Randomized Phase II Trial of Carboplatin-Paclitaxel Compared with Carboplatin-Paclitaxel-Trastuzumab in Advanced (Stage III-IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis

Authors

Amanda N. Fader, John Hopkins School of Medicine, Baltimore, Maryland.
Dana M. Roque, University of Maryland, Baltimore, Maryland.
Eric Siegel, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Natalia Buza, Yale University, New Haven, Connecticut.
Pei Hui, Yale University, New Haven, Connecticut.
Osama Abdelghany, Yale University, New Haven, Connecticut.
Setsuko Chambers, University of Arizona, Tucson, Arizona.
Angeles Alvarez Secord, Duke University School of Medicine, Durham, North Caroline.
Laura Havrilesky, Duke University School of Medicine, Durham, North Caroline.
David M. O'Malley, The Ohio State University School of Medicine, Columbus, Ohio.
Floor J. Backes, The Ohio State University School of Medicine, Columbus, Ohio.
Nicole Nevadunsky, Albert Einstein College/Montefiore Medical Center, Bronx, New York.
Babak Edraki, John Muir Medical Center, Walnut Creek, California.
Dirk Pikaart, Penrose Cancer Center-St. Francis, Colorado Springs, Colorado.
William Lowery, Walter Reed Medical Center, Bethesda, Maryland.
Karim ElSahwi, Hackensack Meridian Health, Neptune, New Jersey.
Paul Celano, Greater Baltimore Medical Center, Baltimore, Maryland.
Stefania Bellone, Yale University, New Haven, Connecticut.
Masoud Azodi, Yale University, New Haven, Connecticut.
Babak Litkouhi, Stanford Women's Cancer Center, Palo Alto, California.
Elena Ratner, Yale University, New Haven, Connecticut.
Dan-Arin Silasi, Yale University, New Haven, Connecticut.
Peter E. Schwartz, Yale University, New Haven, Connecticut.
Alessandro D. Santin, Yale University, New Haven, Connecticut. alessandro.santin@yale.edu.

Document Type

Article

Publication Title

Clinical cancer research : an official journal of the American Association for Cancer Research

Abstract

PURPOSE: Uterine-serous-carcinoma (USC) is an aggressive variant of endometrial cancer. On the basis of preliminary results of a multicenter, randomized phase II trial, trastuzumab (T), a humanized-mAb targeting Her2/Neu, in combination with carboplatin/paclitaxel (C/P), is recognized as an alternative in treating advanced/recurrent HER2/Neu-positive USC. We report the updated survival analysis of NCT01367002. PATIENTS AND METHODS: Eligible patients had stage III to IV or recurrent disease. Participants were randomized 1:1 to receive C/P for six cycles ± T followed by maintenance T until progression or toxicity. Progression-free survival (PFS) was the primary endpoint; overall survival (OS) and toxicity were secondary endpoints. RESULTS: Sixty-one patients were randomized. After a median-follow-up of 25.9 months, 43 progressions and 38 deaths occurred among 58 evaluable patients. Updated median-PFS continued to favor the T-arm, with medians of 8.0 months versus 12.9 months in the control and T-arms (HR = 0.46; 90% CI, 0.28-0.76; P = 0.005). Median-PFS was 9.3 months versus 17.7 months among 41 patients with stage III to IV disease undergoing primary treatment (HR = 0.44; 90% CI, 0.23-0.83; P = 0.015), and 7.0 months versus 9.2 months among 17 patients with recurrent disease (HR = 0.12; 90% CI, 0.03-0.48; P = 0.004). OS was higher in the T compared with the control arm, with medians of 29.6 months versus 24.4 months (HR = 0.58; 90% CI, 0.34-0.99; P = 0.046). The benefit was most notable in those with stage III to IV disease, with survival median not reached in the T-arm versus 24.4 months in the control arm (HR = 0.49; 90% CI, 0.25-0.97; P = 0.041). Toxicity was not different between arms. CONCLUSIONS: Addition of T to C/P increased PFS and OS in women with advanced/recurrent HER2/Neu-positive USC, with the greatest benefit seen for the treatment of stage III to IV disease.

First Page

3928

Last Page

3935

DOI

10.1158/1078-0432.CCR-20-0953

Publication Date

8-1-2020

Identifier

32601075 (pubmed); NIHMS1718747 (mid); PMC8792803 (pmc); 10.1158/1078-0432.CCR-20-0953 (doi); 1078-0432.CCR-20-0953 (pii)

This document is currently not available here.

Share

COinS