Background

We aimed to determine the associations of pre-existing CVD with administration of cancer treatments and survival outcomes in older patients with breast cancer.

Methods

Patients aged ≥ 65 years who were diagnosed with breast cancer from 2004 to 2015 in a large Canadian province were identified from population-based registry. Patients were categorized as old (65-74 years), older (75-84 years) and oldest (≥ 85 years). Multivariable logistic and Cox regression analyses were performed to identify associations of CVD with cancer treatment and to determine its effect on overall survival (OS).

Results

We identified 9,682 patients with breast cancer and the median age was 73 years. Of these, 54.3% were old, 32.9% were older, and 12.8% were oldest. While early breast cancer was diagnosed in 70.4%, 24.0% and 5.6% had locally advanced and metastatic disease. The prevalence of pre-existing CVD was 21.5% and increased with advancing age (13.2% in old patients vs. 40.9% in oldest patients; P<0.001). On multivariable logistic regression, CVD was associated with lower odds of receiving appropriate chemotherapy (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.42-0.68; P < .0001) and radiotherapy (OR, 0.67; 95% CI, 0.57-0.78; P < .0001), but not surgery (OR, 0.89; 95% CI, 0.76-1.04; P =0.155). The 5-year OS was lower in patients with baseline CVD as compared to those without (77.9% vs 49.8%, P <0.001). Upon adjusting for stage and treatment, CVD continued to correlate with worse survival (hazard ratio, 1.58; 95% CI, 1.46-1.71; P < .0001). The 5-year OS of the old, older, and oldest patients were 84.3%, 67.0% and 35.4%, respectively. Table: 1811MO

Conclusions

Older patients with breast cancer and pre-existing CVD are less likely to receive chemotherapy and radiotherapy. The OS of patients with baseline CVD was worse even among those who received treatment. Early cardio-oncology involvement in advanced age patients should be an integral part of cancer management to improve their outcomes.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Treatment with adjuvant endocrine therapy (ET) in patients with breast cancer (BC) increases the risk of becoming less physically active and weight gain. A high body mass index (BMI) and physical inactivity are both independently associated with a higher risk of cancer-related side-effects and mortality. Effects of oncologic rehabilitation on physical activity (PA) in this specific patient population is unknown. This study investigated whether oncologic rehabilitation increased PA in patients receiving adjuvant ET for BC.

Methods

Eligible patients for this multicenter, prospective clinical trial were female, aged 18-75, receiving adjuvant ET for BC, and with a BMI ≥ 25 (NCT02424292). All patients attended a 12-week moderate-intensity aerobic- and resistance exercise program. Moderate to vigorous PA (MVPA) was measured by an accelerometer at baseline (T0), after 12 and 26 weeks (T1 and T2). Primary endpoint was change in proportion of patients with weekly ≥ 150 minutes of MVPA (national guideline recommendations), at T1 compared to T0. Secondary endpoints were metabolic syndrome (MetS), body composition, health-related quality of life (HRQoL) and breast cancer-specific functioning and symptoms (EORTC QLQ-C30 and QLQ-BR23), self-reported PA (PASE), self-efficacy (ALCOS), exercise motivation (PACE) and overall satisfaction with life.

Results

In total, 141 patients with a median age of 61 yrs [54-66] and mean BMI of 31.3 ± 4.4 participated. Proportion of patients with weekly ≥ 150 minutes of MVPA increased from 38.6% at T0, to 48.7% at T1 and 56.3% at T2 [χ²(2) = 8.977, p = .011]. Moreover, MetS, body composition and symptoms (i.e. fatigue) significantly decreased while HRQoL, functioning, self-reported PA, self-efficacy, exercise motivation and satisfaction with life all increased significantly at T1 and T2 compared to T0.

Conclusions

Oncologic rehabilitation significantly increased PA and HRQoL in overweight or obese BC patients, receiving adjuvant ET. Furthermore, MetS, body composition and fatigue significantly decreased. Our findings highlight the beneficial effect of oncologic rehabilitation in these patients, who are particularly vulnerable for poor health outcome.

Clinical trial identification

NCT02424292.

Legal entity responsible for the study

The authors.

Funding

Supported by the Dutch Pink Ribbon foundation (grant number 2011.WO43.C116).

Disclosure

All authors have declared no conflicts of interest.

