| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 6182627 | Gynecologic Oncology | 2015 | 5 Pages |
â¢IP chemotherapy may offer advantages in some high risk endometrial cancer populationsâ¢A modified paclitaxel, doxorubicin, cisplatin regimen with IP administration was evaluatedâ¢The regimen was tolerable and produced promising PFS rates
ObjectiveTo determine the maximum tolerated dose (MTD) of a modified paclitaxel/doxorubicin/cisplatin (TAP) regimen which incorporated intraperitoneal (IP) paclitaxel or IP paclitaxel/cisplatin in advanced endometrial cancer.MethodsPatients (pts) with FIGO (1998) Stage IIIA/IIIC with positive cytologic washings/ascites, adnexa, or serosa or Stage IV (intraperitoneal disease spread), histologically confirmed endometrial cancer were eligible. The study was designed as a phase I, 3Â +Â 3 dose escalation study evaluating 5 dose levels (DL). All pts received cycles 1-2 with IV TAP, and cycles 3-6 with IV/IP therapy, on a 21Â day schedule. Adverse events were evaluated on cycles 3-4 for dose limiting toxicity (DLT) and dose escalation decisions.ResultsTwenty-one pts were enrolled, of which 17 were evaluable for DLT. Most pts had Stage IV disease (76%) and serous/clear cell histology (59%). The MTD was determined to be DL 3 (cycles 3-6 including paclitaxel 90Â mg/m2 IP, doxorubicin 45Â mg/m2 IV, cisplatin 50Â mg/m2). Three DLT events occurred and were related to grades 3-4 metabolic toxicities. There was one grade 2 sensory neuropathy event and myelosupression was tolerable without the use of G-CSF. 88% of evaluable pts completed 6Â cycles of therapy. With a median follow-up of 22Â months, 46% of patients remain progression-free at 2Â years.ConclusionWe described an IV/IP based modification of a standard TAP regimen in endometrial cancer. Based on the high rate of completing 6Â cycles of therapy, low rates of neuropathy, and promising PFS, further study of IP therapy in endometrial cancer is warranted.
