Source: DGNews  |  Posted 8 years ago

By Michael Smith

COPENHAGEN, DENMARK -- September 24, 2003 -- Platinum-based chemotherapy for women whose ovarian cancer has recurred can be boosted by the addition of the taxane paclitaxel, an Italian researcher reported here September 23rd at ECCO 12: The European Cancer Conference.

Two studies with similar designs showed that adding paclitaxel to the platinum-based chemotherapy increased survival by 7% after 2 years, said Nicoletta Colombo, MD, of the European Institute of Oncology, Milan, Italy.

The taxane arms of the 2 studies also had a 10% increase in disease-free survival at the 1-year mark, Dr. Colombo said.

On the other hand, she said, the objective response rate -- defined as greater than a 50% tumor shrinkage -- was in favor of the taxane arm, but did not reach the level of statistical significance.

The Italian ICON4 trial and the German OVAR 2.2 trial were parallel randomised trials comparing six cycles of platinum chemotherapy versus paclitaxel plus platinum. The platinum drug involved was mainly carboplatin, but cisplatin was allowed in some cases, both in the control and treatment arms.

Overall, the studies included 802 patients; 717 have either died or have had disease progression after an average of 42 months of follow-up, Dr. Colombo said.

The best results were seen in patients who had been disease-free for more than a year before relapsing, she said.

The large patient pool in the 2 studies make this "the largest-ever randomised trial in relapsed ovarian cancer," said Elizabeth Eisenhauer, MD, director of the National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada. "It sets the bar high" for future trials, she said.

"All the parameters of efficacy -- overall survival, progression-free survival and response rate -- favor the same arm, the paclitaxel-platinum arm," she said.

On the other hand, differences in control arms between the studies, in particular the variation in which platinum compound was used, make it hard to say how well the results can be extended outside the clinic, she said.

As well, Dr. Eisenhauer said, toxicity was "not trivial -- 49% of patients in the treatment arms stopped therapy, compared to 34% in the control arm."

She concluded that the study results mean physicians "must consider" the combination therapy in relapsing patients whose tumor is platinum-sensitive.

[Study title: Randomised Trial of Paclitaxel in Combination with Platinum Chemotherapy Versus Platinum-Based Chemotherapy in the Treatment of Relapsed Ovarian Cancer (ICON4/OVAR 2.2). Abstract 327]