An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triplenegative breast cancer: Erratum

In the article, “An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triplenegative breast cancer,”[1] which appears in Volume 102, Issue 30 of Medicine, requires several corrections. After receiving a letter of concern regarding the actual number of unique patients of the three studies included in this integrated analysis, the authors re-analyzed their data and made the following corrections. The results section of the abstract should read “Our analysis included 3 trials with 343 patients. Median overall survival was 12.7 months (95% confidence interval [CI], 11.813.7), progression-free survival was 5.6 months (95% CI, 4.86.3), and duration of objective response was 7.4 months (95% CI, 5.28.2). The objective response rate was 34%, and the disease control rate was 71%. Key grade ≥ 3 toxicities (in over 10% of the patients) included neutropenia (49%), leukopenia (11%), febrile neutropenia (13%), and diarrhea (11%). Four treatment-related deaths were reported” instead of “Our analysis included 3 trials (412 patients). Median overall survival was 12.9 months (95% confidence interval [CI], 11.5–14.4), progression-free survival was 5.7 months (5% CI, 5.1–6.3), and duration of objective response was 7.4 months (5% CI, 5.8–9.0). The objective response rate was 34%, and the disease control rate was 71%. Key grade ≥ 3 toxicities (in over 10% of the patients) included neutropenia (46%), leukopenia (12%), febrile neutropenia (11%), diarrhea (11%), and anemia (10%). Four treatment-related deaths were reported.” In section 3.1 “Finally, 3 prospective clinical trials with 412 RM-TNBC patients were eligible for inclusion“ should be written as “Finally, three prospective clinical trials met our inclusion criteria. Since 69 patients were not unique, 343 RM-TNBC patients were eligible for final analysis.” In section 3.2 “Pooled analyses displayed that the integrated median OS was 12.9 months (95% confidence interval [CI] 11.5–14.4), PFS was 5.7 months (95% CI 5.1–6.3), and DOR was 7.4 (5.8–9.0)” should be written as “Pooled analyses displayed that the integrated median OS was 12.7 months (95% CI 11.8-13.7), PFS was 5.6 months (95% CI 4.8-6.3), and DOR was 6.6 months (5.2-8.2).” In section 3.3 “Data of ORR and DCR were available from all enrolled 412 patients. Forest plots showed that the integrated ORR was 34% (95% CI 29–38; Egger’s test, P =.16), and DCR was 71% (95% CI 66–75; Egger’s test, P =.30) without publication bias when previously treated RM-TNBC patients received SG monotherapy (Fig. 2)“ should be written as “Data of ORR and DCR were available from all enrolled 343 patients. Forest plots showed that the integrated ORR was 34% (95% CI 29-40), and DCR was 70% (95% CI 65-74) without publication bias when previously treated RM-TNBC patients received SG monotherapy (Fig. 2).” In section 3.4 “Integrated incidences of all grade and grade ≥ 3 TRAEs are depicted in Table 3. In terms of hematological toxicities, the most common TRAE was neutropenia (all grade: 68%, 95% CI 63–72; grade ≥ 3: 46%, 95% CI 35–58), followed by anemia (all grade: 47%, 95% CI 36–44; grade ≥ 3: 10%, 95% CI 7–14), leukopenia (all grade: 20%, 95% CI 16–24; grade ≥ 3: 12%, 95% CI 9–15), and febrile neutropenia (all grade: 11%, 95% CI 3–23; grade ≥ 3: 11%, 95% (CI 3–21). In terms of non-hematological toxicities, the 5 most common all grade TRAEs were nausea (66%, 95% CI 60–72), diarrhea (63%, 95% CI 59–68), fatigue (51%, 95% CI 46–56), alopecia (44%, 95% CI 35–54), and vomiting (43%, 95% CI 30–57), and the most common grade 3 or worse included diarrhea (11%, 95% CI 8–14), fatigue (6%, 95% CI 3–11), nausea (5%, 95% CI 2–8), and vomiting (5%, 95% CI 1–12). In addition, 1 trial reported 4 treatment-related deaths during the SG monotherapy“ should be written as “Integrated incidences of all grade and grade ≥ 3 TRAEs are depicted in Table 3. In terms of hematological toxicities, the most common TRAE was neutropenia (all grade: 68%, 95% CI 63-73; grade ≥ 3: 49%, 95% CI 35-63), followed by anemia (all grade: 43%, 95% CI 32-55; grade ≥ 3: 9%, 95% CI 5-13), leukopenia (all grade: 19%, 95% CI 15-23; grade ≥ 3: 11%, 95% CI 8-15), and febrile neutropenia (all grade: 13%, 95% CI 2-24; grade ≥ 3: 13%, 95% (CI 2-31). In terms of non-hematological toxicities, the five most common all grade TRAEs were nausea (64%, 95% CI 59-69), diarrhea (64%, 95% CI 59-69), fatigue (51%, 95% CI 45-56), alopecia (44%, 95% CI 30-58), and vomiting (40%, 95% CI 