Real-World Efficacy and Safety of Bevacizumab in the First-Line Treatment of Metastatic Cervical Cancer: A Cohort Study in the Total Population of Croatian Patients

Table 2

Efficacy and safety assessment.

	Chemotherapy + bevacizumab (n = 67)	Chemotherapy alone (n = 62)
Efficacy endpoints
PFS (months), median (95% CI)	10.6 (8.5; 15.4)	5.4 (3.9; 9.1)	0.011
Unadjusted HR (95% CI)	0.60 (0.41; 0.89)	1.00 Referent	0.011
Adjusted HR (95% CI)^a	0.60 (0.39; 0.94)	1.00 Referent	0.027
OS (months), median (95% CI)	27.0 (18.5; n.c.)	15.5 (10.7; 30.1)	0.025
Unadjusted HR (95% CI)	0.56 (0.34; 0.93)	1.00 Referent	0.027
Adjusted HR (95% CI)^a	0.78 (0.44; 1.38)	1.00 Referent	0.389
Objective response, n (%)^b
Complete response (CR)	12 (18)	11 (19)	0.013
Partial response (PR)	26 (39)	13 (22)
Stable disease (SD)	14 (21)	6 (10)
Progressive disease (PD)	13 (19)	21 (36)
Could not be determined	2 (3)	8 (14)
Objective response rate, n (%)^b	38 (57)	24 (41)	0.072
Disease control rate, n (%)^c	52 (78)	30 (51)	0.002
Safety endpoints
Treatment discontinuation because of toxicity, n (%)^d	11 (19)	9 (16)	0.749
Treatment-related adverse events
Any grade	54 (81)	53 (85)	0.461
Grades III-IV	33 (49)	41 (66)	0.053
Treatment-related, haematologic adverse events
Any grade	44 (66)	53 (85)	0.009
Grades III-IV	18 (27)	31 (50)	0.007
Treatment-related, nonhaematologic adverse events
Any grade	51 (76)	50 (81)	0.533
Grades III-IV	22 (33)	21 (34)	0.901

CI = confidence interval; PFS = progression-free survival; OS = overall survival; HR = hazard ratio; n.c. = not calculable. ^aAnalysis was adjusted for age at diagnosis, histology, ECOG performance status before the introduction of first-line treatment for metastatic disease, previous treatment with chemotherapy, and previous treatment with radiotherapy. ^bObjective response rate includes complete and partial response; data were missing for 6/67 (10%) patients treated with TCB and 3/62 (5%) patients treated with chemotherapy alone. ^cDisease control rate includes complete and partial response and stable disease. ^dData on treatment discontinuation because of toxicity were missing in 8 (12%) patients treated with TCB and 7 (11%) patients treated with chemotherapy alone. False discovery rate <5%.