Background

Unplanned readmission in the first 30 days after discharge is an important medical problem and regarded as a quality indicator. However, data on readmissions in oncology services is still limited. So, we planned to evaluate the rates and causes of early readmissions and the predisposing factors in our institution.

Methods

Patients who were hospitalized in Hacettepe University Oncology services between 01.08.2018-31.07.2019 were included. The patients' demographic features, tumor stages, regularly used drugs, comorbidities, last complete blood count and biochemistry parameters, presence and reasons for readmissions in the first 30 days after discharge were recorded. The predisposing features were evaluated with univariate and multivariate analyses.

Results

A total of 562 hospitalizations were included in the analyses. The median age of the patients was 61 (19-96). Almost two-thirds of the hospitalizations were due to symptom palliation and infections. 83% of the patients had advanced disease and over 60% had an ECOG performance score of 2 and above. In the first 30 days after discharge, 127 patients were readmitted to the hospital (22.6%). Of these readmissions, 56 (44.1%) were direct to inpatient service, 61 (48%) were to the emergency department, and 10 (7.9%) were intensive care hospitalizations. In 39 patients (30.7%), the reason for first hospitalization and readmission was the same. Advanced stage disease (stage 4 vs 1-3), presence of polypharmacy (5 or more regular drugs), emergency hospitalization (emergency vs. ambulatory), and hypoalbuminemia (<3 gr/dL) were associated with a statistically significant increase in the risk of readmission. Among these factors, advanced-stage disease (HR: 2.847, 95% CI: 1.375-5.895), emergency hospitalization (HR: 1.832, 95% CI: 1.208-2.777), and polypharmacy (HR: 1.782, 95% CI: 1.173-2.706) remained significant in multivariate analyses.

Conclusions

In this study, 22% of the oncology patients had readmission in the first 30 days after discharge. The readmission risk increased significantly in patients with advanced disease, emergency hospitalization, and polypharmacy. The optimal post-discharge plan may reduce readmissions in all oncology patients, with priority for these patient groups.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Cancer cachexia, characterized by systemic inflammation and muscle wasting, have been associated with poor survival in non-small-cell lung cancer (NSCLC) patients (pts). We hypothesized whether neutrophil-to-lymphocyte ratio (NLR) and the intramuscular adipose tissue/skeletal muscle index (IMAC/SMI) are associated with prognosis in metastatic NSCLC (mNSCLC). We also considered the quality of life (QoL) assessed via the EORTC-QLQ-CAX24 questionnaire on the prognosis of mNSCLC.

Methods

We analyzed a prospective cohort study (Apr/2017 to May/2020) of pts diagnosed with histologically-proven, treatment-naive, mNSCLC. After signed informed consent, we evaluated pts about demographic features and QoL using the EORTC-QLQ-C30 and -CAX24 scales. We used the baseline NLR as a surrogate of systemic inflammation. IMAC/SMI was evaluated using baseline plain computed tomography imaging at the third lumbar vertebra level. To test our hypothesis that NLR and IMAC/SMI are associated with prognosis, we carried out a Cox multivariate regression and included age, gender, ECOG-PS, and histology as covariates.

Results

We collected 128 pts, median age 65 y.o. (23-86), 79 (62%) male. Lung adenocarcinoma was the predominant histology (66%). ECOG-PS was classified as 0-1 in 27 pts (21%) and 2-4 in 101 pts (79%). Median overall survival was 468, 335, 106, 59, and 20 days in pts with ECOG-PS 0, 1, 2, 3, and 4, respectively. Elevated NLR (Hazard ratio (HR) = 1.26, 95% confidence interval (CI) = [1.01 - 1.59], p=0.038), IMAC/SMI ratio (HR = 1.37, 95% CI = [1.03 - 1.84], p=0.032), and CAX24 score for food aversion (HR = 1.52, 95% CI = [1.13 - 2.03], p=0.006) were associated with worse prognosis in mNSCLC. Indeed, higher ECOG-PS (Spearman rho=0.208, p=0.027), CAX24 scores for food aversion (rho=0.197, p=0.036), loss of control (rho=0.212, p=0.024), and eating and weight loss worry domains (rho=0.219, p=0.020) were associated with elevated NLR levels.

Conclusions

Elevated NLR, IMAC/SMA ratio, and CAX24 score for food aversion are independently associated with worse survival in mNSCLC. These data underscore the importance of cachexia features as negative prognostic factors in mNSCLC.

