LBA3500^ The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.
Background For many patients with resected epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC), current standard of care (SoC) is adjuvant chemotherapy; however, disease recurrence remains high. Based on positive results from ADAURA (NCT02511106), adjuvant osimertinib was approved for treatment of resected stage IB‒IIIA EGFRm NSCLC. Objective The aim was to assess the cost-effectiveness of adjuvant osimertinib in patients with resected EGFRm NSCLC. Methods A five-health-state, state-transition model with time dependency was developed to estimate lifetime (38 years) costs and survival of resected EGFRm patients treated with adjuvant osimertinib or placebo (active surveillance), with/without prior adjuvant chemotherapy, using a Canadian Public Healthcare perspective. Transitions between health states were modeled using ADAURA and FLAURA (NCT02296125) data, Canadian life tables, and real-world data (CancerLinQ Discovery ® ). The model used a ‘cure’ assumption: patients remaining disease free for 5 years after treatment completion for resectable disease were deemed ‘cured.’ Health state utility values and healthcare resource usage estimates were derived from Canadian real-world evidence. Results In the reference case, adjuvant osimertinib treatment led to a mean 3.20 additional quality-adjusted life-years (QALYs; (11.77 vs 8.57) per patient, versus active surveillance. The modeled median percentage of patients alive at 10 years was 62.5% versus 39.3%, respectively. Osimertinib was associated with mean added costs of Canadian dollars (C$)114,513 per patient and a cost/QALY (incremental cost-effectiveness ratio) of C$35,811 versus active surveillance. Model robustness was demonstrated by scenario analyses. Conclusions In this cost-effectiveness assessment, adjuvant osimertinib was cost-effective compared with active surveillance for patients with completely resected stage IB‒IIIA EGFRm NSCLC after SoC. Supplementary Information The online version contains supplementary material available at 10.1007/s41669-023-00396-0.
3600 Background: Immune checkpoint blockade has limited activity in microsatellite-stable (MSS) or mis-match repair proficient (pMMR) CRC. Recent findings suggest that immunotherapy efficacy may be modulated by the presence of liver metastases. We conducted a retrospective analysis of the Canadian Cancer Trials Group (CCTG) CO.26 study to investigate the relationship between the presence of liver metastases and activity of immune checkpoint blockade. Methods: The CCTG CO.26 study was a randomized phase II study (NCT02870920). Pts with treatment refractory CRC were randomized to durvalumab, tremelimumab and best supportive care (BSC) or BSC alone in a 2:1 fashion. Treatment consisted of durvalumab (1500 mg) q 28 days and tremelimumab (75 mg) q 28 days for the first 4 cycles. The primary endpoint was overall survival (OS) and a two-sided p-value <0.10 was considered significant. Results: Between 08/20106-06/2017, 180 pts were enrolled and 179 treated as randomized. Pt baseline characteristics were balanced between groups. With a median follow-up of 15.2 months, the median OS was 6.6 months for durvalumab and tremelimumab and 4.1 months for BSC (p = 0.07; Hazard ratio (HR): 0.72, 90% confidence interval (CI): 0.54 – 0.97). Progression free survival (PFS) was 1.8 months and 1.9 months respectively (HR 1.01, 90% CI: 0.76 – 1.34). Disease control rate (DCR) was 22.6% for durvalumab and tremelimumab and 6.6% for BSC (p = 0.006). At study entry, liver metastases were absent in 29.4% pts. Pts without liver metastases had improved OS compared to those with liver metastases, irrespective of treatments. PFS was significantly longer in those without liver metastases on durvalumab and tremelimumab (HR: 0.55, 90% CI: 0.31 – 0.97, p = 0.08, interaction p = 0.02). DCR was 49% in patients without liver metastases with durvalumab and tremelimumab, compared to 10% in those with liver metastases (Odds Ratio: 0.12, 90% CI: 0.05 – 0.26). Conclusions: Pts without liver metastases had improved OS and PFS, and higher DCR. Absence of liver metastases may be an indicator for improved efficacy of immune checkpoint blockade and should be investigated in future studies. [Table: see text]
e24043 Background: Concerns about safety and treatment interference are known barriers to COVID-19 vaccination in cancer patients. Data on safety and tolerability in this population remain scarce. One of the objectives of this study is to describe COVID-19 vaccination safety in cancer patients. Methods: Patients diagnosed with a malignancy requiring systemic treatment in the last 12 months and undergoing COVID-19 vaccination were prospectively enrolled in this single-center study. Validated questionnaires to assess vaccine-related adverse events (VRAEs) were collected; chart review identified baseline characteristics and treatments received. Descriptive statistics and logistic regressions were performed. Results: 253 questionnaires were collected from 171 patients, enrolled between May and September 2021. 130 patients were survey-eligible after the 1st dose (D1) and 185 after 2nd dose (D2). 91 questionnaires were collected after D1 (Questionnaire 1: Q1) and 162 after D2 (Questionnaire 2: Q2). Surveys couldn’t be collected due to interval > 1 month between D1 / enrollment, patients’ unavailability, withdrawal of study or death. Median age was 55 (24-87) and 62.8% were female. 58.5% had solid tumors, treated with chemotherapy (49%) or checkpoint inhibitors only (9.5%); 19.4% malignancies were treated with targeted therapies and 22.1% had hematological malignancies. Most frequent solid tumors were breast (31.3%), lung (15.9%) and gastro-intestinal (GI) (14.3%). Patients received 45.6% Pfizer/BioNTech, 52.8% Moderna and 1.6% Oxford/AstraZeneca. A combination of 2 different vaccines was administered to 11.9%. Interval between D1 and D2 was ≤30 days in 53.1%, 31-90 days in 42.6%, and 91-180 days in 4.3%. Among all patients, 84.1% developed VRAEs after a median of 2 days post-vaccine for a median of 4 days. 74.5% had local symptoms (Sx) (pain, sensitivity and/or redness at injection site and/or arm) and 65.8% had systemic Sx. Most frequent systemic Sx were fatigue, chills or myalgia (39.4%), GI (6.3%) and fever (2.9%). Most patients (90.7%) described their Sx as having no / minimal impact (Gr 1), 7.8% reported seeking medical consultation (Gr 2), and 1.5% lead to hospitalization (Gr 3) (1 cardiovascular event, 1 infection; causality with concurrent systemic treatment not excluded and 1 due to malignancy). Gr 2, but not Gr 3, VRAEs were more common after D2 (11.4% vs 2.5%, p = 0.03). 41.7% considered their Sx as a new health problem. On multivariate analysis, younger age and female sex were significantly associated with the development of any Sx (OR 1.08, p = 0.01; OR 2.92, p = 0.02, respectively) and local Sx (OR 1.04, p = 0.04; OR 2.19, p = 0.04), but not systemic Sx or new health problem. Conclusions: Patients experienced mostly minor and transient symptoms post-vaccination; few perceived these as a new health problem. COVID-19 vaccination is overall safe and well-tolerated among cancer patients.
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