- Cheung Yin Ting (Hong Kong, Hong Kong PRC)
332MO - Comparison of NEPA-based versus olanzapine/aprepitant-based antiemetic regimen for Chinese breast cancer patients undergoing highly emetogenic chemotherapy (ID 163)
- Winnie Yeo (Shatin, Hong Kong PRC)
Abstract
Background
Chemotherapy-induced nausea and vomiting (CINV) is a major concern for patients receiving highly emetogenic doxorubicin and cyclophosphamide (AC) chemotherapy. Recommended antiemetic regimens incorporate neurokinin-1 receptor antagonist, 5-hydroxytryptamine type-3 receptor antagonist, corticosteroid and dopamine antagonist. The present post-hoc analyses compared 2 treatment groups of patients who were enrolled into two recently reported prospective antiemetic studies. The objectives were to compare the effectiveness of emesis control using olanzapine- versus NEPA-containing antiemetic regimens in the first cycle of AC.
Methods
Data from 120 Chinese breast cancer patients who underwent AC were included in this analysis. They were categorized into olanzapine group (aprepitant/ondansetron/dexamethasone/olanzapine) and NEPA group (NEPA [consisted of netupitant/palonosetron]/dexamethasone). Individuals filled in self-reported diaries that recorded CINV and the functional living index – emesis (FLIE) questionnaire for quality of life (QOL) assessment.
Results
During cycle 1 AC, there were no differences in complete response, complete protection and total control between the 2 groups. In the acute phase, the only significant finding was a higher rate of ‘no use of rescue therapy' in the olanzapine group (olanzapine vs NEPA: 96.7% vs 85%, p = 0.0225). In the delayed phase, no differences were found for all studied parameters. In the overall phase, there were significantly higher rates of 'no use of rescue therapy' (91.7% vs 78.6%, p = 0.0244) as well as 'no significant nausea' (91.7% vs 78.3%, p = 0.0408) in the olanzapine group. There were no significant differences in QOL between the 2 groups.
Conclusions
The results support olanzapine may be more efficacious for control of nausea. However, this analysis cannot conclusively support the superiority of either the olanzapine-based regimen or the NEPA-based regimen in terms of antiemetic efficacy or quality of life in a clinical setting of breast cancer patients who were undergoing AC.
Clinical trial identification
NCT03386617 and NCT03079219 respectively.
Legal entity responsible for the study
Chinese University of Hong Kong.
Funding
Madam Diana Hon Fun Kong Donation for Cancer Research and Mundipharma.
Disclosure
W. Yeo: Honoraria (self): Mundipharma. All other authors have declared no conflicts of interest.
333MO - Cost-utility analysis of olanzapine in Japanese patients treated with cisplatin-containing highly emetogenic chemotherapy (ID 188)
- Yu Kondo (Toyota, Japan)
Abstract
Background
Olanzapine has been shown to have an additive effect on triple antiemetic therapy consisting of aprepitant, palonosetron, and dexamethasone in cisplatin-containing highly emetogenic chemotherapy. Although olanzapine may be cost-effective compared with aprepitant or palonosetron because of its low prices, its cost-effectiveness has not been analyzed. We conducted cost-utility analysis to evaluate the cost-effectiveness of olanzapine in Japan.
Methods
We simulated model patients treated with cisplatin-containing highly emetogenic chemotherapy and developed a decision analytical model of patients receiving olanzapine plus triple antiemetic therapy or only triple antiemetic therapy. The costs, probabilities, and incremental cost-effectiveness ratio (ICER) of each treatment were calculated from health insurers’ perspectives, and the ICER threshold was set at 50,000 US dollars (USD) per quality-adjusted life-years (QALYs). The costs calculated in Japanese yen (JPY) were converted to USD; 1 USD = 109 JPY. In the base case analysis, the cost of olanzapine per 5-mg tablet was set at 1.54 USD based on the National Health Insurance Drug Price Standard listed in 2019. The probabilities, utility scores, and other costs were obtained from published sources. The robustness of this model was validated by probabilistic sensitivity analysis and one-way sensitivity analysis.
Results
The ICER was calculated to be 4,478 USD/QALY, which was below the threshold. Under our conditions, the probabilistic sensitivity analysis revealed a 100% probability that olanzapine was cost-effective. In one-way sensitivity analysis, if the cost of olanzapine was less than 13.38 USD, the ICER would be below the threshold.
