Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma

Mark H. Einstein, Marina Frimer, Dennis Y.S. Kuo, Laura L. Reimers, Keyur Mehta, Subhakar Mutyala, Gloria S. Huang, June Y. Hou, Gary L. Goldberg

Research output: Contribution to journalArticle

44 Scopus citations

Abstract

Objective: To evaluate the safety and survival in women treated with adjuvant pelvic radiation "sandwiched" between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods: Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m 2) and carboplatin (AUC = 6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC = 5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results: A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43-82 years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3 and 4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5 ± 3.6 months and 76.5 ± 4.3 months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8 ± 3.0 and 35.9 ± 5.3 months, respectively. Three-year % survival probability for stage 1 and 2 patients was 84% and for stage 3 and 4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays. Conclusions: Compared to prior studies of single modality adjuvant therapy, RT "sandwiched" between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC.

Original languageEnglish (US)
Pages (from-to)21-25
Number of pages5
JournalGynecologic Oncology
Volume124
Issue number1
DOIs
StatePublished - Jan 1 2012

Keywords

  • Adjuvant treatment
  • Chemotherapy
  • Phase II trial
  • Radiation therapy
  • UPSC
  • Uterine cancer

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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