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Adjuvant Pelvic Radiation “Sandwiched” Between Paclitaxel/Carboplatin Chemotherapy in Women With Completely Resected Uterine Serous Carcinoma

Long-term Follow-up of a Prospective Phase 2 Trial

Frimer, Marina, MD*†; Miller, Eirwen M., MD*‡; Shankar, Viswanathan, MS§; Girda, Eugenia, MD*∥; Mehta, Keyur, MD; Smith, Harriet O., MD*; Kuo, Dennis Y. S., MD*; Goldberg, Gary L., MD*†; Einstein, Mark H., MD*#

International Journal of Gynecological Cancer: November 2018 - Volume 28 - Issue 9 - p 1781–1788
doi: 10.1097/IGC.0000000000001359
Uterine Cancer

Objective We prospectively evaluated patients with completely resected uterine serous carcinoma (USC) treated with radiation “sandwiched” between carboplatin/paclitaxel (C/T). The primary objective was to determine the safety profile, and the secondary outcome was to evaluate progression-free and overall survival.

Methods Surgically staged patients with completely resected USC were enrolled to receive 3 cycles of paclitaxel 175 mg/m2 and carboplatin (area under the curve, 6–7.5) every 21 days, followed by radiotherapy and an additional 3 cycles of T/C at area under the curve of 5–6 (6 cycles + radiotherapy). Toxicity was graded according to National Cancer Institute Common Toxicity Criteria, version 4.03. Kaplan-Meier and log-rank tests were used to compare survival probabilities.

Results One hundred forty patients were enrolled, of which 132 were evaluable, completed at least 3 cycles of chemotherapy and radiation. One hundred seven (81%) completed 6 cycles of chemotherapy and radiation. Patients with early-stage (I/II) disease have survival probabilities of 0.96 and 0.81 at 2 and 5 years. Patients with stage I USC and lymphovascular invasion have considerably worse overall survival, with 2.7 times’ higher risk of death than those without lymphovascular invasion. Patients with late-stage (III/IV) disease had overall survival probabilities of 0.64 and 0.18 at 2 and 5 years, which is far higher survival than what has been reported in single-modality trials. Interestingly, and different than what is reported in other studies, there is no difference in survival in African Americans versus whites/other races who were evaluable. Of the 779 cycles administered, 22% and 14% of cycles were associated with grades 3 and 4 hematologic toxicities, respectively. Grades 3 and 4 nonhematologic toxicities occurred in 6.9% of cycles.

Conclusions The long-term follow-up in this study demonstrates that “sandwich” therapy is an efficacious, well-tolerated treatment approach with acceptable toxicities. Lymphovascular invasion (LVSI) is a significantly poor prognostic factor in stage I USC. Multimodal “sandwich” therapy should be considered in all USC patients who have undergone complete surgical resection and staging.

*Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, and Women’s Health, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx;

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Long Island, NY;

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Allegheny Health Network, Pittsburgh, PA;

§Department of Epidemiology & Population Health, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY;

Division of Gynecologic Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ;

Department of Radiation Oncology, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY; and

#Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, NJ.

M.F. and G.L.G. are now with the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Long Island, NY. W.M.M. is now with the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Allegheny Health Network, Pittsburgh, PA. E.G. is now with the Division of Gynecologic Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ. M.H.E. is now with the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, NJ.

This project was funded, in part, by the Albert Einstein Cancer Center National Institutes of Health/National Cancer Institute P30CA013330.

Address correspondence and reprint requests to Marina Frimer, MD, Zucker School of Medicine at Hofstra/Northwell, 1554 Northern Blvd, Suite 5 Manhasset, NY 11030. E-mail: mfrimer@northwell.edu.

M.H.E. receives grant support from the following companies: Cynvec, Photocure, Papivax, Inovio, PDS Biotechnologies, Natera, Immunovaccine, Baxalta, Pfizer, Fujiboro, Eli Lilly, and Becton-Dickinson. The other authors declare no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).

Received April 5, 2018

Received in revised form July 3, 2018

Accepted July 30, 2018

© 2018 by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology.