Treatment deintensification a ‘promising alternative’ for nasopharyngeal carcinoma
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Key takeaways:
- Researchers found nearly identical 3-year PFS data among the two cohorts.
- Grade 3 and 4 short-term toxic effects occurred less frequently among patients in the induction chemotherapy plus radiotherapy cohort.
Patients with locoregionally advanced nasopharyngeal carcinoma may benefit from radiotherapy alone, result from a randomized phase 3 study suggest.
Induction chemotherapy followed by radiotherapy showed noninferior PFS results compared with the current standard of chemoradiotherapy after induction chemotherapy, according to data published in JAMA Oncology.
Results from the study led researchers to conclude that induction chemotherapy plus radiotherapy is a worthwhile approach for this patient population.
“To our knowledge, this is the first noninferiority study that aimed to determine if [induction chemotherapy plus radiotherapy] is noninferior to [induction chemotherapy combined with concurrent chemoradiotherapy] for locoregionally advanced nasopharyngeal carcinoma,” Jinxuan Dai, MD, member of an affiliated hospital of Guilin Medical University, and colleagues wrote.
Dai and colleagues conducted a multicenter study from April 2015 to March 2018 at five Chinese hospitals to evaluate whether radiotherapy is inferior to chemoradiotherapy following induction chemotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.
The trial included 383 adults (74% men) with an untreated histologically confirmed nonkeratinizing tumor, a Karnofsky performance status score of at least 70, proper organ function and stage III to stage IVB nasopharyngeal cancer.
Researchers randomly assigned patients to receive three cycles of induction chemotherapy repeated every 21 days, plus either radiotherapy alone (n = 193) or 30 mg/m2 concomitant cisplatin each week with radiotherapy for 6 to 7 weeks (n = 190).
Three-year PFS served as the study’s primary endpoint, with a noninferiority margin of 10%. OS, locoregional failure-free survival, distant metastasis-free survival, response rate and treatment-related toxicities served as secondary endpoints.
At a median follow-up of 76 months (interquartile range, 70-89), researchers reported a 3-year PFS of 76.2% in the induction chemotherapy plus radiotherapy cohort and 76.8% for induction chemotherapy combined with concurrent chemoradiotherapy, for a difference of 0.6% (95% CI, 7.9% to 9.1%) among patients in the intention-to-treat population.
Researchers observed identical outcomes among patients in the per-protocol population.
Additionally, the incidence of short-term grade 3 and grade 4 treatment-related toxicities among patients in the induction chemotherapy plus radiotherapy cohort occurred less frequently than among those in the induction chemotherapy plus chemoradiotherapy cohort. Meanwhile, researchers observed no difference in late treatment-related toxicities.
Study limitations included data being assembled from endemic areas, making application to potentially nonendemic areas difficult. Additionally, researchers could not analyze other outcomes such as quality of life.
According to study investigators, this trial helped reassess the effect of concomitant chemotherapy because two-dimensional radiotherapy is no longer standard practice.
“This trial aimed to reevaluate the value of concomitant chemotherapy in the era of intensity-modulated radiotherapy era,” researchers wrote.
“The primary result confirmed that after triple-drug induction chemotherapy, omitting concomitant cisplatin during radiotherapy did not compromise clinical efficacy while reducing the toxic effect burden,” they added. “This approach offered a potentially promising alternative choice for treating locoregionally advanced nasopharyngeal carcinoma.”
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