Conclusions
Olanzapine is very cost-effective in Japanese patients treated with cisplatin-containing highly emetogenic chemotherapy. Although it is necessary to pay attention to adverse effects such as hyperglycemia and QT prolongation, it is considered that olanzapine may be recommended, not only in terms of its effects, but also from a cost-effectiveness perspective.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant abstracts 332MO and 333MO (ID 1101)
- Manit Sae-Teaw (Ubon Ratchathani, Thailand)
LIVE Q&A (ID 1102)
- Cheung Yin Ting (Hong Kong, Hong Kong PRC)
290MO - Patient controlled analgesia (PCA) versus non-pca intravenous hydromorphone for severe cancer pain: Update from a multi-center, phase III randomized trial, HMORCT09-1 (ID 413)
- Rongbo Lin (Fuzhou, Fujian, China)
Abstract
Background
HMORCT09-1 trial was submitted in ASCO 2020 as a poster. The result confirmed that PCA titration of IV hydromorphone provides quicker analgesic effect, higher patients satisfaction, and a similar tolerability as compared to non-PCA administration among patients with severe cancer pain. We present the change of cancer symptoms with Edmonton Symptom Assessment System (ESAS) after 24 hrs IV titration of PCA or non-PCA.
Methods
Patients with persistent severe cancer pain (NRS ≥7/10 at rest) were randomized into PCA or non-PCA arm. For both arms, the dosage was 10-20% of the total equianalgesic of the last 24h with opioid tolerance patients and, 0.5 mg among opioid naïve patients. The PCA mode was set at 15 minutes intervals without continuous dose. For non-PCA arm, the hydromorphone was administrated IV by clinicians/nurses at 15 minutes interval. Reassess pain at 15 minutes for all patients. The dose of hydromorphone was increased by 50%-100% if pain unchanged or increased; continuing the same dosage if NRS was 4-6, or continue at current dose as needed if NRS≤3. The primary endpoint was the time to successful titration (TST) – time from start to the time of pain controlled at NRS ≤ 3 in two consecutive evaluation with 15-min intervals. The ESAS scores were assessed at baseline and 24 hrs.
Results
Among 214 patients (PCA=106; non-PCA=108), median TST was 0.50h (PCA) and 0.79h (non-PCA) (HR 1.64, 95% CI 1.23, 2.17, P=0.001). At baseline, median [IQR] overall ESAS score was 36 [34, 38] in the PCA arm and 37 [34, 39] in the non-PCA arm (P=0.154). At hour 24, PCA arm was 25 [16, 29]) and non-PCA arm was 26 [19, 35], P=0.096. After 24h titration, overall ESAS scores significantly decreased in both arms. At baseline, pain items of ESAS were not statistically significant different between PCA and non-PCA arm (median [IQR] was 8 [7, 8] vs 8 [7, 8], p=0.419). At hour 24, there is a trend toward significant decline in pain scores for the PCA vs non-PCA arm (median [IQR] 2 [2, 2] vs 2 [2, 5], p=0.060).
Conclusions
IV hydromorphone titration can improve symptoms of patients with severe cancer pain regardless of PCA or non-PCA administration.
Clinical trial identification
NCT03375515.
Legal entity responsible for the study
Rongbo Lin.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
334MO - Haemoglobin, body mass index and age as risk-factors for paclitaxel- and oxaliplatin-induced peripheral neuropathy (ID 930)
- David Mizrahi (Kogarah, Australia)
Abstract
Background
Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting and debilitating side-effect of neurotoxic cancer treatments including taxanes and platinum agents. Limited knowledge exists of potential pre-chemotherapy biomarkers which may be associated with the development of CIPN.
Methods
Comprehensive neuropathy assessments were undertaken cross-sectionally in patients 3-12 months post-paclitaxel or oxaliplatin. CIPN was objectively assessed using composite neurological grading scales, nerve conduction studies, clinical grading scale, patient-reported outcomes, fine-motor skills and sensory function. Post-treatment CIPN severity was compared with blood-based biomarkers within 30 days prior to commencing chemotherapy. Independent samples t-tests with post-hoc Bonferroni correction were used to compare CIPN between patients according to blood-based biomarker normative ranges, with significance adjusted to p<0.006. Linear regression was used to identify blood-based and clinical biomarker associations with CIPN development.
Results
333 participants were recruited (n=228 paclitaxel, n=105 oxaliplatin; 80% female, mean age=57.6±12.3 years). The majority of participants had ≥grade 1 CIPN (73%). Participants with low haemoglobin pre-treatment had worse CIPN post-treatment (composite grading scale; p=0.002, grooved pegboard p=0.005, grating orientation task p=0.03, two-point discrimination p=0.012), with no other impairments outside blood-based normative ranges impacting CIPN. A multivariable model predicting worse CIPN was significant (F(4,326)=18.5, p<0.0001, r2=0.19) including lower haemoglobin (B=-0.04, 95% CI=-0.07--0.02, p=0.001), higher BMI (B=0.07, 95% CI=0.02-0.12, p=0.007), older age (B=0.08, 95% CI=0.06-0.11, p<0.001) and female sex (B=-0.96, 95% CI=-1.76--0.16, p=0.02).
Conclusions
Patients with low pre-treatment haemoglobin, higher BMI, and older age are more likely to develop paclitaxel- or oxaliplatin-induced CIPN post-treatment. Future research should investigate prospectively whether correcting haemoglobin and BMI mitigates CIPN development.
