{"id":941,"date":"2025-02-28T03:23:14","date_gmt":"2025-02-28T03:23:14","guid":{"rendered":"http:\/\/socmexfito.org\/?p=941"},"modified":"2025-02-28T03:23:14","modified_gmt":"2025-02-28T03:23:14","slug":"1-trial-investigated-two-different-dosages-500-mg-and-1000-mg-of-ofatumumab-in-addition-to-fludarabine-with-cyclophosphamide","status":"publish","type":"post","link":"https:\/\/socmexfito.org\/?p=941","title":{"rendered":"\ufeff1 trial investigated two different dosages (500 mg and 1000 mg) of ofatumumab in addition to fludarabine with cyclophosphamide"},"content":{"rendered":"

\ufeff1 trial investigated two different dosages (500 mg and 1000 mg) of ofatumumab in addition to fludarabine with cyclophosphamide. Randomised Controlled Trials (RCTs) are needed to determine the medical effects of novel anti\\CD20 antibodies, such as ofatumumab or GA101, compared to rituximab. or relapsed CLL. Data collection and analysis We used risk ratios (HR) as effect measures for overall survival (OS), progression\\free survival (PFS) and time to next treatment, and risk ratios (RR) for response rates, treatment\\related mortality (TRM) and adverse events (AEs). Two review authors individually extracted data and assessed quality of tests. Main results We screened a total of 1150 records. Seven RCTs including 1763 patients were identified, but only five could be included in the two independent meta\\analyses we performed. We judged the overall the quality of these tests as moderate to high. All tests were randomised and open\\label studies. However, two tests were published as abstracts only, therefore we were unable to assess the potential risk of bias for these tests in detail. Three RCTs (N = 1421) assessed the effectiveness of monoclonal anti\\CD20 antibodies (i.e. rituximab) plus chemotherapy compared to chemotherapy alone. The meta\\analyses showed a statistically significant OS (HR 0.78, 95% confidence interval (CI) 0.62 to 0.98, P = 0.03, the number needed to treat for an additional beneficial effect (NNTB) was 12) and GSK3368715 dihydrochloride PFS (HR 0.64, GSK3368715 dihydrochloride 95% CI 0.55 to 0.74, P < 0.00001) advantage for individuals receiving rituximab. In the rituximab\\arm occurred more AEs, World Health Organization (WHO) grade 3 or 4 GSK3368715 dihydrochloride 4 (3 tests, N = 1398, RR 1.15, 95% CI 1.08 to 1 1.23, P < 0.0001; the number needed to Rabbit Polyclonal to NDUFS5<\/a> harm for an additional harmful end result (NNTH) was 9), but that did not lead to a statistically significant difference concerning TRM (3 tests, N = 1415, RR 1.19, 95% CI 0.70 GSK3368715 dihydrochloride<\/a> to 2.01, P = 0.52). Two tests (N = 177) evaluated rituximab versus alemtuzumab. Neither study reported OS or PFS. There was no statistically significant difference between arms concerning complete response rate (CRR) (RR 1.21, 95% CI 0.94 to 1 1.58, P = 0.14) or TRM (RR 0.31, 95% CI 0.06 to 1 1.51, P = 0.15). However, the CLL2007FMP trial was halted early owing to an increase in mortality in the alemtuzumab arm. More serious AEs occurred with this arm (43% with alemtuzumab versus 22% with rituximab; P = 0.006). Two tests assessed different dosages or time schedules of monoclonal anti\\CD20 antibodies. One trial (N = 104) evaluated two different rituximab schedules (concurrent arm: fludarabine plus rituximab (Flu\\R) plus rituximab consolidation versus sequential arm: fludarabine only plus rituximab consolidation). The assessment of the concurrent versus sequential routine of rituximab showed a statistically significant difference of the CRR with 33% in the concurrent\\arm and 15% in the sequential\\arm (P = 0.04), that did not lead to statistically significant variations regarding OS (HR 1.14, 95% CI 0.20 to 6.65, GSK3368715 dihydrochloride P = 0.30) or PFS (HR 0.96, 95% CI 0.43 to 2.15, P = 0.11). Furthermore results showed no variations in happening AEs, except for neutropenia, which was more often observed in individuals of the concurrent arm. The additional trial (N = 61) investigated two different dosages (500 mg and 1000 mg) of ofatumumab in addition to FluC. The arm investigating ofatumumab did not assess OS and a median PFS had not been reached owing to the short median follow\\up of eight weeks. It showed no statistically significant variations between arms concerning CRR (32% in the FCO500 arm versus 50%?in the FCO1000 arm; P = 0.10) or AEs (anaemia, neutropenia, thrombocytopenia). Authors’ conclusions This meta\\analysis showed.<\/p>\n","protected":false},"excerpt":{"rendered":"

