Does Adding Chemo to RT Improve Survival in Cervical Cancer?

Adjuvant chemoradiation with weekly cisplatin did not significantly improve survival outcomes — but did increase toxicities — compared with adjuvant radiotherapy alone in women with early-stage cervical carcinoma who have intermediate risk factors following radical hysterectomy, a phase 3 trial found.

The current standard for women with early-stage disease and intermediate-risk factors is radiotherapy alone, but prior clinical data has indicated that adding chemotherapy could potentially improve outcomes in this population, lead author Sang Young Ryu, MD, of the Department of Gynecologic Oncology, Korea Cancer Center Hospital in Seoul, South Korea, explained.

“The outcomes of this trial help confirm that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative,” Ryu said in a statement.

Ryu reported results from the NRG Oncology GOG-263 study during the plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2src25.

The trial included 316 patients with stage I-IIA cervical cancer with at least 2 intermediate-risk factors including a combination of histopathologic factors such as capillary lymphatic space involvement, stromal invasion, and tumor size.

All patients had radical hysterectomy and lymphadenectomy prior to enrollment, and were randomly allocated to receive either adjuvant chemoradiation or adjuvant radiotherapy alone.

Chemoradiation consisted of weekly cisplatin (45 mg/m²) given concurrently with radiotherapy for up to six cycles. Radiotherapy consisted of external beam radiotherapy using four-field standard radiotherapy or intensity-modulated radiation therapy.

Clinical characteristics were well-balanced between the two groups, Ryu noted. Most patients had FIGO (2srcsrc9) stage IB1 (56%) and IB2 (34%) disease and squamous cell carcinoma histology (74%).

Among the entire cohort, 92% of patients had 28 fractions of radiation with median dosage of 5src.4 Gy and duration of 39 days; in the chemoradiation group, 91% of patients received at least four cycles of weekly cisplatin.

Chemoradiation did not improve recurrence-free survival or overall survival, Ryu reported.

The 3-year recurrence-free survival rate was 88.5% with chemoradiation and 85.4% with radiotherapy (hazard ratio [HR], src.6976; P= .src927) and the 3-year overall survival rate was 97.2% and 9src.3%, respectively (HR, src.586; P=.src695).

Grade 3 or 4 adverse events were significantly more common in the chemoradiation group than in the radiotherapy group (43% vs 15%, respectively), Ryu reported, particularly neutropenia (17 % vs 1%) and leukopenia (28% vs 2%).

Prevention: Are We Missing the Boat?

Premal Thaker, MD, discussant for the study, said the key takeaway from this study is that adding chemotherapy to radiotherapy does not significantly improve 3-year outcomes and leads to greater toxicity.

Thaker also emphasized more generally that cervical cancer is a “very preventable disease” but over 66src,srcsrcsrc women were diagnosed with cervical cancer worldwide in 2src22. Thaker urged greater attention to prevention through human papillomavirus (HPV) vaccination.

The HPV vaccine has proven highly effective in preventing cervical cancer, with studies showing a significant reduction in HPV-related infections and precancerous lesions, and a nearly 9src% reduction in cervical cancer incidence among vaccinated individuals, particularly those vaccinated before the age of 17 years.

Although the HPV vaccination has been available for over 15 years, “global coverage remains low and many countries do not even include the HPV vaccination in their national immunization programs,” Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis, told meeting attendees.

This study was supported by the National Cancer Institute. Ryu and Thaker had no relevant disclosures.