24-57), and the most common grade 3 or worse included diarrhea (10%, 95% CI 7-14), fatigue (5%, 95% CI 1-11), nausea (4%, 95% CI 1-8), and vomiting (3%, 95% CI 0-10). In addition, one trial reported four treatment-related deaths during the SG monotherapy.” In section 4, “In this integrated analysis, we found that, among previously treated RM-TNBC patients who had received SG monotherapy, the ORR was 34%, the DCR was 71%, the median OS was 12.9 months, the median PFS was 5.7 months, and the median DOR was 7.4 months. Neutropenia and diarrhea were the most common grade ≥ 3 hematological and non-hematological TRAEs, respectively. “ should be written as “In this integrated analysis, we found that, among previously treated RM-TNBC patients who had received SG monotherapy, the ORR was 34%, the DCR was 70%, the median OS was 12.7 months, the median PFS was 5.6 months, and the median DOR was 6.6 months. Neutropenia and diarrhea were the most common grade ≥ 3 hematological and non-hematological TRAEs, respectively.” Several corrections are also needed for figures and tables in the article: In Table 2: Numbers have been added to the Study column as follows: 1. Aditya Bardia-2017, 2. Aditya Bardia-2019 and 3. Aditya Bardia-2021. After Pooled results, (2 + 3) has been added to indicate Aditya Bardia-2019 and Aditya Bardia-2021 only. The Median OS for Pooled results has been corrected from 12.9 (11.5–14.4) to 12.9 (11.5–14.4). The Median PFS for Pooled results has been corrected from 5.7 (5.1–6.3) to 5.6 (4.8-6.3). The Median DOR for Pooled results has been corrected from 7.4 (5.8–9.0) to 6.6 (5.2-8.2). In Table 3: For Neutropenia, the All grade % (95% CI) has been corrected from 68 (63–72) to 68 (63-73) and the Grade 3 or worse % (95% CI) has been corrected from 46 (35–58) to 49 (35-63). For Anemia, the All grade % (95% CI) has been corrected from 47 (36–44) to 43 (32-55) and the Grade 3 or worse % (95% CI) has been corrected from 10 (7–14) to 9 (5-13). For Leukopenia, the All grade % (95% CI) has been corrected from 20 (16–24) to 19 (15-23) and the Grade 3 or worse % (95% CI) has been corrected from 12 (9–15) to 11 (8-15). For Febrile neutropenia, the All grade % (95% CI) has been corrected from 11 (3–23) to 13 (2-34) and the Grade 3 or worse % (95% CI) has been corrected from 11 (3–21) to 13 (2-31). For Nausea, the All grade % (95% CI) has been corrected from 66 (60–72) to 64 (59-69) and the Grade 3 or worse % (95% CI) has been corrected from 5 (2–8) to 4 (1-8). For Diarrhea, the All grade % (95% CI) has been corrected from 63 (59–68) to 64 (59-69) and the Grade 3 or worse % (95% CI) has been corrected from 11 (8–14) to 10 (7-14). For Fatigue, the All grade % (95% CI) has been corrected from 51 (46–56) to 51 (45-56) and the Grade 3 or worse % (95% CI) has been corrected from 6 (3–11) to 5 (1-11). For Alopecia, the All grade % (95% CI) has been corrected from 44 (35–54) to 44 (30-58). For Vomiting, the All grade % (95% CI) has been corrected from 43 (30–57) to 40 (24-57) and the Grade 3 or worse % (95% CI) has been corrected from 5 (1–12) to 3 (0-10). For Decreased appetite, the All grade % (95% CI) has been corrected from 24 (19–29) to 26 (12-42). For Rash, the All grade % (95% CI) has been corrected from 20 (8–37) to 17 (3-39) and the Grade 3 or worse % (95% CI) has been corrected from 1 (0–2) to 1 (0-3). For Abdominal pain, the All grade % (95% CI) has been corrected from 20 (11–31) to 18 (7-32). For Headache, the All grade % (95% CI) has been corrected from 20 (16–24) to 20 (16-25). For Back pain, the All grade % (95% CI) has been corrected from 20 (16–24) to 19 (15-24) and the Grade 3 or worse % (95% CI) has been corrected from 0 (0–2) to 1 (0-2). For Dizziness, the All grade % (95% CI) has been corrected from 16 (10–23) to 25 (18-33) and the Grade 3 or worse % (95% CI) has been corrected from 0 (0–1) to 1 (0-3). In Figure 2: Aditya Bardia-2017 has been removed from both A and B. In both A and B, the weight for Aditya Bardia-2019 has been corrected from 26.2% to 31.5% and for Aditya Bardia-2021 from 57.0% to 68.5%. In Figure 2A: For the Random effects model, the total has been corrected from 412 to 343 and the 95%-CI has been corrected from [0.29; 0.38] to [0.29; 0.40]. The p-value for Heterogeneity has been corrected from 0.80 to 0.79. In Figure 2B: For the Random effects model, the total has been corrected from 412 to 343, the DCR from 0.71 to 0.70, and the 95%-CI has been corrected from [0.66; 0.75] to [0.65; 0.74]. The p-value for Heterogeneity has been corrected from 0.64 to 0.87.