Objective To date, the only study that has assessed the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2 mRNA) vaccine in systemic lupus erythematosus (SLE) observed a moderate response, but the sample size precluded an accurate analysis of the effect of individual drugs. Therefore, we evaluated the immunogenicity of an inactivated SARS‐CoV‐2 vaccine (Sinovac‐CoronaVac) and the influence of different medications in SLE. Safety was also assessed. Methods We conducted a prospective controlled study of 232 SARS‐CoV‐2–naive SLE patients and 58 SARS‐CoV‐2–naive controls who were vaccinated with 2 doses of Sinovac‐CoronaVac with a 28‐day interval (day 0/day 28 [D0/D28]). Immunogenicity analysis at D0/D28 and D69 included anti‐SARS‐CoV‐2 S1/S2 IgG seroconversion (SC) and neutralizing antibodies (NAb) positivity. The influence of individual drugs on immune response and safety was assessed. Results Patients and controls were well balanced for age (P = 0.771). At D69, SLE patients showed a moderate SC (70.2% versus 98.1%; P < 0.001) and moderate frequency of NAb positivity (61.5% versus 84.6%; P = 0.002), although both frequencies were lower than in controls. Factors associated with lower SC in univariate analysis at D69 were prednisone use (odds ratio [OR] 0.215 [95% confidence interval (95% CI) 0.108–0.427], P < 0.001) and mycophenolate mofetil (MMF) use (OR 0.201 [95% CI 0.107–0.378], P < 0.001), whereas hydroxychloroquine (HCQ) use led to a 2.5 increase in SC (P = 0.011). SLE patients who were receiving HCQ monotherapy had similar SC to controls at D69 (100% versus 98.1%; P = 1.000). In multivariate analysis, prednisone and MMF use were independently associated with lower SC (P < 0.001) and NAb positivity (P < 0.001). Safety analysis revealed no moderate/severe adverse events. Conclusion Sinovac‐CoronaVac has a moderate immunogenicity in SARS‐CoV‐2–naive SLE patients with an excellent safety profile. We further demonstrate that HCQ may improve SC, whereas prednisone and MMF had a major deleterious effect in vaccine response, reinforcing the need to investigate the role of temporary MMF withdrawal or a vaccine‐booster dose (http://clinicaltrials.gov identifier: NCT04754698).

PURPOSE Patients with cancer are at increased risk for unfavorable outcomes from COVID-19. Knowledge about the outcome determinants of severe acute respiratory syndrome coronavirus 2 infection in this population is essential for risk stratification and definition of appropriate management. Our objective was to evaluate prognostic factors for all-cause mortality in patients diagnosed with both cancer and COVID-19. METHODS All consecutive patients with cancer hospitalized at our institution with COVID-19 were included. Electronic medical records were reviewed for clinical and laboratory characteristics potentially associated with outcomes. RESULTS Five hundred seventy-six consecutive patients with cancer and COVID-19 were included in the present study. An overall in-hospital mortality rate of 49.3% was demonstrated. Clinical factors associated with increased risk of death because of COVID-19 were age over 65 years, Eastern Cooperative Oncology Group performance status > 0 zero, best supportive care, primary lung cancer, and the presence of lung metastases. Laboratory findings associated with a higher risk of unfavorable outcomes were neutrophilia, lymphopenia, and elevated levels of D-dimer, creatinine, C-reactive protein, or AST. CONCLUSION A high mortality rate in patients with cancer who were diagnosed with COVID-19 was demonstrated in the present study, emphasizing the need for close surveillance in this group of patients, especially in those with unfavorable prognostic characteristics.

