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

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/m2) 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&4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1&2 patients was 65.5±3.6 months and 76.5±4.3 months, respectively. PFS and OS for combined stage 3&4 patients was 25.8±3.0 and 35.9±5.3 months, respectively. Three-year % survival probability for stage 1&2 patients was 84% and for stage 3&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.

Five-year outcomes of adjuvant carboplatin/paclitaxel chemotherapy and intravaginal radiation for stage I–II papillary serous endometrial cancer

“…However, some favor pelvic RT in early stage UPSC for the potential benefit of preventing pelvic nodal recurrences [10,22]. In the current study using IVRT and chemotherapy, there were no vaginal recurrences and out of 4 pelvic recurrences, only 2 were isolated and both were successfully salvaged.…”

Adjuvant Therapy in Early-Stage Endometrial Cancer: A Systematic Review of the Evidence, Guidelines, and Clinical Practice in the U.S.

“…A phase II nonrandomized prospective trial conducted by Obermair et al [16] Another phase II trial studied the efficacy of a "sandwich" regimen in 72 patients with stage I-IV USC (82% were stage I-II) who received postoperative treatment with 3 cycles of taxane and platinum-based chemotherapy, followed by EBRT to 45 Gy with or without VB, followed by an additional 3 cycles of chemotherapy [17]. Progression free survival (PFS) and OS for stage I-II were 65.5 6 3.6 and 76.5 6 4.3 months, respectively.…”

Early stage uterine serous carcinoma: Management updates and genomic advances

“…Due to the rarity of USC and relative lack of prospective trials, it has been challenging to define the treatment recommendations for women with this disease [16][17][18][19]. Most publications included in this review are retrospective analyses, a critical limitation of this appraisal of the literature.…”