\ufeff1 trial investigated two different dosages (500 mg and 1000 mg) of ofatumumab in addition to fludarabine with cyclophosphamide. Randomised Controlled Trials (RCTs) are needed to determine the medical effects of novel anti\\CD20 antibodies, such as ofatumumab or GA101, compared to rituximab. or relapsed CLL. Data collection and analysis We used risk ratios (HR) as effect measures for overall survival (OS), progression\\free survival (PFS) and time to next treatment, and risk ratios (RR) for response rates, treatment\\related mortality (TRM) and adverse events (AEs). Two review authors individually extracted data and assessed quality of tests. Main results We screened a total of 1150 records. Seven RCTs including 1763 patients were identified, but only five could be included in the two independent meta\\analyses we performed. We judged the overall the quality of these tests as moderate to high. All tests were randomised and open\\label studies. However, two tests were published as abstracts only, therefore we were unable to assess the potential risk of bias for these tests in detail. Three RCTs (N = 1421) assessed the effectiveness of monoclonal anti\\CD20 antibodies (i.e. rituximab) plus chemotherapy compared to chemotherapy alone. The meta\\analyses showed a statistically significant OS (HR 0.78, 95% confidence interval (CI) 0.62 to 0.98, P = 0.03, the number needed to treat for an additional beneficial effect (NNTB) was 12) and GSK3368715 dihydrochloride PFS (HR 0.64, GSK3368715 dihydrochloride 95% CI 0.55 to 0.74, P < 0.00001) advantage for individuals receiving rituximab. In the rituximab\\arm occurred more AEs, World Health Organization (WHO) grade 3 or 4 GSK3368715 dihydrochloride 4 (3 tests, N = 1398, RR 1.15, 95% CI 1.08 to 1 1.23, P < 0.0001; the number needed to Rabbit Polyclonal to NDUFS5 harm for an additional harmful end result (NNTH) was 9), but that did not lead to a statistically significant difference concerning TRM (3 tests, N = 1415, RR 1.19, 95% CI 0.70 GSK3368715 dihydrochloride to 2.01, P = 0.52). Two tests (N = 177) evaluated rituximab versus alemtuzumab. Neither study reported OS or PFS. There was no statistically significant difference between arms concerning complete response rate (CRR) (RR 1.21, 95% CI 0.94 to 1 1.58, P = 0.14) or TRM (RR 0.31, 95% CI 0.06 to 1 1.51, P = 0.15). However, the CLL2007FMP trial was halted early owing to an increase in mortality in the alemtuzumab arm. More serious AEs occurred with this arm (43% with alemtuzumab versus 22% with rituximab; P = 0.006). Two tests assessed different dosages or time schedules of monoclonal anti\\CD20 antibodies. One trial (N = 104) evaluated two different rituximab schedules (concurrent arm: fludarabine plus rituximab (Flu\\R) plus rituximab consolidation versus sequential arm: fludarabine only plus rituximab consolidation). The assessment of the concurrent versus sequential routine of rituximab showed a statistically significant difference of the CRR with 33% in the concurrent\\arm and 15% in the sequential\\arm (P = 0.04), that did not lead to statistically significant variations regarding OS (HR 1.14, 95% CI 0.20 to 6.65, GSK3368715 dihydrochloride P = 0.30) or PFS (HR 0.96, 95% CI 0.43 to 2.15, P = 0.11). Furthermore results showed no variations in happening AEs, except for neutropenia, which was more often observed in individuals of the concurrent arm. The additional trial (N = 61) investigated two different dosages (500 mg and 1000 mg) of ofatumumab in addition to FluC. The arm investigating ofatumumab did not assess OS and a median PFS had not been reached owing to the short median follow\\up of eight weeks. It showed no statistically significant variations between arms concerning CRR (32% in the FCO500 arm versus 50%?in the FCO1000 arm; P = 0.10) or AEs (anaemia, neutropenia, thrombocytopenia). Authors’ conclusions This meta\\analysis showed.\n<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[],"class_list":["post-941","post","type-post","status-publish","format-standard","hentry","category-ligases"],"_links":{"self":[{"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/posts\/941","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/socmexfito.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=941"}],"version-history":[{"count":1,"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/posts\/941\/revisions"}],"predecessor-version":[{"id":942,"href":"https:\/\/socmexfito.org\/index.php?rest_route=\/wp\/v2\/posts\/941\/revisions\/942"}],"wp:attachment":[{"href":"https:\/\/socmexfito.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/socmexfito.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/socmexfito.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}