“This trial provides clear evidence that the addition of chemotherapy after chemoradiation does not extend survival. The results are immediately practice-changing, showing that this approach should not be used to treat locally advanced cervical cancer. We can now spare our patients the side effects and toxicity that comes with additional chemotherapy,” said ASCO President Lori J. Pierce, MD, FASTRO, FASCO.
ALEXANDRIA, Va. – Additional chemotherapy given after standard chemoradiation treatment does not improve survival for women with locally advanced cervical cancer, and is associated with additional side effects, according to results of a phase III international trial. These long-anticipated findings, to be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, are likely to immediately change practice for early adopters, who had hoped the regimen would reduce distant disease recurrence in patients.
Study at a Glance
To determine the effects of adjuvant chemotherapy after standard chemoradiation on survival compared with standard care chemoradiation alone.
919 patients with locally advanced cervical cancer
These eagerly anticipated findings confirm that the current standard treatment, chemoradiation, is the best possible at this time. This study signals a change of practice for early adopters of the additional therapy, eliminating its use of additional therapy – and more frequent serious adverse events – for these patients.
The standard treatment for locally advanced cervical cancer is chemoradiation with cisplatin-based chemotherapy concurrent with radiation. Yet a significant percentage of patients still relapse and die as a result of distant metastatic disease. Because carboplatin and paclitaxel chemotherapy after chemoradiation are active initial treatments for the metastatic and relapsed setting and are successfully used as adjuvant therapy for other cancers, some oncologists routinely treat women with locally advanced cervical cancer with the regimen. However, until now, there has been no evidence from a large phase III study for or against the addition of chemotherapy in this setting.
The phase III OUTBACK trial demonstrated that chemotherapy following chemoradiation did not improve survival over standard chemoradiation alone for patients with locally advanced cervical cancer.
At 5 years, OS was comparable for both groups – 72% versus 71% respectively, for those receiving adjuvant chemotherapy and those receiving standard care. Also, at 5 years disease had not progressed (progression-free survival, PFS) for 63% of patients who received the additional treatment, compared with 61% who did not. Patterns of disease recurrence were similar in the two treatment groups.
Serious adverse events (grade 3-5) were experienced by more patients up to 1 year after randomization – 81% of patients in the adjuvant chemotherapy group compared with 62% in the standard treatment group.
“The study confirms that chemoradiotherapy alone is currently our best possible treatment for women with locally advanced cervical cancer. Not only is there no benefit with adjuvant chemotherapy, but severe side effects are also increased,” said lead author Linda R. Mileshkin, MD, a medical oncologist at Peter McCallum Cancer Centre in Melbourne, Australia.
About the Study
The phase III international trial enrolled 919 patients with locally advanced cervical cancer. Patients were randomly assigned to receive standard cisplatin-based chemoradiation with or without additional chemotherapy with carboplatin and paclitaxel.
The primary endpoint was OS at 5 years. The researchers also examined progression-free survival, adverse side effects, and patterns of disease recurrence.
The researchers plan to complete additional analyses to answer some of the secondary objectives, such as the impact of standard chemoradiation with or without additional chemotherapy on the psycho-sexual health of patients with advanced cervical cancer.
View the full abstract (link not live until embargo lifts)
For your readers:
- Cervical Cancer: Types of Treatment
- Understanding Chemotherapy
- Side Effects of Chemotherapy
- Cancer.Net Blog (English)
- Cancer.Net Blog Post (Spanish)
View the disclosures for the 2021 Cancer Communications Committee: https://www.asco.org/sites/new-www.asco.org/files/content-files/about-asco/pdf/2021-am-news-planning-team-disclosures.pdf
View the disclosures for Dr. Gralow: https://coi.asco.org/share/CKD-HYVM/Julie%20Gralow
View the disclosures for Dr. Pierce: https://coi.asco.org/share/Z2M-8YDX/Lori
ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.
Founded in 1964, the American Society of Clinical Oncology, Inc. (the Society) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO® represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality and equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. Conquer Cancer, the ASCO Foundation, supports the Society by funding groundbreaking research and education across cancer’s full continuum. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, Instagram, and YouTube.