, median number of days visiting the app, and average time spent on the app, which made it difficult to summarize the results,” Bang Wool Eom, researcher at the National Cancer Center in Goyang-si, Republic of Korea, wrote in the publication with study coinvestigators. “Our study demonstrated similar app activity, with 66% (50/76) of patients whose mean age was 60.8 (SD 9.5) years using the mobile app coaching program for ≥8/12 weeks. These app activity data provide a solid foundation for planning further studies, and adherence could increase over time as people become more familiar with mobile apps.”

Regarding eating restriction scores in the conventional counseling and mobile coaching groups, no significant difference was observed, with mean values of 28.2 (SD, 19.3) and 27.9 (SD, 20.4), respectively (

= .89). Additionally, the mobile coaching cohort experienced significantly reduced dyspnea throughout the study period (

= .01), decreased eating restriction at 6 months (

= .045), and lower perceived body image by 3 months postoperatively (

= .04) compared with the conventional counseling group. Furthermore, no other significant differences in the remaining functional and symptom scales emerged between the groups.

Among 196 assessed for enrollment eligibility between May 2020 and August 2022, 180 were enrolled and were randomly assigned 1:1 to receive the mobile coaching approach (n = 89) or conventional counseling (n = 91). However, 160 patients remained after 20 were excluded due to ongoing adjuvant chemotherapy (n = 17) or withdrawal (n = 3), with 84 and 76 patients in the conventional and mobile counseling groups, respectively.

Those enrolled in conventional counseling and mobile coaching groups had a median age of 58.7 years (SD, 9.7) vs 60.8 years (SD, 9.5). Most patients in either group were male (56% vs 64.5%), and 36.9% vs 44.7% had comorbidities. The most common comorbidities included hyperlipidemia (15.5% vs 17.1%), diabetes mellitus (9.5% vs 22.4%), and hypertension (9.5% vs 3.9%).

Most patients in either group had pathological stage IA disease (79.8% vs 71.1%), distal operations (90.5% vs 90.8%), and no complications present (96.4% vs 96.1%). The median duration of hospital stay was 7 days (IQR, 7-7) and 7 days (IQR, 6-7). Tumors were most frequently located in the middle third of the gastrointestinal tract (54.8% vs 52.6%).

The primary end point of the trial was the eating restriction scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (EORTC QLQ STO22), 1 month following gastrectomy. Secondary end points included changes in QOL per EORTC QLQ Core 30 and EORTC QLQ-STO22, which evaluate the general QOL of patients with cancer and the QOL of gastric-specific patients, respectively. Other secondary end points encompassed food intake, body weight, and serum levels for up to 3 months postoperatively.

Eom BW, Han M, Yoon HM, et al. Improvement in quality of life after early interactive human coaching via a mobile app in postgastrectomy patients with gastric cancer: prospective randomized controlled trial. 

Effect of smart phone app-based human coaching program in gastrectomized patients. ClinicalTrials.gov. Updated April 13, 2025. Accessed December 24, 2025. https://tinyurl.com/54m46zea

Articles

Although findings did not show differences in eating restrictions 1 month following gastrectomy, the mobile intervention may help with symptom management.

Human Coaching Via Mobile App May Reduce Postgastrectomy Symptoms

"The novel mTOR inhibitor-based regimen may address the unmet need in CDK4/6 [inhibitor]-failed [HR-positive, HER2-negative] advanced breast cancer," according to the study authors.

Combining the targeted mTOR inhibitor nab-sirolimus (HB1901) with endocrine therapy exhibited promising antitumor activity and a manageable safety profile among patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer, according to data from a phase 2 trial (NCT06957379) presented in a poster session at the 

2025 San Antonio Breast Cancer Symposium (SABCS).

Among patients who received nab-sirolimus in combination with fulvestrant (Faslodex; n = 31) and exemestane (Aromasin; n = 29), the overall response rate (ORR) was 29% and 10.3%, respectively, yielding an ORR of 20% across the overall population (n = 60). In the fulvestrant and exemestane cohorts, the disease control rate (DCR) was 93.5% and 82.8%, and the clinical benefit rate (CBR) was 45.2% and 20.7%.

mutant disease (n = 11) or wild-type disease (n = 20) in the fulvestrant cohort, data showed an ORR of 27.3% and 30.0%, respectively. Partial responses (PRs) occurred in 27.3% and 30.0% of each group. Additionally, the DCRs were 100.0% and 90.0%, and the CBRs were 72.7% and 65.0%.

