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Randomized Phase III second-line trial: Topotecan (TM) vs. Topotecan/Etoposide (TE), vs. Topotecan/Gemcitabine (TG) for patients (pts) with relapsed ovarian cancer (ROC)

Sehouli, J ; Sommer, H ; Klare, P ; Hindenburg, HJ ; Camara, O ; Lichtenegger, W

Geburtshilfe und Frauenheilkunde, 2006, Vol.66 (S 01) [Periódico revisado por pares]

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  • Título:
    Randomized Phase III second-line trial: Topotecan (TM) vs. Topotecan/Etoposide (TE), vs. Topotecan/Gemcitabine (TG) for patients (pts) with relapsed ovarian cancer (ROC)
  • Autor: Sehouli, J ; Sommer, H ; Klare, P ; Hindenburg, HJ ; Camara, O ; Lichtenegger, W
  • É parte de: Geburtshilfe und Frauenheilkunde, 2006, Vol.66 (S 01)
  • Descrição: Aims: Topotecan combined with etoposide (GINECO 1998) and gemcitabine (NOGGO 2001) proved effective second-line treatment for ROC. It is, however, unclear whether combined treatment improves survival and tumor control compared to TM. Methods: Women with ROC after primary surgery and platinum therapy were enrolled in an open-label randomized phase-III trial at 93 German institutions. Stratifying for treatment-free intervals (TFI) or less or more than 12 months, pts were centrally allocated to topotecan 1.25mg/m 2 /d TM, topotecan 1.0mg/m 2 /d plus oral etoposide 50mg/d (TE) on day 6–12, or topotecan 0.5mg/m 2 /d plus gemcitabine 800mg/m 2 /d1 and 600mg/m 2 /d8 (TG) every three weeks. Local institutional review boards approved this study, and all pts provided written informed consent. With 145 pts each arm, this study yielded 90% power to detect HR of 0.60 in OS at a two-sided alpha of 0.01. We employed Cox regression for primary endpoint analysis, and addressed PFS and toxicity descriptively. Results: Between September 1999 and November 2004, 3036 courses were administered to 505 pts (mean age 60.4 [SD 11.3] years), 208 of whom had a TFI<12 months. Women assigned to TM, TE, and TG received a median of 6.7 (range 0–10), 6.2 (0–9), and 5.4 (1–42) cycles. Median OS after TM, TE, and TG was 17.8, 17.8, and 15.3 months. Setting TM as reference, HRs for OS with TE and TG were 1.13 (95% CI 0.87–1.47) and 1.07 (95% CI 0.80–1.43, p=0.59). HRs for PFS with TE and TG vs. TM were calculated at 0.84 (95% CI 0.66–1.07) each. Subgroup analysis suggested enhanced PFS among subjects with TFI 3 12 months who received TE (HR 0.62, 95%CI 0.42–0.91) or TG (HR 0.68, 95% CI 0.46–1.01) rather than TM. TE producer higher CTC grade ¾ hematotoxicity than TM or TG, with cumulative incidences of 24.4% (95% CI 20.2–29.0%), 16.0% (95% CI 11.9–20.9%), and 14.7% (10.6–19.5%). Conclusions: This large RCT does not provide evidence that combined treatment performs generally better than TM in ROC.
  • Idioma: Inglês;Alemão
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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