Phase II Study of Weekly Paclitaxel and Weekly Carboplatinum in Recurrent Platinum Sensitive Ovarian Cancer
Charles J. Dunton
Albert Einstein Healthcare Network
Philadelphia, PA, USA

In patients with recurrent platinum sensitive ovarian cancer, weekly paclitaxel plus weekly carboplatinum is a highly effective regimen. Patients tolerated treatment well. Allergic reactions are not more common than in standard retreatment regimens. This regimen deserves consideration as a front line therapy.

Dr. Dunton and colleagues have evaluated the efficacy and toxicity of a weekly combination therapy for patients with recurrent platinum-sensitive ovarian cancer.

Investigators with the Jefferson Oncology Group enrolled 20 patients with recurrent platinum-sensitive ovarian cancer in a multi-institution phase II study. They evaluated patient response to weekly paclitaxel (80 mg/m2) and weekly carboplatinum (AUC=2) using clinical criteria, radiographic methods and CA-125 response by the Restin criteria.

Patients had to be platinum sensitive (defined as a treatment-free interval greater than 6 months) and had only one previous treatment. They had to have measurable disease by clinical or radiographic methods or CA125 greater than 70 and doubling. Excluded patients had poor performance status, inability to give informed consent, or previous allergic reactions to either paclitaxel or carboplatinum. Patient response was evaluated after 8 treatment cycles.

Dr. Dunton reported the results of this study in a poster session. The mean platinum-free interval in this group of patients was 20.9 months (range 8-56 months). Patients received an average of 13.4 treatment cycles.

The results suggested that a regimen of weekly paclitaxel and weekly carboplatinum was highly effective as second-line therapy. Of the 20 enrolled patients, 17 had clinically evaluable disease. The clinical response rate was 82%; this included 9 complete responses and 5 partial responses. The remaining 3 patients had stable disease.


Response Rate
by Clinical Assessment and Restin Criteria



Criteria
N
Complete
Response
Partial Response
% Response Rate (patients)
Stable Disease
Progressive*
Disease
Clinical
17
9
5
82%
(14)
3
-
Restin
(CA-125)
18
14
4
100%
(18)
- 
-



Of 18 patients evaluable by CA-125 measurements, the response rate was 100%; this included 14 complete responses and 4 partial responses. The median progression free survival was 11.2 months (range 2 to 24 months).

Toxicities were slight. Grade 3 neutropenia occurred in 20% of cases (4 of 20 patients), grade 2 neurotoxicity in 10% (2 of 20 patients). Grade 3 anemia occurred in 5% of cases (1 of 20 patients). Only 15% of patients had an allergic reaction.

Dr. Dunton concluded that weekly paclitaxel plus weekly carboplatin is a highly effective regimen for the treatment of recurrent ovarian cancer in a platinum-sensitive group of patients. It is well tolerated. This suggests weekly dosing may increase effectiveness and decrease toxicity. In the future, clinicians should consider this type of regimen for first-line treatment.

 

Reporter: Andrew Bowser