Clinical trialPhase 3Ovarian cancer

Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study

JCO · 2003792 eligible patients
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, et al. JCO. 2003. 21:3194-3200
Study type
Clinical trial
Study name
GOG-158
Phase
Phase 3
Design
Phase 3 randomised non-inferiority trial
Sample size
792 eligible patients
Source
JCO · 2003

In plain words

This study compared two chemotherapy regimens for women with advanced ovarian cancer who had had optimal surgery: one with cisplatin and the other with carboplatin, both given with paclitaxel. The results showed that the carboplatin regimen works no less well, has fewer side effects and is easier to give.

Key results

20.7 months (carboplatin + paclitaxel) vs 19.4 months (cisplatin + paclitaxel)
Median progression-free survival
57.4 months (carboplatin + paclitaxel) vs 48.7 months (cisplatin + paclitaxel)
Median overall survival
0.88
Relative risk (RR) of progression in the carboplatin + paclitaxel group
95% CI 0.75–1.03
0.84
Relative risk (RR) of death in the carboplatin + paclitaxel group
95% CI 0.70–1.02

Dose and schedule cards

Carboplatin + cyclophosphamide (FDA label)

Initial treatment of advanced ovarian cancerCycle length: Every 4 weeksOn the page “Carboplatin (Paraplatin)” · Standard dosing and combination regimens

Ovary, first line (label)

Previously untreated advanced ovarian cancerCycle length: Every 3 weeksOn the page “Paclitaxel (Taxol)” · Standard doses (FDA label)

Previously untreated advanced ovarian cancer

DrugDoseRouteSchedule
Option A
Paclitaxel175 mg/m²IV infusion over 3 hoursDay 1, before cisplatin
Cisplatin75 mg/m²IVDay 1
Option B
Paclitaxel135 mg/m²IV infusion over 24 hoursDay 1, before cisplatin
Cisplatin75 mg/m²IVDay 1
Cycle length
Every 3 weeks
Duration
According to the treatment protocol

The choice between the two regimens is based on their different toxicities. In practice, carboplatin now usually replaces cisplatin (GOG-158).

On the page “Paclitaxel (Taxol)” · Standard doses (FDA label)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Group 1 (cisplatin + paclitaxel)

Cisplatin 75 mg/m² with a 24-hour infusion of paclitaxel 135 mg/m².

2Group 2 (carboplatin + paclitaxel)

Carboplatin at an area under the curve (AUC) of 7.5 IV with paclitaxel 175 mg/m² over 3 hours.

Source of the regimen details: Abstract of the paper (the number of cycles is not given in the abstract)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with advanced ovarian cancer (stage 3 epithelial ovarian cancer) with no residual mass larger than 1.0 cm after surgery (optimal resection).

Endpoints

The aim of the study was to assess the non-inferiority of carboplatin + paclitaxel compared with cisplatin + paclitaxel. The abstract reports progression-free survival, overall survival and toxicities.

Safety and side effects

Gastrointestinal, renal and metabolic toxicities and grade 4 leucopenia were significantly more common in the cisplatin + paclitaxel group. Grade 2 or higher thrombocytopenia was more common in the carboplatin + paclitaxel group. Neurotoxicity was similar with the two regimens.

Clinical significance and place in guidelines

Based on the abstract, carboplatin plus paclitaxel, with less toxicity, easier administration and non-inferior efficacy, is an acceptable alternative to cisplatin plus paclitaxel in optimally resected advanced ovarian cancer. The current place of this regimen in clinical guidelines should be checked in up-to-date sources.

Limitations

Based on the abstract, the 95% CI for the relative risk of progression (0.75–1.03) and of death (0.70–1.02) includes 1, so a significant superiority of carboplatin was not shown and the result only demonstrates non-inferiority. The two groups also differed in the paclitaxel infusion schedule (24 hours versus 3 hours). Other limitations are not reported in the abstract.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.