For newly diagnosed patients with ovarian cancer, a recent study shows how too much chemotherapy can lead to less favorable results.
Patients with newly diagnosed ovarian cancer who received weekly chemotherapy reported a lower mean quality of life (QOL) compared to patients who received the standard treatment every three weeks, according to results of a recent study published in The Lancet Oncology.
The primary endpoint of the iCON8 study also found that patients who received weekly chemotherapy saw no increase in progression-free survival (PFS) compared to patients who received the standard treatment, making it a poor choice for the management of newly diagnosed ovarian cancer.
Prior to this study, the phase 3 JGOG-3016 trial in Japan found that weekly paclitaxel combined with three-weekly carboplatin improved PFS and overall survival (OS) when compared to standard treatment in Japanese patients with advanced disease. But given the increasing evidence of the difference in response to treatment between Asian and white populations, the creators of the ICON8 trial set out to build on these results and determine if the same survival advantage could be found in a mostly European population.
While PFS was the primary endpoint of the ICON8 trial, the secondary endpoints examining QOL in these patients are what the Lancet analysis focused on.
The open-label, randomized, controlled phase 3 study included patients from 117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea and the Republic of Ireland, between June 6, 2011 and November 28, 2014. All patients were then randomly assigned to one of three groups:
All patients had either epithelial ovarian, primary peritoneal or fallopian tube carcinoma (collectively termed ovarian cancer in the study) and had not received previous systemic therapy for their ovarian cancer.
Out of the 1,566 patients in the study, 1,540 completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires. The QLQ-C30 includes questions that measure a global health status score, function scales to determine physical, role, emotional, cognitive, and social QOL, and symptom scales to measure fatigue, nausea or vomiting, pain, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. The QLQ-OV28 measures experiences more specific to ovarian cancer, including abdominal or gastrointestinal symptoms, peripheral neuropathy, chemotherapy side effects, hormonal or menopausal symptoms, and other factors.
These questionnaires were completed by patients during outpatient attendances at day one of each chemotherapy cycle, and during follow-up visits every six weeks until nine months from randomization, then every three months for the next 2 years, and finally, every six months for up to five years from randomization. Researchers also had patients complete these surveys at six-month intervals after disease progression.
Baseline questionnaires were completed by 1,438 (92%) of patients, and of the 1,280 patients available for 9-month follow-up questionnaires 882 patients (69%) contributed data to that set. When accounting for patients who dropped out of the study due to disease progression, withdrawal or death, a total of 828 patients contributed QOL data both at 9 months and baseline.
Upon examination, the researchers found no significant difference in the global health score at 9 months between the study groups, but upon a longitudinal analysis, found lower global health scores for those receiving weekly paclitaxel compared to patients who received the standard chemotherapy every three weeks.
“We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after randomization,” the authors concluded.
“Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer.”