Lenalidomide (Revlimid), Bortezomib (Velcade) and Dexamethasone (RVD) for Heavily Pretreated Relapsed or Refractory Multiple Myeloma
Notice bibliographique
Résumé
Abstract Abstract 5028 Lenalidomide (len) and bortezomib (btz) are active in multiple myeloma (MM). In preclinical studies, lenalidomide sensitized MM cells to bortezomib and dexamethasone (Mitsiades N, et al). The combination of lenalidomide (Revlimid), bortezomib (velcade), and dexamethasone (RVD) has shown excellent efficacy in relapsed/refractory (rel/ref) multiple myeloma (MM) patients (pts), with an overall response rate (ORR) of 84% and a partial response (PR) rate of 68%, including 21% complete/near complete responses (CR/nCR), median duration of response was 24 weeks in responding patients and median number of cycles was 6 (Anderson KC, et al. ASCO 2009: abstract 8536). The aim of this study is to assess the efficacy and toxicity profile when len is used in combination with btz and dexamethasone (dex) for pts with relapsed/refractory (rel/ref) disease outside the setting of clinical trials. Patients and Methods We retrospectively reviewed the records of all pts with rel/ref MM who were treated with RVD at Princess Margaret Hospital between March 2009 and March 2010. Eighteen pts were treated with at least 1 full cycle of RVD therapy given as len 10 mg/d on days 1–14, btz 1.0 or 1.3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles and dex (20 mg or 40 mg on days of and after btz). Pts routinely received concomitant antithrombotic and antiviral prophylaxis. Primary endpoints were response rate, time to progression (TTP) and toxicity. Responses were assessed according to modified EBMT and Uniform criteria. Toxicity was assessed using NCI-CTC, version 3.0. Results Clinical characteristics are seen in Table 1. Median age was 57 (37-71) years; 55% were female. The median number of prior therapies was 3 (2-6), and the majority of pts had already been treated with len (83%) and btz (78%) separately, and 77% had received both drugs previously but not in combination. In many instances, pts previously treated with len had len added to btz + dex at progression (n=5), or pts previously treated with btz had btz added to len + dex, at progression (n=4). After a median of 4.9 cycles (range 1–14), PR was observed in 7 (39%) and stable disease (SD) in 2 (11%) pts, for an ORR of 39%. Disease progression was seen in 14 pts at a median TTP of 4 months (1-13.6 months). Currently, 6 pts (33%) remain alive at a median F/U of 6.83 months (1.4-18.6 months). Median overall survival was 6.88 months (1-18.6 months) and six patients had a greater than 6 month response. Six pts have experienced grade 3/4 adverse events, including anemia, neutropenia, muscle weakness, hyperglycemia, and pneumonia. No deep vein thrombosis was observed. The side effect profile was manageable; importantly no patient experienced worsening of peripheral neuropathy. Conclusions The ORR for our heavily treated patient population was 39% which is lower than that reported by Anderson et al (ASCO, 2009). The median TTP was also short at 4 months. These differences can be partly explained by the fact the majority of our pts had previously received all the agents in RVD, while only 8% of the pts in the Anderson series had prior len exposure. These data suggest that the RVD combination can be effective in rel/ref MM, but responses/duration are affected by very advanced disease stage at relapse and the extent of prior treatment. Disclosures: Reece: Celgene: Honoraria, Research Funding. Chen:Celgene Corporation: Consultancy, Honoraria, Research Funding. Kukreti:Celgene: Honoraria.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».