NEW YORK (Reuters Health) – Survival is significantly greater with cisplatin and optimal radiation compared to radiation treatment alone for women with FIGO (International Federation of Gynecology and Obstetrics) stage IIIB squamous cell carcinoma of the uterine cervix, researchers in India say.
“Cervical cancer is one of the common cancers in women in the developing world, Dr. Umesh Mahantshetty of Homi Bhabha National Institute in Mumbai told Reuters Health by email. “In addition, the majority of the cancers are diagnosed in advanced stages.”
“Advanced stages are associated with anemia, cachexia and malnutrition,” he added. “These factors interfere with the radiation treatment, resulting in poor compliance and outcome.”
“Several clinical studies conducted in 1990s showed a significant improvement in outcomes, including survival, with the use of chemotherapy along with radiation for cervical cancers,” he noted. “However, the benefit of concurrent chemotherapy with adequate radiation in women with FIGO Stage IIIB squamous cell cervical cancer was not conclusively proven.”
To investigate, Dr. Mahantshetty and colleagues conducted a phase 3, open-label, randomized clinical trial of 850 women (mean age, 49) in Mumbai. All had been diagnosed with FIGO stage IIIB squamous cell carcinoma of the uterine cervix. Participants received either concurrent cisplatin chemotherapy and radiation (CT-RT) or radiation (RT) alone.
As reported online February 8 in JAMA Oncology, at a median follow-up of seven years, 222 recurrences and 213 deaths occurred in the CT-RT arm compared with 252 recurrences and 243 deaths in the RT arm.
Five-year disease-free survival was significantly higher in the CT-RT arm versus the RT arm (52.3% vs. 43.8%), with a hazard ratio for relapse or death of 0.81. Similarly, five-year overall survival was significantly higher in the CT-RT arm (54.0%) than in the RT arm (46.0%), with a hazard ratio for death of 0.82.
After adjustment for various covariates, including age, tumor size, RT doses and overall treatment time, CT-RT continued to be significantly better than RT for both disease-free and overall survival. However, there was a higher incidence of acute hematological adverse events in the CT-RT arm.
Dr. Mahantshetty said the study “conclusively proves that the outcome for women is significantly better (with) cisplatin-based chemo-radiation. It provides level I (quality) evidence from a single institution that answers a very pertinent question that is applicable across the world.”
“One may argue the necessity of this study to prove a forgone conclusion from various similar trials in cervical cancer,” he noted. “As mentioned earlier, many factors associated with more advanced disease not only interfere with compliance to treatment but also lead to higher toxicities, leading to compromised outcomes.”
“Our results should be taken as a benchmark for designing further studies to improve the outcome further,” he concluded.
Dr. Akila Viswanathan of Johns Hopkins Medicine in Baltimore, coauthor of a related editorial, told Reuters Health, “Though chemoradiation is already the standard of care for women with locally advanced (stages IB-IVA) cervical cancer in developed countries, physicians in resource-limited areas have questioned the value, particularly in patients with stage IIIB cervical cancer.”
“This randomized trial of patients with stage IIIB cervical cancer closes this discussion, proving that there is indeed a survival advantage to chemo-radiation over radiation alone,” she said by email.
“Global access to radiation is crucial to prevent unnecessary deaths from cervical cancer in women of all ages,” she stressed, “and should be a key priority for Ministries of Health around the world.”
SOURCES: http://bit.ly/2EQ71xn and http://bit.ly/2H200u4
JAMA Oncol 2018.
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