Sequential chemoradiation was found to result in longer disease-free survival (DFS) and a lower risk for cancer death compared with concurrent chemoradiation or radiation (RT) alone in the postoperative adjuvant setting in patients with early-stage cervical cancer and adverse pathological factors, according to the results of the phase 3 STARS study.1
Based on these results, “sequential chemoradiation should be considered a preferred adjuvant treatment after radical hysterectomy for patients with early-stage cervical cancer,” the researchers wrote.
The STARS study (ClinicalTrials.gov identifier: NCT00806117) included 1048 women (median age, 48 years) who had undergone radical hysterectomy for stage IB to IIA cervical cancer with adverse pathological factors. Patients were randomly assigned to receive adjuvant RT ( total dose, 45-50 Gy), concurrent chemoradiation (weekly cisplatin 30-40 mg/m2), or sequential chemoradiation (cisplatin 60-75 mg/m2 plus paclitaxel 135-175 mg/m2) in a 21-day cycle given 2 cycles before and 2 cycles after RT, respectively.
At a median follow-up of 56 months, sequential chemoradiation was associated with an improved 3-year DFS rate of 90.0% compared with RT (82.0%; HR, 0.52; 95% CI, 0.35-0.76) or concurrent chemoradiation (85.0%; HR, 0.65; 95% CI, 0.44-0.96).
The 5-year rate of cancer death was 92.0% for sequential treatment compared with 88.0% for radiation alone, even after adjustment for lymph node involvement (HR, 0.58). DFS rates and cancer death were similar with concurrent chemoradiation and RT.
A subgroup analysis showed that sequential treatment improved DFS compared vs the other 2 treatment arms for patients with high-risk factors, and improved DFS compared with RT alone for those with intermediate-risk factors.
Patients assigned to RT alone (12.9%) had the lowest rate of grade 3 or 4 adverse events compared with concurrent (28.5%) or sequential (25.3%) treatment groups (P <.001). Rates of hematological adverse events were similar between the concurrent and sequential chemoradiation subsets, but concurrent treatment was associated with higher rates of grade 3 or 4 gastrointestinal events.
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.
Huang H, Feng Y-L, Wan T, et al. Effectiveness of sequential chemoradiation vs concurrent chemoradiation or radiation alone in adjuvant treatment after hysterectomy for cervical cancer. The STARS phase 3 randomized clinical trial. JAMA Oncol. Published online January 14, 2021. doi:10.1001/jamaoncol.2020.7168