Randomized Phase II Study of Irinotecan or Irinotecan in Combination with Cisplatinum or Cisplatinum in First Line in Patients with Metastatic Squamous Cell Carcinoma of the Cervix
Avguste Garin, M.D. All-Union Cancer Research Center, Moscow, Russia
Summary:Despite the testing of more than 55 agents in the last 25 years, there is no optimal therapy for metastatic squamous cell cancer of the cervix. Dr. Garin reported on a combination of irinotecan and cisplatin that yielded better responses than any single agent used to date as first-line therapy for the disease.
Metastatic squamous cell carcinoma of the cervix currently has no optimal therapy. Of the more than 50 single agents tested over the last 25 years, the most active have shown response rates of 15-35% with no effect on survival. Researchers including Dr. Avguste Garin and colleagues at other European centers hoped that a new combination of irinotecan and cisplatin would improve the outlook for patients with the disease.
In a Phase II trial conducted by the group, 106 patients with metastatic squamous cell carcinoma of the cervix who had not received any prior chemotherapy were randomized to receive irinotecan alone, irinotecan/cisplatin or cisplatin alone, with the last acting as the reference group.
Patients receiving the irinotecan/cisplatin combination had an overall response rate of 53% compared with 17% with irinotecan alone and 21% with cisplatin alone. Complete response was achieved in two patients on the combination regimen. There were no complete responders in either single agent group.
The median survival of 14.3 months for the irinotecan/cisplatin group was also higher compared with median survival for the irinotecan group (8.0 months) or the cisplatin group (9.6 months).
Neutropenia was the most common toxicity, occurring at much higher levels in patients treated with the irinotecan/cisplatin combination (81%) than in patients treated with single agent irinotecan (32%) or cisplatin (10%). No deaths occurred due to toxicity.
"We were surprised by the two complete responses and the increased survival with the irinotecan/cisplatin combination because this tumor usually doesn't respond. In some countries, metastatic squamous cell cancer of the cervix currently is not even treated," Dr. Garin noted.
He also stated that although the rate of neutropenia was much higher with the combination, it was a manageable toxicity.
Based on the results of the Phase II trial, the researchers are planning a Phase III trial comparing the irinotecan/cisplatin combination with cisplatin alone for treatment of metastatic squamous cell cervical cancer.
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