15 januari 2024:

zie ook dit artikel: https://kanker-actueel.nl/s-1-plus-oxaliplatine-samen-met-pembrolizumab-geeft-hoopvolle-resultaten-bij-patienten-met-gevorderde-maag-darmkanker-met-72-procent-objectieve-respons.html

15 januari 20234: Bron: Publication: Journal of Clinical Oncology Volume 39Number 9

Uit de resultaten van de fase III studie JAVELIN Gastric 100 bij patiënten met inoperabele maagkanker en tumoren in de overgang van maag en slokdarm (bovenste gedeelte darmkanaal) met type human epidermal growth factor receptor 2–negatief, blijkt dat onderhoudsbehandeling met immuuntherapie met anti-PD medicijn Avelumab een betere 2-jaars overleving geeft in vergelijking met doorgaan met chemotherapie (oxaliplatine plus een fluoropyrimidine) . Op 2 jaars meting was het verschil in overleving 22.1 procent met Avelumab versus 15.5 procent voor doorgaan met chemotherapie. Na 1 jaar was het verschil in overall overleveing 75 procent voor Avelumab versus 40 procent voor chemotherapie. Desalniettemin waren deze resultaten niet statistisch significant volgens de onderzoekers.

Maar als je op 2 jaar een verschil maakt in overall overleving van 6 maanden wat wil je dan nog meer? 

Want ook de bijwerkingen voor de patiënten uit de chemotherapiegroep waren aanzienlijk hoger voor de chemotherapie dan voor de immuuntherapiegroep. Bij avelumab en chemotherapie traden behandelingsgerelateerde bijwerkingen (TRAE’s) op bij respectievelijk 184 patiënten in de chemogroep (77,3%) en bij 149 patiënten (61,3%), waaronder TRAE’s van graad ≥ 3 bij respectievelijk 78 (32,8%) patiënten voor de chemogroep en 31 (12,8%) voor de Avelumabgroep.

Fig 2. Overall survival (OS; measured from random assignment after 12 weeks of induction chemotherapy) in (A) all randomly assigned patients, (B) prespecified programmed death ligand-1 (PD-L1)–positive population (tumor cell PD-L1 expression, ≥ 1% cutoff; 73-10 assay), and (C) exploratory subset of patients with PD-L1–positive tumors based on combined positive score (≥ 1 cutoff; 22C3 assay). HR, hazard ratio; NR, not reached.

Hier de vertaling van de resultaten uit het abstract en studieverslag. 


  • In totaal kregen 805 patiënten inductie; 499 werden willekeurig toegewezen aan avelumab (n = 249) of voortgezette chemotherapie (n = 250).
  • De mediane overall overleving (OS) was 10,4 maanden (95%-BI: 9,1 tot 12,0 maanden) versus 10,9 maanden (95%-BI: 9,6 tot 12,4 maanden)
  • Het OS-percentage na 24 maanden was 22,1% versus 15,5% met respectievelijk avelumab versus chemotherapie (hazard ratio). HR], 0,91; 95% BI, 0,74 tot 1,11; P = 0,1779).
  • In de PD-L1-positieve populatie (n = 54) was de HR voor OS 1,13 (95% BI, 0,57 tot 2,23; P = 0,6352).
  • In een verkennende analyse van de PD-L1-positieve populatie, gedefinieerd als een gecombineerde positieve score ≥ 1 (22C3-assay; n = 137), was de mediane OS 14,9 maanden (95% BI, 8,7 tot 17,3 maanden) met avelumab versus 11,6 maanden ( 95% BI, 8,4 tot 12,6 maanden) met chemotherapie (niet-gestratificeerde HR, 0,72; 95% BI, 0,49 tot 1,05).
  • Bij avelumab en chemotherapie traden behandelingsgerelateerde bijwerkingen (TRAE’s) op bij respectievelijk 149 (61,3%) en 184 (77,3%) patiënten, waaronder TRAE’s van graad ≥ 3 bij respectievelijk 31 (12,8%) en 78 (32,8%) patiënten.

Waaruit de onderzoekers deze conclusie trekken:

JAVELIN Gastric 100 vertoonde geen superieure OS met onderhoud van avelumab versus voortgezette chemotherapie bij patiënten met gevorderde GC of GEJC in het algemeen of in een vooraf gespecificeerde PD-L1-positieve populatie.

Het volledige studierapport is gratis in te zien of te downloaden. Klik op de titel van het abstract:



The role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti–programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC.

Patients and Methods

JAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2–negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia v non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1–positive randomly assigned population (≥ 1% of tumor cells; 73-10 assay).


A total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio , 0.91; 95% CI, 0.74 to 1.11; P = .1779). In the PD-L1–positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23; P = .6352). In an exploratory analysis of the PD-L1–positive population, defined as combined positive score ≥ 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade ≥ 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively.


JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.


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