The 6-month progression-free survival (PFS) rates were 58.3% with nab-sirolimus plus fulvestrant compared with 39.9% with nab-sirolimus plus exemestane. In the 

 mutant and wild-type subgroups of patients who received nab-sirolimus plus fulvestrant, the 6-month PFS rates were 70.1% vs 52.6%, respectively; the median PFS in each group was 9.1 months (95% CI, 3.75-not evaluable [NE]) and 7.4 months (95% CI, 4.40-9.20).

“Nab-sirolimus exhibited manageable toxicity and promising antitumor activity, particularly when combined with fulvestrant (achieving an ORR of 29% and a median PFS of [7.4] months),” lead study author Fei Ma, from the Medical Oncology Department of China Cancer Institute and Hospital in Beijing, China, wrote with coauthors in the poster.

 “The novel mTOR inhibitor-based regimen may address the unmet need in CDK4/6 [inhibitor]-failed [HR-positive, HER2-negative] advanced breast cancer.”

In the phase 2 trial, 34 patients who progressed on prior aromatase inhibitors with or without CDK4/6 inhibitors were assigned to receive nab-sirolimus plus fulvestrant, while 31 patients who progressed on previous fulvestrant with or without CDK4/6 inhibitors received nab-sirolimus plus exemestane. All patients received nab-sirolimus at 100 mg/m

The trial’s primary end points were the 6-month PFS rate and safety. Secondary end points included PFS, ORR, CBR, and overall survival.

Patients 18 years and older with pathologically confirmed HR-positive, HER2-negative breast cancer, no more than 3 prior lines of chemotherapy for inoperable locally advanced or metastatic disease, and at least 1 measurable lesion per RECIST v1.1 criteria were eligible for enrollment on the trial.

 Other eligibility criteria included having an ECOG performance status of 0 or 1, a life expectancy of at least 3 months, and adequate organ and bone marrow function.

Across the overall population, 64.6% of patients were postmenopausal, and 46.2% received 2 prior lines of systemic therapy. Additionally, most patients had an ECOG performance status of 1 or higher (60.0%), prior CDK4/6 inhibitor therapy (98.5%), and visceral metastases (78.5%). Overall, 36.9% of patients had 

Any-grade treatment-related adverse effects (TRAEs) occurred in 98.5% of the population, with 40% experiencing grade 3 or higher events. One patient in the fulvestrant cohort discontinued study therapy due to an AE; there were no drug-related toxicities that resulted in death.

At least 1 grade 3 or higher AE occurred in 38.2% of patients in the fulvestrant cohort and 41.9% of those in the exemestane cohort. In each respective cohort, the most common grade 3 or higher toxicities included hypokalemia (23.5% vs 9.7%), hypertriglyceridemia (14.7% vs 6.5%), decreased neutrophil counts (2.9% vs 6.5%), and hyperglycemia (0% vs 6.5%).

Ma F, Zhang Q, Mo H, et al. A multicenter, open-label, phase 2 study of nab-sirolimus (HB1901) plus endocrine therapy in HR+/HER2- advanced breast cancer following standard therapy failure. Presented at: 2025 San Antonio Breast Cancer Symposium; December 9-12, 2025; San Antonio, TX. Abstract 911.

Sirolimus for injection (Albumin-bound) in combination with endocrine therapy for HR+/​HER2- advanced/​metastatic breast cancer patients who have failed standard therapy. ClinicalTrials.gov. Updated May 4, 2025. Accessed December 23, 2025. https://tinyurl.com/2rrz7zfp

Data from a phase 2 study may support a novel mTOR inhibitor-based regimen in previously treated, HR-positive, HER2-negative breast cancer.

