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 |
Externí odkaz: |