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1.
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

2.
Clinical Cancer Research ; 26(18 SUPPL), 2020.
Article in English | EMBASE | ID: covidwho-992049

ABSTRACT

The National Cancer Institute (NCI) has a large portfolio of ongoing cancer clinical trials that involve biospecimencollection and are supported by the NCI-funded National Clinical Trials Network (NCTN) Biospecimen Banks locatedacross the United States and Canada. At the start of the COVID-19 pandemic, NCTN biobanks rapidly responded tostaffing consequences of state- and institution-issued stay-at-home orders. Many of the NCTN biobanks weredeemed essential by their institutions, allowing for limited and/or socially distanced operations. NCTN biobanksquickly worked with NCI and their respective groups to advise participating sites of changes to usual biospecimencollection procedures in order to accommodate limited staffing at the biobanks. In many instances, participating sites were navigating their own institutional process change due to the pandemic. NCTN cancer clinical trials experiencedan approximate 40% decrease in enrollment from March 11 to May 19, 2020, compared to the same time frame in2019. Likewise, NCTN biobanks saw an approximate 40% and 60% decrease in biospecimen receipt anddistribution, respectively. The decrease in biospecimen receipt was likely due to two factors: (1) participating siteCOVID-19 policies limiting patient enrollment on NCI cancer clinical trials and/or biospecimen collection for thosetrials, and (2) NCTN biobank requests for participating sites to hold nonurgent and/or nonmandatory biospecimensduring the initial phase of the pandemic. Decrease in biospecimen distributions was mainly due to receivinglaboratory closures as dictated by their institutional COVID-19 policies. On May 20, 2020, all states had begun initialreopening phases to some extent. At this time, several, but not all, NCTN biobanks had begun measured return tofull operations, following institutional guidance. NCTN biobanks are making numerous considerations towardreturning to full operations and will continue to work with NCI and their respective groups to responsibly collect anddistribute biospecimens collected during the COVID-19 pandemic. Likely, some patients enrolled on NCTN cancerclinical trials may have had clinical or subclinical COVID-19 at the time of biospecimen collection. Additionally, biospecimens will be collected on two recently activated NCI COVID-19 studies: (1) the NCI COVID-19 in CancerPatients Study (NCCAPS): A Longitudinal Natural History Study ( NCT04387656 ), and (2) a tocilizumab treatmenttrial for COVID-19-related acute respiratory distress syndrome in cancer patients ( NCT04370834 ). Retrospectiveannotation of these biospecimens may provide a unique resource for translational research efforts and will also be aneeded caveat for interpreting biomarker studies conducted using these biospecimens, as the impact of COVID-19on various biomarkers is currently unknown.

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