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Conventional Chemotherapy Plus Paclitaxel Benefits Some Women with Relapsed Ovarian Cancer

Paclitaxel in combination with platinum chemotherapy results in an absolute 2-year survival rate of 57% compared with 50% for conventional treatment among patients with platinum sensitive relapsed ovarian cancer.

Progression-free survival also seems to improve with paclitaxel plus platinum chemotherapy over conventional chemotherapy in this patient population.

Investigators participating in the International Collaborative Ovarian Neoplasm 4 (ICON4), coordinated by the Istituto Mario Negri in Milan, Italy and the Medical Research Council's Clinical Trials Unit, London, the United Kingdom, combined data with that from the Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) OVAR2.2, coordinated by AGO in Karlsruhe, Germany. The data from the randomised trials were combined to determine whether the addition of paclitaxel to platinum-based chemotherapy would offer any benefit over conventional platinum-based regimens in women with relapsed platinum- sensitive epithelial ovarian cancer.

The protocols were designed so that patients received a minimum of 3 to 6 cycles and a maximum of 6 to 8 cycles (based on protocols and response) of conventional platinum- based chemotherapy or conventional chemotherapy plus paclitaxel. The conventional therapy consisted of a minimum of 6 mg carboplatin based on glomerular filtration rate and a minimum of 75 mg per meter squared of cisplatin alone or 50 mg per meter squared cisplatin if combined with other drugs. Paclitaxel was added to the conventional chemotherapy dosages at 175 or 185 mg per meter squared, based on study protocols, and was given in 3-hour infusions.

Overall, 410 patients were randomised to conventional therapy while 392 entered the paclitaxel arm of the study. After a median follow-up of 42 months, the researchers report that 530 patients died. A median survival of 5 months is reported for 29% of the paclitaxel arm and 24% of the conventional group. Median progression-free survival of 13 months was achieved in the paclitaxel group compared with 10 months for the conventional group.

The paclitaxel, compared with the conventional group, had higher rates of alopecia (86% versus 25%) and higher rates of neurological toxic effects (20% versus 1%). Haematological toxic effects were higher in the conventional (46%) versus the paclitaxel (29%) group.

In the patients' assessment of their own quality of life the investigative team noted, "no clear indication that one regimen is worse than the other for functional ability, symptomatic experience, or global health status."

They conclude that the findings of these studies, "suggest a beneficial effect for paclitaxel in combination with platinum chemotherapy on survival and progression-free survival among patients with platinum-sensitive relapsed ovarian cancer."
Lancet 2003;361:2099-106.

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