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

Vici P, Sergi D, Pizzuti L, Mariani L, Arena MG, Barba M, Maugeri-Saccà M, Vincenzoni C, Vizza E, Corrado G, Paoletti G, Tomao F, Tomao S, Giannarelli D, Di Lauro L - J. Exp. Clin. Cancer Res. (2013)

Bottom Line: Objective responses plus disease stabilization (clinical benefit) occurred in 78% of patients.The most common adverse effects of any grade were gastrointestinal symptoms, fatigue and neutropenia.Under circumstances requiring a rapid disease control, this combination regimen may offer a particularly viable option, particularly in heavily pretreated patients.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

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.

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Overall survival (OS).
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Figure 2: Overall survival (OS).

Mentions: Based on ITT analysis, 2 (5%) complete responses (CR) and 13 (32%) partial responses (PR) were observed in 41 enrolled patients, for an overall response rate of 37% (95% CI, 22.3 to-51.7%.). Stable disease was observed in 17 patients (41%). A clinical benefit (objective responses + stable disease) was documented in 32 patients (78%) (95% CI, 65–91) (Table 2). Among patients whose disease was originally partially platinum-sensitive, response rate was 50%, while in platinum-resistant or refractory patients response rate was 26%. The PFS was 6.8 months (95% CI, 5.8–7.8) (Figure 1), with no significant difference between initially platinum-sensitive and platinum-resistant patients (7.0 and 6.7 months, respectively). After a median follow-up of 14.5 months (range, 2 to 30), 69.2% and 10.1% patients were alive at 1 and 2 years, respectively; the median OS for the whole cohort was 16.5 months (95% CI, 12.2–20.8) (Figure 2). The median time to self-reported symptom relief, which occurred in 22 out of 27 symptomatic patients (81.5%), was 4 weeks (range, 2–8 weeks); even if symptom improvement translated into objective response in only 8 patients, some degree of amelioration in quality of life was reported by the vast majority of symptomatic patients.


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

Vici P, Sergi D, Pizzuti L, Mariani L, Arena MG, Barba M, Maugeri-Saccà M, Vincenzoni C, Vizza E, Corrado G, Paoletti G, Tomao F, Tomao S, Giannarelli D, Di Lauro L - J. Exp. Clin. Cancer Res. (2013)

Overall survival (OS).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750635&req=5

Figure 2: Overall survival (OS).
Mentions: Based on ITT analysis, 2 (5%) complete responses (CR) and 13 (32%) partial responses (PR) were observed in 41 enrolled patients, for an overall response rate of 37% (95% CI, 22.3 to-51.7%.). Stable disease was observed in 17 patients (41%). A clinical benefit (objective responses + stable disease) was documented in 32 patients (78%) (95% CI, 65–91) (Table 2). Among patients whose disease was originally partially platinum-sensitive, response rate was 50%, while in platinum-resistant or refractory patients response rate was 26%. The PFS was 6.8 months (95% CI, 5.8–7.8) (Figure 1), with no significant difference between initially platinum-sensitive and platinum-resistant patients (7.0 and 6.7 months, respectively). After a median follow-up of 14.5 months (range, 2 to 30), 69.2% and 10.1% patients were alive at 1 and 2 years, respectively; the median OS for the whole cohort was 16.5 months (95% CI, 12.2–20.8) (Figure 2). The median time to self-reported symptom relief, which occurred in 22 out of 27 symptomatic patients (81.5%), was 4 weeks (range, 2–8 weeks); even if symptom improvement translated into objective response in only 8 patients, some degree of amelioration in quality of life was reported by the vast majority of symptomatic patients.

Bottom Line: Objective responses plus disease stabilization (clinical benefit) occurred in 78% of patients.The most common adverse effects of any grade were gastrointestinal symptoms, fatigue and neutropenia.Under circumstances requiring a rapid disease control, this combination regimen may offer a particularly viable option, particularly in heavily pretreated patients.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus