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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 740-740
    Abstract: 740 Background: Several inflammatory scores such as the Systemic Inflammation Response Index (SIRI), the Inflammation Index Score (IIS), and the Neutrophil Lymphocyte Ratio (NLR) have been reported to have prognostic value in PDAC with different results. We hypothesize that the KS, designed to predict the risk of cancer-associated thrombosis, may also be a surrogate marker for inflammation to be included as a relevant prognostic index for PDAC. Methods: Baseline characteristics and individual SIRI, IIS, NLR and KS indexes from 197 PDAC patients diagnosed in our center between 2019 and 2021 have been retrospectively recorded. PFS and OS (Log-rank test) have been used to compare the different scores of each index in the whole population as well as in the metastatic setting. Kruskal-Wallis test and Mann-Whitney test were also done to determine if the SIRI varies significantly between KRS values. Results: Of the 197 patients analyzed, 41 were resectable (20.8%), 54 locally advanced (27.4%) and 102 metastatic (51.8%). Patients with intermediate risk according to KS (2 points, n = 131, 66.5%) had a significantly higher median PFS (8.4 vs. 4.8 months, p = 0.03) and significantly higher OS (12.9 vs. 7.7 months, p = 0.002) than those with high-risk ( 〉 3 points, n = 66, 33.5%). The median OS for patients with low ( 〈 3,000) and high ( 〉 3,000) SIRI was 13.1 and 9.3 months respectively (p = 0.05). No significant differences were observed in PFS. In the metastatic setting, a low SIRI was significantly associated with higher OS (10.6 vs. 5.8, p = 0.016). No significant differences were observed in patients with low vs. high IIS and NLR. The Kruskal-Wallis test indicates that SIRI values vary between at least two KS values (p 〈 0.001). The Mann-Whitney test found significant differences between the SIRI values from S 2 and 3 (p = 0.002) as well as 2 and 4 (p = 0.04). SIRI values were higher in patients with KRS 〉 3 vs. 2. Conclusions: This retrospective analysis showed that patients with lower KS live longer and progress later than those with higher KS. Lower SIRI is associated with better survival in metastatic patients, being on the verge of statistical significance in the whole cohort. There is a strong correlation between SIRI and KS. In this cohort of unselected PDAC patients, KS is a prognostic factor for OS and PFS that correlates with subclinical inflammation and demonstrates to be a better predictor than other inflammatory indexes that deserves further analysis.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 66-66
    Abstract: 66 Background: Patients with mCRC harboring BRAF mutation have worse prognosis and poor outcomes. However, those who have resectable metastatic disease and undergo surgery may have better outcomes compared to those who do not. Differences in clinical characteristics are not well known and may be critical to identify patients with better prognosis. Methods: We performed a retrospective analysis of 299 patients with mCRC in a tumor registry from 2015 to 2021. We compared the clinical characteristics and survival trends of both cohorts (BRAF mutated and BRAF wild type). Furthermore, we analyzed clinical and survival features of 23 patients with BRAF mutated mCRC who received metastases resection. Results: We identified 34 patients with BRAF mutation (11.37%). Several characteristics were significantly more frequent in this group: age 〈 65 years (n = 24, OR 1.38, p = 0.03), female sex (n = 24, OR 1.74, p = 0.008), primary tumor in the right colon (n = 15, OR 1.93, p = 0.003), peritoneal carcinomatosis (n = 18, OR 2.29, p = 0.007) and increased CA19.9 levels at diagnosis (n = 18, OR 1.79, p = 0.003). They received more peritoneal surgery (n = 12, OR 4.27, p = 0.000) and less liver metastases resection (n = 7, OR 0.51, p = 0.011). Median PFS in the first line of treatment was shorter in patients with BRAF mutation (9.5 vs 12.6 months; HR 1.69; IC 95%: 1.16 – 2.45; p = 0.006); however, we did not found differences in OS. Within the 23 patients with BRAF mutated mCRC who underwent surgery (67,64%), we found significant differences compared with those without metastases surgery: primary tumor resection (n = 21, OR 2.51, p = 0.0017) and having a single metastatic location (n = 18, OR 2.04, p = 0.01). Other features were more frequent in patients who underwent surgery but did not reach statistical significance: right colon location (63.6% vs 37.5%), metachronic disease (47.8% vs 18.2%), normal