Fiche publication
Date publication
février 2010
Auteurs
Membres identifiés du Cancéropôle Est :
Pr FUMOLEAU Pierre
,
Pr PETIT Thierry
Tous les auteurs :
Pautier P, Joly F, Kerbrat P, Bougnoux P, Fumoleau P, Petit T, Rixe O, Ringeisen F, Carrasco AT, Lhomme C
Lien Pubmed
Résumé
OBJECTIVE: This phase II investigated efficacy and tolerability of gefitinib in combination with paclitaxel (P) and carboplatin (C) for second-line treatment of patients (pts) with ovarian, tubal or peritoneal adenocarcinoma. PATIENTS AND METHODS: Women (>18 years) with platinum-resistant/refractory (relapsed6 months) disease after first-line platinum-based and P chemotherapy. Pts received 6-8 cycles of gefitinib (500 mg/day), P (175 mg/m(2) 3 h infusion) and C (AUC 5) every 3 weeks, followed by gefitinib alone. The primary endpoint was objective response rate (ORR) (RECIST or Rustin criteria). RESULTS: Sixty-eight patients (26 resistant/refractory and 42 sensitive) were enrolled (median age: 57 years). ORR and disease control rates were 19.2% and 69.2% for resistant/refractory, and 61.9% and 81.0%, for sensitive disease. Median time to progression and overall median survivals were 6.1 and 16.9 months for resistant/refractory and 9.2 and 25.7 months for sensitive disease. Grade 3/4 toxicities (in > or = 10% patients) were neutropenia (59%), diarrhea (25%), leukopenia (22%), anemia (13%), and acne (13%). Two secondary myelodysplastic syndromes (MDS) and one secondary acute leukemia occurred during treatment, and one MDS 34 months after treatment discontinuation. CONCLUSION: Gefitinib, administered in combination with paclitaxel and carboplatin, provides a good clinical response but associated with an increased risk of hematologic disorders.
Référence
Gynecol Oncol. 2010 Feb;116(2):157-62.
