Evidenzprofil_Lorlatinib

Lungenkarzinom · Version 5.1

Lorlatinib (Neues Anwendungsgebiet: Nicht-kleinzelliges Lungenkarzinom, ALK+, Erstlinie)
Wirkstoff Lorlatinib Handelsname Lorviqua
Pharmazeutischer Unternehmer Pfizer Pharma GmbH Beschlussdatum 01.09.2022
Anwendungsgebiet Lungenkarzinom, nicht-kleinzelliges
Population/ZVT Titel Mortalität Morbidiät QoL Sicherheit Zusatznutzen
A Erwachsene Patientinnen und Patienten mit ALK-positivem, fortgeschrittenem NSCLC, die zuvor nicht mit einem ALK-Inhibitor behandelt wurden ↔

kein statistisch signifikanter Unterschied von Lorlatinib gegenüber Brigatinib

 Ø

keine hinreichende Ähnlichkeit bei der Operationalisierung

 Ø

keine hinreichende Ähnlichkeit bei der Operationalisierung

 Ø

keine hinreichende Ähnlichkeit bei der Operationalisierung

 ist nicht belegt
ZVT Brigatinib
↑↑/↓↓: positiver/negativer statistisch signifkanter Effekt, hohe Aussagesicherheit; ↑/↓: positiver/negativer statistisch signifkanter Effekt, niedrige oder unklare Aussagesicherheit; ↔: kein signifikanter/relevanter Unterschied; ↓: n.b.: nicht bewertbar; Ø: keine Daten
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER (NCT03052608)
Short Name Design Population Intervention Comparator Outcomes
CROWN
B7461006, 2016-003315-35		 Randomized, Parallel Assignment, Phase 3 Open Label study Treatment-naive with Stage 2-4 and ECOG 0-2 Carcinoma, Non-Small-Cell Lung Lorlatinib (N=149)1 1. Crizotinib (N=147)2
2. Indirekter Vergleich: Brigatinib (ALTA-1L) (N=137)3
  1. Primary: Progression-Free Survival
  2. Secondary: Overall Survival
  3. Secondary: Objective Response Rate
  4. Secondary: Intracranial Objective Response Rate
  5. Secondary: Intracranial Time to Progression
  6. Secondary: Duration of Response
  7. Secondary: Intracranial Duration of Response
  8. Secondary: Time to Tumor Response
  9. Secondary: Intracranial Time to Tumor Response
  10. Secondary: Treatment-Emergent Adverse Events
  11. Secondary: Change in EORTC-QLQ-C30
  12. Secondary: Change in EORTC-QLQ-Lung Cancer 13 (LC13)
  13. Secondary: Change in EQ-5D-5L-VAS
Levels of Evidence
GRADE ⊕⊕⊕⊖a We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
2: Crizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously; 3: Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
a: Open Label Study

