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Efficacy and safety of nintedanib and docetaxel in patients with previously treated lung non-squamous non-small cell lung cancer: a multicenter retrospective real-world analysis

Lidija Ljubicic
Lidija Ljubicic
, 
Urska Janzic
Urska Janzic
, 
Mojca Unk
Mojca Unk
, 
Ana Sophie Terglav
Ana Sophie Terglav
, 
Katja Mohorcic
Katja Mohorcic
, 
Fran Seiwerth
Fran Seiwerth
, 
Lela Bitar
Lela Bitar
, 
Sonja Badovinac
Sonja Badovinac
, 
Sanja Plestina
Sanja Plestina
, 
Marta Korsic
Marta Korsic
, 
Suzana Kukulj
Suzana Kukulj
, 
Miroslav Samarzija
Miroslav Samarzija
 und 
Marko Jakopovic
Marko Jakopovic
   | 04. Sept. 2023
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Article Category: Research Article
Online veröffentlicht: 04. Sept. 2023
Seitenbereich: 397 - 404
Eingereicht: 15. Mai 2023
Akzeptiert: 16. Juli 2023
DOI: https://doi.org/10.2478/raon-2023-0040
Schlüsselwörter
© 2023 Lidija Ljubicic et al., published by Sciendo
This work is licensed under the Creative Commons Attribution 4.0 International License.

FIGURE 1.

Swimmer plot of treatment duration and best treatment response in EGFR-positive patients. Different colours of the horizontal bars represent different treatment lines, while the symbols at the end of each bar represent the relevant responses.AF = Afatinib; DTX = Docetaxel; DTX_NIN = Docetaxel plus nintedanib; EGFR = epidermal growth factor receptor; ER = Erlotinib; GEM = Gemcitabine; OSM = Osimertinib; PC_CB = Paclitaxel and carboplatin; PD = progressive disease; PR = partial response; PTD_CIS = Pemetrexed and cisplatin; PTD = Pemetrexed; PTD_CB = Pemetrexed and carboplatin; SD = stable disease
Swimmer plot of treatment duration and best treatment response in EGFR-positive patients. Different colours of the horizontal bars represent different treatment lines, while the symbols at the end of each bar represent the relevant responses.AF = Afatinib; DTX = Docetaxel; DTX_NIN = Docetaxel plus nintedanib; EGFR = epidermal growth factor receptor; ER = Erlotinib; GEM = Gemcitabine; OSM = Osimertinib; PC_CB = Paclitaxel and carboplatin; PD = progressive disease; PR = partial response; PTD_CIS = Pemetrexed and cisplatin; PTD = Pemetrexed; PTD_CB = Pemetrexed and carboplatin; SD = stable disease

FIGURE 2.

(A) Progression-free survival of all patients(PFS) (n = 96) treated with nintedanib and docetaxel combination therapy. (B) Overall survival (OS) of all patients treated with nintedanib and docetaxel combination therapy. (C) Progression-free survival (PFS) of patients with and without brain metastases. (D) Median progression-free survival of patients with and without adverse events.
(A) Progression-free survival of all patients(PFS) (n = 96) treated with nintedanib and docetaxel combination therapy. (B) Overall survival (OS) of all patients treated with nintedanib and docetaxel combination therapy. (C) Progression-free survival (PFS) of patients with and without brain metastases. (D) Median progression-free survival of patients with and without adverse events.

FIGURE 3.

Outcomes with docetaxel and nintedanib across different treatment lines. Progression-free survival (PFS) of patients receiving docetaxel plus nintedanib as second-line treatment after first-line combination chemotherapy-checkpoint inhibitors (ChT-ICI) therapy (A), third-line treatment after first-line platinum-based ChT and second-line ICI monotherapy (B), third-line treatment after first-line ICI monotherapy and second-line platinum-based ChT (C), and second-line treatment after first-line platinum-based ChT (D).
Outcomes with docetaxel and nintedanib across different treatment lines. Progression-free survival (PFS) of patients receiving docetaxel plus nintedanib as second-line treatment after first-line combination chemotherapy-checkpoint inhibitors (ChT-ICI) therapy (A), third-line treatment after first-line platinum-based ChT and second-line ICI monotherapy (B), third-line treatment after first-line ICI monotherapy and second-line platinum-based ChT (C), and second-line treatment after first-line platinum-based ChT (D).

