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2.
Clinical Cancer Research ; 27(6 SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1816939

ABSTRACT

Background: Previous reports indicate that lung cancer patients are at an increased risk of severe COVID-19 disease and higher mortality rate compared to general population. However, prognostic factors are not yet clearly identified. The LunG canceR pAtients coVid19 Disease (GRAVID) study aimed to describe clinical characteristics, outcomes and predictors of poor prognosis in patients with lung cancer and COVID-19. Methods: In this large nationwide prospective study, medical records of lung cancer patients with COVID-19 diagnosis from 65 spanish hospitals were included. Clinical features, treatments and disease outcomes were collected. The primary endpoint was to determine any-cause mortality;secondary endpoints were hospitalization and admission at intensive care units (ICU). Risk factors of poor prognosis were identified by univariable and multivariable logistic regression models. Results: Overal, 447 patients were analysed. Mean age was 67.1 ± 9.8 years, and the majority were men (332, 74.3%) and current/former smokers (383 (85.7%). NSCLC was the most frequent cancer type (377, 84.5%), being adenocarcinoma (228, 51.0%) the predominant histology. 354 patients (79.2%) had unresectable stage III or metastatic disease, and 266 (59.5%) where receiving anticancer treatment, mostly first-line chemotherapy. 350 (78.3%) patients were hospitalized for a mean of 13.4 ± 11.4 days, 9 (2.0%) patients were admitted to ICU, and 146 (32.7%) patients died. Advanced disease and corticosteroid treatment at hospitalization were predictors of mortality. Non-terminal stage hospitalized patients with lymphocytopenia and high LDH showed an increased risk of death. Severity of COVID-19 correlated to mortality, admission at ICU and mechanical ventilation. Conclusion: With underlying comorbidities and immunocompromised status, patients with lung cancer and COVID-19 present high hospitalization and mortality rates. These outcomes, alongside the identification of prognostic factors, may inform physicians on risks and benefits for this population to provide individualized oncological care.

3.
Journal of Thoracic Oncology ; 16(10):S883-S884, 2021.
Article in English | EMBASE | ID: covidwho-1474794

ABSTRACT

Introduction: There are currently no predictive biomarkers for long-term survival after neoadjuvant chemoimmunotherapy. However, the identification of non-small lung cancer (NSCLC) patients who obtain long-term benefit from chemoimmunotherapy is essential to optimize therapies. Methods: Using samples from NADIM clinical trial (NCT03081689), in which resectable stage IIIA NSCLC patients were treated with neoadjuvant chemo-immunotherapy with nivolumab, we have evaluated the capacity of ctDNA levels before treatment initiation to predict overall survival (OS) and progression-free survival (PFS) by calculating Harrell’s C-statistic and we compare its predictive value with classical survival surrogates as the pathological response and clinical response assessed according to RECIST criteria v.1.1. The ctDNA was analyzed by NGS, using the Oncomine Pan-Cancer Cell-Free Assay™ (Thermo Fisher Scientific®). To explore the prognostic value of the amount of ctDNA at baseline, for each positive plasma sample, we calculated the sum of the mutant allele frequency (MAF) for all detected mutations. Patients who died from COVID19 were excluded from this analysis. Results: In our study, clinical responses based on RECIST criteria were not predictive for OS or PFS. On the contrary, in the multivariate analysis, patients with low ctDNA levels (<1% MAF), in the baseline sample, had significantly improved PFS and OS than patients in whom the opposite situation occurred (adjusted HR: 0.22;95%CI: 0.06-0.75;P=0.016 and adjusted HR: 0.04;95%CI: 0.00-0.45;P=0.008 for PFS and OS, respectively). The adjusted C-statistic (c) to predict PFS for ctDNA was 0.68 (95%CI: 0.51-0.84), which was superior to that of RECIST criteria (c=0.61;95%CI: 0.45-0.78) and similar to that of pathological response (c=0.68;95%CI: 0.52-0.84). Similarly, baseline ctDNA levels predicted OS (c=0.85;95%CI: 0.72-0.99) better than RECIST criteria (c=0.68;95%CI: 0.44-0.93). Conclusion: Pre-treatment ctDNA levels predicted more accurately long-term survival than radiological assessments in NADIM study and might be useful for the design of new clinical trials.