Nab-Sirolimus Regimens Show Promise in HR+/HER2-Negative Breast Cancer

"ALIDHE is still enrolling; future analyses will focus on safety outcomes from extended follow-up, effectiveness, and quality of life," according to the study authors.

Combining ivosidenib (Tibsovo) with azacitidine (Vidaza) showed early real-world activity that was comparable with prior clinical trial results among patients with newly diagnosed 

-mutated acute myeloid leukemia (AML), according to findings from the phase 3b ALIDHE trial (NCT05907057) presented in a poster session at the 

2025 American Society of Hematology Annual Meeting and Exhibition.

Among 89 patients who received the ivosidenib combination in the ALIDHE trial, the objective response rate (ORR) was 58.4%. These responses included complete responses (CRs) in 41.6% of patients, CR with hematologic recovery (CRh) in 3.4%, CR with incomplete hematologic recovery in 7.9%, and partial responses (PRs) in 4.5%. According to the investigators, these outcomes were comparable to those reported in the phase 3 AGILE trial (NCT03173248), in which ivosidenib and azacitidine yielded an ORR of 62.5% among 72 evaluable patients.

“Preliminary findings from ALIDHE are consistent with the AGILE pivotal trial; ivosidenib [plus] azacitidine shows similar safety results, and efficacy outcomes are promising. Data from ALIDHE will enrich knowledge on safety and help translate efficacy to effectiveness, bridging the gap between clinical trials and clinical practice,” lead study author Paresh Vyas, MRCP, FRCP, FRCPath, from the MRC Molecular Haematology Unit in the Radcliffe Department of Medicine of Weatherall Institute of Molecular Medicine at the University of Oxford, wrote with coauthors in the poster.

 “ALIDHE is still enrolling; future analyses will focus on safety outcomes from extended follow-up, effectiveness, and quality of life.”

FDA previously approved ivosidenib plus azacitidine

 for patients with newly diagnosed AML harboring 

mutations in May 2022 based on data from the AGILE trial.

Investigators of the ongoing post-approval ALIDHE study are assessing the safety and efficacy of the ivosidenib combination in a real-world setting that is inclusive of all patients with 

-mutated disease who are ineligible for intensive induction chemotherapy. Patients were assigned to receive oral ivosidenib at 500 mg once daily plus azacitidine at 75 mg/m

 intravenously or subcutaneously for 7 days in each 28-day cycle.

The study’s primary end points include treatment-emergent adverse effects (TEAEs), serious AEs (SAEs), AEs of special interest, transfusion requirements, and infection rates. Secondary end points include event-free survival, responses, patient- or caregiver-reported outcomes, length of hospital stay, outpatient visits, and emergency room visits.

Patients 18 years and older with newly diagnosed, previously untreated AML harboring a documented 

R132 mutation are eligible for inclusion. Other eligibility criteria include being unsuitable to receive intensive chemotherapy and having an ECOG performance status of 0 to 2.

As of the data cutoff date of May 5, 2025, 89 patients were evaluable for safety and efficacy, with 68 (76.4%) still receiving treatment at the time of analysis. The median duration of therapy was 5.1 months (range, 0.2-14.9).

The median patient age was 75.0 years (range, 51-84), and most patients were female (57.3%). Additionally, most patients had de novo disease (58.4%) and an ECOG performance status of 1 (42.7%). Data showed that the most common 

mutation allele variants were R132C and R132H, with the most frequent co-occurring mutations being those located in genes associated with epigenetics, chromatin regulation, differentiation, and splicing. Overall, 25% of patients had at least 1 

pathway mutation; these findings were comparable to those observed in the AGILE trial.

