Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...
Forty-three dogs with lymphoma that had relapsed or had failed to achieve complete remission to previous chemotherapy were treated with lomustine (1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea [CCNU]) at a dosage of 90-100 mg/m2 body surface area p.o. every 3 weeks. Durable complete or partial responses occurred in 11 dogs for a median of 86 days. The acutely dose-limiting toxicosis was neutropenia 7 days after administration, resulting in a recommended dosage of 90 mg/m2. Cumulative thrombocytopenia occurred in dogs receiving continued CCNU treatment, and a dose interval of 3 weeks may be too short for continued administration of this drug. Toxicoses evident as fever or central nervous system signs or renal damage were uncommon or rare. CCNU is effective in the treatment of relapsed lymphoma.
Thirty-eight cats with lymphoma were treated with vincristine, cyclophosphamide, and prednisone (COP). They were randomized at entry to receive maintenance chemotherapy consisting of either single-agent doxorubicin or continued COP therapy, starting on week 4 of treatment and continuing for 6 months or until relapse. Eighteen cats achieved complete clinical remission after COP induction chemotherapy. The median remission duration for 11 cats continuing to ymphoma is the most common cancer in cats.' Although L considerable advances have been made in the treatment of lymphoma in dogs with combination chemotherapy protocols, relatively little information is available regarding the treatment of lymphoma in cats.When treated with vincristine, cyclophosphamide, and prednisone (COP) protocol, 79% of cats with lymphoma achieved a complete remission (CR) for a median of 150 days2 The addition of methotrexate andor L-asparaginase did not improve remission rates or duration of remission in 2 studies'; however, in 1 of these studies, the median survival was 21 0 days.' The duration of chemotherapy necessary to provide the longest remission has yet to be determined. Cats treated with COP induction chemotherapy alone relapsed more rapidly (median 42 days)4 than did those that received maintenance COP chemotherapy for 1 year (median 150 days).' Other reports recommend treating cats for 2 years' or for more than 3 years.' Doxorubicin is considered to be the most effective single agent in the treatment of lymphoma in dogshX; however, it has yet to be evaluated as a single agent for the treatment of cats with lymphoma. Another anthracycline derivative (idarubicin) was found to be effective when administered as a single maintenance agent to cats with lymphoma that had achieved a CR with COP chemotherapy. ' The purposes of this study were to determine the efficacy of doxorubicin when compared with COP chemotherapy for the maintenance of CR attained after COP induction, and to determine if cats treated with chemotherapy for 6 months had remission times similar to those reported for cats treated for 1 year or more.
A retrospective analysis was performed on the case records of 32 dogs with Stage I or II splenic hemangiosarcoma that were treated by splenectomy alone and that survived the seven-day postoperative period. Median survival time for these 32 cases was 86 days (mean, 116 days; range, 14 to 470 days), and the one-year survival rate was estimated to be 6.25%. Survival was not influenced by signalment, presenting signs, stage of disease, or clinicopathological findings. The data provides a basis from which to evaluate adjuvant chemotherapy for splenic hemangiosarcoma that is confined to the spleen macroscopically.
Ninety-eight dogs with lymphoma treated with a 5-drug combination chemotherapy regimen (vincristine. L-asparaginase. cyclophosphamide. doxorubicin, prednisone [VELCAP-L]) were evaluated for pretreatment characteristics predictive for response and remission duration. The complete remission rate was 6970, with a median remission duration of 55 weeks. Dogs with advanced stage of disease, constitutional signs, dogs that were older, and dogs that were dyspneic were less likely to achieve remission. Once in remission, small dogs and dogs without pretreatment thrombocytopenia were likely to have longer remission duration. Toxicoses were frequent, but rarely fatal. and no predictitive factors were found for a dog developing toxicoses. VELCAP-L is an effective treatment for dogs in stage 1-111 lymphoma, particularly in young, small animals.Key words: Cancer: Remission; Treatment.ymphoma is the most common hematopoietic neo- Although maintenance therapy may be important for duration of remission, it appears that an aggressive induction protocol may also be important in determining both remission rate and duration. The ACOPA-11' protocol had an induction period designed to decrease toxicity and minimize patient visits; this protocol had a low remission rate, possibly due to its decreased dose intensity. The protocol VELCAP-L was designed to provide an intense induction period, followed by a maintenance protocol identical to that used in the ACOPA-I1 protocol (see Fig. 1). Materials and Methods Criteria for Selection of CasesOne hundred eleven dogs with a histologic or cytologic diagnosis of multicentric lymphoma and that had not received prior chemotherapy other than prednisone were eligible for entry into this study. Of these 1 I 1 dogs, 13 were excluded because of poor adherence to protocol or a change in diagnosis (from lymphoma to leukemia). The remaining 98 dogs were treated with the VELCAP-L combination chemotherapy protocol.
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