Outcome Lorlatinib
N=149		 Crizotinib
N=147		 Effect Estimate GRADE
First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer.: Shaw, AT 2020. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer.. ; 383 (21); 2018-2029*
Dichotomous Outcomes
OS - Time To Event N=149 N=147 HR 0.72 [0.41; 1.25] ⊕⊕⊕⊕
PFS - Time To Event N=149 [; ] N=147 9.3 [7.6; 11.1] HR 0.28 [0.19; 0.41]; p<0.001 ⊕⊕⊖⊖a
Age
<65 N=90 N=103 HR 0.22 [0.13; 0.37]
≥65 N=59 N=44 HR 0.35 [0.2; 0.64]
ECOG Performance Status
0/1 N=146 N=138 HR 0.28 [0.19; 0.42]
Ethnic Origin
Asian N=66 N=65 HR 0.47 [0.27; 0.82]
Non-Asian N=83 N=82 HR 0.19 [0.11; 0.32]
Gender
Female N=84 N=91 HR 0.26 [0.16; 0.44]
Male N=65 N=56 HR 0.31 [0.18; 0.54]
Histology
Adenocarcinoma N=140 N=140 HR 0.26 [0.18; 0.39]
Presence of Brain Metastases
No N=111 N=107 HR 0.32 [0.2; 0.49]
Yes N=38 N=40 HR 0.2 [0.1; 0.43]
Smoking Status
Current/Former N=68 N=52 HR 0.36 [0.2; 0.63]
Never N=81 N=94 HR 0.24 [0.14; 0.4]
DOR - Time To Event N=149 [; ] N=147 11.0 [9; 12.9] ⊕⊕⊕⊖
IC-DOR - None N=38 [; ] N=40 9.4 [6; 11.1] ⊕⊕⊕⊖
IC-ORR - TuDD N=38 25 (65.79%) N=40 8 (20%) RR 3.29 [1.699; 6.37]; p=0.0004 ⊕⊕⊕⊖
IC-TTR - TTE N=38 1.9 [1.8; 3.7] N=40 1.8 [1.7; 2.7] ⊕⊕⊕⊖
ORR - TuDD N=149 113 (75.84%) N=147 85 (57.82%) RR 1.31 [1.112; 1.547]; p=0.0013 ⊕⊕⊕⊖
TTR - TTE N=149 1.8 [1.7; 1.9] N=147 1.8 [1.7; 1.9] ⊕⊕⊕⊖
AE (Any) N=149 149 (100%) N=142 140 (98.59%) RR 1.01 [0.991; 1.039]; p=0.2378 ⊕⊕⊕⊖
AE (CTCAE ≥3) N=149 108 (72.48%) N=142 79 (55.63%) RR 1.3 [1.091; 1.555]; p=0.0034 ⊕⊕⊕⊖
AE-D (CTCAE ≥3) N=149 7 (4.7%) N=142 7 (4.93%) RR 0.95 [0.343; 2.649]; p=0.9265 ⊕⊕⊕⊖
AE-Disc (Any) N=149 10 (6.71%) N=142 13 (9.15%) RR 0.73 [0.332; 1.618]; p=0.4421 ⊕⊕⊕⊖
AE-Disc (CTCAE ≥3) N=149 8 (5.37%) N=142 8 (5.63%) RR 0.95 [0.368; 2.471]; p=0.9211 ⊕⊕⊕⊖
SAE (Any) N=149 51 (34.23%) N=142 39 (27.46%) RR 1.25 [0.88; 1.765]; p=0.2148 ⊕⊕⊕⊖
SAE (CTCAE ≥3) N=149 41 (27.52%) N=142 32 (22.54%) RR 1.22 [0.818; 1.824]; p=0.3291 ⊕⊕⊕⊖
Outcome Lorlatinib
N=149		 Crizotinib
N=147		 Effect Estimate GRADE
Modul 4 der Nutzenbewertung von Lorlatinib (Lorviqua®): Pfizer Pharma GmbH 2022. Modul 4 der Nutzenbewertung von Lorlatinib (Lorviqua®). **
Dichotomous Outcomes
OS - Time To Event N=149 [; ] N=147 [; ] HR 0.719 [0.414; 1.249]; p=0.2395 ⊕⊕⊕⊕
PFS - Time To Event N=149 [; ] N=147 9.3 [7.6; 11.11] HR 0.281 [0.191; 0.413]; p<0.0001 ⊕⊕⊖⊖a
EORTC QLQ-C30 (Fatigue) - TTC N=148 8.3 [4.6; 19.4] N=140 6.0 [2.8; 12] HR 0.858 [0.626; 1.177]; p=0.3591 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Nausea) - TTC N=148 [; ] N=140 2.0 [1; 3.7] HR 0.221 [0.148; 0.33]; p<0.0001 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Pain) - TTC N=148 4.9 [3.7; 12] N=140 9.2 [6.4; ] HR 1.222 [0.89; 1.679]; p=0.2152 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Dyspnea) - TTC N=148 22.1 [5.7; ] N=140 17.5 [9.6; ] HR 1.13 [0.79; 1.615]; p=0.5020 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Insomnia) - TTC N=148 [; ] N=140 [20.3; ] HR 0.714 [0.467; 1.092]; p=0.1203 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Lack of Appetite) - TTC N=148 [26.7; ] N=140 10.2 [5.6; ] HR 0.225 [0.143; 0.355]; p<0.0001 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Constipation) - TTC N=148 14.7 [6.5; ] N=140 3.7 [2; 8.2] HR 0.694 [0.503; 0.959]; p=0.0264 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Diarrhea) - TTC