Clinical trial identification

NCT03960034.

Legal entity responsible for the study

The authors.

Funding

FAPESP grants 2015/22814-5 and 2016/20187-6.

Disclosure

All authors have declared no conflicts of interest.

Background

The use of aprepitant as an add-on prophylactic agent has been shown to improve chemotherapy-induced vomiting (CIV) in children receiving highly emetogenic chemotherapy. Anti-emetic prophylaxis is additionally challenging during induction chemotherapy for acute myeloid leukemia (AML), where the role of aprepitant has not been formally evaluated.

Methods

A randomized, open-label trial was conducted at our centre where chemotherapy naïve children between 5-18 years with diagnosis of AML being planned for induction chemotherapy (3+7 regimen) were included. All study participants received ondansetron (0.15mg/kg) 8 hourly for 8 days starting 30min prior to chemotherapy. Children belonging to aprepitant group additionally received aprepitant capsules (15-40 kg = days 1-3, 80 mg; >40 kg = day 1, 125 mg and days 2-3, 80 mg) starting from 1 h before chemotherapy. The proportion of patients with CIV in acute phase (day 1-day 8), delayed phase (day 9-day 13) and reported adverse effects were recorded. Acute and delayed nausea was also recorded as secondary end point.

Results

Total of 78 children were randomized (37 in the aprepitant group and 41 in the control group). The proportion of participants achieving a complete response in CIV was significantly higher in the aprepitant group compared to the control group overall (51% vs 22%; p=0.007) and especially in the acute phase (59% vs 29%; p=0.007). The time to the first episode of vomiting was also significantly higher in the aprepitant group (p=0.0004). The reported adverse events were similar between the two groups. There was no difference in acute and delayed nausea.

Conclusions

The use of aprepitant as add-on prophylactic anti-emetic during induction chemotherapy for AML significantly improves CIV rate in children especially in acute phase.

Legal entity responsible for the study

Dr Atul Sharma.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

To reduce the overall exposure to DEX in cisplatin-based chemotherapy, we evaluated the non-inferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with NEPA, a fixed combination of the NK-1 receptor antagonist (RA), netupitant and the pharmacologically distinct 5-HT₃RA, palonosetron, compared with the guideline-recommended 4-day use of DEX.

Methods

In this open-label, multicenter study, chemo-naïve lung cancer patients receiving cisplatin (>=70 mg/m²), were given a single oral dose of NEPA and DEX (12 mg i.v.) prior to chemotherapy and randomized (1:1:1) to receive no further DEX (DEX1), oral DEX (4 mg once daily) on days 2 and 3 (DEX3), or oral DEX (4 mg twice daily) on days 2 to 4 (DEX4; reference arm). The primary efficacy endpoint was complete response (CR: no emesis and no use of rescue medication) during the overall (days 1-5) phase. Non-inferiority was defined as a lower 95% CI greater than the non-inferiority margin threshold of -15% difference (Arms DEX1 or DEX3 minus Arm DEX4). Impact of Chemotherapy-Induced Nausea and Vomiting (CINV) on daily life as assessed by the Functional Living Index-Emesis (FLIE) questionnaire was also evaluated.

Results

A total of 222 patients (76% male), 74 in each arm, were evaluated. CR rates during the overall and delayed phases were 77.0% in Arms DEX1 and DEX3 and 74.3% in Arm DEX4 (95% CI, -11.1% to 16.5%). No significant differences were observed between groups in proportions of patients who reported no impact on daily life due to nausea, vomiting, or both during the 5-day observation period after cisplatin administration.

Conclusions

Since efficacy results were comparable between the two DEX-sparing regimens in this study, we conclude that the simplified three-drug regimen with NEPA plus single-dose DEX is an option that is not associated with significant reduction in anti-emetic control during the 5-day period or an impact on patient functioning in the setting of cisplatin.

Clinical trial identification

NCT04201769 EudraCT Number: 2015-005704-29 Protocol Number: LUNG-NEPA.

Legal entity responsible for the study

Consorzio Oncotech.

Funding

Has not received any funding.

