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Niels Reinmuth
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P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)
- Event: WCLC 2020
- Type: Posters
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P09.18 - COVID-19 Outcomes in Patients With Thoracic Malignancies According to Gender and Ethnicity (TERAVOLT) (ID 3702)
00:00 - 00:00 | Author(s): Niels Reinmuth
- Abstract
Introduction
Previously reported data on patients with thoracic malignancies who develop COVID-19 have suggested a higher mortality rate compared to the general population and to other cancer types, particularly in patients over 65 years of age or suffering from active or progressive disease. Preliminary data from other studies have suggested that gender and ethnicity may also impact patient outcomes.
Methods
TERAVOLT is a multi-center, international observational study composed of a cross-sectional component and a longitudinal cohort component. Eligibility criteria include the presence of any thoracic cancer and a COVID-19 diagnosis confirmed in the laboratory with RT-PCR/serology, highly suspicious radiological and clinical findings, or suspected with symptoms and known contact with a positive person. The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus. Clinical outcomes including hospitalization, ICU admission, oxygen requirement and mortality were collected. The association between demographic/clinical characteristics and outcomes were measured with odds ratio with 95% confidence intervals using a logistic regression model.
Results
As of August 20, 2020, a total of 1,053 patients with COVID-19 and thoracic cancers from 19 countries and 130 centers have been identified, including 42% females and 84% White, 9.3% African American, 25% Hispanic. The median age of male patients was 69 compared to 66 years of age for females. While ECOG PS was similar between treatment groups, 77% of males were admitted to hospital with a mortality rate of 37% compared to 66% of females with a mortality rate of 28%. The median age of African American patients was 66 years of age compared to 68 and 69 years of age for white and Hispanic patients, respectively; 26% of African American and 25% White patients had an ECOG PS ≥2 compared to 19% of Hispanics. A similar percentage of patients were admitted to the hospital and ICU, while the mortality rate for Hispanics was 36% compared to 34% for whites and 26% for African Americans.
Conclusion
Similar to the general population, the mortality rate of males with thoracic cancer is higher than females. Regarding ethnicity, there is a difference in the median age of African American patients compared to Whites and Hispanics. Although the severity of COVID-19 disease, as defined by hospital admission, is similar between ethnic groups, the mortality rate in Hispanics is higher. We will present a multivariate analysis of these data according to gender and ethnicity, including the impact of cancer stage, prior cancer therapy, and COVID-19 therapy on outcomes.
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P48 - Small Cell Lung Cancer/NET - Chemo - IO (ID 236)
- Event: WCLC 2020
- Type: Posters
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P48.03 - First-Line Durvalumab plus Platinum-Etoposide in ES-SCLC: Exploratory Analyses Based on Extent of Disease in CASPIAN (ID 3437)
00:00 - 00:00 | Presenting Author(s): Niels Reinmuth
- Abstract
Introduction
In the Phase 3, randomised, open-label CASPIAN study, first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved overall survival (OS) compared with EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the planned interim analysis (data cut-off: 11 March 2019): hazard ratio (HR) 0.73 (95% confidence interval [CI] 0.59–0.91; p=0.0047). This OS benefit was sustained after a median follow-up of more than 2 years (data cut-off 27 Jan 2020): HR 0.75 (95% CI 0.62‒0.91; nominal p=0.0032). Here we present post-hoc exploratory analyses at the updated data cut-off based on the extent of disease at baseline.
Methods
Treatment-naïve patients (WHO performance status 0/1) with ES-SCLC received 4 cycles of durvalumab 1500 mg + EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression (PD) or up to 6 cycles of EP q3w and optional prophylactic cranial irradiation (investigator’s discretion). Planned consolidation thoracic radiotherapy (TRT) was not permitted. The primary endpoint was OS. Progression-free survival (PFS) was a secondary endpoint. Patients with M0 or M1a classification at diagnosis were included in the thoracic-only disease subgroup and M1b in the extra-thoracic disease subgroup. Data cut-off: 27 Jan 2020.
Results
At baseline, 151 (28.1%) of 537 patients had thoracic-only disease, of whom 77 (28.7%) were in the durvalumab + EP arm and 74 (27.5%) were in the EP arm. Among 386 (71.9%) patients with any extra-thoracic disease at baseline, 191 (71.3%) were in the durvalumab + EP arm and 195 (72.5%) were in the EP arm; across both arms, the most common sites of extra-thoracic disease were liver (52.8%), adrenal gland (35.8%), bone (31.3%) and brain (13.7%). Durvalumab + EP improved OS vs EP regardless of the extent of disease (thoracic-only HR 0.73 [95% CI 0.51–1.06]; extra-thoracic HR 0.77 [0.62–0.96]); PFS was also improved with durvalumab + EP vs EP in these subgroups (HR 0.70 [95% CI 0.49–1.00] and 0.85 [0.68–1.05], respectively). Among patients with extra-thoracic disease, 52.8% in the EP arm developed new lesions at first PD vs 44.5% in the durvalumab + EP arm (EP vs durvalumab + EP: lung 14.4% vs 8.9%; liver 11.8% vs 6.8%; bone 8.7% vs 4.7%). In the thoracic-only disease subgroup, a similar proportion of patients had new lesions at first PD in the EP (36.5%) and durvalumab + EP (36.4%) arms, however more patients developed new lesions in the lung in the EP arm compared with the durvalumab + EP arm (20.3% vs 7.8%). TRT was administered concurrently with study treatment in 1.1% of all patients across both arms. TRT was administered subsequent to study treatment in a higher proportion of patients in the EP arm compared with the durvalumab + EP arm, regardless of whether patients had thoracic-only disease (31.1% vs 7.8%) or extra-thoracic disease (12.3% vs 7.3%).
Conclusion
In CASPIAN, OS and PFS were improved with durvalumab + EP vs EP, regardless of the presence or absence of extra-thoracic disease, consistent with the intention-to-treat analyses.