6008 Background: Optimal treatment of larynx squamous cell carcinoma (LC) maximizes functional outcomes and survival. Surgery and radiotherapy (RT) may lead to significant morbidity, notably dysphonia and dysphagia. Our group published durable pathologic complete response (pCR) with normal function in 33% of patients (pts) with stage II-IV LC treated with single modality chemotherapy. We hypothesized that pembrolizumab (P), cisplatin (C), and docetaxel (D) will cure a subset of LC pts and preserve larynx function. Methods: Eligible pts had stage II-III LC measurable per RECIST 1.1. Treatment consisted of P 200 mg, C 75 mg/m2 or carboplatin AUC 6, and D 75 mg/m2 IV Q3W. After 2 PCD cycles, pts with radiological response (complete [CR], partial [PR], or stable disease [SD]) received 2 additional PCD cycles. After 4 cycles, pts underwent larynx biopsy. Those with pCR received 4 doses of consolidation P; those without pCR received local therapy (LT; RT or surgery). Co-primary endpoints are disease control rate (DCR; CR+PR+SD) after 2 PCD cycles and pCR rate after 4 cycles. Secondary endpoints include safety, laryngeal preservation rate, relapse-free survival, and swallow function. Per Bayesian design (H0: 65% DCR, 15% pCR; H1: 85% DCR, 30% pCR), we reject H0 if of 25 pts, 19 have DCR or > 7 achieve pCR (10% alpha, 88% power). Results: 24 pts enrolled from 8/9/19-12/15/22, 62.5% were stage III (54.2% were T3 and 16.7% were N1); 23 were evaluable for the efficacy endpoints. DCR was 100% with 74% (17/23) being objective responses and 52% CR; pCR rate to date is 77.3% (17/22; 1 pt is on-treatment). 6 of 17 (35%) pts with pCR developed recurrence, mostly (4/6) within 4 months of pCR, and were salvaged with LT. 5 pCR lasted ≥ 1 y; 2 additional pCR pts unable to perform serial laryngoscopy or imaging due to loss of insurance (n = 1) or moving to another state (n = 1) have not had clinical recurrence for ≥ 2 ys. The median follow-up is 17.2 mos (range: 1.4 – 39.4 mos). One patient who refused LT at early recurrence was lost to follow-up and eventually underwent a total laryngectomy and RT then recurred locally and died of disease. An additional patient who had pCR with early recurrence received definitive RT with CR, but subsequently developed a solitary lung metastasis treated with RT; 2 pts remain on trial treatment. The most common treatment-related adverse events (TRAE) were fatigue (91.6%), anemia (79%), diarrhea (45.8%), and nausea (41.6%). 10 grade 3-4 TRAE were reported in 5 (20.8%) pts with the most common being neutropenia (3/24, 12.5%) and anemia (2/24; 8.3%). 2 pts discontinued PCD treatment due to toxicity. Conclusions: The study reached its primary endpoint with a DCR of 100% (23/23) and a pCR in 77.3% (17/22) of evaluable patients; 5 pCR last ≥ 1 y. Recurrences after pCR occurred stressing the importance of close follow-up. Updated efficacy and swallow function results will be presented at the meeting. Clinical trial information: NCT04030455 .

The liver is the world’s sixth most common primary tumor site, responsible for approximately 5% of all cancers and over 8% of cancer-related deaths. Hepatocellular carcinoma (HCC) is the predominant type of liver cancer, accounting for approximately 75% of all primary liver tumors. A major therapeutic tool for this disease is liver transplantation. Two of the most significant issues in treating HCC are tumor recurrence and graft rejection. Currently, the detection and monitoring of HCC recurrence and graft rejection mainly consist of imaging methods, tissue biopsies, and alpha-fetoprotein (AFP) follow-up. However, they have limited accuracy and precision. One of the many possible components of cfDNA is circulating tumor DNA (ctDNA), which is cfDNA derived from tumor cells. Another important component in transplantation is donor-derived cfDNA (dd-cfDNA), derived from donor tissue. All the components of cfDNA can be analyzed in blood samples as liquid biopsies. These can play a role in determining prognosis, tumor recurrence, and graft rejection, assisting in an overall manner in clinical decision-making in the treatment of HCC.