Legal entity responsible for the study
The authors.
Funding
Cancer Institute NSW Program Grant (14/TPG/1-05) National Health and Medical Research Council of Australia (NHMRC) Project Grant (no. 1080521).
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant abstracts 290MO and 334MO (ID 1103)
- Kimberley Alexander (Brisbane, Australia)
LIVE Q&A (ID 1104)
- Cheung Yin Ting (Hong Kong, Hong Kong PRC)
335MO - Intervention combining nurse navigators (NNs) and a mobile application vs standard of care (SOC) in neuro-oncology patients (pts) treated with oral anticancer agents (OAA): A subgroup analysis of CAPRI, a single-center, randomized phase III trial (ID 970)
- Adeline Duflot-Boukobza (Villejuif, France)
Abstract
Background
Oral treatments are standards in neuro-oncology (e.g. temozolomide-based). Adherence issues are particularly relevant in this setting due to possible concomitant cognitive impairment and discontinuous treatment schedules. In this context, efforts to better manage oral anticancer agents (OAA) are needed.
Methods
We did a randomized phase III trial comparing an intervention combining nurse navigators (NNs) and a mobile application vs. standard-of-care (SOC) in adult cancer pts treated with OAA in our tertiary cancer center. Patients (pts) initiating OAA (all cancers, PS < 3, life expectancy > 6 months) were randomized in a 1:1 basis. NNs provided regular phone follow-ups to manage symptoms and assess toxicities, adherence and supportive care needs. Pts had access to a mobile application to record tracking data and contact NNs via secure messaging or a dedicated phone line. The intervention lasted 6 months. The primary endpoint was the Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response and survival, quality of life, pt experience (PACIC Score), end-of-life support, and economic estimation of the use of healthcare resources. We herein present a subgroup analysis of the neuro- oncology population.
Results
From October 2016 to May 2019, 51 patients (63% high-grade glioblastoma) were included (26 were randomized in the intervention arm) and 98% received temozolomide. RDI was significantly higher in the intervention arm (105%±0.12 vs 97.6% ±0.13, p = 0.04). The intervention also significantly decreased visits to the emergency room and subsequent hospitalizations, and improved pt experience and use of supportive care resources (all p-values < 0.05). No difference was seen in treatment-related toxicity in both arms.
Conclusions
Compared to SOC, the CAPRI intervention improved RDI, pt experience and emergency admissions. This intervention became a standard in our institution for neuro-oncology pts and deserves larger-scale investigations in neuro-oncology pts.
Legal entity responsible for the study
The authors.
Funding
French National Research Agency, Philanthropia Lombard Odier Foundation, Novartis and AstraZeneca. The funding bodies were not involved in the study design.
Disclosure
F. Lemare: Full/Part-time employment: AstraZeneca. O. Mir: Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli-Lilly; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Ipsen; Advisory/Consultancy: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Servier; Shareholder/Stockholder/Stock options: Transgene; Advisory/Consultancy: Servier. All other authors have declared no conflicts of interest.
291MO - Coping strategies and performance status among patients with advanced cancer in Indonesia (ID 733)
- Nurul Huda (Pekanbaru, Indonesia)
Abstract
Background
Performance status among patients with advanced cancer may impact significantly on their prognosis, quality of life, and survival. Proper coping strategies may optimalize performance status among patients with advanced cancer. The purposes of this study were to explore the coping strategies used by patients with advanced cancer in Indonesia. In addition, the determinants of performance status, including sociodemoghraphic and clinical characteristics, as well as coping strategies, were also examined.
Methods
This cross-sectional study collected demographic data, clinical characteristic and coping measurements from 440 patients with advanced cancer in Indonesia. The Brief Cope Inventory was used to assess coping strategies which can be classified into Problem Focused Coping (PFC) and Emotional Focused Coping (EFC). The Karnofsky Performance Scale was used to assess the Performance status. Descriptive analysis, Mann-Whitney U test, Kruskal-Wallis test, and multiple linear regression with stepwise method were used to analyze the data.
Results
The 3 most often used coping strategies were religion followed by emotional support and acceptance. PFC was asscociated with stage of diseases and time of diagnosis. EFC did not related to any demoghraphic variable and clinical characteristic. The determinants of functional status were higher education and PFC. Subjects who reported a higher education and higher EFC score were associated with better performance status. however, higher PFC score was found to be negatively related to performance status.
Conclusions
Patients with advanced cancer in Indonesia predominantly used PFC particularly religion coping strategy. Proper interventions to optimize performance status for patients with advanced cancer should be incorprating appropriate type of coping strategies and identifying related factors in Indonesia taking into account possible culture characteristics such as religion.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant abstracts 335MO and 291MO (ID 1105)
- Cho Lee Wong (Sha Tin, Hong Kong PRC)
LIVE Q&A (ID 1106)
- Cheung Yin Ting (Hong Kong, Hong Kong PRC)