Phase II study of gefitinib in combination with paclitaxel (P) and carboplatin (C) as second-line therapy for ovarian, tubal or peritoneal adenocarcinoma (1839IL/0074).
Gynecol Oncol
; 116(2): 157-62, 2010 Feb.
Article
en En
| MEDLINE
| ID: mdl-20109725
ABSTRACT
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 ANDMETHODS:
Women (>18 years) with platinum-resistant/refractory (relapsed<6 months), or platinum-sensitive (relapsed >6 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.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Neoplasias Ováricas
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Neoplasias Peritoneales
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Adenocarcinoma
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias de las Trompas Uterinas
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Año:
2010
Tipo del documento:
Article
País de afiliación:
Francia