A second surgery followed by chemotherapy is no better than chemotherapy alone at extending the lives of women with platinum-sensitive ovarian cancer who experienced disease recurrence after a first surgery. Instead, it might shorten their lives, findings from a Phase 3 clinical trial show.
Results from the first randomized trial testing the approach challenge the routine use of secondary surgery, which has been strongly considered for women with recurrent ovarian cancer.
The study, “Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer,” was published in The New England Journal of Medicine.
In most cases, ovarian cancer treatment involves a combination of cytoreductive surgery, intended to remove the tumor and nearby tissues to which the cancer may have spread, and chemotherapy, which eliminates the small traces of cancer cells that remain after surgery and kill other cells that may have spread to distant regions of the body.
Despite success in erasing all signs of cancer in large numbers of women, more than 80% of patients see their cancer return. When this happens, a second cytoreductive surgery is often considered.
Although there are studies that support a second surgery for recurrent ovarian cancer, these studies were retrospective and evaluated medical data and survival outcomes from past procedures.
To date, there have been no formal, randomized clinical trials to determine if a second surgery would increase the survival time of a patient with ovarian cancer.
So, a team of researchers based at the University of Texas MD Anderson Cancer Center, designed the Gynecologic Oncology Group (GOG)–0213 Phase 3 trial (NCT00565851) to assess the survival of platinum-sensitive recurrent ovarian cancer following a second cytoreductive surgery.
From December 2007 to June 2017, 485 women with recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer were recruited. Of these, 240 were selected randomly to have a second surgery followed by platinum-based chemotherapy; 245 patients were chosen randomly to receive chemotherapy alone.
In most patients (84%), the chemotherapy — consisting of paclitaxel and carboplatin — was accompanied by the biological cancer therapy bevacizumab (sold as Avastin, among others), and followed by bevacizumab maintenance.
After a median follow-up of 48 months, a total of 197 patients (56%) on the surgery group had died, compared to 153 (62%) among those given chemotherapy.
After adjusting for factors like age, country, functional status, type of chemotherapy, and time without platinum-based chemotherapy, researchers found that people without surgery lived a median of 64.7 months, compared to 50.6 months for the surgery group.
While the results did not reach statistical significance, they suggest that surgery does not help women live longer and might instead shorten their lives.
A secondary measure of the trial, progression-free survival, also was not met, with patients with or without surgery living for a similar amount of time without their disease progressing (18.9 months for surgery vs. 16.2 months for no surgery).
Patients were given questionnaires regarding quality of life (using the Functional Assessment of Cancer Therapy – Ovarian Cancer), a physical functioning assessment (with the RAND 36-item Short Form Survey), and surgery-related symptoms.
Although patients on the surgery group reported decreased physical functioning and quality of life immediately after the surgical procedure, no significant differences in patient self-assessments were found between groups after recovery.
“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,” the team concluded.
“Given these study results, we need to question the value of secondary surgery for recurrent ovarian cancer patients,” lead investigator Robert Coleman, MD, said in a press release. “Hopefully this study and other ongoing trials will provide the data needed to determine the best course of treatment that will maximize treatment outcomes and quality of life for these patients.”
There are three other ongoing Phase 3 trials designed to compare surgery and chemotherapy in recurrent ovarian cancer patients: DESKTOP-III (NCT01166737), SOC 1 (NCT01611766), and SOCceR, in the Netherlands (NL3137). Together with GOG–0213, these trials are expected to “shape the debate on the value or merit of surgery in this patient population,” researchers wrote.
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