Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients: A retrospective, multicenter study

Gabriella Ferrandina, Giacomo Corrado, Floriana Mascilini, Paola Malaguti, Riccardo Samaritani, Mariagrazia Distefano, Valeria Masciullo, Alessia Di Legge, Antonella Savarese, Giovanni Scambia

Research output: Contribution to journalArticle

Abstract

Background: The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients. Methods: oral cyclophosphamide (Endoxan®, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed. Results: 54 patients were analyzed: 20 patients (37.0%) were considered primarily platinum refractory/resistant, while 34 patients (63.0%) were defined as platinum sensitive; 79.6% of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4%. Eleven patients (20.4%) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.%) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6%; median OS was 13 months, and the 12-month OS rate was 51.5%. Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients. Conclusions: MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients.

Original languageEnglish
Article number947
JournalBMC Cancer
Volume14
Issue number1
DOIs
Publication statusPublished - Dec 13 2014

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Salvage Therapy
Ovarian Neoplasms
Cyclophosphamide
Multicenter Studies
Retrospective Studies
Platinum
Survival
Disease Progression
Palliative Care
Italy
Anemia

Keywords

  • Cyclophosphamide
  • Metronomic administration
  • Ovarian cancer
  • Salvage treatment

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Genetics

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Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients : A retrospective, multicenter study. / Ferrandina, Gabriella; Corrado, Giacomo; Mascilini, Floriana; Malaguti, Paola; Samaritani, Riccardo; Distefano, Mariagrazia; Masciullo, Valeria; Di Legge, Alessia; Savarese, Antonella; Scambia, Giovanni.

In: BMC Cancer, Vol. 14, No. 1, 947, 13.12.2014.

Research output: Contribution to journalArticle

Ferrandina, Gabriella ; Corrado, Giacomo ; Mascilini, Floriana ; Malaguti, Paola ; Samaritani, Riccardo ; Distefano, Mariagrazia ; Masciullo, Valeria ; Di Legge, Alessia ; Savarese, Antonella ; Scambia, Giovanni. / Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients : A retrospective, multicenter study. In: BMC Cancer. 2014 ; Vol. 14, No. 1.
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abstract = "Background: The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients. Methods: oral cyclophosphamide (Endoxan{\circledR}, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed. Results: 54 patients were analyzed: 20 patients (37.0{\%}) were considered primarily platinum refractory/resistant, while 34 patients (63.0{\%}) were defined as platinum sensitive; 79.6{\%} of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4{\%}. Eleven patients (20.4{\%}) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.{\%}) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6{\%}; median OS was 13 months, and the 12-month OS rate was 51.5{\%}. Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients. Conclusions: MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients.",
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T1 - Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients

T2 - A retrospective, multicenter study

AU - Ferrandina, Gabriella

AU - Corrado, Giacomo

AU - Mascilini, Floriana

AU - Malaguti, Paola

AU - Samaritani, Riccardo

AU - Distefano, Mariagrazia

AU - Masciullo, Valeria

AU - Di Legge, Alessia

AU - Savarese, Antonella

AU - Scambia, Giovanni

PY - 2014/12/13

Y1 - 2014/12/13

N2 - Background: The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients. Methods: oral cyclophosphamide (Endoxan®, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed. Results: 54 patients were analyzed: 20 patients (37.0%) were considered primarily platinum refractory/resistant, while 34 patients (63.0%) were defined as platinum sensitive; 79.6% of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4%. Eleven patients (20.4%) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.%) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6%; median OS was 13 months, and the 12-month OS rate was 51.5%. Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients. Conclusions: MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients.

AB - Background: The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients. Methods: oral cyclophosphamide (Endoxan®, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed. Results: 54 patients were analyzed: 20 patients (37.0%) were considered primarily platinum refractory/resistant, while 34 patients (63.0%) were defined as platinum sensitive; 79.6% of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4%. Eleven patients (20.4%) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.%) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6%; median OS was 13 months, and the 12-month OS rate was 51.5%. Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients. Conclusions: MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients.

KW - Cyclophosphamide

KW - Metronomic administration

KW - Ovarian cancer

KW - Salvage treatment

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