Demographic and baseline characteristics of 96 patients treated with docetaxel plus nintedanib

Variable N = 96
Age, mean (years) 59.5 (39–75)
Sex
  Male 55 (57.3%)
  Female 41 (42.7%)
ECOG performance status
  0 35 (36.4%)
  1 57 (59.4%)
  2 4 (4.2%)
Smoking status
  Current smokers 56 (58.3%)
  Never smokers 18 (18.8%)
  Former smokers 18 (18.8%)
  Unknown 4 (4.2%)
Clinical stage at diagnosis
  Stage ≤ IIIB 9 (9.4%)
  Stage IIIC 1 (1.0%)
  Stage IV 86 (89.6%)
Brain metastases
  Yes 18 (18.7%)
  No 78 (81.3%)
PD-L1 expression
  0% 35 (36.5%)
  1–49% 34 (35.4%)
  ≥ 50% 16 (16.7%)
  Unknown 11 (11.5%)
Biomarker testing
  EGFR mutation positive 5 (5.2%)
   ALK re arrangement present 0 (0.0%)
   ROS1 rearrangement present 0 (0.0%)
   KRAS mutation present 7 (7.3%)
   MET rearrangement present 1 (1.0%)
  RET rearrangement present 3 (3.1%)
  FGFR rearrangement present 1 (1.0%)
Docetaxel plus nintedanib line
  Second-line therapy after first line combination ChT-ICI 24 (25%)
  Second-line therapy after first-line platinum-based ChT 7 (7.3%)
  Third-line therapy after first-line ChT and second-line ICI 47 (49.0%)
  Third-line therapy after first-line ICI and second-line ChT 13 (13.5%)
  Fourth or later-lines 3 (3.1%)
  Other¶ 2 (2.1%)

Response to treatment with docetaxel plus nintedanib in all patients

Tumor response according to RECIST version 1.1 criteria10 All patientsN = 96
CR 0 (0.0)
PR 18 (18.8)
SD 37 (38.5)
PD 31 (32.3)
ORR (CR+PR) 18 (18.8)
DCR (CR+PR+SD) 55 (57.3)
Non-evaluable 10 (10.4)
Median PFS, months 3.0 (95% CI: 3–5)
Median OS, months 8.0 (95% CI: 7–10)

Response to treatment with docetaxel plus nintedanib in different treatment patterns

Tumor response according to RECIST version 1.1 criteria7 Second-line after a first-line combination ChT-ICI regimen (n = 24) Second-line after a first-line platinum-based ChT (n = 7) Third-line therapy following first-line ChT and second-line ICI (n = 47) Third-line after first-line ICI and second-line ChT (n = 13) Fourth or later-line treatment (n = 3)
CR, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
PR, n (%) 7 (29.2) 1 (14.3) 9 (19.1) 1 (7.7) 0 (0.0)
SD, n (%) 9 (37.5) 2 (28.6) 18 (38.3) 7 (53.8) 1(33.3)
PD, n (%) 3 (12.5) 3 (42.9) 18 (38.3) 5 (38.5) 2(66.7)
ORR, n (%) 7 (29.2) 1 (14.3) 9 (19.1) 1 (7.7) 0 (0.0)
DCR, n (%) 16 (66.7) 3 (42.9) 27 (57.4) 8 (61.5) 1(33.3)
Non-evaluable, n (%) 5 (20.8) 1 (14.3) 2 (4.3) 0 (0.0) 0 (0.0)

Overview of adverse events with docetaxel plus nintedanib treatment

Adverse Event* All grades n (%) Grade 3 n (%)
Total 53 (55.2) 8 (8.3)
Diarrhea 29(30.2) 1 (1.0)
Elevated liver enzymes 17(17.7) 6 (6.3)
Rash 6 (6.2)
Neutropenia 4 (4.2)
Peripheral neuropathy 3 (3.1)
Stomatitis 2 (2.1)
Nausea 2 (2.1)
Hypertension 2 (2.1) 1 (1.0)

Differences in progression-free survival (PFS) and overall survival (OS) for each subset of patients according to the treatment line of docetaxel plus nintedanib

All patients (n = 96) Second-line after a first-line combination ChT-ICI regimen (n = 24) Second-line after a first-line platinum-based ChT (n = 7) Third-line therapy after first-line ChT and second-line ICI (n = 47) Third-line after first-line ICI and (n = 13) second-line ChT Fourth- or later-lines treatment (n = 3)
Median progression-free survival, months (95% CI) 3 (3–5) 4 (3–8) 2 (1–inf) 4 (3–8) 4 (3–inf) 3 (0–inf)
Median overall survival, months (95% CI) 8 (7–10) 9 (6–inf) 10 (4–inf) 10 (8–14) 7 (3–inf) 8 (2–inf)
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