Reduced SARS-CoV-2 infection and death after two doses of COVID-19 vaccines in a series of 1503 cancer patients Barrière et al. reported less effective immune responses after COVID-19 vaccination in cancer patients versus patients without cancers. 1 Cancer patients are at high risk of death from COVID-19, 2 but also develop less effective antiviral immune responses after COVID-19 or vaccination. 1,3,4 In this report we analyze the clinical efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in cancer patients receiving active cancer treatment in 1503 cancer patients receiving one or two doses of COVID-19 vaccine in the Centre Léon Bérard.From 4 January to 6 April 2021, 1503 cancer patients without previously documented COVID-19 infection [female N ¼ 735 (48.9%)], median age: 64.8 years, (range 16.7-95.4 years), under active cancer treatment received at least one dose of SARS-CoV-2 vaccine. <10% of patients refused vaccination. 1127 (74.9%), 317 (21.1%) and 59 (4%) received BNT162b2, messenger RNA (mRNA)-1273 and Chadox1 vaccines respectively as first doses, depending on availability. 1203 (80%) patients had a solid tumor and 300 (20%) had hematological malignancy, including 72 patients with chronic lymphocytic leukemia. 1081 (71.9%) had metastatic disease. 1003 (66.7%), 60 (3.9%), 245 (16.3%) and 189 (12.5%) had received cytotoxic chemotherapy, anti-CD20, radiotherapy, or surgery, respectively, in the previous 3 months.1091 (72.6%) patients received two injections of COVID-19 vaccine at a median interval of 26 days (range 13-80 days), and 412 (27.4%) received only one injection (median follow-up after the day of vaccination for this group was 43 days, range 1-130 days).With a median follow-up of 44 (range 1-130) days for the whole group of 1503 patients, 24 of the 1503 (1.5%) patients developed COVID-19 symptoms with documented SARS-CoV-2 on RT-PCR: 4/1091 (0.4%) in patients who received two doses of vaccine versus 20/412 (5%) for those who received a single dose (P < 0.0001). With a landmark analysis at 21 days after first dose, these numbers were 4/1001 (0.4%) versus 5/283 (1.7%) for patients who received two versus one dose of vaccine (P ¼ 0.016). Figure 1A and 1B show the cumulative risk of documented COVID-19 with positive RT-PCR for SARS-CoV-2. The same differences were observed when mRNA vaccines were selected (not shown). Diagnosis of RT-PCR documented SARS-CoV-2 was not correlated with age, comorbidities (e.g. diabetes, renal failure, obesity), solid or hematological malignancies (not shown).Three of the 24 (12.5%) RT-PCRþ patients died of COVID-19; 2 of 5 (40%) versus 1 of 19 (5%) patients with hematological and solid tumors, respectively (P ¼ 0.036), representing an overall mortality rate of 0.7% and 0.08% in these two groups. The overall survival within 2 months from
Background: In 2014, UNICANCER (composed of 18 French Comprehensive Cancer Centers) launched the Epidemiological Strategy and Medical Economics (ESME) program to investigate real-world data in solid tumors. Real-world data give the opportunity to assess for the activity of specific drugs outside clinical trials. Eribulin is approved for pre-treated metastatic breast cancer (MBC). Marketing authorization has been granted in France in July 2012. However few data are available regarding its efficacy in real life. We evaluated eribulin use as second and third line of chemotherapy in MBC patients from the ESME database. Methods: Data from all newly diagnosed MBC patients having initiated at least one treatment between Jan. 2008 and Dec. 2014 are included in the ESME database. Data were collected retrospectively using a clinical trial-like methodology. Primary endpoint was overall survival (OS), defined from the starting date of second or third line chemotherapy (eribulin versus other chemotherapy). Progression-free survival (PFS) was calculated as a secondary endpoint. Results: Of 16,703 MBC patients included in the ESME database, 7,412 received at least 2 lines of chemotherapy: eribulin/other chemotherapy, total 1,966/5,446, second line 363/5,446, third line 654/2,669. Depending on second or third line chemotherapy use classification, median age was 59 years (range 20-97) and 58 year (range 21 – 94), triple negative tumors accounted for 20% and 19% of cases, and median follow-up reached 26 months and 22 months respectively. Table reports median OS and PFS, according to lines and type of chemotherapy. OS eribulin (months)OS other chemotherapy (months)pPFS Eribulin (months)PFS other chemotherapy (months)pSecond line12.4 (11.3-15.1)11.8 (11.3-12.3)0.4654.1 (3.7-4.9)4.1 (4.0-4.3)0.9225Third line10.3 (9.3-11.5)7.7 (7.3-8.0)<.00013.6 (3.2-3.9)3.0 (2.9-3.2)0.0058 Supportive analyses (using a propensity score for adjustment and as a matching factor for nested case–control analyses) and sensitivity analyses will be available for full presentation at the meeting. Conclusion: In this large-scale real-life setting, MBC patients treated with third line eribulin showed an improved OS and PFS compared with those receiving another chemotherapy. The difference was not statistically significant for second line treatment. Citation Format: Jacot W, Heudel P-E, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero J-M, Eymard J-C, Petit T, Mouret-Reynier M-A, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin among metastatic breast cancer patients in the multicenter national observational ESME program [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-14-02.
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