Usually with paclitaxel
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cisplatin | 75 to 100 mg/m² | Slow IV infusion | Day 1 |
Dosing as per the FDA label.
In the GOG trial (410 women): cisplatin 75 mg/m² with paclitaxel 135 mg/m² over 24 hours.
Cyclophosphamide and Cisplatin Compared with Paclitaxel and Cisplatin in Patients with Stage III and Stage IV Ovarian Cancer
McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. N Engl J Med. 1996. 334:1-6
- Study type
- Clinical trial
- Study name
- GOG-111
- Phase
- Phase 3
- Design
- Randomised controlled trial with two treatment groups
- Sample size
- 410 patients randomised (386 met all eligibility criteria)
- Source
- N Engl J Med · 1996
In plain words
This study compared two chemotherapy combinations for women with advanced ovarian cancer who still had some tumour left after surgery. Women who received paclitaxel with cisplatin lived longer on average without the disease getting worse (18 versus 13 months) and lived longer overall (38 versus 24 months). Side effects such as hair loss, low white blood cell counts, fever and allergic reactions were more common in this group.
Key results
73% vs 60% (cisplatin-paclitaxel vs cisplatin-cyclophosphamide)
Response rate (patients with measurable disease, 216 patients)
P=0.01
Similar frequency in the two groups
Surgically confirmed complete response
18 months vs 13 months
Progression-free survival (median)
P<0.001
38 months vs 24 months
Overall survival (median)
P<0.001
Dose and schedule cards
Advanced ovarian cancer (FDA label)
Usually with paclitaxelCycle length: Every 3 to 4 weeksOn the page “Cisplatin (Platinol)” · Regimens and dosing
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
1Cisplatin + cyclophosphamide
Cisplatin 75 mg/m² with cyclophosphamide 750 mg/m².
For 6 cycles (according to the paclitaxel label).
2Cisplatin + paclitaxel
Cisplatin 75 mg/m² with paclitaxel 135 mg/m² over 24 hours.
For 6 cycles (according to the paclitaxel label).
Source of the regimen details: Abstract of the paper and the FDA label for paclitaxel (DailyMed, Clinical Studies section; 6 cycles)
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
Women with advanced (stage 3 and 4) ovarian cancer with residual masses larger than 1 cm after primary surgery. Of the 410 randomised patients, 386 met all eligibility criteria and 216 had measurable disease.
Endpoints
The abstract does not explicitly state the primary endpoint. Reported measures included response to treatment (in patients with measurable disease), surgically confirmed complete response, progression-free survival and overall survival.
Safety and side effects
Alopecia, neutropenia, fever and allergic reactions were reported more often in the cisplatin-paclitaxel group. Numerical rates of grade ≥3 adverse events are not given in the abstract.
Clinical significance and place in guidelines
This study showed that, in first-line treatment of suboptimally debulked advanced ovarian cancer, paclitaxel with cisplatin improves progression-free and overall survival compared with cisplatin-cyclophosphamide. The current place of this regimen in clinical guidelines should be checked in up-to-date reliable sources, as the abstract does not address it.
Limitations
Based on the abstract, numerical rates of severe adverse events and the primary endpoint are not specified. Response was assessed only in the subgroup with measurable disease (216 patients). Other methodological details are in the full text of the paper.
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.