Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer

Updated results and long-term survival

Gabriella Ferrandina, Ida Paris, Manuela Ludovisi, Giuseppe D'Agostino, Antonia Testa, Domenica Lorusso, Mariangela Zanghi, Salvatore Pisconti, Giuseppa Pezzella, Vincenzo Adamo, Enrico Breda, Giovanni Scambia

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Objective. The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients. Methods. This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinum/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m-2, was administered on day 1 followed by GEM, 1000 mg m-2, on days 1 and 8, every 21 days. Results. 106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively. Conclusions. GEM/PLD combination represents a valid approach in recurrent ovarian cancer patients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low.

Original languageEnglish
Pages (from-to)267-273
Number of pages7
JournalGynecologic Oncology
Volume98
Issue number2
DOIs
Publication statusPublished - Aug 2005

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gemcitabine
Salvage Therapy
Ovarian Neoplasms
Survival
Platinum
liposomal doxorubicin

Keywords

  • Gemcitabine
  • Liposomal doxorubicin
  • Recurrent ovarian cancer

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology

Cite this

Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer : Updated results and long-term survival. / Ferrandina, Gabriella; Paris, Ida; Ludovisi, Manuela; D'Agostino, Giuseppe; Testa, Antonia; Lorusso, Domenica; Zanghi, Mariangela; Pisconti, Salvatore; Pezzella, Giuseppa; Adamo, Vincenzo; Breda, Enrico; Scambia, Giovanni.

In: Gynecologic Oncology, Vol. 98, No. 2, 08.2005, p. 267-273.

Research output: Contribution to journalArticle

Ferrandina, G, Paris, I, Ludovisi, M, D'Agostino, G, Testa, A, Lorusso, D, Zanghi, M, Pisconti, S, Pezzella, G, Adamo, V, Breda, E & Scambia, G 2005, 'Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: Updated results and long-term survival', Gynecologic Oncology, vol. 98, no. 2, pp. 267-273. https://doi.org/10.1016/j.ygyno.2005.04.018
Ferrandina, Gabriella ; Paris, Ida ; Ludovisi, Manuela ; D'Agostino, Giuseppe ; Testa, Antonia ; Lorusso, Domenica ; Zanghi, Mariangela ; Pisconti, Salvatore ; Pezzella, Giuseppa ; Adamo, Vincenzo ; Breda, Enrico ; Scambia, Giovanni. / Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer : Updated results and long-term survival. In: Gynecologic Oncology. 2005 ; Vol. 98, No. 2. pp. 267-273.
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AU - D'Agostino, Giuseppe

AU - Testa, Antonia

AU - Lorusso, Domenica

AU - Zanghi, Mariangela

AU - Pisconti, Salvatore

AU - Pezzella, Giuseppa

AU - Adamo, Vincenzo

AU - Breda, Enrico

AU - Scambia, Giovanni

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N2 - Objective. The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients. Methods. This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinum/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m-2, was administered on day 1 followed by GEM, 1000 mg m-2, on days 1 and 8, every 21 days. Results. 106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively. Conclusions. GEM/PLD combination represents a valid approach in recurrent ovarian cancer patients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low.

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