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Table 2 Tumor-associated assessments based on a blinded central radiology review of the primary efficacy population

From: A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

 

BTH1677/Bevacizumab/

Carboplatin/Paclitaxel

(N = 48)

Bevacizumab/

Carboplatin/Paclitaxel

(N = 23)

 

n (%)

95% CI

n (%)

95% CI

P valuef

Objective Response Ratea,b

29 (60.4)

(45.3, 74.2)

10 (43.5)

(23.2, 65.5)

0.2096

Disease Control Rateb,c

45 (93.8)

(82.8, 98.7)

21 (91.3)

(72.0, 98.9)

0.6563

Best Observed Responseb

 Complete response

1 (2.1)

(0.1, 11.1)

0

NA

 

 Partial response

28 (58.3)

(43.2, 72.4)

10 (43.5)

(23.2, 65.5)

0.3113

 Stable disease

16 (33.3)

(20.4, 48.4)

11 (47.8)

(26.8, 69.4)

0.2992

 Progressive disease

3 (6.3)

(1.3, 17.2)

2 (8.7)

(1.1, 28.0)

0.6563

Duration of Objective Tumor Responsed

  

HR (95% CI)g

Patients with objective response (CR + PR)

29

10

 

Patients (% responding patients) with known duration (uncensored)

9 (31.0)

3 (30.0)

 

Patients (% responding patients) with unknown duration (censored)

20 (69.0)

7 (70.0)

 

Duration of objective response (months)

 Median (95% CI)

10.3 (5.6, NE)

5.6 (1.5, NE)

0.92 (0.27, 4.20)

 Log-rank P value

  

0.9040

Progression-Free Survivale

  

HR (95% CI)g

Patients with PD or died, n (%)

17 (34.0)

6 (26.1)

 

Patients censored, n (%)

33 (66.0)

17 (73.9)

 

Progression-free survival (months)

 Median (95% CI)

11.6 (7.0, NE)

9.6 (7.1, NE)

1.31 (0.54, 3.65)

 Log-rank P value

  

0.5639

  1. Abbreviations: CI confidence interval, CR complete response, NA not applicable, PD progressive disease, PR partial response, HR hazard ratio, n number of patients, N overall sample size, NE not estimable
  2. aObjective response rate was defined as the percent of central radiology review response-evaluable patients experiencing a best overall tumor
  3. response of either CR or PR at any time on study according to modified RECIST v1.0 criteria
  4. bTumor response data reported as the number (n) and percent (%) of response-evaluable patients and the 95% exact binomial confidence interval
  5. cDisease control rate was defined as the percent of blinded central radiology review response-evaluable patients experiencing a best overall tumor response of CR, PR, or stable disease (SD) per modified RECIST v1.0 criteria
  6. dDuration of objective response (months) was based on Kaplan-Meier estimates and was measured from the time at which criteria were met for CR or PR (whichever status was recorded first) until the first date on which recurrence or progressive disease (PD) was objectively documented per modified RECIST v1.0. Patients who did not progress as of the data cutoff date were censored at their last tumor assessment
  7. eProgression-free survival (PFS) (months) was based on Kaplan-Meier estimates from the total blinded central radiological review population (BTH1677/Bevacizumab/Carboplatin/Paclitaxel, n = 50 and Bevacizumab/Carboplatin/Paclitaxel, n = 23) and was defined as the time from randomization to the first date of documented PD or death. PD was identified by radiologic PD according to modified RECIST v1.0. If a patient received any further anticancer therapy without prior documentation of PD, the patient was censored at the date of last imaging assessment before the treatment. Patients who were lost to follow-up or who were alive without PD as of the data cut-off date were censored at the last imaging assessment date or at the analysis data cut-off date, whichever came first
  8. fP value was obtained using Fisher’s Exact Test
  9. gHazard ratio (95% exact binomial CI) was based on Cox proportional hazards model with treatment as factor
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