A phase 2, single agent study of CI-1033 administered at two doses in ovarian cancer patients who failed platinum therapy
Notice bibliographique
Résumé
5054 Background: Ovarian cancer that is refractory to platinum-based therapies is a therapeutic challenge, particularly in the setting of erbB-1 and -2 receptor over- expression. CI-1033 is an irreversible, 4-anilinoquinazoline pan-erbB tyrosine kinase inhibitor with activity in a wide variety of human tumor xenografts, particularly erbB+ tumors including ovarian SK-OV-3. Methods: This study evaluated 50- and 200mg doses of CI-1033, given daily for 21 days repeated every 28 until disease progression in pts with platinum-refractory ovarian cancer. Primary eligibility criteria included disease progression following platinum therapy, measurable disease, and Karnofsky Performance Status (KPS) of 60–100. Baseline tumor erbB receptor profiles were determined by IHC staining retrospectively in 56 of the 105 pts. Endpoints included 1-yr progression-free survival (PFS) and overall survival (OS). Results: Between January and May of 2002, 105 patients were enrolled. Baseline characteristics were balanced between both groups: overall median number of prior chemotherapy regimens was 4 (1–12); median KPS was 90. Fifty-three pts received 146 cycles in the 50-mg arm; 52 pts received 138 cycles in the 200-mg arm. Dose reductions were necessary in 59% of pts in the 200-mg arm predominantly due to gastrointestinal adverse effects (AEs); no pts required dose reductions in the 50-mg arm. The most common treatment-related AEs in the 50-mg arm were Grade 1–2 diarrhea (57%), asthenia (43%), and nausea (41%); AEs in the 200-mg arm were Grade 2–3 diarrhea (85%), stomatitis (69%), and rash (58%). There were no objective responders in either arm; stable disease (≥8 weeks) was achieved in 28% and 34% of pts in the 50- and 200-mg arms, respectively. One-yr PFS rates were 0% and 9%, and 1-year OS were 37% and 38% for 50- and 200-mg dose group, respectively. No associations were apparent between baseline tumor erbB expression profiles and PFS or OS. Conclusions: CI-1033 has minimal activity in this heavily pretreated, platinum-refractory population. The 50-mg dosing regimen was better tolerated than the 200-mg arm, with gastrointestinal AEs being most common toxicities. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Employed by Pfizer Eli-Lilly Pfizer Eli Lilly; GlaxoSmithKline
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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 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| 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) | 0,000 | 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 ».