Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer
| Autor: | Keiichi Fujiwara, Sang Yoon Park, Thomas J. Herzog, Krishnansu S. Tewari, Mark F. Brady, Robert L. Coleman, Ann C. Casey, Susan A. Davidson, Paul Sabbatini, Paul DiSilvestro, David E. Cohn, Karen M Basen-Engquist, Jae Weon Kim, Deborah K. Armstrong, Angeles Alvarez Secord, Byoung Gie Kim, Danielle Enserro, Helen Q. Huang, Joo Hyun Nam, Joan L. Walker, John K. Chan, Steve Rubin, Nick M. Spirtos, Robert S. Mannel |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
endocrine system medicine.medical_specialty endocrine system diseases Bevacizumab 030204 cardiovascular system & hematology Article 03 medical and health sciences chemistry.chemical_compound Percutaneous Coronary Intervention 0302 clinical medicine Cytoreduction Surgical Procedures Internal medicine medicine Carcinoma Humans Combined Modality Therapy 030212 general & internal medicine Peritoneal Neoplasms Survival analysis Ovarian Neoplasms business.industry Cancer Hyperthermia Induced General Medicine Prognosis medicine.disease female genital diseases and pregnancy complications Carboplatin Survival Rate Clinical trial chemistry Female Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | N Engl J Med |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1902626 |
| Popis: | BACKGROUND: Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (“ovarian”) cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS: We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel–carboplatin or gemcitabine–carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS: A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P=0.08), which corresponded to a median overall survival of 50.6 month and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS: In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.) |
| Databáze: | OpenAIRE |
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