4.
Journal of Thoracic Oncology ; 16(10):S883, 2021.
Article in English | EMBASE | ID: covidwho-1474793

ABSTRACT

Introduction: Neoadjuvant chemoimmunotherapy been shown to be highly effective in resectable stage IIIA NSCLC. Now we provide long term survival data Methods: This was an open-label, multicentre, single-arm phase 2 trial in which patients with histologically or cytologically documented stage IIIA NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 and who were deemed locally to be surgically resectable by a multidisciplinary clinical team were treated with neoadjuvant intravenous paclitaxel (200 mg/m2) and carboplatin (area under curve 6;6 mg/mL per min) plus nivolumab (360 mg) on day 1 of each 21-day cycle, for three cycles before surgical resection, followed by adjuvant intravenous nivolumab monotherapy for 1 year (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months). Here we report progression-free survival (PFS) and Overall survival (OS) at 36 and 42 months, assessed in the modified intention-to-treat population (ITT), which included all patients who received neoadjuvant treatment, and in the per-protocol population (PP), which included all patients who had tumour resection and received at least one cycle of adjuvant treatment. Results: Median follow-up time was 37.9 months (95%CI: 36.7-40.7), with a 94% maturity at 36 months. Among the ITT population (N=46), 37 patients, constituting the PP population, received subsequent adjuvant therapy. Of them, 27 (58.7%) patients completed the adjuvant treatment (16 cycles), 10 (21.7%) patients received between 3 and 15 cycles of adjuvant therapy, and 9 (19.6%) patients did not receive adjuvant therapy. At the time of data cutoff (March 2021), progression disease was diagnosed in 14 patients and 9 deaths were recorded in the ITT population. Of these, three deaths corresponded to patients who did not undergo surgery and had disease progression, four deaths corresponded to patients who underwent surgery and had disease progression, and the two remaining deaths corresponded to patients who were diagnosed as being disease free but died from COVID19 infection. Notably, among patients who could not undergo surgery (N=5), one of them is still alive and with no evidence of disease. PFS at 36 and 42 months in the ITT population were 69.6% (95%CI: 54.1-80.7), in both cases. Similarly, PFS at 36 and 42 in the PP population were 81.1% (95%CI: 64.4-90.5) in both cases. The percentage of patients who were alive at 36 and 42 months in the modified ITT population were 81.86% (95% CI: 66.8-90.6) and 78.94% (95%CI: 63.1-88.6), respectively. Likewise, OS at 36 and 42 months in the PP population was 91.0% (95%CI: 74.2-97.0) and 87.3% (95%CI: 69.3-95.1), respectively. Conclusion: The efficacy of nivolumab in combination with platinum-based chemotherapy in patients with resectable stage IIIA NSCLC is clearly supported by long term survival data. Keywords: NADIM trial, neoadjuvant chemo-therapy, long term survival