CEA (50% vs 25%) and CA19.9 (45% vs 12%) at diagnosis, and receiving 3 or more lines of systemic treatment (57% vs 22%). Median PFS after metastasectomy was 14.9 months, but we found no differences between both groups. Conclusions: In our cohort, BRAF mutated mCRC patients were more frequently younger, women, had right-sided primary tumors, higher rates of peritoneal metastases and abnormal CA19.9 levels at diagnosis, including worse outcomes in terms of PFS. On the other hand, resection of the primary tumor and single metastatic location were associated with higher probability of having metastases surgery, although in this study no subsequent survival benefit was found, probably due to the small number of BRAF mutated patients analyzed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 3
    Online Resource
    Online Resource
    American Association for Cancer Research (AACR) ; 2020
    In:  Clinical Cancer Research Vol. 26, No. 18_Supplement ( 2020-09-15), p. PO-031-PO-031
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 26, No. 18_Supplement ( 2020-09-15), p. PO-031-PO-031
    Abstract: Background: Cancer patients represent a vulnerable population for COVID-19 illness. We aimed to analyze outcomes of lung cancer patients affected by COVID-19 in a tertiary hospital of a high-incidence region during the pandemic. Methods: We retrospectively collected all lung cancer patients diagnosed with COVID-19 at our institution (HGUGM; Madrid, Spain) between February 24th, 2020 to May 12th, 2020. Patients must have a confirmatory SARS-CoV-2 RT-PCR to be included in the study. Clinically suspected cases and cases with close contact to COVID-19 confirmed cases were not included if either not tested or tested negative by RT-PCR. Results: On March 4th, 2020, we confirmed our first lung cancer patient with COVID-19 in our institution. Since then, 23 lung cancer pts developed COVID-19 confirmed by SARS-CoV-2 PCR. Median age was 69 years-old (range 49-86), predominantly male (78%), with smoking history (former, 52%; current, 35%), and 87% presented comorbidities. Histology was 61% adenocarcinoma, 26% squamous cell carcinoma (SqCC), and 9% small-cell lung cancer (SCLC). Stage IV was the most commonly found (IVa 22%, IVb 39%), followed by stage III (35%) and stage I-II (4%). 70% of pts were receiving active treatment at the time of COVID-19 diagnosis (30-day window for systemic treatment, 15 days for radiation therapy): chemotherapy (n=4), immune checkpoint inhibitors (n=5), targeted therapy (n=1), thoracic chemo-radiation (n=1), and nonradical nonthoracic radiation therapy (n=6). All lung cancer patients had at least 1 COVID-19 related symptom; cough (48%), shortness of breath (48%), fever (39%), and low-grade fever (30%) were the most common COVID-19 symptoms. Time from symptoms onset to first positive SARS-CoV-2 PCR was 5.5 days (range 1-17), with 13% of cases needing a 2nd PCR to confirm diagnosis. High variability on thoracic imaging findings were found (no pneumonia, n=4; unilobar, n=1; multilobar, n=17). 87% of pts received treatment for COVID-19: hydroxychloroquine (n=20), lopinavir/ritonavir (n=17), azithromycin (n=3), interferon (n=3), and tocilizumab (n=1). In our series, hospitalization rate was 74%, and 39% of pts developed ARDS within 6 days after symptoms initiation (range 2-22 days). Only 1 patient was admitted in the ICU for VM and received tocilizumab and was discharged 42 days after admission. Case fatality rate was 35% (8/23), with 3 pts still on 30-day follow-up period. Considering only those patients with lung cancer who were actively receiving systemic therapy during the pandemic in our institution, we estimated a 4.5% incidence and a 2.1% mortality from COVID-19. Analysis of prognostic factors of mortality is under way. Conclusions: Lung cancer patients represent a vulnerable population for COVID-19, according to the high rate of hospitalization, onset of ARDS, and high mortality rate. Although larger series are needed, no differences in mortality were found by type of cancer treatment. Measures to minimize the risk of SARS-CoV-2 infection remain key to protect lung cancer patients. Citation Format: Antonio Calles, Inmaculada Aparicio, Manuel Alva, Marianela Bringas, Natalia Gutierrez, Javier Soto, Mar Galera, Rosa Alvarez. Outcomes of COVID-19 in patients with lung cancer treated in a tertiary hospital in Madrid [abstract] . In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-031.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
    detail.hit.zdb_id: 1225457-5
    detail.hit.zdb_id: 2036787-9