N=148 15.7 [12.1; ] N=140 1.9 [1.4; 2.8] HR 0.349 [0.254; 0.48]; p<0.0001 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Peripheral neuropathy) - TTC N=146 3.7 [2.9; 6.2] N=139 5.5 [3.7; 7.6] HR 1.082 [0.805; 1.454]; p=0.6011 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Sore mouth) - TTC N=146 [19.4; ] N=138 [14.5; ] HR 0.9 [0.598; 1.355]; p=0.6232 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Dysphagia) - TTC N=146 [21.2; ] N=138 [11.1; ] HR 0.664 [0.449; 0.984]; p=0.0394 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Haemoptysis) - TTC N=146 [; ] N=138 [; ] HR 0.995 [0.45; 2.198]; p=0.9916 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Alopcia) - TTC N=145 [12.9; ] N=139 [; ] HR 1.127 [0.759; 1.673]; p=0.5451 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Pain in arm or shoulder) - TTC N=146 [13.8; ] N=139 [; ] HR 1.32 [0.877; 1.987]; p=0.1838 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Pain in chest) - TTC N=143 [; ] N=139 [; ] HR 1.022 [0.673; 1.552]; p=0.9128 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Dyspnea) - TTC N=144 6.4 [3.8; 11.2] N=137 8.4 [6.4; ] HR 1.335 [0.965; 1.846]; p=0.0801 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Coughing) - TTC N=146 [23.3; ] N=139 [23.1; ] HR 0.72 [0.471; 1.102]; p=0.1291 ⊕⊕⊖⊖b
IC-TTP - TTE N=149 [; ] N=147 16.6 [11.1; ] HR 0.059 [0.023; 0.151]; p<0.0001 ⊕⊕⊕⊖
EORTC QLQ-C30 (Social Function) - TTC N=148 8.3 [5.6; 26.5] N=140 17.2 [10.2; ] HR 1.235 [0.877; 1.739]; p=0.2104 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Emotional Function) - TTC N=148 [; ] N=140 [12.9; ] HR 0.812 [0.544; 1.211]; p=0.3091 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Cognitive Function) - TTC N=148 2.8 [1.9; 5.6] N=140 3.9 [2.9; 8.2] HR 1.234 [0.921; 1.655]; p=0.1516 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Physical Function) - TTC N=148 [14.9; ] N=140 14.8 [9.7; ] HR 0.805 [0.56; 1.158]; p=0.2428 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Global Health Status) - TTC N=148 24.0 [6.5; ] N=139 12.0 [6.5; ] HR 0.917 [0.65; 1.294]; p=0.6255 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Role Function) - TTC N=148 9.5 [5.2; 18.4] N=140 11.1 [6.5; ] HR 0.979 [0.703; 1.361]; p=0.9255 ⊕⊕⊖⊖b
AE (Any) N=149 149 (100%) N=142 140 (98.59%) RR 1.01 [0.991; 1.039]; p=0.2378 ⊕⊕⊕⊖
AE (Any) - TTE N=149 0.3 [0.2; 0.3] N=142 0.1 [0; 0.1] HR 0.854 [0.671; 1.088]; p=0.1950 ⊕⊕⊕⊖
AE (CTCAE ≥3) N=149 115 (77.18%) N=142 86 (60.56%) RR 1.27 [1.087; 1.494]; p=0.0028 ⊕⊕⊕⊖
AE (CTCAE ≥3) - TTE N=149 4.3 [2.8; 6.2] N=142 5.6 [4.6; 8.3] HR 1.239 [0.935; 1.644]; p=0.1328 ⊕⊕⊕⊖
AE-Disc (Any) N=149 10 (6.71%) N=142 13 (9.15%) RR 0.73 [0.332; 1.618]; p=0.4421 ⊕⊕⊕⊖
AE-Disc (Any) - TTE N=149 [; ] N=142 [; ] HR 0.659 [0.288; 1.509]; p=0.3208 ⊕⊕⊕⊖
SAE (Any) N=149 51 (34.23%) N=142 39 (27.46%) RR 1.25 [0.88; 1.765]; p=0.2148 ⊕⊕⊕⊖
SAE (Any) - TTE N=149 [22.1; ] N=142 [19.5; ] HR 1.038 [0.679; 1.587]; p=0.8593 ⊕⊕⊕⊖
Outcome Lorlatinib
N=149		 Indirekter Vergleich: Brigatinib (ALTA-1L)
N=137		 Effect Estimate GRADE
Modul 4 der Nutzenbewertung von Lorlatinib (Lorviqua®): Pfizer Pharma GmbH 2022. Modul 4 der Nutzenbewertung von Lorlatinib (Lorviqua®). ***
Dichotomous Outcomes
OS - Time To Event N=149 N=137 HR 0.79 [0.382; 1.635]; p=0.526 ⊕⊕⊕⊖c
Hirnmetastasen zu Baseline
