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

Autor: Elena Ratner, Alessandro D. Santin, Laura J. Havrilesky, Osama Abdelghany, Amanda N. Fader, Angeles Alvarez Secord, Dan-Arin Silasi, Eric R. Siegel, Stefania Bellone, David M. O'Malley, K. ElSahwi, Babak Edraki, Pei Hui, Dana M. Roque, Masoud Azodi, Dirk Pikaart, Natalia Buza, Babak Litkouhi, Setsuko K. Chambers, Paul Celano, Nicole S. Nevadunsky, Floor J. Backes, William J. Lowery, Peter E. Schwartz
Rok vydání: 2020
Předmět:
0301 basic medicine
Cancer Research
medicine.medical_specialty
Paclitaxel
Receptor
ErbB-2
medicine.medical_treatment
Gastroenterology
HER2/neu
Drug Administration Schedule
Article
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
Endometrium
0302 clinical medicine
Trastuzumab
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
Progression-free survival
Survival analysis
Aged
Neoplasm Staging
Chemotherapy
biology
business.industry
Endometrial cancer
Cytoreduction Surgical Procedures
Middle Aged
medicine.disease
Survival Analysis
Progression-Free Survival
Cystadenocarcinoma
Serous
Endometrial Neoplasms
030104 developmental biology
Oncology
chemistry
Chemotherapy
Adjuvant
030220 oncology & carcinogenesis
biology.protein
Female
Neoplasm Recurrence
Local
business
medicine.drug
Follow-Up Studies
Zdroj: Clin Cancer Res
ISSN: 1557-3265
Popis: 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.
Databáze: OpenAIRE
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