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  • 4
    In: Alzheimer's Research & Therapy, Springer Science and Business Media LLC, Vol. 15, No. 1 ( 2023-12-13)
    Abstract: NeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid content. NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer’s disease (AD) models. The aim of this study was to assess efficacy and safety of neuroEPO plus. Methods This was a double-blind, randomized, placebo-controlled, phase 2–3 trial involving participants ≥ 50 years of age with mild-to-moderate AD clinical syndrome. Participants were randomized in a 1:1:1 ratio to receive 0.5 or 1.0 mg of neuroEPO plus or placebo intranasally 3 times/week for 48 weeks. The primary outcome was change in the 11-item cognitive subscale of the AD Assessment Scale (ADAS-Cog11) score from baseline to 48 weeks (range, 0 to 70; higher scores indicate greater impairment). Secondary outcomes included CIBIC+, GDS, MoCA, NPI, Activities of Daily Living Scales, cerebral perfusion, and hippocampal volume. Results A total of 174 participants were enrolled and 170 were treated (57 in neuroEPO plus 0.5 mg, 56 in neuroEPO plus 1.0 mg and 57 in placebo group). Mean age, 74.0 years; 121 (71.2%) women and 85% completed the trial. The median change in ADAS-Cog11 score at 48 weeks was −3.0 (95% CI, −4.3 to −1.7) in the 0.5 mg neuroEPO plus group, −4.0 (95% CI, −5.9 to −2.1) in the 1.0 mg neuroEPO plus group and 4.0 (95% CI, 1.9 to 6.1) in the placebo group. The difference of neuroEPO plus 0.5 mg vs. placebo was 7.0 points (95% CI, 4.5–9.5) P = 0.000 and between the neuroEPO plus 1.0 mg vs. placebo was 8.0 points (95% CI, 5.2–10.8) P = 0.000. NeuroEPO plus treatment induced a statistically significant improvement in some of clinical secondary outcomes vs. placebo including CIBIC+, GDS, MoCA, NPI, and the brain perfusion. Conclusions Among participants with mild-moderate Alzheimer’s disease clinical syndrome, neuroEPO plus improved the cognitive evaluation at 48 weeks, with a very good safety profile. Larger trials are warranted to determine the efficacy and safety of neuroEPO plus in Alzheimer’s disease. Trial registration https://rpcec.sld.cu Identifier: RPCEC00000232.
    Type of Medium: Online Resource
    ISSN: 1758-9193
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2506521-X
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  • 5
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    Online Resource
    Elsevier BV ; 2020
    In:  Medicina Clínica Vol. 155, No. 1 ( 2020-07), p. 42-43
    In: Medicina Clínica, Elsevier BV, Vol. 155, No. 1 ( 2020-07), p. 42-43
    Type of Medium: Online Resource
    ISSN: 0025-7753
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 59-59
    Abstract: 59 Background: Over the last decades the incidence of EOCRC (age 50 or less) has dramatically increased, and so has the scientific interest in this field, given that clinical and molecular characteristics in these patients are not well understood, and may be critical to identify prognostic factors. Methods: We conducted a retrospective analysis of 554 patients with metastatic colorectal cancer (mCRC), analyzing the PFS and OS of 68 (12.25%) patients with EOCRC, as well as their clinical and molecular characteristics. We used a log-rank test to compare PFS and OS, and the estimate of hazard ratio (HR) between the studied groups was calculated by means of Cox proportional hazard model. We also used the exact test of Fisher to identify significant association between categoric variants, while Mann-Whitney test was applied to identify significant differences between numeric values. Results: We performed a survival analysis: those patients with EOCRC had significantly higher median PFS in first line of treatment (16.2 vs. 11.3 months, p = 0.042) and significantly higher median OS (121.5 vs. 58.1 months, p = 0.011). Several characteristics were significantly more frequent in patients with EOCRC (n=68): BMI 〈 18.5 (n = 16, OR = 1.9, p = 0.046), primary tumor site at transverse colon (n = 9, OR = 2.61, p = 0.03) and ECOG 0 (n = 32, OR = 2.21, p = 0.003). Having peritoneal metastases almost reached statistical signification (n = 17, OR = 1.82, p = 0.055). Some other characteristics were less frequent: BMI 25-30 (n = 13, OR = 0.51, p = 0.046), primary tumor site at sigmoid colon (n = 14, OR = 0.49, p = 0.038) and former-smoker status (n = 7, OR = 0.44, p = 0.048). Moreover, mean values of LDH at diagnosis were significantly higher in EOCRC patients (359 U/L vs. 280 U/L, p = 0.015). EOCRC patients received a significantly higher number of lines of chemotherapy (2.94 vs. 2.38, p = 0.027) and underwent more surgeries (2,42 vs. 1.24, p 〈 0,001) than patients with 〉 50 years. Significant differences in tumor mutational status (BRAF, KRAS, NRAS, MSI, PI3K and HER2), sex, primary tumor resection or number of metastatic sites between groups were not found. Conclusions: This retrospective analysis showed that EOCRC patients had significant higher rates of PFS in first-line treatment and OS. Moreover, EOCRC patients had more frequently BMI 〈 18.5, primary tumor located at transverse colon and ECOG 0.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 4_suppl ( 2019-02-01), p. 682-682
