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Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

ABSTRACT: 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 months 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.).

SUBMITTER: Coleman RL

PROVIDER: S-EPMC6941470 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

Coleman Robert L RL Spirtos Nick M NM Enserro Danielle D Herzog Thomas J TJ Sabbatini Paul P Armstrong Deborah K DK Kim Jae-Weon JW Park Sang-Yoon SY Kim Byoung-Gie BG Nam Joo-Hyun JH Fujiwara Keiichi K Walker Joan L JL Casey Ann C AC Alvarez Secord Angeles A Rubin Steve S Chan John K JK DiSilvestro Paul P Davidson Susan A SA Cohn David E DE Tewari Krishnansu S KS Basen-Engquist Karen K Huang Helen Q HQ Brady Mark F MF Mannel Robert S RS

The New England journal of medicine 20191101 20

<h4>Background</h4>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.<h4>Methods</h4>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-dete ...[more]

PMID: 31722153

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Project description:UnlabelledBackgroundThere is no consensus regarding the management of ovarian cancer patients, who have shown complete clinical response (CCR) to primary therapy and have rising cancer antigen CA-125 levels but have no symptoms of recurrent disease. The present study aims to determine whether follow-up CA-125 levels can be used to identify the need for imaging studies and secondary cytoreductive surgery (CRS).MethodsWe identified 410 ovarian cancer patients treated at The University of Texas MD Anderson Cancer Center between 1984 and 2011. These patients had shown CCR to primary therapy. Follow-up was conducted based on the surveillance protocol of the MD Anderson Cancer Center. We used the Cox proportional hazards model and log-rank test to assess the associations between the follow-up CA-125 levels and secondary CRS and survival duration.ResultsThe CA-125 level of 1.68?×?nadir was defined as the indicator of recurrent disease (p?<?0.001). The specificity and sensitivity of this criterion were 82.9% and 85.6%, respectively, and the median lead-time of the CA-125 biochemical progression prior to clinically-defined relapse was 31?days (ranging from 1 to 391?days). The median number of the negative imaging studies for the clinical relapse findings in patients with a CA-125 level of?<?1.68?×?nadir was 3 (ranging from 0 to 24 times). The increase of CA-125 level at relapse was an independent predictor of overall and progression free survival in patients who had shown CCR to primary therapy (p?=?0.04 and 0.02 respectively). The overall and progression free survival durations in patients with a CA-125 level???1.68?×?nadir at relapse (69.4 and 13.8?months) were longer than those with a CA-125 level?>?1.68?×?nadir at relapse (55.7 and 10.4?months; p?=?0.04 and 0.01, respectively). The overall and progression free survival duration of patients with asymptomatic relapse and underwent a secondary CRS was longer than that of patients with symptomatic relapse (p?=?0.02 and 0.04 respectively).ConclusionsThe increase of serum CA-125 levels is an early warning of clinical relapse in ovarian cancer. Using CA-125 levels in guiding the treatment of patients with asymptomatic recurrent ovarian cancer, who have shown CCR to primary therapy, can facilitate optimal secondary CRS and extend the survival duration of the patients.

Dataset Information

Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

Publications

Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

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