A landmark study showed that a new drug
combinationpaclitaxel (Taxol) and 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-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, 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
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.