LBA2 First-line (1L) durvalumab (D) + platinum-etoposide (EP) for patients (pts) with extensive-stage SCLC (ES-SCLC): Primary results from the phase IIIb LUMINANCE study
Notice bibliographique
Résumé
The phase 3 CASPIAN study (NCT03043872) of 1L D + EP (4 cycles) vs EP alone (up to 6 cycles) in pts with ES-SCLC (WHO performance status [PS] 0–1) established D + EP as a global standard of care. However, like most phase 3 registration studies, elements of the study design did not fully reflect real-world clinical practice. The phase 3b LUMINANCE study (NCT04774380) evaluated D + up to 6 cycles of EP in pts with ES-SCLC, including those with WHO PS 2. We report results of the primary analysis. Pts with treatment (tx)-naïve ES-SCLC and WHO PS 0–2 received D 1500 mg + EP Q3W for up to 6 cycles (investigator decision), followed by D Q4W until progression. Primary endpoints were rates of grade ≥3 AEs and immune-mediated AEs (imAEs); secondary endpoints included objective response rate (ORR), duration of response (DoR), PFS and OS. As of 12 June 2023, 152 pts from 32 sites/5 countries had received tx, median follow-up was 37.3 weeks and 23.7% were still receiving D. Median age was 64.0 years, 64.5% of pts were male and 99.3% were white. Median no. of D doses was 8.5 (Table); 63.8% of pts received carboplatin and 38.8% received cisplatin. Grade ≥3 AEs occurred in 59.2% of pts (Table); most common were neutropenia (26.3%), anaemia (9.9%) and neutrophil count decreased (7.9%). Grade ≥3 AEs occurred in 44/66 (66.7%) and 45/85 (52.9%) pts who received 1–4 or ≥5 cycles of EP*, respectively. imAEs occurred in 13.8% of pts; most common was hypothyroidism (6.6%). Confirmed ORR (95% CI) was 65.8% (57.7–73.3); median PFS (95% CI) was 6.2 (5.3–6.5) months (mo); and median OS (95% CI) was 13.1 (10.1–not estimable [NE]) mo. Numerically better outcomes were observed in pts who received ≥5 cycles of EP (Table).Table: LBA2Total (N=152)Median (range) D doses8.5 (1–19)EP cycles* Median (range) ≥4, n (%) ≥5, n (%) 6, n (%)– 5.0 (1–6) 133 (87.5) 85 (55.9) 74 (48.7)Any-cause AE, n (%) Grade ≥3 Serious Led to tx discontinuation Led to death† imAE142 (93.4) 90 (59.2) 49 (32.2) 22 (14.5) 15 (9.9) 21 (13.8)Total (N=152)1–4 cycles of EP‡ (n=68)≥5 cycles of EP‡ (n=84)Confirmed ORR, n (%) 95% CI100 (65.8) 57.7–73.332 (47.1) 34.8–59.668 (81.0) 70.9–88.7Median DoR, mo 95% CI5.1 4.9–5.34.8 3.3–5.25.2 5.0–6.3Median PFS, mo 95% CI6.2 5.3–6.54.6 3.7–4.66.5 6.3–7.6Median OS, mo 95% CI13.1 10.1–NE10.7 6.4–16.8NR 11.0–NE*Based on etoposide; 1 pt received no etoposide. †4 possibly related to EP; none to D. ‡Based on platinum. NR, not reached Open table in a new tab *Based on etoposide; 1 pt received no etoposide. †4 possibly related to EP; none to D. ‡Based on platinum. NR, not reached Safety and efficacy findings from LUMINANCE, including those pts who received ≥5 cycles of induction chemo-IO, were consistent with those observed in CASPIAN. The results further support the use of D + EP as 1L tx for pts with ES-SCLC.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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 tête enseignante, 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 ».