7 februari 2022: Bron: Blood Cancer Journal

Wanneer patiënten met de ziekte van Kahler - multiple myeloma die nog geen behandeling hebben gehad naast de standaard behandeling van lenalidomide en dexamethason ook vanaf het begin van de behandeling bortezomib erbij krijgen dan blijkt de progressievrije ziektetijd langer te duren (plus 12 maanden) en de overall overleving sterk te verbeteren (minimaal 15 maanden maar eindpunt was nog niet bereikt voor bortezomib) in vergelijking met aanpak zonder bortezomib. Dit blijkt uit een update van een fase III studie SWOG S0777 .

SWOG S0777, een gerandomiseerde fase III-studie, vergeleek bortezomib, lenalidomide en dexamethason (VRd) met lenalidomide en dexamethason (Rd).
Deze bijgewerkte analyse omvat 460 patiënten die evalueerbaar zijn voor overlevingseindpunten: 225 in aanmerking komende en analyseerbare patiënten werden gerandomiseerd naar Rd en 235 naar VRd. De inductie van 6 maanden bestond uit zes cycli van 28 dagen met Rd en acht cycli van 21 dagen van VRd gevolgd door Rd-onderhoud voor alle patiënten.

De mediane follow-up is 84 maanden.
De mediane PFS is 41 maanden voor VRd en 29 maanden voor Rd: gestratificeerde hazard ratio (96% Wald-betrouwbaarheidsinterval) was 0,742 (0,594; 0,928) en eenzijdig gestratificeerde log-rank P-waarde 0,003.
De mediane OS voor VRd is nog steeds niet bereikt met een mediane OS voor Rd van 69 maanden: gestratificeerde hazard ratio (96% Wald-betrouwbaarheidsinterval) was 0,709 (0,543; 0,926) en de gestratificeerde tweezijdige P-waarde was 0,0114.
Zowel PFS als OS waren verbeterd met VRd versus Rd-correctie voor leeftijd (P-waarden: 0,013 ; 0,033 )). De mediane duur van Rd-onderhoud was 17,1 maanden.

Conclusie: De toevoeging van bortezomib aan lenalidomide dexamethason voor inductietherapie resulteert in een statistisch significante en klinisch relevante verbetering van de PFS en een betere OS. VRd blijft een passende zorgstandaard vertegenwoordigen, ongeacht de leeftijd.

Het studierapport is gratis in te zien. Klik op de titel van het abstract.

Article
Open Access
Published: 11 May 2020

Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT)

Blood Cancer Journal volume 10, Article number: 53 (2020) Cite this article

Abstract

SWOG S0777, a randomized phase III trial, compared bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd). This updated analysis includes 460 patients evaluable for survival endpoints: 225 eligible and analyzable patients were randomized to Rd and 235 to VRd. The 6-month induction was six 28-day cycles of Rd and eight 21-day cycles of VRd followed by Rd maintenance for all patients. Median follow up is 84 months. Median PFS is 41 months for VRd and 29 months for Rd: stratified hazard ratio (96% Wald Confidence Interval) was 0.742 (0.594, 0.928) and one-sided stratified log-rank P-value 0.003. Median OS for VRd is still not reached with median OS for Rd being 69 months: stratified hazard ratio (96% Wald Confidence Interval) was 0.709 (0.543, 0.926) and stratified two-sided P-value was 0.0114. Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 ; 0.033 )). Median duration of Rd maintenance was 17.1 months. The addition of bortezomib to lenalidomide dexamethasone for induction therapy results in a statistically significant and clinically meaningful improvement in PFS as well as better OS. VRd continues to represent an appropriate standard of care irrespective of age.

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