A landmark study showed that a new drug combinationpaclitaxel (Taxol) and carboplatin(Drug information on carboplatin) (Paraplatin)is better for the treatment of advanced ovarian cancer because it is significantly less toxic in patients. The combination also maintained the high level of efficacy of the previous paclitaxel(Drug information on paclitaxel)-based chemotherapy regimen (paclitaxel/cisplatin [Platinol]). This phase III, multicenter trial conducted by the Gynecologic Oncology Group (GOG) was presented at the 35th annual meeting of the American Society of Clinical Oncology (ASCO).
There were concerns that carboplatin would be less effective when compared to cisplatin(Drug information on cisplatin), the drug that had been previously used with paclitaxel, said Robert F. Ozols, MD, PhD, senior vice president of Medical Science at Fox Chase Cancer Center in Philadelphia. Not only does this study prove that carboplatin is at least as effective as cisplatin, but it presents fewer troublesome side effects for patients. Toxic side effects, such as nausea and weight loss, decreased.
Three-Hour Carboplatin Infusion Safe and Effective
The study also confirmed that paclitaxel and carbo-platin can be administered safely and effectively over a 3-hour infusion period. Previously, the paclitaxel/cisplatin combination was administered over 24 hours, requiring a hospital stay.
The paclitaxel/carboplatin regimen was well tolerated by patients and caused fewer gastrointestinal, genitourinary, and metabolic effects, such as nausea, vomiting, weight loss, and kidney damage. The decrease in toxicity, however, was not associated with any decrease in efficacy.
The study (GOG 158) randomized 808 patients to receive either carboplatin plus paclitaxel by a 3-hour infusion or cisplatin plus paclitaxel by a 24-hour infusion. The trial was designed as a follow-up to GOG study 111.
That study (GOG 111), completed in 1996, showed that the median survival of women with advanced ovarian cancer was extended by more than 50% when they received paclitaxel plus cisplatin as first-line chemotherapy. The paclitaxel-based regimen in the study extended median survival to 37.5 months, compared to 24.4 months achieved with the standard cisplatin/cyclophosphamide (Cytoxan, Neosar) combinationadding a median of 13 months to patients lives.
The large, well-controlled GOG study 111 represented the first trial in 15 years, (since cisplatin was developed and incorporated as initial therapy for ovarian cancer) that showed a notable improvement in survival for ovarian cancer patients.