Disclosure

L. Celio: Advisory/Consultancy: Italfarmaco, Kyowa. D. Cortinovis: Advisory/Consultancy: Helsinn Healthcare SA. L. Cavanna: Advisory/Consultancy: AstraZeneca, Merck; Travel/Accommodation/Expenses: Celgene, Pfizer, Ipsen. R. Chiari: Speaker Bureau/Expert testimony, Conventions speaker: Roche, MSD, BMS, Astrazeneca, Pfizer. E. Bonizzoni: Advisory/Consultancy, Spot consultancy assignments by Italfarmaco and statistical consultant at Helsinn: Italfarmaco, Helsinn. S. Pilotto: Honoraria (self), Speaker Bureau/Expert testimony, S.P. received honoraria or speakers’ fee from Astra-Zeneca, BMS, Boehringer Ingelheim, MSD and Roche: Astra-Zeneca, BMS, Boehringer Ingelheim, MSD and Roche. S. De Placido: Advisory/Consultancy: GSK, Novartis, Roche, Celgene, Astrazeneca, Amgen, Eisai, Italfarmaco, Pfizer, Eli Lilly; Speaker Bureau/Expert testimony, Invited speech: GSK, Novartis, Roche, Celgene, Astrazeneca, Amgen, Pfizer, Eli Lilly. E. Bria: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, E.B. received speakers’ and travels’ fee: MSD, Astra-Zeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis and Roche; Research grant/Funding (institution), E.B. received institutional research grants: Astra-Zeneca, Roche. All other authors have declared no conflicts of interest.

Background

Chemotherapy induced nausea and vomiting (CINV) following carboplatin containing chemotherapy regimen remains a considerable problem for cancer patients (pts) despite standard antiemetic prophylaxis. This MASCC study was undertaken to prospectively evaluate the incidence of CINV in pts undergoing carboplatin-based chemotherapy receiving guidelines consistent CINV prophylaxis (GCCP). All sites did not prescribe NK1-RA as it is not included in all institutional guidelines.

Methods

The study enrolled 207 pts undergoing carboplatin-based chemotherapy, the current analysis evaluated cycle 1 of the first 155 pts. Pt diaries were used to collect data from day 1-10 beginning with cycle 1. Nausea was reported by the pts using a visual analog scale (VAS) with the end-point being no nausea. Vomiting episodes were recorded in the pts’ diaries.

Results

There were 103 females and 52 males, with a mean age of 64 (30-85). The overall incidence of acute and delayed nausea for was 17% and 25% respectively. The incidence of nausea of entire population was significantly higher than vomiting (58% vs. 14%; Chi² 22.271 p<0.000). The use of NK1-RA was associated with a significant decrease in time to first vomiting for cycle 1 (p<0.041) and subsequent cycle 2-6 (p<0.0075). Time to first nausea was not significant for cycle 1 or subsequent cycles. In a logistic regression model factors associated with acute nausea in cycle 1 included history of motion sickness (p< 0.0090), comorbidities (p< 0.0084), history of morning sickness (p< 0.0090), previous chemotherapy (p< 0.0096), anemia (p< 0.0209). A separate logistic regression analysis for delayed nausea in cycle 1 showed that prior radiotherapy (p<0.0093) and a history of morning sickness (p<0.0195) were significant.

Conclusions

Despite GCCP and the usage of NK1-RA, carboplatin induced nausea remains a major unmet medical need in cancer pts. Further research should focus on management of nausea, risk factors and the impact of nausea on quality of life and in pts undergoing carboplatin-based treatment.

Clinical trial identification

ICES.

Legal entity responsible for the study

The Medical Oncology Centre of Rosebank.

Funding

GSK (Tesaro).

Disclosure

S. Bošnjak: Honoraria (self): Helsinn; Honoraria (self): Angelini; Honoraria (self): Amicus, ; Honoraria (self): Infarm ; Honoraria (self): MSD, ; Honoraria (self): Merck; Honoraria (self): PharmaSwiss, ; Honoraria (self): Actavis. B.L. Rapoport: Research grant/Funding (self): GSK (TESARO); Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. All other authors have declared no conflicts of interest.

Background

Short-term side-effects of G-CSF were reported in EBC, including bone pain and transitory leukocytosis and thrombocytopenia. Few data exist on the long-term effects of G-CSF on quality of life and hematological toxicity.