    Abstract: 682 Background: Prognostic and predictive factors are becoming more important in mCRC patients, and may have an impact in overall survival and in the number of lines of chemotherapy that a patient can receive. Methods: We conducted a retrospective analysis of 334 patients with mCRC. We analyzed the clinical characteristics of 113 (33.8%) mCRC patients who received ≥3 lines of chemotherapy. We apply the statistical test Chi square in order to identify significant association. Results: Several characteristics were significantly associated with receiving ≥ 3 lines of chemotherapy (n = 113): age 〈 80 years (n = 93, OR = 3.07, p = 0.001), ECOG 0-1 (n = 98, OR = 3.21, p = 0.055), primary tumor resection (n = 62, OR = 2.36, p = 0.000) and resection of metastases (n = 56, OR = 2.07, p = 0.002). Partial or complete response rate in the first line of chemotherapy was also significantly associated with receiving ≥ 3 lines of treatment (n = 65, p = 0.011). Tumor mutational status was analyzed in 333 patients: KRAS mutation was detected in 163 over 333 patients genotyped (48.9%), NRAS in 25/206 (12.1%), BRAF in 15/217 (6.9%) and PI3K in 31/213 (14.5%). In the group of patients receiving ≥ 3 lines of chemotherapy (n = 113): KRAS mutation was found in 60/113 patients (53.1%), NRAS in 5/77 (6.5 %), BRAF in 5/84 (5.9%) and PI3K in 8/80 (11.1%). Tumor mutations were not significantly associated with ≥ 3 lines of chemotherapy. No significant association was found between sex, tumor location (right [n = 33, 29.2%] or left [n = 76, 73%] ), liver or lung isolated metastases and 3 or later lines of chemotherapy. We also performed in our database a survival analysis in the 334 patients: those who received ≥3 lines of chemotherapy had significantly higher survival rates (median OS 18 m in the group of 〈 3 lines of treatment vs. 37.2 m in the group of ≥ 3 lines of chemotherapy, HR = 1,6; CI 95% 1,2-2.1; p 〈 0,001). Conclusions: This retrospective analysis showed that mCRC patients with 〈 80 years, ECOG 0-1, primary tumor and or metastases resected and those with complete or partial response in the first line of treatment have a higher probability of receiving ≥ 3 lines of chemotherapy. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 4041-4041
    Abstract: 4041 Background: Approximately 25% of patients with colorectal cancer (CRC) debut with metastatic disease. In addition, 25-35% of patients with localized disease at diagnosis develop metastatic lesions during the evolution of their disease. Consequently, approximately 50-60% of patients with CRC will present metastatic lesions at some point in their lives. Metastasis resection has improved the prognosis of these patients, achieving overall survival (OS) that exceed 40 months. However, there are doubts about the benefit of this approach in patients with mutations in oncogene BRAF or tumors located on the right-side, due their poor prognosis. The aim of the study is to analyze the impact of metastases resection on OS of these populations. Methods: We conducted a retrospective analysis of patients with mCRC attended in the Medical Oncology Department of the Hospital General Universitario Gregorio Marañón (Spain) between January 2010 and 2018. Results: 487 patients were identified and included in the analysis. Median age was 71 years (62-81). Most patients were males (62.4%). 55.2% had metastatic lesions at diagnosis. Most patients had ECOG 0-1 at diagnosis of metastatic disease (91.0%). 8.9% of patients had BRAF mutations (n = 21) and 31.8% of patients had primary tumors located on the right-side (n = 152). 474 patients received first-line chemotherapy (97.3%). OS of the entire cohort was 29.67 months; 30.69 months in BRAF mutated patients vs 35.89 in wild-type patients (p = 0.161); 25.29 months in right-side tumors vs 31.02 in left-side tumors (p = 0.044). 306 patients (62.8%) underwent metastases resection. Most common location was liver (51.4%). 