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
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
Recommended Citation
Fader, Amanda N.; Roque, Dana M.; Siegel, Eric; Buza, Natalia; Hui, Pei; Abdelghany, Osama; Chambers, Setsuko; Secord, Angeles Alvarez; Havrilesky, Laura; O'Malley, David M.; Backes, Floor J.; Nevadunsky, Nicole; Edraki, Babak; Pikaart, Dirk; Lowery, William; ElSahwi, Karim; Celano, Paul; Bellone, Stefania; Azodi, Masoud; Litkouhi, Babak; Ratner, Elena; Silasi, Dan-Arin; Schwartz, Peter E.; and Santin, Alessandro D., "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" (2020). Obstetrics and Gynecology. 170.
https://scholar.bridgeporthospital.org/obgyn/170
Identifier
32601075 (pubmed); NIHMS1718747 (mid); PMC8792803 (pmc); 10.1158/1078-0432.CCR-20-0953 (doi); 1078-0432.CCR-20-0953 (pii)