No N=111 N=96 HR 0.511 [0.204; 1.279]; p=0.152
Yes N=38 N=41 HR 1.647 [0.489; 5.545]; p=0.421
PFS - Time To Event N=149 N=137 HR 0.585 [0.352; 0.974]; p=0.039 ⊕⊖⊖⊖a,c
Hirnmetastasen zu Baseline
No N=111 N=96 HR 0.482 [0.265; 0.877]; p=0.017
Yes N=38 N=41 HR 0.989 [0.354; 2.764]; p=0.984
EORTC QLQ-C30 (Fatigue) - TTC N=148 N=131 HR 1.281 [0.811; 2.023]; p=0.289 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Nausea) - TTC N=148 N=131 HR 0.402 [0.24; 0.672]; p=0.001 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Pain) - TTC N=148 N=131 HR 1.49 [0.94; 2.362]; p=0.090 ⊕⊕⊖⊖c
Gender
Female N=84 N=86 HR 2.636 [1.437; 4.834]; p=0.002
Male N=64 N=66 HR 0.718 [0.335; 1.54]; p=0.395
EORTC QLQ-C30 (Dyspnea) - TTC N=148 N=131 HR 1.153 [0.685; 1.942]; p=0.592 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Insomnia) - TTC N=148 N=131 HR 0.785 [0.439; 1.403]; p=0.414 ⊕⊕⊖⊖c
ECOG-PS
≥ 1 N=81 N=88 HR 0.49 [0.223; 1.08]; p=0.077
0 N=67 N=53 HR 1.369 [0.562; 3.338]; p=0.490
EORTC QLQ-C30 (Lack of Appetite) - TTC N=148 N=131 HR 0.363 [0.202; 0.652]; p=0.001 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Constipation) - TTC N=148 N=131 HR 1.335 [0.843; 2.112]; p=0.218 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Diarrhea) - TTC N=1498 N=131 HR 0.349 [0.227; 0.537]; p<0.0001 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Peripheral neuropathy) - TTC N=146 N=63 HR 2.042 [1.131; 3.686]; p=0.018 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Sore mouth) - TTC N=146 N=63 HR 0.789 [0.419; 1.487]; p=0.464 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Dysphagia) - TTC N=146 N=63 HR 0.678 [0.347; 1.324]; p=0.255 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Alopcia) - TTC N=145 N=63 HR 1.483 [0.742; 3.038]; p=0.282 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Haemoptysis) - TTC N=146 N=63 HR 0.686 [0.182; 2.587]; p=0.578 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Coughing) - TTC N=146 N=63 HR 0.742 [0.374; 1.473]; p=0.394 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Pain in other parts) - TTC N=143 N=63 HR 1.092 [0.602; 1.982]; p=0.772 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Pain in arm or shoulder) - TTC N=146 N=63 HR 2.588 [1.317; 5.088]; p=0.006 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Pain in chest) - TTC N=143 N=63 HR 1.327 [0.666; 2.647]; p=0.421 ⊕⊕⊖⊖c
EORTC QLQ-LC13 (Dyspnea) - TTC N=144 N=63 HR 2.086 [1.154; 3.77]; p=0.015 ⊕⊕⊖⊖c
IC-TTP - TTE N=149 N=137 HR 0.197 [0.066; 0.59]; p=0.004 ⊕⊕⊖⊖c
ECOG-PS
≥ 1 N=82 N=83 HR 0.197 [0.049; 0.8]; p=0.023
0 N=67 N=54 HR 0.914 [0.121; 6.918]; p=0.931
Geographic Region
Europe N=72 N=70 HR 0.6 [0.126; 2.861]; p=0.522
Other regions N=77 N=77 HR 0.105 [0.019; 0.579]; p=0.010
EORTC QLQ-C30 (Global Health Status) - TTC N=148 N=131 HR 1.31 [0.798; 2.151]; p=0.286 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Physical Function) - TTC N=148 N=131 HR 1.201 [0.719; 2.007]; p=0.483 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Role Function) - TTC N=148 N=131 HR 1.165 [0.733; 1.853]; p=0.518 ⊕⊕⊖⊖c
Gender
Female N=84 N=65 HR 1.947 [1.051; 3.607]; p=0.034
Male N=64 N=66 HR 0.619 [0.288; 1.332]; p=0.220
EORTC QLQ-C30 (Emotional Function) - TTC N=148 N=131 HR 1.414 [0.814; 2.456]; p=0.218 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Cognitive Function) - TTC N=148 N=131 HR 1.645 [0.632; 4.282]; p=0.308 ⊕⊕⊖⊖c