147 patients (30.2%) underwent a second metastases resection. Mean number of metastases surgeries was 1.35 (+/-1.40). OS since metastases resection was 24.83 months in BRAF mutated patients vs 41.55 months in wild-type patients (p = 0.020). According to location, it was 35.49 months in right-side tumors vs 43.78 months in left-side tumors (p = 0.106). In BRAF mutated patients, OS was 38.19 months in patients underwent metastases resection vs 18.52 months in non-surgical patients (p = 0.043); 41.51 months vs 16.18 months respectively in patients with tumors located on the right-side (p 〈 0.001). Conclusions: Metastases resection has a positive impact on overall survival of patients with mutations in oncogene BRAF or right-side tumors, even though their prognosis is still poor compared to patients without these alterations.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
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  • 9
    Online Resource
    Online Resource
    American Association for Cancer Research (AACR) ; 2020
    In:  Clinical Cancer Research Vol. 26, No. 18_Supplement ( 2020-09-15), p. PO-036-PO-036
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 26, No. 18_Supplement ( 2020-09-15), p. PO-036-PO-036
    Abstract: Background: We aimed to describe how patients with lung cancer affected by COVID-19 recovered and were subsequently treated. Methods: From March 4th to May 12th, 2020, we have previously identified 23 COVID-19 lung cancer patients confirmed by SARS-CoV-2 RT-PCR in our institution (HGUGM; Madrid, Spain). After symptom recovery patients were tested weekly with nasopharyngeal swabs for SARS-CoV2. We did not start any anticancer treatment until at least 1 PCR confirmed a negative SARS-CoV-2 result. We reviewed treatment records, hospitalization, and outcomes of patients who recovered from COVID-19. Results: With a median follow-up of 9.7 weeks after COVID-19 diagnosis (range 3.7-13 weeks), 15 patients are clinically recovered (65%) and 8 patients died (35%) from COVID-19. In COVID-19 survivors, time to SARS-CoV-2 PCR negativization from symptoms onset was 31 days (range 13-54 days). Three patients remain SARS-CoV-2 RT-PCR positive to date. Of the 12 patients who negativized for SARS-CoV-2, 8 pts have started systemic anticancer treatment as follows: immune checkpoint inhibitors (n=3), chemotherapy (n=3), and initiation of definitive thoracic chemoradiation (n=2). All 3 pts on immunotherapy resumed the same treatment that they were receiving before COVID-19 (pembrolizumab, atezolizumab), as 2 out of 3 pts did with chemotherapy (pemetrexed; carboplatin + paclitaxel). With a median time on treatment of 40 days (range 22-48 days), only 1 patient has developed treatment-related adverse events so far (grade 1 thrombocytopenia after cycle 1, and grade 2 neutropenia after cycle 2 of carboplatin plus etoposide in a patient with relapsed SCLC previously treated with chemoradiation). The 4 patients with negative SARS-CoV-2 PCR who did not start any further treatment had either already completed planned treatment just before COVID-19 or were under surveillance without evidence of disease. Readmission was required in 4/15 patients: 1 pt due to tumor progression and pulmonary embolism, 1 pt due to brain edema from known brain metastasis, 1 pt due to Salmonella gastroenteritis, and 1 pt with hematuria due to prostate cancer. Of note, 1 patient who previously tested negative for SARS-CoV-2 -and who already resumed chemotherapy tested positive again upon admission without COVID-19-related symptoms. Conclusions: Lung cancer patients who survived COVID-19 can be considered for cancer treatment without preliminary early safety concerns. Long-term efficacy and safety evaluation by treatment modality is needed. Citation Format: Antonio Calles, Mar Galera, Inmaculada Aparicio, Manuel Alva, Marianela Bringas, Natalia Gutierrez, Javier Soto, Victoria Tirado, Rosa Alvarez. Safety outcomes of resuming anticancer treatment in patients with lung cancer affected by COVID-19 illness [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-036.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    RVK:
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
    detail.hit.zdb_id: 1225457-5
    detail.hit.zdb_id: 2036787-9
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  • 10
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 10 ( 2020-9-16)
    Type of Medium: Online Resource
    ISSN: 2234-943X
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2020
    detail.hit.zdb_id: 2649216-7
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