5.
Journal of Clinical Oncology ; 39(15 SUPPL), 2021.
Article in English | EMBASE | ID: covidwho-1339252

ABSTRACT

Background: Patients with cancer may be more susceptible to infection and at increased risk of more severe COVID-19 disease;however, prognostic factors are not yet clearly identified. The LunG canceR pAtients coVid19 Disease (GRAVID) study aimed to describe clinical characteristics, outcomes, and predictors of poor outcome in patients with lung cancer and COVID-19. Methods: In this large nationwide study, we reviewed medical records of patients with lung cancer and confirmed COVID-19 diagnosis from 65 Spanish hospitals. Clinical features, treatments and disease outcomes were collected. The primary endpoint was to determine all-cause mortality;secondary endpoints were hospitalization and admission to intensive care units (ICU). Risk factors for poor prognosis were identified by univariate and multivariate logistic regression models. Results: Overall, 447 patients were included for analysis. Mean age was 67 1 ± 9 8 years;332 (74 3%) were men, and 383 (85 7%) current/former smokers. NSCLC was the most frequent type of cancer (377, 84 5%), consisting mainly of adenocarcinoma (228, 51 0%), and stage III metastatic or unresectable disease (354, 79 2%). Two-hundred and sixty-six (59 5%) patients were receiving anticancer treatment, mostly first-line chemotherapy. In total, 350 (78 3%) patients were hospitalized for a mean of 13 4 ± 11 4 days, nine (2 0%) patients were admitted to the ICU, and 146 (32 7%) died. Advanced disease and the use of corticosteroids to treat COVID-19 during hospitalization were predictors of mortality. Hospitalized, non-endof-life stage patients with lymphocytopenia and high LDH had an increased risk of death. Severity of COVID-19 correlated to higher mortality, ICU admission, and mechanical ventilation rates. Conclusions: Due to their underlying comorbidities and immunocompromised status, patients with lung cancer and COVID-19 show high hospitalization and mortality rates. These outcomes, alongside the identification of prognostic factors, may inform physicians on the risks and benefits in this population, in order to provide individualized oncological care.

6.
Clinical Cancer Research ; 26(18 SUPPL), 2020.
Article in English | EMBASE | ID: covidwho-992107

ABSTRACT

Background: At the last update of the TERAVOLT registry, patients with thoracic malignancies and COVID-19showed a high mortality rate (35.5% overall and 31% due to COVID-19) compared to the general population and toother solid tumors. Major determinants of mortality were age, Eastern Cooperative Oncology Group PerformanceStatus (ECOG-PS), and previous administration of chemotherapy. No cancer-specific data are available with respectto small-cell lung cancer (SCLC) and other rare thoracic malignancies. Methods: TERAVOLT is an international, multicenter observational registry launched to collect data on patients withthoracic malignancies diagnosed with COVID-19 infection. Risk factors for hospitalization and mortality wereidentified by Wilcoxon rank sum tests (continuous variables) or χ2 tests (categorical variables). Here we present thesubgroup analyses of SCLC and other rare thoracic malignancies, including malignant pleural mesothelioma (MPM), thymic carcinoma/thymoma, and carcinoid/neuroendocrine lung tumors. Results: As of June 4th, 2020, a total of 581 patients with COVID-19 and thoracic cancers have been entered;among them, 66 (11%) were SCLC, 22 (4%) were MPM, 18 (3%) were thymic carcinoma/thymoma, 12 (2%) werecarcinoid/neuroendocrine lung tumors, and 442 (76%) NSCLC;21 were an unknown type. Among SCLC patients,54% were > 65 years old, 56% were males, 98% were current/former smokers, 31% had an ECOG-PS ≥ 2, 67%had stage IV disease, 82% were on current oncologic treatment at the COVID-19 diagnosis, and 58% werereceiving chemotherapy alone or in combination with immune checkpoint inhibitors. Among other non-NSCLCpatients, 56% were > 65 years old, 56% were males, 69% were current/former smokers, 24% had an ECOG-PS ≥ 2,50% had stage IV disease, 52% were on current oncologic treatment at the COVID-19 diagnosis, and 37% werereceiving chemotherapy alone or in combination with immune checkpoint inhibitors. Overall, 79.7% of the patientsrequired hospitalization, 15.4% were admitted to an ICU, and 39.8% died (36.2% due to COVID-19). Among SCLCpatients, 74.2% required hospitalization, 14.3% were admitted to an ICU, and 42.2% died (37.5% due to COVID-19).Among SCLC patients, age > 65 years old (p=0.81), gender (p=0.71), smoking status (p=1.0), ECOG-PS ≥2(p=0.17), disease stage of IV (p=0.37), and having received chemotherapy alone or with checkpoint inhibitors(p=0.84) were not associated with mortality. Conclusions: This analysis confirmed that patients with thoracic malignancies have a high mortality and risk forhospitalization due to COVID-19 overall. SCLC patients showed the highest mortality rate among thoracic cancerpatients.

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