EORTC QLQ-C30 (Social Function) - TTC N=148 N=131 HR 2.093 [1.281; 3.421]; p=0.003 ⊕⊕⊖⊖c
Gender
Female N=84 N=65 HR 3.62 [1.842; 7.116]; p<0.001
Male N=64 N=66 HR 1.187 [0.547; 2.577]; p=0.664
AE (Any) - TTE N=149 N=136 HR 1.356 [0.959; 1.916]; p=0.085 ⊕⊕⊖⊖c
AE (CTCAE ≥3) - TTE N=149 N=136 HR 0.991 [0.661; 1.486]; p=0.966 ⊕⊕⊖⊖c
AE-Disc (Any) - TTE N=149 N=136 HR 0.464 [0.153; 1.409]; p=0.176 ⊕⊕⊖⊖c
SAE (Any) - TTE N=149 N=136 HR 1.281 [0.797; 2.059]; p=0.305 ⊕⊕⊖⊖c
Age
≥ 65 N=59 N=44 HR 0.43 [0.181; 1.023]; p=0.056
18-64 N=90 N=92 HR 2.604 [1.152; 5.885]; p=0.021
Outcome Lorlatinib
N=149		 Indirekter Vergleich: Brigatinib (ALTA-1L)
N=137		 Effect Estimate GRADE
Nutzenbewertung IQWiG der Nutzenbewertung von Lorlatinib (Lorviqua®): IQWiG 2022. Nutzenbewertung IQWiG der Nutzenbewertung von Lorlatinib (Lorviqua®). ****
Dichotomous Outcomes
OS - Time To Event N=149 N=137 HR 0.89 [0.44; 1.77]; p=0.736 ⊕⊕⊕⊕
*Database cutoff: 17.03.2020
**Database cutoff: not reported
***Database cutoff: not reported
****Database cutoff: not reported
a: Missing individual analysis of combined endpoint componenets (progression); b: Decreasing response rate in course of study; c: keine hinreichende Ähnlichkeit der Populationen
AE: Adverse Events; AE-D: Adverse Events Leading to Death; AE-Disc: Adverse Events Leading to Treatment Discontinuation; Alopcia: Alopcia; Any: Any Grade; Cognitive Function: Cognitive Function; Constipation: Constipation; Coughing: Coughing; CTCAE ≥3: Common Terminology Criteria for Adverse Events, Grade ≥3; Diarrhea: Diarrhea; DOR: Duration Of Response; Dysphagia: Dysphagia; Dyspnea: Dyspnea; Emotional Function: Emotional Function; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; EORTC QLQ-LC13: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Module; Fatigue: Fatigue; Global Health Status: Global Health Status; Haemoptysis: Haemoptysis; IC-DOR: Intracranial Duration Of Response; IC-ORR: Intracranial Objective Response Rate; IC-TTP: Intracranial Time to Progression; IC-TTR: Intracranial Time to Tumor Respone; Insomnia: Insomnia; Lack of Appetite: Lack of Appetite; MCID: Minimal Clinically Important Difference; Nausea: Nausea; ORR: Objective Response Rate; OS: Overall Survival; Pain: Pain; Pain in arm or shoulder: Pain in arm or shoulder; Pain in chest: Pain in chest; Pain in other parts: Pain in other parts; Peripheral neuropathy: Peripheral neuropathy; PFS: Progression-Free Survival; Physical Function: Physical Function; Role Function: Role Function; SAE: Serious Adverse Events; Social Function: Social Function; Sore mouth: Sore mouth; TTC: Time To Change ; TTE: Time To Event ; TTR: Time To Response; TuDD: Time to Definitive Deterioration
Outcome Lorlatinib
N=149		 Crizotinib
N=147		 Effect Estimate GRADE
First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer.: Shaw, AT 2020. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer.. ; 383 (21); 2018-2029*
Continuous Outcomes
EORTC QLQ-C30 (Global Health Status) N=149 N=147 LSMD 4.65 [1.14; 8.16] ⊕⊕⊖⊖a
*Database cutoff: 17.03.2020
a: im Studienverlauf sinkender Rücklauf von Fragebogen
EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; Global Health Status: Global Health Status; MCID: Minimal Clinically Important Difference