Methods

EBC pts (stage I-III) treated with CT were identified from the prospective, longitudinal, multicenter CANTO cohort (NCT01993498). PRO data (EORTC QLQ-C30/BR23) and blood cell counts were obtained at diagnosis (baseline) and at year (Y)1, Y2, and Y4 after diagnosis. Our primary outcome was QLQ-C30 pain score. Exploratory outcomes included all QLQ domains, C30 summary score (Husson O, 2020), leucocyte and platelet count. The independent variable was G-CSF use. Multivariable mixed models examined associations of G-CSF use with outcomes.

Results

Among 2926 pts included from 2012-15, 49% (n=1427) used G-CSF and 51% (n=1499) did not. Baseline mean age was 53 years (SD=11), >80% pts received non dose-dense anthracyclines + taxanes regimens. Pts receiving G-CSF were older, had higher stage BC and worse baseline PRO (Table). Over time, pain score was not statistically different between groups (adjusted overall mean difference [adjMD] vs no-use [95% CI]: +1.32 [-0.28 to +2.92]). Consistently, remaining PRO were substantially similar between groups, including summary score (adjMD vs no-use [95% CI]: -1.04 [-2.01 to -0.08]). PRO had a differential longitudinal evolution between groups, with slightly worse scores at Y4 among pts receiving G-CSF, of trivial clinical significance (Table). No major differences were observed in leucocyte or platelet count (adjMD vs no-use [95% CI]: -280/mm³ [-393 to -167/mm³] and -133/mm³ [-4326 to +4060/mm³], respectively). Table: 1817MO

Mean differences* (95% CI) over time in QLQ-C30 scores among pts treated with G-CSF vs not

Conclusions

This is the first large study assessing long-term and late associations of G-CSF use in EBC. G-CSF seemed overall well-tolerated, with no major clinical impact on PRO and hematologic toxicity.

Clinical trial identification

NCT01993498.

Legal entity responsible for the study

UNICANCER.

Funding

This research was supported by the French Government under the “Investment for the Future” program managed by the National Research Agency (ANR), grant n° ANR-10-COHO-0004.

Disclosure

I. Vaz-Luis: Speaker Bureau/Expert testimony: Novartis; Amgen; AstraZeneca; Kephren. A. Di Meglio: Honoraria (self): Thermo Fisher. All other authors have declared no conflicts of interest.

Background

Cancer is implicated in multiple pathways increasing thrombogenicity. Cance associated thrombosis can delay cancer treatment and results in increased mortality, morbidity, and surcharge on healthcare resources. An effective antithrombotic strategy in high-risk patients (pts) in postoperative and chemotherapy periods may improve outcome.

Methods

The Metaxas’s Hospital THromboprophylaxis program in Oncological & Surgical Patients (MeTHOS), is a prospective observational study aiming to record our thromboprophylaxis program in high-risk active cancer pts undergoing surgical and/or chemotherapy treatment. According to our program, patients receiving tinzaparin (fixed dose of 0,5 ml, 10.000 Anti-Xa IU, OD) were enrolled after signing informed consent.

Results

We report intermediate results of the MeTHOS study for 237 enrolled ambulatory pts receiving chemotherapy. There were 55% males and 45% females, with median age 67.0 years (interquartile range (IQR): 59-74 years). Primary cancers included GI 35%, lung 20%, gynecological 16%, urinary 9% and others 20%; 67% of patients had metastatic disease; 90% were receiving Highly Thrombogenic Agents (HTAs) e.g. platinum, taxanes, 5-FU and antiangiogenics; 20% had undergone surgery; 62% had a history of cardiovascular disease, 32% diabetes, 31% respiratory disease, 38% dyslipidemia and 19% prior thrombosis; 22% had central venous catheter; 27% were smokers and 40% ex-smokers. Median duration of tinzaparin administration was 6.9mo (IQR: 3.7-12.0 mo). Four pts experienced thrombotic events (1.7%, 95%CI: 0.5-4.3%, 3 DVT, 1 PE). Seven bleeding events were recorded (3.0%, 95%CI: 1.2-6.0%); 5 of them were graded as minor. Thrombotic risk was higher in patients with thrombosis history (OR: 4.2), metastatic disease (OR: 2.8) and diabetes (OR: 2.2).

Conclusions

Thromboprophylaxis with tinzaparin in active cancer pts receiving chemotherapy was safe and effective. Cancer pts may tolerate higher doses of LMWH without increasing bleeding events. A high-thrombotic burden-adapted strategy with more effective LMWH doses, could benefit high risk pts without compromising safety. Further research is needed.

Clinical trial identification

NCT04248348.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.