In the AGILE trial and ALIDHE trial, respectively, any TEAEs occurred in 98.6% and 93.3% of patients, with 93.0% vs 80.9% having grade 3 or higher events. Common TEAEs in each population included neutropenia (28.2% vs 32.6%), nausea (42.3% vs 29.2%), QT prolongation (19.7% vs 23.6%), and anemia (31.0% vs 20.2%). Across both trials, safety data revealed TEAEs leading to interruption of ivosidenib/azacitidine (52.1% vs 23.6%), discontinuation of ivosidenib/azacitidine (26.8% vs 4.5%), dose reduction of ivosidenib/azacitidine (5.6% vs 1.1%), and death (14.1% vs 6.7%).

Vyas P, Recher C, Döhner H, et al. ALIDHE: An ongoing open-label phase 3b study investigating ivosidenib with azacitidine in clinical practice in adult patients with newly diagnosed mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy (IC). Presented at the 2025 American Society of Hematology Annual Meeting and Exhibition; December 6-9, 2025; Orlando, FL. Abstract 3443.

Montesinos P, Recher C, Vives S, et al. Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia. 

 2022;386(16):1519-1531. doi:10.1056/NEJMoa2117344.

Servier announces FDA approval of TIBSOVO® (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. News release. Servier. May 25, 2022. Accessed December 23, 2025. https://prn.to/3wMibQh

Data from the phase 3b ALIDHE study may enrich knowledge on ivosidenib plus azacitidine’s safety and efficacy in IDH1-mutated acute myeloid leukemia.

Ivosidenib Combo Shows Preliminary Activity in IDH1-Mutated AML

Interpreting Overall Survival and Subgroup Outcomes in MATTERHORN: Where DFLOT Shows Strength and Where Questions Remain

This segment reviews the overall survival findings from the MATERHORN trial and explores how subgroup analyses shape understanding of who may benefit most from DFLOT. The panel discusses the sustained separation of survival curves through nearly five years of follow-up and the statistically significant hazard ratio observed despite median OS not yet being reached. They highlight known challenges in interpreting subgroups with small sample sizes, such as TAP-negative disease, diffuse-type tumors, and certain demographic subsets, where confidence intervals cross 1 and definitive conclusions cannot be drawn. The conversation also considers whether biology, rather than treatment, drives poorer outcomes in diffuse subtype and how PD-L1–negative cohorts may influence regulatory decisions, particularly in regions where biomarker thresholds determine immunotherapy access. The segment further examines geographic representation, differences in practice patterns between Asian and non-Asian centers, and the importance of understanding how these variations influence results. The panel closes by reflecting on pathologic complete response rates and whether higher PCR rates meaningfully translate into long-term survival advantages within immunotherapy-based perioperative strategies.

Experts discuss the significance of event-free survival and overall survival in cancer trials, emphasizing patient quality of life and treatment decisions.

Interpreting Endpoints and Pathologic Response: Applying EFS, PCR, and Biomarkers in Perioperative Decision Making

This segment examines how event-free survival, overall survival, and pathologic response measures inform clinical interpretation of the MATTERHORN trial. The discussion begins with an overview of the study’s statistical hierarchy and alpha allocations, providing context for how efficacy signals were evaluated. The panel considers whether EFS is an appropriate primary endpoint in locally advanced, resectable disease, noting that while OS remains the definitive measure of benefit, EFS also reflects meaningful clinical outcomes by capturing recurrence, progression, and surgical complications that directly affect patient experience. The conversation then explores how pathologic complete response serves as an early indicator of favorable prognosis and can influence discussions about postoperative therapy, even though PCR does not fully replace long-term survival data. The panel describes how they counsel patients on PCR, R0 resection, and nodal status after surgery and how biomarkers, including ctDNA, PD-L1, MSI/MMR, HER2, and CLDN18.2, may eventually guide duration of adjuvant immunotherapy. The segment highlights ongoing uncertainty about whether all patients require a full year of postoperative treatment, especially those with deep responses or toxicity concerns.

Experts discuss the significance of event-free survival and overall survival in cancer trials, emphasizing the importance of patient quality of life.