Gemcitabine-oxaliplatin (GEMOX) as salvage treatment in pretreated epithelial ovarian cancer patients

Journal of Experimental & Clinical Cancer Research

Luigi Di Lauro²  Diana Giannarelli³  Silverio Tomao⁵  Federica Tomao⁶  Giancarlo Paoletti²  Giacomo Corrado⁴  Enrico Vizza⁴  Cristina Vincenzoni⁴  Marcello Maugeri-Saccà⁷  Maddalena Barba⁷  Maria Grazia Arena¹  Luciano Mariani⁴  Laura Pizzuti²  Domenico Sergi²  Patrizia Vici² 

[1] Division of Medical Oncology, Toraldo Hospital, Tropea, Italy;Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy;Biostatistics Unit, Regina Elena National Cancer Institute, Rome, Italy;Division of Gynecologic Oncology, Regina Elena National Cancer Institute, Rome, Italy;Department of Medico-Surgical Sciences and Biotechnologies, Oncology Unit, “SM Goretti” Hospital, “Sapienza” University, Latina, Italy;Department of Gynecologic and Obstetric Sciences, La Sapienza University of Rome, Rome, Italy;Department of Medical Oncology-Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy

关键词: Platinum-resistant;    Oxaliplatinum;    Ovarian cancer;    Gemcitabine;    Combination therapy;   

Others  :  824825
DOI  :  10.1186/1756-9966-32-49

 received in 2013-06-25, accepted in 2013-08-07,  发布年份 2013

【 摘 要 】

Background

Currently, no clearly superior management strategy exists for recurrent, platinum-resistant ovarian cancer. We tested the efficacy and safety of gemcitabine combined with oxaliplatin (GEMOX) in a multicentre phase II clinical trial.

Methods

Forty one patients with recurrent, platinum-resistant ovarian cancer were enrolled. Prior to study entry, all the participants had received at least one platinum-based regimen. Gemcitabine was administered at 1000 mg/m² as protracted infusion (100 min) on day 1, and oxaliplatin at the dose of 100 mg/m² on day 2 in a 2 hour infusion. Cycles were repeated every two weeks.

Results

We observed an overall response rate of 37% [95% Confidence Interval (CI), 22.3–51.7]. Objective responses plus disease stabilization (clinical benefit) occurred in 78% of patients. Median progression-free survival was 6.8 months (95% CI, 5.8–7.8), and median overall survival was 16.5 months (95% CI, 12.2–20.8). Median time to self-reported symptom relief, which was described by 22 out of 27 symptomatic patients (81.5%), was 4 weeks (range, 2–8). Grade 4 neutropenia and febrile neutropenia were observed in 2 (5%) and 1 (2.5%) patients, while grade 3 anemia was encountered in 2 (5%) patients, respectively. The most common adverse effects of any grade were gastrointestinal symptoms, fatigue and neutropenia. Nine patients (22%) experienced mild allergic reaction to oxaliplatin, with no treatment discontinuation.

Conclusions

In our cohort of recurrent, platinum-resistant ovarian cancer patients, GEMOX showed encouraging activity and manageable toxicity. Under circumstances requiring a rapid disease control, this combination regimen may offer a particularly viable option, particularly in heavily pretreated patients.

【 授权许可】

   
2013 Vici et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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