Chemoradiation remains the best treatment for locally advanced cervical cancer


Results from the OUTBACK trial (NCT01414608) show that adjuvant chemotherapy with carboplatin and paclitaxel after standard cisplatin-based chemoradiation therapy for unselected locally advanced cervical cancer does not improve overall survival. was not seen.1

Findings showed a median follow-up of 60 months (IQR, 45-65) with a data cut-off date of 12 April 2021. The 5-year overall survival rate was 72% (95% CI, 67-76) in the adjuvant chemotherapy group and 71% (95% CI, 66-75) in the chemoradiation-only group and was similar between groups. (95% CI 0.70-1.17; P. = .81).

“Standard pelvic chemoradiation for locally advanced cervical cancer followed by adjuvant carboplatin and paclitaxel chemotherapy did not improve treatment efficacy or overall survival, but it did significantly increase it. bottom [adverse events] Linda R. Mileschkin, M.D., Ph.D., a medical oncologist at Peter McCallum Cancer Center and principal investigator of the study, told Targeted Oncology.TMs.

A multicenter, open-label, randomized, Phase 3 study was conducted at 157 hospitals including the United States, Australia, China, Canada, New Zealand, Saudi Arabia and Singapore.

Patients enrolled in the trial were ≥18 years of age with histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, ECOG performance status 0/2, and bone marrow and organ function were adequate.

Patients were randomized in a 1:1 ratio to receive standard cisplatin-based chemoradiation therapy at a dose of 40 mg/m.2 Cisplatin intravenously (IV) weekly for 5 weeks with 45.0–50.4 Gy external beam radiotherapy during radiotherapy followed by 1.8 Gy fractions and brachytherapy to the whole pelvis (chemoradiotherapy only). group) or standard cisplatin-based radiation therapy followed by adjuvant chemotherapy with 4 cycles of 155 mg/m carboplatin and paclitaxel2 It will be administered via IV infusion on day 1 of a 21-day cycle (adjuvant chemotherapy group).

The primary endpoint of the trial was overall survival at 5 years. Secondary endpoints were 5-year progression-free survival, adverse events (AEs), disease recurrence patterns, adherence to radiation protocols, and global health quality of life.2

A total of 926 patients were enrolled and randomly assigned between 15 April 2011 and 26 June 2017. 456 in the chemoradiation-only group and 463 in the adjuvant chemotherapy group).1

Median patient age 46 years (interquartile range) [IQR]663 (72%) Caucasian, 121 (13%) Black or African American, 53 (6%) Asian, 24 (3%) Aboriginal or Pacific Islanders, 57 (6%) were of other races.

PFS rates were similar in the adjuvant chemotherapy and chemoradiation-only groups at 63% and 61%, respectively. Regarding safety, compared with women receiving standard chemotherapy (62%), women receiving adjuvant chemotherapy (81%) were more likely to experience severe AEs within 1 year of randomization. The percentage was high.

The most common grade 3–4 AEs included neutropenia in 71 (20%) patients in the adjuvant chemotherapy group and 34 (8%) in the chemoradiation-only group, and Anemia was included in 66 (18%) and 34 (8%) cases. A total of 107 (30%) patients in the adjuvant chemotherapy group and 98 (22%) patients in the chemoradiation-only group had serious AEs, most commonly infectious complications. and there were no treatment-related deaths.

“A recent analysis of the US National Cancer Database suggested that 1 in 10 patients received multi-adjuvant chemotherapy in addition to chemoradiotherapy with no survival benefit. Concerningly, brachytherapy completion rates were also lower in patients treated with adjuvant chemotherapy, which is essential for obtaining local control of the cancer,” Mileshkin added.

Overall, these data support chemoradiation alone as the current best standard of care for women with locally advanced cervical cancer. This was because the addition of adjuvant chemotherapy did not improve her 5-year survival and added a significant AE.

reference:
  1. Mileshkin LR, Moore KN, Barnes EH, et al.Chemoradiation followed by adjuvant chemotherapy versus chemoradiation alone (OUTBACK) as first-line treatment for locally advanced cervical cancer: an international, open-label, randomized, phase 3 trial [published online ahead of print, 2023 Apr 17]. lancet on call2023;S1470-2045(23)00147-X.doi:10.1016/S1470-2045(23)00147-X
  2. Cisplatin and radiation therapy with or without carboplatin and paclitaxel in patients with locally advanced cervical cancer. ClinicalTrials.gov. Updated November 7, 2022. Accessed May 4, 2023. https://clinicaltrials.gov/ct2/show/NCT01414608



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