An international, phase III randomized trial in patients with mucinous epithelial ovarian cancer (mEOC/GOG 0241) with long-term follow-up: and experience of conducting a clinical trial in a rare gynecological tumor.
Gynecol Oncol
; 153(3): 541-548, 2019 06.
Article
en En
| MEDLINE
| ID: mdl-31005287
ABSTRACT
OBJECTIVES:
We evaluated four different treatment regimens for advanced-stage mucinous epithelial ovarian cancer.METHODS:
We conducted a multicenter randomized factorial trial (UK and US). Patients were diagnosed with primary mEOC FIGO stage II-IV or recurrence after stage I disease. Treatment arms were paclitaxel-carboplatin, oxaliplatin-capecitabine, paclitaxel-carboplatin-bevacizumab, or oxaliplatin-capecitabine-bevacizumab. Chemotherapy was given 3-weekly for 6â¯cycles, and bevacizumab (3-weekly) was continued as maintenance (for 12â¯cycles). Endpoints included overall-survival (OS), progression-free survival (PFS), toxicity and quality of life (QoL).RESULTS:
The trial stopped after 50 patients were recruited due to slow accrual. Median follow-up was 59â¯months. OS hazard ratios (HR) for the two main comparisons were 0.78 (pâ¯=â¯0.48) for Oxal-Cape vs. Pac-Carbo (each with/without bevacizumab), and 1.04 (pâ¯=â¯0.92) for bevacizumab vs. no bevacizumab. Corresponding PFS HRs were 0.84 and 0.80. Retrospective central pathology review revealed only 45% (18/40) cases with available material had confirmed primary mEOC. Among these, OS HR for Oxal-Cape vs. Pac-Carbo was 0.36 (pâ¯=â¯0.14); PFS HRâ¯=â¯0.62 (pâ¯=â¯0.40). Grade 3-4 toxicity was seen in 61% Pac-Carbo, 61% Oxal-Cape, 54% Pac-Carbo-Bev, and 85% Oxal-Cape-Bev. QoL was similar between the four arms.CONCLUSION:
mEOC/GOG0241 represents an example of a randomized rare tumor trial. Logistical challenges led to early termination, including difficulties in local histopathological diagnosis and accessing drugs outside their labelled indication. There was misalignment between central funders who support clinical trials in rare cancers and the deprioritisation of such work by those managing and funding research at a local level. Rare cancer trials should include centralised pathology review before treatment. Clinical trial registry number ISRCTN83438782.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Ováricas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias Quísticas, Mucinosas y Serosas
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Carcinoma Epitelial de Ovario
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Recurrencia Local de Neoplasia
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido